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Reid L, Webster RK. Exploring the Relationship Between Medicine Related Beliefs and Side-Effect Experience Among White Oral Contraceptive Users in the UK. PERSPECTIVES ON SEXUAL AND REPRODUCTIVE HEALTH 2025. [PMID: 40420696 DOI: 10.1111/psrh.70012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/23/2023] [Revised: 03/17/2025] [Accepted: 05/15/2025] [Indexed: 05/28/2025]
Abstract
OBJECTIVES Side-effects are often central to the decision to discontinue oral contraceptives. However, many oral contraceptive side-effects may be the result of a psychological nocebo effect. In this preliminary study, we investigate whether correlates of nocebo effects are associated with oral contraceptive side-effect experience. DESIGN An exploratory online cross-sectional survey of 275 female, predominantly young, White respondents was conducted. Associations between psychological factors previously implicated in nocebo responses (beliefs about medicines, perceived sensitivity to medicines, side-effect expectations, medicine information seeking, anxiety and trust in medicines), and oral contraceptive side-effect experience were assessed using regression analyses. RESULTS Increased side-effect expectations, stronger beliefs that medicines cause harm and are overused, increased perceived sensitivity to medicines, and decreased trust in medicine development were associated with increased attribution of symptoms to the oral contraceptive. Higher side-effect attribution scores were also associated with discontinued oral contraceptive use. CONCLUSION These preliminary findings demonstrate a potential role that nocebo-related factors may have in impacting oral contraceptive side-effect experience. Importantly, these factors are amenable to psychological interventions which could be employed to reduce oral contraceptive side-effect experience and, as a result, unnecessary discontinuation. Future research must first assess such relationships using a prospective design to confirm the direction of the associations identified using more diverse samples of oral contraceptive users to increase the generalisability of findings.
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Affiliation(s)
- Lorna Reid
- Department of Psychology, University of Sheffield, ICOSS, Sheffield, UK
| | - Rebecca K Webster
- Department of Psychology, University of Sheffield, ICOSS, Sheffield, UK
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Lluch-Girbés E, Dueñas L, Struyf F, Camerone EM, Rossettini G. Negative expectations and related nocebo effects in shoulder pain: a perspective for clinicians and researchers. Pain Manag 2025; 15:93-104. [PMID: 39973297 PMCID: PMC11853614 DOI: 10.1080/17581869.2025.2467022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/17/2024] [Accepted: 02/11/2025] [Indexed: 02/21/2025] Open
Abstract
The nocebo effect, a phenomenon wherein negative expectations can worsen symptoms, is increasingly acknowledged within the context of musculoskeletal conditions. While experimental evidence has, to some extent, examined negative expectations in shoulder pain, their specific relationship with nocebo effects and their manifestation in clinical practice remains unexplored. In this perspective, clinicians and researchers are guided by first examining the psychobiology and neurophysiology underlying nocebo effects from a basic science standpoint, thereby equipping clinicians with a robust understanding of the phenomenon. What are considered the primary potential sources of nocebo effects in individuals with shoulder pain are then outlined - namely, diagnostic labels, diagnostic imaging and special tests, the medicalization of normality, and overtreatment. Practical clinical strategies are subsequently proposed to mitigate nocebo effects arising from these sources. Finally, the research implications for advancing the study of nocebo effects in people with shoulder pain are discussed. Overall, this perspective provides a comprehensive overview of the impact of negative expectations and associated nocebo effects on shoulder pain outcomes. By identifying potential sources of nocebo effects that may emerge in everyday clinical practice, guidance on mitigating related negative expectations in patients with shoulder pain is offered.
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Affiliation(s)
- Enrique Lluch-Girbés
- Physiotherapy in Motion, Multi-Speciality Research Group (PTinMOTION), Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain
- Pain in Motion International Research Group, Vrije Universiteit Brussel, Brussels, Belgium
| | - Lirios Dueñas
- Physiotherapy in Motion, Multi-Speciality Research Group (PTinMOTION), Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain
- Pain in Motion International Research Group, Vrije Universiteit Brussel, Brussels, Belgium
| | - Filip Struyf
- Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium
| | | | - Giacomo Rossettini
- School of Physiotherapy, University of Verona, Verona, Italy
- Department of Physiotherapy, Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Spain
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Wienand PE, Wilhelm M. Expectations versus reality: Two cross-sectional studies on expected and experienced discontinuation symptoms in current and former contraceptive pill users. WOMEN'S HEALTH (LONDON, ENGLAND) 2025; 21:17455057251338401. [PMID: 40402150 PMCID: PMC12099172 DOI: 10.1177/17455057251338401] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/15/2024] [Revised: 02/06/2025] [Accepted: 04/11/2025] [Indexed: 05/23/2025]
Abstract
BACKGROUND Discontinuation of the contraceptive pill is common, but little research has explored women's personal experiences with discontinuation symptoms and associated psychological factors. OBJECTIVES These studies provide initial cross-sectional data on symptoms associated with discontinuation of the contraceptive pill, focusing on both expected symptoms in current users and experienced symptoms in former users. We examined how psychological factors (e.g., beliefs about medicine, trait anxiety) relate to these symptoms. DESIGN Two parallel online questionnaires were administered: One with current and another with former contraceptive pill users (n = 642). METHODS We analyzed expected discontinuation symptoms in current users and experienced symptoms in former users. Multiple linear regressions assessed the relationships between psychological factors (beliefs about and sensitivity to medicine, trait anxiety, reason for usage, time since discontinuation) and discontinuation symptoms. RESULTS In current users, expected symptoms were associated with concerns about (b = 0.32, p < 0.001, 95% CI [0.35, 0.97], f2 = 0.10) and perceived necessity of (b = 0.24, p < 0.001, 95% CI [0.22, 0.86], f2 = 0.06) the contraceptive pill, perceived overuse of medication (b = 0.17, p = 0.013, 95% CI [0.13, 1.11], f2 = 0.03), and trait anxiety (b = 0.21, p = 0.003, 95% CI [0.06, 0.29], f2 = 0.05). Former users who indicated non-contraceptive reasons for using the contraceptive pill experienced more discontinuation symptoms (b = 1.68, p < 0.001, 95% CI [0.78, 2.59], f2 = 0.03). CONCLUSIONS These studies provide the first data on contraceptive pill discontinuation symptoms, showing that current users expect them, and former users experienced them. Psychological factors (e.g., trait anxiety) were linked to expected symptoms, suggesting nocebo-like mechanisms. Future research integrating nocebo theory (e.g., addressing negative expectations directly) could help empower women to make informed choices when discontinuing the contraceptive pill.
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Affiliation(s)
- Philine Elise Wienand
- Division of Clinical Psychology and Psychotherapy, Department of Psychology, Philipps-University of Marburg, Germany
| | - Marcel Wilhelm
- Division of Clinical Psychology and Psychotherapy, Department of Psychology, Philipps-University of Marburg, Germany
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Car E, Vandenplas Y, Lacosta TB, Simoens S, Huys I, Vulto AG, Barbier L. Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review. Pharmaceut Med 2024; 38:429-455. [PMID: 39612120 PMCID: PMC11625068 DOI: 10.1007/s40290-024-00541-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 09/26/2024] [Indexed: 11/30/2024]
Abstract
BACKGROUND In the context of biosimilar use and switching, a patient's negative perception of a biosimilar might trigger a nocebo effect, where negative expectations unrelated to its pharmacologic action may lead to worsened symptoms, resulting in less perceived therapeutic benefit or worsened adverse events. Considering the crucial role biosimilars have in reducing health care costs and expanding access to safe biologics globally, it is essential to develop and implement effective strategies to mitigate the possible occurrence of such nocebo effects. OBJECTIVE The aim of this systematic literature review was two-fold: (i) to review strategies that have been applied and/or tested for minimising the nocebo effect in clinical practice, within and outside the context of biosimilar switching, and (ii) to propose recommendations on useful mitigation strategies to minimise the occurrence of the nocebo effect in the context of biosimilar switching. METHODS Biomedical databases PubMed and Embase were screened up until the end of April 2023 with a search string consisting of the following search terms "nocebo", "biosimilar", "mitigation", "strategy", and "prevention" and related synonyms. The search strategy was supplemented by snowballing of the included studies. The quality of the studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses, the Scale for the Assessment of Narrative Review Articles, and the Mixed Methods Appraisal Tool. RESULTS Of the 1617 identified and screened records, 60 met the inclusion criteria. Among these, 10 (17%) were conducted within the context of biosimilar switching, 7 of which specifically tested strategies to mitigate the nocebo effect. Among the remaining 50 studies conducted outside the biosimilar switching context, 46 tested mitigation strategies. Across the included studies, 13 distinct mitigation strategies were identified, which can be employed within the context of biosimilar switching: (i) open non-verbal communication, (ii) positive framing, (iii) empathic communication, (iv) validating communication, (v) shared decision making, (vi) self-affirmation, (vii) education of patients and health care professionals about the nocebo effect, (viii) education of patients and health care professionals about biosimilars, (ix) soft-skills training for health care professionals, (x) personalised information, (xi) supporting information, (xii) multidisciplinary approach, (xiii) organisation of the switch. CONCLUSION This review has identified a set of strategies that have been tested to mitigate the nocebo effect, which can be applied by health care professionals in the context of biosimilar switching with the aim of mitigating the occurrence of a nocebo effect. We recommend implementing a combination of mitigation strategies for patients and health care professionals to utilise before, during, and after a switch. It should be noted that given the limited number of studies specifically testing nocebo mitigation strategies within the biosimilar switching context to date, it is not yet possible to draw definite conclusions about the effect size of each mitigation strategy individually or in combination.
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Affiliation(s)
- Elif Car
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
| | - Yannick Vandenplas
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
| | | | - Steven Simoens
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
| | - Isabelle Huys
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
| | - Arnold G Vulto
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
- Hospital Pharmacy, Erasmus MC, Rotterdam, The Netherlands.
| | - Liese Barbier
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
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Tang B, Livesey E, Colagiuri B. The downside to choice: instrumental control increases conditioned nocebo hyperalgesia. Pain 2024; 165:2257-2273. [PMID: 38709490 DOI: 10.1097/j.pain.0000000000003251] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/22/2023] [Accepted: 03/12/2024] [Indexed: 05/07/2024]
Abstract
ABSTRACT Nocebo hyperalgesia is a pervasive problem in which the treatment context triggers negative expectations that exacerbate pain. Thus, developing ethical strategies to mitigate nocebo hyperalgesia is crucial. Emerging research suggests that choice has the capacity to reduce nocebo side effects, but choice effects on nocebo hyperalgesia have not been explored. This study investigated the impact of choice on conditioned nocebo hyperalgesia using a well-established electrocutaneous pain paradigm where increases in noxious stimulation were surreptitiously paired with the activation of a sham device. In study 1, healthy volunteers (N = 104) were randomised to choice over (nocebo) treatment administration, nocebo administration without choice, or a natural history control group. Nocebo hyperalgesia was greater for those with choice than no choice, suggesting that choice increased rather than diminished nocebo hyperalgesia. Study 2 tested whether providing positive information about the benefits of choice in coping with pain could counteract heightened nocebo hyperalgesia caused by choice. A different sample of healthy adults (N = 137) were randomised to receive nocebo treatment with choice and positive choice information, choice only, or no choice. The positive choice information failed to attenuate the effect of choice on nocebo hyperalgesia. The current results suggest that, rather than decreasing nocebo hyperalgesia, treatment choice may exacerbate pain outcomes when a painful procedure is repeatedly administered. As such, using choice as a strategy to mitigate nocebo outcomes should be treated with caution.
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Affiliation(s)
- Biya Tang
- School of Psychology, The University of Sydney, Sydney, Australia
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Ausi Y, Yunivita V, Santoso P, Sunjaya DK, Barliana MI, Ruslami R. A Mixed-Method Study of Medication-Related Burden Among Multi-Drug Resistant Tuberculosis Patients in West Java, Indonesia. CLINICOECONOMICS AND OUTCOMES RESEARCH 2024; 16:707-719. [PMID: 39345348 PMCID: PMC11438463 DOI: 10.2147/ceor.s473768] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/15/2024] [Accepted: 09/11/2024] [Indexed: 10/01/2024] Open
Abstract
Background Multidrug-resistant tuberculosis presents a challenging obstacle in global TB control. It necessitates complex and long-term therapy, which can potentially lead to medication-related burdens that may ultimately reduce therapy adherence and quality of life. Purpose This study aimed to gain a deep understanding of the medication-related burdens experienced by multidrug-resistant tuberculosis patients. Methods The study was conducted using a convergent mixed-method approach involving MDR-TB patients and their caregivers. Qualitative data were collected through semi-structured in-depth interviews, while quantitative data were gathered using the validated Living with Medicine Questionnaire 3. In the quantitative part, associations between patients' characteristics and burden levels were analysed using bivariate and multivariate analyses. Results Seventy-four participants were involved in the study, with 71 of them completing the questionnaire and 36 participating in interviews. The qualitative results revealed the subjectivity of medication-related burden perception, which could not be fully captured by the quantitative method. Four themes of medication-related burdens emerged: personal beliefs, regimen burdens, socioeconomic burdens, and healthcare burdens. The quantitative results provided a generalized representation of the population. Age and side effects were found to be significantly associated with higher burden levels, with those aged 18-30 having an odds ratio (OR) of 7.303 (95% CI: 1.045-51.034), and those aged 31-40 having an OR of 6.53 (95% CI: 1.077-39.607). Additionally, experiencing side effects had a substantial impact, with an OR of 46.602 (95% CI: 2.825-768.894). Both sets of results are valuable for designing patient-centered care. Conclusion MDR-TB therapy imposes a significant burden, particularly regarding the characteristics of regimen. By understanding this burden, healthcare professionals can help improve the quality of life for these patients.
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Affiliation(s)
- Yudisia Ausi
- Department of Biological Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
| | - Vycke Yunivita
- Division of Pharmacology and Therapy, Department of Biomedical Sciences, Faculty of Medicine, Universitas Padjadjaran, Bandung, West Java, Indonesia
| | - Prayudi Santoso
- Division of Pulmonary and Critical Care, Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran, Bandung, West Java, Indonesia
- Hasan Sadikin General Hospital, Bandung, West Java, Indonesia
| | - Deni Kurniadi Sunjaya
- Department of Public Health, Faculty of Medicine, Universitas Padjadjaran, Bandung, West Java, Indonesia
| | - Melisa Intan Barliana
- Department of Biological Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia
- Center of Excellence for Pharmaceutical Care Innovation, Universitas Padjadjaran, Bandung, West Java, Indonesia
| | - Rovina Ruslami
- Division of Pharmacology and Therapy, Department of Biomedical Sciences, Faculty of Medicine, Universitas Padjadjaran, Bandung, West Java, Indonesia
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7
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Răducan-Florea IV, Leaşu FG, Dinu EA, Rogozea LM. The Nocebo Effect: A Bias in Clinical Practice-An Ethical Approach. Am J Ther 2024; 31:e541-e549. [PMID: 38557480 DOI: 10.1097/mjt.0000000000001730] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/04/2024]
Abstract
BACKGROUND The nocebo effect is often disregarded in medical practice and is certainly much less known than the placebo effect, although, in reality, both can influence therapeutic decision making and the quality of life of patients. However, the nocebo effect raises a number of issues not only of a practical nature related to clinical activity but also ethical dilemmas related to the observance of the patient's autonomy, nonmaleficence, or informed consent and the information on which it is based. AREAS OF UNCERTAINTY The ethical dilemmas raised by the nocebo effect revolve around how informed consent can be achieved, the accuracy and volume of information that is transmitted to the patient, and how to report negative side effects of therapeutic treatment. DATA SOURCES In September 2023, a narrative analysis of the literature was conducted using a combination of keywords such as nocebo, placebo, ethics, therapeutic relationship from PubMed, Scopus, Google Scholar, and so on, as well as from official documents developed at an international level (World Health Organization), for a period of 10 years (2012-2021). RESULTS Analyzing the articles that remarked upon the significant impact of ethics in nocebo research or in the therapeutic relationship, we can state that the existence of several relevant issues of interest have been detected regarding the ethical use of nocebo and its impact in research or in clinics and thus the need for proper knowledge and management of the impact of nocebo effects. The ethical paradox of obtaining informed consent with the 2 goals, first, the need for complete information and second, the preservation of the autonomy of the patient, respectively, that of "primum non-nocere" and of avoiding unnecessary harm by revealing probable adverse effects is a point of interest for numerous studies. The potential for a nocebo effect is present when we inform patients about the risks and benefits of treatment, there being a clear link between the moral and ethical duty to inform patients and the need to avoid situations that increase the nocebo impact on how the disease or the adverse effects of the treatment are perceived. Adapting information about the side effects of medicines should focus on ensuring a balance between transparency and caution, especially in patients with a high potential for nocebo effect. CONCLUSIONS The nocebo effect had for a long time been unknown or denied, although it can interfere with the results of the treatment used. As the nocebo phenomenon becomes increasingly known in medical practice, the clinical and ethical implications are identified by medical staff, and nocebo's adverse responses are no longer ignored.
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Affiliation(s)
| | - Florin G Leaşu
- Basic, Preventive and Clinical Sciences Department, Transilvania University, Brasov, Romania
| | - Eleonora A Dinu
- Basic, Preventive and Clinical Sciences Department, Transilvania University, Brasov, Romania
| | - Liliana M Rogozea
- Basic, Preventive and Clinical Sciences Department, Transilvania University, Brasov, Romania
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Skvortsova A, Meeuwis SH, Derksen S, Kerkkänen K, Sutter E, Evers AWM, Veldhuijzen DS. The role of self-reported and physiological stress in nocebo hyperalgesia. Biol Psychol 2024; 190:108818. [PMID: 38762001 DOI: 10.1016/j.biopsycho.2024.108818] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/12/2023] [Revised: 05/03/2024] [Accepted: 05/14/2024] [Indexed: 05/20/2024]
Abstract
Negative expectations can increase pain sensitivity, leading to nocebo hyperalgesia. However, the physiological and psychological factors that predispose individuals to this phenomenon are still not well understood. The present study examined whether stress induced by a social stressor affects nocebo hyperalgesia, and whether this effect is mediated by self-reported and physiological stress responses. We recruited 52 healthy participants (15 men) who were randomly assigned to either the Trier Social Stress Test (TSST) or a control condition (a friendly version of the TSST). Nocebo hyperalgesia was induced using negative suggestions combined with a validated pain conditioning paradigm. We assessed self-reported (anxiety and stress) and physiological (cortisol, alpha-amylase, heart rate, and skin conductance) responses to stress. Both groups exhibited significant nocebo hyperalgesia. The stress group showed higher levels of anxiety, self-reported stress, and cortisol levels compared to the control group while no significant differences were found in other physiological markers. The stress and control groups did not differ in the magnitude of nocebo hyperalgesia, but anxiety levels partially mediated the effects of the stress test on nocebo hyperalgesia. Our findings suggest that an external social stressor does not directly affect nocebo hyperalgesia, but that increased anxiety due to the stressor enhances its magnitude. Thus, it may be worthwhile to investigate whether reducing stress-related anxiety in clinical settings would help alleviate nocebo effects.
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Affiliation(s)
- A Skvortsova
- Health, Medical and Neuropsychology unit, Faculty of Social and Behavioural Sciences, Leiden University, the Netherlands.
| | - S H Meeuwis
- Health, Medical and Neuropsychology unit, Faculty of Social and Behavioural Sciences, Leiden University, the Netherlands.
| | - S Derksen
- Health, Medical and Neuropsychology unit, Faculty of Social and Behavioural Sciences, Leiden University, the Netherlands.
| | - K Kerkkänen
- Health, Medical and Neuropsychology unit, Faculty of Social and Behavioural Sciences, Leiden University, the Netherlands.
| | - E Sutter
- Health, Medical and Neuropsychology unit, Faculty of Social and Behavioural Sciences, Leiden University, the Netherlands.
| | - A W M Evers
- Health, Medical and Neuropsychology unit, Faculty of Social and Behavioural Sciences, Leiden University, the Netherlands; Department of Psychiatry, Leiden University Medical Center, Leiden, the Netherlands; Medical Delta, Leiden University, Technical University Delft and Erasmus University, the Netherlands.
| | - D S Veldhuijzen
- Health, Medical and Neuropsychology unit, Faculty of Social and Behavioural Sciences, Leiden University, the Netherlands.
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Nasiri-Dehsorkhi H, Vaziri S, Esmaillzadeh A, Adibi P. Negative expectations (nocebo phenomenon) in clinical interventions: A scoping review. JOURNAL OF EDUCATION AND HEALTH PROMOTION 2024; 13:106. [PMID: 38726093 PMCID: PMC11081451 DOI: 10.4103/jehp.jehp_269_23] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 02/26/2023] [Accepted: 05/06/2023] [Indexed: 05/12/2024]
Abstract
Unpredictable, undesirable, and confusing reactions in the face of psychological or medical interventions make the clinical presentation more complicated and may represent clinically unexplained symptoms and also disturbed the doctor-patients relationship and decrease patients' benefits of treatment. It seems that negative expectations from the treatment (nocebo phenomenon) can explain such reactions. The aim of the current study is a scoping review and investigate different aspects of the nocebo phenomenon (negative expectations) in clinical interventions. This paper follows a scoping review of the existence, importance, and multidimensions of the nocebo phenomenon in medical and psychological interventions. Data sources include literature databases (ProQuest, PubMed, Google Scholar, and Scopus) reviewed from inception dates to 2023, and the terms negative expectations, nocebo effect, placebo effect, negative placebo, and clinical interventions were searched. The review of the available articles showed that negative expectations play an important role in the process and effectiveness of clinical interventions. Negative expectations (here named nocebo effect) can significantly interfere with rapport and treatment processes. Some underlying components of the nocebo effect include negative expectancies, conditioning, social learning, memory, cognitive distortions, meaning, motivation, somatic focus, negative reinforcements, personality, anxiety, and neurophysiological factors such as CCK, dopamine, and cortisol are proposed for development and presence of nocebo phenomenon in clinical practice. Negative expectations with its biopsychosocial aspects play an important and amazing role in disorganizing medical and psychological interventions. Using appropriate methods to reduce nocebo effects in therapeutic interventions may increase treatment compliance and adherence and increase the effectiveness of interventions.
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Affiliation(s)
- Hamid Nasiri-Dehsorkhi
- Department of Clinical Psychology, Roudehen Branch, Islamic Azad University, Roudehen, Iran
- Isfahan Gastroenterology and Hepatology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Shahram Vaziri
- Department of Clinical Psychology, Roudehen Branch, Islamic Azad University, Roudehen, Iran
| | - Ahmad Esmaillzadeh
- Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
| | - Peyman Adibi
- Isfahan Gastroenterology and Hepatology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
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Materia FT, Smyth JM. Acceptability and concerns about innovative wearable health sensors in persons with and without chronic disease diagnosis. Internet Interv 2024; 35:100702. [PMID: 38221944 PMCID: PMC10787257 DOI: 10.1016/j.invent.2023.100702] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/18/2023] [Revised: 11/19/2023] [Accepted: 12/17/2023] [Indexed: 01/16/2024] Open
Abstract
Advances in biomedical engineering continue to produce innovative wearable health sensors capable of real-time ambulatory assessments (e.g., of physiology, the environment), holding great potential for advancing precision monitoring and interventions through the integration of such devices and data into eHealth systems. As with any novel device, however, user views on acceptability and concerns about the technology must be evaluated to facilitate widespread implementation and user adoption of such devices. One factor that may strongly influence user views is the potential relevance to, and need for, self-care for chronic disease management. We examined if acceptability and concerns regarding innovative wearable devices differed between individuals living with or without chronic disease. A U.S. adult sample (N = 448; 20-70 yrs.; 34 % Female; 60 % White, 35 % Hispanic) completed a web-based survey regarding their thoughts/opinions related to innovative wearable sensors. Two-thirds (67 %, N = 298) reported at least one chronic disease; one-third (33 %, N = 150) reported no chronic health conditions. Participants viewed learning modules about two innovative devices: a watch to detect environmental gases for respiratory health, and a chest-patch monitoring real-time ECG. For each device, participants rated acceptability across multiple dimensions, and then rated potential concerns (including general concerns and specific worries about negative health impacts). Respondents with and without chronic disease differed in education, race, and ethnicity. Controlling for these differences, individuals with chronic disease reported significantly higher acceptability for the watch and for the chest-patch. Healthy participants reported significantly higher general concerns about technology. However, when concern questions were asked specifically about the potential negative impacts of the two study devices on physical health and well-being, participants with chronic disease reported significantly higher concerns. Overall, results show that living with chronic disease influences acceptability and concerns associated with adoption of innovative sensors. These findings suggest it is essential to take potential users' health status into account when studying the design and implementation of innovative wearable sensors. Dissemination strategies may benefit from emphasizing the beneficial features of these devices, addressing hesitations, and customizing implementation approaches by user group.
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Affiliation(s)
- Frank T. Materia
- Departments of Otolaryngology and Population Health, University of Kansas Medical Center, Kansas City, KS, United States of America
| | - Joshua M. Smyth
- Department of Psychology, The Ohio State University, Columbus, OH, United States of America
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11
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Żegleń M, Kryst Ł, Bąbel P. Want to be fit? Start with your mind! The role of the placebo effect in physical fitness in children: a preliminary systematic review and meta-analysis. Int J Obes (Lond) 2024; 48:177-187. [PMID: 38081926 PMCID: PMC10824660 DOI: 10.1038/s41366-023-01413-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/07/2023] [Revised: 10/26/2023] [Accepted: 11/06/2023] [Indexed: 01/31/2024]
Abstract
Physical activity is crucial to prevent and reduce excess body mass. The placebo effect can influence the outcomes of fitness-related interventions; however, this topic has not yet been extensively investigated in children. Summarising the data on placebo effects in fitness-related interventions is essential to understand this problem better. A systematic review of PubMed, Cochrane, PsycINFO, PsycARTICLES, TripDatabase and Embase was carried out. A meta-analysis of the results of studies with comparable research plans was performed. There were significant differences, favouring the placebo intervention. At the final follow-up, the children in placebo groups had higher maximal heart rates, shorter recovery times, longer ergometry phases, running time and lower peak and average perceived exertion than the control. The placebo effect is present in fitness-related parameters in children, regardless of the Body Mass Index status. It is crucial, as for youth with excess body mass, it is difficult to be active, especially to show appropriate levels of motivation and involvement. Importantly, the benefits of the placebo were the strongest in the motivation/ engagement-related parameters and self-assessed exertion. Notably, the nocebo effect was not observed, which is advantageous when considering placebo interventions in practice.
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Affiliation(s)
- Magdalena Żegleń
- Jagiellonian University, Institute of Psychology, Pain Research Group, Kraków, Poland.
| | - Łukasz Kryst
- University of Physical Education in Kraków, Faculty of Physical Education and Sport, Department of Anthropology, Kraków, Poland
| | - Przemysław Bąbel
- Jagiellonian University, Institute of Psychology, Pain Research Group, Kraków, Poland
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12
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Gioia C, Picchianti Diamanti A, Perricone R, Chimenti MS, Afeltra A, Navarini L, Migliore A, Massafra U, Bruzzese V, Scolieri P, Meschini C, Paroli M, Caccavale R, Scapato P, Scrivo R, Conti F, Laganà B, Di Franco M. Anti-tumor necrosis factor α: originators versus biosimilars, comparison in clinical response assessment in a multicenter cohort of patients with inflammatory arthropathies. Reumatismo 2023; 75. [PMID: 38115772 DOI: 10.4081/reumatismo.2023.1602] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/16/2023] [Accepted: 09/25/2023] [Indexed: 12/21/2023] Open
Abstract
OBJECTIVE To compare etanercept and adalimumab biosimilars (SB4 and ABP501) and respective bioriginators in terms of safety and efficacy in a real-life contest. METHODS We consequently enrolled patients affected by rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, treated with SB4, and ABP501, or with corresponding originators, belonging to the main biological prescribing centers in the Lazio region (Italy), from 2017 to 2020. Data were collected at recruitment and after 4, 8, 12, and 24 months of therapy. RESULTS The multicenter cohort was composed by 455 patients treated with biosimilars [SB4/ABP501 276/179; female/male 307/146; biologic disease-modifying anti-rheumatic drug (b-DMARD) naïve 56%, median age/ interquartile range 55/46-65 years] and 436 treated with originators (etanercept/adalimumab 186/259, female/ male 279/157, b-DMARD naïve 67,2%, median age/interquartile range 53/43-62 years). No differences were found about safety, but the biosimilar group presented more discontinuations due to inefficacy (p<0.001). Female gender, being a smoker, and being b-DMARD naïve were predictive factors of reduced drug survival (p=0.05, p=0.046, p=0.001 respectively). The retention rate at 24 months was 81.1% for bioriginators and 76.5% for biosimilars (median retention time of 20.7 and 18.9 months, respectively) (p=0.002). Patients with remission/low disease activity achievement at 4 months showed a cumulative survival of 90% to biosimilar therapy until 24 months (p=0.001); early adverse reactions instead represented a cause of subsequent drug discontinuation (p=0.001). CONCLUSIONS Real-life data demonstrated a similar safety profile between biosimilars and originators, but a reduced biosimilar retention rate at 24 months. Biosimilars could be considered a valid, safe, and less expensive alternative to originators, allowing access to treatments for a wider patient population.
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Affiliation(s)
- C Gioia
- Division of Rheumatology, Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University, Rome.
| | - A Picchianti Diamanti
- Rheumatology, Clinical and Molecular Medicine, Sapienza University, Sant'Andrea University Hospital, Rome.
| | - R Perricone
- Rheumatology, Allergology and Clinical Immunology, Department of Systems Medicine, Tor Vergata University, Rome.
| | - M S Chimenti
- Rheumatology, Allergology and Clinical Immunology, Department of Systems Medicine, Tor Vergata University, Rome.
| | - A Afeltra
- Allergology, Clinical Immunology and Rheumatology, Bio-Medical Campus, University of Rome.
| | - L Navarini
- Allergology, Clinical Immunology and Rheumatology, Bio-Medical Campus, University of Rome.
| | - A Migliore
- San Pietro Fatebenefratelli Hospital, Rome.
| | - U Massafra
- San Pietro Fatebenefratelli Hospital, Rome.
| | - V Bruzzese
- Department of Internal Medicine, Rheumatology and Gastroenterology, Nuovo Regina Margherita Hospital, Rome.
| | - P Scolieri
- Department of Internal Medicine, Rheumatology and Gastroenterology, Nuovo Regina Margherita Hospital, Rome.
| | - C Meschini
- General Medicine, Belcolle Hospital, Viterbo.
| | - M Paroli
- Department of Medical-Surgical Sciences and Biotechnology, Polo Pontino, Sapienza University, Latina.
| | - R Caccavale
- Department of Medical-Surgical Sciences and Biotechnology, Polo Pontino, Sapienza University, Latina.
| | - P Scapato
- Rheumatology, Department of Medicine, S. Camillo de Lellis Hospital, Rieti.
| | - R Scrivo
- Division of Rheumatology, Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University, Rome.
| | - F Conti
- Division of Rheumatology, Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University, Rome.
| | - B Laganà
- Rheumatology, Clinical and Molecular Medicine, Sapienza University, Sant'Andrea University Hospital, Rome.
| | - M Di Franco
- Division of Rheumatology, Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University, Rome.
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13
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MacKrill K, Witthöft M, Wessely S, Petrie KJ. Health Scares: Tracing Their Nature, Growth and Spread. CLINICAL PSYCHOLOGY IN EUROPE 2023; 5:e12209. [PMID: 38357430 PMCID: PMC10863677 DOI: 10.32872/cpe.12209] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/19/2023] [Accepted: 10/18/2023] [Indexed: 02/16/2024] Open
Abstract
Background Health scares are highly publicised threats to health that increase public concern and protective behaviours but are later shown to be unfounded. Although health scares have become more common in recent times, they have received very little research attention. This is despite the fact that health scares often have negative outcomes for individuals and community by affecting health behaviours and causing high levels of often unnecessary anxiety. Method In this paper we undertook a review and analysis of the major types of health scares as well as the background factors associated with health scares and their spread. Results We found most health scares fell into seven main categories; environmental contaminants, food, malicious incidents, medical treatments, public health interventions, radiation from technology and exotic diseases. For most health scares there are important background factors and incident characteristics that affect how they develop. Background factors include conspiracy theories, trust in governmental agencies, anxiety, modern health worries and wariness of chemicals. Incident characteristic include being newly developed, not understood or unseen, man-made rather than natural and whether the incident is out of personal control. We also identified the aspects of traditional and social media that exacerbate the rapid spread of health scares. Conclusion More research is needed to identify the characteristics of media stories that intensify the levels of public concern. Guidelines around the media's reporting of health incidents and potential health threats may be necessary in order to reduce levels of public anxiety and the negative public health impact of health scares.
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Affiliation(s)
- Kate MacKrill
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Michael Witthöft
- Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg University of Mainz, Mainz, Germany
| | - Simon Wessely
- Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, United Kingdom
| | - Keith J. Petrie
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
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14
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Nasiri-Dehsorkhi H, Vaziri S, Esmaillzadeh A, Adibi P. Psychological distress, perceived stress and nocebo effect (multifood adverse reaction) in irritable bowel syndrome patients. JOURNAL OF EDUCATION AND HEALTH PROMOTION 2023; 12:257. [PMID: 37727431 PMCID: PMC10506782 DOI: 10.4103/jehp.jehp_221_23] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 02/18/2023] [Accepted: 04/03/2023] [Indexed: 09/21/2023]
Abstract
BACKGROUND Psychological distress and perceived stress may complicate the clinical presentation, course, and treatment of patients with functional gastrointestinal disorders. The correlation between psychological distress, perceived stress, and the nocebo effect (multifood adverse reaction) in patients with irritable bowel syndrome (IBS) was the main aim of the present study. MATERIALS AND METHODS In this cross-sectional correlation study, data on 4,763 Iranian adults, 748 of whom by purposive sampling were patients with IBS (65.1% female), working in 50 different health centers affiliated to the Isfahan University of Medical Sciences across Isfahan province were examined. For assessing dietary intake, a 106-item self-administered Dish-based Semi-Quantitative Food Frequency Questionnaire that was specifically designed and validated for Iranian adults was used. General Heath Questionnaire 12 and Stressful Life event Questionnaire were used to assess psychological distress and perceived stress. By using a modified Persian version of the Rome III questionnaire, IBS was assessed. Based on researcher-made definition of nocebo effect (multiitem food intolerance), 164 people had the nocebo phenomenon in IBS group. RESULTS Age, sex, education, marital status, antidepressant use, and specifically chronic underlying disease (odds ratio [OR]: 3.54, 95% confidence interval [CI]: 1.73-7.23) of general characteristics had a significant correlation (P <.05) with presenting nocebo responses in IBS patients. Psychological distress (OR: 1.415; 95% CI: 0.992-2.020; P = 0.056) had a significant correlation with nocebo effect and did not find significant correlation with perceived stress (OR: 0.999; 95% CI: 0.990-1.008; P = 0.865). Data were analyzed by Chi-square test, analysis of variance, and OR. CONCLUSION The present study showed that psychological distress with chronic underlying disease and antidepressant use are important elements in presenting multifood adverse reactions that we named here as the nocebo effect in IBS patients. Reducing psychological distress and managing chronic underlying diseases appear to be an effective factor in reducing the nocebo phenomenon in IBS patients. For managing the nocebo responses in IBS patients, these findings may help clinicians to improve their interventions. Further studies are required to confirm these findings.
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Affiliation(s)
- Hamid Nasiri-Dehsorkhi
- Department of Clinical Psychology, Roudehen Branch, Islamic Azad University, Roudehen, Iran
- Isfahan Gastroenterology and Hepatology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Shahram Vaziri
- Department of Clinical Psychology, Roudehen Branch, Islamic Azad University, Roudehen, Iran
| | - Ahmad Esmaillzadeh
- Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
| | - Peyman Adibi
- Isfahan Gastroenterology and Hepatology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
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15
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Follow-Up of Side Effects throughout the Entire Course of Coronavirus Vaccination. Vaccines (Basel) 2023; 11:vaccines11030704. [PMID: 36992288 DOI: 10.3390/vaccines11030704] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2023] [Revised: 03/10/2023] [Accepted: 03/12/2023] [Indexed: 03/22/2023] Open
Abstract
Vaccines are considered the best protective means against coronavirus infection. There is increasing interest in reporting the side effects of vaccines, especially for individuals younger than 18 years old. Accordingly, this analytical cohort study aims to report on the side effects of adult and young individuals who received vaccination within 24 h, 72 h, 5 days, and 1 week through the entire course of vaccination (ECoV). A validated online survey was used to collect information. In total, 1069 individuals were completely followed. Most individuals received the Pfizer vaccine (59.6%). Most individuals had received two doses (69.4%). Very strong and statistically significant associations with side effects (p < 0.05, Phi (Φ) > 0.25) throughout the ECoV were reported for the type of vaccine and female gender. Non-smokers reported weak statistically significant associations. Fatigue and localized pain were the most commonly reported side effect, with onset within 24 h and duration of less than 72 h. The prevalence of reported side effects was statistically significantly higher among young individuals (<18 years old) than among adults (X2 (1) =7.6, p = 0.006. Phi φ = 0.11).
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16
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Quinn V, Pearson S, Huynh A, Nicholls K, Barnes K, Faasse K. The influence of video-based social modelling on the nocebo effect. J Psychosom Res 2023; 165:111136. [PMID: 36610337 DOI: 10.1016/j.jpsychores.2022.111136] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/24/2022] [Revised: 12/22/2022] [Accepted: 12/22/2022] [Indexed: 12/25/2022]
Abstract
OBJECTIVE Seeing someone else experience side effects (i.e., social modelling) can increase negative expectations and subsequent nocebo effects. In face-to-face contexts, this effect appears stronger in female participants. Less is known about the influence of gender on negative expectations and nocebo effects generated via video-based social modelling. METHODS One hundred and seven undergraduate participants recruited from a participant pool at an Australian university took part in a study ostensibly investigating the influence of beta-blocker medications (actually a sham treatment) on physiological and psychological aspects of anxiety. Participants were randomly assigned to either a no-treatment control group, a standard treatment group, or a video modelling group, in which participants viewed video-recorded confederates (one male, one female) report experiencing four side effects (two each) after taking the study treatment. Symptoms were assessed 15-min following pill ingestion, and at follow-up 24 h later. RESULTS Video modelling of side effects, compared to standard treatment, interacted with gender and was associated with increased reporting of modelled symptoms in female compared to male participants, p = .01, ηp2=0.06. Video modelling also increased negative expectations in female compared to male participants, p = .03, ηp2=0.07, and expectations mediated the influence of modelling on modelled symptoms in female participants. CONCLUSIONS Social modelling of side effects via video increased negative expectations, and nocebo symptoms, to a greater extent in female participants. These findings suggest that males and females are differentially impacted by video-based side effect modelling. Results have implications for social modelling of side effects via social media and patient-support websites.
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Affiliation(s)
- Veronica Quinn
- Department of Psychology, Macquarie University, Australia
| | - Sarah Pearson
- School of Psychology, University of New South Wales, Australia
| | - Anna Huynh
- School of Psychology, University of New South Wales, Australia
| | - Kate Nicholls
- School of Psychology, University of New South Wales, Australia
| | - Kirsten Barnes
- School of Psychology, University of New South Wales, Australia
| | - Kate Faasse
- School of Psychology, University of New South Wales, Australia.
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17
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Really just a little prick? A meta-analysis on adverse events in placebo control groups of seasonal influenza vaccination RCTs. Vaccine 2023; 41:294-303. [PMID: 36464541 DOI: 10.1016/j.vaccine.2022.11.033] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/06/2021] [Accepted: 11/15/2022] [Indexed: 12/04/2022]
Abstract
BACKGROUND The Corona pandemic and ongoing mass vaccinations raise the question of the nocebo mechanisms involved. Since immunization is usually administered to healthy people as a preventive health measure, adverse events (AE) following immunization are less accepted and could contribute to vaccine hesitancy. Assuming that vaccinees experience nocebo responses, the aim of this meta-analysis was to investigate the effect sizes of solicited adverse events (or assumed reactogenicity) reported in placebo groups in RCTs on seasonal influenza vaccination. METHODS Literature search via PubMed, Web of Science, and CENTRAL was conducted considering gray literature. Only RCTs with placebo groups using pharmacologically inert substances (like saline) were included. Quality was assessed using Cochrane Collaboration's Risk of Bias Tool. Effect sizes were estimated using a random mixed effects model based on k = 31 studies covering 14,326 participants in placebo groups. RESULTS Reported solicited AEs in placebo groups showed significant effect sizes of proportions (ESp). In k = 13 analyzed placebo groups, 35 % of the participants reported at least one solicited systemic AE (p = 0.007). The most common particular solicited systemic AEs were headache (k = 27; 17 %; p = 0.001), malaise (k = 13; 12 %; p = 0.004), and hyperhidrosis (k = 4; 12 %; p < 0.001) within one week after vaccination. CONCLUSION The results show significant solicited AEs in placebo groups, indicating substantial nocebo responses after vaccination. Based on the fact that most vaccination programs include similar groups of healthy people, we expect that comparable nocebo effects occur during other campaigns. Health care professionals should be aware of the nocebo response and take action to prevent or decrease the burden of adverse events following immunization. Fear of side effects must be addressed early in order to diminish vaccine hesitancy. Prospero identifier: CRD42020156287, October 2019.
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18
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Smith LE, Sim J, Sherman SM, Amlôt R, Cutts M, Dasch H, Sevdalis N, Rubin GJ. Psychological factors associated with reporting side effects following COVID-19 vaccination: A prospective cohort study (CoVAccS - Wave 3). J Psychosom Res 2023; 164:111104. [PMID: 36495757 PMCID: PMC9708101 DOI: 10.1016/j.jpsychores.2022.111104] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2022] [Revised: 11/24/2022] [Accepted: 11/26/2022] [Indexed: 12/03/2022]
Abstract
OBJECTIVE To investigate symptom reporting following the first and second COVID-19 vaccine doses, attribution of symptoms to the vaccine, and factors associated with symptom reporting. METHODS Prospective cohort study (T1: 13-15 January 2021, T2: 4-15 October 2021). Participants were aged 18 years or older, living in the UK. Personal, clinical, and psychological factors were investigated at T1. Symptoms were reported at T2. We used logistic regression analyses to investigate associations. RESULTS After the first COVID-19 vaccine dose, 74.1% (95% CI 71.4% to 76.7%, n = 762/1028) of participants reported at least one injection-site symptom, while 65.0% (95% CI 62.0% to 67.9%, n = 669/1029) reported at least one other (non-injection-site) symptom. Symptom reporting was associated with being a woman and younger. After the second dose, 52.9% (95% CI 49.8% to 56.0%, n = 532/1005) of participants reported at least one injection-site symptom and 43.7% (95% CI 40.7% to 46.8%, n = 440/1006) reported at least one other (non-injection-site) symptom. Symptom reporting was associated with having reported symptoms after the first dose, having an illness that put one at higher risk of COVID-19 (non-injection-site symptoms only), and not believing that one had enough information about COVID-19 to make an informed decision about vaccination (injection-site symptoms only). CONCLUSIONS Women and younger people were more likely to report symptoms from vaccination. People who had reported symptoms from previous doses were also more likely to report symptoms subsequently, although symptom reporting following the second vaccine was lower than following the first vaccine. Few psychological factors were associated with symptom reporting.
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Affiliation(s)
- Louise E Smith
- Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, Weston Education Centre, King's College London, London SE5 9RJ, UK; NIHR Health Protection Research Unit in Emergency Preparedness and Response, Weston Education Centre, King's College London, London SE5 9RJ, UK.
| | - Julius Sim
- School of Medicine, David Weatherall Building, University Road, Keele University, Staffordshire, ST5 5BG, UK
| | - Susan M Sherman
- School of Psychology, Dorothy Hodgkin Building, Keele University, Staffordshire, ST5 5BG, UK
| | - Richard Amlôt
- NIHR Health Protection Research Unit in Emergency Preparedness and Response, Weston Education Centre, King's College London, London SE5 9RJ, UK; UK Health Security Agency, Chief Scientific Officer's Group, 17 Smith Square, London, SW1P 3HX, UK
| | - Megan Cutts
- School of Psychology, Dorothy Hodgkin Building, Keele University, Staffordshire, ST5 5BG, UK
| | - Hannah Dasch
- Centre for Implementation Science, NIHR ARC South London, King's College London, Institute of Psychiatry, Psychology & Neuroscience, De Crespigny Park, London SE5 8AF, UK
| | - Nick Sevdalis
- Centre for Implementation Science, NIHR ARC South London, King's College London, Institute of Psychiatry, Psychology & Neuroscience, De Crespigny Park, London SE5 8AF, UK
| | - G James Rubin
- Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, Weston Education Centre, King's College London, London SE5 9RJ, UK; NIHR Health Protection Research Unit in Emergency Preparedness and Response, Weston Education Centre, King's College London, London SE5 9RJ, UK
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19
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Lieffering AS, Hommes JE, Ramerman L, Rakhorst HA, Mureau MAM, Verheij RA, van der Hulst RRWJ. Prevalence of Local Postoperative Complications and Breast Implant Illness in Women With Breast Implants. JAMA Netw Open 2022; 5:e2236519. [PMID: 36205992 PMCID: PMC9547313 DOI: 10.1001/jamanetworkopen.2022.36519] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/15/2022] Open
Abstract
IMPORTANCE It is unknown how often breast implant illness (BII) is the indication for revision in women with silicone breast implants. OBJECTIVE To examine how often women with silicone breast implants have their implants explanted or replaced because of BII compared with local postoperative complications. DESIGN, SETTING, AND PARTICIPANTS A legacy cohort study on breast implant revision surgery was conducted between April 1, 2015, and December 31, 2020, and a prospective cohort study on breast implantation and revision surgery was conducted between April 1, 2015, and December 31, 2019 (with follow-up until December 31, 2020). Data were obtained from the Dutch Breast Implant Registry. Data analysis was performed from September 2021 to August 2022. EXPOSURES Silicone breast implant. MAIN OUTCOMES AND MEASURES Breast implant revision with the indication BII or local postoperative complications. RESULTS All 12 882 cosmetic breast implants (6667 women; mean [SD] age, 50.6 [12.7] years) and 2945 reconstructive breast implants (2139 women, mean [SD] age, 57.9 [11.3] years) in the legacy cohort and all 47 564 cosmetic breast implants (24 120 women, mean [SD] age, 32.3 [9.7] years) and 5928 reconstructive breast implants (4688 women, mean [SD] age, 50.9 [11.5] years) in the prospective cohort were included for analysis. In the prospective cohort, 739 cosmetic breast implants (1.6%) were revised after a median (IQR) time to reoperation of 1.8 (0.9-3.1) years, and 697 reconstructive breast implants (11.8%) were revised after a median (IQR) time to reoperation of 1.1 (0.5-1.9) years. BII was registered as the reason for revision in 35 cosmetic revisions (4.7%) and 5 reconstructive revisions (0.7%) in the prospective cohort, corresponding to 0.1% of the inserted implants. In the legacy cohort, 536 cosmetic revisions (4.2%) and 80 reconstructive breast implant revisions (2.7%) were performed because of BII. CONCLUSIONS AND RELEVANCE In this cohort study of women with silicone breast implants, BII was an uncommon indication for revision compared with local complications, both in the short and long term. In contrast to the increasing public interest in BII, these results showed that local complications are a far more common reason for breast implant revision.
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Affiliation(s)
- Annemiek S. Lieffering
- Netherlands Institute for Health Services Research (Nivel), Utrecht, the Netherlands
- Tranzo, Tilburg School of Social Sciences and Behavioral Research, Tilburg University, Tilburg, the Netherlands
| | - Juliëtte E. Hommes
- Department of Plastic, Reconstructive and Hand Surgery, Zuyderland Medical Centre, Heerlen & Sittard, the Netherlands
- Department of Plastic, Reconstructive and Hand Surgery, and GROW School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands
| | - Lotte Ramerman
- Netherlands Institute for Health Services Research (Nivel), Utrecht, the Netherlands
| | - Hinne A. Rakhorst
- Department of Plastic, Reconstructive and Hand Surgery, Medical Spectrum Twente, Enschede, the Netherlands
| | - Marc A. M. Mureau
- Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands
| | - Robert A. Verheij
- Netherlands Institute for Health Services Research (Nivel), Utrecht, the Netherlands
- Tranzo, Tilburg School of Social Sciences and Behavioral Research, Tilburg University, Tilburg, the Netherlands
| | - René R. W. J. van der Hulst
- Department of Plastic, Reconstructive and Hand Surgery, Zuyderland Medical Centre, Heerlen & Sittard, the Netherlands
- Department of Plastic, Reconstructive and Hand Surgery, and GROW School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands
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20
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Shafir R, Olson E, Colloca L. The neglect of sex: A call to action for including sex as a biological variable in placebo and nocebo research. Contemp Clin Trials 2022; 116:106734. [PMID: 35306216 PMCID: PMC9332926 DOI: 10.1016/j.cct.2022.106734] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/28/2021] [Revised: 03/08/2022] [Accepted: 03/14/2022] [Indexed: 11/22/2022]
Abstract
Sex differences exist in the prevalence, progression and treatment efficacy of a wide array of medical conditions. While the placebo and nocebo effects have become increasingly relevant in the clinical arena, little is known about the influence of biological sex on placebo and nocebo effects. This paper discusses the existing, relatively limited and sometimes conflicting evidence about how sex impacts the occurrence and magnitude of the placebo and nocebo effects, mainly focusing on pain studies. We present recent evidence that when compared to men, women suffering from chronic orofacial pain may derive greater benefit from the placebo effect for analgesia. Nonetheless, we broadly argue that the field is not currently positioned to draw definitive conclusions and propose several important factors that may explain the inconsistency in the literature and that should be taken into account in future research. These include the specific target symptom of the placebo or nocebo manipulation and whether or not the target is related to the medical condition, the placebo or nocebo induction method, the sex of the experimenter or physician, and so forth. Future research should intentionally include sex a biological variable to favor translation of placebo and nocebo mechanisms into clinical applications.
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Affiliation(s)
- Roni Shafir
- Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, USA.
| | - Elizabeth Olson
- School of Medicine, University of Maryland, Baltimore, MD, United States
| | - Luana Colloca
- Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, USA; Departments of Anesthesiology and Psychiatry, School of Medicine, University of Maryland, Baltimore, USA; Center to Advance Chronic Pain Research, University of Maryland, Baltimore, USA.
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21
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Decrease in Antidepressant Efficacy After Change in Generic Formulation: A Representative Case. J Clin Psychopharmacol 2022; 42:221-222. [PMID: 34935656 DOI: 10.1097/jcp.0000000000001512] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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22
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Heller MK, Chapman SCE, Horne R. Beliefs About Medicines Predict Side-Effects of Placebo Modafinil. Ann Behav Med 2022; 56:989-1001. [PMID: 35512392 DOI: 10.1093/abm/kaab112] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022] Open
Abstract
BACKGROUND Patients receiving placebo in clinical trials often report side-effects (nocebo effects), but contributing factors are still poorly understood. PURPOSE Using a sham trial of the cognition-enhancing "smart pill" Modafinil we tested whether medication beliefs and other psychological factors predicted detection and attribution of symptoms as side-effects to placebo. METHODS Healthy students (n = 201) completed measures assessing beliefs about medication, perceived sensitivity to medicines, negative affectivity, somatization, and body awareness; 66 were then randomized to receive Deceptive Placebo (told Modafinil-given placebo, 67 to Open Placebo (told placebo-given placebo, and 68 to No Placebo. Memory and attention tasks assessed cognitive enhancement. Nocebo effects were assessed by symptom checklist. RESULTS More symptoms were reported in the Deceptive Placebo condition (M = 2.65; SD = 2.27) than Open Placebo (M = 1.92; SD = 2.24; Mann-Whitney U = 1,654, z = 2.30, p = .022) or No Placebo (M = 1.68; SD = 1.75, Mann-Whitney U = 1,640, z = 2.74, p = .006). Participants were more likely to attribute symptoms to Modafinil side-effects if they believed pharmaceuticals to be generally harmful (incidence rate ratio [IRR] = 1.70, p = .019), had higher perceived sensitivity to medicines (IRR = 1.68, p = .011), stronger concerns about Modafinil (IRR = 2.10, p < .001), and higher negative affectivity (IRR = 2.37, p < .001). CONCLUSIONS Beliefs about medication are potentially modifiable predictors of the nocebo effect. These findings provide insight into side-effect reports to placebo and, potentially, active treatment.
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Affiliation(s)
- Monika K Heller
- Centre for Behavioural Medicine, UCL School of Pharmacy, UCL, Tavistock Square, WC1H 9JP, London, UK
| | - Sarah C E Chapman
- Centre for Behavioural Medicine, UCL School of Pharmacy, UCL, Tavistock Square, WC1H 9JP, London, UK.,Department of Pharmacy & Pharmacology, University of Bath, Claverton Down Road, Bath, UK
| | - Rob Horne
- Centre for Behavioural Medicine, UCL School of Pharmacy, UCL, Tavistock Square, WC1H 9JP, London, UK
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Wakob I, Wintsche I, Frisch A, Remane Y, Laufs U, Bertsche T, Schiek S. Assessment of Patients' Views on Drug Benefits and Risks: An Interview Study with Cardiovascular Patients. Int J Clin Pract 2022; 2022:6585271. [PMID: 36474547 PMCID: PMC9678459 DOI: 10.1155/2022/6585271] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2022] [Accepted: 10/17/2022] [Indexed: 11/16/2022] Open
Abstract
Better and balanced information strategies supporting cardiovascular patients' adherence are required. Cardiovascular drugs have outstanding morbidity and mortality benefits. This can be counteracted by patients' perceptions of risks. Drug information should help the patient but not fuel unwarranted fears. We performed a cross-sectional survey of patients admitted to a cardiology ward. We evaluated (i) the patients' general benefit-risk estimation of their pharmacotherapy; (ii) views on benefits; (iii) views on risks; and (iv) information sources. Additionally, we assessed aspects of anxiety and depression with the Patient Health Questionnaire-4 (PHQ-4). (i) 67 patients (66%) rated expected drug benefits higher than potential risks. (ii) 72% of benefits motivated the patients to take their medication as prescribed. Patients more frequently mentioned surrogate markers as benefits than clinical benefits (p < 0.001). (iii) 56% of risks mentioned were perceived as bothersome and 35% as concerning. Risks were more often perceived as bothersome and concerning by patients with higher PHQ-4 scores (p=0.016). (iv) Physicians were the most frequent information source of benefits (92% of patients) and risks (45%), and pharmacy staff for 27% and 14%, respectively. Laymen or media served as sources of information on benefits in 39%, for risks in 40%, and package leaflets in 26% and 36%. 42% of the patients would like to receive more information on benefits versus 27% on risks. Our results suggest that knowledge of benefits motivates patients to take their drugs as prescribed. There is already good information on surrogate markers for process control with active patient involvement. However, a lack of knowledge still exists in relation to clinical benefits. Regarding risks, it has been shown that patients with higher PHQ-4 scores are more likely to be bothered or concerned. Both emphases on clinical benefits and individualization depending on PHQ-4 scores may be valuable resources for patient counseling to support adherence.
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Affiliation(s)
- Ines Wakob
- Clinical Pharmacy, Institute of Pharmacy, Medical Faculty, Leipzig University, Leipzig, Germany
- Drug Safety Center, Leipzig University and Leipzig University Hospital, Leipzig, Germany
| | - Ina Wintsche
- Clinical Pharmacy, Institute of Pharmacy, Medical Faculty, Leipzig University, Leipzig, Germany
- Drug Safety Center, Leipzig University and Leipzig University Hospital, Leipzig, Germany
- Pharmacy Department, Leipzig University Hospital, Leipzig, Germany
| | - Annett Frisch
- Drug Safety Center, Leipzig University and Leipzig University Hospital, Leipzig, Germany
- Pharmacy Department, Leipzig University Hospital, Leipzig, Germany
| | - Yvonne Remane
- Drug Safety Center, Leipzig University and Leipzig University Hospital, Leipzig, Germany
- Pharmacy Department, Leipzig University Hospital, Leipzig, Germany
| | - Ulrich Laufs
- Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Germany
| | - Thilo Bertsche
- Clinical Pharmacy, Institute of Pharmacy, Medical Faculty, Leipzig University, Leipzig, Germany
- Drug Safety Center, Leipzig University and Leipzig University Hospital, Leipzig, Germany
| | - Susanne Schiek
- Clinical Pharmacy, Institute of Pharmacy, Medical Faculty, Leipzig University, Leipzig, Germany
- Drug Safety Center, Leipzig University and Leipzig University Hospital, Leipzig, Germany
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24
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Meijboom RW, Gardarsdottir H, Egberts TCG, Giezen TJ. Patients Retransitioning from Biosimilar TNFα Inhibitor to the Corresponding Originator After Initial Transitioning to the Biosimilar: A Systematic Review. BioDrugs 2021; 36:27-39. [PMID: 34870802 PMCID: PMC8847209 DOI: 10.1007/s40259-021-00508-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/02/2021] [Indexed: 12/30/2022]
Abstract
Background Transitioning patients from an originator to a corresponding biosimilar has been extensively studied in both randomized controlled trials and observational studies. Although transitioning is considered well-tolerated, with no negative impacts on efficacy and/or safety, 2.6–25.8% of patients restart treatment with the originator (retransitioning). Retransitioning to the originator can be considered an indication of biosimilar treatment failure or dissatisfaction with biosimilar treatment. Increasing our knowledge of patients who retransition might help to reduce the number of patients retransitioning. Objective Our objective was to estimate the cumulative incidence of patients who retransitioned from a tumor necrosis factor (TNF)-α inhibitor biosimilar to originator and to explore potential patient, disease, and treatment and implementation strategy factors associated with retransitioning. Method We conducted a systematic literature search in the PubMed, EMBASE, and Cochrane Central Register of controlled trials databases until March 2021. Studies on TNFα inhibitors, biosimilar transitioning, and retransitioning were included. Transitioning was defined as switching from an originator to a biosimilar, and retransitioning was defined as switching from an originator to a biosimilar and back to the originator. Characteristics of the studies were descriptively analyzed. Studies were weighted by the number of patients transitioning, and the primary outcome was the median cumulative incidence of retransitioning. For each of the factors related to patient, disease, and treatment and implementation strategy, studies were stratified according to the categories of that factor. The weighted medians and interquartile ranges (IQRs) of the cumulative incidence of retransitioning in these studies were calculated and compared to explore whether a potential association existed between these factors and the cumulative incidence of retransitioning. Results Of 994 screened publications, 37 were included. The weighted median cumulative incidence of retransitioning was 7.6% (IQR 6.8–17.2). Studies that included only patients with inflammatory bowel disease (6.6 vs. 15.1–17.7% for other indications), included only patients with stable disease (7.0 vs. 13.7% for including all patients), and did not offer retransitioning at the introduction of the biosimilar (7.0 vs. 11.1% for studies that offered retransitioning) reported less retransitioning. In addition, the incidence of retransitioning was lower when extra laboratory monitoring was part of the implementation strategy (1.6 vs. 6.1%) and when gainsharing (patients’ healthcare directly benefits from financial savings from transitioning) (1.4 vs. 7.2% for studies without gainsharing) was applied. Conclusions In studies on transitioning patients from TNFα originator to biosimilar, 8% of patients retransitioned. Retransitioning appeared to be lower in studies that included only patients with stable disease and in studies that did not offer patients the option of retransitioning at the introduction of the biosimilar. In addition, retransitioning appeared to be lower in studies that implemented extra laboratory monitoring as part of the biosimilar implementation strategy. Clinicians should consider implementing these suggestions as they might reduce retransitioning rates and improve the introduction of biosimilars in clinical practice. PROSPERO registration ID: CRD42021226381 Supplementary Information The online version contains supplementary material available at 10.1007/s40259-021-00508-4.
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Affiliation(s)
- Rosanne W Meijboom
- Pharmacy Foundation of Haarlem Hospitals, Haarlem, The Netherlands
- Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands
| | - Helga Gardarsdottir
- Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands
- Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands
- Department of Pharmaceutical Sciences, University of Iceland, Reykjavík, Iceland
| | - Toine C G Egberts
- Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands
- Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands
| | - Thijs J Giezen
- Pharmacy Foundation of Haarlem Hospitals, Haarlem, The Netherlands.
- Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, The Netherlands.
- Department of Clinical Pharmacy, Spaarne Gasthuis, Haarlem and Hoofddorp, The Netherlands.
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25
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El-Krab R, Kalichman SC. Alcohol-Antiretroviral Therapy Interactive Toxicity Beliefs and Intentional Medication Nonadherence: Review of Research with Implications for Interventions. AIDS Behav 2021; 25:251-264. [PMID: 33950339 DOI: 10.1007/s10461-021-03285-x] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/23/2021] [Indexed: 02/07/2023]
Abstract
The successful treatment of HIV infection relies on adherence to antiretroviral therapy (ART). Alcohol use remains a threat to ART adherence, including the beliefs held by people who drink alcohol that it is harmful to take ART when consuming alcohol (i.e., alcohol-ART interactive toxicity beliefs, AA-ITB). We reviewed the current research that has investigated AA-ITB and their relationship to intentional ART nonadherence. The review of 17 published studies found that AA-ITB are prevalent among people receiving ART and that AA-ITB are directly associated with ART nonadherence and incomplete HIV suppression. Family, friends and healthcare providers are common sources and reinforcers of AA-ITB. Studies suggest that AA-ITB may best be explained by the Medication Necessity and Concerns Beliefs Model, treating AA-ITB as a specific circumstance of medication concerns. Interventions are needed to communicate the realities of potential medication interactions and dispel myths that it is harmful to mix alcohol with ART, while not inadvertently suggesting that it is safe to drink with all medications, which could undermine adherence to ART by increasing alcohol use.
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Affiliation(s)
- Renee El-Krab
- Institute for Collaboration On Health Intervention and Policy, University of Connecticut, 2006 Hillside Road, Storrs, CT, 06269, USA
| | - Seth C Kalichman
- Institute for Collaboration On Health Intervention and Policy, University of Connecticut, 2006 Hillside Road, Storrs, CT, 06269, USA.
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Thiele F, Klein A, Hospach A, Windschall D, Mrusek S, Ruehlmann JM, Horneff G. Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study. ACR Open Rheumatol 2021; 3:779-787. [PMID: 34449981 PMCID: PMC8593791 DOI: 10.1002/acr2.11325] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/27/2021] [Accepted: 07/13/2021] [Indexed: 12/13/2022] Open
Abstract
OBJECTIVE Analysis of etanercept biosimilars in pediatric patients with juvenile idiopathic arthritis (JIA) in comparison with the etanercept originator in terms of efficacy and safety. METHODS Patients diagnosed with JIA who started treatment with either the etanercept originator or a biosimilar after January 1, 2017, were selected from the German BIKER registry (Biologics in Paediatric Rheumatology Registry). Furthermore, patients who started therapy with the originator and switched to a biosimilar during the course of therapy were identified. For both patient groups, disease activity and safety were examined and compared separately. RESULTS After January 1, 2017, 348 patients started treatment with the etanercept originator (n = 293) or a biosimilar (n = 55). Another 57 patients switched to a biosimilar during the course of therapy. A significant decrease or a stable remission of disease activity was observed in both patient groups. The safety profiles were comparable, and frequencies and types of adverse events (AEs) and serious AEs were similar in patients starting therapy with the originator or a biosimilar. Only injection site reactions occurred slightly more frequently under biosimilar therapy, without having an impact on therapy adherence. In patients who switched therapy, the AE rate per 100 patient-years was comparable before (26.4) and after (32.1) the switch. CONCLUSION In patients with JIA who require treatment with etanercept, the originator is still used much more frequently. However, our study highlights the equivalence of etanercept biosimilars for therapy for JIA. Increased use of these biosimilars in pediatric patients can therefore be recommended without hesitation.
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Affiliation(s)
- Franz Thiele
- Asklepios Clinic Sankt AugustinSankt AugustinGermany
| | - Ariane Klein
- Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, and University of CologneCologneGermany
| | - Anton Hospach
- Klinikum StuttgartOlgahospital StuttgartStuttgartGermany
| | - Daniel Windschall
- Northwest German Rheumatology CenterSt. Josef StiftSendenhorstGermany
| | - Sonja Mrusek
- Practice for Paediatric RheumatologyBaden‐BadenGermany
| | | | - Gerd Horneff
- Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, and University of CologneCologneGermany
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27
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Barth J, Muff S, Kern A, Zieger A, Keiser S, Zoller M, Rosemann T, Brinkhaus B, Held L, Witt CM. Effect of Briefing on Acupuncture Treatment Outcome Expectations, Pain, and Adverse Side Effects Among Patients With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open 2021; 4:e2121418. [PMID: 34505889 PMCID: PMC8433606 DOI: 10.1001/jamanetworkopen.2021.21418] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022] Open
Abstract
IMPORTANCE In observational studies, patients' treatment outcome expectations have been associated with better outcomes (ie, a placebo response), whereas concerns about adverse side effects have been associated with an in increase in the negative effects of treatments (ie, a nocebo response). Some randomized trials have suggested that communication from clinicians could affect the treatment outcomes by changing patients' expectations. OBJECTIVE To investigate whether treatment outcome expectations and reported adverse side effects could be affected by different briefing contents before a minimal acupuncture treatment in patients with chronic low back pain (CLBP). DESIGN, SETTING, AND PARTICIPANTS This randomized single-blinded clinical trial was conducted among patients with CLBP at 1 outpatient clinic in Switzerland who had a pain intensity of at least 4 on a numeric rating scale from 0 to 10. Different recruitment channels were used to enroll patients. Data were collected from May 2016 to December 2017 and were analyzed from June to November 2018. INTERVENTIONS Patients were randomized to receive either a regular expectation briefing or a high expectation briefing (effectiveness) and either a regular adverse side effect briefing or an intense adverse side effect briefing (adverse side effect) in a 2 × 2 factorial design. The intervention (briefing sessions and written materials) was standardized and delivered before the acupuncture treatment, with additional booster informative emails provided during the 4-week, 8-session acupuncture course. MAIN OUTCOMES AND MEASURES The primary end point was the patients' expectations regarding the effectiveness of the acupuncture treatment (Expectation for Treatment Scale [ETS]) after the briefing and the subsequent pain intensity (numeric rating scale). The primary end point for the adverse side effect briefing was the adverse side effect score at the end of the acupuncture treatment, derived from session-by-session assessments of adverse side effects. RESULTS A total of 152 patients with CLBP (mean [SD] age, 39.54 [12.52] years; 100 [65.8%] women) were included. The estimated group difference (regular vs high) for the ETS was -0.16 (95% CI -0.81 to 0.50, P = .64), indicating no evidence for a difference between intervention groups. There was also no evidence for a difference in pain intensity at the end of the acupuncture treatment between the groups with different expectation briefings. The adverse side effects score in the group with the intense adverse side effect briefing were estimated to be 1.31 times higher (95% CI, 0.94 to 1.82; P = .11) than after a regular adverse side effect briefing, but the finding was not statistically significant. CONCLUSIONS AND RELEVANCE In this study, suggestions regarding treatment benefits (placebo) and adverse side effects (nocebo) did not affect treatment expectations or adverse side effects. Information regarding adverse side effects might require more research to understand nocebo responses. TRIAL REGISTRATION German Clinical Trials Register Identifier: DRKS00010191.
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Affiliation(s)
- Jürgen Barth
- Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland
| | - Stefanie Muff
- Department of Biostatistics at the Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
- Department of Mathematical Sciences, Norwegian University of Science and Technology, Trondheim, Norway
| | - Alexandra Kern
- Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland
| | - Anja Zieger
- Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland
| | - Stefanie Keiser
- Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland
| | - Marco Zoller
- Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland
| | - Thomas Rosemann
- Institute of Primary Care, University Hospital Zurich, Zurich, Switzerland
| | - Benno Brinkhaus
- Charité–Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany
| | - Leonhard Held
- Department of Biostatistics at the Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
| | - Claudia M. Witt
- Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland
- Charité–Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Social Medicine, Epidemiology and Health Economics, Berlin, Germany
- Center for Integrative Medicine, University of Maryland, School of Medicine, Baltimore
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28
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Gasteiger C, den Broeder AA, Stewart S, Gasteiger N, Scholz U, Dalbeth N, Petrie KJ. The mode of delivery and content of communication strategies used in mandatory and non-mandatory biosimilar transitions: a systematic review with meta-analysis. Health Psychol Rev 2021; 17:148-168. [PMID: 34409923 DOI: 10.1080/17437199.2021.1970610] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
Effective patient-provider communication is crucial to promote shared decision-making. However, it is unclear how to explain treatment changes to ensure patient acceptance, such as when transitioning from a bio-originator to a biosimilar. This review investigates communication strategies used to educate patients on transitioning to biosimilars and explores whether the willingness to transition and treatment persistence differs for the delivery (verbal or written) and the amount of information provided. MEDLINE, Embase, Scopus, and relevant conference databases were systematically searched. Communication strategies from 33 studies (88% observational cohort studies) published from 2012 to 2020 were synthesized and willingness to transition, persistence, and subjective adverse events explored. Patients only received information verbally in 11 studies. The remaining 22 studies also provided written information. Cost-saving was the main reason provided for the transition. Patients were most willing to transition when receiving written and verbal information (χ2 = 5.83, p = .02) or written information that only addressed a few (3-5) concerns (χ2 = 16.08, p < .001). There was no significant difference for persistence or subjective adverse events (p's > .05). Few randomized controlled trials have been conducted. Available data shows more willingness to transition when patients received written and verbal information. Initial documents should contain basic information and consultations or telephone calls used to address concerns.
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Affiliation(s)
- Chiara Gasteiger
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | | | - Sarah Stewart
- Bone & Joint Research Group, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Norina Gasteiger
- School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom
| | - Urte Scholz
- Department of Psychology- Applied Social and Health Psychology, University of Zurich, Zurich, Switzerland.,University Research Priority Program 'Dynamics of Healthy Aging', University of Zurich, Zurich, Switzerland
| | - Nicola Dalbeth
- Department of Rheumatology, Auckland District Health Board, Auckland, New Zealand.,Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Keith J Petrie
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
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29
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Barton BL, Burke PF, Waller DS. Effects of anxiety on preferences for generic medicines in Australia. Health Promot Int 2021; 36:187-195. [PMID: 32529220 DOI: 10.1093/heapro/daaa034] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022] Open
Abstract
Generic medicines have been available to consumers for ∼40 years, with varying degrees of uptake in different countries. Despite offering equivalent therapeutic qualities, generic medicines still struggle to be accepted by consumers. This study examines the role of a consumer's affective state and framing effects on the purchase of a branded versus a generic pharmaceutical product. These issues are examined in an experiment, with independent manipulations of consumer anxiety levels and the framing of generic alternatives by the pharmacist. The sample comprised 426 men and women within Australia who completed an online survey with a scenario of purchasing a pharmaceutical after visiting a General Practitioner. Results indicate that those consumers experiencing higher levels of anxiety and where the doctor prescribed the branded medicine are more likely to choose branded medicines over cheaper, generic alternatives. The effect of framing the generic alternative as either 'generic' or 'cheaper' was not significant.
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Affiliation(s)
- Belinda L Barton
- University of Technology Sydney, UTS Business School, Broadway, NSW 2007, Australia
| | - Paul F Burke
- University of Technology Sydney, UTS Business School, Broadway, NSW 2007, Australia
| | - David S Waller
- University of Technology Sydney, UTS Business School, Broadway, NSW 2007, Australia
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30
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Kalichman SC, Katner H, Hill M, Ewing W, Kalichman MO. Perceived sensitivity to medicines and the experience of side-effects: understanding intentional medication nonadherence among people living with HIV. PSYCHOL HEALTH MED 2021; 27:2261-2272. [PMID: 34319180 DOI: 10.1080/13548506.2021.1960391] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
Patient initiated decisions to forgo taking medications (i.e. intentional nonadherence) pose significant challenges to managing chronic health conditions. Identifying factors and their underlying mechanisms that impede medication adherence is essential to designing treatment improvement interventions. This study tested a conceptual model that posits the effects of perceived sensitivity to medicines on adherence can be explained by the experience of side-effects, leading to intentionally nonadherent behaviors. Patients receiving HIV care in the southern United States (N = 209) completed measures of perceived sensitivity to medicines, antiretroviral therapy (ART) side-effects, intentional nonadherence and overall adherence. Patients also provided consent to access their electronic medical records to collect subsequent reports of HIV viral load tests. Results indicated that more than one in four participants were intentionally nonadherent to ART. Mediation modeling showed that perceived sensitivity to medicines was associated with greater experience of ART side-effects and intentional nonadherence, which impacted overall ART adherence and HIV viral load. There were also significant indirect effects of perceived sensitivity to medicines on HIV viral load through side-effects and intentional nonadherence. Patients with increased perceived sensitivity to medicines are at risk for poor treatment outcomes and these negative outcomes are partly explained by experiencing greater side-effects and intentional nonadherence.
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Affiliation(s)
- Seth C Kalichman
- Institute for Collaborative Health Intervention and Policy, University of Connecticut, Storrs, CT, USA
| | - Harold Katner
- Department of Medicine, Mercer University Medical School
| | - Marnie Hill
- Department of Medicine, Mercer University Medical School
| | - Wendy Ewing
- Department of Medicine, Mercer University Medical School
| | - Moira O Kalichman
- Institute for Collaborative Health Intervention and Policy, University of Connecticut, Storrs, CT, USA
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Daniali H, Flaten MA. Experiencing COVID-19 symptoms without the disease: The role of nocebo in reporting of symptoms. Scand J Public Health 2021; 50:61-69. [PMID: 34041973 PMCID: PMC8807543 DOI: 10.1177/14034948211018385] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
Background: A nocebo effect occurs when inactive factors lead to worsening of symptoms or reduce treatment outcomes. Believing that one is or has been infected with COVID-19 may act as a nocebo. However, not much is known about potential nocebo effects associated with the reporting of COVID-19 symptoms. Aim: An online survey investigated whether certainty of being infected with COVID-19, age, sex, cognitive, emotional and personality factors were associated with perceived severity of COVID-19 symptoms. Methods: Participants (N=375) filled out an online survey containing 57 questions asking about symptoms resembling COVID-19, certainty of being infected with COVID-19, anxiety, stress and personality dimensions. Results: Certainty of being infected with COVID-19 and anxiety predicted 27% of the variance in reporting of COVID-like symptoms. The mediation analysis showed that both higher certainty of being infected and anxiety independently predicted increased reports of COVID-like symptom. Females had higher anxiety and stress levels, and reported more COVID-like symptoms than males did. Older age was not associated with reporting COVID-like symptoms. Conclusions: Believing to be infected with COVID-19, along with anxiety, can enhance the severity of COVID-like symptoms. Thus, the nocebo effect was due to both cognitive and emotional factors and was higher in females.
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Affiliation(s)
- Hojjat Daniali
- Department of Psychology, Norwegian University of Science and Technology (NTNU), Norway
| | - Magne Arve Flaten
- Department of Psychology, Norwegian University of Science and Technology (NTNU), Norway
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The times they are a-changin - Don´t panic with a generic! Seizure 2021; 91:513-514. [PMID: 34030934 DOI: 10.1016/j.seizure.2021.05.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
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Nestoriuc Y, Pan Y, Kinitz T, Weik E, Shedden-Mora MC. Informing About the Nocebo Effect Affects Patients' Need for Information About Antidepressants-An Experimental Online Study. Front Psychiatry 2021; 12:587122. [PMID: 33986697 PMCID: PMC8112550 DOI: 10.3389/fpsyt.2021.587122] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/24/2020] [Accepted: 03/15/2021] [Indexed: 11/27/2022] Open
Abstract
Relevance: Understanding patients' informational needs and adapting drug-related information are the prerequisites for a contextualized informed consent. Current information practices might rather harm by inducing nocebo effects. Objective: To investigate whether informing about the nocebo effect using a short information sheet affects patients' need for information about antidepressants. Methods: A total of 97 patients taking recently prescribed antidepressants (≤4 months intake) were recruited over the internet and randomized to receiving either a one-page written information about the nocebo effect or a control text about the history of antidepressants. After experimental manipulation, informational needs about the side effects and mechanisms of antidepressants were assessed with 3 and 7 items on categorical and 5-point Likert scales. Group differences in informational needs were calculated with Chi-square tests and ANOVAs. Results: Patients received antidepressants for depression (84.5%) and/or anxiety disorders (42.3%). Three participants (6.0%) of the nocebo group reported previous knowledge of the nocebo effect. After the experimental manipulation, participants in the nocebo group reported a reduced desire for receiving full side effect information [X ( 4 , 97 ) 2 = 12.714, Cramer's V = 0.362, p = 0.013] and agreed more frequently to the usefulness of withholding information about possible side effects [X ( 4 , 97 ) 2 = 14.878, Cramer's V = 0.392, p = 0.005]. Furthermore, they desired more information about the mechanisms of antidepressants (F = 6.373, p = 0.013, partial η2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations (F = 16.857, p < 0.001, partial η2 = 0.151). Conclusions: Learning about the nocebo effect can alter patients' informational needs toward desiring less information about the potential side effects of antidepressants and more information about general mechanisms, such as expectations. The beneficial effects of including nocebo information into contextualized informed consent should be studied clinically concerning more functional information-seeking behavior, which may ultimately lead to improved treatment outcomes, such as better adherence and reduced side effect burden.
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Affiliation(s)
- Yvonne Nestoriuc
- Clinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces Hamburg, Hamburg, Germany
- Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
| | - Yiqi Pan
- Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
| | - Timm Kinitz
- Neuropsychology, Westerwald Clinic, Waldbreitbach, Germany
| | - Ella Weik
- Department of Psychiatry, British Columbia Mental Health and Addictions Research Institute, University of British Columbia, Vancouver, BC, Canada
| | - Meike C. Shedden-Mora
- Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
- Department of Psychology, Medical School Hamburg, Hamburg, Germany
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Kalaria S, Spence O, Hong K, dosReis S, Gopalakrishnan M. Evaluation of Switch-to-Brand Rates as a Potential Signal for Therapeutic Equivalency of Generic Antidepressants: A Real-World Retrospective Cohort Study. Clin Pharmacol Ther 2021; 110:443-451. [PMID: 33811324 DOI: 10.1002/cpt.2249] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2021] [Accepted: 03/21/2021] [Indexed: 11/23/2022]
Abstract
Negative clinical outcomes after switching from brand to generic antidepressants have raised concerns regarding therapeutic equivalency. This research aims to estimate the prevalence of switching and to identify predictors for generic to brand switching for various antidepressants. This retrospective cohort study utilized data from a 10% random sample of enrollees in the IQVIA PharMetrics Plus claims database from 2007-2015. The base cohort consisted of commercially insured patients who were prescribed escitalopram, duloxetine, or venlafaxine extended release (ER) anytime from the year prior to the generic launch through December 2014. The primary outcome was defined as a switch from generic to a brand within 14 days of sustained generic use in a 1-year follow-up period. Adjusted logistic regression and generalized estimating equations for repeated measures estimated the drug specific and overall odds of switch-to-brand among brand initiators relative to generic initiators, respectively. A total of 102,831 unique patients across 3 drug products contributed to the final analytic sample. The overall prevalence of switch from generic to brand was 0.74%. Across all three antidepressants, brands initiators were more likely to experience a switch-to-brand: escitalopram (odds ratio (OR): 14.41, 95% confidence interval (CI): 11.14-18.64), duloxetine (OR: 8.08, 95% CI: 4.85-13.41) and venlafaxine ER (OR: 16.46, 95% CI: 11.56-23.46). The pooled odds of a switch-to-brand in brand vs. generic initiators was 13.77 (95% CI: 11.35-16.71). This study suggests a low overall switch-to-brand prevalence and may support therapeutic equivalence between brand and generic antidepressants. Initiating with a brand product was the strongest predictor for switching back to brand and suggests that patient experience may play a role in drug utilization.
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Affiliation(s)
- Shamir Kalaria
- Center for Translational Medicine, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA
| | - O'Mareen Spence
- Department of Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA
| | - Kyungwan Hong
- Department of Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA
| | - Susan dosReis
- Department of Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA
| | - Mathangi Gopalakrishnan
- Center for Translational Medicine, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA
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35
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Daniali H, Flaten MA. What Psychological Factors Make Individuals Believe They Are Infected by Coronavirus 2019? Front Psychol 2021; 12:667722. [PMID: 33967926 PMCID: PMC8100307 DOI: 10.3389/fpsyg.2021.667722] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2021] [Accepted: 03/29/2021] [Indexed: 01/17/2023] Open
Abstract
Background: We previously showed, by means of an online-based survey, that the belief of being infected by coronavirus disease 2019 (COVID-19) acted as a nocebo and predicted higher perception of symptoms similar to COVID-19 symptoms. However, there is little known about the psychological mechanisms that give rise to beliefs such as certainty of being infected by COVID-19, and this was investigated in the present study. Objective: Using the same data from the previous online survey with the same research team, we further investigated whether certainty of being infected by COVID-19 is associated with age, sex, health anxiety, and/or personality traits. Methods: Respondents (N = 375) filled out an online survey with 57 questions about symptoms similar to COVID-19, certainty of being infected by COVID-19, anxiety, stress, health anxiety, and personality dimensions (based on the five-factor model of personality). Results: Higher levels of conscientiousness and health anxiety were independently associated with certainty of being infected by COVID-19. The model predicted 29% of the variance in certainty of being infected by COVID-19. Conclusion: Being conscientious and worried about health issues were associated with the belief of being infected by COVID-19. Such finding may have implications for health care personnel who provide COVID-19 testing or consulting services to general population, as individuals high in these traits may over-report COVID-like symptoms. Theoretically, these findings point to psychological factors that may increase nocebo and possibly placebo effects. Clinically, the findings suggest that individuals high in conscientiousness and health anxiety may be more likely to over-report their bodily experiences.
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Affiliation(s)
- Hojjat Daniali
- Department of Psychology, Norwegian University of Science and Technology, Trondheim, Norway
| | - Magne Arve Flaten
- Department of Psychology, Norwegian University of Science and Technology, Trondheim, Norway
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Kaertner LS, Steinborn MB, Kettner H, Spriggs MJ, Roseman L, Buchborn T, Balaet M, Timmermann C, Erritzoe D, Carhart-Harris RL. Positive expectations predict improved mental-health outcomes linked to psychedelic microdosing. Sci Rep 2021; 11:1941. [PMID: 33479342 PMCID: PMC7820236 DOI: 10.1038/s41598-021-81446-7] [Citation(s) in RCA: 79] [Impact Index Per Article: 19.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2020] [Accepted: 12/28/2020] [Indexed: 12/20/2022] Open
Abstract
Psychedelic microdosing describes the ingestion of near-threshold perceptible doses of classic psychedelic substances. Anecdotal reports and observational studies suggest that microdosing may promote positive mood and well-being, but recent placebo-controlled studies failed to find compelling evidence for this. The present study collected web-based mental health and related data using a prospective (before, during and after) design. Individuals planning a weekly microdosing regimen completed surveys at strategic timepoints, spanning a core four-week test period. Eighty-one participants completed the primary study endpoint. Results revealed increased self-reported psychological well-being, emotional stability and reductions in state anxiety and depressive symptoms at the four-week primary endpoint, plus increases in psychological resilience, social connectedness, agreeableness, nature relatedness and aspects of psychological flexibility. However, positive expectancy scores at baseline predicted subsequent improvements in well-being, suggestive of a significant placebo response. This study highlights a role for positive expectancy in predicting positive outcomes following psychedelic microdosing and cautions against zealous inferences on its putative therapeutic value.
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Affiliation(s)
- L S Kaertner
- Centre for Psychedelic Research, Division of Psychiatry, Imperial College London, London, UK.
| | - M B Steinborn
- Departmant of Psychology, Julius-Maximilans-University Würzburg, Würzburg, Germany
| | - H Kettner
- Centre for Psychedelic Research, Division of Psychiatry, Imperial College London, London, UK
| | - M J Spriggs
- Centre for Psychedelic Research, Division of Psychiatry, Imperial College London, London, UK
| | - L Roseman
- Centre for Psychedelic Research, Division of Psychiatry, Imperial College London, London, UK
| | - T Buchborn
- Centre for Psychedelic Research, Division of Psychiatry, Imperial College London, London, UK
| | - M Balaet
- Computational, Cognitive and Clinical Neuroimaging Laboratory, Imperial College London, London, UK
| | - C Timmermann
- Centre for Psychedelic Research, Division of Psychiatry, Imperial College London, London, UK
| | - D Erritzoe
- Centre for Psychedelic Research, Division of Psychiatry, Imperial College London, London, UK
| | - R L Carhart-Harris
- Centre for Psychedelic Research, Division of Psychiatry, Imperial College London, London, UK
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Lin CH. Nocebo effects from COVID-19 and vaccination Hesitancy: The question of to be or not to be vaccinated. TAIWANESE JOURNAL OF PSYCHIATRY 2021. [DOI: 10.4103/tpsy.tpsy_33_21] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
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The Unintended Consequences of Adverse Event Information on Medicines' Risks and Label Content. Pharmaceut Med 2020; 34:369-380. [PMID: 33196966 DOI: 10.1007/s40290-020-00367-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/01/2020] [Indexed: 10/23/2022]
Abstract
Patients and prescribers need to be aware of adverse drug events to minimize the risk of their occurrence and the severity with which they appear. However, numerous studies show that being informed about adverse events can increase the possibility of suffering from them. Patients tend to overestimate the likelihood of experiencing the adverse events included in the label, and this can contribute to worsening the negative expectations which are at the root of the nocebo effect. In fact, patients can become anxious after reading the undesirable effects section of the leaflet and, in addition to suffering from the nocebo effect, might not take a drug they could benefit from due to the fear of experiencing adverse events. In addition, patients' attention can focus towards non-specific symptoms of daily living that can be misattributed to the drug and included in the labelling. This article proposes a number of suggestions to reduce the abovementioned unintended effects associated with labelling, namely, an increased focus on the excess risk of experiencing adverse events rather than crude incidence, using attribute framing to help patients to better understand the risk of experiencing adverse events, dividing the undesirable effect section of the leaflet into subsections according to the level of evidence supporting causal relationships and, finally, restricting the addition of non-specific adverse events that are also symptoms of daily living to only those where there is enough evidence to show they have been caused by the drug. More studies on how to minimize the nocebo effect induced by adverse event information should be performed, and these should be done in collaboration with health authorities, to reach a shared consensus on how to better present adverse event information in the label.
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39
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Affiliation(s)
- Kate Faasse
- School of Psychology, University of New South Wales, Sydney, New South Wales, Australia
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40
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D'Amico F, Solitano V, Peyrin-Biroulet L, Danese S. Nocebo effect and biosimilars in inflammatory bowel diseases: what's new and what's next? Expert Opin Biol Ther 2020; 21:47-55. [PMID: 32857634 DOI: 10.1080/14712598.2020.1817374] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
INTRODUCTION The use of biosimilars for the treatment of patients with chronic inflammatory bowel diseases (IBD) showed to be a valid strategy to reduce the economic burden of biologics on health-care costs and to increase patient access to treatment. However, the nocebo effect constitutes an important limitation to the wide use of biosimilars. AREAS COVERED We conducted a literature overview to summarize information on nocebo effect in IBD population and to provide physicians with practical key strategies to prevent the nocebo effect in daily clinical practice and to improve patients' outcomes. EXPERT OPINION Despite the proven efficacy and safety of biosimilars, further clinical studies are needed to define the effects of reverse and multiple switches in the management of patients with IBD. The development of new subcutaneous formulations, better accepted by patients, could contribute to reduce patients' negative expectations, and limit the nocebo effect.
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Affiliation(s)
- Ferdinando D'Amico
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele , Milan, Italy.,Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy , France
| | - Virginia Solitano
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele , Milan, Italy
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy , France
| | - Silvio Danese
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele , Milan, Italy.,Department of Gastroenterology, IBD Center, Humanitas Clinical and Research Center - IRCCS, Rozzano , Milan, Italy
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41
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Piedimonte A, Benedetti F, Guerra G, Zamfira DA, Vighetti S, Carlino E. I expect what you expect: An electrophysiological study on social expectation of pain. Psychophysiology 2020; 57:e13666. [DOI: 10.1111/psyp.13666] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/03/2020] [Revised: 07/09/2020] [Accepted: 07/09/2020] [Indexed: 12/14/2022]
Affiliation(s)
| | - Fabrizio Benedetti
- Department of Neuroscience University of Turin Medical School Turin Italy
- Plateau Rosa Laboratories Zermatt Switzerland
| | - Giulia Guerra
- Department of Neuroscience University of Turin Medical School Turin Italy
| | | | | | - Elisa Carlino
- Department of Neuroscience University of Turin Medical School Turin Italy
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42
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Faasse K, Huynh A, Pearson S, Geers AL, Helfer SG, Colagiuri B. The Influence of Side Effect Information Framing on Nocebo Effects. Ann Behav Med 2020; 53:621-629. [PMID: 30204841 DOI: 10.1093/abm/kay071] [Citation(s) in RCA: 43] [Impact Index Per Article: 8.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/12/2018] [Revised: 06/07/2018] [Accepted: 08/20/2018] [Indexed: 11/13/2022] Open
Abstract
BACKGROUND One contributing factor to the development of nocebo effects is information provided about possible side effects. However, nondisclosure of information can be problematic. PURPOSE We assessed whether positively framed side effect information (highlighting likelihood of not experiencing side effects) can reduce nocebo effects compared to negatively framed information (highlighting likelihood of experiencing side effects). METHODS One hundred twelve participants took part in research ostensibly assessing the influence of benzodiazepines (actually sham capsules) on anxiety. Participants were randomized to receive a sham capsule with positively or negatively framed information about four side effects, or a no-treatment control condition. Side effect expectations were assessed after information provision. Framed side effects and other unmentioned symptoms were assessed during the session and 24-hr follow-up. RESULTS Nocebo effects occurred in symptoms presented as side effects (regardless of framing) during the study session and follow-up (ps < .003). At follow-up, there was also a nocebo effect in other unmentioned symptoms (p = .018). Positive framing reduced side effect symptoms compared with negative framing during the study session (p = .037), but this effect was no longer present at follow-up (p = .53). Side effect expectations did not differ between the framing conditions (p = .14). CONCLUSIONS Positive framing reduced side effects short-term, but not at follow-up. Expectations did not differ between negative and positive framing. Nocebo effects appeared to generalize to other unmentioned symptoms over a 24-hr period. Further research is needed to determine whether the initial impact of positive framing can be maintained over time.
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Affiliation(s)
- Kate Faasse
- School of Psychology, University of New South Wales, Sydney, Australia
| | - Anna Huynh
- School of Psychology, University of New South Wales, Sydney, Australia
| | - Sarah Pearson
- School of Psychology, University of New South Wales, Sydney, Australia
| | - Andrew L Geers
- Department of Psychology, The University of Toledo, Toledo, OH, USA
| | | | - Ben Colagiuri
- School of Psychology, University of Sydney, Sydney, Australia
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43
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Materia FT, Faasse K, Smyth JM. Understanding and Preventing Health Concerns About Emerging Mobile Health Technologies. JMIR Mhealth Uhealth 2020; 8:e14375. [PMID: 32449688 PMCID: PMC7281144 DOI: 10.2196/14375] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/12/2019] [Revised: 12/05/2019] [Accepted: 02/09/2020] [Indexed: 12/14/2022] Open
Abstract
New technologies and innovations have often improved population well-being and societal function; however, these are also often initially accompanied by worry and fear. In some cases, such worries can impede, or even prevent entirely, the adoption of the technology. Mobile health (mHealth), a discipline broadly focused on employing ambulatory technologies to improve the affordability, reach, and effectiveness of health promotion and clinical intervention approaches, offers new innovations and opportunities. Despite emerging evidence supporting mHealth efficacy (eg, for improving health outcomes), some individuals have concerns about mHealth technology that may impede scalability, efficacy, and, ultimately, the public health benefits of mHealth. We present a review and conceptual framework to examine these issues, focusing on three overarching themes: biophysiological, psychological, and societal concerns. There are features of mHealth that lead to worries about the potential negative effects on an individual’s health (eg, due to exposure to electromagnetic or radio waves), despite evidence supporting the safety of these technologies. When present, such beliefs can lead to worry that gives rise to the experience of unpleasant and concerning physical symptoms—the nocebo effect. This may represent an important implementational barrier because of apprehension toward beneficial mHealth products (or features thereof, such as wireless charging, wearable or implantable sensors, etc) and may also have broader ramifications (eg, leading to economic, governmental, and legislative actions). In addition to reviewing evidence on these points, we provide a broad three-step model of implementation research in mHealth that focuses on understanding and preventing health concerns to facilitate the safe and effective scalability of mHealth (and that may be generalizable and applied to similar technologies): (1) evaluating and better discerning public perceptions and misperceptions (and how these may differ between populations), (2) developing theory-based public health communication strategies regarding the safety of mHealth, and (3) disseminating this messaging using evidence-based methods. Collectively, these steps converge on reviewing evidence regarding the potential role of worry and nocebo in mHealth and providing a model for understanding and changing attitudes and preventing unfounded negative perceptions related to mHealth technology.
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Affiliation(s)
- Frank T Materia
- The Pennsylvania State University, University Park, PA, United States
| | - Kate Faasse
- University of New South Wales, Sydney, Australia
| | - Joshua M Smyth
- The Pennsylvania State University, University Park, PA, United States
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Optimizing expectations about endocrine treatment for breast cancer: Results of the randomized controlled psy-breast trial. CLINICAL PSYCHOLOGY IN EUROPE 2020; 2:e2695. [DOI: 10.32872/cpe.v2i1.2695] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/20/2019] [Accepted: 11/05/2019] [Indexed: 11/25/2022] Open
Abstract
Background
Medication side effects are strongly determined by non-pharmacological, nocebo mechanisms, particularly patients’ expectations. Optimizing expectations could minimize side effect burden. This study evaluated whether brief psychological expectation management training (EXPECT) optimizes medication-related expectations in women starting adjuvant endocrine therapy (AET) for breast cancer.
Method
In a multisite randomized controlled design, 197 women were randomized to EXPECT, supportive therapy (SUPPORT), or treatment as usual (TAU). The three-session cognitive-behavioral EXPECT employs psychoeducation, guided imagery, and side effect management training. Outcomes were necessity-concern beliefs about AET, expected side effects, expected coping ability, treatment control expectations, and adherence intention.
Results
Both interventions were well accepted and feasible. Patients’ necessity-concern beliefs were optimized in EXPECT compared to both TAU and SUPPORT, d = .41, p < .001; d = .40, p < .001. Expected coping ability and treatment control expectations were optimized compared to TAU, d = .35, p = .02; d = .42, p < 001, but not to SUPPORT. Adherence intention was optimized compared to SUPPORT, d = .29, p = .02, but not to TAU. Expected side effects did not change significantly.
Conclusion
Expectation management effectively and partly specifically (compared to SUPPORT) modified medication-related expectations in women starting AET. Given the influence of expectations on long-term treatment outcome, psychological interventions like EXPECT might provide potential pathways to reduce side effect burden and improve quality of life during medication intake.
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El Brihi J, Horne R, Faasse K. Prescribing Placebos: An Experimental Examination of the Role of Dose, Expectancies, and Adherence in Open-Label Placebo Effects. Ann Behav Med 2020; 53:16-28. [PMID: 29547962 DOI: 10.1093/abm/kay011] [Citation(s) in RCA: 34] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022] Open
Abstract
Background Recent evidence indicates that placebo effects can occur even when patients know that they are taking a placebo, termed the open-label placebo effect. Aim To assess whether placebo dose (one pill per day vs. four pills per day), treatment expectancies, and adherence contribute to open-label placebo effects. Method Healthy undergraduate participants were randomly assigned to take one or four open-label placebo pills per day or to a no-treatment control group. Placebo-treated participants took a 5-day course of an open-label placebo described as enhancing physical (symptoms and sleep) and psychological (positive and negative emotional experience) well-being. Expectancies about placebo effectiveness and well-being were assessed at baseline, and well-being and adherence were assessed after the 5-day course of treatment. Results Medium-to-large open-label placebo effects were evidenced in all well-being outcomes including sleep quality. Dose did not influence these effects. Both treatment expectancies and adherence were significant independent predictors of enhanced well-being in the two psychological well-being outcomes and the experience of physical symptoms, but sleep quality improved independently. Conclusions This is the first study to demonstrate the effect of open-label placebos in improving well-being and sleep quality and to show that open-label placebo reposes do not appear to be dose-dependent, but for most well-being outcomes are independently predicted by both positive expectancies and treatment adherence.
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Affiliation(s)
- Jason El Brihi
- School of Psychology, Faculty of Science, University of New South Wales, Sydney NSW, Australia
| | - Rob Horne
- School of Pharmacy, Faculty of Life Sciences, University College London, London, England
| | - Kate Faasse
- School of Psychology, Faculty of Science, University of New South Wales, Sydney NSW, Australia
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46
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Raglin J, Szabo A, Lindheimer JB, Beedie C. Understanding placebo and nocebo effects in the context of sport: A psychological perspective. Eur J Sport Sci 2020; 20:293-301. [PMID: 32023170 PMCID: PMC10181913 DOI: 10.1080/17461391.2020.1727021] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/27/2022]
Abstract
Research over the past 15 years on the placebo effect has substantiated its contribution to the efficacy of established treatments for a range of clinical conditions and identified its underlying mechanisms. There is also evidence that placebo effects contribute to the performance benefits of many ergogenic aids, and that performance can worsen when dummy treatments are associated with expectations of a harmful outcome (i.e. nocebo effect). Unfortunately, the bulk of sport research involving placebos and nocebos continues to be hampered by outdated definitions and conceptualizations of placebo effects and their mechanisms. This has implications not only for research but also application, as nearly 50% of athletes report experiencing a beneficial placebo effect, and a similar proportion of coaches report providing placebos to their athletes. The objective of this paper is to attempt to stimulate research by presenting updated definitions of placebo and nocebo effects in the context of sport, describing their major mechanisms and, highlighting the importance of the psychosocial context on placebo effects in the sport setting.
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Affiliation(s)
- John Raglin
- Department of Kinesiology, School of Public Health, Indiana University, Bloomington, IN, USA
| | - Attila Szabo
- Institute of Health Promotion and Sport Sciences, ELTE Eötvös Loránd University, Budapest, Hungary
| | - Jacob B Lindheimer
- William S. Middleton Veterans Memorial Hospital, Madison, WI, USA.,Department of Kinesiology, University of Wisconsin-Madison, Madison, WI, USA
| | - Chris Beedie
- School of Psychology, University of Kent, Canterbury, UK
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Al Sulais E, AlAmeel T. Biosimilars to Antitumor Necrosis Factor Agents in Inflammatory Bowel Disease. Biologics 2020; 14:1-11. [PMID: 32021084 PMCID: PMC6966952 DOI: 10.2147/btt.s236433] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/29/2019] [Accepted: 12/19/2019] [Indexed: 12/17/2022]
Abstract
Anti- tumor Necrosis Factor (anti-TNF) agents are the backbone treatment of moderate to severe cases of inflammatory bowel disease. One of the main drawbacks of these agents is the high cost. The introduction of biosimilar products to anti-TNF agents is expected to lower the cost. Health care providers ought to be aware of the available data that addresses the safety and efficacy of biosimilars in IBD patients. This article outlines the current evidence-based data regarding the available biosimilar products, their safety, efficacy and how to deal with patients’ concerns.
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Affiliation(s)
- Eman Al Sulais
- Department of Medicine, Royal Commission Hospital, Jubail, Saudi Arabia
| | - Turki AlAmeel
- Department of Medicine, King Fahad Specialist Hospital, Dammam, Saudi Arabia
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48
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Arnold MH, Finniss D, Luscombe GM, Kerridge I. An Exploration of Knowledge and Attitudes of Medical Students and Rheumatologists to Placebo and Nocebo Effects: Threshold Concepts in Clinical Practice. JOURNAL OF MEDICAL EDUCATION AND CURRICULAR DEVELOPMENT 2020; 7:2382120520930764. [PMID: 32613080 PMCID: PMC7309386 DOI: 10.1177/2382120520930764] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 04/19/2020] [Accepted: 05/08/2020] [Indexed: 06/11/2023]
Abstract
INTRODUCTION Understanding placebo and nocebo responses (context/meaning effects [CMEs]) is fundamental to physician agency. Specific instruction in CMEs is often lacking in medical education. Patient-practitioner interactions may challenge medical students' understanding of biomedical causality and the nexus between this, practical ethics and professionalism across various conceptual and applied aspects of CMEs. This study compared the corpus of knowledge and phronesis related to CMEs between Australian graduate medical students and rheumatologists to gain a sophisticated understanding of this relationship to inform curriculum development. METHOD In 2013 and 2014, the authors surveyed third-year medical students undertaking a graduate programme in an Australian medical school and Australian rheumatologists to ascertain their understanding of placebo and nocebo responses. The survey ascertained (1) the alignment of the respondents' understanding of CMEs with accepted facts and concepts; (2) opinions on the ethical status of CMEs; and (3) responses to 2 scenarios designed to explore matters of biomedical causality, practical ethics and professionalism. RESULTS There were 88 completed surveys returned, 53 rheumatologists and 35 students. Similar proportions within each group identified CMEs, with most (n = 79/88 [89.8%]) correctly recognising a placebo (rheumatologists: 50 [94.3%], students: 29 [82.9%]) and approximately three-quarters (n = 65/88 [73.9%]) correctly recognising nocebo effects (rheumatologists: 39 [73.6%], students: 26 [74.3%]). Statistically significant differences between practitioners and students were observed in relation to the following: placebo responders and placebo responsiveness; placebos as a 'diagnostic tool'; placebos usage in clinical practice and research, and nocebo effects. CONCLUSIONS Physicians require an awareness of CMEs and the fact that they arise from and influence the effective agency of health care professionals. Curricular emphasis is needed to permit an honest assessment of the components that influence when, how and why patient outcomes arise, and how one's agency might have neutral or negative effects but could be inclined towards positive and away from negative patient outcomes.
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Affiliation(s)
- Mark H Arnold
- School of Rural Health (Dubbo/Orange), Sydney Medical School, Faculty of Medicine and Health, University of Sydney, NSW, Australia
| | - Damien Finniss
- Department of Anaesthesia & Pain Management Research Institute, Royal North Shore Hospital and; Faculty of Medicine and Health, University of Sydney, NSW, Australia
| | - Georgina M Luscombe
- School of Rural Health (Dubbo/Orange), Sydney Medical School, Faculty of Medicine and Health, University of Sydney, NSW, Australia
| | - Ian Kerridge
- Sydney Health Ethics, Faculty of Medicine and Health, University of Sydney, and Department of Haematology, Royal North Shore Hospital, NSW, Australia
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[Biosimilars and the nocebo effect]. Z Rheumatol 2019; 79:267-275. [PMID: 31802197 DOI: 10.1007/s00393-019-00729-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Abstract
Biosimilars have been approved for use in Germany for many years and in the meantime also in rheumatology but only a few years ago. Biosimilars, which are biotechnologically manufactured products the same as reference biologicals, have actually now achieved a substantial proportion of the market in some regions but there are still doubters among patients and physicians who fear a loss of quality even if there is no evidence for this. A part of this problem can be explained by the nocebo effect but which furthermore also has a substantial medical importance. This effect is described and explained in this article. Psychosocial and context-related factors, such as the relationship between patient and physician, previous experience with treatment and treatment expectations can either improve or impair the efficacy of treatment interventions. These phenomena are commonly known as placebo and nocebo effects. As placebo and nocebo effects can influence the development of symptoms, the frequency of undesired events and the efficacy of treatment, it is decisive to know these effects and to develop strategies for prevention in order to optimize the treatment results. Although in recent years experimental studies have achieved substantial progress in the clarification of the psychosocial and neurobiological mechanisms of placebo effects, detailed mechanisms of nocebo effects are still widely unexplored. An improved understanding of these mechanisms promises the development of user-friendly strategies for the clinical care to improve treatment results and patient satisfaction.
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Newman CB, Preiss D, Tobert JA, Jacobson TA, Page RL, Goldstein LB, Chin C, Tannock LR, Miller M, Raghuveer G, Duell PB, Brinton EA, Pollak A, Braun LT, Welty FK. Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association. Arterioscler Thromb Vasc Biol 2019; 39:e38-e81. [PMID: 30580575 DOI: 10.1161/atv.0000000000000073] [Citation(s) in RCA: 449] [Impact Index Per Article: 74.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
One in 4 Americans >40 years of age takes a statin to reduce the risk of myocardial infarction, ischemic stroke, and other complications of atherosclerotic disease. The most effective statins produce a mean reduction in low-density lipoprotein cholesterol of 55% to 60% at the maximum dosage, and 6 of the 7 marketed statins are available in generic form, which makes them affordable for most patients. Primarily using data from randomized controlled trials, supplemented with observational data where necessary, this scientific statement provides a comprehensive review of statin safety and tolerability. The review covers the general patient population, as well as demographic subgroups, including the elderly, children, pregnant women, East Asians, and patients with specific conditions such as chronic disease of the kidney and liver, human immunodeficiency viral infection, and organ transplants. The risk of statin-induced serious muscle injury, including rhabdomyolysis, is <0.1%, and the risk of serious hepatotoxicity is ≈0.001%. The risk of statin-induced newly diagnosed diabetes mellitus is ≈0.2% per year of treatment, depending on the underlying risk of diabetes mellitus in the population studied. In patients with cerebrovascular disease, statins possibly increase the risk of hemorrhagic stroke; however, they clearly produce a greater reduction in the risk of atherothrombotic stroke and thus total stroke, as well as other cardiovascular events. There is no convincing evidence for a causal relationship between statins and cancer, cataracts, cognitive dysfunction, peripheral neuropathy, erectile dysfunction, or tendonitis. In US clinical practices, roughly 10% of patients stop taking a statin because of subjective complaints, most commonly muscle symptoms without raised creatine kinase. In contrast, in randomized clinical trials, the difference in the incidence of muscle symptoms without significantly raised creatinine kinase in statin-treated compared with placebo-treated participants is <1%, and it is even smaller (0.1%) for patients who discontinued treatment because of such muscle symptoms. This suggests that muscle symptoms are usually not caused by pharmacological effects of the statin. Restarting statin therapy in these patients can be challenging, but it is important, especially in patients at high risk of cardiovascular events, for whom prevention of these events is a priority. Overall, in patients for whom statin treatment is recommended by current guidelines, the benefits greatly outweigh the risks.
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