Clinical Trials Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 21, 2015; 21(15): 4652-4659
Published online Apr 21, 2015. doi: 10.3748/wjg.v21.i15.4652
Effect of clinician-patient communication on compliance with flupentixol-melitracen in functional dyspepsia patients
Xiu-Juan Yan, Wen-Ting Li, Xin Chen, Er-Man Wang, Qing Liu, Hong-Yi Qiu, Zhi-Jun Cao, Sheng-Liang Chen
Xiu-Juan Yan, Wen-Ting Li, Xin Chen, Er-Man Wang, Qing Liu, Hong-Yi Qiu, Zhi-Jun Cao, Sheng-Liang Chen, Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
Author contributions: Chen SL and Cao ZJ designed the study and provided a critical review of the manuscript; Chen X, Wang EM, Liu Q and Qiu HY collected data, and helped to draft the manuscript; Yan XJ and Li WT conducted the statistical analysis and drafted the manuscript; all authors have read and approved the final manuscript.
Supported by National Natural Science Foundation of China, No. 81470812, No. 81270463, No. 31171106, and No. 81070302 (to Chen SL).
Ethics approval: The study was reviewed and approved by the Ethics Committee of Shanghai Jiao Tong University School of Medicine, Renji Hospital.
Clinical trial registration: This study is registered at https://clinicaltrials.gov/show/NCT01851863. The registration identification number is NCT01851863.
Informed consent: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest: The authors declare that there are no conflicting interests.
Data sharing: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Zhi-Jun Cao, MD, Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, No. 145 Shandong Road, Shanghai 200001, China. caozj_renji@163.com
Telephone: +86-21-58752345 Fax: +86-21-63730455
Received: December 22, 2014
Peer-review started: December 23, 2014
First decision: January 22, 2015
Revised: February 10, 2015
Accepted: March 18, 2015
Article in press: March 19, 2015
Published online: April 21, 2015
Processing time: 118 Days and 18.7 Hours
Abstract

AIM: To explore whether clinician-patient communication affects adherence to psychoactive drugs in functional dyspepsia (FD) patients with psychological symptoms.

METHODS: A total of 262 FD patients with psychological symptoms were randomly assigned to four groups. The patients in Groups 1-3 were given flupentixol-melitracen (FM) plus omeprazole treatment. Those in Group 1 received explanations of both the psychological and gastrointestinal (GI) mechanisms of the generation of FD symptoms and the effects of FM. In Group 2, only the psychological mechanisms were emphasized. The patients in Group 3 were not given an explanation for the prescription of FM. Those in Group 4 were given omeprazole alone. The primary endpoints of this study were compliance rate and compliance index to FM in Groups 1-3. Survival analyses were also conducted. The secondary end points were dyspepsia and psychological symptom improvement in Groups 1-4. The correlations between the compliance indices and the reductions in dyspepsia and psychological symptom scores were also evaluated in Groups 1-3.

RESULTS: After 8 wk of treatment, the compliance rates were 67.7% in Group 1, 42.4% in Group 2 and 47.7% in Group 3 (Group 1 vs Group 2, P = 0.006; Group 1 vs Group 3, P = 0.033). The compliance index (Group 1 vs Group 2, P = 0.002; Group 1 vs Group 3, P = 0.024) with the FM regimen was significantly higher in Group 1 than in Groups 2 and 3. The survival analysis revealed that the patients in Group 1 exhibited a significantly higher compliance rate than Groups 2 and 3 (Group 1 vs Group 2, P = 0.002; Group 1 vs Group 3, P = 0.018). The improvement in dyspepsia (Group 1 vs Group 2, P < 0.05; Group 1 vs Group 3, P < 0.05; Group 1 vs Group 4, P < 0.01) and psychological symptom scores (anxiety: Group 1 vs Group 2, P < 0.01; Group 1 vs Group 3, P < 0.05; Group 1 vs Group 4, P < 0.01; depression: Group 1 vs Group 2, P < 0.01; Group 1 vs Group 3, P < 0.01; Group 1 vs Group 4, P < 0.01) in Group 1 were greater than those in Groups 2-4. The compliance indices were positively correlated with the reduction in symptom scores in Groups 1-3.

CONCLUSION: Appropriate clinician-patient communication regarding the reasons for prescribing psychoactive drugs that emphasizes both the psychological and GI mechanisms might improve adherence to FM in patients with FD.

Keywords: Functional dyspepsia; Anxiety; Depression; Psychoactive drug; Compliance

Core tip: Antianxiety and antidepressant agents are reportedly more effective in the treatment of functional dyspepsia than the regular first-line medications such as proton pump inhibitors and prokinetics. However, their efficacies are greatly hindered by the poor compliance of functional dyspepsia patients. Appropriate clinician-patient communication regarding the reason for prescribing a psychoactive drug that emphasized both the psychological and gastrointestinal mechanisms might improve drug adherence and thus contribute to improvements in their clinical outcomes.