Systematic Reviews
Copyright ©The Author(s) 2022.
World J Methodol. May 20, 2022; 12(3): 132-147
Published online May 20, 2022. doi: 10.5662/wjm.v12.i3.132
Table 1 Baseline study characteristics, and summary of risk of bias assessment
No
Ref.
Country of 1st author
Type of randomized controlled trial
Patient profile
Intervention1
Comparator1
Overall risk of bias as per RoB-2 tool2
Sample size
Mean age
Male (N, %)
Sample size
Mean age
Male (N, %)
1Enesel et al[18], 2005RomaniaParallel groupPatients undergoing surgery for GIT cancer4062 (range 37-87)23 (57.5)30NANA-
2Ishikawa et al[21], 2006JapanParallel groupPatients with inoperable colon/liver/pancreatic cancer2563.6 ± 8.321 (84)2565.8 ± 6.318 (72%)?
3Brush et al[22], 2006United StatesParallel groupHealthy adult volunteers3NANA2NANA-
4Schink et al[27], 2007GermanyParallel groupPrimary/locally relapsed colorectal carcinoma patients undergoing open (complete/partial) tumour resection1172 ± 8.27 (63.6)1169 ± 10.45 (45.5)?
5Purandare et al[33], 2007IndiaParallel groupPatients with diabetic foot ulcer2356.2617 (73.9)2256.3219 (86.4)?
6Uebaba et al[29], 2008JapanCrossoverHealthy adult female volunteers1639 ± 90 (0)1639 ± 90 (0)?
7Bhat et al[28], 2010IndiaParallel group (I) Healthy adult volunteers13NANA13NANA?
Crossover (II)Healthy adult volunteers110NANA110NANA-
8Işik et al[23], 2010TurkeyParallel groupAllergic rhinitis patients with house dust mite sensitivity12NANA12NANA-
9Kianbakht et al[30], 2011IranParallel groupHealthy adult male volunteers4522.5 ± 0.645 (100)4421.1 ± 0.544 (100)?
10Mondal et al[24], 2011IndiaCrossoverHealthy adult volunteers22NANA22NANA?
11Nantz et al[26], 2012United StatesParallel groupHealthy adult volunteers5625.4 ± 5.723 (41.1)5626.9 ± 7.126 (46.4)?
12Suprabha et al[32], 2017IndiaParallel groupUncomplicated pregnant women in 20-24 wk of pregnancy15NANA15NANA?
13Gupta et al[34], 2017IndiaParallel groupHealthy children aged 5-12 yr3137.3 ± 1.8161 (51.4)3147.4 ± 1.8164 (52.2)?
14Rais et al[36], 2021IndiaParallel group25-60 yr, asymptomatic/ uncomplicated COVID-19 RTPCR +ve, mild symptoms80NA57 (71.3)40NA30 (75)-
15Bhaskaran et al[31], 2019IndiaParallel groupHealthy full-term infants (< 12 mo age), > 2.5 kg birth weight, with normal growth and development47NANA34NANA-
16Kumar et al[35], 2014IndiaParallel groupAdult patients with T2DM of any stage56NANA28NANA-
17Ravindran et al[25], 2014IndiaParallel groupPatients with head & neck cancer in complete remission following primary treatment37NANA38NANA?
18Somarathna et al[20], 2010IndiaParallel groupHIV +ve patients without AIDS surveillance signs as per WHO, and no concurrent illness21NANA6NANA-
19Gupta et al[19], 2010IndiaParallel groupNew HIV +ve patients with CD4 count not < 150/microliter and no complications or comorbidities12NANA8NANA-
1Not all studies had reported demographics of participants including age and sex.
2Separate versions of RoB-2 were used for RCTs with parallel group design and crossover design. Interpretation: ?: Some concerns of bias; -: High risk of bias. Detailed risk of bias assessment results: Supplementary Table 4. HIV: Human immunodeficiency virus; NA: Not available; GIT: Gastrointestinal tract; COVID-19: Coronavirus disease 2019; RTPCR: Reverse transcription polymerase chain reaction.
Table 2 Details of intervention and comparators
No
Ref.
Description
Intervention: Ayurvedic name1
Intervention: Scientific name
Intervention: Route; dose, frequency, duration2
Comparator: Description; route, dose, frequency, duration2
1Enesel et al[18], 2005Isorel® (Mistletoe, firtree)Bandaaka, Suvarna-bandaaka etc.Viscum albumSubcutaneous; 2 wk pre-operatively, 2 wk post-operatively; dose details not clearStandard care
2Ishikawa et al[21], 2006Aged garlic extractLashuna, Rasona etc.Allium sativumOral; 125 mg, 4 capsules daily, 12 wkMatching placebo
3Brush et al[22], 2006Glycyrrhizia glabra tinctureYashtimadhu, Madhuyashtyaahvaa etc.Glycyrrhiza glabraOral; 0.44 g/7.5 mL, twice daily, 7 dMatching placebo tincture
4Schink et al[27], 2007Standard care + Iscador® (Standardized mistletoe extract)Bandaaka, Suvarna-bandaaka etc.Viscum albumIV infusion; 5 mg, single doseStandard care
5Purandare et al[33], 2007Standard care + Tinospora cordifoliaGuduuchi, Guduuchikaa etc.Tinospora cordifoliaDetails not availableStandard care + matching Placebo
6Uebaba et al[29], 2008Shirodhara oil-dripping treatment using sesame oilShirodhara; Tila, SnehphalaSesamum indicumOil dripping on forehead; single sittingControl supine position; single sitting
7Bhat et al[28], 2010Fortified tea with Withania somnifera, Glycyrrhzia glabra, Zingiber officinale, Ocimum sanctum & Elettaria cardamomumAshwagandha; Yashtimadhu; Aardraka, Shunthi; Tulasi; ElaaWithania somnifera, Glycyrrhzia glabra, Zingiber officinale, Ocimum sanctum, Elettaria cardamomumOral; 2.06 g, thrice daily, 2 moRegular tea; Oral; 2 g, thrice daily, 2 mo
8Işik et al[23], 2010Specific immunotherapy + Nigella sativaKaalaajaaji, Kalikaa etc.Nigella sativaOral; 2 g daily, 1 moSpecific immunotherapy alone
9Kianbakht et al[30], 2011Saffron tabletKumkuma, Rudhira, Kaashmiraka etc.Crocus sativusOral; 100 mg daily, 6 wkMatching placebo
10Mondal et al[24], 2011Tulsi capsulesTulasi, Surasa, Suravalli etc.Ocimum sanctumOral; 300 mg daily, 4 wkMatching placebo
11Nantz et al[26], 2012Aged garlic extractLashuna, Rasona etc.Allium sativumOral; 640 mg, 4 capsules daily, 90 dMatching placebo
12Suprabha et al[32], 2017Rasayana Avaleha with milkComposite4Composite4Oral; 12 g, twice daily, 2 moCalcium carbonate (500 mg) with ferrous sulfate (200 mg); Oral; daily, 2 mo
13Gupta et al[34], 2017Cyavanaprasa (Dabur) with milkComposite4Composite4Oral; 6 g, twice daily, 6 moMilk; Oral, 100-200 mL, twice daily, 6 mo
14Rais et al[36], 2021Intervention 1: Vyaghryadi Kashaya (50 mL) + Pippali (250 mg) + Samshamani vati (500 mg)Vyaghryadi Kashaya: Kantakari, Shunthi, Guduchi; Pippali; Samshamani vati: GuduchiSolanum xanthocarpum, Zingiber officinale, Tinospora cordifolia, Piper longumOral; twice daily, 10 dVitamin C (500 mg) twice daily, Paracetamol (500 mg) as needed
Intervention 2: Shunthi churna (2 g) + Rasona kalka (1 g)Shunthi; Rasona, LasunaZingiber officinale, Allium sativumOral; Shunti churna: Twice daily, Rasona: once daily; 10 d
15Bhaskaran et al[31], 2019Swarna Bhasma (Calcined powder of gold), honey, ghritaSwarna prashana, madhu, ghritaNAOral; Swarna bhasma: 0.2-2.4 mg3; once daily, 4 wkOral Honey + ghrita; dose details not available
16Kumar et al[35], 2014Intervention 1: Mamajjaka capsulesMaamajjaka, Naagjhvaa etc.Enicostemma littoraleOral; 500 mg, twice daily, 3 moControl; no details available
Intervention 2: Shilajatu capsulesShilajatuAsphaltum punjabinumOral; 500 mg, twice daily, 3 mo
17Ravindran et al[25], 2014Varunadi Ghrita + Standard careComposite4Composite4Oral; 5 g, twice daily, 1 yStandard care
18Somarathna et al[20], 2010Ranahamsa RasayanaComposite4Composite4Oral; 5 g, twice daily, 90 dStandard care
19Gupta et al[19], 2010Shilajatu RasayanaComposite4Composite4Oral; 95 g over first 15 d, later 6 g per day for 75 dStandard care
1Out of various Ayurvedic names, only two are mentioned.
2d: Day; wk: Week; m: Month; yr: Year.
3Dosage varied based on age of infant.
4Detailed composition: Supplementary Table 3. IV: Intravenous.
Table 3 Results from the included studies: Impact of Ayurvedic medication on components of the immune system
No
Ref.
Intervention
T Helper cells
T cytotoxic cells
T cells: Other results
NK cell count/ activity
B lymphocyte count
Immunoglobulins
Complement
Cytokines
WBC count/ activity
Other variables
Indirect evidence
1Enesel et al, 2005Isorel® (Mistletoe, firtree)+-++-++NA++NA
2Ishikawa et al, 2006Aged garlic extract--NA+NANANANA-NANA
3Brush et al, 20061Glycyrrhizia glabra tincture+/-+/-NA+/-+/-NANANANANANA
4Schink et al, 2007Iscador® (Standardized mistletoe extract)NANANA+NANANANANA-NA
5Purandare et al, 2007Tinospora cordifoliaNANANANANANANANA+NANA
6Uebaba et al, 20082Shirodhara oil-dripping (sesame oil)NANANA+/-NANANANANANANA
7Bhat et al, 20103Fortified tea with multiple Ayurvedic ingredientsNANANA+/-NANANANANANANA
8Işik et al, 2010Specific immunotherapy + Nigella sativa+/-+/-+/-+/-+/-NANANA+NANA
9Kianbakht et al, 2011Saffron tabletNANANANANA--NA-NANA
10Mondal et al, 20114Tulsi capsules+/-+/-NA+/-+/-NANA+/-NANANA
11Nantz et al, 20125Aged garlic extractNANA+/-+/-NANANA+/-NANA+
12Suprabha et al, 2017Rasayana Avaleha with milkNANANANANA-NANANANANA
13Gupta et al, 2017Cyavanaprasa (Dabur) with milkNANANANANANANANANANA+
14Rais et al, 2021Intervention 1: Vyaghryadi Kashaya + Pippali + Samshamani vati NANANANANANANANANANA-
Intervention 2: Shunthi churna + Rasona kalkaNANANANANANANANANANA-
15Bhaskaran et al, 20196Swarna Bhasma, honey, ghritaNANANANANA+/-NANA+/-NANA
16Kumar et al, 2014Intervention 1: Mamajjaka capsulesNANANANANANANANANANA+
Intervention 2: Shilajatu capsulesNANANANANANANANANANA+
17Ravindran et al, 2014Varunadi Ghrita + Standard careNANA+++NANANANANANA
18Somarathna et al, 2010Ranahamsa Rasayana+NANANANANANANA-NANA
19Gupta et al, 2010Shilajatu Rasayana+NANANANANANANANANANA
SUMMARY+30241110314
+/-33263102100
-12001210312
+: Evidence suggests significant immune enhancement; +/-: Ambiguous, confusing, or incomplete results; -: Evidence does not suggest significant immune enhancement.
1Sample size is 5 participants; significance values of any results not reported in the paper.
2paper reports only significance (P value) without reporting the value of NK cell activity.
3study I (parallel group study design) reports only significance (P value) without reporting the value of NK cell activity, and study II (crossover design) has less than optimal washout period, and there is a difference in numbers between text and table.
4paper reports only significance (P value) without reporting the value of T lymphocytes, B lymphocytes, NK cells, and cytokines.
5paper reports only significance (P value) without reporting the value of T lymphocytes and NK cells.
6paper reports only significance (P value) and mean difference without reporting the value of immunoglobulins and total or differential white blood cell counts.
NA: Not available; NK: Natural killer; WBC: White blood cell.