Developing the criteria for evaluating quality of individualization in homeopathic clinical trial reporting: a preliminary study

Saha, Subhranil; Koley, Munmun; Ganguly, Shirshendu; Rath, Prasanta; Chowdhury, Pulak Roy; Hossain, Seikh Intaj

doi:10.1016/s2095-4964(14)60009-1

Cited by 13 publications

(6 citation statements)

References 17 publications

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“…Subsequent prescriptions were generated according to Kent's observations and second prescription. Thus results of this study adhered to the criteria for reporting individualization in homeopathy [24].…”

Section: Methodssupporting

confidence: 53%

Treatment of hemorrhoids with individualized homeopathy – an open observational pilot study

Ghosh

Debdas²,

et al. 2017

AHZ

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Aim: Controversies and disagreement exist on conventional treatment strategies of hemorrhoids due to relapse, inefficacy, and complications. We intend to evaluate the role of individualized homeopathic treatment in hemorrhoids. Materials and Methods: In this prospective, open, observational trial, hemorrhoids patients were treated using five standardized scales measuring complaints severity and anoscopic score. It was conducted at two homeopathic hospitals in India, during from mid-July 2014 to mid-July 2015. Patients were intervened as per individualized homeopathic principles and followed up every month up to 6 months. Results: Total 73 were screened, 52 enrolled, 38 completed, 14 dropped out. Intention to treat population (n = 52) was analyzed in the end. Statistically significant reductions of mean bleeding (month 3: −21.8, 95% confidence interval [CI]: −30.3, −13.3, P < 0.00001, d = 0.787; month 6: −25.5, 95% CI −35.4, −15.6, P < 0.00001, d = 0.775), pain (month 3: −21.3, 95% CI −28.6, −14.0, P < 0.00001, d = 0.851; month 6: −27.6, 95% CI −35.6, −19.6, P < 0.00001, d = 1.003), heaviness visual analog scales (VASs) (month 3: −8.1, 95% CI −13.9, −2.3, P = 0.008, d = 0.609; month 6: −12.1, 95% CI −19.1, −5.1, P = 0.001, d = 0.693), and anoscopic score (month 3: −0.4, 95% CI −0.6, −0.2, P < 0.0001, d = 0.760; month 6: −0.5, 95% CI −0.7, −0.3, P < 0.0001, d = 0.703) were achieved. Itching VASs reduced significantly only after 6 months (−8.1, 95% CI −14.6, −1.6, P = 0.017, d = 0.586). No significant lowering of discharge VASs was achieved after 3 and 6 months. Conclusion: Under classical homeopathic treatment, hemorrhoids patients improved considerably in symptoms severity and anoscopic scores. However, being observational trial, our study cannot provide efficacy data. Controlled studies are required. Trial Reg. CTRI/2015/07/005958.

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Section: Methodssupporting

confidence: 53%

Treatment of hemorrhoids with individualized homeopathy – an open observational pilot study

Ghosh

Debdas²,

et al. 2017

AHZ

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“…The quality of homeopathic individualization was evaluated by the six judgemental criteria proposed by Saha et al [25] (2014):…”

Section: Methodsmentioning

confidence: 99%

A Systematic Review of Controlled Trials of Homeopathy in Bronchial Asthma

et al. 2019

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Homeopathy is a controversial form of complementary therapy, but is widely practised to treat asthma. The aim of this systematic review is to evaluate the controlled trials of homeopathy in bronchial asthma. Relevant trials published between Jan 1, 1981, and Dec 31, 2016, were considered. Substantive research articles, conference proceedings, and master and doctoral theses were eligible. Methodology was assessed by Jadad’s scoring, internal validity by the Cochrane tool, model validity by Mathie’s criteria, and quality of individualization by Saha’s criteria. Sixteen trials were eligible. The majority were positive, especially those testing complex formulations. Methodological quality was diverse; 8 trials had “high” risk of bias. Model validity and individualization quality were compromised. Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive. The trials were positive (evidence level A), but inconsistent, and suffered from methodological heterogeneity, “high” to “uncertain” risk of bias, incomplete study reporting, inadequacy of independent replications, and small sample sizes.

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“…Reporting adhered to the “reporting data on homeopathic treatments” guidelines 25 and criteria for reporting individualization in homeopathy. 26…”

Section: Methodsmentioning

confidence: 99%

“…26 Statistical analyses were performed using computational websites. The intention-to-treat population (n ¼ 60) was analyzed in the end.…”

Section: Inclusion Criteriamentioning

confidence: 99%

A Double-Blind Randomized Placebo-Controlled Feasibility Study Evaluating Individualized Homeopathy in Managing Pain of Knee Osteoarthritis

Koley

Saha

Ghosh

2015

J Evid Based Complementary Altern Med

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Developing the criteria for evaluating quality of individualization in homeopathic clinical trial reporting: a preliminary study

Cited by 13 publications

References 17 publications

Treatment of hemorrhoids with individualized homeopathy – an open observational pilot study

Treatment of hemorrhoids with individualized homeopathy – an open observational pilot study

A Systematic Review of Controlled Trials of Homeopathy in Bronchial Asthma

A Double-Blind Randomized Placebo-Controlled Feasibility Study Evaluating Individualized Homeopathy in Managing Pain of Knee Osteoarthritis

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