Efficacy of individualized homeopathic medicines in primary dysmenorrhea: a double-blind, randomized, placebo-controlled, clinical trial
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Shubhamoy Ghosh
, Rai Khushboo Ravindra
Abstract
Objectives
Homeopathic treatment is claimed to be beneficial for primary dysmenorrhoea (PD); still, systematic research evidences remain compromised. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IH) against placebo in the treatment of PD.
Methods
A double-blind, randomized, placebo-controlled trial was conducted at the gynecology outpatient department of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IH (n=64) or identical-looking placebo (n=64). Primary and secondary outcome measures were 0–10 numeric rating scales (NRS) measuring intensity of pain of dysmenorrhea and verbal multidimensional scoring system (VMSS) respectively; all measured at baseline, and every month, up to 3 months. Group differences and effect sizes (Cohen’s d) were calculated on intention-to-treat (ITT) sample.
Results
Groups were comparable at baseline (all p>0.05). Attrition rate was 10.9% (IH: 7, placebo: 7). Differences between groups in both pain NRS and VMSS favoured IH over placebo at all time points (all p<0.001, unpaired t-tests and two-ways repeated measures analysis of variance) with medium to large effect sizes. Natrum muriaticum and Pulsatilla nigricans (n=20 each; 15.6%) were the most frequently prescribed medicines. No harms, serious adverse events and intercurrent illnesses were recorded in either of the groups.
Conclusions
Homeopathic medicines acted significantly better than placebo in the treatment of PD. Independent replication is warranted. Trial registration: CTRI/2018/10/016013.
Acknowledgments
The authors are grateful to institutional heads, both academic and hospital section for allowing us to conduct the trial. We sincerely thank the fellow postgraduate trainees, staff, pharmacists and the patients for their sincere participation in the study.
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Research funding: None declared.
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Author contributions: SG, RKR, AM, and SM: Concept, literature search, clinical study, data acquisition, data interpretation and preparation of the article; AN, MK and SS: Concept, literature search, design, data interpretation, statistical analysis, preparation of the article. All the authors reviewed and approved the final paper.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The study protocol was sanctioned by the institutional ethical committee (IEC) [Ref. No. 1364/MBHMHC/CH/PRIN/ADM/18; dated September 25, 2018].
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Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/jcim-2020-0512).
© 2021 Walter de Gruyter GmbH, Berlin/Boston
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- Frontmatter
- Reviews
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- Non-alcoholic fatty liver disease – discussed under the light of Unani medicine
- Phytochemistry and pharmacology of Celastrus paniculatus Wild.: a nootropic drug
- Low back pain patients’ perceived effectiveness of utilizing complementary and alternative medicine: a systematic review of qualitative studies
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- Evaluation of the toxicity of crude aqueous Pleurotus tuber-regium (Fr.) Singer extract in mice
- Effects of crude methanol extract of Adansonia digitata fruit pulp on Naja nigricollis venom-induce toxicity in Wistar rats
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- Antimicrobial, anti-adhesion, anti-biofilm properties of goji berry (Lycium barbarum) against periodontal bacteria: potential benefits for periodontal diseases
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