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Efficacy of Individualized Homeopathic Medicines in Plantar Fasciitis: Double-blind, Randomized, Placebo-Controlled Clinical TrialFunding We received no funding for the project. The institution played no role in analysis of the study results or in the preparation of the paper.
Introduction Plantar fasciitis (PF) is a chronic degenerative condition causing marked thickening and fibrosis of the plantar fascia, and collagen necrosis, chondroid metaplasia and calcification. There is little convincing evidence in support of various approaches, including homeopathy, for treating PF. This study was undertaken to examine the efficacy of individualized homeopathic medicines (IHMs) compared with placebo in the treatment of PF.
Methods A double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomized to receive either IHMs or identical-looking placebo in the mutual context of conservative non-medicinal management. The Foot Function Index (FFI) questionnaire, as an outcome measure, was administered at baseline, and every month, up to 3 months. Group differences (unpaired t-tests) and effect sizes (Cohen's d) were calculated on an intention-to-treat sample. The sample was analyzed statistically after adjusting for baseline differences.
Results The target sample size was 128; however, only 75 could be enrolled (IHMs: 37; Placebo: 38). Attrition rate was 9.3% (IHMs: 4, Placebo: 3). Differences between groups in total FFI% score favored IHMs against placebo at all the time points, with large effect sizes: month 1 (mean difference, −10.0; 95% confidence interval [CI], −15.7 to −4.2; p = 0.001; d = 0.8); month 2 (mean difference, −14.3; 95% CI, −20.4 to −8.2; p <0.001; d = 1.1); and month 3 (mean difference, −23.3; 95% CI, −30.5 to −16.2; p <0.001; d = 1.5). Similar significant results were also observed on three FFI sub-scales (pain%, disability%, and activity limitation%). Natrum muriaticum (n = 14; 18.7%) and Rhus toxicodendron and Ruta graveolens (n = 11 each; 14.7%) were the most frequently prescribed medicines. No harms, serious adverse events, or intercurrent illnesses were recorded in either of the groups.
Conclusion IHMs acted significantly better than placebo in the treatment of PF; however, the trial being underpowered, the results should be interpreted as preliminary only. Independent replications are warranted.
Trial registration: CTRI/2018/10/016014.
Keywordsfoot function index - homeopathy - placebo - plantar fasciitis - randomized controlled trial
S.S., S.G., A.S.C. and S.M. developed the concept, carried out the literature search, the clinical study, the data acquisition and management, data interpretation, and the preparation of the article; S.S., M.K. and S. Saha contributed to the design, data interpretation, statistical analysis, and preparation of the article. All the authors reviewed and approved the final article.
The trial was performed as the postgraduate dissertation of the corresponding author.
Received: 09 January 2021
Accepted: 02 March 2021
07 September 2021 (online)
© 2021. Faculty of Homeopathy. This article is published by Thieme.
Georg Thieme Verlag KG
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