Homeopathy
DOI: 10.1055/s-0040-1722232
Original Research Article

A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Individualized Homeopathic Medicines for Cutaneous Warts

1  Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India
,
Shifa Hashmi
2  D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India
,
Sangita Saha
3  Department of Organon of Medicine and Homoeopathic Philosophy, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Mahakas Mandal
4  Department of Practice of Medicine, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Abdur Rahaman Shaikh
2  D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India
,
Ekta Agrawal
5  Department of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Priyanka Ghosh
6  Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India
,
Nisha Sehrawat
7  Department of Pediatrics, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India
,
Munmun Koley
8  Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh
9  Independent Researcher; Champsara, Baidyabati, Hooghly, West Bengal, India
,
Subhranil Saha
1  Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India
10  Independent Researcher, Shibpur, Howrah, West Bengal, India
› Author Affiliations
Funding We received no funding for the project. The institution had no role to play in the analysis or interpretation of the study results or in the preparation of the paper.

Abstract

Background Though frequently used in practice, research studies have shown inconclusive benefits of homeopathy in the treatment of warts. We aimed to assess the feasibility of a future definitive trial, with preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in treatment of cutaneous warts.

Methods A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebo (n = 30). Primary outcome measures were numbers and sizes of the warts; secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample.

Results Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all p < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes—both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%) and Sulphur (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported.

Conclusion As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted.

Trial Registration CTRI/2019/10/021659; UTN: U1111–1241–7340

Highlights

• A double-blind, randomized, placebo-controlled, two parallel arms, pilot trial was conducted at D.N. De Homoeopathic Medical College and Hospital, West Bengal, India, in 60 patients suffering from cutaneous warts.


• There was a statistically non-significant direction of effect favoring homeopathy.


• Adequately powered definitive trials are warranted.


Authors' Contribution

S.D., S.H., S.S., M.M., A.R.S., E.A., P.G., N.S., M.K. and S.Saha contributed toward concept, design, literature search, data interpretation, and preparation of the article; S.D., S.H., A.R.S. and P.G. contributed to the clinical study and data acquisition. S.H. and A.R.S. contributed to data management and master-chart preparation; M.K. and S.Saha contributed to data interpretation and statistical analysis. All the authors reviewed and approved the final article.


Note

The trial was performed under the Short-Term Studentship (STSH) scheme, 2019 (STSH190292) of the Central Council for Research in Homoeopathy, India, under the guidance of Dr. Samit Dey, teaching faculty and employee of the institute D.N. De Homoeopathic Medical College and Hospital, where the work was performed.


Supplementary Material



Publication History

Received: 09 September 2020

Accepted: 05 November 2020

Publication Date:
24 March 2021 (online)

© 2021. Faculty of Homeopathy. This article is published by Thieme.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany