A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Individualized Homeopathic Medicines for Cutaneous WartsFunding 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.
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
Keywordscutaneous warts - dermatological life quality index - homeopathy - randomized controlled trial
• 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.
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.
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.
Received: 09 September 2020
Accepted: 05 November 2020
24 March 2021 (online)
© 2021. Faculty of Homeopathy. This article is published by Thieme.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 Griffiths C, Barker J, Bleiker TO. et al. Rook's Textbook of Dermatology. Vol. I. 9th ed.. John Wiley & Sons Ltd.; 2016: 25.46-25.54
- 2 Wolff K, Johnson RA, Saavedra AP, Roh EK. Fitzpatrick's Color Atlas and Synopsis of Clinical Dermatology. 8th ed.. McGraw-Hill Education; 2017: 658-665
- 3 Wolf K, Goldsmith L, Katz S. et al. Fitzpatricks' Dermatology in General Medicine. 7th ed.. New York: McGrow-Hill Comp; 2008: 1914-1922
- 4 James W, Berger T, Elstom D. Andrews' Diseases of the Skin: Clinical Dermatology: Viral Disease. 10th ed.. Elsevier; 2006: 403-413
- 5 Al Aboud AM, Nigam PK. Wart (Plantar, Verruca Vulgaris, Verrucae), In: NCBI Bookshelf. A Service of the National Library of Medicine. National Institutes of Health: StatPearls Publishing; 2019
- 6 Hay RJ, Johns NE, Williams HC. et al. The global burden of skin disease in 2010: an analysis of the prevalence and impact of skin conditions. J Invest Dermatol 2014; 134: 1527-1534
- 7 Al Aboud AM, Nigam PK. Wart (Plantar, Verruca Vulgaris, Verrucae). In: StatPearls. Treasure Island, FL: StatPearls Publishing; 2020
- 8 Chandrashekar L, Thappa DM, Jaisankar TJ. Viral warts—a clinico-epidemiological study. Indian J Dermatol 2003; 48: 142-145
- 9 Khondker L, Shah MOR, Khan MSI. Verruca: need to know about human papilloma virus (HPV) infection. J Bangladesh Coll Phys Surg 2012; 30: 151-158
- 10 van Brederode RL, Engel ED. Combined cryotherapy/70% salicylic acid treatment for plantar verrucae. J Foot Ankle Surg 2001; 40: 36-41
- 11 Bruggink SC, Gussekloo J, Berger MY. et al. Cryotherapy with liquid nitrogen versus topical salicylic acid application for cutaneous warts in primary care: randomized controlled trial. CMAJ 2010; 182: 1624-1630
- 12 Bavinck JNB, Eekhof JAH, Bruggink SC. Treatments for common and plantar warts. BMJ 2011; 342: d3119
- 13 Kang S, Fitzpatrick TB. Debilitating verruca vulgaris in a patient infected with the human immunodeficiency virus. Dramatic improvement with hyperthermia therapy. Arch Dermatol 1994; 130: 294-296
- 14 Locricchio Jr J, Haserick JR. Hot-water treatment for warts. Cleve Clin Q 1962; 29: 156-161
- 15 Weber ND, Andersen DO, North JA, Murray BK, Lawson LD, Hughes BG. In vitro virucidal effects of Allium sativum (garlic) extract and compounds. Planta Med 1992; 58: 417-423
- 16 Seki T, Tsuji K, Hayato Y, Moritomo T, Ariga T. Garlic and onion oils inhibit proliferation and induce differentiation of HL-60 cells. Cancer Lett 2000; 160: 29-35
- 17 Focht III DR, Spicer C, Fairchok MP. The efficacy of duct tape vs cryotherapy in the treatment of verruca vulgaris (the common wart). Arch Pediatr Adolesc Med 2002; 156: 971-974
- 18 Stulberg DL, Hutchinson AG. Molluscum contagiosum and warts. Am Fam Physician 2003; 67: 1233-1240
- 19 Bedinghaus JM, Niedfeldt MW. Over-the-counter foot remedies. Am Fam Physician 2001; 64: 791-796
- 20 Abeck D, Tetsch L, Lüftl M, Biedermann T. Extragenital cutaneous warts—clinical presentation, diagnosis and treatment. J Dtsch Dermatol Ges 2019; 17: 613-634
- 21 Pringle WM, Helms DC. Treatment of plantar warts by blunt dissection. Arch Dermatol 1973; 108: 79-82
- 22 Baruch K. Blunt dissection for the treatment of plantar verrucae. Cutis 1990; 46: 145-147 , 151–152
- 23 Hanif J, Tasca RA, Frosh A, Ghufoor K, Stirling R. Silver nitrate: histological effects of cautery on epithelial surfaces with varying contact times. Clin Otolaryngol Allied Sci 2003; 28: 368-370
- 24 Lipke MM. An armamentarium of wart treatments. Clin Med Res 2006; 4: 273-293
- 25 Sudhakar GK, Pai V, Pai A, Kamath V. Therapeutic approaches in the management of plantar warts by human papillomaviruses: a review. Asian J Biomed Pharm Sci 2013; 3: 1-4
- 26 Hahnemann S. Organon of Medicine. New Delhi: B. Jain Publishers; 5th & 6th ed.. 2017: Aph.187
- 27 Close S. The Genius of Homeopathy: Lectures and Essays on Homoeopathic Philosophy. New Delhi: B. Jain Publishers; 2011: 56
- 28 Chakraborty PS, Khurana A, Singh JP. et al. Ephedra vulgaris—a multicentric clinical verification study conducted by CCRH. Indian J Res Homoeopathy 2009; 3: 14-20
- 29 Rajatrashmi SM. Vikramaditya Pharmacognostic studies of Thuja occidentalis Linn. – a good remedy for warts and tumours, used in homoeopathy. Anc Sci Life 1999; 19: 52-58
- 30 Nawrot J, Wilk-Jędrusik M, Nawrot S. et al. Milky sap of greater celandine (Chelidonium majus L.) and anti-viral properties. Int J Environ Res Public Health 2020; 17: 1540
- 31 Shraddhamayananda S, Pradhan AK. Rapid recovery from skin warts by explicit homeopathic medicines. Int J Clin Dermatol Res 2015; 3: 71-75
- 32 Shraddhamayananda S. Healing of skin warts with ultradiluted homeopathic medicines—a study in 200 cases. Clin Res Dermatol Open Access 2017; 4: 1-4
- 33 Shaikh MI. Case studies for treatment of warts with Homoeopathy. Indian J Res Homoeopathy 2016; 10: 272-278
- 34 Mathur M. A case of plantar warts cured with homoeopathy. Homœopathic Links 2020; 33: 64
- 35 Garg AK, Agarwal N. Wart treated with constitutional homoeopathic remedy Natrum muriaticum: a case study. Homœopathic Links 2020; 33: 126-129
- 36 Smolle J, Prause G, Kerl H. A double-blind, controlled clinical trial of homeopathy and an analysis of lunar phases and postoperative outcome. Arch Dermatol 1998; 134: 1368-1370
- 37 Kainz JT, Kozel G, Haidvogl M, Smolle J. Homoeopathic versus placebo therapy of children with warts on the hands: a randomized, double-blind clinical trial. Dermatology 1996; 193: 318-320
- 38 Schultz M. The homoeopathic treatment of warts [Thesis]. Durban: Technikon Natal; 1994
- 39 Labrecque M, Audet D, Latulippe LG, Drouin J. Homeopathic treatment of plantar warts. CMAJ 1992; 146: 1749-1753
- 40 Manchanda RK, Mehan N, Bahl R, Atey R. Double-blind, placebo-controlled, clinical trials of homoeopathic medicines in warts and molluscum contagiosum. CCRH Quar Bull 1997; 19: 25-29
- 41 Simonart T, de Maertelaer V. Systemic treatments for cutaneous warts: a systematic review. J Dermatolog Treat 2012; 23: 72-77
- 42 Mathie RT. The research evidence base for homeopathy: a fresh assessment of the literature. Homeopathy 2003; 92: 84-91
- 43 Central Council for Research in Homoeopathy. Efficacy of predefined homoeopathic medicines in the treatment of warts: Study protocol of double blind randomised placebo controlled trial. Indian J Res Homoeopathy 2019; 13: 41-47
- 44 Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)— a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19: 210-216
- 45 Cohen J. Statistical Power Analysis for the Behavioural Sciences. 2nd ed.. Hillsdale, NJ: Erlbaum; 1988
- 46 Fritz CO, Morris PE, Richler JJ. Effect size estimates: current use, calculations, and interpretation. J Exp Psychol Gen 2012; 141: 2-18
- 47 Coolican H. Research Methods and Statistics in Psychology. London: Hodder; 2009
- 48 Eldridge SM, Chan CL, Campbell MJ. et al; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016; 355: i5239
- 49 Dean ME, Coulter MK, Fisher P, Jobst K, Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. Homeopathy 2007; 96: 42-45
- 50 Ghadgepatil SS, Gupta S, Sharma YK. Clinico-epidemiological study of different types of warts. Dermatol Res Pract 2016; 2016: 7989817
- 51 Villeda LL, Dorantes GL, Gonzalez FB. Thuja occidentalis homeopatica vs placebo en verrugas vulgares. Dermatol Rev Mex 2001; 45: 14-18
- 52 Faber J, Fonseca LM. How sample size influences research outcomes. Dental Press J Orthod 2014; 19: 27-29