Efficacy of Individualized Homeopathic Medicines in the Treatment of Atopic Dermatitis in Adults: A Double-Blind, Randomized, Placebo-Controlled, Preliminary Trial.

INTRODUCTION: Individualized homeopathy (IH) in atopic dermatitis (AD) remained under-researched. OBJECTIVE: We aimed at evaluating efficacy of IH in AD. METHODS: A double-blind, randomized, placebo-controlled, short-term, preliminary trial was conducted in an Indian homeopathy hospital. Patients were randomized to either IH (n = 30) or identical-looking placebo (n = 30) using computerized randomization and allocation. Outcomes were patient-oriented scoring of AD (PO-SCORAD; primary end point), Dermatological Life Quality Index (DLQI) score, and AD burden score for adults (ADBSA; secondary end points), measured monthly for 3 months. An intention-to-treat sample was analyzed after adjusting baseline differences. RESULTS: On PO-SCORAD, improvement was higher in IH against placebo, but nonsignificant statistically (pmonth 1 = 0.433, pmonth 2 = 0.442, pmonth 3 = 0.229). Secondary outcomes were also nonsignificant - both DLQI and ADBSA (p > 0.05). Four adverse events (diarrhea, injury, common cold) were recorded. CONCLUSIONS: There was a small, but nonsignificant direction of effect towards homeopathy, which renders the trial inconclusive. A properly powered robust trial is indicated.

Homeopathic Medicines Used as Prophylaxis in Kolkata during the COVID-19 Pandemic: A Community-Based, Cluster-Randomized Trial.

INTRODUCTION: There is some evidence that homeopathic treatment has been used successfully in previous epidemics, and currently some countries are testing homeoprophylaxis for the coronavirus disease 2019 (COVID-19) pandemic. There is a strong tradition of homeopathic treatment in India: therefore, we decided to compare three different homeopathic medicines against placebo in prevention of COVID-19 infections. METHODS: In this double-blind, cluster-randomized, placebo-controlled, four parallel arms, community-based, clinical trial, a 20,000-person sample of the population residing in Ward Number 57 of the Tangra area, Kolkata, was randomized in a 1:1:1:1 ratio of clusters to receive one of three homeopathic medicines (Bryonia alba 30cH, Gelsemium sempervirens 30cH, Phosphorus 30cH) or identical-looking placebo, for 3 (children) or 6 (adults) days. All the participants, who were aged 5 to 75 years, received ascorbic acid (vitamin C) tablets of 500 mg, once per day for 6 days. In addition, instructions on healthy diet and general hygienic measures, including hand washing, social distancing and proper use of mask and gloves, were given to all the participants. RESULTS: No new confirmed COVID-19 cases were diagnosed in the target population during the follow-up timeframe of 1 month-December 20, 2020 to January 19, 2021-thus making the trial inconclusive. The Phosphorus group had the least exposure to COVID-19 compared with the other groups. In comparison with placebo, the occurrence of unconfirmed COVID-19 cases was significantly less in the Phosphorus group (week 1: odds ratio [OR], 0.1; 95% confidence interval [CI], 0.06 to 0.16; week 2: OR, 0.004; 95% CI, 0.0002 to 0.06; week 3: OR, 0.007; 95% CI, 0.0004 to 0.11; week 4: OR, 0.009; 95% CI, 0.0006 to 0.14), but not in the Bryonia or Gelsemium groups. CONCLUSION: Overall, the trial was inconclusive. The possible effect exerted by Phosphorus necessitates further investigation. TRIAL REGISTRATION: CTRI/2020/11/029265.

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

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.

Patients' preference for integrating homeopathy (PPIH) within the standard therapy settings in West Bengal, India: The part 1 (PPIH-1) study.

There is lack of studies assessing the preference of Indian patients for integration of homeopathy into standard therapy settings. The objectives of this study were to examine the knowledge, attitudes, and practice of homeopathy among Indian patients already availing homeopathy treatment and its integration into mainstream healthcare. A cross-sectional survey was conducted among adult patients attending the out-patients of the four government homeopathic hospitals in West Bengal, India. A self-administered 24-items questionnaire in local vernacular Bengali was developed and administered to the patients. A total of 1352 patients' responses were included in the current analysis. 40% patients thought that homeopathic medicines can be used along with standard therapy. 32.5% thought that homeopathic medicines might cause side effects, while only 13.3% believed that those might interact with other medications. Patients' knowledge ranged between 25.1 and 76.5% regarding regulations of practicing and safety of homeopathic medicine in India and abroad; while positive attitude towards the same ranged between 25.4 and 88.5%. 88.6% of the patients had favorable attitude toward integrated services. 68.2% of the patients used homeopathic medicines in any acute or chronic illness for themselves and 76.6% for their children. Preference for integrated services was significantly associated with better knowledge (P = 0.002), positive attitudes toward safety and regulations (P < 0.0001), and integration (P < 0.0001), but not with the level of practice (P = 0.515). A favorable attitude toward integrating homeopathy into conventional healthcare settings was obtained among the patients attending the homeopathic hospitals in West Bengal, India.