A multicentric randomized clinical trial of homoeopathic medicines in fifty millesimal potencies vis-à -vis centesimal potencies on symptomatic uterine fibroids

Abstract

Objective: The primary objective was to evaluate the effects of homoeopathic medicines in fifty millesimal (LM) potencies vis-à -vis centesimal (CH) potencies on symptomatic uterine fibroids.Materials and Methods: A multicentric randomized clinical trial was conducted at six centers under the Central Council for Research in Homoeopathy. Patients were screened for symptomatic uterine fibroids with the preset inclusion and exclusion criteria. A consultant specialized in obstetrics and gynecology was engaged at each center to screen and follow-up the enrolled patients. Homoeopathic physicians engaged in the study were responsible for prescription and follow up for 12 months. The primary outcome was changes in symptoms of uterine fibroid on a visual analog scale (VAS) of 0–10 and findings through ultrasonography (USG) between LM and CH potencies. The secondary outcome was to assess the changes in uterine fibroid symptom quality of life questionnaire (UFSQOL). Data analysis was done as per intention to treat (ITT) analysis.Results: Of 216 patients enrolled in the study (LM: 108 and CH: 108), 209 patients were analyzed under modified ITT (LM: 106, CH: 103). Both LM and CH potencies were equally effective in reducing the symptoms (percentage change) due to uterine fibroid on VAS scale after 1 year of treatment (P > 0.05). The health-related quality of life (HRQOL) and subdomains of UFSQOL also showed equal effectiveness in both the groups (P = 0.05). However, no difference was observed in all the USG findings except for uterine volume (P = 0.03). There was overall difference before and after homoeopathic treatment irrespective of assigned groups, i.e., LM or CH (P < 0.05) in all the above parameters. The medicines frequently prescribed were: Pulsatilla, Sulphur, Lycopodium, Sepia, Phosphorus, Calcarea carbonica, and Natrum muriaticum.Conclusion: LM and CH potencies are equally effective in giving symptomatic relief to patients suffering from symptomatic uterine fibroids.