A Multi-Centric Single-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the Individualized Homeopathic Intervention in Breast Fibroadenoma

The primary objective of this study was to evaluate the efficacy homeopathic medicines in reduction or resolution breast fibroadenoma (FA) through ultrasound (US) assessment intervention and control groups. secondary compare single multiple fibroadenomas. A single-blind, randomized, placebo-controlled pilot conducted from January 2014 June 2018 at 4 research centers with 6 months follow-up. Females age group 18 35 years, a confirmed diagnosis measuring between 1 cm 5 cm, measured by US, only one per quadrant were randomized either (HI) identical placebo (P) (n = 85) each group. All patients enrolled due consent them. Ethical Committee, Central Council for Research Homoeopathy (CCRH), New Delhi, India, approved study. trial registered Clinical Trial Registry-India (CTRI) vide no. CTRI/2013/11/004144 [Registered on: 14/11/2013]. Out 85 cases group, ITT analysis done n 73 participants mean area FA (3.11 ± 3.00) HI 77 (3.65 3.29) P baseline. US 12 8 exceeded duration. Therefore, analyzed as sub-group not considered under analysis. unit At months, complete occurred 2 none Although there is significant difference groups 3<sup>rd</sup> 6<sup>th</sup> within-group insignificant. No observed within FAs medicine 78 received remedy throughout centesimal potencies. frequently prescribed Pulsatilla, Silicea, Phosphorus, Sepia, Calcarea Carbonica. IIndividualized homeopathy has significantly reduced compared However, statistically significant. Future studies should be based on adequate samples long-term follow-up recurrence if any.