Effectiveness of individualized homoeopathic medicines and mother tinctures in benign prostatic hypertrophy: an open randomized pragmatic trial

Benign Prostatic Hyperplasia (BPH) is the most common condition in ageing men, associated with Lower Urinary Tract Symptoms (LUTS). The prevalence of BPH increases with age. The lifetime risk of developing histological confirmed BPH has been approximately 8% between the age 31 to 40 years, 50% between 51 to 60 years, 70% between 61 to 70 years and 90% between 81 to 90 years. Correspondingly, symptomatic (clinical) BPH is present in approximately 26% of the men in the fifth decade, 33% in the sixth decade, 41% in the seventh decade and 46% in the eighth decade of life and beyond. There is sufficient homeopathic literature wherein a number of constitutional as well as organopathic medicines are listed for the treatment of BPH. In a clinical trial conducted by AK Hati, et al, 2012 on 180 patients comparing the homeopathic treatment strategies using Constitutional Medicines (CM) or Organopathic Medicines (OM) alone or in combination of both Constitutional and Organopathic Medicines (BCOM) in patients suffering from BPH reports the highest treatment response in patients prescribed BCOM. However, this study was not randomized and instead sequentially allocated. The authors consider it very important to replicate the study in similar design, but with enhanced methodological rigor. In this open, randomized, prospective, three parallel arms, pragmatic trial, 120 patients suffering from symptomatic BPH will be randomized to either individualized homeopathic medicines (n=40), or mother tincture (n=40), or individualized homeopathic medicines plus mother tincture (n=40). Outcomes will be measured in terms of AUASS, prostate size and RUV, measured at baseline, after 3 months and 6 months. Comparative analysis will be carried out in the end to detect group differences, if any. Results will be published in scientific journals.