Homoeopathic treatment for lower urinary tract symptoms in men with benign prostatic hyperplasia: An open label randomised multicentric placebo‑controlled clinical trial

Abstract

Objectives: The objectives of the study are to evaluate the effectiveness of Homoeopathic Constitutional remedy (HC) and Homoeopathic Constitutional + Organ remedy (HCOM) in comparison to Placebo (PL) in cases of benign prostatic hyperplasia (BPH) using International Prostate Symptom Score (IPSS), ultrasonographic changes in prostate volume, post‑void residual urine, uroflowmetry and in WHO Quality of Life (QOL)‑BREF. Materials and Methods: A multicentric, three‑armed, randomised clinical trial was conducted at five centres. Patients were enrolled following the pre‑defined inclusion and exclusion criteria, randomised into three groups in 2:2:1 ratio and were followed up for 6 months. The statistical analysis was done with modified intention‑to‑treat principle (mITT). Results: Out of 461 patients screened, 254 patients were enrolled in the study and 241 patients were analysed as per mITT. The mean changes in IPSS and QOL due to urinary symptoms from baseline to end of study had shown a positive trend in all the three groups. However, in HC group, the changes were more prominent as compared to the other two groups. There was no difference between HC and HCOM groups and they were equally effective in terms of managing lower urinary tract symptoms due to BPH. With regard to secondary outcome, there was no difference between the groups. The psychological, social and environmental domains of WHOQOL‑BREF have shown positive trend, but there was no statistically significant difference in intervention groups. Conclusion: In this study, statistical significance was found in the IPSS in all the three groups but only in HC and not in any of the objective parameters.