Randomized comparison of the effectiveness of phytotherapy (Uriphytol) versus Tamsulosin in management of benign prostatic enlargement at Kilimanjaro Christian medical centre: a pilot study

Phytotherapy is commonly used in Africa for various health conditions including lower urinary tract symptoms (LUTS) related to benign prostatic enlargement (BPE). However, high-level evidence supporting its effectiveness in BPE remains limited. We compared the effectiveness of Uriphytol, a phytotherapy from Cucurbita pepo and Curcuma longa, with Tamsulosin in managing benign prostatic enlargement. This was a 6-months, parallel-designed, randomized, open-label, non-inferiority pilot trial at Kilimanjaro Christian Medical Centre in Tanzania. It included men aged ≥ 40 years with benign prostatic features and prostatic specific antigen (PSA) density less than 0.15ng/mL². Participants were block randomized using computer-generated numbers in sealed envelopes into intervention or control arms by a research assistant, receiving either Uriphytol 500 mg three times daily or Tamsulosin 0.4 mg once daily. The primary outcome was the change in the International Prostate Symptom Score (IPSS) with a 3-point non-inferiority margin. Secondary outcomes included changes in post-void residual volume (PVR) and change in International Index of Erectile Function (IIEF-5) score. Analysis of non-inferiority was done by using the fixed-margin (95%-95% method). The trial was registered in Pan African Clinical Trials Registry on 19th April, 2023 with registration number PACTR202304488683045. Between August 2023 and July 2024, 87 participants were recruited (43 in the intervention arm, 44 in the control arm), with 82 completing the study (40 on Uriphytol, 42 on Tamsulosin). Two participants in the intervention and one in the control arm experienced urine retention, and one participant in each arm was lost to follow-up. At the endpoint, there was no significant difference in IPSS reduction, but Uriphytol showed a significant improvement in IPSS-related quality of life (QoL) [Uriphytol vs. Tamsulosin, IPSS: 16.20 ± 7.38 vs. 15.52 ± 5.38, p = 0.206; QoL: 5.45 ± 0.99 vs. 4.81 ± 1.17, p = 0.0049]. No significant difference in PVR changes was noted, but erectile function improved significantly in the Uriphytol group (p = 0.044). This study has demonstrated that a full-scale prospective non-inferiority randomized clinical trial to determine the effectiveness of phytotherapy versus tamsulosin is feasible in our setting. We found that Uriphytol was not inferior to Tamsulosin in managing BPE, offering better erectile function and quality of life. These findings suggest that Uriphytol could be an alternative to tamsulosin for managing symptoms of BPE.