Cannabidiol-hyaluronic acid combination delivered rectally for attenuating abacterial prostatitis symptoms: Single-arm open-label pilot clinical trial

Abstract

Background. Chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent urological disorder with a significant impact on quality-of-life. This study assessed the effects of rectal administration of dual cannabidiol (CBD)/hyaluronic acid (HA)-based therapy in men with CP/CPPS. Methods. A single-arm, open-label pilot trial on 16 men (24–49 years) with CP/CPPS (NIH Chronic Prostatitis Symptom Index [NIH-CPSI] >10, pain subscore ≥4). The participants self-administered rectal CANNEFF® suppositories containing CBD (100 mg) and HA (6.6 mg) as active ingredients, nightly for 30 days. Outcome measures included changes in NIH-CPSI total score, International Prostate Symptom Score (IPSS), and International Index of Erectile Function (IIEF-5). Safety and tolerability were also assessed. Results. The median baseline NIH-CPSI score was 24.5 points (range 11, 39) decreasing to a median 20.0 (range 2, 26) at day 30 (P=0.003), with a median reduction of 7.0 points (range −20.0, 6.0). Symptom improvement was found in 81.3 % (13/16) of participants. The IPSS total score decreased from a median of 14.0 points (range 4, 32) to a median 12.0 (range 3, 18) (P=0.033), with voiding symptoms showing the largest improvement. The IIEF-5 score increased modestly but without statistical significance. No adverse events were reported. Conclusions. The administration of the suppositories with CBD/HA action demonstrated potential symptom relief in CP/CPPS with a favourable tolerability profile. A more nuanced analysis of NIH-CPSI changes and IPSS and IIEF-5 data suggests a clinically meaningful benefit for most participants.