Study: No Clinical Benefit for Botox in BPH
Previous studies may have overlooked the placebo effect.
Botulinum toxin type A provides no clinical benefit for lower urinary tract symptoms (LUTS) or benign prostatic hyperplasia (BPH), a new review and meta-analysis confirms.
"Although some studies have shown efficacy, the scientific evidence for botulinum toxin type A in BPH is low,” lead researcher Jae Heon Kim, MD, PhD, assistant professor at Soonchunhyang University in South Korea, told Renal & Urology News. “The indication for botulinum toxin type A in BPH patients should be recommended as third line."
Improving on previous reviews, Dr Kim and colleagues pooled results from 3 double-blind, randomized, controlled trials comparing botulinum toxin type A with placebo. Of 522 men with LUTS/BPH, 260 were treated with a single dose of botulinum toxin type A (200 U) and 262 received a placebo injection.
After 8 to 24 weeks, the group that received botulinum toxin barely showed improvement over the group that received placebo based on International Prostate Symptom Score (IPSS). There were no significant differences between groups in maximal urinary flow rate (Qmax), prostate volume, and post-void residual volume.
The researchers discovered that the placebo effect was substantial, ranging from 0 to 28% for IPSS and up to 29% for Qmax. “It is well known that patients with LUTS/BPH can have a significant placebo response,” the investigators explained in International Urology and Nephrology.
Dr. Kim's group observed no significant differences in any reported adverse events between the groups. The most frequent adverse events with botulinum toxin or placebo were hematuria and hematospermia.
Among the limitations, the investigators could not conclusively determine whether botulinum toxin is suitable for LUTS/BPH refractory to medications.