Men with premature ejaculation (PE) may benefit from taking tramadol off-label, suggests a new meta-analysis of randomized controlled trials.
In pooled results, the drug was significantly more effective than placebo at increasing intra-vaginal ejaculatory latency time (IELT) time over 8 to 12 weeks. The limited evidence, however, leaves many unanswered questions, including what is a safe and effective minimum daily dose of tramadol, appropriate treatment duration, unacceptable adverse effect profile, and worrisome addiction rate.
Dapoxetine, a selective serotonin re-uptake inhibitor (SSRI), is currently the only oral medication FDA approved to treat PE. In Europe, guidelines suggest that tramadol, an opioid analgesic, has similar efficacy to dapoxetine; both appear moderately beneficial for PE.
For the meta-analysis, Marrissa Martyn-St. James, MD, of the University of Sheffield in the United Kingdom, and colleagues reviewed 8 randomized controlled trials of tramadol conducted on or before August 2014.
The studies varied widely in quality and scope, according to the researchers. Most studies were conducted in Middle Eastern countries. Since aspects of PE may differ culturally, that could limit the relevance of these findings to men living elsewhere, such as in the United States.
Single trial results indicated that tramadol was significantly more effective at increasing IELT than paroxetine taken on-demand, sildenafil, lidocaine gel, or behavioral therapy, according to findings published online in BMC Urology.
Tramadol was associated with significantly more adverse effects than placebo or behavioral therapy, such as erectile dysfunction, drowsiness, and dizziness over a few months of treatment.
The researchers pointed out more studies comparing tramadol with other PE drugs and therapies are needed. Addiction problems and breathing difficulties would also need to be assessed.
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