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BMC Urology Jan 2015Tramadol is a centrally acting analgesic prescribed off-label for the treatment of premature ejaculation (PE). However, tramadol may cause addiction and difficulty in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Tramadol is a centrally acting analgesic prescribed off-label for the treatment of premature ejaculation (PE). However, tramadol may cause addiction and difficulty in breathing and the beneficial effect of tramadol in PE is yet not supported by a high level of evidence. The purpose of this study was to systematically review the evidence from randomised controlled trials (RCT) for tramadol in the management of PE.
METHODS
We searched bibliographic databases including MEDLINE to August 2014 for RCTs. The primary outcome was intra-vaginal ejaculatory latency time (IELT). Methodological quality of RCTs was assessed. Between-group differences in IELT and other outcomes were pooled across RCTs in a meta-analysis. Statistical and clinical between-trial heterogeneity was assessed.
RESULTS
A total of eight RCTs that evaluated tramadol against a comparator were included. The majority of RCTs were of unclear methodological quality due to limited reporting. Pooled evidence (four RCTs, 721 participants), suggests that tramadol is significantly more effective than placebo at increasing IELT over eight to 12 weeks (p = 0.0007). However, a high level of statistical heterogeneity is evident (I-squared = 74%). Single RCT evidence indicates that tramadol is significantly more effective than paroxetine taken on-demand, sildenafil, lidocaine gel, or behavioural therapy on IELT in men with PE. Tramadol is associated with significantly more adverse events including: erectile dysfunction, constipation, nausea, headache, somnolence, dry mouth, dizziness, pruritus, and vomiting, than placebo or behavioural therapy over eight to 12 weeks of treatment. However, addiction problems or breathing difficulties reported by patients for PE is not assessed in the current evidence base.
CONCLUSIONS
Tramadol appears effective in the treatment of PE. However, these findings should be interpreted with caution given the observed levels of between-trial heterogeneity and the reporting quality of the available evidence. The variability across placebo-controlled trials in terms of the tramadol dose evaluated and the treatment duration does not permit any assessment of a safe and effective minimum daily dose. The long-term effects and side effects, including addiction potential, for men with PE have not been evaluated in the current evidence base.
TRIAL REGISTRATION
The review is registered on PROSPERO 2013: CRD42013005289 .
Topics: Drug Administration Schedule; Evidence-Based Medicine; Humans; Male; Off-Label Use; Orgasm; Patient Satisfaction; Premature Ejaculation; Prevalence; Randomized Controlled Trials as Topic; Tramadol; Treatment Outcome
PubMed: 25636495
DOI: 10.1186/1471-2490-15-6 -
Journal of Pain Research 2021Compared to low concentrations of local anesthetics with opioids for labor epidural analgesia, very high concentrations of local anesthetics are associated with an...
A Systematic Review and Meta-Analysis of Randomized Controlled Trials of Labor Epidural Analgesia Using Moderately High Concentrations of Plain Local Anesthetics versus Low Concentrations of Local Anesthetics with Opioids.
PURPOSE
Compared to low concentrations of local anesthetics with opioids for labor epidural analgesia, very high concentrations of local anesthetics are associated with an increased risk of assisted vaginal delivery. We aimed to investigate if moderately high concentrations of plain local anesthetics are also associated with this risk.
METHODS
We searched for published randomized controlled trials that compared moderately high concentrations of plain local anesthetics (>0.1% but ≤0.125% bupivacaine, >0.1% but ≤0.125% levobupivacaine, or >0.17% but ≤0.2% ropivacaine) to low concentrations of local anesthetics (≤0.1% bupivacaine, ≤0.1% levobupivacaine, or ≤0.17% ropivacaine) with opioids for labor analgesia. Meta-analyses were performed to compare the risk of assisted vaginal delivery and other perinatal outcomes between these two groups.
RESULTS
We identified nine randomized controlled trials with a total of 1334 participants. Meta-analysis of these nine trials showed no differences in the risks of assisted vaginal delivery (odds ratio [OR] = 1.18; 95% confidence interval [CI], 0.93-1.49) or Cesarean delivery (OR = 0.96; 95% CI, 0.71-1.29) between the two groups. The incidence of motor block was higher in the group of moderately high concentrations (OR = 4.05; 95% CI, 2.19-7.48), while the incidence of pruritus was lower (OR = 0.07; 95% CI, 0.03-0.16).
CONCLUSION
This systematic review and meta-analysis suggests that the current evidence is inadequate to support that moderately high concentrations of plain local anesthetics increase the risk of assisted vaginal delivery compared to low concentrations of local anesthetics with opioids.
PubMed: 34054305
DOI: 10.2147/JPR.S305838