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Safety and efficacy of tramadol hydrochloride on treatment of premature ejaculation.

ABSTRACT: Premature ejaculation (PE) is the most common sexual disorder. It affects 20%-30% of adult men; the aetiology of this condition has not yet been elucidated. The aim of this study is to evaluate the efficacy, safety, tolerability, undesirable effects and improved satisfaction with sexual intercourse with tramadol hydrochloride at different dosages for the treatment of PE. A total of 300 patients who presented with lifelong (primary) PE were included in this study. The study was performed for 28 weeks, in which placebo (starch tablet) was given for 4 weeks, and active ingredient (tramadol hydrochloride) was administered at different therapeutic dosages for 24 weeks. Patients were divided into three equal groups, each consisting of 100 patients. The first group (A) was given tramadol hydrochloride capsule 25 mg. The second group (B) was given tramadol hydrochloride capsule 50 mg. The third group (C) was given tramadol hydrochloride capsule 100 mg. All of the 300 participants included completed the study voluntarily. The age of the patients varied from 25 to 50 years. After the treatment period, the recorded data were collected for each group and analysed. The results showed a highly significant increase in the mean intravaginal ejaculatory latency time (IELT) in all groups compared to baseline data (P<0.0001). We concluded that using tramadol hydrochloride at different doses on demand for the treatment of PE is effective, safe and tolerable, with minimal undesirable effects, and approval for this indication should be sought.

SUBMITTER: Eassa BI

PROVIDER: S-EPMC3739134 | biostudies-other | 2013 Jan

REPOSITORIES: biostudies-other

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Project description:BackgroundTramadol 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.MethodsWe 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.ResultsA 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.ConclusionsTramadol 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 registrationThe review is registered on PROSPERO 2013: CRD42013005289 .

Project description:INTRODUCTION:Current evidence suggests that Cognitive Behavioral therapy (CBT) has a limited role in the contemporary management of premature ejaculation (PE). AIM:The aim of this study was to determine the efficacy of a new CBT for the PE called Sphincter Control Training (SCT) in combination with a masturbation aid device. METHODS:The present study included 35 patients' that met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ?2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ?11. Participants completed all phases of a randomized controlled clinical study with a parallel group design, which was approved by the Ethical Committee of the Hospital Morales Meseguer of Murcia (Spain).The two treatment groups completed SCT over 7 weeks. The SCT consists of four different exercises and an educational session. Its objective is to provide patients with greater knowledge, awareness, and control of the external urethral sphincter. The only difference between groups was the use of a masturbation aid device called Flip Zero (TFZ-001) from the Japanese company Tenga Co., Ltd. OUTCOMES:The main measure was the "fold increase" (FI) of the IELT, which was calculated using the geometric mean pre-treatment and post-treatment. In addition, Premature Ejaculation Profile PE was used as a secondary measure. RESULTS:The geometric mean of the measurements corresponding to the 7 weeks of treatment was calculated, and both groups were compared by means of an ANCOVA test, finding a statistically significant difference (F: 10.51, 1; p = .003) in the increase experienced by subjects in the group with the device (GWD) mean = 166.63, SD = 106.54) compared with that experienced by subjects in the group without device (GWtD) (mean = 86.99, SD = 59.98).Using Student's t-test, the Fold increase (FI) corresponding to both groups were compared. The results showed statistically significant differences (p = .008) between the measurements corresponding to the GWtD (1.38 (0.50)) and those relative to the GWD (2.69 (1.81)). CLINICAL IMPLICATIONS:The FI in the GWD at the end of the trial allow us to consider this new CBT as a potential and viable PE treatment alternative. No side effects were observed in either treatment group and it required little therapeutic input and no partner involvement. STRENGTHS & LIMITATIONS:The main limitation of this study is the lack of a 3- to 6-month follow-up of the treatment and placebo control. CONCLUSIONS:This SCT exercise program combined with the use of a masturbation device shows promise because has numerous advantages in relation to current recommended treatments in patients with PE.

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Safety and efficacy of tramadol hydrochloride on treatment of premature ejaculation.

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