Although phosphodiesterase type 5 inhibitors (PDE5i) have a therapeutic effect on diabetic erectile dysfunction, its therapeutic effect is not as good as that of non-diabetic population. In recent years, several randomized controlled trials(RCTs) found that the therapeutic effect of traditional Chinese medicine(TCM) combined with PDE5i on diabetic erectile dysfunction may be better than that of PDE5i alone, and we now conduct a systematic review and meta-analysis of these studies. We searched China national knowledge internet (CNKI), Wanfang database, Pubmed, and Embase database. Mean difference (MD) or pooled odds ratio (OR), as well as their 95% confidence intervals (CIs) were calculated. Risk bias tool was used to evaluate the quality of RCTs included in the meta-analysis. Publication bias was estimated by Begg’s funnel plots and Egger’s test. Results of this systematic review and meta-analysis revealed that the change in the IIEF-5 score of TCM + PDE5i group was significantly higher than that of PDE5i group(MD = 3.6, 95% CI [2.34, 4.86]). The clinical efficacy of TCM + PDE5i group was significantly higher than that of PDE5i group(OR = 2.86, 95% CI [1.83, 4.48]). Furthermore, the sexual satisfaction of TCM + PDE5i group was significantly higher than that of PDE5i group (OR = 3.07, 95% CI[1.63, 5.80]). There was no significant difference of the number of adverse events between TCM + PDE5i group and PDE5i group(OR = 0.93, 95% CI [0.49,1.78]). According to the meta-analysis, compared with using PDE5i alone, the regimen combined TCM plus PDE5i has more advantages in terms of IIEF-5, efficiency, and sexual satisfaction, with no increase in adverse effects for erectile dysfunction in patients with type 2 diabetes mellitus. More strict and larger sample size RCTs are needed to verify the findings of this meta-analysis.
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