OBJECTIVETo evaluate the clinical efficacy and safety of phosphodiesterase 5 (PDE-5) inhibitors for erectile dysfunction (ED) in patients with diabetes mellitus and provide some evidence for the clinical treatment of the disease.

METHODSWe searched MedMed, EMbase, Cochrane Library, CNKI, Wan Fang Data, VIP and ZADL for randomized controlled trials on PDE-5 inhibitors for ED in diabetic men and evaluated the methodology of the included trials with the Jadad scale. We used the erectile function domain in the IIEF (IIEF-EF), IIEF questions (IIEF-Q) 3 and 4, SEP-2 and -3, and Global Assessment Questions (GAQ) as the main evaluation indexes and employed the Review Manager 5. 1. 0 software for meta analysis.

RESULTSA total of 13 studies were included, which were all high quality trials with Jadad score > 3. The IIEF-EF scores in 10 of the included studies were subjected to meta analysis using the random-effect model (REM), with a weighted mean difference (WMD) of 5.64 (95% CI 4.41 - 6.83, P < 0.001). The fixed-effect model (FEM) analysis of the IIEF-Q scores in 6 of the studies showed the WMD to be 0.96 (95% CI 0.83 -1.08, P < 0.001) for IIEF-Q3 and 1.11 (95% CI 0.98 - 1.25, P < 0.001) for IIEF-Q4. FEM analysis of the SEP-2 scores showed WMD = 17.67 (95% CI 12. 38 - 22. 97, P < 0.001) in 2 of the studies, and that of the SEP-3 scores WMD = 23.64 (95% CI 17. 49 - 29.79, P < 0.001) in 5 of the studies. The GAQ scores in 11 of the studies were subjected to REM analysis, with OR = 6. 20 and 95% CI 3.65 - 10.52 (P < 0.001). REM analysis was performed on the adverse reactions in 11 of the studies, with OR = 7.43 and 95% CI 4.11 - 13.44 (P < 0.001).

CONCLUSIONPDE-5 inhibitors can effectively and safely improve erectile function in patients with diabetes mellitus.