Work

Efficacy of Hongjing Qiwei Formula Combined with Tadalafil in the Treatment of Erectile Dysfunction Associated with Type 2 Diabetes Mellitus: A Double-Blind, Single-Dummy, Randomized Controlled Trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Background: Erectile dysfunction associated with diabetes mellitus (DMED) is common and may respond inadequately to phosphodiesterase type 5 inhibitor therapy. Evidence regarding traditional Chinese medicine combined with tadalafil for DMED remains limited. This study evaluated the efficacy and safety of Hongjing Qiwei Formula (HJQWF) plus tadalafil in patients with type 2 DMED. Methods: In this double-blind, single-dummy, randomized controlled trial, 76 participants were randomly assigned in a 1:1 ratio to receive HJQWF plus tadalafil 5 mg (treatment group) once daily or matched HJQWF placebo plus tadalafil 5 mg (control group) once daily for 6 weeks, followed by a 4-week post-treatment follow-up. The primary outcome was the International Index of Erectile Function-5 (IIEF-5). Secondary outcomes included erection hardness score (EHS), Traditional Chinese Medicine syndrome score (TCMSS), Sexual Encounter Profile Questions 2 and 3 (SEP-2 and SEP-3), and safety outcomes. Results: Seventy-one participants completed the intervention (treatment group, n = 36; control group, n = 35). At week 6, the mean change in IIEF-5 from baseline was greater in the treatment group than in the control group (5.53 ± 3.81 vs 3.26 ± 3.89; P < 0.05). The corresponding improvement in EHS was also greater with HJQWF (0.92 ± 0.84 vs 0.46 ± 0.70; P < 0.05). TCMSS decreased more markedly in the treatment group than in the control group (-16.14 ± 5.32 vs -2.77 ± 4.60; P < 0.05). At week 6, the proportion of participants reporting successful intercourse on SEP-3 was higher in the treatment group than in the control group (72.22% vs 45.71%; P < 0.05). No serious adverse events or clinically significant laboratory abnormalities were reported. Conclusion: HJQWF added to tadalafil may provide additional short-term improvement in erectile-function outcomes in men with type 2 DMED, and can still continuously improve erectile function even four weeks after discontinuation with no major safety signal observed during the study period.

Source: Diabetes Metabolic Syndrome and Obesity

DOI: 10.2147/dmso.s644621