DIABETES mellitus-induced erectile dysfunction (DMED) remains a complex and challenging condition to manage effectively. While phosphodiesterase type 5 inhibitors (PDE5Is) such as sildenafil and tadalafil are widely used, they often yield limited results in this subgroup of patients. Growing interest has focused on combining conventional therapy with traditional Chinese medicine (TCM), which is thought to target broader pathophysiological mechanisms. In this context, a recent systematic review and meta-analysis examined whether adding TCM to standard PDE5I treatment could improve outcomes in men with DMED. A key finding was that a combined approach was nearly three times more likely to lead to clinical improvement compared with PDE5I monotherapy.
The authors followed PRISMA 2020 guidelines and registered the study on PROSPERO. They systematically searched six international and Chinese databases up to May 2024 to identify randomised controlled trials (RCTs) comparing PDE5Is alone versus in combination with TCM in DMED patients with an International Index of Erectile Function-5 (IIEF-5) score of 21 or lower. Twelve RCTs totalling 1,070 participants were included. Data extraction, risk-of-bias assessments, and meta-analyses were conducted using RevMan 5.3 with fixed or random-effects models depending on heterogeneity.
The combination of PDE5Is and TCM significantly improved clinical efficacy (relative risk=2.86; 95% CI: 2.13–3.84; p<0.001). Patients receiving combination therapy also reported greater improvements in IIEF-5 scores (tadalafil + TCM SMD=1.07; sildenafil + TCM SMD=1.38; both p<0.001). Additionally, TCM syndrome scores, which reflect broader symptom profiles, showed marked reductions. Importantly, the incidence of adverse events such as dizziness, flushing, and gastrointestinal discomfort did not differ significantly between groups (all p>0.05).
The findings suggest a potentially valuable role for integrative therapy in the management of DMED, particularly in patients with limited response to PDE5Is alone. However, clinical application should proceed with caution due to several limitations, including heterogeneity in TCM formulations, treatment durations, and limited information on blinding and study quality. These factors may influence both internal validity and real-world generalisability. Larger, well-designed RCTs are needed to establish standardised protocols and evaluate long-term safety and efficacy in routine practice.
Reference
Xiang L et al. Phosphodiesterase type 5 inhibitors combined with traditional Chinese medicine for diabetes mellitus-induced erectile dysfunction: A systematic review and meta-analysis. Medicine (Baltimore). 2025;104(28):e43243.
