Traditional Chinese medicine fumigation combined with Musk hemorrhoid suppository for wound healing and inflammation control in patients with mixed hemorrhoids after Milligan-Morgan hemorrhoidectomy

Objective To evaluate the efficacy, safety, and underlying mechanism of traditional Chinese medicine (TCM) fumigation combined with Musk hemorrhoid suppository for postoperative recovery in patients with mixed hemorrhoids undergoing Milligan-Morgan Hemorrhoidectomy (MMH). Methods A prospective, stratified randomized controlled study enrolled 160 patients, who were stratified by hemorrhoid grade and randomized into four groups (40 cases each): combined (TCM fumigation + Musk suppository), fumigation alone, suppository alone, and control (1:5,000 potassium permanganate sitz bath). An internal validation cohort (40 cases, 25% of the main trial size) was included to confirm result consistency. The primary endpoint was complete wound epithelialization rate at postoperative day (POD) 14, with secondary endpoints including wound healing time, total effective rate at 4 weeks postoperatively, anal function, serum inflammatory factors (IL-6, TNF-α, CRP) and tissue NF-κB p65 protein, complication incidence, and quality of life (GQOL-30). Statistical analyses used Bonferroni correction for multiple comparisons to control Type I error ( α = 0.0125). Safety was evaluated via adverse events (AEs) and liver/kidney function tests. Results All groups had balanced baseline characteristics (all P > 0.05). The combined group achieved the highest POD14 complete epithelialization rate, with the shortest wound healing time (5.15 ± 0.60 days, a 2.30-day reduction vs. control group's 7.45 ± 0.75 days, P < 0.001) and the highest 4-week total effective rate (97.50% vs. control's 65.00%, P < 0.001). Additionally, the combined group showed significantly improved anal function, marked reductions in inflammatory markers (relative reduction: NF-κB p65 51.5%, IL-6 33.0%, all P < 0.001), fewer Grade I/II complications (7.50% vs. control's 22.50%, P = 0.032), and higher GQOL-30 scores ( P < 0.001). Efficacy was consistent between the main trial and validation cohort ( P = 0.618). No severe AEs were reported. Conclusion The combined TCM regimen safely accelerates postoperative recovery after MMH, reduces inflammation and complications, and improves patient quality of life.