Zhongguo Zhong Yao Za Zhi. 2025 Nov;50(22):6491-6496. doi: 10.19540/j.cnki.cjcmm.20250724.501.
ABSTRACT
Pien Tze Huang has the efficacy of clearing heat, removing toxins, cooling the blood, removing blood stasis, subduing swelling, and relieving pain. It is widely used in the treatment of acute viral hepatitis, carbuncles and furuncles, unidentified swelling and poison, blunt trauma, and various inflammations. To investigate the clinical efficacy and safety of Pien Tze Huang Capsules combined with Compound Pien Tze Huang Hemorrhoid Ointment in controlling the postoperative inflammatory response of wounds in patients undergoing surgery for mixed hemorrhoids, a multicenter, randomized, open-label, and positive-controlled clinical trial was conducted at 12 tertiary medical institutions in China. A total of 240 patients who underwent Milligan-Morgan hemorrhoidectomy for mixed hemorrhoids were enrolled and randomly assigned to the treatment or control group(1∶1). Both groups received sitz baths with Compound Jingjie for Fumigation and Washing as basic treatment. The treatment group additionally received Pien Tze Huang Capsules orally(2 capsules per dose, 3 times per day) and topical application of Compound Pien Tze Huang Hemorrhoid Ointment(2.5 g, twice per day), while the control group received topical Mayinglong Shexiang Hemorrhoid Ointment(2.5 g, twice per day). The treatment duration was 7 days. Primary efficacy endpoints included wound exudation scores, wound bleeding scores, and wound granulation tissue formation scores, and secondary endpoints included perianal edema scores, pain score using pain visual analogue scale(VAS) scores, postoperative analgesic use, and adverse events. RESULTS:: showed that in the full analysis set(FAS), the wound exudation scores on postoperative day 7 was significantly lower in the treatment group compared to that in the control group(P<0.05). In the per-protocol set(PPS), the wound exudation scores on postoperative days 3 and 7 was also significantly lower in the treatment group(P<0.05). While the treatment group showed lower perianal edema scores and pain VAS scores than the control group, the differences were not statistically significant. No statistically significant differences were observed between the two groups in wound bleeding scores, wound granulation tissue formation scores, analgesic use rate or amount, or incidence of adverse reactions. A total of 56 adverse events were observed, with 25 in the treatment group and 31 in the control group. The incidence of adverse reactions was comparable between groups, with no statistically significant difference. No serious drug-related adverse events were observed in either group. The results suggest that the Pien Tze Huang Capsules combined with Compound Pien Tze Huang Hemorrhoid Ointment can reduce wound exudation after surgery for mixed hemorrhoids, playing a beneficial role in controlling postoperative inflammation. The treatment offers good safety and tolerability, showing great potential as a postoperative adjunctive therapy integrating traditional Chinese medicine and western medicine.
PMID:41508088 | DOI:10.19540/j.cnki.cjcmm.20250724.501
