Efficacy of an Herbal Cream on Patients with Hemorrhoids: a randomized triple-blind controlled trial.

Objectives: Traditional Persian medicine offers various topical treatments for hemorrhoids. This study investigated the efficacy of an herbal cream (HC) containing common myrtle, chamomile, wild leek, and Russian olive extracts. Methods: This randomized triple-blind controlled trial compared the effects of the HC and a conventional cream (CC) on hemorrhoids. Standardization involved measuring the total phenolic content (TPC) and analyzing the HC by gas chromatography. In total, 110 outpatients with hemorrhoids were randomly assigned to intervention (n = 58) and control (n = 52) groups. The outcomes were evaluated using the visual analog scale (VAS [1-10]); anal pain, difficult defecation, and burning sensation) and four-point Likert scale anal bleeding and anal pruritus) during the intervention phase (14 days) and follow-up (28 days). Results: The HC was safe and well tolerated, with no major adverse effects observed in toxicological or clinical evaluations. Physicochemical assays confirmed the quality parameters, and the TPC was determined. In the clinical trial involving 49 patients, both HC and CC reduced hemorrhoidal symptoms over time (p = 0.011). However, no significant treatment-group effect (p = 0.50) or treatment-by-time interaction (p = 0.77) was observed. Exploratory analyses indicated that the HC produced clinically meaningful reductions in bleeding and anal pain from baseline. Conclusion: The HC was safe and well tolerated in patients with grade I-II hemorrhoids. Although it did not show statistical superiority over the CC, potentially due to high dropout rates and limited sample size, HC was associated with clinically meaningful improvements in anal bleeding and pain along with favorable changes in other symptoms. These findings suggest that the HC has potential as a safe herbal alternative for hemorrhoid symptom relief, without side effects and an acceptable safety profile.