The efficacy of topical sodium pentaborate formulation on hemorrhoid disease: A randomized, double-blind, placebo-controlled trial

Background: The topical application of boron has been significantly associated with intensifying wound healing. Using 3% boric acid in deep wounds significantly contributes to wound healing and reduces the duration of hospitalization in the intensive care. The objective of this study was to assess the therapeutic impact of a topical gel containing sodium pentaborate pentahydrate on the management of wounds resulting from grade 1 to 3 hemorrhoids. Methods: In this randomized double-blind placebo-controlled trial, we applied a topical gel consisting of sodium pentaborate pentahydrate 3% on 206 eligible patients with the diagnosis of grade 1, 2, and 3 hemorrhoid diseases. Then patients were randomly allocated to two groups of sodium pentaborate pentahydrate or placebo gel with a ratio of 1:1 and received the allocated gel for four weeks. Patient hemorrhoid symptoms severity, hemorrhoid degree, and anoscopy findings were compared before and after the trial. Results: Before the intervention, symptom severity (p > 0.05) and anoscopy findings (p = 0.815) were similar between the two groups. Subsequent to the intervention, a majority of patients in the intervention group experienced a reduction in anal itching compared to the placebo group [adjusted mean difference (aMD) 95% CI: -1.98 (-2.2 to -1.8), p = 0.007]. Moreover, resting pain [aMD (95% CI): -1.37 (-1.6 to -1.1), p = 0.015], pain during defecation [aMD (95% CI): -2.19 (-2.4 to -2.0), p = 0.005], feeling a lump in the anus (aMD (95% CI): -0.71 (-1.2 to -0.2), p = 0.011), bleeding during defecation (41.7% vs. 66.9%, p = 0.027), and hemorrhoid degree (p < 0.001) in the intervention group was less than the placebo group. Conclusion: Our findings indicate the effectiveness of the study gel on hemorrhoid symptoms and anoscopy findings in patients.