A Study on the Effectiveness and Safety of Herbal Extract Combination Compared to 3% Minoxidil Solution for the Treatment of Androgenetic Alopecia: A Randomized, Double-blind, Controlled Trial

Abstract

Background Androgenetic alopecia (AGA) affects both men and women. Standard treatments include topical minoxidil and oral finasteride, which can cause undesirable side effects. Therefore, a natural herbal extract is required for an alternative treatment. Objectives This study aims to assess both the efficacy and safety profiles of an herbal extract comprising a combination of dihydroquercetin glucoside, epigallocatechin gallate glucoside, zinc, and glycine, compared to the minoxidil solution for the treatment of AGA. Methods About 30 males and 30 females were recruited. The males and females were divided equally into two groups (n=30), randomly receiving either a minoxidil solution or herbal extraction twice a day for 24 weeks. Clinical efficacy, total hair count, and hair mass index (HMI) were evaluated. Results A total of 30 males and 30 females completed the study. The total hair counts (hairs/cm2) at baseline in the herbal group and minoxidil group were 334.8±108.8 and 368.3±178.4, respectively, and the total hair counts at 24 weeks in the herbal group and minoxidil group were 345.0±119.2 and 391.5±183.1 (p<0.001, p<0.001), respectively. The HMI in the herbal and minoxidil groups significantly increased by 25.83±17.18 and 33.70±15.17 (p=0.001, p<0.001) at 24 weeks. However, there was no significant difference in total hair count and HMI between the two groups at 24 weeks (p= 0.250, p=0.065). No local adverse effects were observed in both groups. Conclusions The non-significant difference in efficacy and safety to minoxidil solution suggests that the herbal extraction could be an alternative treatment for AGA. Clinical Trial Registration Number TCTR20220927001.