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.