Guo Lin, Zhang Yuanxin, Wu Siqing, Bai Ming, Tian Shuo, Miao Mingsan
Department of Pharmacology, Henan University of Chinese Medicine, Zhengzhou, China.
Academy of Traditional Chinese Medicine, Henan University of Chinese Medicine, Zhengzhou, China.
Heliyon. 2024 Mar 15;10(6):e28096. doi: 10.1016/j.heliyon.2024.e28096. eCollection 2024 Mar 30.
To systematically evaluate the efficacy and safety of topical application of botanical (TAB) adjuvants in the treatment of melasma and provide evidence-based medical evidence for their clinical application.
Medline, Web of Science, EMBASE, Cochrane Library, CNKI, VIP, Wanfang Data, and SinoMed, databases were searched to identify all randomized controlled clinical trials on TAB adjuvant treatment for melasma from inception to May 2023. The primary outcomes included clinical efficacy, adverse effects, recurrence rate, and melanin index. Subgroup analyses were performed using the Melasma Area Severity Index (MASI) scores.
This study included 16 randomized trials with 1386 participants. Eligible trials demonstrated that topical phytomedicine adjuvant treatment for melasma increased clinical effectiveness (RR = 1.14, 95% CI (1.10, 1.19), ＜0.00001), decreased recurrence rate (RR = 0.28, 95% CI (0.13, 0.59), = 0.0009), and decreased melanin index (MI) (MD = -22.2,95% CI (-31.79, -12.61), < 0.00001). In addition, subgroup analysis showed that topical phytomedicines reduced MASI scores (I = 0%, MDI = -0.95, 95% CI (-1.23,0.67), < 0.00001), but when scored as the rate of decrease in MASI, topical phytomedicines had high MASI scores (I = 15%, MD = 0.3, 95% CI (0, 0.59), = 0.05), indicating a slower rate of melasma mitigation when botanicals were applied topically. Although burning pain, redness and other mild adverse reactions may occur during the treatment period, they can be recovered on their own, and there is no statistical significance in the comparison of the two groups (RR = 0.95, 95% CI (0.42, 2.51), = 0.91).
TAB for melasma has a clear adjuvant clinical efficacy, a low recurrence rate, and does not cause serious adverse effects. An appropriate administration method may achieve better efficacy; however, this requires further verification.
系统评价植物提取物外用佐剂治疗黄褐斑的有效性和安全性，为其临床应用提供循证医学依据。
检索Medline、Web of Science、EMBASE、Cochrane图书馆、中国知网、维普资讯、万方数据和中国生物医学文献数据库，以识别从建库至2023年5月所有关于植物提取物外用佐剂治疗黄褐斑的随机对照临床试验。主要结局包括临床疗效、不良反应、复发率和黑素指数。使用黄褐斑面积和严重程度指数（MASI）评分进行亚组分析。
本研究纳入16项随机试验，共1386名参与者。符合条件的试验表明，植物提取物外用佐剂治疗黄褐斑可提高临床疗效（RR = 1.14，95%CI（1.10，1.19），P＜0.00001），降低复发率（RR = 0.28，95%CI（0.13，0.59），P = 0.0009），并降低黑素指数（MI）（MD = -22.2，95%CI（-31.79，-12.61），P＜0.00001）。此外，亚组分析显示，植物提取物外用可降低MASI评分（I² = 0%，MD = -0.95，95%CI（-1.23，-0.67），P＜0.00001），但以MASI降低率评分时，植物提取物外用的MASI评分较高（I² = 15%，MD = 0.3，95%CI（0，0.59），P = 0.05），表明外用植物提取物时黄褐斑缓解速度较慢。虽然治疗期间可能会出现灼痛、发红等轻度不良反应，但可自行恢复，两组比较无统计学意义（RR =
0.95，95%CI（0.42，2.51），P = 0.91）。
植物提取物外用佐剂治疗黄褐斑具有明确的临床辅助疗效，复发率低，且不引起严重不良反应。适当的给药方法可能会取得更好的疗效；然而，这需要进一步验证。
