{"title":"含柚木叶提取物的生发配方的有效性和安全性:一项针对雄激素性脱发男性患者的随机、双盲、安慰剂对照研究。","authors":"Nutchaninad Tanuphol, Neti Waranuch, Vanuchawan Wisuitiprot, Wudtichai Wisuitiprot, Kamonlak Insumrong, Prapapan Temkitthawon, Nungruthai Suphrom, Katechan Jampachaisri, Corine Girard, Kornkanok Ingkaninan","doi":"10.1177/2515690X241291141","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Androgenic alopecia (AGA) is commonly known as male patterned baldness. A high level of dihydrotestosterone (DHT) plays a significant role in AGA development. Inhibition of the enzyme steroid 5-alpha reductase (S5AR), responsible for converting testosterone into DHT, has been shown to delay the progression of AGA. Teak (<i>Tectona grandis</i> L.f) leaf extract exhibited a potent S5AR inhibitory activity. To prove the effectiveness and safety of teak leaf extract as a hair growth promotor, a double-blind, randomized placebo-controlled trial was conducted.</p><p><strong>Methods: </strong>Eighty-one AGA subjects were randomly assigned to receive either a hair tonic containing 1% teak leaf extract (HT-teak), 5%minoxidil (positive control), or a placebo administered twice daily, for 24 weeks. Efficacy was assessed through target area hair count (TAHC), anagen-to-telogen ratio (A/T), hair shedding every 4 weeks, and patients' subjective assessments of hair regrowth were assessed at the end of the experiment. Data was analyzed using repeated measure ANOVA.</p><p><strong>Results: </strong>Both the HT-teak and minoxidil groups exhibited a significant increase in TAHC and A/T, along with a decrease in hair shedding compared to baseline values. Conversely, the placebo group showed no observable signs of hair regrowth. Furthermore, the HT-teak group reported the highest satisfaction scores, and there were no indications of skin irritation or systemic effects on sexual dysfunction and palpitation after 24 weeks of HT-teak application.</p><p><strong>Conclusion: </strong>Teak leaf extract, as incorporated in HT-teak, demonstrates potential as an alternative mild hair growth promoter for individuals with AGA, offering both efficacy and safety.</p><p><strong>Trial registration: </strong>This study was retrospectively registered on International Standard Randomised Controlled Trial Number (ISRCTN.com); ISRCTN24541842 (registered on January 8, 2024).</p>","PeriodicalId":15714,"journal":{"name":"Journal of Evidence-based Integrative Medicine","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and Safety of Hair Growth Formulation Containing <i>Tectona grandis</i> L.f (Teak) Leaf Extract: A Randomized, Double-Blind, Placebo-Controlled Study on Males with Androgenic Alopecia.\",\"authors\":\"Nutchaninad Tanuphol, Neti Waranuch, Vanuchawan Wisuitiprot, Wudtichai Wisuitiprot, Kamonlak Insumrong, Prapapan Temkitthawon, Nungruthai Suphrom, Katechan Jampachaisri, Corine Girard, Kornkanok Ingkaninan\",\"doi\":\"10.1177/2515690X241291141\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Androgenic alopecia (AGA) is commonly known as male patterned baldness. A high level of dihydrotestosterone (DHT) plays a significant role in AGA development. Inhibition of the enzyme steroid 5-alpha reductase (S5AR), responsible for converting testosterone into DHT, has been shown to delay the progression of AGA. Teak (<i>Tectona grandis</i> L.f) leaf extract exhibited a potent S5AR inhibitory activity. To prove the effectiveness and safety of teak leaf extract as a hair growth promotor, a double-blind, randomized placebo-controlled trial was conducted.</p><p><strong>Methods: </strong>Eighty-one AGA subjects were randomly assigned to receive either a hair tonic containing 1% teak leaf extract (HT-teak), 5%minoxidil (positive control), or a placebo administered twice daily, for 24 weeks. Efficacy was assessed through target area hair count (TAHC), anagen-to-telogen ratio (A/T), hair shedding every 4 weeks, and patients' subjective assessments of hair regrowth were assessed at the end of the experiment. Data was analyzed using repeated measure ANOVA.</p><p><strong>Results: </strong>Both the HT-teak and minoxidil groups exhibited a significant increase in TAHC and A/T, along with a decrease in hair shedding compared to baseline values. Conversely, the placebo group showed no observable signs of hair regrowth. Furthermore, the HT-teak group reported the highest satisfaction scores, and there were no indications of skin irritation or systemic effects on sexual dysfunction and palpitation after 24 weeks of HT-teak application.</p><p><strong>Conclusion: </strong>Teak leaf extract, as incorporated in HT-teak, demonstrates potential as an alternative mild hair growth promoter for individuals with AGA, offering both efficacy and safety.</p><p><strong>Trial registration: </strong>This study was retrospectively registered on International Standard Randomised Controlled Trial Number (ISRCTN.com); ISRCTN24541842 (registered on January 8, 2024).</p>\",\"PeriodicalId\":15714,\"journal\":{\"name\":\"Journal of Evidence-based Integrative Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Evidence-based Integrative Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/2515690X241291141\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Evidence-based Integrative Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/2515690X241291141","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
引用次数: 0
摘要
背景:雄激素性脱发(AGA)俗称男性型秃发。高水平的双氢睾酮(DHT)在 AGA 的发病中起着重要作用。抑制负责将睾酮转化为双氢睾酮的类固醇 5-α还原酶(S5AR)已被证明可以延缓 AGA 的发展。柚木(Tectona grandis L.f)叶提取物具有强效的 S5AR 抑制活性。为了证明柚木叶提取物作为生发促进剂的有效性和安全性,我们进行了一项双盲、随机安慰剂对照试验:81名AGA受试者被随机分配到含有1%柚叶提取物(HT-teak)、5%米诺地尔(阳性对照)或安慰剂的生发剂中,每天服用两次,连续服用24周。疗效通过目标区毛发计数(TAHC)、生长期与新生期毛发比率(A/T)、每 4 周一次的毛发脱落情况进行评估,并在实验结束时评估患者对毛发再生的主观评价。数据采用重复测量方差分析:与基线值相比,HT-teak 组和米诺地尔组的 TAHC 和 A/T 均有显著增加,头发脱落也有所减少。相反,安慰剂组则没有明显的头发再生迹象。此外,HT-柚木组的满意度得分最高,在使用 HT- 柚木 24 周后,没有迹象表明皮肤受到刺激,或对性功能障碍和心悸产生系统性影响:结论:HT-teak 中的柚叶提取物具有促进 AGA 患者毛发生长的潜力,是一种替代性的温和生发剂,既有效又安全:本研究在国际标准随机对照试验编号(ISRCTN.com)上进行了回顾性注册;ISRCTN24541842(注册日期:2024年1月8日)。
Effectiveness and Safety of Hair Growth Formulation Containing Tectona grandis L.f (Teak) Leaf Extract: A Randomized, Double-Blind, Placebo-Controlled Study on Males with Androgenic Alopecia.
Background: Androgenic alopecia (AGA) is commonly known as male patterned baldness. A high level of dihydrotestosterone (DHT) plays a significant role in AGA development. Inhibition of the enzyme steroid 5-alpha reductase (S5AR), responsible for converting testosterone into DHT, has been shown to delay the progression of AGA. Teak (Tectona grandis L.f) leaf extract exhibited a potent S5AR inhibitory activity. To prove the effectiveness and safety of teak leaf extract as a hair growth promotor, a double-blind, randomized placebo-controlled trial was conducted.
Methods: Eighty-one AGA subjects were randomly assigned to receive either a hair tonic containing 1% teak leaf extract (HT-teak), 5%minoxidil (positive control), or a placebo administered twice daily, for 24 weeks. Efficacy was assessed through target area hair count (TAHC), anagen-to-telogen ratio (A/T), hair shedding every 4 weeks, and patients' subjective assessments of hair regrowth were assessed at the end of the experiment. Data was analyzed using repeated measure ANOVA.
Results: Both the HT-teak and minoxidil groups exhibited a significant increase in TAHC and A/T, along with a decrease in hair shedding compared to baseline values. Conversely, the placebo group showed no observable signs of hair regrowth. Furthermore, the HT-teak group reported the highest satisfaction scores, and there were no indications of skin irritation or systemic effects on sexual dysfunction and palpitation after 24 weeks of HT-teak application.
Conclusion: Teak leaf extract, as incorporated in HT-teak, demonstrates potential as an alternative mild hair growth promoter for individuals with AGA, offering both efficacy and safety.
Trial registration: This study was retrospectively registered on International Standard Randomised Controlled Trial Number (ISRCTN.com); ISRCTN24541842 (registered on January 8, 2024).