{"title":"Therapeutic efficacy and safety of traditional Thai herbal medicines for insomnia: A double-blind randomized controlled trial","authors":"Thanyaluck Siriyong , Hatairat Chanphool , Sarinrat Jitjum , Sirirat Laohaprapanon , Supayang Piyawan Voravuthikunchai","doi":"10.1016/j.aimed.2025.01.006","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Traditional Thai herbal medicine has been commonly used for insomnia therapy in Asian countries for centuries. However, there has been a limited amount of clinical efficacy and safety research on Yahom-Navakot and Suk-Sai-Yat for patients with insomnia.</div></div><div><h3>Objective</h3><div>This study aims to evaluate the efficacy and safety of traditional Thai herbal medicines such as Yahom-Navakot and Suk-Sai-Yat, in the treatment of insomnia.</div></div><div><h3>Design setting participants and intervention</h3><div>This randomised, double-blind clinical investigation was conducted at a Thai Traditional Medical Clinic. A total of 58 participants diagnosed with insomnia were randomly allocated to receive either Yahom-Navakot or Suk-Sai-Yat; the therapy consisted of a 1000 mg dosage, administered once daily at bedtime for a duration of 2 weeks. Following a 2-week therapy period, the participants were followed for an additional 2 weeks.</div></div><div><h3>Main outcome measures</h3><div>The primary outcome measures of sleep quality, sleepiness, and quality of life were assessed at baseline and weekly during the treatment period with the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and Health-Related Quality of Life Measure (EQ-5D), respectively. Adverse drugs responses were investigated as a secondary outcome measure during a clinical study.</div></div><div><h3>Results</h3><div>The findings demonstrated that at weeks 1 and 2 after initiating Yahom-Navakot or Suk-Sai-Yat, all parameters, including PSQI, ESS, and EQ-5D scores, exhibited statistically significant changes (p < 0.05) in response to the Yahom-Navakot intervention, in comparison to Suk-Sai-Yat. Clinically significant changes (p < 0.05) were observed in the overall PSQI, ESS, and EQ-5D scores within Yahom-Navakot after the first follow-up, in comparison to Suk-Sai-Yat. Moreover, statistically significant changes were noted in both groups post-intervention, relative to baseline measurements. No significant adverse responses were noticed in either group.</div></div><div><h3>Conclusion</h3><div>The findings indicated that Yahom-Navakot was significantly more effective than Suk-Sai-Yat in enhancing sleep quality, including sleep quality, sleep latency, sleep duration, sleep efficiency, and daytime dysfunction in the treatment of insomnia. Additional research is recommended to clarify the mechanism beneath the anti-insomnia properties of Yahom-Navakot.</div></div>","PeriodicalId":7343,"journal":{"name":"Advances in integrative medicine","volume":"12 3","pages":"Article 100459"},"PeriodicalIF":1.7000,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in integrative medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2212958825000060","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Traditional Thai herbal medicine has been commonly used for insomnia therapy in Asian countries for centuries. However, there has been a limited amount of clinical efficacy and safety research on Yahom-Navakot and Suk-Sai-Yat for patients with insomnia.
Objective
This study aims to evaluate the efficacy and safety of traditional Thai herbal medicines such as Yahom-Navakot and Suk-Sai-Yat, in the treatment of insomnia.
Design setting participants and intervention
This randomised, double-blind clinical investigation was conducted at a Thai Traditional Medical Clinic. A total of 58 participants diagnosed with insomnia were randomly allocated to receive either Yahom-Navakot or Suk-Sai-Yat; the therapy consisted of a 1000 mg dosage, administered once daily at bedtime for a duration of 2 weeks. Following a 2-week therapy period, the participants were followed for an additional 2 weeks.
Main outcome measures
The primary outcome measures of sleep quality, sleepiness, and quality of life were assessed at baseline and weekly during the treatment period with the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and Health-Related Quality of Life Measure (EQ-5D), respectively. Adverse drugs responses were investigated as a secondary outcome measure during a clinical study.
Results
The findings demonstrated that at weeks 1 and 2 after initiating Yahom-Navakot or Suk-Sai-Yat, all parameters, including PSQI, ESS, and EQ-5D scores, exhibited statistically significant changes (p < 0.05) in response to the Yahom-Navakot intervention, in comparison to Suk-Sai-Yat. Clinically significant changes (p < 0.05) were observed in the overall PSQI, ESS, and EQ-5D scores within Yahom-Navakot after the first follow-up, in comparison to Suk-Sai-Yat. Moreover, statistically significant changes were noted in both groups post-intervention, relative to baseline measurements. No significant adverse responses were noticed in either group.
Conclusion
The findings indicated that Yahom-Navakot was significantly more effective than Suk-Sai-Yat in enhancing sleep quality, including sleep quality, sleep latency, sleep duration, sleep efficiency, and daytime dysfunction in the treatment of insomnia. Additional research is recommended to clarify the mechanism beneath the anti-insomnia properties of Yahom-Navakot.
期刊介绍:
Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.