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Background <p>The National List of Essential Medicines in Thailand selects herbal medicines through a consensus-based process, in which experts independently assess the evidence. However, there is a lack of standardised criteria for evaluating the evidence of efficacy and safety. This study aimed to develop two sets of modified criteria—one for traditional medicines and another for herbal medicines derived from traditional use—focusing on evidence-based efficacy and safety.</p> Methods <p>A mixed-methods study was conducted. The criteria were modified for decision-making regarding herbal medicines based on evidence and the 2009 National Health and Medical Research Council guidelines. They were also aligned with the World Health Organisation guidelines for assessing herbal medicines, the European Medicines Agency regulations on traditional herbal medicines, the Australian guidelines for levels and kinds of evidence to support claims for therapeutics goods, and the standards of the National Center for Complementary and Alternative Medicine. Content and face validity were assessed, and interrater reliability was tested.</p> Results <p>The efficacy criteria consist of six aspects: levels of evidence, study outcomes, consistency of the evidence, clinical significance, availability of herbal products in Thailand, and rational application of herbal medicine. The safety criteria include seven components: adverse effects of herbal medicines from post-marketing surveillance; safety information from herbal monographs or the National Thai Traditional Medicine Formulary; meta-analyses or systematic reviews; clinical trials or pragmatic trials; observational studies; case reports; and preclinical studies. Each component of the efficacy and safety criteria consists of three decision-making levels: accepted, requires more information, and rejected/expert judgment. The mean item-objective congruence for the criteria for traditional medicines and herbal products was 0.93 and 0.74, respectively. The kappa coefficients of interrater agreement were 0.74 and 0.71.</p> Conclusions <p>The criteria clearly identified traditional and herbal medicines into three categories: 1) fully accepted for herbal medicines with robust evidence of efficacy and safety; 2) herbal medicines requiring additional information to prove their efficacy or safety; and 3) rejected herbal medicines lacking evidence of efficacy or safety.</p>

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Developing evidence-based criteria for selecting herbal medicines for the national list of essential medicines

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  • 发表日期：

    2026年8月1日

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  • Mayuree Tangkiatkumjai,
  • Narisa Kamkaen,
  • Duangkamol Pakdeesattayapong,
  • Nidchakarn Namthongbai,
  • Wannisa Theantawee,
  • Phantipa Sakthong

摘要

Background

The National List of Essential Medicines in Thailand selects herbal medicines through a consensus-based process, in which experts independently assess the evidence. However, there is a lack of standardised criteria for evaluating the evidence of efficacy and safety. This study aimed to develop two sets of modified criteria—one for traditional medicines and another for herbal medicines derived from traditional use—focusing on evidence-based efficacy and safety.

Methods

A mixed-methods study was conducted. The criteria were modified for decision-making regarding herbal medicines based on evidence and the 2009 National Health and Medical Research Council guidelines. They were also aligned with the World Health Organisation guidelines for assessing herbal medicines, the European Medicines Agency regulations on traditional herbal medicines, the Australian guidelines for levels and kinds of evidence to support claims for therapeutics goods, and the standards of the National Center for Complementary and Alternative Medicine. Content and face validity were assessed, and interrater reliability was tested.

Results

The efficacy criteria consist of six aspects: levels of evidence, study outcomes, consistency of the evidence, clinical significance, availability of herbal products in Thailand, and rational application of herbal medicine. The safety criteria include seven components: adverse effects of herbal medicines from post-marketing surveillance; safety information from herbal monographs or the National Thai Traditional Medicine Formulary; meta-analyses or systematic reviews; clinical trials or pragmatic trials; observational studies; case reports; and preclinical studies. Each component of the efficacy and safety criteria consists of three decision-making levels: accepted, requires more information, and rejected/expert judgment. The mean item-objective congruence for the criteria for traditional medicines and herbal products was 0.93 and 0.74, respectively. The kappa coefficients of interrater agreement were 0.74 and 0.71.

Conclusions

The criteria clearly identified traditional and herbal medicines into three categories: 1) fully accepted for herbal medicines with robust evidence of efficacy and safety; 2) herbal medicines requiring additional information to prove their efficacy or safety; and 3) rejected herbal medicines lacking evidence of efficacy or safety.