Development of an adverse event reporting template for Ephedrae Herba for weight loss

Abstract

Introduction

Ephedrae Herba is a medicinal herb that has been frequently used for weight loss for several centuries. However, there are concerns regarding the safety and potential adverse events (AE) associated with Ephedrae Herba. This study aimed to develop a template suitable for reporting the AE of a Ephedrae Herba as a weight loss treatment in a clinical setting.

Methods

An initial consensus questionnaire was developed based on a literature review and discussion with the project management group. Delphi votes were performed, and three indices – content validity ratio, consensus, and convergence–were used to determine the core symptoms to be reported as AE. Finally, 12 Korean medicine doctors used the template for 1,043 patients from the Korean Medicine Registry of Herbal Medicine for weight loss, and evaluated its applicability.

Results

Following a two round Delphi survey, six items reached a consensus as the core symptoms of AE in Ephedrae Herba: headache, nausea, palpitations, dry mouth, constipation, and insomnia. The template has two main domains: (1) prescription of the herbal medicine, including Ephedrae Herba, and the dose and usage period; and (2) periods, severity, and causality of AE.

Conclusions

This is the first template specifically for reporting the AE of Ephedrae Herba. This template will help collect data in daily practice regarding the AE associated with Ephedrae Herba use for weight loss. This study could be valuable for practitioners who prescribe herbal medicines, including Ephedrae Herba, and stakeholders who manage the AE of herbal medicines to obtain long-term safety information associated with Ephedrae Herba.