# International Clinical Practice Guidelines on Traditional Chinese Medicine Therapy for Dysmenorrhea: Development Protocol

## TL;DR

This paper outlines a protocol for creating the first international guidelines for using traditional Chinese medicine to treat dysmenorrhea, a common gynecological condition.

## Contribution

The paper introduces a structured protocol for developing the first international clinical guidelines for TCM therapy in dysmenorrhea.

## Key findings

- A protocol has been established for developing the first international clinical practice guidelines on TCM therapy for dysmenorrhea.
- The guidelines will be developed using systematic reviews and the Delphi method, incorporating patient preferences and intervention costs.
- Two rounds of the Delphi method have already been completed as part of the protocol.

## Abstract

Traditional Chinese medicine (TCM) functions according to the concepts of “holism” and treatment based on syndrome differentiation, and it has achieved good clinical results in treating patients with dysmenorrhea, which is a common gynecological disorder. However, there are currently no international clinical practice guidelines involving TCM therapies for dysmenorrhea. This study aims to establish a protocol for the development of such guidelines.

This protocol will provide a road map for the development of the first international clinical practice guidelines on TCM therapy for dysmenorrhea.

The guidelines will be developed with reference to the General Rules of Preparation of Diagnosis and Treatment Guideline in Traditional Chinese Medicine and the Western Medicine Guideline and Traditional Chinese Medicine Guideline: Improving Together in Mutual Learning. They will be developed in accordance with the Appraisal of Guidelines for Research and Evaluation II and the World Health Organization guideline handbook and will make recommendations based on systematic reviews. We have established a guideline working group and will formulate clinical questions using the participants, interventions, comparisons, outcomes, and study design framework. The recommendations will be developed through evidence retrieval, synthesis, and the Delphi method. We will consider the preferences and values of patients, as well as the costs and the pros and cons of interventions.

This work was supported by the National Key R&D Program of China (grant 2019YFC1712000) in 2019. The writing group for guidelines was formed in January 2021. The literature search and screening process began in May 2022. So far, the literature search and 2 rounds of the Delphi method have been completed. The protocol will provide a road map for the development of the first international clinical practice guidelines on TCM therapy for dysmenorrhea.

The guideline will be developed in accordance with this protocol, which may provide support and evidence for TCM treatment in patients with dysmenorrhea. There is currently a need for clinical practice guidelines in TCM for the treatment of dysmenorrhea.