# Application of patient-reported outcomes in clinical trials of traditional Chinese medicine registered in international clinical trials registry platform, from 2010 to 2022: a cross-sectional study

## TL;DR

This study examines how patient-reported outcomes are used in traditional Chinese medicine clinical trials from 2010 to 2022, finding uneven regional use and a need for better standardized tools.

## Contribution

The study provides the first comprehensive analysis of PRO application in TCM clinical trials registered internationally.

## Key findings

- 62.4% of TCM trials listed explicit PRO tools, with musculoskeletal diseases being the most common focus.
- PRO application was most common in the Western Pacific region and least in Africa.
- There is a lack of standardized PRO tools tailored for TCM, indicating a need for improvement in clinical research quality.

## Abstract

Patient-reported outcomes (PROs) assist patients and clinicians in assessing treatment effectiveness and enhancing healthcare quality. This study aims to explore and analyze the application and characteristics of PROs in clinical trials of Traditional Chinese Medicine (TCM).

This cross-sectional study was based on randomized clinical trials of TCM between January 1, 2010, and December 31, 2022 in International Clinical Trials Registry Platform. For each included trial, data including study phase, design, participant demographics, target diseases, PROs, and PRO measurements were extracted. Trials were categorized into three groups: (1) recorded specified patient-reported outcome tools, (2) referenced patient subjective outcomes without specified tools, and (3) did not mention any PROs. Further descriptive statistical analysis were conducted on the most commonly used PRO tools in different countries and for different diseases.

Among a total of 7783 eligible trials, 4858 (62.4%) listed explicit PRO tools, and 850 (10.9%) referenced PROs without specified tools. The most common conditions evaluated by PRO tools were musculoskeletal diseases (935 trials, 19.2%), symptoms (714, 14.7%), and neurological diseases (500, 10.3%). Frequently used PRO tools included the Visual Analogue Scale (VAS), 36-item Short-Form Health Questionnaire, and Pittsburgh Sleep Quality Index. Regionally, most PRO-related trials were in the Western Pacific (3904, 68.4%) and fewest in Africa (8, 0.1%). Countries conducting the most PRO-related trials were China, Iran, the USA, South Korea, and Brazil, focusing on musculoskeletal, symptoms, neurological, genitourinary, and digestive diseases, with varying popular disease-specific PRO tools by country. Musculoskeletal diseases were the primary focus in China, Brazil, and South Korea.

The use of PROs in TCM clinical trials has grown during the study period. However, there was an uneven regional distribution of PRO application and a lack of standardized, reliable PRO tools tailored for TCM. Great efforts are needed to enhance the quality and promote the use of PRO tools in TCM clinical research.

The online version contains supplementary material available at 10.1186/s41687-025-00982-2.