Objective: This study develops a core outcome set (COS) for clinical research concerning Chinese medicine (CM) dampness syndrome (COS-CMDS) that might improve heterogeneity of outcomes, reporting, and inadequate attention to the CM characteristic outcomes in clinical research on CM dampness syndrome.

Methods: An initial outcome pool was constructed based on a systematic review of clinical studies related to CM dampness, registered trials, and semi-structured interviews with patients and healthcare professionals. Various stakeholders were invited to participate in a 2-round Delphi survey to scrutinize the important outcomes. A consensus meeting was held to determine the final COS-CMDS.

Results: We identified 1904 studies and 73 registered trials in the systematic review. Six patients and seven healthcare professionals were invited to participate in a semi-structured interview. Then, 541 outcomes were extracted, of which 397 were physicochemical. After combining certain outcomes (especially the physicochemical outcomes) and excluding those with weak relevance by discussion, 26 outcomes were included in round 1 of the Delphi survey. Round 1 was completed by 82.89% of participants, and 22 outcomes were carried on to round 2. Round 2 was completed by 92.06% of participants, and 14 outcomes achieved consensus for inclusion in the COS. Nineteen stakeholders attended the consensus meeting, voted, and discussed the final COS. It included evaluation of dampness syndrome, CM syndrome assessment, effective response, validated laboratory outcomes of CM dampness syndrome, and adverse events.

Conclusion: The COS-CMDS provides a reference for the selection and reporting of outcomes in clinical research concerning CM dampness syndrome, embodying the characteristics of CM. Please cite this article as: Qiu XY, Tang Q, Cheng T, Cao WC, Liu BQ, Wen ZH, Li G. Developing a core outcome set for clinical research on Chinese medicine dampness syndrome. J Integr Med. 2026; 24(2):201-209.

Key words: Chinese medicine, Core outcome set, Dampness syndrome, Effectiveness evaluation, Outcome