Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a...

Area of Science:

• Integrative Medicine
• Neurology
• Clinical Trials

Background:

• Tension-type headache (TTH) is a prevalent condition globally.
• Traditional Chinese Medicine (TCM) shows therapeutic promise for TTH.
• Current TCM research for TTH lacks standardized outcomes, hindering evidence synthesis.

Purpose of the Study:

• To develop a standardized Core Outcome Set (COS) for clinical studies evaluating TCM treatments for TTH.
• To enhance the quality, comparability, and robustness of evidence for TCM in TTH management.

Main Methods:

• Systematic reviews and interviews to identify potential outcomes.
• Two-round Delphi surveys with experts and patients to assess outcome importance.
• A consensus meeting to finalize the COS and recommend measurement times.

Main Results:

• Protocol registered (PROSPERO), systematic reviews initiated October 2024.
• Anticipated results by November 2024, with Delphi and consensus phases in late 2024/early 2025.
• Findings will be reported following COS-STAR guidelines and disseminated widely.

Conclusions:

• A COS is essential for standardizing TCM clinical studies on TTH.
• This initiative will maximize data value and provide high-quality research evidence.
• The developed COS will facilitate more reliable and comparable research on TCM for TTH.