Core Outcome Sets of integrity of modern and Traditional Chinese Medicine on treatment of chronic Hepatitis B

Many RCTs and systemic reviews failed to prove the effectiveness of Traditional Chinese Medicine (TCM) for chronic Hepatitis B (CHB), due to 1) the potential outcome selective reporting or publication bias, or 2) the outcome heterogeneity leading to few meta-analyses or comparisons.

We need to develop the Core Outcome Set (COS) of TCM for CHB (TCM-COS-CHB),whose frame includes the core outcome domains, outcomes, the instruments measuring outcomes,and the time points of measurement.

TCM-COS-HBV represents the minimum outcome set at least to be measured in the clinical trials of TCM treatment for pure CHB patients without any comorbidies. It will help to make it easier to compare, contrast and combine the results.


Principle investigator: Yanan Sun, Changhe Yu
Supervisor: Liyun He and Jiping Fan
Affiliation: China Academy of Chinese Medical Sciences

Further Study Information

Current Stage: Completed – pending publication
Date: January 2015 - 2015
Funding source(s): Ministry of finance of People’s Republic of China

Health Area

Disease Category: Infectious disease

Disease Name: Hepatitis B

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors

Study Type

- COS for clinical trials or clinical research


- Consensus meeting
- Survey
- Systematic review

In a systematic review, search and medical subject terms focus on two factors: hepatitis B participant sample and the experimental designs. Data extraction includes general information about the identity of the reference, specific information regarding the study and information pertaining to the potential outcomes and their measures and measuring time. Two rounds of expert panels will be implemented, and each will have two stages. At the first meeting, participants will be firstly asked to complete the ratings about the importance of various potential domains and outcomes in two rounds of questionnaires (one before the meeting and the other one during the meeting); and then to review and make a consensus relating to the core domains and underlying outcomes. At the second meeting, they will be asked to attend a consensus meeting to rate specific outcome instruments identified from the review and pre-prepared information during two meetings, and to agree the results relating to the measuring time.

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