Core outcome sets of traditional Chinese medicine on the treatments of chronic hepatitis B clinical trails

Objective: To develop the core outcome set (COS) of TCM for chronic hepatitis B (CHB) (TCM-COS-CHB).

Methods: Two stages were conducted in the study. In the first stage, a systematic review of random clinical trails (RCTs) on CHB participant sample was conducted to determine the core domains and underlying outcomes and their measuring time.

Results: Nine hundred and sixty literatures were included in the systematic review during 2009 and 2014, and 123 outcomes with their measuring time and 20 instruments were identified. With the priori domains according to the sources of the specimen, methods of test and the discipline categories, the outcomes and domains were firstly identified, and outcomes were clustered within their own domains. Besides, outcomes based on the criteria that the frequency of more than 20 or the top frequency of the outcome among the domain remained in the Stage Two. The results of expert panel were that the domains and their own outcomes were serum indexes [including alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamyltransferase (GGT), total bilirubin (TBIL), direct bilirubin (DBIL), albumin (A), globulin (G), alpha fetoprotein (AFP), prothrombin time (PT), prothrombin activity (PTA), international normalized ratio (INR)], virus index (five index of hepatitis b, quantity level of HBVDNA), quality of life (chronic liver disease questionnaire (CLDQ), safety indexes(renal function test, blood, urine and stool routine test, electrocardiogram), imaging indicators (ultrasounds of liver and spleen) the adverse reaction or adverse events, and calculation of TCM patterns. The measuring time points of each core outcomes were baseline, treatment periods of first, third, sixth, and twelfth month, and the follow-up of sixth month. However, the consensus of instruments has not been reached due to different equipment, methods applied in different researches.

Conclusion: TCM-COS-HBV representing the minimum outcome set at least to be measured in the clinical trials of TCM treatment for CHB patients was established by the consensus and could be recommended in the RCTs. However, the larger consensus should be reached with modernized medicine and international experts in the future.


SUN Ya-nan1,2, HE Li-yun2, LUO Lin2, YU Chang-he2,3

1. Department of TCM, Xuanwu Hospital, Capital Medical University, Beijing 100053, China;
2. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
3. Tuina and Pain Management Department, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China


Journal: Chinese Journal of Traditional Chinese Medicine (formerly Chinese Journal of Medicine)
Volume: 35
Issue: 9
Pages: -
Year: 2020

Further Study Information

Current Stage: Completed
Date: January 2015 - 2015
Funding source(s): National during the ‘Twelfth Five-year’ Plan Period Program Major Infectious Disease Prevention and Control Project of AIDS and Viral Hepatitis, ‘Research on Curative Effect Evaluation and Common Technologies of Traditional Chinese Medicine in the Prevention and Control of Major Infectious Diseases’ (No.2012ZX10005009), Young Scientists Fund of the National Natural Science Foundation of China (No.81803956, No.81603719)

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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