Xiao Chai Hu Tang, A Chinese Herbal Medicine Formula ... - Cochrane

Review question

To assess the benefits and harms of Xiao Chai Hu Tang formula versus placebo or no intervention in people with chronic hepatitis B virus infection.

Background

Chronic hepatitis B virus infection is a common liver disease, associated with high morbidity (illness) and death. It causes psychological stress and is a burden to people with chronic hepatitis B and their families. Xiao Chai Hu Tang formula has been used for treating people with chronic hepatitis B as it is believed that it decreases discomfort and prevents the replication of the virus in people with chronic hepatitis B. However, the benefits and harms of Xiao Chai Hu Tang formula have never been established in reviews with rigorous review methodology.

Search date

The review includes trials published up to 1 March 2019.

Study characteristics

We included 10 randomised clinical trials (studies where people are randomly put into one of two or more treatment groups) with 934 participants. All trials compared Xiao Chai Hu Tang formula with no treatment. The trials assessed different formulas and doses for three to eight months. One trial included participants with tuberculosis (a disease of the lungs that can make you cough mucous), and one trial included participants with liver cirrhosis (scarring). Only five trials with 490 participants provided data for analysis

Study funding sources

Two of the 10 included trials reported receiving academic funding. None of the remaining eight trials reported information of support or funding.

Key results

None of the 10 included trials reported data on all-cause mortality (death from any cause), serious side effects (untoward medical occurrences that result in serious outcomes such as death or disability), health-related quality of life (a measure of physical, mental, emotional, and social functioning a measure of a person's satisfaction with their life and health), hepatitis B-related death, and hepatitis B-related morbidity. We are uncertain whether Xiao Chai Hu Tang formula versus no intervention has a positive or negative effect regarding side effects considered 'not to be serious', the proportion of people with detectable HBeAg (a hepatitis B viral protein that indicates active viral replication), and separately reported side effects considered 'not to be serious'. Xiao Chai Hu Tang formula compared with no intervention seems to reduce the proportion of people with detectable HBV-DNA (which is used to indicate how much hepatitis B virus is in the blood) but the reliability of this finding is low. Surrogate outcomes are markers that are used in research as a substitute for a clinically meaningful measure that directly measures patient outcomes. We cannot always be certain that such surrogate outcomes are reliable substitutes for important outcomes as they need to be officially examined. Caution is needed with this beneficial finding as the trials are at high risk of bias, and this outcome has not yet been proven relevant to patients. We identified an additional 47 studies as potential randomised clinical trials, but the data they reported were of no use. Accordingly, properly designed randomised clinical trials are needed before the benefits and harms of Xiao Chai Hu Tang formula for chronic hepatitis B can be determined.

Reliability of the evidence

The reliability of the evidence on the use of Xiao Chai Hu Tang formula in people with chronic hepatitis B virus in terms of its beneficial or harmful effects on death, health-related quality of life, risk of dying due to hepatitis B virus infection, and serious side effects cannot be determined as no trials aimed to explore these. The reliability of the evidence that Xiao Chai Hu Tang formula, when compared with no intervention, in terms of side effects considered 'not to be serious', the proportion of people with detectable HBV-DNA, and the proportion of people with detectable HBeAg is very low. These assessments of the reliability of the evidence are due to the poor design and reporting of the included trials.

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