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Chinese Herbal Medicine Safety Project

Bin Liu worked with the Research Director in conducting this pilot when she was an MSc student at the University of York. In June 2004, we invited 549 herbalists who were members of the UK Register of Chinese Herbal Medicine to ask 10 consecutive patients to participate in the survey. Consenting patients returned their baseline survey forms direct to the research centre. Four weeks later patients were sent a follow-up questionnaire in which they reported adverse events that they perceived were caused by the Chinese herbal medicine over the previous four weeks. We analysed the data, exploring types and frequencies of adverse events as well as assessing potential risk factors using multi-level logistic regression while taking into account the clustering of patients with practitioners. 

Of the 161 responding practitioners of Chinese herbal medicine, 71 agreed to participate, 13% of the total membership. 194 patients returned baseline questionnaires, an average of 2.7 patients per practitioner. 144 (74%) patients completed the four-week follow-up questionnaires. 32 adverse events associated with Chinese herbal medicine were reported by 20 patients (14% of patients over four weeks, 95 % CI: 9% to 20%) who were consulting 14 herbalists. No serious adverse events were reported. The most commonly reported adverse events were diarrhoea, fatigue and nausea. When controlling for potential confounders, patients consulting for Chinese herbal medicine for the first time were more likely to report an adverse event than repeat attenders (OR 3.03; 95% CI: 1.03 to 8.89, p<0.02). 

In this pilot, the recruitment rate was low with only 13% of practitioners participating, and only 27% of potential patients returning consent forms, raising questions about potential bias. This research has provided some useful data which will assist in the initiation of future studies. We hope to use the published results of this pilot as a platform for a bid for major funding of this project.