Background: Chinese herbal medicine (CHM) is widely used to assist conventional medication and rehabilitation for patients with stroke, particularly in hospitals for Chinese medicine, in China. Literature review suggests overuse and inappropriate use of herbal products for stroke. However, the risk of the integrative use is not systematically evaluated and informing clinicians of evidence of harm is lacking.
Objectives: To analyse the adverse events associated with CHM systematically when it is used with conventional medication for patients with stroke, and to interview a group of Chinese medicine clinicians about their attitude to and understanding of this evidence of harm, as well as possible solutions to reducing the risks in clinical practice.
Methods: This program will be a two-phase study, including a systematic review and a semi-structured interview.
Phase 1: Relevant information will be identified by searching research databases and regular reports published by food and drug administration. Types of studies are not limited. Causal relation will be assessed if the primary study does not have it. The primary outcome will be the total adverse effects specific to CHM in people with stroke. Meta-analysis will be conducted if appropriate; otherwise, qualitative synthesis will be performed.
Phase 2: Purposive sampling will be adopted to identify 20 participants in terms of their qualifications in Chinese medicine and clinical expertise in stroke management. The interview will be semi-structured, face-to-face and audio-recorded. Demographics will be collected and informed consent will be obtained. Three essential questions will be asked, including the attitude to and understanding of the evidence of harm collected by the Phase 1 study and the suggested solutions to reducing the risks. Probing questions will be asked in terms of specific risks and clinical scenarios. Grounded theory and discourse analysis will be used to analyse the data.
Discussion: This study will inform the framework for implementing an evidence-based education program for clinicians, which aims to reducing the risk of integrative use of Chinese herbal medicine for stroke.