Clinical efficacy and safety of traditional Chinese patent medicine for hyperthyroid heart disease: study protocol for a systematic review and meta-analysis.

Background: Hyperthyroid heart disease (HHD), one of the most common complications of hyperthyroidism, is a serious public health problem due to the direct toxic or indirect effects of excessive thyroid hormone on the heart, resulting in high mortality and increasing health care costs. Traditional Chinese patent medicines (TCPMs), developed by combining modernized pharmaceutical technologies with ancient TCM theories, have been widely used in the treatment of HHD. However, the safety and efficacy of TCPMs used in patients with HHD has been uncertain and there has been no standard clinical trial published to confirm this. Thus, we conduct a study to evaluate the safety and efficacy of TCPMs for HHD.

Methods: The reference lists of randomized controlled trials and 8 electronic databases will be independently and systematically searched by 2 review authors in August 2018. Four English databases [EMBASE, PubMed, National Guideline Clearinghouse (NGC), and Cochrane Central Register of Controlled Trials (CENTRAL)] and 4 Chinese databases [Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure [CNKI], Wanfang Database, and VIP Database] will be included. The primary outcomes will be assessed according to the effective rate of treatment, electrocardiogram, and thyroid hormone levels. Data synthesis will be precisely computed using the RevManV5.3 software when a data-analysis is allowed. Methodological quality will be assessed according to Cochrane Handbook.

Results: This study will provide a high-quality synthesis of current evidence of TCPMs for HHD from different aspects, including the clinical symptoms, thyroid hormone levels, and ECG changes.

Conclusion: The conclusion of this systematic review will provide evidence to prove whether TCPMs are effective therapeutic intervention for patient with HHD.