Objective： To evaluate the quality and consistency of recommendations in the clinical practice guidelines（CPGs） for hypertension in Chinese medicine（CM）. Methods： CM CPGs were identified from 5 electronic databases and hand searches through related handbooks published from January 1990 to December 2013. Three reviewers independently appraised the CPGs based on the Appraisal of Guidelines for Research and Evaluation（AGREE Ⅱ） instrument, and compared the CPGs＇ recommendations on CM syndrome pattern classification and treatment. Results： Five CM CPGs for hypertension were included. The quality score of the evidence-based（EB） guideline was higher than those of the consensus-based with no explicit consideration of evidence-based（CB-EB） and the consensus-based（CB） guidelines. Three out of five patterns in the CPGs were recommended by the EB guideline. Tianma Gouteng Formula（天麻钩藤复方） in the EB guideline was recommended mostly for hypertension patients with pattern of ascendant hyperactivity of Gan（Liver）-yang and pattern of yin deficiency with yang hyperactivity in the CPGs. Acupuncture and massage were recommended for Grade Ⅰ and Grade Ⅱ hypertension with severe symptoms weakening the quality of life in the EB guideline. For Grade Ⅰ and Grade Ⅱ hypertension, CM could be used alone, while for Grade Ⅲ hypertension, they should be used in combination with Western medicines. Conclusion： The quality of EB guideline was higher than those of CB and CB-EB CPGs in CM for hypertension and CM should be prescribed alone or combined with Western medicines based on the grade of hypertension.
BACKGROUND： Despite a recent American Heart Association （AHA） consensus statement emphasizing the importance of resistant hypertension （RH）, its control is still a challenge for conventional medicine. The Chinese herbal formula, Qutan Huayu Fang, has been used effectively to assist antihypertensive agents in blood pressure control, but its effect for RH patients is still unclear. This pilot study aims to explore the effects of taking the formula in addition to antihypertensive medication in the management of RH. METHODS/DESIGN： A prospective cohort study will be conducted in two first-class hospitals of traditional Chinese medicine （TCM）. Eligible RH patients will be classified as the experimental group （n = 100） and the control group （n = 100） based on the interventions they receive. Participants taking antihypertensive agents and the Chinese herbal formula will be in the experimental group and those taking antihypertensive agents alone will be in the control group. The whole study will last 24 weeks, including an 8-week observation and follow-up at 24 weeks. The primary outcomes, assessed against patient baseline conditions, will be the reduction of systolic blood pressure and diastolic blood pressure as well as changes in TCM symptoms and signs. These outcomes will be assessed at weeks 2, 4, 6, and 8. The reductions of blood pressure will also be assessed at week 24. Cardiac events and mortality rate will be secondary outcomes and will be assessed at weeks 8 and 24. Any adverse reactions will be recorded during the study. The causal inference method will be used to assess the effectiveness of the inclusion of TCM herbal medicine in the management of patients with RH. DISCUSSION： This study will determine whether the Chinese herbal formula is helpful for RH patients treated with antihypertensive agents and the findings will provide a basis for further confirmatory studies TRIAL REGISTRATION NUMBER： ClinicalTria/s.gov Identifier NCT01904695
Ya YuwenYu-qi LiuYan-ping WangJin-gang DaiDa-sheng LiuYue-xi WangXue-jie Han
