The add-on effect of a Chinese herbal formula for patients with resistant hypertension： study protocol for a pilot cohort study

• Published in: Journal of integrative medicine Vol. 13; no. 2; pp. 122 - 128
• Main Authors: Yuwen, Ya, Liu, Yu-qi, Wang, Yan-ping, Dai, Jin-gang, Liu, Da-sheng, Wang, Yue-xi, Han, Xue-jie
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-03-2015
• Subjects: Antihypertensive Agents - pharmacology; Blood Pressure - drug effects; Clinical Protocols; Cohort Studies; cohort study; Complementary therapies; Drug Resistance; Drugs, Chinese Herbal - pharmacology; Female; Humans; Hypertension - drug therapy; Hypertension - physiopathology; Male; medicine, Chinese traditional; Pilot Projects; Plants, Medicinal; Prospective Studies; resistant hypertension; study protocol; Treatment Outcome; 中国; 中草药配方; 插件; 相对湿度; 研究试验; 队列研究; 顽固性; 高血压患者; Complementary therapies; study protocol; cohort study; medicine, Chinese traditional; resistant hypertension
• ISSN: 2095-4964
• DOI: 10.1016/S2095-4964(15)60162-5

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