Department of Vascular Surgery, Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Suzhou, P R China.
Medicine (Baltimore). 2021 Feb 26;100(8):e24663. doi: 10.1097/MD.0000000000024663.
Varicose veins of the lower extremities are common chronic venous diseases in the clinic. Although Western medicine has various surgical methods to treat varicose veins in the lower extremities, there are still a variety of complications. Some studies have shown that Buyang Huanwu decoction treatment of varicose veins of the lower extremities has a certain effect, and can reduce the occurrence of postoperative complications, but there is no evidence of evidence-based medicine. The research carried out in this scheme is to systematically evaluate the efficacy and safety of Buyang Huanwu decoction in the treatment of varicose veins in the lower extremities, and to provide reliable evidence for guiding clinical practice.
This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial, which studies the effectiveness and safety of Buyang Huanwu decoction in the treatment of varicose veins of the lower extremities. The patients are randomly and evenly divided into treatment group and control group, the former one is given Buyang Huanwu decoction and the latter one is given placebo. The study will last 49 days, including a 7-day washout period, 14-day intervention and 28-day follow-up, focusing on its efficacy and safety indicators. Observation indicators include: TCM syndrome score, Venous Clinical Severity Score (VCSS), Venous Disability Scote (VDS), Aberdeen Varicose Vein Questionnaire (AVVQ), Hemorheology Indicators, Adverse Reactions, etc. Data analysis is performed using SPSS 25.0 software.
This study will evaluate the effectiveness and safety of Buyang Huanwu decoction and provide clinical evidence for the treatment of varicose veins of the lower extremities.
OSF Registration number: DOI 10.17605/OSF.IO/WGJXT.
下肢静脉曲张是临床常见的慢性静脉疾病。西医治疗下肢静脉曲张有多种手术方法，但仍有多种并发症。一些研究表明，补阳还五汤治疗下肢静脉曲张有一定疗效，能降低术后并发症的发生，但缺乏循证医学证据。本方案开展的研究旨在系统评价补阳还五汤治疗下肢静脉曲张的疗效和安全性，为指导临床实践提供可靠依据。
本研究为随机、双盲、安慰剂对照、平行分组临床试验，研究补阳还五汤治疗下肢静脉曲张的有效性和安全性。患者随机分为治疗组和对照组，分别给予补阳还五汤和安慰剂。研究持续 49 天，包括 7 天洗脱期、14 天干预期和 28 天随访期，重点观察其疗效和安全性指标。观察指标包括：中医证候评分、静脉临床严重程度评分（VCSS）、静脉残疾评分（VDS）、阿伯丁静脉曲张问卷（AVVQ）、血液流变学指标、不良反应等。采用 SPSS 25.0 软件进行数据分析。
本研究将评价补阳还五汤的有效性和安全性，为下肢静脉曲张的治疗提供临床证据。
OSF 注册号：DOI 10.17605/OSF.IO/WGJXT。
