背景:大蒜素(2-丙烯-1-亚磺硫代酸S-2-丙烯基酯,二烯丙基硫代亚磺酸酯)从大蒜中提取,已证明对幽门螺杆菌(H.幽门螺杆菌)感染。近年来,临床试验已经探索了其作为附加治疗的效用,报道了不同的结局.
目的:对大蒜素作为幽门螺杆菌感染的附加治疗进行系统评价,并在随机对照试验(RCT)中评估其疗效。
方法:电子数据库,包括MEDLINE,EMBASE,WebofScience,Cochrane数据库,中国国家知识基础设施数据库,中国贵宾信息数据库,中国医学数据库,并在万方数据库中搜索关键词,包括“大蒜素”,“幽门螺杆菌”,“随机临床试验”,和他们的同义词。使用低异质性的固定效应模型和高异质性的随机效应模型进行了荟萃分析。使用Egger的测试对偏差进行了评估。试验序贯分析(TSA)用于评估信息大小和治疗益处。建议评估的分级,开发和评估(GRADE)用于评估质量水平,研究被归类为“高质量”,“质量适中”,\"低质量\",和“非常低的质量”。
结果:共纳入8个RCT,由867名参与者组成(大蒜素组435名,对照组432名)。大蒜素组的根除率(93.33%,406/435)显著高于对照组(83.56%,361/432)[I2=0%,比值比(OR)=2.75,95%置信区间(CI):1.74-4.35,P<0.001]。大蒜素组幽门螺杆菌治疗后溃疡愈合率(86.17%,349/405)显著高于对照组(75.87%,305/402)[I2=0%,OR=2.05,95CI:1.39-3.03,P<0.001]。所有大蒜素组消化性溃疡的总缓解率为97.16%,显着高于对照组[96.05%(389/405)vs86.55%(360/402),I2=0,OR=3.04,95CI:1.51-6.12,P=0.015]。没有观察到副作用的显著差异。TSA建议这些试验具有足够的标准,可以得出可靠的结论。由于“偏倚风险”和“间接性”的降级,包括根除率和副作用在内的结果质量被评为“非常低”。其他结果,如溃疡愈合率和溃疡总缓解率,由于“偏倚风险”的降级,被评为“低”。
结论:大蒜素作为附加疗法可改善幽门螺杆菌的根除,溃疡的愈合,症状缓解.由于质量有限,建议谨慎处理这些结果。
BACKGROUND: Allicin (2-propene-1-sulfinothioic acid S-2-propenyl ester, diallyl thiosulfinate) extracted from garlic, has proven activity against Helicobacter pylori (H. Pylori) infection. In recent years, clinical trials have explored its utility as an add-on therapy with variable outcomes reported.
OBJECTIVE: To perform a systemic
review of allicin as an add-on treatment for H. Pylori infection and assess its efficacy in randomized controlled trials (RCTs).
METHODS: Electronic databases including MEDLINE, EMBASE, the Web of Science, the Cochrane Database, the China National Knowledge Infrastructure Database, Chinese VIP Information Databases, Chinese Medical Databases, and the Wan-Fang Database were searched for keywords including \"allicin\", \"Helicobacter pylori\", \"randomized clinical trials\", and their synonyms. A meta-analysis was performed using the fixed-effects model for low heterogeneity and the random-effects model for high heterogeneity with sensitivity analysis. Bias was evaluated using Egger\'s tests. Trial sequential analysis (TSA) was used to evaluate information size and treatment benefits. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to assess the level of quality, and studies were classed as \"high quality\", \"moderate quality\", \"low quality\", and \"very low quality\".
RESULTS: A total of eight RCTs consisting of 867 participants (435 from the allicin group and 432 from the control group) were included. Eradication rate in the allicin group (93.33%, 406/435) was significantly higher than that of the control group (83.56%, 361/432) [I 2 = 0%, odds ratio (OR) = 2.75, 95% confidence interval (CI): 1.74-4.35, P < 0.001]. The healing rate of ulcers following H. pylori therapy in the allicin group (86.17%, 349/405) was significantly higher than that of the control group (75.87%, 305/402) [I 2 = 0%, OR = 2.05, 95%CI: 1.39-3.03, P < 0.001]. The total remission rate of peptic ulcers across all allicin groups was 97.16%, which was significantly higher than that of controls [96.05% (389/405) vs 86.55% (360/402), I 2 = 0, OR = 3.04, 95%CI: 1.51-6.12, P = 0.015]. No significant differences in side effects were observed. TSA suggested that the trials were of sufficient standard to draw reliable conclusions. The quality of outcomes including eradication rates and side effects was graded as \"very low\" due to downgrades for \"risk of bias\" and \"indirectness\". Other outcomes such as ulcer healing rates and total ulcer remission rates were graded as \"low\" due to downgrades for \"risk of bias\".
CONCLUSIONS: Allicin as an add-on therapy improves H. pylori eradication, healing of ulcers, and remission of symptoms. These results are suggested to be treated with caution due to limited quality.