背景:在这项比较当前针刺与卡马西平治疗三叉神经痛的随机对照试验(RCT)中,利用元分析和序贯分析。
目的:为指导卡马西平治疗三叉神经痛的临床决策。
方法:在包括中国生物医学文献数据库在内的各种中国生物医学数据库中搜索了有关针头比较的RCT文献,万方数据,VIP数据库,以及国际数据库,如摘录医学数据库,科克伦图书馆,PubMed,和WebofScience,以及相关的临床注册平台,如世界卫生组织国际临床试验注册平台,ChiCTR,以及截至2020年4月1日的临床试验。使用Cochrane协作风险偏差工具评估偏差风险,主要结局指标(疼痛减轻)使用STATA荟萃分析进行分析,结果测量采用试验序贯分析0.9.5.10Beta序贯分析,等级被用来评估证据,并记录不良反应。
结果:本研究分析了16项随机对照试验,共1231名参与者。荟萃分析显示,针灸和卡马西平在减轻疼痛方面存在统计学上的显着差异[标准化平均差(SMD)=1.47;95%置信区间(CI):0.99-1.95],尽管证据质量被认为是极低质量的.基于发表年份的累积荟萃分析表明,卡马西平治疗在2014年首次显示出疼痛减轻的统计学差异,并且随着时间的推移保持相对稳定[SMD=1.84;95CI:0.22-3.47]。此外,与卡马西平相比,与针灸相关的不良事件数量显著降低.
结论:针刺治疗三叉神经痛优于镇痛,比卡马西平更安全;坚定的结论仍然需要高质量,多中心,大样本RCT来证实这些发现。
BACKGROUND: In this randomized controlled trial (RCT) comparing current acupuncture with
carbamazepine for trigeminal neuralgia, meta- and sequential analyses were utilized.
OBJECTIVE: To guide clinical decision making regarding the treatment of trigeminal neuralgia with
carbamazepine.
METHODS: The RCT literature on needle comparison was searched in various Chinese biomedical databases including Chinese Biomedical Literature Database, Wanfang Data, VIP Database, as well as international databases such as Excerpt Medica Database, Cochrane Library, PubMed, and Web of Science, along with related clinical registration platforms such as World Health Organization International Clinical Trial Registry Platform, ChiCTR, and Clinical Trials up to 1 April 2020. Risk of bias was evaluated using the Cochrane Collaborative Risk Bias tool, primary outcome measures (pain reduction) were analyzed using STATA meta-analysis, outcome measures were analyzed using trial sequential analysis 0.9.5.10 Beta sequential analysis, GRADE was used to assess the evidence, and adverse reactions were documented.
RESULTS: This study analyzed 16 RCTs with a total of 1231 participants. The meta-analysis revealed a statistically significant difference in pain reduction between acupuncture and
carbamazepine [standardized mean difference (SMD) = 1.47; 95% confidence interval (CI): 0.99-1.95], although the quality of evidence was deemed to be of extremely low quality. Cumulative meta-analysis based on the year of publication indicated that
carbamazepine treatment first demonstrated a statistically significant difference in pain reduction in 2014 and remained relatively stable over time [SMD = 1.84; 95%CI: 0.22-3.47]. Additionally, the number of adverse events associated with acupuncture was significantly lower compared to carbamazepine.
CONCLUSIONS: Acupuncture for trigeminal neuralgia is better than analgesia and safer than
carbamazepine; however, firm conclusions still require a high-quality, multicenter, large-sample RCT to confirm these findings.