【Cochrane简语概要】 针灸治疗慢性乙型肝炎

（图片来源于网络）

系统综述问题 

评价针灸与无干预或假针（不是真正的针灸）相比，对慢性乙型肝炎患者的获益与伤害。

研究背景 

慢性乙型肝炎感染对患者及其家人会产生重大的经济、心理和生活影响。因认为针灸可以减少患者的不适症状，提高患者的免疫功能，现在针灸已经被用于慢性乙型肝炎患者的治疗。然而，针灸治疗的获益和伤害从未在系统综述中得到严格证实。

检索日期 

本系统综述纳入了2019年3月1日前发表的临床试验。

研究特征 

我们纳入了8项随机临床试验，共涉及555 名受试者。所有的试验都比较了针灸和无干预之间的差异。7项试验纳入的受试者仅患有慢性乙型肝炎。1项试验纳入的受试者同时患有慢性乙型肝炎、腹水和肺结核。这些试验评价了多种针灸干预措施（即手法针、草药穴位贴敷、穴位注射和艾灸）。穴位是针灸手法操作所选择的特殊身体区域。所有试验均在组间使用了相同的多种联合干预措施。

研究资金来源 

8项临床试验中，有3项获得了学术资助。其余5项试验均未报告有关资助或资助信息。

主要结果 

纳入的8试验均未报告全因死亡率、严重不良反应、健康相关生存质量和乙肝相关死亡数、乙肝相关发病率等临床重要结局。我们不确定与无干预相比，针灸是否降低或升高不严重的不良反应。针灸相比无干预似乎减少了可检测出乙型肝炎病毒（HBV）DNA患者的比例（未经验证的结果；仅1项试验）。我们无法确定针灸与无干预相比是否影响了可检测HBeAg（阳性）患者的比例（一种未验证的结果；仅2项试验）。在解释这些结果时需要谨慎，因为数据仅由一项或几个具有高风险偏倚的试验提供，而且尚未证明这些结局与慢性乙型肝炎患者相关。我们不确定针灸与无干预相比，是否对分别报告的不严重不良事件有影响。我们无法使用其他79项研究的数据，虽然这些研究与本综述内容相关，但研究作者所提供的研究设计和方法的信息非常少。因此，在确定针灸对慢性乙型肝炎的益处或伤害之前，还需从随机临床试验获得更多的信息。

证据质量 

“证据的可信度”指的是“对综述结果能够支持或反对其结论的正确程度的信心”。对死亡率、健康相关生存质量、HBV感染致死风险、和严重不良反应等方面，针灸治疗的正面或负面影响的可信度无法确定。原因是缺乏相关数据。在不严重的不良反应、可检测出HBV DNA患者的比例、可检测HBeAg（阳性）患者比例等方面，针灸与无干预相比的证据质量极低。最后两个结局（HBV DNA与HBeAg）是否与慢性乙型肝炎患者的福祉有关，目前尚没有科学证明。现有证据质量极低，原因是目前数据仅从1项、2项或很少的试验产生，且报告不充分。

结论: 

针灸治疗慢性乙型肝炎的临床效果仍不得而知。纳入的试验未报告全因死亡、健康相关生存质量、严重不良反应、乙肝相关死亡数和乙肝相关发病率的结局。大量被排除的试验缺乏对其设计和方法的明确描述。针灸是否影响不严重不良事件尚不确定。目前不清楚针灸是否影响HBeAg（阳性率），以及它是否与可检测的HBV DNA减少有关。给予仅从1或2项小试验提供的数据，我们认为不严重的不良事件、HBeAg和HBVDNA的相关结果，其证据质量极低。鉴于针灸的广泛应用，人们在未来试图得出的任何结论，都应基于患者和临床相关结局，基于大型、组间同质、资金透明、高质量的随机对照试验（随机-无效对照试验）的验证。

【Cochrane Plain Language Summary】Acupuncture for chronic hepatitis B

Review question

To assess the benefits and harms of acupuncture versus no intervention or sham acupuncture (not real acupuncture) in people with chronic hepatitis B.

Background

Chronic hepatitis B infection has a substantial economic, psychological, and life impact on people with chronic hepatitis B and their families. Acupuncture has been used in treating people with chronic hepatitis B, as it is believed that it decreases discomfort and improves immune function in people with this disease. However, the benefits and harms of acupuncture have never been established in systematic reviews in a rigorous way.

Search date

The review includes trials published by 1 March 2019.

Study characteristics

We included eight randomised clinical trials with 555 participants. All trials compared acupuncture versus no intervention. Seven trials included participants with chronic hepatitis B. One trial included chronic hepatitis B participants with tuberculosis and ascites. These trials assessed heterogeneous acupuncture interventions (i.e. manual needle acupuncture, acupoint herbal patching, acupoint injection, and moxibustion). Acupoint is a specifically chosen site for acupuncture manipulation. All trials used heterogeneous co-interventions applied equally in the compared groups.

Study funding sources

Three of the eight included randomised clinical trials received academic funding. None of the remaining five trials reported information on support or funding.

Key results

None of the eight included trials reported data on clinically important outcomes such as all-cause mortality, serious adverse events, health-related quality of life, hepatitis B-related mortality, or hepatitis B-related morbidity. We are uncertain whether acupuncture compared with no intervention has a beneficial or harmful effect regarding adverse events considered not to be serious. Acupuncture compared with no intervention seems to reduce the proportion of people with detectable hepatitis B virus (HBV) DNA (a non-validated surrogate outcome; only one trial). We are uncertain whether acupuncture compared with no intervention has an effect on the proportion of people with detectable HBeAg (a non-validated surrogate outcome; only two trials). Caution is needed in interpreting these findings as data are provided by only one or a few trials at high risk of bias, and these surrogate outcomes have not yet been proven relevant for people with chronic hepatitis B. We are uncertain whether acupuncture compared with no intervention has an effect on the remaining separately reported adverse events considered not to be serious. We could not use data from 79 other studies, of possible interest to our review, because study authors provided highly insufficient information on their study design and methods. Accordingly, we need more information from randomised clinical trials before benefits or harms of acupuncture for chronic hepatitis B can be determined.

Certainty of the evidence

Certainty of evidence means 'the extent of one's confidence that review results are correct in supporting or rejecting a finding'. The certainty of evidence on the use of acupuncture in people with chronic hepatitis B virus infection in terms of its beneficial or harmful effects on death, health-related quality of life, risk of dying due to HBV infection, and serious adverse events cannot be determined, as data on these outcomes were lacking. The certainty of evidence on acupuncture, when compared with no intervention, in terms of adverse events considered not to be serious, the proportion of people with detectable HBV DNA, and the proportion of people with detectable HBeAg, is very low. Whether the last two outcomes are relevant to the well-being of people with chronic hepatitis B is still not scientifically proven. The very low certainty of the evidence is due to insufficient data ensuing from one, two, or very few trials with insufficient reporting.

Authors' conclusions: 

The clinical effects of acupuncture for chronic hepatitis B remain unknown. The included trials lacked data on all-cause mortality, health-related quality of life, serious adverse events, hepatitis-B related mortality, and hepatitis-B related morbidity. The vast number of excluded trials lacked clear descriptions of their design and conduct. Whether acupuncture influences adverse events considered not to be serious is uncertain. It remains unclear if acupuncture affects HBeAg, and if it is associated with reduction in detectable HBV DNA. Based on available data from only one or two small trials on adverse events considered not to be serious and on the surrogate outcomes HBeAg and HBV DNA, the certainty of evidence is very low. In view of the wide usage of acupuncture, any conclusion that one might try to draw in the future should be based on data on patient and clinically relevant outcomes, assessed in large, high-quality randomised sham-controlled trials with homogeneous groups of participants and transparent funding.

译者：姜若文，黑龙江中医药大学；审校：李迅，北京中医药大学循证医学中心；编辑排版：张晓雯，北京中医药大学循证医学中心

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