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针刺治疗成人膀胱过度活动症。

Acupuncture for treating overactive bladder in adults.

机构信息

Department of Physiotherapy, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.

Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.

出版信息

Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.

Abstract

BACKGROUND

Overactive bladder is a common, long-term symptom complex, which includes frequency of micturition, urgency with or without associated incontinence and nocturia. Around 11% of the population have symptoms, with this figure increasing with age. Symptoms can be linked to social anxiety and adaptive behavioural change. The cost of treating overactive bladder is considerable, with current treatments varying in effectiveness and being associated with side effects. Acupuncture has been suggested as an alternative treatment.

OBJECTIVES

To assess the effects of acupuncture for treating overactive bladder in adults, and to summarise the principal findings of relevant economic evaluations.

SEARCH METHODS

We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (including In-Process, Epub Ahead of Print, Daily), ClinicalTrials.gov and WHO ICTRP (searched 14 May 2022). We also searched the Allied and Complementary Medicine database (AMED) and bibliographic databases where knowledge of the Chinese language was necessary: China National Knowledge Infrastructure (CNKI); Chinese Science and Technology Periodical Database (VIP) and WANFANG (China Online Journals), as well as the reference lists of relevant articles.  SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs and cross-over RCTs assessing the effects of acupuncture for treating overactive bladder in adults.

DATA COLLECTION AND ANALYSIS

Four review authors formed pairs to assess study eligibility and extract data. Both pairs used Covidence software to perform screening and data extraction. We assessed risk of bias using Cochrane's risk of bias tool and assessed heterogeneity using the Chi testand I statistic generated within the meta-analyses. We used a fixed-effect model within the meta-analyses unless there was a moderate or high level of heterogeneity, where we employed a random-effects model. We used the GRADE approach to assess the certainty of evidence.

MAIN RESULTS

We included 15 studies involving 1395 participants in this review (14 RCTs and one quasi-RCT). All included studies raised some concerns regarding risk of bias. Blinding of participants to treatment group was only achieved in 20% of studies, we considered blinding of outcome assessors and allocation concealment to be low risk in only 25% of the studies, and random sequence generation to be either unclear or high risk in more than 50% of the studies. Acupuncture versus no treatment One study compared acupuncture to no treatment. The evidence is very uncertain regarding the effect of acupuncture compared to no treatment in curing or improving overactive bladder symptoms and on the number of minor adverse events (both very low-certainty evidence). The study report explicitly stated that no major adverse events occurred. The study did not report on the presence or absence of urinary urgency, episodes of urinary incontinence, daytime urinary frequency or episodes of nocturia. Acupuncture versus sham acupuncture Five studies compared acupuncture with sham acupuncture. The evidence is very uncertain about the effect of acupuncture on curing or improving overactive bladder symptoms compared to sham acupuncture (standardised mean difference (SMD) -0.36, 95% confidence interval (CI) -1.03 to 0.31; 3 studies; 151 participants; I = 65%; very low-certainty evidence). All five studies explicitly stated that there were no major adverse events observed during the study. Moderate-certainty evidence suggests that acupuncture probably makes no difference to the incidence of minor adverse events compared to sham acupuncture (risk ratio (RR) 1.28, 95% CI 0.30 to 5.36; 4 studies; 222 participants; I² = 0%). Only one small study reported data for the presence or absence of urgency and for episodes of nocturia. The evidence is of very low certainty for both of these outcomes and in both cases the lower confidence interval is implausible. Moderate-certainty evidence suggests there is probably little or no difference in episodes of urinary incontinence between acupuncture and sham acupuncture (mean difference (MD) 0.55, 95% CI -1.51 to 2.60; 2 studies; 121 participants; I = 57%). Two studies recorded data regarding daytime urinary frequency but we could not combine them in a meta-analysis due to differences in methodologies (very low-certainty evidence). Acupuncture versus medication Eleven studies compared acupuncture with medication. Low-certainty evidence suggests that acupuncture may slightly increase how many people's overactive bladder symptoms are cured or improved compared to medication (RR 1.25, 95% CI 1.10 to 1.43; 5 studies; 258 participants; I = 19%). Low-certainty evidence suggests that acupuncture may reduce the incidence of minor adverse events when compared to medication (RR 0.34, 95% CI 0.26 to 0.45; 8 studies; 1004 participants; I² = 51%). The evidence is uncertain regarding the effect of acupuncture on the presence or absence of urinary urgency (MD -0.40, 95% CI -0.56 to -0.24; 2 studies; 80 participants; I = 0%; very low-certainty evidence)and episodes of urinary incontinence (MD -0.33, 95% CI -2.75 to 2.09; 1 study; 20 participants; very low-certainty evidence) compared to medication. Low-certainty evidence suggests there may be little to no effect of acupuncture compared to medication in terms of daytime urinary frequency (MD 0.73, 95% CI -0.39 to 1.85; 4 studies; 360 participants; I = 28%). Acupuncture may slightly reduce the number of nocturia episodes compared to medication (MD -0.50, 95% CI -0.65 to -0.36; 2 studies; 80 participants; I = 0%, low-certainty evidence). There were no incidences of major adverse events in any of the included studies. However, major adverse events are rare in acupuncture trials and the numbers included in this review may be insufficient to detect these events.

AUTHORS' CONCLUSIONS: The evidence is very uncertain about the effect acupuncture has on cure or improvement of overactive bladder symptoms compared to no treatment. It is uncertain if there is any difference between acupuncture and sham acupuncture in cure or improvement of overactive bladder symptoms. This review provides low-certainty evidence that acupuncture may result in a slight increase in cure or improvement of overactive bladder symptoms when compared with medication and may reduce the incidence of minor adverse events. These conclusions must remain tentative until the completion of larger, higher-quality studies that use relevant, comparable outcomes. Timing and frequency of treatment, point selection, application and long-term follow-up are other areas relevant for research.

摘要

背景

膀胱过度活动症是一种常见的长期症状综合征,包括尿频、尿急伴或不伴尿失禁和夜尿症。约有 11%的人群有症状,且该数字随年龄增长而增加。症状可能与社交焦虑和适应性行为改变有关。治疗膀胱过度活动症的费用相当高,目前的治疗方法在有效性和副作用方面存在差异。针灸已被提议作为一种替代治疗方法。

目的

评估针灸治疗成人膀胱过度活动症的效果,并总结相关经济评估的主要发现。

检索策略

我们检索了 Cochrane 尿控专题注册库,其中包含从 Cochrane 中央对照试验注册库(CENTRAL)、MEDLINE(包括正在处理的、提前出版的、每日更新的)、ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台(检索日期为 2022 年 5 月 14 日)检索到的试验。我们还检索了补充和替代医学数据库(AMED)和必要时使用中文知识的文献数据库:中国国家知识基础设施(CNKI);中国科技期刊数据库(VIP)和万方(中国在线期刊),以及相关文章的参考文献列表。

纳入标准

我们纳入了随机对照试验(RCT)、准随机对照试验和交叉 RCT,评估针灸治疗成人膀胱过度活动症的效果。

排除标准

我们排除了重复发表的研究、综述、病例报告和动物研究。

资料提取和分析

四位综述作者组成对子,评估研究的纳入标准并提取数据。两位对子都使用 Covidence 软件进行筛选和数据提取。我们使用 Cochrane 偏倚风险工具评估偏倚风险,并使用 Chi 检验和在 meta 分析中生成的 I²统计量评估异质性。如果存在中度或高度异质性,我们使用固定效应模型进行 meta 分析,否则使用随机效应模型。我们使用 GRADE 方法评估证据的确定性。

主要结果

我们纳入了 15 项研究,共纳入 1395 名参与者(14 项 RCT 和 1 项准 RCT)。所有纳入的研究都存在一定程度的偏倚风险。只有 20%的研究实现了对治疗组的盲法,我们认为对结局评估者和分配隐藏的盲法在 25%的研究中为低风险,而超过 50%的研究中随机序列的产生为不清楚或高风险。

针灸与无治疗

一项研究比较了针灸与无治疗。与无治疗相比,针灸在治愈或改善膀胱过度活动症症状以及治疗轻度不良反应方面的效果的证据非常不确定(非常低确定性证据)。研究报告明确表示没有发生重大不良事件。该研究没有报告尿急、尿失禁发作、日间尿频或夜尿发作的情况。

针灸与假针灸

五项研究比较了针灸与假针灸。与假针灸相比,针灸在治愈或改善膀胱过度活动症症状方面的效果的证据非常不确定(标准化均数差(SMD)-0.36,95%置信区间(CI)-1.03 至 0.31;3 项研究;151 名参与者;I²=65%;非常低确定性证据)。所有五项研究都明确表示在研究过程中没有观察到重大不良事件。中度确定性证据表明,与假针灸相比,针灸在治疗轻度不良反应方面可能没有差异(风险比(RR)1.28,95%CI 0.30 至 5.36;4 项研究;222 名参与者;I²=0%)。只有一项小型研究报告了尿急和夜尿发作的存在或不存在的数据。这两个结局的证据都非常不确定,且置信区间下限都不太可能。中度确定性证据表明,针灸与假针灸相比,尿失禁发作的差异可能较小或无差异(均数差(MD)0.55,95%CI-1.51 至 2.60;2 项研究;121 名参与者;I=57%)。两项研究记录了日间尿频的数据,但由于方法学的差异,我们无法将其合并进行 meta 分析(非常低确定性证据)。

针灸与药物

十一项研究比较了针灸与药物。低确定性证据表明,与药物相比,针灸可能略微增加膀胱过度活动症症状被治愈或改善的人数(RR 1.25,95%CI 1.10 至 1.43;5 项研究;258 名参与者;I=19%)。低确定性证据表明,与药物相比,针灸可能减少轻度不良反应的发生(RR 0.34,95%CI 0.26 至 0.45;8 项研究;1004 名参与者;I²=51%)。关于针灸在尿急(MD-0.40,95%CI-0.56 至-0.24;2 项研究;80 名参与者;I=0%;非常低确定性证据)和尿失禁发作(MD-0.33,95%CI-2.75 至 2.09;1 项研究;20 名参与者;非常低确定性证据)方面与药物相比的效果的证据是不确定的。低确定性证据表明,与药物相比,针灸对日间尿频(MD 0.73,95%CI-0.39 至 1.85;4 项研究;360 名参与者;I=28%)的影响可能较小或无影响。针灸可能会稍微减少夜尿发作的次数(MD-0.50,95%CI-0.65 至-0.36;2 项研究;80 名参与者;I=0%,低确定性证据)。在纳入的研究中均未发生重大不良事件。然而,针灸试验中重大不良事件很少见,本研究纳入的样本量可能不足以检测到这些事件。

结论

与无治疗相比,针灸对改善或治愈膀胱过度活动症症状的效果的证据非常不确定。目前尚不确定针灸与假针灸在改善或治愈膀胱过度活动症症状方面是否存在差异。本综述提供了低确定性证据,表明针灸可能会略微增加治愈或改善膀胱过度活动症症状的可能性,与药物相比,并可能减少轻度不良反应的发生。这些结论在更大、更高质量的研究完成之前都应保持暂定,这些研究应使用相关、可比的结局进行。治疗的时机和频率、穴位选择、应用和长期随访等都是需要研究的领域。

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