Acupuncture for insomnia

 

Abstract

Background

Although conventional non-pharmacological and pharmacological treatments for insomnia are effective in many people, alternative therapies such as acupuncture are still widely practiced. However, it remains unclear whether the existing evidence is rigorous enough to support its use.

Objectives

To determine the efficacy and safety of acupuncture in people with insomnia.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, Dissertation Abstracts International, CINAHL, AMED (the Allied and Complementary Medicine Database), TCMLARS (Traditional Chinese Medical Literature Analysis and Retrieval System), National Center for Complementary and Alternative Medicine, the National Institute of Health Clinical Trials Database, the Chinese Acupuncture Trials Register, the Trials Register of the Cochrane Complementary Medicine Field, from inception to 2006, and the sleep bibliography, which is available at www.websciences.org/bibliosleep. We searched reference lists of retrieved articles, and contacted trial authors and experts in the field for information on ongoing/completed trials.

Selection criteria

Randomised controlled trials evaluating any form of acupuncture involving participants of any age with any type of insomnia were included. Included trials compared acupuncture with placebo or sham or no treatment, or acupuncture plus other treatments compared with the same other treatments. Trials that compared only acupuncture methods or compared acupuncture alone against other treatments alone were excluded, since they did not yield the net effect of acupuncture.

Data collection and analysis

Two review authors independently extracted data and assessed quality according to a set of criteria for risk of selection bias, performance bias, attrition bias and detection bias. Relative risk (RR) and standardised mean difference (SMD) with 95% confidence intervals were used for binary and continuous outcomes respectively. Data were combined in meta-analyses (on an intention-to-treat basis), where more than one trial without significant clinical heterogeneity presented the same outcome.

Main results

Seven trials met the inclusion criteria. The studies included 590 participants with insomnia, of whom 56 dropped out. Participant age ranged from 15 to 98 years, and the duration of insomnia varied from 6 months to 19 years. Co-existing medical conditions contributing to insomnia included stroke, end-stage renal disease and pregnancy. Apart from conventional needle acupuncture, different variants of acupuncture such as acupressure, auricular magnetic and seed therapy, and transcutaneous electrical acupoint stimulation (TEAS) were evaluated. Meta-analysis was limited because of considerable heterogeneity between comparison groups and between outcome measures.

Based on the findings from individual trials, the review suggested that acupuncture and acupressure may help to improve sleep quality scores when compared to placebo (SMD = -1.08, 95% CI = -1.86 to -0.31, p=0.006) or no treatment (SMD -0.55, 95% CI = -0.89 to -0.21, p=0.002). TEAS also resulted in better sleep quality score in one trial (SMD = -0.74, 95% CI = -1.22 to -0.26, p=0.003). However, the efficacy of acupuncture or its variants was inconsistent between studies for many sleep parameters, such as sleep onset latency, total sleep duration and wake after sleep onset. The combined result from three studies reporting subjective insomnia improvement showed that acupuncture or its variants was not more significantly effective than control (RR = 1.66, 95% CI = 0.68 to -4.03) and significant statistical heterogeneity was observed. Only one study reported an adverse event, with one out of 16 patients (6.3%) withdrawing from acupuncture because of pain.

Authors' conclusions

The small number of randomised controlled trials, together with the poor methodological quality and significant clinical heterogeneity, means that the current evidence is not sufficiently extensive or rigorous to support the use of any form of acupuncture for the treatment of insomnia. Larger high quality clinical trials employing appropriate randomisation concealment and blinding with longer follow-up are needed to further investigate the efficacy and safety of acupuncture for the treatment of insomnia.

 

Plain language summary

Acupuncture for insomnia

Although conventional non-pharmacological and pharmacological treatments for insomnia are effective in many people, alternative therapies such as acupuncture are still widely practiced. Acupuncture is mainly evaluated in observational and uncontrolled studies, and randomised controlled trials are scarce and of poor methodological quality. This review was conducted to examine the effectiveness of acupuncture in treating insomnia. Seven studies were eligible for inclusion in the review, involving 590 participants. The studies were of low methodological quality and were diverse in the types of participant, acupuncture treatments and sleep outcome measures used, which limited the ability to pool the findings and draw conclusions. Currently there is a lack of high quality clinical evidence supporting the treatment of people with insomnia using acupuncture. More rigorous studies are needed to assess the efficacy and safety of various forms of acupuncture for treating people with insomnia.

 

摘要

背景

失眠的針灸治療

即便傳統對於失眠的藥物及非藥物治療對於許多人而言是有效的，然而採用如針灸治療這種替代療法仍然廣為患者接受。但是，現有支持其療效的證據是否夠嚴謹仍有待探究。

目標

考驗針灸治療對於失眠患者的療效與安全性。

搜尋策略

我們收集了CENTRAL(Cochrane Central Register of Controlled Trials控制試驗統合中心紀錄)、MEDLINE、EMBASE、 PsycINFO、國際博士論文、CINAHL、 AMED(the Allied and Complementary Medicine Database聯合醫學資料庫)、 TCMLARS (Traditional Chinese Medical Literature Analysis and Retrieval System中國傳統醫學分析與檢索系統)、國際衛生臨床試驗中心資料庫(the National Institute of Health Clinical Trials Database) 、中國針灸治療試驗紀錄(the Chinese Acupuncture Trials Register)、由創立到2006年的醫學統合領域試驗紀錄(the Trials Register of the Cochrane Complementary Medicine Field)以及www.websciences.org/bibliosleep所列出的睡眠參考書目。我們找出所檢索文章的參考文獻，與進行試驗的作者及專家聯繫，收集此領域進行中或完成的試驗資料。

選擇標準

選取採用隨機控制的試驗，包含對於任何年齡層、任何失眠類型患者所採用的任何針灸治療方法，如比較針灸治療合併採用安慰劑、偽藥或無處理的差異，或者針灸治療合併其他治療與類似療法的比較。對於只是比較針灸治療方法，或者單獨比較針灸治療與其他治療方法的差異則與以排除，因為它們無法看出針灸治療的淨效應。

資料收集與分析

兩位作者分別萃取資料及評估資料的品質，依據的標準為選擇偏誤、表現偏誤、耗損偏誤和偵測偏誤等。另外，我們有分別以Relative risk (RR), standardised mean difference (SMD) with 95% confidence intervals 來計算連續性及雙方面的結果。所有的結果都合併入統計分析研究(以治療意向的基礎)，在此多於一個以上的研究都呈現相同的結論,且不具有意義的臨床異質性.

主要結論

7個研究符合納入的規則.此研究包含590個失眠診斷的參與者,其中56個退出。參與者年紀範圍在15到98歲，失眠的時期在6到19年。共病的內科問題影響失眠的因素包括中風,末期腎臟疾病和懷孕。除了傳統針灸,另外也評估其他針灸的變異型包括針壓法,關節磁力及種子療法(auricular magnetic and seed therapy),經皮針灸點電刺激法(TEAS).統計分析研究受限於各組別間的異質性及不同的評估方法。根據個別研究的結果,回顧研究建議針灸和針壓法相較於安慰劑(SMD = −1.08, 95% CI = −1.86 to −0.31, p = 0.006);相對於不治療結果為(SMD −0.55, 95% CI = −0.89 to −0.21, p = 0.002)，可以改善睡眠品質分數。TEAS在1個臨床試驗也有較佳睡眠品質分數的結果(SMD = −0.74, 95% CI = −1.22 to −0.26, p = 0.003)。然而，針灸和其變異型的治療在各研究的各種變數中並未取得一致性，例如睡眠潛伏期,睡眠總時數,入睡後清醒時間。來自於3項試驗綜合的結論呈現針灸和其變異型的治療對於主觀睡眠改善相較對照組並未取得明顯的效果(RR = 1.66, 95% CI = 0.68 to −4.03);另外在這些結果也觀察到統計上的異質性。只有一項研究報告副作用，16位病患中有一位因為疼痛退出針灸治療。

作者結論

隨機控制研究個案數過少，且方法學上的品質及明顯的臨床異質性代表目前的證據並未能有效地支持對於睡眠上任何形式的針灸治療。未來針對針灸在失眠治療上的效度及安全性仍需要大型高品質的臨床試驗，以提供適當地隨機分配及後續追蹤的延續。

翻譯人

本摘要由彰化基督教醫院張庭綱翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

針灸在失眠的治療，雖然傳統非藥物及藥物對於失眠的治療在許多人都有效果，替代性的治療例如針灸仍廣泛持續施行。針灸療效評估大多在觀察性實驗及非控制性試驗中呈現,缺少了隨機分配試驗且研究方法品質不佳。此篇文獻回顧目標在於研究針灸在治療失眠的效果，7個研究合乎選擇標準並納入此篇文獻回顧，包含590位參與者。這些研究方法學上的品質較低且對於包括參與者,針灸治療,睡眠結果評估的多樣化分類限制了統計結果及歸納結論的能力。目前並沒有高品質的臨床證據能夠支持針灸對睡眠族群的治療。仍需要精確的研究來評估各種不同形式的針灸治療對失眠族群的效度及安全性。