背景

針灸在英國廣泛應(yīng)用，估計每年提供400萬次治療,，主要用于慢性疼痛病癥,，如肌肉骨骼疼痛,，頭痛或偏頭痛,。除慢性疼痛癥狀外，心理困擾,，包括抑郁癥,，也一直是人們咨詢針灸師的常見原因。針灸的證據(jù)依然是斑駁的,，對臨床效果有一些爭議,，尤其是針灸不僅僅是安慰劑的程度。關(guān)于針灸在日常實踐中的作用的臨床問題仍然存在,，針灸是否具有成本效益的問題仍然存在,。該領(lǐng)域的挑戰(zhàn)之一是現(xiàn)有證據(jù)的質(zhì)量,。在大多數(shù)情況下，對針灸的系統(tǒng)評價對于有效性得出任何明確結(jié)論的能力有限,。與對許多其他慢性疼痛物理療法的研究一樣,，進行了太多的弱勢試驗，方法學(xué)標準不夠健壯,。然而,，在這種不確定性的氣氛中，針灸試驗的質(zhì)量和數(shù)量最近急劇增加,，特別是針對慢性疼痛病癥,，這使得該研究計劃成為大幅降低不確定性的獨特機會。在這方面,，我們的主要目標是使用高質(zhì)量的方法和最佳證據(jù)來確定針灸對慢性疼痛和抑郁癥的臨床和經(jīng)濟影響,。

針灸慢性疼痛

雖然針灸廣泛用于慢性疼痛，但對于如何工作的理解有限,，反過來又導(dǎo)致其作為治療方式的潛在作用的一些不確定性,。不確定性與針灸可能僅僅是一個戲劇性的安慰劑的關(guān)注以及當考慮到偏見問題時，任何效果的大小可能會消失的建議相關(guān),。為了解決不確定性,，在我們的第一項研究中，我們根據(jù)這些比較的直接試驗數(shù)據(jù),，確定針灸針對慢性疼痛的影響大小,，針灸是否與假針灸或非針灸控制進行比較。在建立針灸Triallists協(xié)作（ATC）的關(guān)鍵演習(xí)者的協(xié)作下,，我們能夠進行個人患者數(shù)據(jù)（IPD）薈萃分析,。為了建立符合條件的研究，我們確定了針對四種慢性疼痛病癥的隨機對照試驗（RCT）,，其中分配隱藏被明確地確定為足夠,。對31項符合條件的RCT患者中的29項，共有17,922例患者進行了分析,。在包括所有符合條件的RCT時,，我們的主要結(jié)果是，所有四種疼痛狀況下,，針灸在統(tǒng)計學(xué)上顯著高于假手術(shù)對照組和非針灸對照組（p \u003c0.001）,。當排除強烈傾向于針灸的偏僻RCT的一組時，每個疼痛狀況的影響大小相似,。接受針灸的患者的疼痛少于接受假手術(shù)治療的患者,，其效果大小基于0.23 [95％置信區(qū)間（CI）0.13?0.33]的標準平均差異（SMD），0.16（95％CI 0.07?0.25）和0.15 95％CI 0.07?0.24）,，分別為背痛和頸痛,，骨關(guān)節(jié)炎和慢性頭痛,。針刺與非針刺對照組比較，效果分別為0.55（95％CI 0.51?0.58）,，0.57（95％CI 0.50?0.64）和0.42（95％CI 0.37?0.46）,。進行了各種靈敏度分析，包括與出版偏倚相關(guān)的敏感性分析,，對研究的主要發(fā)現(xiàn)影響不大,。總而言之,，在這些高質(zhì)量的研究中,，針灸和非針灸對照之間發(fā)現(xiàn)了臨床相關(guān)性和統(tǒng)計學(xué)上的顯著性差異，這表明針灸是適合慢性疼痛的轉(zhuǎn)診選擇,。真實針灸與假針灸的統(tǒng)計學(xué)顯著性差異表明針灸不僅僅是安慰劑,。 

骨關(guān)節(jié)炎的物理治療

許多系統(tǒng)評價已經(jīng)評估了膝關(guān)節(jié)骨性關(guān)節(jié)炎的各種物理治療方法，但是在同一分析中沒有研究將這些不同的物理治療相互比較,。在第二項研究中,，我們使用網(wǎng)絡(luò)薈萃分析來解決膝關(guān)節(jié)骨關(guān)節(jié)炎的有效物理治療相對于減輕疼痛的問題。我們回顧了截至2013年1月的文獻,，其中涉及搜索17個電子數(shù)據(jù)庫,。我們確定膝關(guān)節(jié)骨性關(guān)節(jié)炎患者身體治療的RCTs，其中疼痛報告為結(jié)果,。在網(wǎng)絡(luò)薈萃分析中,，合成了直接和間接證據(jù)，以比較針灸與其他相關(guān)物理治療緩解疼痛的療效,?？偣?14項試驗（共22項治療和9709例）納入分析。許多試驗被歸類為質(zhì)量差,，幾個領(lǐng)域的偏倚風(fēng)險很高,。統(tǒng)計學(xué)上顯著優(yōu)于標準（通常）護理，與標準護理相比,，統(tǒng)計學(xué)顯著優(yōu)于標準（通常）護理,，產(chǎn)生疼痛改善：干預(yù)療法，針灸,，經(jīng)皮神經(jīng)電刺激（TENS）,，脈沖電刺激，平衡療法,，有氧運動，假針灸和肌肉強化運動,。靈敏度分析包括更好的研究,，最常見的針灸（11項試驗）,，肌肉強化運動（9項試驗）和假針灸（8項試驗）。針灸在統(tǒng)計學(xué)上顯著高于肌肉強化運動和假針刺（SMD 0.49,95％CI 0.00至0.98;分別為0.34,95％CI 0.03至0.66）,。針灸統(tǒng)計學(xué)顯著優(yōu)于標準護理（SMD 1.01,95％CI 0.61至1.43）,。總之,，在網(wǎng)絡(luò)薈萃分析中,，針灸被發(fā)現(xiàn)是減輕膝骨關(guān)節(jié)炎膝關(guān)節(jié)疼痛的最有效的物理治療方法之一。然而,，鑒于許多證據(jù)質(zhì)量差,，許多物理治療的有效性存在不確定性。

評估針灸治療骨關(guān)節(jié)炎的成本效益

為了解決針灸對慢性疼痛的成本效益問題,，我們受益于ATC資料庫的數(shù)據(jù)可用性,。在第三項研究中，我們對ATC資料庫的個別患者級數(shù)據(jù)進行了網(wǎng)絡(luò)薈萃分析,。通過綜合所有數(shù)據(jù),，包括間接數(shù)據(jù)，我們得出了治療效果估計值,，這是用于資源分配決策的成本效益分析的關(guān)鍵參數(shù),。在這種主要的方法研究中，開發(fā)了用于分析報告異質(zhì)連續(xù)結(jié)果的多個個體患者級數(shù)據(jù)集的新貝葉斯方法,。成本效益分析的一個重要步驟是基于偏好的健康相關(guān)生活質(zhì)量衡量標準,，如EuroQol-5維度（EQ-5D）。為了合成異質(zhì)結(jié)果,，我們使用映射將異質(zhì)結(jié)果轉(zhuǎn)換和比較到EQ-5D摘要指標量表,。開發(fā)的模型需要貝葉斯隨機效應(yīng)網(wǎng)絡(luò)薈萃分析規(guī)范，包括可交換的疼痛型相互作用效應(yīng),。還證明了對成本效益分析的影響,。使用針灸治療初級保健慢性疼痛的案例研究，包括頭痛/偏頭痛,，肌肉骨骼疼痛和膝關(guān)節(jié)骨性關(guān)節(jié)炎的方法,。通過使用與第一項研究相同的證據(jù)基礎(chǔ)，我們的分析包括來自28項試驗的大約17,500名患者（我們無法使用一次試驗中的IPD）,，其中我們將針灸,，假針灸和常規(guī)護理相互比較。映射EQ-5D估計的綜合發(fā)現(xiàn),，針灸與常規(guī)護理相比有效,，中位治療效果估計為頭痛/偏頭痛的0.056 [95％可信區(qū)間（CrI）0.021至0.092],，0.082（95％CrI 0.047至0.116 ）,，肌肉骨骼疼痛為0.079（95％，CrI 0.042?0.114）。針灸針灸EQ-5D的益處較小,，更不確定（頭痛：0.004,95％CrI -0.035?0.042;肌肉骨骼疼痛：0.023,95％CrI -0.007?0.053;膝關(guān)節(jié)骨性關(guān)節(jié)炎：0.022,95％ CrI -0.014至0.060）,。盡管并非所有相關(guān)干預(yù)措施都進行了比較,，但成本效益結(jié)果表明,，針灸與常規(guī)護理相比較，具有成本效益,，成本效益比（IQER）從7000英鎊到14,000英鎊不等質(zhì)量調(diào)整生命年（QALY）跨痛苦類型的頭痛/偏頭痛,，肌肉骨骼科學(xué)綜合NIHR期刊圖書館www.journalslibrary.nihr.ac.uk xx膝關(guān)節(jié)疼痛和骨關(guān)節(jié)炎。在這種面向方法的案例研究中,，我們表明異質(zhì)結(jié)果映射到EQ-5D摘要指標為進行成本效益分析提供了有用的一步,。

非藥物治療骨關(guān)節(jié)炎的成本效益

在這項研究計劃的第四項研究中，我們進行了經(jīng)濟評估,，以評估用于減輕膝關(guān)節(jié)骨性關(guān)節(jié)炎慢性疼痛的非藥物治療的成本效益,。我們使用新的網(wǎng)絡(luò)薈萃分析方法來綜合17項積極干預(yù)和三項控制干預(yù)措施的RCT證據(jù)。數(shù)據(jù)來自第二項研究進行的系統(tǒng)評價,，其中包括7507例患者的88例RCT,。第一項研究的IPD可用于五項RCT，其中包括1329例患者,。在試驗中報告了廣泛的與健康有關(guān)的生活質(zhì)量結(jié)果,。由于分析的最終目的是為了通報英國的資源分配決策，將這些儀器的數(shù)據(jù)映射到合成之前的EQ-5D偏好權(quán)重,，擴展了第三項研究中開發(fā)的方法,。進行靈敏度分析以解決與不良學(xué)習(xí)行為相關(guān)的潛在偏差，并探討報告時間點對研究結(jié)果的重要性,。來自NHS信托網(wǎng)站的試驗數(shù)據(jù),，專家意見，文獻資料和資料,，對干預(yù)措施的資源使用情況進行了估算,。與其他EQ-5D的變化有關(guān)的非干預(yù)資源使用是從另一項英國試驗獲得的。結(jié)果和成本是使用時間范圍為8周的曲線下成本效益模型進行合成的,。當所有試驗都包括在綜合中時,，與常規(guī)護理相比，TENS具有成本效益,，每QALY的ICER為2690英鎊,。當分析僅限于具有適當分配隱藏的試驗時，與TENS相比,，針灸具有成本效益,，ICAL為13,502英鎊/ QALY。關(guān)于用于治療膝關(guān)節(jié)骨性關(guān)節(jié)炎的許多非藥物干預(yù)的長期影響的數(shù)據(jù)有限。通過這種分析的試驗中的積極和控制干預(yù)措施受到方法的不均勻性,，持續(xù)時間和施用強度的影響,。這些結(jié)果受到一些決定的不確定性,，完美信息的預(yù)期價值相對較高,，這表明額外的研究可能具有成本效益。

針灸或咨詢抑郁癥

抑郁癥是發(fā)病的重要原因,。許多患者將非藥理療法的興趣傳達給其全科醫(yī)生,。初級保健中針灸和抑郁癥咨詢的系統(tǒng)評價發(fā)現(xiàn)有限證據(jù)。第五項研究的目的是評估針灸與常規(guī)護理和咨詢相比,，與常規(guī)護理相比,，在初級保健中繼續(xù)患有抑郁癥的患者。此外,，需要進行成本效益分析,，以了解這些療法是否應(yīng)被視為有利的衛(wèi)生資源?？偣?55例抑郁癥患者（Beck Depression Inventory-II評分≥20）被招募到英國北部27個初級保健實踐中進行的RCT,。分配到三個武器之一，使用比例為2：2：1針灸（n = 302）,，咨詢（n = 302）和平時護理（n = 151）,。平均患者健康問卷9項（PHQ-9）在3個月時的差異是主要結(jié)果?；颊唠S訪12個月以上,，分析為意向治療。進行了額外的定量和定性研究,。關(guān)于PHQ-9評分的數(shù)據(jù)可在614個患者3個月和572例12個月,。參加針灸10次，平均9次,，參加咨詢,。與普通護理相比，針灸3個月平均PHQ-9抑郁評分差異有統(tǒng)計學(xué)意義（-2.46,95％CI為-3.72?-1.21）,，輔助治療與常規(guī)護理相比（-1.73,95％CI -3.00到-0.45）,，針灸12個月（-1.55,95％CI -2.41?-0.70）和咨詢（-1.50,95％CI -2.43?-0.58）與常規(guī)護理相比。在控制時間和注意力的情況下,，針灸和咨詢之間沒有發(fā)現(xiàn)臨床療效差異,。沒有報告嚴重的治療相關(guān)不良事件。該試驗的目的不在于分開DOI：10.3310 / pgfar05030應(yīng)用研究計劃GRANTS 2017 VOL,。 5號3皇后的HMSO打印機和控制器2017.這項工作是由MacPherson等人制作的,。根據(jù)衛(wèi)生國務(wù)秘書簽發(fā)的委托合同條款。為了私人研究和研究的目的，這個問題可以自由復(fù)制,，并提?。ɑ蛘咄暾膱蟾妫┛梢员话ㄔ趯I(yè)期刊中，只要適當?shù)拇_認和復(fù)制與任何形式的廣告無關(guān),。商業(yè)復(fù)制申請應(yīng)提交給：NIHR期刊圖書館,，國家衛(wèi)生研究所，評估,，試驗和研究協(xié)調(diào)中心,，阿姆斯特丹，南安普敦科學(xué)園大學(xué),，南安普敦SO16 7NS,，英國研究所。 xxi具體來自非特定效果,。針灸和咨詢被發(fā)現(xiàn)具有比常規(guī)護理更高的平均QALY和成本,。在基礎(chǔ)案例分析中，針灸的ICAL為每加值QALY 4560英鎊,，成本效益高達0.62,，每QALY的成本效益門檻為20,000英鎊。與普通護理相比,，輔導(dǎo)的情景分析（不包括針灸作為比較對象,，不適當或不可用）導(dǎo)致ICER為7935英鎊，成本效益為0.91的概率,?？偠灾邮芏唐卺樉幕蜉o導(dǎo)治療的初級保健中持續(xù)抑郁癥患者與常規(guī)護理相比經(jīng)歷統(tǒng)計學(xué)顯著降低的抑郁癥,。

結(jié)論

總之,，這項研究方案迄今為止提供了針對針灸及其潛在影響的最實質(zhì)性證據(jù)。利用RCT的現(xiàn)有數(shù)據(jù),，我們使用IPD薈萃分析,，發(fā)現(xiàn)針灸在頭痛和偏頭痛，背部和頸部疼痛以及膝關(guān)節(jié)骨性關(guān)節(jié)炎的慢性疼痛狀況下臨床有效,。我們從這個數(shù)據(jù)集的證據(jù)表明,，針灸是一個統(tǒng)計學(xué)顯著更有效的干預(yù)比安慰劑。在網(wǎng)絡(luò)薈萃分析中,，我們針對膝關(guān)節(jié)骨性關(guān)節(jié)炎的一系列物理療法的證據(jù)表明,，針灸與任何其他療法相比，具有更高質(zhì)量的試驗,，也是最有效的療法之一,。如果僅分析高質(zhì)量的試驗,，針灸也是成本效益的。當所有試驗都包括在綜合報告中,，包括低質(zhì)量和高質(zhì)量的試驗時,，我們發(fā)現(xiàn)TENS具有成本效益。在我們對抑郁癥進行的試驗中,，我們發(fā)現(xiàn)針灸和咨詢的統(tǒng)計學(xué)顯著優(yōu)于常規(guī)護理,，針灸也具有成本效益。我們的結(jié)果仍然存在一些不確定性,。例如,，關(guān)于針灸對肌肉骨骼疼痛,，頭痛和偏頭痛的成本效益分析,，并不是所有與決策相關(guān)的競爭療法都包括在分析中。關(guān)于用于治療膝關(guān)節(jié)骨性關(guān)節(jié)炎的許多非藥物干預(yù)的長期影響的數(shù)據(jù)很少,，敏感性分析表明,，成本效益模型結(jié)果可能對這些影響的程度敏感。當比較針灸和普通護理抑郁癥時,，盡管在比較針灸和輔導(dǎo)時,，我們對時間和注意力進行了控制。然而,，我們的研究計劃使用高質(zhì)量的方法來提供針對慢性疼痛和抑郁癥的臨床有效性和成本效益的最佳數(shù)據(jù),。有力的證據(jù)符合所有利益相關(guān)者的利益，我們的結(jié)果將用于通知患者,，從業(yè)人員,，決策者和服務(wù)專員。

原文：

Background 

Acupuncture is widely practised in the UK, with an estimated 4 million treatments provided a year, primarily for chronic pain conditions such as musculoskeletal pain and headache or migraine. In addition to chronic pain conditions, psychological distress, including depression, has been a common reason that people have consulted acupuncturists. The evidence base on acupuncture has been patchy, with some controversy regarding the clinical benefits and specifically the extent that acupuncture is more than simply a placebo. Clinical questions remain as to the effect of acupuncture in everyday practice and there are unanswered questions regarding whether or not acupuncture is cost-effective. One of the challenges in the field has been the quality of the available evidence. For most conditions, systematic reviews of acupuncture have had a limited ability to draw any definitive conclusions regarding effectiveness. As with research into many other physical therapies for chronic pain, there have been too many underpowered trials conducted and the methodological standards have been insufficiently robust. In this climate of uncertainty, however, there has been a recent and dramatic increase in the quality and quantity of trials of acupuncture, especially for chronic pain conditions, which has provided this programme of research a unique opportunity to substantially reduce the uncertainty. In this context, our primary aim was to use high-quality methods and the best evidence available to determine the clinical and economic impact of acupuncture for chronic pain and depression.

Acupuncture for chronic pain

Although acupuncture is widely used for chronic pain, there is limited understanding of how it works, which in turn fuels some of the uncertainty as to its potential role as a treatment modality. The uncertainty is associated with a concern that acupuncture might simply be a theatrical placebo and the suggestion that when issues of bias are taken into account, the size of any effect might vanish. To address the uncertainty, in our first study we set out to determine the effect size of acupuncture for chronic pain, whether acupuncture is compared with sham acupuncture or with a non-acupuncture control, based on direct trial data on these comparisons. On building a collaboration of key triallists, the Acupuncture Triallists’ Collaboration (ATC), we were able to conduct an individual patient data (IPD) meta-analysis. To establish eligible studies we identified randomised controlled trials (RCTs) of acupuncture for the four chronic pain conditions in which allocation concealment was determined unambiguously to be adequate. Data from 29 of 31 eligible RCTs, with a total of 17,922 patients, were analysed. Our primary result, when including all eligible RCTs, was that acupuncture was statistically significantly more effective than both sham controls and non-acupuncture controls for all four pain conditions (p < 0.001). When an outlying set of RCTs that strongly favoured acupuncture was excluded, the effect size across each pain condition was similar. Patients receiving acupuncture had less pain than those receiving sham controls, with effect sizes based on standardised mean differences (SMDs) of 0.23 [95% confidence interval (CI) 0.13 to 0.33], 0.16 (95% CI 0.07 to 0.25) and 0.15 (95% CI 0.07 to 0.24) for back and neck pain, osteoarthritis and chronic headache, respectively. In the comparison between acupuncture and non-acupuncture controls, effect sizes were 0.55 (95% CI 0.51 to 0.58), 0.57 (95% CI 0.50 to 0.64) and 0.42 (95% CI 0.37 to 0.46), respectively. A variety of sensitivity analyses was conducted, including those related to publication bias, with little impact on the main findings of the study. To conclude, in these high-quality studies, a clinically relevant and statistically significant difference was found between acupuncture and non-acupuncture controls, suggesting that acupuncture is a suitable referral option for chronic pain. Statistically significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo

. ? Queen’s Printer and Controller of HMSO 2017. This work was produced by MacPherson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Xix

Physical therapies for osteoarthritis

Many systematic reviews have evaluated individual types of physical treatments for osteoarthritis of the knee, but no study has compared these different physical treatments against each other in the same analysis. In a second study we used a network meta-analysis to address the question of how effective physical treatments for osteoarthritis of the knee are, when compared with each other, for relieving pain. We reviewed the literature up to January 2013, which involved searching 17 electronic databases. We identified RCTs of physical treatments in patients with osteoarthritis of the knee in which pain was reported as an outcome. In a network meta-analysis, both direct and indirect evidence was synthesised to compare the effectiveness of acupuncture with that of other relevant physical treatments for alleviating pain. In total, 114 trials (covering 22 treatments and 9709 patients) were included in the analysis. Many trials were classed as being of poor quality with a high risk of bias in several domains. Eight interventions statistically significantly outperformed standard (usual) care, producing an improvement in pain compared with standard care: interferential therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), pulsed electrical stimulation, balneotherapy, aerobic exercise, sham acupuncture and muscle-strengthening exercise. The better-quality studies, most commonly of acupuncture (11 trials), muscle-strengthening exercise (nine trials) and sham acupuncture (eight trials), were included in a sensitivity analysis. Acupuncture was statistically significantly more effective than muscle-strengthening exercise and sham acupuncture (SMD 0.49, 95% CI 0.00 to 0.98; and 0.34, 95% CI 0.03 to 0.66, respectively). Acupuncture was also statistically significantly better than standard care (SMD 1.01, 95% CI 0.61 to 1.43). To conclude, in a network meta-analysis, acupuncture was found to be one of the more effective physical treatments for alleviating osteoarthritis knee pain in the short term. However, given that much of the evidence was of poor quality, there is uncertainty about the effectiveness of many physical treatments. 

Towards evaluating the cost-effectiveness of acupuncture for osteoarthritis 

To address the question of the cost-effectiveness of acupuncture for chronic pain, we have benefited from the availability of the data from the ATC repository. In this third study we conducted a network meta-analysis of the individual patient-level data from the ATC repository. By synthesising all of the data, including indirect data, we derived treatment effect estimates, a key parameter for cost-effectiveness analyses to be used for resource allocation decisions. In this primarily methodological study, new Bayesian methods for analysing multiple individual patient-level data sets reporting heterogeneous continuous outcomes were developed. An essential step towards a cost-effectiveness analysis is a preference-based measure of health-related quality of life, such as the EuroQol-5 Dimensions (EQ-5D). To synthesise heterogeneous outcomes, we used mapping to convert and compare heterogeneous outcomes on to the EQ-5D summary index scale. The models developed entailed a Bayesian random-effects network meta-analysis specification, including exchangeable pain type interaction effects. The implications for cost-effectiveness analysis were also demonstrated. The methods were illustrated using a case study of acupuncture for chronic pain in primary care, including headache/migraine, musculoskeletal pain and osteoarthritis of the knee. By using the same evidence base as in the first study, our analysis included approximately 17,500 patients from 28 trials (we were unable to use IPD from one trial), in which we compared acupuncture, sham acupuncture and usual care with each other. The synthesis of mapped EQ-5D estimates found that acupuncture was effective compared with usual care, with median treatment effects estimated as 0.056 [95% credible interval (CrI) 0.021 to 0.092] for headache/migraine, 0.082 (95% CrI 0.047 to 0.116) for musculoskeletal pain and 0.079 (95% CrI 0.042 to 0.114) for osteoarthritis of the knee. The EQ-5D benefit of acupuncture over sham acupuncture was smaller and more uncertain (headache: 0.004, 95% CrI –0.035 to 0.042; musculoskeletal pain: 0.023, 95% CrI –0.007 to 0.053; osteoarthritis of the knee: 0.022, 95% CrI –0.014 to 0.060). Although not all relevant interventions were compared for decision-making purposes, cost-effectiveness results suggest that when acupuncture is compared with usual care alone it is cost-effective, with incremental cost-effectiveness ratios (ICERs) ranging from ￡7000 to ￡14,000 per quality-adjusted life-year (QALY) across the pain types of headache/migraine, musculoskeletal SCIENTIFIC SUMMARY NIHR Journals Library www.journalslibrary.nihr.ac.uk xx pain and osteoarthritis of the knee. In this methodologically oriented case study we showed that the mapping of heterogeneous outcomes on to the EQ-5D summary index provides a useful step towards conducting a cost-effectiveness analysis. Cost-effectiveness of non-pharmacological treatments for osteoarthritis

In a fourth study within this programme of research, we conducted an economic evaluation to evaluate the cost-effectiveness of non-pharmacological treatments used to reduce chronic pain in osteoarthritis of the knee. We used novel network meta-analysis methods to synthesise RCT evidence for 17 active interventions and three control interventions. Data were obtained from the systematic review carried out in the second study, which were available for 88 RCTs including 7507 patients. IPD from the first study were available for five of the RCTs, including 1329 patients. A wide range of health-related quality-of-life outcomes were reported in the trials. As the ultimate objective of the analysis was to inform resource allocation decisions in the UK, data from these instruments were mapped to EQ-5D preference weights prior to synthesis, extending methods developed in the third study. Sensitivity analyses were conducted to address potential bias associated with poor study conduct and to explore the importance of the time point of reporting for the study results. Resource use associated with the interventions was estimated from trial data, expert opinion, the literature and information obtained from NHS trust websites. Non-intervention resource use related to changes in EQ-5D was obtained from another UK trial. Outcomes and costs were synthesised using an area-under-the-curve cost-effectiveness model with a time horizon of 8 weeks. When all trials were included in the synthesis, TENS was cost-effective with an ICER of ￡2690 per QALY compared with usual care. When the analysis was restricted to trials with adequate allocation concealment, acupuncture was cost-effective with an ICER of ￡13,502 per QALY compared with TENS. There were limited data regarding the long-term effects of many non-pharmacological interventions used to treat osteoarthritis of the knee. The active and control interventions in the trials informing this analysis were subject to heterogeneity in the method, duration and intensity with which they were administered. These results are subject to some decision uncertainty and the expected value of perfect information is relatively high, suggesting that additional research may be cost-effective.

Acupuncture or counselling for depression

Depression is a significant cause of morbidity. Many patients have communicated an interest in non-pharmacological therapies to their general practitioners. Systematic reviews of acupuncture and counselling for depression in primary care have identified limited evidence. The aim of the fifth study was to evaluate acupuncture compared with usual care and counselling compared with usual care for patients who continue to experience depression in primary care. Moreover, a cost-effectiveness analysis is needed to understand whether or not such therapies should be considered a good use of limited health resources. In total, 755 patients with depression (Beck Depression Inventory-II score of ≥ 20) were recruited to a RCT carried out in 27 primary care practices in the north of England. Allocation was to one of three arms using a ratio of 2 : 2 : 1 to acupuncture (n = 302), counselling (n = 302) and usual care alone (n = 151). The difference in mean Patient Health Questionnaire-9 items (PHQ-9) score at 3 months was the primary outcome. Patients were followed up over 12 months and analysis was by intention to treat. Additional quantitative and qualitative substudies were conducted. Data on PHQ-9 scores were available for 614 patients at 3 months and 572 patients at 12 months. A mean of 10 sessions was attended for acupuncture and a mean of nine sessions was attended for counselling. There was a statistically significant reduction in mean PHQ-9 depression score at 3 months for acupuncture compared with usual care (–2.46, 95% CI –3.72 to –1.21) and counselling compared with usual care (–1.73, 95% CI –3.00 to –0.45), and at 12 months for acupuncture (–1.55, 95% CI –2.41 to –0.70) and counselling (–1.50, 95% CI –2.43 to –0.58) compared with usual care. When controlling for time and attention, no significant differences in clinical outcome were found between acupuncture and counselling. No serious treatment-related adverse events were reported. The trial was not designed to separate DOI: 10.3310/pgfar05030 PROGRAMME GRANTS FOR APPLIED RESEARCH 2017 VOL. 5 NO. 3 ? Queen’s Printer and Controller of HMSO 2017. This work was produced by MacPherson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xxi out specific from non-specific effects. Acupuncture and counselling were found to have higher mean QALYs and costs than usual care. In the base-case analysis, acupuncture had an ICER of ￡4560 per additional QALY and was cost-effective with a probability of 0.62 at a cost-effectiveness threshold of ￡20,000 per QALY. A scenario analysis of counselling compared with usual care, excluding acupuncture as a comparator when inappropriate or unavailable, resulted in an ICER of ￡7935 and a probability of being cost-effective of 0.91. To summarise, patients with ongoing depression in primary care who received a short course of either acupuncture or counselling experienced statistically significant reductions in depression compared with usual care alone. 

Conclusion

In conclusion, this programme of research has provided the most substantive evidence to date on acupuncture and its potential impact. Drawing on the existing data from RCTs, we used an IPD meta-analysis and found acupuncture to be clinically effective across the chronic pain conditions of headache and migraine, back and neck pain, and osteoarthritis of the knee. Our evidence from this data set suggests that acupuncture is a statistically significantly more effective intervention than placebo. In a network meta-analysis, our evidence across a range of physical therapies for osteoarthritis of the knee suggested that acupuncture is associated with more high-quality trials than any of the other therapies and is also one of the most effective therapies. Acupuncture was also cost-effective if only high-quality trials were analysed. When all trials were included in the synthesis, including both low- and high-quality trials, we found TENS to be cost-effective. In the trial that we conducted on depression, we found that acupuncture and counselling were statistically significantly better than usual care and that acupuncture was also cost-effective. There remains some uncertainty regarding our results. For example, with regard to the cost-effectiveness analyses of acupuncture for musculoskeletal pain and headache and migraine, not all competing therapies relevant to decision-making were included in the analysis. There are few data regarding the long-term effects of many non-pharmacological interventions used to treat osteoarthritis of the knee, and sensitivity analyses suggested that the cost-effectiveness model results may be sensitive to the magnitude of these effects. When comparing acupuncture with usual care for depression, there was no control for non-specific effects, although we did control for time and attention when comparing acupuncture with counselling. Nevertheless, our programme of research has used high-quality methods to provide the best possible data on the clinical effectiveness and cost-effectiveness of acupuncture for chronic pain and depression. Robust evidence is in the interests of all stakeholders and our results will be used to inform patients, practitioners, policy-makers and commissioners of services