「具有里程碑意義」的試驗顯示阿片類藥物治療背部、頸部疼痛並不比安慰劑更好
資料來源:梅根·布魯克斯 / 2023 年 6 月 29 日 / Medscape 醫學新聞
阿片類藥物不能在短期內緩解急性腰背或頸部疼痛,從長遠來看會導致更糟糕的結果,第一個隨機對照試驗的結果測試了短期阿片類藥物治療急性非特異性腰背/頸部疼痛的有效性和安全性建議。
6週後,服用阿片類藥物的患者與服用安慰劑的患者相比,疼痛評分沒有顯著差異。一年後,服用安慰劑的患者疼痛評分略有降低。此外,使用阿片類藥物的患者一年後濫用阿片類藥物的風險更大。
雪梨大學的資深作者 Christine Lin 博士告訴 Medscape 醫學新聞,這是一項具有「改變實踐」結果的「里程碑式」試驗。
「在這項試驗之前,我們沒有充分的證據證明阿片類藥物是否對急性腰痛或頸部疼痛有效,但阿片類藥物是治療這些疾病最常用的藥物之一,」林解釋道。
根據這些結果,「根本不應該推薦阿片類藥物來治療急性腰痛和頸部疼痛,」林說道。
OPAL 研究結果於 6 月 28 日於線上發表在《剌胳針》雜誌上。
嚴格的實驗
該試驗在澳大利亞 157 個初級保健或急診室進行,涉及 347 名患有腰痛、頸部疼痛或兩者均持續 12 週或更短時間的成年人。
他們被隨機分配 (1:1) 接受指引所推薦的照護(保證和保持活躍的建議)加上阿片類藥物(羥考酮(oxycodone) 每天最多 20 毫克)或相同的安慰劑,為期長達 6 週。 提供納洛酮 ( Naloxone) 是為了幫助預防阿片類藥物引起的便秘並改善盲測情況。
主要結果是第 6 週時的疼痛嚴重程度,採用簡要疼痛量表(10 分制)的疼痛嚴重程度子量表進行測量。
6 週後,阿片類藥物治療並沒有比安慰劑更好地緩解急性背部/頸部疼痛或改善功能。
阿片類藥物組 6 週時的平均疼痛評分為 2.78,而安慰劑組為 2.25(調整後平均差,0.53;95% CI,–0.00 至 1.07;P = 0.051)。 1 年時,安慰劑組的平均疼痛評分略低於阿片類藥物組(1.8 比 2.4)。
此外,與分配接受安慰劑 6 週的患者相比,隨機分配接受阿片類藥物治療 6 週的患者在 1 年時阿片類藥物濫用的風險增加了一倍。
根據當前阿片類藥物濫用測量 (Current Opioid Misuse Measure, COMM ) 量表,1 年時,接受阿片類藥物治療的123 名患者中有24 名(20%) 存在濫用風險,而安慰劑組128 名患者中有13 名( 10%) 存在濫用風險(P = .049)。 COMM 是一種廣泛用於衡量正在接受阿片類藥物治療的慢性疼痛患者當前異常藥物相關行為的指標。
結果引發「嚴重問題」
「我相信這項研究的結果需要傳播給醫生和患者,以便他們收到有關阿片類藥物的最新證據,」林告訴 Medscape 醫學新聞。
「我們需要向醫生和患者保證,大多數患有急性腰痛和頸部疼痛的人隨著時間的推移(通常需要6 週)就會恢復得很好,因此治療很簡單——保持活躍,避免臥床休息,如有必要,短期可以使用熱敷包緩解疼痛,「如果需要藥物,可以考慮服用消炎藥。」,林補充道。
相關評論的作者表示,OPAL 試驗「對使用阿片類藥物治療急性腰背和頸部疼痛提出了嚴重質疑」。
西雅圖華盛頓大學的 Mark Sullivan 醫學博士和 Jane Ballantyne 醫學博士指出,當其他藥物治療失敗或禁忌時,當前的臨床指引建議對急性背痛和頸部疼痛患者使用阿片類藥物。
「多達三分之二的患者在治療背部或頸部疼痛時可能會接受阿片類藥物治療。現在是重新審視這些指引和實踐的時候了,」沙利文和巴蘭坦總結道。
OPAL 研究的資金由國家健康和醫學研究委員會、雪梨大學醫學與健康學院和南澳大利亞的健康和安全監管機構 (SafeWork SA) (註)提供。 研究作者透露沒有任何相關的財務關係。沙利文和巴蘭坦是負責任阿片類藥物處方醫師協會的董事會成員(無薪),並在阿片類藥物訴訟中擔任有償顧問。
剌胳針。 2023 年 6 月 28 日線上發布。 摘要
引用此內容:「里程碑」試驗顯示阿片類藥物治療背部、頸部疼痛並不比安慰劑好 – Medscape – 2023 年 6 月 29 日。
註:SafeWork SA 是南澳大利亞的健康和安全監管機構。此機構提供有關工作健康和安全的建議和教育、調查工作場所事故、執行南澳大利亞的工作健康和安全法、為工人和工廠提供許可證和註冊。
‘Landmark’ Trial Shows Opioids for Back, Neck Pain No Better Than Placebo
Megan Brooks / June 29, 2023 / Medscape Medical News
Opioids do not relieve acute low back or neck pain in the short term and lead to worse outcomes in the long term, results of the first randomized controlled trial testing the efficacy and safety of a short course of opioids for acute nonspecific low back/neck pain suggest.
After 6 weeks, there was no significant difference in pain scores of patients who took opioids compared to those who took placebo. After 1 year, patients given the placebo had slightly lower pain scores. Also, patients using opioids were at greater risk of opioid misuse after 1 year.
This is a “landmark” trial with “practice-changing” results, senior author Christine Lin, PhD, with the University of Sydney, told Medscape Medical News.
“Before this trial, we did not have good evidence on whether opioids were effective for acute low back pain or neck pain, yet opioids were one of the most commonly used medicines for these conditions,” Lin explained.
On the basis of these results, “opioids should not be recommended at all for acute low back pain and neck pain,” Lin said.
Results of the OPAL study were published online June 28 in The Lancet.
Rigorous Trial
The trial was conducted in 157 primary care or emergency department sites in Australia and involved 347 adults who had been experiencing low back pain, neck pain, or both for 12 weeks or less.
They were randomly allocated (1:1) to receive guideline-recommended care (reassurance and advice to stay active) plus an opioid (oxycodone up to 20 mg daily) or identical placebo for up to 6 weeks. Naloxone was provided to help prevent opioid-induced constipation and improve blinding.
The primary outcome was pain severity at 6 weeks, measured with the pain severity subscale of the Brief Pain Inventory (10-point scale).
After 6 weeks, opioid therapy offered no more relief for acute back/neck pain or functional improvement than placebo.
The mean pain score at 6 weeks was 2.78 in the opioid group, vs 2.25 in the placebo group (adjusted mean difference, 0.53; 95% CI, –0.00 to 1.07; P = .051). At 1 year, mean pain scores in the placebo group were slightly lower than in the opioid group (1.8 vs 2.4).
In addition, there was a doubling of the risk of opioid misuse at 1 year among patients randomly allocated to receive opioid therapy for 6 weeks compared with those allocated to receive placebo for 6 weeks.
At 1 year, 24 (20%) of 123 of the patients who received opioids were at risk of misuse, as indicated by the Current Opioid Misuse Measure (COMM) scale, compared with 13 (10%) of 128 patients in the placebo group (P = .049). The COMM is a widely used measure of current aberrant drug-related behavior among patients with chronic pain who are being prescribed opioid therapy.
Results Raise “Serious Questions”
“I believe the findings of the study will need to be disseminated to the doctors and patients, so they receive this latest evidence on opioids,” Lin told Medscape Medical News.
“We need to reassure doctors and patients that most people with acute low back pain and neck pain recover well with time (usually by 6 weeks), so management is simple ― staying active, avoiding bed rest, and, if necessary, using a heat pack for short term pain relief. If drugs are required, consider anti-inflammatory drugs,” Lin added.
The authors of a linked comment say the OPAL trial “raises serious questions about the use of opioid therapy for acute low back and neck pain.”
Mark Sullivan, MD, PhD, and Jane Ballantyne, MD, with the University of Washington, Seattle, note that current clinical guidelines recommend opioids for patients with acute back and neck pain when other drug treatments fail or are contraindicated.
“As many as two-thirds of patients might receive an opioid when presenting for care of back or neck pain. It is time to re-examine these guidelines and these practices,” Sullivan and Ballantyne conclude.
Funding for the OPAL study was provided by the National Health and Medical Research Council, the University of Sydney Faculty of Medicine and Health, and SafeWork SA. The study authors have disclosed no relevant financial relationships. Sullivan and Ballantyne are board members (unpaid) of Physicians for Responsible Opioid Prescribing and have been paid consultants in opioid litigation.
Lancet. Published online June 28, 2023. Abstract
Cite this: ‘Landmark’ Trial Shows Opioids for Back, Neck Pain No Better Than Placebo – Medscape – Jun 29, 2023.