Thomas K J, MacPherson H, Ratcliffe J, Thorpe L, Brazier J, Campbell M, Fitter M, Roman M, Walters S, Nicholl J P
School of Health and Related Research, University of Sheffield, UK.
Health Technol Assess. 2005 Aug;9(32):iii-iv, ix-x, 1-109. doi: 10.3310/hta9320.
To test whether patients with persistent non-specific low back pain, when offered access to traditional acupuncture care alongside conventional primary care, gained more long-term relief from pain than those offered conventional care only, for equal or less cost. Safety and acceptability of acupuncture care to patients, and the heterogeneity of outcomes were also tested.
A pragmatic, two parallel group, randomised controlled trial. Patients in the experimental arm were offered the option of referral to the acupuncture service comprising six acupuncturists. The control group received usual care from their general practitioner (GP). Eligible patients were randomised in a ratio of 2:1 to the offer of acupuncture to allow between-acupuncturist effects to be tested.
Three non-NHS acupuncture clinics, with referrals from 39 GPs working in 16 practices in York, UK.
Patients aged 18-65 years with non-specific low back pain of 4-52 weeks' duration, assessed as suitable for primary care management by their general practitioner.
The trial protocol allowed up to ten individualised acupuncture treatments per patient. The acupuncturist determined the content and the number of treatments according to patient need.
The Short Form 36 (SF-36) Bodily Pain dimension (range 0-100 points), assessed at baseline, and 3, 12 and 24 months. The study was powered to detect a 10-point difference between groups at 12 months post-randomisation. Cost--utility analysis was conducted at 24 months using the EuroQoL 5 Dimensions (EQ-5D) and a preference-based single index measure derived from the SF-36 (SF-6D). Secondary outcomes included the McGill Present Pain Index (PPI), Oswestry Pain Disability Index (ODI), all other SF-36 dimensions, medication use, pain-free months in the past year, worry about back pain, satisfaction with care received, and safety and acceptability of acupuncture care.
A total of 159 patients were in the 'acupuncture offer' arm and 80 in the 'usual care' arm. All 159 patients randomised to the offer of acupuncture care chose to receive acupuncture treatment, and received an average of eight acupuncture treatments within the trial. Analysis of covariance, adjusting for baseline score, found an intervention effect of 5.6 points on the SF-36 Pain dimension [95% confidence interval (CI) -1.3 to 12.5] in favour of the acupuncture group at 12 months, and 8 points (95% CI 0.7 to 15.3) at 24 months. No evidence of heterogeneity of effect was found for the different acupuncturists. Patients receiving acupuncture care did not report any serious or life-threatening events. No significant treatment effect was found for any of the SF-36 dimensions other than Pain, or for the PPI or the ODI. Patients receiving acupuncture care reported a significantly greater reduction in worry about their back pain at 12 and 24 months compared with the usual care group. At 24 months, the acupuncture care group was significantly more likely to report 12 months pain free and less likely to report the use of medication for pain relief. The acupuncture service was found to be cost-effective at 24 months; the estimated cost per quality-adjusted (QALY) was 4241 pounds sterling (95% CI 191 pounds sterling to 28,026 pounds sterling) using the SF-6D scoring algorithm based on responses to the SF-36, and 3598 pounds sterling (95% CI 189 pounds sterling to 22,035 pounds sterling) using the EQ-5D health status instrument. The NHS costs were greater in the acupuncture care group than in the usual care group. However, the additional resource use was less than the costs of the acupuncture treatment itself, suggesting that some usual care resource use was offset.
Traditional acupuncture care delivered in a primary care setting was safe and acceptable to patients with non-specific low back pain. Acupuncture care and usual care were both associated with clinically significant improvement at 12- and 24-month follow-up. Acupuncture care was significantly more effective in reducing bodily pain than usual care at 24-month follow-up. No benefits relating to function or disability were identified. GP referral to a service providing traditional acupuncture care offers a cost-effective intervention for reducing low back pain over a 2-year period. Further research is needed to examine many aspects of this treatment including its impact compared with other possible short-term packages of care (such as massage, chiropractic or physiotherapy), various aspects of cost-effectiveness, value to patients and implementation protocols.
测试对于持续性非特异性腰痛患者，在接受常规初级护理的同时提供传统针灸护理，与仅接受常规护理的患者相比，是否能以相同或更低的成本获得更长期的疼痛缓解。还测试了针灸护理对患者的安全性和可接受性，以及结果的异质性。
一项实用的、两组平行、随机对照试验。试验组的患者可选择转介至由六名针灸师组成的针灸服务机构。对照组接受其全科医生（GP）的常规护理。符合条件的患者按2:1的比例随机分配接受针灸服务，以便测试不同针灸师之间的效果差异。
三家非国民保健服务（NHS）针灸诊所，由英国约克郡16家诊所的39名全科医生进行转介。
年龄在18 - 65岁之间、患有持续4 - 52周非特异性腰痛的患者，经其全科医生评估适合初级护理管理。
试验方案允许每位患者接受多达十次个性化针灸治疗。针灸师根据患者需求确定治疗内容和次数。
在基线、3个月、12个月和24个月时评估简短健康调查问卷（SF - 36）身体疼痛维度（范围0 - 100分）。该研究的效能足以检测随机分组后12个月时两组之间10分的差异。在24个月时使用欧洲五维健康量表（EQ - 5D）和基于SF - 36得出的偏好单指标测量法（SF - 6D）进行成本 - 效用分析。次要结局包括麦吉尔疼痛现状指数（PPI）、奥斯威斯疼痛残疾指数（ODI）、所有其他SF - 36维度、药物使用情况、过去一年无痛月数、对背痛的担忧、对所接受护理的满意度，以及针灸护理的安全性和可接受性。
“针灸服务提供组”共有159名患者，“常规护理组”有80名患者。随机分配到针灸护理组的159名患者均选择接受针灸治疗，在试验期间平均接受了八次针灸治疗。经协方差分析并调整基线评分后发现，在12个月时，针灸组在SF - 36疼痛维度上比常规护理组有5.6分的干预效果优势[95%置信区间（CI） - 1.3至12.5]，在24个月时为8分（95%CI 0.7至15.3）。未发现不同针灸师之间存在效果异质性的证据。接受针灸护理的患者未报告任何严重或危及生命的事件。除疼痛维度外，在任何其他SF - 36维度、PPI或ODI方面均未发现显著治疗效果。与常规护理组相比，接受针灸护理的患者在12个月和24个月时报告对背痛的担忧明显减轻。在24个月时，针灸护理组报告12个月无痛的可能性显著更高，且报告使用药物缓解疼痛的可能性更低。研究发现针灸服务在24个月时具有成本效益；使用基于对SF - 36的回答的SF - 6D评分算法，每质量调整生命年（QALY）的估计成本为4241英镑（95%CI 191英镑至28,026英镑），使用EQ - 5D健康状况工具时为3598英镑（95%CI 189英镑至22,035英镑）。国民保健服务的成本在针灸护理组高于常规护理组。然而，额外的资源使用低于针灸治疗本身的成本，这表明一些常规护理资源的使用得到了抵消。
在初级护理环境中提供的传统针灸护理对非特异性腰痛患者是安全且可接受的。在12个月和24个月的随访中，针灸护理和常规护理均与临床上显著的改善相关。在24个月的随访中，针灸护理在减轻身体疼痛方面比常规护理显著更有效。未发现与功能或残疾相关的益处。全科医生转介至提供传统针灸护理的服务机构，对于在两年期间减轻腰痛是一种具有成本效益的干预措施。需要进一步研究来考察这种治疗的许多方面，包括与其他可能的短期护理方案（如按摩、整脊或物理治疗）相比的影响、成本效益的各个方面、对患者的价值以及实施方案。
