Dagenais S, Yelland M J, Del Mar C, Schoene M L
CHEO Research Institute, 401 Smyth Rd, Ottawa, Ontario, Canada, K1H 8L1.
Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD004059. doi: 10.1002/14651858.CD004059.pub3.
Prolotherapy involves repeated injections of irritant solutions to strengthen lumbosacral ligaments and reduce some types of chronic low-back pain; spinal manipulation and exercises are often used to enhance its effectiveness.
To determine the efficacy of prolotherapy in adults with chronic low-back pain.
We searched CENTRAL 2006, Issue 3 and MEDLINE, EMBASE, CINAHL, and AMED from their respective beginnings to October 2006, with no restrictions on language, and consulted content experts.
We included randomised (RCT) and quasi-randomised controlled trials (QRCT) that compared prolotherapy injections to control injections, alone or in combination with other treatments, which measured pain or disability before and after the intervention.
Two review authors independently selected the trials and assessed methodological quality. Intervention protocols varied from study to study, making meta-analysis impossible.
We identified five high quality studies with a total of 366 participants. All measured pain or disability levels at six months, and four measured the proportion of participants reporting a greater than 50% reduction in pain or disability scores. Three randomized controlled trials (206 participants) found that prolotherapy injections alone are no more effective than control injection for chronic low-back pain and disability. At six months, there was no difference between groups in mean pain or disability scores (2 RCTs; 184 participants) and no difference in proportions who reported over 50% improvement in pain or disability (3 RCTs; 206 participants). These trials could not be pooled due to clinical heterogeneity. Two RCTs (160 participants) found that prolotherapy injections, given with spinal manipulation, exercise, and other therapies, are more effective than control injections for chronic low-back pain and disability. At six months, one study reported a significant difference between groups in mean pain and disability scores, whereas the other study did not. Both studies reported a significant difference in the proportion of individuals who reported over 50% reduction in disability or pain. Co-interventions confounded interpretation of results and clinical heterogeneity in the trials prevented pooling.
AUTHORS' CONCLUSIONS: There is conflicting evidence regarding the efficacy of prolotherapy injections for patients with chronic low-back pain. When used alone, prolotherapy is not an effective treatment for chronic low-back pain. When combined with spinal manipulation, exercise, and other co-interventions, prolotherapy may improve chronic low-back pain and disability. Conclusions are confounded by clinical heterogeneity amongst studies and by the presence of co-interventions.
注射疗法包括反复注射刺激性溶液以强化腰骶韧带并减轻某些类型的慢性下腰痛；脊柱推拿和锻炼常被用于提高其疗效。
确定注射疗法对成年慢性下腰痛患者的疗效。
我们检索了Cochrane系统评价数据库2006年第3期、MEDLINE、EMBASE、护理学与健康领域数据库（CINAHL）和澳大利亚医学数据库（AMED），检索时间从各数据库建库起始至2006年10月，无语言限制，并咨询了内容专家。
我们纳入了随机对照试验（RCT）和半随机对照试验（QRCT），这些试验比较了注射疗法与对照注射，单独使用或与其他治疗联合使用，测量了干预前后的疼痛或残疾情况。
两位综述作者独立选择试验并评估方法学质量。各研究的干预方案各不相同，因此无法进行荟萃分析。
我们确定了5项高质量研究，共有366名参与者。所有研究均在6个月时测量了疼痛或残疾水平，4项研究测量了报告疼痛或残疾评分降低超过50%的参与者比例。3项随机对照试验（206名参与者）发现，单独使用注射疗法治疗慢性下腰痛和残疾并不比对照注射更有效。在6个月时，两组之间的平均疼痛或残疾评分没有差异（2项随机对照试验；184名参与者），报告疼痛或残疾改善超过50%的比例也没有差异（3项随机对照试验；206名参与者）。由于临床异质性，这些试验无法合并。2项随机对照试验（160名参与者）发现，注射疗法与脊柱推拿、锻炼及其他疗法联合使用时，治疗慢性下腰痛和残疾比对照注射更有效。在6个月时，一项研究报告两组之间的平均疼痛和残疾评分有显著差异，而另一项研究则没有。两项研究均报告了报告残疾或疼痛降低超过50%的个体比例有显著差异。联合干预混淆了结果的解释，试验中的临床异质性妨碍了合并分析。
关于注射疗法治疗慢性下腰痛患者的疗效，证据相互矛盾。单独使用时，注射疗法不是治疗慢性下腰痛的有效方法。与脊柱推拿、锻炼及其他联合干预措施联合使用时，注射疗法可能改善慢性下腰痛和残疾情况。研究之间的临床异质性以及联合干预措施的存在混淆了结论。
