Pragmatic Randomized Trial Evaluating the Clinical and Economic Effectiveness of Acupuncture for Chronic Low Back Pain

Abstract

In a randomized controlled trial plus a nonrandomized cohort, the authors investigated the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic low back pain and assessed whether the effects of acupuncture differed in randomized and nonrandomized patients. In 2001, German patients with chronic low back pain were allocated to an acupuncture group or a no-acupuncture control group. Persons who did not consent to randomization were included in a nonrandomized acupuncture group. All patients were allowed to receive routine medical care in addition to study treatment. Back function (Hannover Functional Ability Questionnaire), pain, and quality of life were assessed at baseline and after 3 and 6 months, and cost-effectiveness was analyzed. Of 11,630 patients (mean age=52.9 years (standard deviation, 13.7); 59% female), 1,549 were randomized to the acupuncture group and 1,544 to the control group; 8,537 were included in the nonrandomized acupuncture group. At 3 months, back function improved by 12.1 (standard error (SE), 0.4) to 74.5 (SE, 0.4) points in the acupuncture group and by 2.7 (SE, 0.4) to 65.1 (SE, 0.4) points among controls (difference=9.4 points (95% confidence interval 8.3, 10.5); p<0.001). Nonrandomized patients had more severe symptoms at baseline and showed improvements in back function similar to those seen in randomized patients. The incremental cost-effectiveness ratio was euro10,526 (euros) per quality-adjusted life year. Acupuncture plus routine care was associated with marked clinical improvements in these patients and was relatively cost-effective.

Acupuncture in the Treatment of Chronic Low Back Pain

“…The majority of trials examined in this systematic review were already included in the 2005 Cochrane systematic review update; however, Ammendolia et al contributed three novel trials of interest. 30,31,32 26 Yuan and colleagues were in accordance with Ammendolia et al, concluding that acupuncture did not differ from sham in pain reduction or functional improvement. They also affirmed previous findings that acupuncture is more effective than no treatment at all, and that acupuncture improves outcomes as an adjunct to other therapy.…”

Predicting response to a cognitive–behavioral approach to treating low back pain: Secondary analysis of the BeST data set

“…The size of both of these studies was based on finding a main treatment effect rather than a moderation of such an effect. To our knowledge, only 1 trial has been explicitly powered to show moderator effects (n ϭ 3,093) (28). In that trial, Witt et al found that acupuncture was more effective for those with worse initial back function, younger patients, and those with Ͼ10 years of schooling (28).…”

“…To our knowledge, only 1 trial has been explicitly powered to show moderator effects (n ϭ 3,093) (28). In that trial, Witt et al found that acupuncture was more effective for those with worse initial back function, younger patients, and those with Ͼ10 years of schooling (28). Although we consider we have used the most appropriate statistical approach to our data, this approach may not yield positive results unless there are resources to run more trials of a similar size to the acupuncture trial by Witt et al It is, therefore, perhaps surprising that some other studies have found apparently important effects on much smaller numbers.…”

Acupuntura: prática baseada em evidências

“…Witt et al 8 realizaram um estudo clínico randomizado e controlado (acupuntura versus grupo controle), com um braço de coorte não-randomizado e prospectivo, onde pacientes negaram-se a ser alocados para o grupo controle para avaliar o custoefetividade de acupuntura no tratamento de dor lombar baixa. Todos os grupos receberam medicação consagrada para dor lombar.…”