Acupuncture for patients with allergic rhinitis (ARC) - a pragmatic randomized trial

Acupuncture for patients with allergic rhinitis (ARC) - a pragmatic randomized trial

 

Background: Acupuncture is widely used in patients with allergic rhinitis, but the available evidence of its effectiveness and cost-effectiveness is insufficient.

Objective: To evaluate the effectiveness and cost-effectiveness of acupuncture in addition to routine care in patients with allergic rhinitis compared with treatment with routine care alone.

Methods: Patients with allergic rhinitis were randomly allocated to receive up to 15 acupuncture sessions during a period of 3 months or to a control group receiving no acupuncture. Patients who did not consent to random assignment received acupuncture treatment. All patients were allowed to receive usual medical care. The Rhinitis Quality of Life Questionnaire (RQLQ) and general health-related quality of life (36-Item Short-Form Health Survey) were evaluated at baseline and after 3 and 6 months. Direct and indirect costs in both randomized groups, were assessed at baseline and after 3 months, and the incremental cost-effectiveness ratio of acupuncture treatment was calculated.

Results: Of 5,237 patients (mean [SD] age, 40 [12] years; 62% women), 487 were randomly assigned to acupuncture and 494 to control, and 4,256 were included in the nonrandomized acupuncture group. At 3 months, the RQLQ improved by a mean (SE) of 1.48 (0.06) in the acupuncture group and by 0.50 (0.06) in the control group (3-month scores, 1.44 [0.06] and 2.42 [0.06], respectively; difference in improvement, 0.98 [0.08]; P < .001). Similarly, quality-of-life improvements were more pronounced in the acupuncture vs the control group (P < .001). Six-month improvements in both acupuncture groups were lower than they had been at 3 months. Overall costs in the randomized acupuncture group were significantly higher than those in the randomized control group (Euro (euro; 1 euro = US $1.27) 763, 95% confidence interval: 683, 844 vs. 332 euro, 95% confidence interval: 252, 412; mean difference 432 euro, 95% confidence interval: 318, 545). The incremental cost-effectiveness ratio was 17,377 euro per quality-adjusted life year (women, 10,155 euro; men, 44,871 euro) and was robust in sensitivity analyses.

Conclusion: The results of this trial suggest that treating patients with allergic rhinitis in routine care with additional acupuncture leads to clinically relevant and persistent benefits. In addition, it seems that physician characteristics play a minor role in the effectiveness of acupuncture treatment, although this idea needs further investigation. Acupuncture, supplementary to routine care, was beneficial and, according to international benchmarks, cost-effective.

Publications:
Brinkhaus B, Witt CM, Jena S, Liecker B, Wegscheider K, Willich SN. Acupuncture in patients with allergic rhinitis - a pragmatic randomized trial. Annals of Allergy, Asthma and Immunology 2008;101(5):535-543.

Witt CM, Reinhold T, Jena S, Brinkhaus B, Willich SN. Cost-effectiveness of acupuncture in women and men with allergic rhinitis: a randomized controlled study in usual care. Am J Epidemiol 2009;169(5):562-571.

Principle investigator:
Willich, MD, MPH, MBA
Witt, MD, MBA

Research associate:
Jena, PhD
Brinkhaus, MD
Reinhold, PhD

Statistics:
Wegscheider, PhD

Data management:
Icke

Study nurse:
Eden

Bartsch

Project duration:
2000-2007

Project status:
completed

Funding:
Techniker Krankenkasse (statutory health insurance)