To assess quality of life and cost-effectiveness of additional acupuncture treatment for allergic rhinitis, patients were randomly allocated to 2 groups; both received usual care, but one group received an additional 10 acupuncture sessions. Quality of life (according to the SF-36 Health Survey), and direct and indirect costs, were assessed at baseline and after 3 months, and the incremental cost-effectiveness ratio of acupuncture treatment was calculated. This German study (December 2000-June 2004) involved 981 patients (64% women, mean age 40.9 years (standard deviation, 11.2); 36% men, mean age 43.2 years (standard deviation, 13.0)). At 3 months, quality of life was higher in the acupuncture group than in the control group (mean Physical Component Score 51.99 (standard error (SE), 0.33) vs. 48.25 (SE, 0.33), P < 0.001; mean Mental Component Score 48.55 (SE, 0.42) vs. 45.35 (SE, 0.42), respectively, P < 0.001). Overall costs in the acupuncture group were significantly higher than those in the 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. Acupuncture, supplementary to routine care, was beneficial and, according to international benchmarks, cost-effective. However, because of the study design, it remains unclear whether the effects are acupuncture specific.