Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care.

OBJECTIVE To investigate the clinical effectiveness and cost-effectiveness of acupuncture in patients with dysmenorrhea. STUDY DESIGN In a randomized controlled trial plus non-randomized cohort, patients with dysmenorrhea were randomized to acupuncture (15 sessions over three months) or to a control group (no acupuncture). Patients who declined randomization received acupuncture treatment. All subjects were allowed to receive usual medical care. RESULTS Of 649 women (mean age 36.1 +/- 7.1 years), 201 were randomized. After three months, the average pain intensity (NRS 0-10) was lower in the acupuncture compared to the control group: 3.1 (95% CI 2.7; 3.6) vs. 5.4 (4.9; 5.9), difference -2.3 (-2.9; -1.6); P<.001. The acupuncture group had better quality of life and higher costs. (overall ICER 3,011 euros per QALY). CONCLUSION Additional acupuncture in patients with dysmenorrhea was associated with improvements in pain and quality of life as compared to treatment with usual care alone and was cost-effective within usual thresholds.