Patients with a recent (< 4 weeks) episode of stroke were randomised to receive 12 sessions of either real or sham acupuncture during 2 weeks. The primary outcome was the change in Barthel activities of daily living score at the end of treatment. Secondary outcome measures included the NIH Stroke Scale score, motoricity index and quality of life (EuroQoL-5 dimensional form and EuroQoL-VAS). Assessments were carried out by blinded physicians. A total of 116 patients (56 in the real acupuncture group and 60 in the sham group) were randomised, and 98 (real, 48; sham, 50) completed treatment and the 2-week assessment. Patient blinding by means of the sham acupuncture device was successful. Acupuncture was well tolerated except for one seizure during a real acupuncture session. The improvements in the Barthel scores were 4 points vs. 3 points in the real and sham acupuncture groups, respectively. The secondary outcome measures also essentially showed no significant effect of acupuncture. Post hoc analysis by baseline severity showed a greater improvement in leg function in the subgroup with baseline Barthel score less than the median (median score, 6): 22 points vs. 0 (corrected) points in the acupuncture and sham control groups, respectively (P = 0.02). The authors conclude that acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients.