摘要Objective:To explore the effects of acupuncture in comparison with sham acupuncture on cognitive functions in patients with relapsing-remitting multiple sclerosis(RRMS).Methods:In this randomized controlled trial,31 RRMS patients in the acupuncture group were treated with traditional Chinese acupuncture based on the treatment principle of calming the mind,reinforcing qi and blood,and 31 patients in the control group were treated with sham acupuncture(shallow needling at non-acupuncture points)twice a week for 12 weeks.The primary outcome was the Brief International Cognitive Assessment for Multiple Sclerosis(BICAMS)score,which was evaluated by a psychologist at baseline and after 12 weeks of treatment.The secondary outcomes were the Symptom Checklist 90-Revised(SCL-90-R),Pittsburgh Sleep Quality Index(PSQI),and Fatigue Severity Scale(FSS)scores.The participants were provided with contact information from the researchers with constant access to report any adverse symptoms.Results:In total,62 participants were enrolled and allocated to the acupuncture group(31 cases)or control group(31 cases).After 12 weeks of acupuncture treatment,BICAMS including Symbol Digit Modalities Test(SDMT),California Verbal Learning Test-2(CVLT-2)and delayed CVLT-2 scores were significantly improved in comparison with the control group(P＜0.01).However,the changes in the Brief Visuospatial Memory Test-Revised(BVMT-R)and delayed BVMT-R scores related to visual/spatial memory did not differ significantly between the two groups(both P＞0.05).The FSS,PSQI,and SCL-90-R scores were significantly reduced after 12-week treatment in the acupuncture group compared to the control group(P＜0.05 or P＜0.01).No life-threatening adverse events occurred throughout the study.Conclusions:Twelve weeks of acupuncture treatment was effective in improving immediate and short-term auditory/verbal memory,attention and processing speed;reducing fatigue and decreasing sleep latency and the use of sleeping medications;alleviating depression,somatization,obsessive-compulsive and paranoid disorders in patients with RRMS.(Iranian Registry of Clinical Trials,No.IRCT20220101053582N1)