Evaluation of the efficacy and safety of the use of acupuncture for the adjuvant treatment of patients with post-stroke cognitive impairment: protocol for a randomized controlled trial

Trials. 2020 Aug 28;21(1):753. doi: 10.1186/s13063-020-04656-w.

Abstract

Background: Post-stroke cognitive impairment (PSCI) is a series of syndromes that meet the diagnostic criteria for cognitive impairment that appear after a stroke. The treatment of PSCI with oral drugs alone is not ideal and has obvious side effects. Therefore, complementary and alternative treatments are needed for patients with insufficient or significant side effects of oral medications. Therefore, we will evaluate the clinical effectiveness and safety of acupuncture in the treatment of PSCI.

Methods/design: In this study, patients will be randomly divided into two groups. Intervention group: acupuncture combined with oral medication.

Control group: Western medicine treatment plan. All participants will continue to receive conventional drug treatment. The selection of outcomes will be evaluated by Mini Mental State Examination Scale (MMSE) at week 12. The scale will be conducted by two well-trained reviewers who will conduct joint MMSE inspections on participants. The test time will be selected 3 days before treatment and once 4 weeks after treatment. After the MMSE test, the two raters scored independently, and the average of the two was used as the final score.

Discussion: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with PSCI.

Trial registration: ClinicalTrials.gov ChiCTR2000029926. Registered on 17 February 2020 http://www.chictr.org.cn/showproj.aspx?proj=49356.