Efficacy and safety assessment of acupuncture and nimodipine to treat mild cognitive impairment after cerebral infarction: a randomized controlled trial.

Shuhua Wang,Jiangang Zheng,Hongling Yang,Tao Liu,Bin Zhang,Jie Zhang,Lu Gan

doi:10.1186/s12906-016-1337-0

Abstract

BackgroundCerebral infarction frequently leads to mild cognitive impairment (MCI). Prompt management of MCI can prevent vascular dementia and improve patient outcome. This single center randomized controlled trial aims to investigate the efficacy and safety of acupuncture and nimodipine to treat post-cerebral infarction MCI.MethodsA total of 126 Chinese patients with post-cerebral infarction MCI recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine between April 2013 and June 2014 were randomized at 1:1: 1 ratio into nimodipine alone (30 mg/time and 3 times daily), acupuncture alone (30 min/time, 6 times/week), and nimodipine + acupuncture groups. The treatments were 3 months. Cognitive function was evaluated using Montreal Cognitive Assessment (MoCA) scale at enrollment interview, at the end of 3-month therapy, and at the post-treatment 3-month follow-up.ResultsThe per-protocol set included 39, 40, and 40 patients from nimodipine alone, acupuncture alone, and the combination group, respectively, was analyzed. Intra-group comparison revealed that MoCA score at the follow-up improved significantly by 15.8 ± 10.9, 20.9 ± 13.8 %, and 30.2 ± 19.7 % compared with the baseline MoCA for nimodipine alone, acupuncture alone, and the combination group, respectively. Inter-group comparison demonstrated that the combination therapy improved MoCA score (5.5 ± 2.2) at significantly higher extent than nimodipine alone (3.1 ± 1.8) and acupuncture alone (4.3 ± 2.3) at the follow-up (All P < 0.05), and significantly higher proportion of patients in acupuncture alone group (80 %) and the combination therapy group (90 %) than in nimodipine alone group (56.4 %) showed ≥12 % MoCA score improvement compared with the baseline MoCA (All P < 0.05). No adverse event was reported during the study.ConclusionAcupuncture may be used as an additional therapy to conventional pharmacological treatment to further improve the clinical outcomes of patients with post-cerebral infarction MCI.Trial registrationThe study was registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/, Unique Identifier: ChiCTR-IOR-15007366). The date of registration is November 4, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12906-016-1337-0) contains supplementary material, which is available to authorized users.

Highlights

Cerebral infarction frequently leads to mild cognitive impairment (MCI)
Patients Patients that met all of the following inclusion criteria were enrolled: 1) aged 50 to 80 years; 2) a confirmed history of cerebrovascular ischemia based on the results from cerebral perfusion computed tomography or magnetic resonance imaging; 3) a recent episode of cerebral infarction that occurred 0.5 to 6 months prior to the enrollment interview; 4) a Modified Ashworth Scale score of muscle tone ≥ 3; 5) no severe language and cognitive disorder but presenting MCI with a Montreal Cognitive Assessment (MoCA) score < 26; [15] the definition of MCI in this study was that the cognitive impairment was not severe enough to interfere with everyday life; [16] 6) was literate and able to read and understand the informed consent form; 7) voluntarily signed the informed consent form
Age was significantly different among the 3 groups (P = 0.021), and patients in the nimodipine alone group appeared to have younger mean age than patients in acupuncture alone and acupuncture + nimodipine group (Table 1)

Summary

Introduction

Cerebral infarction frequently leads to mild cognitive impairment (MCI). Prompt management of MCI can prevent vascular dementia and improve patient outcome. This single center randomized controlled trial aims to investigate the efficacy and safety of acupuncture and nimodipine to treat post-cerebral infarction MCI. Cerebrovascular disease such as stroke often causes cognitive dysfunction ranging from mild cognitive impairment (MCI) to dementia. Previous clinical trials have shown that drugs that are usually used to treat Alzheimer’s disease, such as the cholinesterase inhibitors donepezil, galantamine, and rivastigmine, and the noncompetitive N-methyl-D-aspartate receptor antagonist memantine, were associated with neurological benefits in patients with post-stroke cognitive impairment [3,4,5,6,7,8,9]. Because of uncertain effect of the drugs on global and daily function, none of the drugs has achieved regulatory approval for the treatment of vascular cognitive impairment (VCI) [10]

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