Combination of acupuncture and Chinese herbal formula for elderly adults with mild cognitive impairment: protocol for a randomized controlled trial.
BACKGROUND
Mild cognitive impairment (MCI) is known as a transitional status between normal cognitive function and Alzheimer's disease (AD). Acupuncture and Chinese herbal medicines (CHMs) are considered to be beneficial to patients with cognitive impairment. However, it is still unknown whether the combination of the two therapies could optimize the therapeutic effect for MCI. This trial is aimed to evaluate the therapeutic effects of acupuncture and the herbal formula Yishen Granule (YSG) for elderly patients with MCI.


METHODS/DESIGN
This is a multi-sited, patient-blinded, randomized controlled trial (RCT). Two hundred and forty eligible patients will be randomly divided into four groups: A. acupuncture with YSG, B. acupuncture with placebo herbal medicine, C. sham acupuncture with YSG or D. sham acupuncture with placebo herbal medicine. Acupuncture treatment will be given twice a week for 8 weeks and then once a week for 4 weeks. The herbal treatment patients will be given granules daily for 12 weeks, 8 weeks of standard-dose followed by 4 weeks of mid-dose. The primary outcome is scored by the Montreal Cognitive Assessment (MoCA). The secondary outcomes will be scored by the Mini-Mental State Examination (MMSE) and event-related potential (ERP). All the assessments will be conducted at baseline, and at the eighth and 12th week after intervention starts. The follow-up assessments will be performed with the MoCA in the 12th, 24th, and 36th weeks after intervention ends. Intention-to-treat (ITT) analysis will be used in this RCT.


DISCUSSION
This RCT will provide us information on the effect of treating MCI patients with only acupuncture, herbal formula as well as the combination of both. The additive effect or synergistic effect of acupuncture and Chinese herbal formula will then be analyzed.


TRIAL REGISTRATION
This trial is registered with ChiCTR-INR-17011569 on 5 June 2017, and has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2017SHL-KY-05).
['Chen|Yueqi|Y|', 'Zhang|Wenjing|W|', 'Wu|Huangan|H|', 'Lao|Lixing|L|', 'Xu|Jian|J|', 'Xu|Shifen|S|http://orcid.org/0000-0001-5595-3480']
D015670:Acupuncture Therapy D000367:Age Factors D000368:Aged D000369:Aged, 80 and over D002681:China D003071:Cognition D000066492:Cognitive Aging D060825:Cognitive Dysfunction D003131:Combined Modality Therapy D004365:Drugs, Chinese Herbal D005071:Evoked Potentials D005260:Female D006801:Humans D008297:Male D000073216:Mental Status and Dementia Tests D015337:Multicenter Studies as Topic D016032:Randomized Controlled Trials as Topic D013997:Time Factors D016896:Treatment Outcome
Acupuncture Chinese herbal formula Protocol Mild cognitive impairment (MCI) Randomized controlled trial (RCT)