Trials. 2014 Nov 13;15:442. doi: 10.1186/1745-6215-15-442.
Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial.
Yang BF, Zeng XH, Liu Y, Fu QN, He T, Li F, Shi GX, Liu BZ, Sun SF, Wang J, Xiao L, Deng YM, Liu CZ1.
1Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China. firstname.lastname@example.org.
Vascular cognitive impairment, no dementia (VCIND) is a condition at risk for future dementia and should be the target of preventive strategies. Preliminary evidence suggests that acupuncture may be a clinically effective intervention for people with early-stage vascular cognitive impairment. We will do a multicenter, 6-month, drug-controlled, nonblinded, randomized, parallel-group trial to determine whether acupuncture is effective for improving cognitive function and quality of life for patients with VCIND.
A total of 216 eligible patients will be recruited and randomly assigned acupuncture for two sessions/week (n = 108) or citicoline 300 mg/day (n = 108) in a multicenter, 6-month trial. The primary endpoint is cognition (Alzheimer’s Disease Assessment Scale, Cognitive Subscale (ADAS-cog)). Secondary endpoints include assessments of activities of daily living and behavioral symptoms (Clock Drawing Test (CDT), Activities of Daily Living (ADL) and Instrumental Activities of Daily Living scale (IADL)).
This will be the first large-scale trial specifically evaluating acupuncture therapy in VCIND. If the study confirms the effectiveness and safety of acupuncture treatment, it will be important to examine how the acupuncture approach could most effectively be integrated into the provision of routine healthcare.
This study is registered as an International Standard Randomised Controlled Trial on 17 January 2014, number ISRCTN 82980206.
PMCID: PMC4242470 Free PMC Article
PMID: 25391431 [PubMed – indexed for MEDLINE]
Trials. 2014 Oct 27;15:410. doi: 10.1186/1745-6215-15-410.
Acupressure for agitation in nursing home residents with dementia: study protocol for a randomized controlled trial.
Kwan RY, Leung MC, Lai CK1.
1School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China. email@example.com.
Agitation is prevalent among people with dementia (PWD) in nursing homes. It frustrates both the PWD and their caregivers. Acupressure is a non-pharmacological intervention whose effectiveness is supported by preliminary studies. However, there is still a dearth of evidence to explain its effect for clinical use and further research. The present study is being conducted primarily to investigate the effects of acupressure as compared with sham-acupressure and usual care.
This study is a multicenter, assessor/participant/statistician-blinded, parallel group, randomized controlled trial taking place in Hong Kong nursing homes. We have been recruiting PWD over 65 years of age in nursing homes, who are experiencing agitation; 99 participants will be recruited in order to demonstrate a significant effect difference (that is, f =0.27) with a power of 0.8 and a significance level of 0.05 among the three groups. Participants are assigned by permuted block randomization into three groups in a 1:1:1 ratio. In the acupressure group, participants receive acupressure at the Fengchi (GB20), Baihui (GV20), Shenmen (HT7), Niguan (PC6) and Yingtang (EX-HN3) acupoints. In the sham-acupressure group, participants receive pressure on five non-acupoints. In the usual-care group, participants receive no intervention apart from the care provided by the nursing homes. Participants assigned to the sham-acupressure and usual-care groups receive free acupressure, like those in the acupressure group, after completion of the study. The whole study lasts for 30 weeks, and its primary outcome measure is agitation. The general estimated equation model will be used to compare the effects among groups and time points. The trial is currently recruiting participants.
This trial will provide a higher quality of evidence than previous studies on the use of acupressure for agitation in PWD. It will also provide newer evidence on acupressure in the population of PWD with agitation for clinical application and further research, including the effect on moderating stress, the delayed effect, the added effect on the placebo, and the effect on moderating the participant’s use of psychotropic drugs.
Centre for Clinical Trials Clinical Trials Registry: CUHK_CCT00347 (Registration date: 13 December 2012).
PMCID: PMC4216849 Free PMC Article
PMID: 25346026 [PubMed – indexed for MEDLINE]