Contact information
Type
Scientific
Primary contact
Dr Jing Guo
ORCID ID
Contact details
Acupuncture Department of Beijing TCM Hospital
Meishuguanhoujie Road 23
Beijing
100011
China
+86 (0)10 5217 6910
guojing_2002@163.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02
Study information
Scientific title
A single-blind, randomised, sham controlled study of acupuncture in improving daytime functioning of patients suffering from primary insomnia compared with sham acupuncture and estazolam
Acronym
EAPI
Study hypothesis
Patients suffering from long time of insomnia always complain of daytime impairments such as sleepiness, fatigue, alertness, anxiety, worrying, and quality of life, etc., and daytime deficits would presumably have a more negative impact on quality of life. Studies have mainly reported treatment effects of the nocturnal aspects of insomnia, so sufficient attention to daytime functions is needed. Hypnotics are by far the most common treatment offered for insomnia. More or less hypnotics may change the normal structure of sleep which causes worse daytime impairment. Comparatively acupuncture has the advantages of fewer side effects than hypnotics. Studies have shown its significant improvements in nocturnal aspects of insomnia, so it may be also effective in improving daytime functioning as well.
Ethics approval
Medical Ethical Committee of the Beijing TCM Hospital approved on the 25th August 2009
Study design
Single centre single-blind randomised sham-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary insomnia
Intervention
This is a six-week, single-blind, randomised, sham-controlled study. A total of 150 untreated patients with primary insomnia will be recruited. Under single-blind conditions, patients will be randomly assigned to one of the three groups:
Group A:
Active acupuncture with estazolam placebo tablet for six weeks. Active acupuncture is conducted by stimulating 5 acupoints: Shen-Ting (DU-24), Si-Shen-Cong (EX-HN1), San-Yin-Jiao (SP-6), Shen-Men (HT-7) and Bai-Hui (DU-20) for 30 minutes every other day. Stainless steel needles of 0.35 mm diameter are inserted at a depth of 10 mm obliquely into Bai-Hui (Du-20) Shen-Ting (DU-24) and Si-Shen-Cong (EX-HN1), 10 mm straightly into San-Yin-Jiao (SP-6) and 5 mm straightly into Shen-Men (HT-7). In the day without acupuncture intervention one estazolam placebo tablet should be taken before sleep.
Group B:
Estazolam combined with sham acupuncture for six weeks. Sham acupuncture is conducted by stimulating 4 acupoints every other day: Bi-Nao (LI-14), Shou-San-li (LI-10), Yu-Ji (LU-10) and Feng-Shi (GB-31). Stainless steel needles of 0.35 mm diameter are inserted straightly at a depth of 10 mm into the four points. According to traditional Chinese medicine theory, these four acupoints have no effect for insomnia. Estazolam dose is given 1 mg in the day without acupuncture intervention before sleep.
Group C:
Sham acupuncture with estazolam placebo tablet for six weeks. Sham acupuncture is conducted as the group B. In the day without acupuncture one estazolam placebo tablet should be taken before sleep.
The reason for taking the invention every other day is for the convenience of the patients and avoiding addiction of estazolam.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Sleepiness measured using the Epworth Sleepiness Scale. Assessments will be conducted at baseline and at day 7, 14, 28, 42 and 2 months follow-up.
2. Sleep diary assessments will be conducted every day until 2 months follow-up
Secondary outcome measures
1. Changes in the Pittsburgh Sleep Quality Index (PSQI). Assessments will be conducted at baseline and at day 28, 42 and 2 months follow-up.
2. Changes in the 36-item Short Form Health Survey (SF-36) scores. Assessments will be conducted at baseline and at day 28, 42 and 2 months follow-up.
Overall trial start date
01/08/2009
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Either gender aged 25 - 75 years
2. Have primary insomnia diagnosed from International Classification of Diseases, 10th Edition (ICD-10)
3. Patients with insomnia persistent for 4 weeks or longer before the start of observation period
4. Have not yet received any psychoactive medications
5. Patients who submit written informed consent for study entry
6. Able to take part in the entire treatment and data collection procedure
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Diagnosis of depression, anxiety or schizophrenia
2. Diagnosis of serious disease of heart, brain, kidney or liver
3. History of sleep apnoea (temporary cessation of breathing during sleep)
4. Suffering from insomnia less than 4 weeks
5. Treatment with investigational drugs in past six months
6. Ever received acupuncture against insomnia, or during the last year received acupuncture for any indication
Recruitment start date
01/08/2009
Recruitment end date
01/12/2010
Locations
Countries of recruitment
China
Trial participating centre
Acupuncture Department of Beijing TCM Hospital
Beijing
100011
China
Sponsor information
Organisation
Beijing Hospital of Traditional Chinese Medicine (China)
Sponsor details
c/o Jing Guo
Acupuncture Department
Meishuguanhoujie Road 23
Beijing
100011
China
+86 (0)10 5217 6910
guojing_2002@163.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Beijing Administration Bureau of Traditional Chinese Medicine (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24159338
Publication citations
-
Results
Guo J, Wang LP, Liu CZ, Zhang J, Wang GL, Yi JH, Cheng JL, Efficacy of acupuncture for primary insomnia: a randomized controlled clinical trial., Evid Based Complement Alternat Med, 2013, 2013, 163850, doi: 10.1155/2013/163850.