Condition category
Nervous System Diseases
Date applied
24/01/2010
Date assigned
10/03/2010
Last edited
29/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bjzhongyi.com/

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

  1. 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.

Additional files

Editorial Notes