Sedative and tranquilising acupuncture in the treatment of primary insomnia with anxiety
| ISRCTN | ISRCTN10474528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10474528 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Shunyi Hospital of Beijing Traditional Chinese Medicine Hospital |
| Funders | Young Qihuang Scholars Cultivation Project, National Traditional Chinese Medicine Innovation Backbone Talent Project |
- Submission date
- 22/05/2024
- Registration date
- 04/06/2024
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study aimed to compare the effectiveness of sedative and tranquilising acupuncture with that of conventional medicine in the treatment of primary insomnia with anxiety to provide a novel approach to the clinical treatment of this type of insomnia.
Who can participate?
Patients aged 18-65 years with primary insomnia with anxiety
What does the study involve?
Patients were randomly divided into a treatment group and a control group. The treatment group were treated with sedative and tranquilising acupuncture, and the control group were treated with estazolam, a conventional drug. Treatment effectiveness was determined after 4 and 8 weeks of treatment.
What are the possible benefits and risks of participating?
Sedative and tranquilising acupuncture can significantly improve sleep quality in patients with primary insomnia, and it can alleviate anxiety in these patients.
Where is the study run from?
Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital (China)
When is the study starting and how long is it expected to run for?
January 2020 to March 2023
Who is funding the study?
1. Young Qihuang Scholars Cultivation Project (China)
2. National Traditional Chinese Medicine Innovation Backbone Talent Project (China)
Who is the main contact?
Peng Bai, baipeng_bp3147@163.com
Contact information
Public, Scientific, Principal investigator
No. 51 of Anwai Xiaoguan Street
Chaoyang District
Beijing
100029
China
 ORCID ID |
0009-0007-3264-7721 |
|---|---|
| Phone | +86 (0)1084980281 |
| baipeng_bp3147@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre double-blinded interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical effects of sedative and tranquilising acupuncture in the treatment of primary insomnia with anxiety in different Traditional Chinese Medicine constitutions |
| Study objectives | Sedative and tranquilising acupuncture can significantly improve sleep quality and efficacy in patients with primary insomnia, and it can alleviate anxiety in these patients. Compared with the control group, the treatment group exhibited long-term efficacy. |
| Ethics approval(s) |
Approved 09/04/2020, Ethics Committee of Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital (No. 1 Jiansheng Street, Shunyi District, Beijing, 100000, China; +86 (0)1089413365; syzyjjxf2020@163.com), ref: 2020SYKY03-01 |
| Health condition(s) or problem(s) studied | Patients with primary insomnia with anxiety |
| Intervention | A total of 113 patients who met the inclusion criteria were selected for this study using a convenience sampling method. The simple random sampling method was used to divide them into a treatment group using sedative and tranquilising acupuncture and a control group using estazolam, a conventional drug. Acupuncture procedure: Acupoint selection: Four Shencong, bilateral Shenmen and bilateral Sanyinjiao were the main acupoints. Technique: The needle was inserted to a shallow depth at Four Shencong, to a medium depth at Shenmen and perpendicularly at Sanyinjiao. Once inserted, the needle was left for 30 minutes, with the lifting-and-thrusting method applied after every 10 minutes. 30 minutes each time, five times a week from Monday to Friday (rest on Saturday and Sunday). Ten treatments were taken as a course, and a total of two courses of treatment (4 weeks) were given. Estazolam treatment (control group): estazolam 1 mg every night (Shandong Xinyi Pharmaceutical Co., LTD). Efficacy was determined after 4 and 8 weeks of treatment. The statistical analysis was performed using SPSS 26.0 statistical software. The measurement data were expressed as mean ± standard deviation. Data conforming to a normal distribution were compared between the two groups using an independent sample t-test, and the within-group comparison was conducted using a paired sample t-test. Data not conforming to a normal distribution were compared using the Wilcoxon rank-sum test, and the count data were tested using a chi-square test. The difference was considered statistically significant at P <0.05. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Primary insomnia assessed using the Pittsburgh Sleep Quality Index (PSQI) after 4 and 8 weeks of treatment |
| Key secondary outcome measure(s) |
1. Anxiety states assessed using the Self-Assessment Scale (SAS) after 4 and 8 weeks of treatment |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Total final enrolment | 113 |
| Key inclusion criteria | 1. Those who met the above diagnostic criteria of primary insomnia and anxiety state 2. Age between 18 and 65 years, with no restriction on gender 3. Those who have not taken other anti-insomnia and anxiety medication in the last month 4. Permission was obtained from the patient |
| Key exclusion criteria | 1. Those who did not meet the above inclusion criteria 2. Age <18 or >65 years, and pregnant or lactating women 3. Individuals with combined visceral diseases, severe diseases of the immune and blood systems, mental illnesses and recent neurological injuries such as traumatic brain injury or spinal cord injury 4. Skin infection at the acupoint area |
| Date of first enrolment | 20/08/2020 |
| Date of final enrolment | 13/03/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Shunyi District
Beijing
100000
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Peng Bai (baipeng_bp3147@163.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/05/2024: Study's existence confirmed by the Ethics Committee of Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital.
