Effects of acupuncture on hot flushes in peri-menopausal and post-menopausal women: a multicentre randomised clinical trial
| ISRCTN | ISRCTN49335612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49335612 |
| Secondary identifying numbers | KE0801 |
- Submission date
- 09/09/2008
- Registration date
- 18/09/2008
- Last edited
- 30/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Kun Hyung Kim
Scientific
Scientific
Department of Medical Research
Korea Institute of Oriental Medicine
483 Expo-ro
Yuseong-gu
Daejeon
305811
Korea, South
| Phone | +82 (0)42 868 9269 |
|---|---|
| pdchrist@kiom.re.kr |
Study information
| Study design | Multicentre randomised controlled trial with two parallel arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects of acupuncture on hot flushes in peri-menopausal and post-menopausal women: a multicentre randomised clinical trial |
| Study objectives | Acupuncture could reduce the frequency and severity of hot flushes and alleviate menopausal symptoms in peri-menopausal and post-menopausal women. |
| Ethics approval(s) | 1. The Research Ethics Board of Dongguk International Hospital on 2nd July 2008 2. East-West Neo Medical Centre, Kyung Hee University on 17th June 2008 3. Dong Eui Medical Centre, Dong Eui University on 5th June 2008 4. Semyung University Hospital on 10th June 2008 |
| Health condition(s) or problem(s) studied | Hot flushes |
| Intervention | Arm A : Standardised traditional korean acupuncture plus usual care Arm B : Usual care alone Arm A receives acupuncture 3 times/week, total 12 sessions for 4 weeks, and will be followed up 4 weeks after finishing acupuncture treatment. Total duration will be 8 weeks (4 weeks treatment plus 4 weeks follow up). Arm B receives no acupuncture treatments during 4 weeks. After 4 weeks, if they want to take the acupuncture treatment, the same treatment will be provided. But we will not use this data for the current trial. Total duration will be 4 weeks (4 weeks usual care alone). Both groups maintain usual care during the trial. Use of over-the-counter (OTC) drugs for managing usual symptoms like episodic colds, headaches and dyspepsia, and of some supplements for self-care on menopausal symptoms will be permitted as usual care. All participants will be asked to notice any other attempts of receiving new treatments or cares for their health condition before employing them to avoid the protocol violation. |
| Intervention type | Other |
| Primary outcome measure | Hot flush score: calculated by multiplying daily frequency and severity (0 : none, 1: mild, 2: moderate, 3: severe, 4: very severe) of hot flushes. Frequency and severity of hot flushes will be derived from self-reported daily logs, and data will be collected every 1 week. Participants are required to fill the diary during the treatment and follow-up phases. |
| Secondary outcome measures | Menopause Rating Scale (MRS): measured at baseline, 2 and 4 weeks after randomisation in both group. Additional measure at 6 and 8 weeks after randomisation will be conducted in Arm A during follow-up phase. |
| Overall study start date | 15/06/2008 |
| Completion date | 01/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 180 |
| Key inclusion criteria | 1. Peri-menopausal or post-menopausal women within 45 and 60 years old 2. Average daily hot flush scores greater than 10 for last one week at screening visit |
| Key exclusion criteria | 1. Participants under serious medical conditions (like uncontrolled hypertension, diabetes mellitus needed to be controlled by insulin injection, etc.) 2. Any type of thyroid dysfunction 3. History of past or current malignant tumour 4. Severe dyslipidaemia 5. Other infectious diseases or systemic diseases which is inadequate for acupuncture treatment 6. Use of any hormones, antidepressants, gabapentin, selective serotonin reuptake inhibitor (SSRI) and sedatives 7. Use of black cohosh and human placenta extracts 8. Any additional acupuncture treatment, herb prescription, therapeutic performance by other traditional Korean medicine (TKM) doctor during the study 9. Night-workers |
| Date of first enrolment | 15/06/2008 |
| Date of final enrolment | 01/11/2008 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Department of Medical Research
Daejeon
305811
Korea, South
305811
Korea, South
Sponsor information
Korea Institute of Oriental Medicine (South Korea)
Research organisation
Research organisation
c/o Sun-Mi Choi
483 Expo-ro
Yuseong-gu
Daejeon
305811
Korea, South
| Phone | +82 (0)42 868 9485 |
|---|---|
| smchoi@kiom.re.kr | |
| Website | http://www.kiom.re.kr/index.jsp |
"ROR" |
https://ror.org/005rpmt10 |
Funders
Funder type
Research organisation
Korea Institute of Oriental Medicine (South Korea) - Acupuncture, Moxibustion and Meridian Research Project (ref: K08010)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/12/2008 | 30/12/2020 | Yes | No |
Editorial Notes
30/12/2020: Publication reference added.
