Hot flushes Urological and Genital Diseases Menopausal and other perimenopausal disorders
Conditions
Interventions
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, an
Sponsors
Korea Institute of Oriental Medicine (South Korea)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Korea, South
Outcome results
None listed