Effects of acupuncture on hot flushes in peri-menopausal and post-menopausal women: a multicentre randomised clinical trial

Not Applicable

Completed

• Conditions: Hot flushes; Urological and Genital Diseases; Menopausal and other perimenopausal disorders

• Registration Number: ISRCTN49335612
• Lead Sponsor: Korea Institute of Oriental Medicine (South Korea)

Brief Summary

2008 protocol in https://pubmed.ncbi.nlm.nih.gov/19055763/ (added 30/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-18
• Study Completion: 2008-11-01
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 180

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.