The present study aimed to evaluate the effects of electro–acupuncture on hot flashes in postmenopausal women. In this randomized, placebo-controlled trial, 41 postmenopausal women with hot flashes were randomly assigned into intervention or control groups. In the intervention group, the electro-acupuncture was carried out while in the control group needles taped to the skin in the same acupoints without any electricity. The treatment period was 10 weeks then patients were followed for 3 months after the last session. The rate of hot flashes was recorded daily during 10 weeks treatment and 3 months follow-up periods. The severity of hot flashes was measured by VAS at the end of weeks 2, 6, and 10 after initiation of treatment and at the end of follow up period. Serum levels Follicle Stimulating Hormone (FSH) and Estradiol (E2) were measured at the end of 10 weeks treatment and 3 months follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902222891N1
Registration date:2010-05-12, 1389/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-12, 1389/02/22
Registrant information
Name
Afsar Foroud
Name of organization / entity
Islamic Azad University- Branch of Kerman
Country
Iran (Islamic Republic of)
Phone
+98 34 1244 5335
Email address
foroud@iauk.ac.ir
Recruitment status
Recruitment complete
Funding source
Rasearch Center of Islamic Azad University of Kerman
Expected recruitment start date
2005-03-05, 1383/12/15
Expected recruitment end date
2006-02-04, 1384/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of electro-acupuncture in postmenopausal women with hot flashes
Public title
Acupuncture and Hot flashes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Average of 5 hot flashes per day, average severity of hot flashes of 3 or more on the VAS in two weeks before treatment, having a natural menopause of at least 6 months without medical or surgical interferences, healthy post-menopause women, age 49-62 years, not having previous experience of acupuncture, E2 <25 pg/ml, FSH>30 mIu/ml
Exclusion criteria: Severe cardiovascular, metabolic, thromboembolic, endocrine, thyroid, or malignant diseases, uncontrolled hypertension, using hormone or medications interfering with vasomotor symptoms in 4 weeks prior to the study
Age
From 49 years old to 62 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman Islamic Azad University
Street address
First Kilometer of Jopar Road, Kerman-
City
Kerman
Postal code
7618644941
Approval date
2010-02-14, 1388/11/25
Ethics committee reference number
28702
Health conditions studied
1
Description of health condition studied
Hot flashes in postmenopause women
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Number of hot flashes
Timepoint
Two weeks before treatment, daily during 10 weeks treatment, weekly during 3 months after the last treatment
Method of measurement
a self-report hot flash diary
2
Description
hormon levels of E2 and FSH
Timepoint
Baseline, at the end of 10 weeks treatment and 3 months after the last treatment.
Method of measurement
laboratory kits
3
Description
Severity hot flashes
Timepoint
baseline, weeks 2, 6, and 10 and 3 months after the end of therapy
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Needles taped to the skin in the same acupoint without any electricity
Category
Treatment - Other
2
Description
The electro-acupuncture was carried out in the menopause acupoint
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecological Clinics of Kerman
Full name of responsible person
Masoumeh Nakhei
Street address
Kashani Hospital, Abohamed Street
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman Islamic Azad University
Full name of responsible person
Dr. Kazemipour
Street address
First Kilometers of Jopar Road, Islamic Azad University
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman Islamic Azad University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman Islamic Azad University
Full name of responsible person
Afsar Foroud
Position
Lecturer of Midwifery
Other areas of specialty/work
Street address
Kerman Islamic Azad University- Frst Kilometer of Jopar Road
City
Kerman
Postal code
7618644941
Phone
+98 34 1244 5335
Fax
+98 34 1321 0051
Email
foroud@iauk.ac.ir afsarforoud@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Islamic Azad University
Full name of responsible person
Afsar Foroud
Position
Lecturer of Midwifery
Other areas of specialty/work
Street address
Islamic Azad University
City
Kerman
Postal code
7618644941
Phone
+98 34 1244 5335
Fax
+98 34 1321 0051
Email
afsarforoud@yahoo.comforoud@iauk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman Islamic Azad University
Full name of responsible person
Afsar Foroud
Position
Lecturer of Midwifery- Academic membership
Other areas of specialty/work
Street address
Kerman Islamic Azad University- First Kilometer of Jopar Road
City
Kerman
Postal code
7618644941
Phone
+98 34 1244 5335
Fax
+98 34 1321 0051
Email
foroud@iauk.ac.irafsarforoud@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)