MenopauseNCT02471755
Electro-acupuncture for Menopausal Transition Symptoms
A study testing Eelectro-acupuncture in people with Menopause, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Eelectro-acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants meeting the following criteria were included in study:
- Had a diagnosis of MT (cycle length irregularity: 7 days earlier or later than usual, the last menstruation was no longer than 11 month earliar over the previous year; Specific symptoms of MT: hot flashes, night sweating, insomnia, sexual problems, anxiety, depression etc.);
- Aged from 40 to 55 years old;
- Pregnancy test was negative;
- Participants were informed about the study and signed a consent form voluntarily.
Who cannot join
- Participants with any of the following criteria were omitted from the study:
- 3 month regular cycle length before enrollment;
- Took drugs for treatment in past month like estrogen, soybeans isoflavone, SSRIs, progestin, black sesame or vitamin E;
- Ovarian and uterine disease: ovarian cyst, uterine myoma more than 4cm in diameter, history of ovariectomy or hysterectomy;
- Willing or plan to become pregnant or to breast-feed;
- Regular took sedatives or anxiolytics;
- Habitual smoker or heavy alcoholic;
- Severe disease: history of radio-chemotherapy, coagulation disorders, severe dysfunction of liver or kidney, application of cardiac pacemaker or artificial joints, insufficiency controlled hypertension, diabetes, thyroid diseases, malignant tumor and psychiatric problems).
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
About this study
Official title: A Randomized Pilot Study of Electro-acupuncture for Menopausal Transition Symptoms
This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms.
Read the detailed description
This was a RCT pilot study to assess the efficacy of Electro-acupuncture for menopausal transition participants.90 patients were randomly assigned to electro-acupuncture or sham electro-acupuncture group with a ratio of 1:1.During the whole process,all participants, evaluators and statisticians apart from acupuncturists remained strictly blinded.The changes of average 24 h hot flash scores of week8 from baseline was set as primary outcome. With statistical power of 90%, and a two-sided α at 0.05, as well as a drop-out rate less than 20%, sample size was estimated at 90 participants. Data analysis was based on ITT principles, and 89 participants were included in data analysis(1 participant didn't want to participate).According to methods of LOCF, missing data were imputed to fill any gaps according to the last visit. For comparison between baseline and treatment (average 24h hot flash scores, MRS, hormone levels), data was tested by the t test or nonparametric test; for comparison between two independent samples, data were tested with t test, nonparametric test or X2 test. P<0.05 was regarded as statistically significance.
- Conditions
- Menopause
- Being tested
- Eelectro-acupuncture, Sham Eelectro-acupuncture
- Keywords
- electro-acupuncture, menopause, menopausal transition symptoms, efficacy, RCT, placebo control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eelectro-acupunctureDevice
The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
Sham Eelectro-acupunctureDevice
Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
| Study group | Role | What they receive |
|---|---|---|
| Electro-acupuncture Group | Active comparator | Not described Receives: Device: Eelectro-acupuncture |
| Sham Electro-acupuncture Group | Placebo comparator | Not described Receives: Device: Sham Eelectro-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Average 24 h Hot Flash Score From Baseline
Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe. Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.
Measured: week8;wee4,20,32
Secondary outcomes (5)
Change of MRS (Menopause Rating Scale) From Baseline
MRS(Menopause Rating Scale) was designed to measure MT symptoms and to explore the influences on life qualities in a standardized way. In MRS, symptoms such as impaired memory, depression, insomnia, sweating, hot flashes, nervousness, joints complaints, lack of concentration were evaluated and calculated in numbers to describe the situation of patient. Scores on MRS range from 0 to 44, with higher scores indicating more severe symptoms.
Measured: week8;wee4,20,32
Change of FSH From Baseline
Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
Measured: week8,week20
Change of LH From Baseline
Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
Measured: week8,week20
Change of FSH/LH From Baseline
Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
Measured: week8,week20
Change of E2 From Baseline
Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
Measured: week8,week20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaoxuliu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Doctor, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471755
- Sponsor's protocol ID
- 2012BAI24B01-012
- Status last verified
- Oct 2015
- First submitted
- 7 Jun 2015
- Last updated
- 23 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of Electro-acupuncture for Menopausal Transition Symptoms
- ClinicalTrials.gov ID
- NCT02471755
- Acronym / sponsor ID
- 2012BAI24B01-012
- Conditions
- Menopause
- Keywords
- electro-acupuncture, menopause, menopausal transition symptoms, efficacy, RCT, placebo control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Posted 23 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms.
Detailed description
This was a RCT pilot study to assess the efficacy of Electro-acupuncture for menopausal transition participants.90 patients were randomly assigned to electro-acupuncture or sham electro-acupuncture group with a ratio of 1:1.During the whole process,all participants, evaluators and statisticians apart from acupuncturists remained strictly blinded.The changes of average 24 h hot flash scores of week8 from baseline was set as primary outcome. With statistical power of 90%, and a two-sided α at 0.05, as well as a drop-out rate less than 20%, sample size was estimated at 90 participants. Data analysis was based on ITT principles, and 89 participants were included in data analysis(1 participant didn't want to participate).According to methods of LOCF, missing data were imputed to fill any gaps according to the last visit. For comparison between baseline and treatment (average 24h hot flash scores, MRS, hormone levels), data was tested by the t test or nonparametric test; for comparison between two independent samples, data were tested with t test, nonparametric test or X2 test. P<0.05 was regarded as statistically significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electro-acupuncture Group | Active comparator | Device: Eelectro-acupuncture |
| Sham Electro-acupuncture Group | Placebo comparator | Device: Sham Eelectro-acupuncture |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants meeting the following criteria were included in study:
Key exclusion criteria (8 listed)
- Participants with any of the following criteria were omitted from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eelectro-acupunctureThe bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes. | Device | Electro-acupuncture Group |
| Sham Eelectro-acupunctureNon-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group. | Device | Sham Electro-acupuncture Group |
Primary outcome
Change of Average 24 h Hot Flash Score From Baseline
Time frame: week8;wee4,20,32
Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe. Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.
5 secondary outcomes
Change of MRS (Menopause Rating Scale) From Baseline
Time frame: week8;wee4,20,32
Change of FSH From Baseline
Time frame: week8,week20
Change of LH From Baseline
Time frame: week8,week20
Change of FSH/LH From Baseline
Time frame: week8,week20
Change of E2 From Baseline
Time frame: week8,week20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu, Doctor principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eelectro-acupuncture in people with Menopause, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Average 24 h Hot Flash Score From Baseline (time frame: week8;wee4,20,32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.