Clinical trial NCT02471755: Electro-acupuncture for Menopausal Transition Symptoms
Official title: A Randomized Pilot Study of Electro-acupuncture for Menopausal Transition Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: electro-acupuncture
menopause
menopausal transition symptoms
efficacy
RCT
placebo control
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Participants meeting the following criteria were included in study:

  1. 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.);
  2. Aged from 40 to 55 years old;
  3. Pregnancy test was negative;
  4. Participants were informed about the study and signed a consent form voluntarily.

     Exclusion Criteria:
* Participants with any of the following criteria were omitted from the study:

  1. 3 month regular cycle length before enrollment;
  2. Took drugs for treatment in past month like estrogen, soybeans isoflavone, SSRIs, progestin, black sesame or vitamin E;
  3. Ovarian and uterine disease: ovarian cyst, uterine myoma more than 4cm in diameter, history of ovariectomy or hysterectomy;
  4. Willing or plan to become pregnant or to breast-feed;
  5. Regular took sedatives or anxiolytics;
  6. Habitual smoker or heavy alcoholic;
  7. 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).

Primary outcomes:
measure: Change of Average 24 h Hot Flash Score From Baseline
timeFrame: week8;wee4,20,32
Secondary outcomes:
measure: Change of MRS (Menopause Rating Scale) From Baseline
timeFrame: week8;wee4,20,32
measure: Change of FSH From Baseline
timeFrame: week8,week20
measure: Change of LH From Baseline
timeFrame: week8,week20
measure: Change of FSH/LH From Baseline
timeFrame: week8,week20
measure: Change of E2 From Baseline
timeFrame: week8,week20
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: