N/A
N=90
Electro-acupuncture for Menopausal Transition Symptoms
Menopause
Bottom Line
View on ClinicalTrials.gov: NCT02471755 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Change of Average 24 h Hot Flash Score From Baseline — -2.29; -0.71; -0.78; -0.71 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Eelectro-acupuncture (Device); Sham Eelectro-acupuncture (Device)
- Age
- Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Average 24 h Hot Flash Score From Baseline |
-2.29; -0.71; -0.78; -0.71; -2.43; -1.14 | — |
| SECONDARY Change of MRS (Menopause Rating Scale) From Baseline |
-4.00; -6.00; -1.50; -4.00; -6.00; -5.00 | — |
| SECONDARY Change of FSH From Baseline |
-1.90; 0.70; -1.69; 1.93 | — |
| SECONDARY Change of LH From Baseline |
-2.58; 0.99; -0.66; 0.79 | — |
| SECONDARY Change of FSH/LH From Baseline |
0.10; -0.01; 0.06; -0.01 | — |
| SECONDARY Change of E2 From Baseline |
2.92; 0.40; 13.75; 2.43 | — |
Summary
This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT02471755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.