Electro-acupuncture for Menopausal Transition Symptoms
22. oktober 2015 oppdatert av: xiaoxuliu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100053
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Electro-acupuncture Group
|
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.
|
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Placebo komparator: Sham Electro-acupuncture Group
|
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change of Average 24 h Hot Flash Score From Baseline
Tidsramme: 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.
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week8;wee4,20,32
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change of MRS (Menopause Rating Scale) From Baseline
Tidsramme: week8;wee4,20,32
|
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.
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week8;wee4,20,32
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Change of FSH From Baseline
Tidsramme: week8,week20
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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.
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week8,week20
|
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Change of LH From Baseline
Tidsramme: week8,week20
|
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.
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week8,week20
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Change of FSH/LH From Baseline
Tidsramme: week8,week20
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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.
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week8,week20
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Change of E2 From Baseline
Tidsramme: week8,week20
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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.
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week8,week20
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Zhishun Liu, Doctor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2013
Primær fullføring (Faktiske)
1. desember 2014
Studiet fullført (Faktiske)
1. desember 2014
Datoer for studieregistrering
Først innsendt
7. juni 2015
Først innsendt som oppfylte QC-kriteriene
10. juni 2015
Først lagt ut (Anslag)
15. juni 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. november 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. oktober 2015
Sist bekreftet
1. oktober 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2012BAI24B01-012
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