Electro-acupuncture for Menopausal Transition Symptoms
22 de octubre de 2015 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
90
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100053
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 55 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Electro-acupuncture Group
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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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Comparador de placebos: Sham Electro-acupuncture Group
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change of Average 24 h Hot Flash Score From Baseline
Periodo de tiempo: week8;wee4,20,32
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change of MRS (Menopause Rating Scale) From Baseline
Periodo de tiempo: week8;wee4,20,32
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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
Periodo de tiempo: 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
Periodo de tiempo: 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 FSH/LH From Baseline
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Zhishun Liu, Doctor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2013
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
7 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2015
Publicado por primera vez (Estimar)
15 de junio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
23 de noviembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
22 de octubre de 2015
Última verificación
1 de octubre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2012BAI24B01-012
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