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Efficacy Of Electroacupuncture For Symptoms Of Menopausal Transition:A Randomized Controlled Trial

Posted on:2016-11-07Degree:DoctorType:Dissertation
Country:ChinaCandidate:R S DuFull Text:PDF
GTID:1224330464955952Subject:Acupuncture and Massage
Abstract/Summary:PDF Full Text Request
BackgroundThe menopausal transition (MT) means the period from the trend to menopause which reflected in the clinical characteristics, endocrine and biological aspects, to the final menstrual period. MT marks the loss of ovarian function and the female reproductive function. MT is the stage before the final menstrual period of perimenopause. There are many studies on the stage of menopause transition, the generally recognized study is STRAW (Stages of Reproductive Aging Workshop) According to the symptoms appearing during different phases of the MT, it can be divided into two phases:the’early MT’which has variable cycle length(more than 7 days from the typical length) and the’late MT’, characterized by at least two skipped cycles and at least one period of amenorrhea exceeding 60 days. Hot flashes are the most commom symptoms. Other symptoms include anxiety, depress, sleep disturbances, dizziness, palpitation, fatigue, vaginal dryness, dyspareunia, urinary infections, etc. All these symptoms will disturb women’s normal life.In ancient books of traditional Chinese medicine, there is not a particular na me describing MT. However, according to the specific symptoms of MT, MT can be attributed to the category of the following diseases, "zangzao", "yuzheng", "nianlaoxuebeng", "benglou" "linzheng", "irregular menstruation", "insomnia", "baihebing" and so on. In modern times, traditional Chinese medicine has named MT as"juejingqianhouzhuzheng", "jingduanqianhouzhuzheng". The main pathogenesis of symptoms associated with MT is the kidney deficiency, meanwhile, three main organs are often affected:heart, liver and spleen.Hormone therapy (HT) is the recommended therapy for women with symptoms related to menopause, but there may be long-term risks for increasing the morbidities of breast cancer, endometrial carcinoma and oophoroma. So there is a need to find other therapies that can treat symptoms of MT. acupuncture has been widely used in the treatment of menopausal symptoms, but high quality literature is rare.ObjectiveThe objective is to evaluate the efficacy of electroacupuncture (EA) on meno pausal transition (MT) symptoms, which would be helpful for clinicians to make clinical decisions.MethodsA large-scale multicenter, single-blinded, randomized controlled trial was conducted. The stratified and block random method was used. The center was the factor of the stratification. The patients who met the standards were randomly assigned to electroacupuncture (EA) group and sham EA group with a proportion of 1:1. A total of 180 patients were collected from 6 research centers with 30 patients per center. During the experiment, the patients, the outcome reviewers and the statisticians were blinded, only the treatment operators knew the group of the patients.The EA group received EA with needling at ST25、BL26、Zigong and SP6, while the sham EA group received sham EA with non-penetrating needling at sham acupoints beside the acupoints mentioned aboved. The wires of electric acupuncture apparatus in the sham EA group have been cut, so the electric acupuncture apparatus in the sham EA group just looked like normal ones, while they didn’t work. Interventions were given 30m every time, three sessions a week for 8 weeks. A 24-week long follow-up was conducted.The primary outcome was the change in the MRS score at the 8th week from baseline. The secondary outcomes included changes in the mean 24-h hot flash score (1-week sum score evaluated at the 4th,8th,20th, and 32nd week), MENQOL(at the 4th, 8th,20th, and 32nd week), and FSH, LH, FSH/LH, and E2 (at the 8th and 20th week) compared with baseline and subgroup analysis stratified by the stage of MT. Besides, the safely of EA was also assessed.Results1. The primary outcome, the decrease of the MRS score measured after 8 weeks’ treatment:The MRS score in EA group was 18.00(8.00)at baseline, and was 12.00(8.00)after 8-weeks’ treatment, reduced by 7.00 (6.50) from the baseline. The MRS score in sham EA group was 17.50(8.50) at baseline, and was 13.00(12.00) after 8-weeks’ treatment, reduced by 3.00 (5.00) from the baseline. The decrease in EA group was larger than that in the sham EA group.2. The decrease of the mean 24-h hot flash score and MENQOL score measured at the 4th,8th,20th and 32nd week; the decreases in EA group were all larger than lhat in the sham EA group.3. EA group is better than sham EA group on the improvement of FSH、E2、FSH/LH after 8 weeks’treatment and on the improvement of FSH、E2、LH at the 20th.4. Subgroup analysis:The decrease of MRS score from the baseline to the 4th,8th, 20th and 32nd week in EA group was equal to that in sham EA group in the early stage of MT, while the decreases were larger in EA group than that in sham EA group in the subgroup of late stage of MT.5. Patient compliance:176 patients have completed the experiment, while 4 patients haven’t.98.13% of the patient compliance was observed in in EA group and 99.03% in sham EA group. There is no significant difference between the two groups.6. Safety analysis:The adverse events seldom occurred in both groups, with an incidence of 7.87% in EA group and 2.22% in sham EA group. There was no report of severe adverse event.ConclusionsElectroacupuncture is effective in treating MT symptoms, excluding placebo effect. EA shows not only a good short-term effect but also a long-term effect which can last 24 months. The MRS score, the mean 24-h hot flash score and the MENQOL score were all improved by EA. Meanwhile, electroacupuncture can partly adjust the hormones, which means it can decrease the FSH level and increase the E2.
Keywords/Search Tags:Electroacupuncture, menopausal transition (MT), randomized controlled, placebo control, sham electroacupuncture, multicenter
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