| Objective:Menopause mood disorders is prominent and typical symptoms of menopause women, serious impact on the patient’s quality of life, at present the research hotspots focus on menopausal depression symptoms, the treatment is currently a lack of standardized, and hormone therapy (HT) and selective 5-HT reuptake inhibitors (SSRI), antidepressants and other functions of the central nervous system drugs are used, including antidepressants and antipsychotic drugs as first-line drugs are widely used for the treatment of depression. However, due to the adverse reaction of drugs itself limits its popularization and application. And traditional Chinese medicine, including traditional/replacement therapy for menopausal transition mood disorders research increasingly, but overall, the literature, there are few number, and because the problems such as research quality, cause there is no high level clinical evidence to support the clinical efficacy of traditional Chinese medicine. Belongs to psychosomatic disease related to mood disorders, menopause group always USES the psychosomatic word+modern treatment of traditional Chinese medicine (TCM) of traditional Chinese medicine treatment of the disease have achieved good clinical effect, in order to further confirm with psychosomatic therapy on the efficacy and safety of the disease, on the basis of previous study, the psychosomatic development scheme of TCM (traditional Chinese medicine and modern therapy of traditional Chinese medicine) and pure Chinese medicine treatment of moderately severe mood disorders, menopause syndrome, adopts GREENE menopause scale, SDS and SAS scale, safety index, and the evaluation of the adverse reactions to observe the efficacy and security of the treatment of traditional Chinese medicine.MethodsNational multicenter, randomized, controlled trial was adopted to design, include is given priority to with moderately severe mental nerve symptoms of menopause syndrome women and 144 cases were randomly divided into Chinese medicine treatment group and psychosomatic syndrome differentiation of traditional Chinese medicine, Chinese medicine of traditional Chinese medicine treatment group given free decoction granules, psychosomatic syndrome differentiation of traditional Chinese medicine group on the basis of traditional Chinese medicine decoction granules free treatment, at the same time to give modern treatment of traditional Chinese medicine. Compare the effectiveness of the psychosomatic development of traditional Chinese medicine and simple Chinese medicine therapy, and security. Effectiveness is mainly through Greene menopause scale, SDS and SAS score evaluation. Safety evaluation is mainly three routine, liver and kidney function, blood lipids, ultrasound, ecg and adverse reaction of department of gynaecology and adverse events, etc. Treatment for 2 months, followed up for 1 month, first diagnosis, treatment of 4 weeks,8 weeks, follow-up time 1 month after treatment. Each point observation scale indicator in evaluating the effect of index, before and after treatment and follow-up time for all laboratory testing.Results1. The scale analysis:before and after the treatment in the two groups after treatment GREENE scale scores, and a decrease of each group to compare differences were statistically significant (P<0.05); The two groups after treatment of SDS scale total score and each dimension score decreased, within each group before and after treatment comparison difference had statistical significance (P<0.05); Two way SAS scale total score decreased after treatment, each group before and after treatment comparison difference had statistical significance (P<0.05), suggesting psychosomatic development of traditional Chinese medicine, Chinese traditional medicine group have very good treatment effect.2. Each scale between the observation point total analysis:GREENE scale score t inspection/rank and analysis results indicate:both the scale of total difference has no statistical significance (P> 0.05), comparable. (first visit to eight weeks) in the treatment cycle score psychosomatic group of traditional Chinese medicine and Chinese medicine group were significantly lower, total score line chart suggests two groups begin to eight weeks decreased, and the falling faster psychosomatic development of traditional Chinese medicine treatment group decreased slightly larger, but the comparative differences between groups have no statistical significance (P > 0.05), explain psychosomatic development of traditional Chinese medicine treatment group and Chinese traditional medicine group. Follow-up (eight weeks to 12 weeks) two sets of scores is eight weeks continued to decline, prompt withdrawal treatment last two groups, but the psychosomatic development of traditional Chinese medicine group, the treatment group decreased, the difference between the two groups was statistically significant (P<0.05), explain psychosomatic development of traditional Chinese medicine treatment group is superior to the traditional Chinese medicine group. SDS scores of independent samples t test/rank and inspection results indicate:both the scale score differences between the two groups have no statistical significance (P> 0.05), comparable. (new to eight weeks) in the treatment of cycle psychosomatic development of traditional Chinese medicine and Chinese medicine group total score were significantly decreased. Line chart prompt primary-care to drop around, and drop quickly, four weeks to eight weeks fell a bit slow, psychosomatic development of traditional Chinese medicine treatment group decreased slightly in the Chinese traditional medicine group, but there was no statistically significant difference between groups compare (P> 0.05). Follow-up for 12 weeks (8 weeks) psychosomatic development of traditional Chinese medicine and Chinese medicine group total score than eight weeks with continued to slow down, prompt treatment last after the drug was stopped, psychosomatic development of traditional Chinese medicine is Chinese traditional medicine group decreased slightly larger, PP and ITT analysis results, because PP containing fall off cases, missing value alternative, less results close to the real situation, so choose PP chi-chi analysis results. Therefore, comparing differences between groups were statistically significant (P<0.05). SAS scores of independent sample t test/rank and inspection results indicate:both the SAS scores in the two groups there was no statistically significant difference (P> 0.05), comparable. (new to eight weeks) in the treatment of cycle psychosomatic development of traditional Chinese medicine and Chinese medicine group total score were significantly decreased. Line chart prompt primary-care to eight weeks decreased, and drop rapidly. Psychosomatic development of traditional Chinese medicine treatment group decreased slightly in the Chinese traditional medicine group, but there was no statistically significant difference between groups compare (P> 0.05). Follow-up (12 weeks) total score is eight weeks fell slightly, prompt treatment last after the drug was stopped, psychosomatic development of traditional Chinese medicine is Chinese traditional medicine group decreased, PP and ITT analysis results are inconsistent, due to the PP set analysis does not include the loss in case of missing value alternative, less results close to the real situation, so choose PP collection of analysis results. Therefore, comparing differences between groups were statistically significant (P<0.05).Conclusion1. Traditional Chinese medicine and psychosomatic development scheme can effective treatment in TCM symptoms of menopause mood disorders, before and after treatment group differences were statistically significant.2. in patients with moderately severe mood disorders, psychosomatic development of traditional Chinese medicine treatment the curative effect of menopause mood disorders from pure Chinese medicine more has the advantage of integrity and stability. Chinese medicine for patients with moderately severe psychosomatic development group, although in many scale difference is compared between group had no statistical significance, but in the curative effect of curve prompt psychosomatic development efforts on the improvement of the symptoms have a tendency to is better than that of pure traditional Chinese medicine treatment, especially in the treatment of 8 weeks and follow-up. In addition, psychosomatic pathogenesis treatment also reflected in the body symptoms improved and the advantage of curative effect is superior to the pure Chinese traditional medicine group during the follow-up period.3. The psychosomatic development scheme of traditional Chinese medicine treatment for menopause anxiety symptoms have more advantages:the study conclusion the psychosomatic development to the outstanding effect of anxiety symptoms improve. Psychosomatic development scheme for the treatment of menopausal symptoms of anxiety provides an efficient, standardized, safety, high adherence method. |
PDF Full Text Request