| ObjectiveThis randomized controlled clinical trial intends to discuss the clinical effect of Traditional Chinese Medicine cyclic therapy (CT for short) on treating Menstruation delay, and provide scientific basic for the clinical application of it.MethodsThe objects in January2011to November2011in Taiwan of traditional Chinese medicine clinics late menstruation patients. Are the clinic patients. Clinical study design using randomized controlled experiment method, the participants will be qualified to:the ratio of distribution to treatment with a control group. Each group of45patients. Looking at an object can be in hospital and clinic patients, outpatient cases shall be strictly controlled variable factors. Cases using simple random method group. Specific randomized allocation methods clinical study by researchers through the operation SAS (statistical analysis system) software that random Numbers, and made into random distribution CARDS, add the envelope seal, the envelope with the same serial number card serial number. Qualified into test cases, according to the into the order of, to open the same envelope number, according to the provisions of the envelope card group for treatment. Random number table according to the requirements to be saved. The control group therapy methods:the pure Chinese herbal medicine treatment method, the principle for liver and kidney function, raise blood to regulate the menstrual function. Based on free and unfettered scattered and party. Drug composition:radix10grams, angelica10grams, the root of herbaceous peony10grams, white atractylodes10grams, poria cocos10grams, dodder12grams, renewal12grams, broken containing10grams, sweet with10grams, mint5g, roasted liquorice5grams. Along with the card use:with blood and astragalus, dangshen hand; And phlegmy wet block adds the sprouting, dried tangerine or orange peel, cangzhu; And cold empty adds the cinnamon, with the sheep. Fry the potion take a daily agent, morning and evening each, from menstrual cycle fifth day began to use, to the menstrual cramps for a period of treatment. The treatment group:ChuFu the traditional Chinese medicine with cycle economy by the treatment, a periodic therapy as follows:(1) the1, with the late party (left to pills and four things tonga minus):cultivated land, medlar, radix morindae officinalis, every10g, BaiFang12g, yam, angelica, dogberry, danshen, poria cocos every15g, dodder30g.7agent.(2) with oviposit period2party (abital yan Pope tonga minus): cultivated land, medlar, peachseed every10g, faeries spleen, danshen every12g, raspberry, CheQianZi, each15g semen wei son.7agent.(3) in the early3party (two fairy decoction and eight Jane tonga minus):angelica, tuckahoe, danshen every15g, largehead atractylodes rhizome, JiXieTeng each30g, the sweet, faeries spleen with all12g, radix morindae officinalis,10g.7agent.(4) period with4party (biochemical tonga minus):angelica24g, river xiong, nut, every10g beef shanks, motherwort, danshen every15g, the sweet with12g, liquorice6g.7agent. Fry the potion take a daily agent, morning and evening each, a menstrual cycles for a period of treatment. During the tests, shall not use the other healing drug therapy. A menstrual cycles for a period of treatment, total view:three treatment was. Each group before and after treatment according to the requirements in to fill out the observation table, after treatment for outcome. Watch project:clinical symptoms:menstrual cycle after wrong and menstrual quantity, color, a qualitative change, fundamental temperature changes, along with the change of the symptoms, the change of the tongue veins. Adverse reaction:record the whole body and local adverse reactions. Clinical outcome:curative effect index=[(before treatment after a treatment integral points) make before treatment;*100%points. Well:after treatment, the integral reduce)95%, menstrual cycles and menstrual quantity, color, mass are back to normal, fundamental temperature is duplex, other symptoms disappeared, withdrawal of three menstrual cycle without recurrence after, or pregnancy. Powerfully:after treatment, the integral reduce)70%, menstrual cycle after wrong7to10days, the rest of the symptoms disappeared or loss. Effective:after treatment,30%more points lower, menstrual cycles>10days after wrong, but has significantly shortened, the rest of the symptom is reduced. Invalid:after treatment, the integral is reduced to before treatment of integral<30%, menstruation still wrong, no obvious shorten, other symptoms without the change. The ZhouXiaoGuo evaluation standard:well: menstrual cycle back to its original state, stopped taking the drug after three menstrual cycle without recurrence. Powerfully:menstrual cycles seven to10days after the wrong, the marking down two grades, not to reach zero. Effective: menstrual cycles>10days after the wrong, the marking down a level, not to reach zero. Invalid:menstrual cycles are still wrong, without significantly shortened, score no decline. Fundamental temperature curative effect evaluation standard:well:fundamental temperature single phase or not by typical dual phase into a duplex. Effective:fundamental temperature by a single not typical dual phase. Invalid:fundamental temperature without significantly improved determination. After the clinical research, clinical material with Epi Data3.01software in statistical analysis. In two groups of clinical treatment effect, the total clinical symptoms and signs efficacy analysis and comparison of the statistics, and finally an objective evaluation of clinical curative effect and its safety. Statistical methods: classification material with2inspection, level with two sample data comparison Wilcoxon rank and inspection (correct), two sample mean differences with more t test or Wilcoxon rank and inspection, compared with before and after their matching t test or Wilcoxon matching rank and inspection. The statistical analysis SPSS17.0statistical software, statistical graphics using Graphd Prism4.03draw.ResultsThe study participants were qualified to90. The treatment group in45cases; The control group in45cases; All for the clinic patients. Two groups of age composition more, the difference was not statistically significant (P>2inspection,0.05). Two groups of average age composition more, the difference was not statistically significant (P>0.05, t test). Hint two groups are comparable age. The treatment group course the shortest five months, the longest six years; The control group course the shortest4months, the longest5years. Two groups of course is, the difference was not statistically significant. Two groups of age at menarche comparison, the difference was not statistically significant. Two groups of illness after Wilcoxon rank and inspection, no statistical significance difference. Two groups of patients with symptoms of traditional Chinese medicine total score is, the difference was not statistically significant. Comparable. Two groups of patients before treatment after menstruation wrong, scanty periods, the dark purple color with piece, menstrual period of lubricious weak, thin waist sour abdominal pain and so on TCM symptoms comparison, no statistically significant difference between the difference, with comparability. The two groups before treatment situation is more fundamental temperature, the difference was not statistically significant. The two groups before treatment serum sex hormones ESH(follicle-stimulating mature grain), LH (luteinizing), E2(estradiol), T (testosterone) test the situation is more, before treatment serum sex hormones FSH (mlU/ml), LH (mlU/ml), PRL (ng/ml), E2(ng/ml), T (nmol/L) two groups of comparisons, the difference was not statistically significant. The two groups before treatment have45examples of gynecological examination, not found combined other diseases.The treatments two groups comparable testing results show that the two groups age, duration, illness, basic body temperature, the main symptoms of serum sex hormones, gynecology inspection comparison, there are no significant differences between the significance, indicating that the two groups of comparable.Two groups of traditional Chinese medical syndrome is the total curative effect, the difference was statistically significant (rank material the rank of and examine, P<0.05). The curative effect of treatment group was better than control. The two groups before and after treatment total score more symptoms, the t test, two groups before and after treatment were total score more symptoms very significant difference (P<0.01), between the two groups before treatment total score is no significant difference (P>0.05), after1.reatment, the total score more symptoms very significant difference (P<0.01). Two groups of the week is curative effect, the difference was statistically significant. The curative effect of treatment group was better than control. Two groups of menstrual wrong, menstrual quantity is little, after the dark purple color with piece, menstrual period of lubricious weak, thin waist sour abdominal pain and so on TCM symptoms is efficient, the chi-square test, the (?)reatment group the clinical symptoms improved more, the difference was statistically significant (P<0.05); The same symptoms compared between groups, the treatment group in improving after menstruation wrong, scanty periods with the symptoms such as compared with a statistically significant (P<0.05).The two groups after treating fundamental temperature improved (healed: fundamental temperature single phase or not by typical dual phase into a duplex, effectively:fundamental temperature by a single not typical dual phase; invalid:fundamental temperature was obviously improved. No) Comparison, two groups after treating fundamental temperature is improved, the difference was statistically significant (P<0.05). The two groups after treating fundamental temperature comparison, the difference was statistically significant (P<0.05). Among them, the group has14people BBT back to normal, after often rate%, group of10people BBT back to normal, after often rate%. Two groups of complex rate quite often, the chi-square test, the difference was statistically significant (P<0.05). Two groups before and after treatment serum sex hormones FSH (follicle-stimulating mature grain), LH (luteinizing), PRL (prolactin), E2(estradiol), T (testosterone) change detection, the two groups before treatment more, the difference was not statistically significant. The treatment group and control is in the way, a statistically significant difference were. The two groups after treating comparison, the difference was not statistically significant. Two groups after treatment three conventional, liver and kidney function, electrocardiogram safety index such as testing, the results compared with before treatment without change. Two groups of treatment cure period all did not appear adverse reaction symptoms. ConclusionFree and unfettered wulingsan and combination therapy menstrual cycle period of clinical curative effect is distinct, can be effectively treated the late period, and can significantly improve the clinical symptoms, his own good adjustment of the menstrual cycle and overall adjustment function, the curative effect of treatment group was better than control. Two groups of treatment cure period all did not appear adverse reaction symptoms. Clinical application security, a popular value.CT can treat Menstruation, delay and ameliorate the correlate symptom through its good effect of adjusting menstrual cycle and regulating the body as a wholel and it's safe in clinical application. |
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