A Clinic Study Of KT And LFB Capsule On Climacteric Syndrome Through Randomized Controlled Trial

Menopause is a physiological phenomenon in natural proceeding, whichleads to many systematical changes on genitourinary system,cardiovascular system, skeletal system, nervous system etc. The changesaffect severely physical and mental health and quality of life ofmenopause women. With the coming of the aging society, the number ofmenopause women are increasing and the span of postmenopausal longevityis extending. Women will pass through their out 1/3 life in thepostmenopause. Therefore, prevention and treatment on climactericsyndrome have become an important medical course in the whold. Hormonereplacement therapy (HRT) can relieve and prevent a series of climactericsigns and symptoms, and retain and improve health status and quality oflife on the climacteric women. People pay close attention to it day byday, Modern medical science mainly adopts the substituting treatment ofthe climacteric syndrome. But the side effect is unable to get rid of,so it is difficult to be accepted by the women, there is certain limitationin its application.Traditional Chinese medicine treatment of the climacteric syndromehas already been launched for many years in clinic, it can improve theclinical symptom and has no obvious side effects. A large of researcheson small samples indicate: Chinese medicine is therapeutic and safety.However, We need large samples and rigorous projection to testify theconclusion about traditional Chinese medicine treatment of theclimacteric syndrome.Research objective: Making clear the effect and safty of KT capsuleand LFB capsule in the treatment of the climacteric syndrome, we design a multicentre, large sample, random-controlled and double-blind clinicaltrial. This research is drafted through the clinical scientific researchdesign method, which can appraise its clinical curative effect furtherand more safty. All this will provide scientific evidence for traditionalChinese medicine treatment of the climacteric syndrome.Content of research: Choose patient as the research object who isaccording with the diagnostic standard of climacteric syndrome, includedstandard, excluded standard. And divide them into two groups at random,including the Chinese medicine group and the placebo group. Among theChinese medicine group, the ShenYinXu use KT capsule and the Shenyangxuare offered LFB capsule. Among the placebo group, the ShenYinXu use KTplacebo capsule and the Shenyangxu are offered LFB placebo capsule. Allthe choosen patients are interved for there months and follow-up visitedafter a month. Separately observe the influence that KT capsule and LFBcapsule acted on women who have climacteric syndrome on the index suchas Kupperman's grade, Menopause-Specific Quality of Life's grade,Menopause Rating Scale of TCM and safety index: heart rate, blood pressure,blood routine, urin- routine, sed- routine, EKG, ALT,Cr,BUN, breast andgynecology supersound. At the same time, infaust events and adverseeffects will be observed, recorded and reported.Result of research: 345 eligible subjects have been collected, 174in Chinese medicine group and 171 in placebo group. Among the Chinesemedicine group, there are 139 in the Shenyinxu group and 35 in theShenyangxu group. Among the placebo group, there are 140 in the Shenyinxugroup and 31 in the Shenyangxu group. 23 entrolled subjects didn'tcomplete the clinical trial, incling 14 in the Chinese medicine groupand 9 in placebo group. The baseline of two groups, such as age, culturedegree, drug treatment, complicated disease and the grade of KI etc. werecomparable. There weren't statistics significance between twogroups. To testify the effects of the two kind of Chinese medicinecapsule, we choose many kinds of tese methods, including t-test, analysisof covariance, repeated measure. Result of research of the three scalesindicate: in the Chinese medicine group, there are significatedifferencecs in the whole course (P＜0.05), but there are no significatedifferencecs between the two groups in the whole course (P＞0.05). there happens 9 infaust events in the clinical trails, including 5 in theChinese medicine group and 4 in the placebo group. No evidences testifythe outcomings caused by capsules.Conclusion: Menopause Rating Scale of TCM is more sensitivity andIntegrity in evaluating therapeutic effect than the other two scales.However, the studydosen't show the superiority about traditional Chinesemedicine. The traditional Chinese medicine have some advantages fortreating patients. Therefore, we will move forward a single step toidentify the principle of the outcoming.