| ObjectiveTo evaluate the clinical curative effect of Tongxieyaofang Decoction on irritable bowel syndrome. And according to the comparative analysis of the effect, so as to provide a preliminary basis for the indiacations optimization of this prescription in treating IBS.MethodsTo carry out the clinical observation of using Tongxieyaofang Decoction to treat IBS that embedded "different classification and individual factors", the IBS patients who comply with the implementation of individualized treatment of traditional Chinese medicine received the treatment of Tongxieyaofang Decoction. They took the medicine twice a day, the treatment courses were 4 weeks, and at the same time, the patient get health education. We design different classificaions and individual factors and make prospective observation, evaluate the curative effect of Tongxieyaofang Decoction in treating IBS patients, collect patients’data, and establish the database. In summary, based on the efficacy analysis, further analysis of the efficacy of different etiology/predisposing factors, the main symptoms, condition assessment, disease evaluation TCM information and other related factors.ResultsClinical characteristics and curative effect were observed in 52 cases of patients with IBS. Overall, the score of IBS symptom severity scale (IBS-SSS) and IBS quality of life scale (IBS-QOL) decreased in different degree after the treatment. Before treatment IBS-SSS score was 225.1+79.2, after treatment IBS-SSS score was 161.7+83.5, compared with before treatment with statistical difference (P<0.05).29 patients responded to IBS-SSS(55.8%), the responder rate of AR was 61.5%, and 11 patients responded to IBS-QOL (21.2%). The anxiety subscale score of Hospital Anxiety and Depression Scale (HAD) had no obvious change after the treatment. The score of anxiety subscale decreased slightly (baseline, scores after treatment were 7.4±3.3、7.2±3.2). Acorrding to the individual analysis that embedded in " different classification and individual factors", IBS-SSS responders with "abdominal distension" factors were significantly less than the proportion of non responders (P=0.038), AR responders with "dietary factors" (P=0.037), "disease/staging" (P=0.040), "abdominal distension" (P=0.040) etc. The proportion was significantly lower than non responders; IBS-QOL responders with "endless sense" factors such as the proportion was significantly lower than non responders (P=0.017). It indicates that these factors has a greater likelihood of response to the interventions.ConelusionThe result of prospective observation of clinical curative effect of Tongxieyaofang Decoction showed that there were 29 and 32 patients responded to IBS-SSS and AR respectively. This study indicates that Tongxieyaofang decoction has a good therapeutic effect on IBS. Except to the syndrome of "liver stagnation and spleen deficiency", Tongxieyaofang can also play a good effect on the treatment of "weakness of the spleen and stomach " and "damp abundance due to spleen asthenia". It means that this prescription can treat other syndromes. Tongxieyaofang can significantly improve IBS patients’stool, reduce patient defecate frequency, relieve abdominal distention symptoms. And it also has certain effect on constipation-predominant IBS. This prescription is safe and effective,no adverse effects were found.By statistical analysis, we can find the influencing factors for the different indicators. By carrying out "effect'intervention' object characteristics" analysis, we compare the difference between the effective and ineffective group of people, in response to the group level on the basis of effectiveness, be sub-group/individual level indications refinement and positioning, and finally achieve the optimal indications for clinical research to improve the efficiency, effectiveness and lay the foundation to facilitate clinical practice. |
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