The Clinical Study Of TCM In Treating Opioid-induced Constipation

ObjectiveCollecting cases with constipation caused by the use of Opioid for the study, and use Cleveland Constipation Score(CCS) and Quality of Life (QOL) score as primary observed indicators to observe the efficacy of Traditional Chinese Medicine (TCM) dialectical treating Opioid-induced constipation and its influence on quality of life.MethodsAdopting prospective randomized controlled trial research methods, and enrolled40cases met inclusion criteria. All the cases were divided into2groups:treatment group(TCM group)20cases, control group(per os Phenolphthalein Tablets group)20cases. Project for TCM group:with combination of Xiao Cheng Qi Tang and Zeng Ye Tang as basic herb decoctions. And different herbs were added according to different disease patterns:pyrexia type, qi-deficiency type, blood-deficiency type and yang-deficiency type. Project for control group:per os Phenolphthalein Tablets. Use CCS and QOL score as primary observed indicators to observed situation of the two groups after received treatment one week and two weeks. Use SPSS17.0statistics sofeware analyse data and evaluate the curative effect of two groups.ResultsTreatment group pre-treatment and post-treatment compare:compare pre-treatment with post-treatment1week, post-treatment2weeks, the CCS, the score of symptom field, the score of function field and the score of general health field in QOL, all P<0.01, showing significant differences. Compared with pre-treatment, CCS of post-treatment was reduced, suggesting that the condition of constipation was improved after treatment.As QOL,the score of symptom field was decreased after treatment, in function field and the general health field the score increased. Determined in accordance with the EORTC-QLQ-C3O(European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-C30) scale scoring rules, suggesting that status of QOL in symptom fields function field and general health field had been improved after treatment.Compare pain NRS (Numerci Rating Scales) score of pre-treatment with post-treatment1wee、post-treatment2weeks, both P>0.05, no significant difference, suggesting the test drugs had no effect on the analgesic effect of Opioid.Control group pre-treatment and post-treatment compare:compare pre-treatment with post-treatment1week、post-treatment2weeks, the CCS^the score of symptom field in QOL, all P<0.01, showing significant differences. Compared with pre-treatment,CCS of post-treatment was reduced, suggesting that the condition of constipation was improved after treatment. Score of symptom field in QOL was decreased after treatment, suggesting that status of QOL in symptom field has been improved after treatment.Compare pre-treatment with post-treatment1week^post-treatment2weeks, the score of function field and the score of general health field in QOL, all P>0.05, no significant differences. Suggesting that status of QOL in function field and general health field had no improvement after treatment.Compare NRS score of pre-treatment with post-treatment1week、 post-treatment2weeks, both P>0.05, no significant difference, suggesting the test drugs had no effect on the analgesic effect of Opioid.Compare CCS minus score between the both groups:compare CCS minus score of post-treatment1week、2weeks between the both groups, both P<0.01, showing significant difference. CCS minus score in TCM group was more than the control group, suggesting that the degree of improvement of constipation in TCM group was better than the control group.Efficiency of the two groups:after one week’s treatment:the treatment group clinical recovered4cases (20.0%), excel lent11cases (55.0%), effective3cases (15.0%)and ineffective2cases (10.0%), the total effective rate was90.0%. The control group clinical recovered1cases (5.0%), excellent6cases(30.0%), effective10cases (50.0%)and ineffective3cases (15.0%), the total effective rate was85.0%.The two groups Ridit test:P=0.018, P<0.05, showing significant differences, efficiency of the treatment group was better than the control group.After two week’s treatment:the treatment group clinical recovered4cases (20.0%), excellent11cases(55.0%), effective4cases (20.0%)and ineffective1cases (5.0%), the total effective rate was95.0%. The control group clinical recovered1cases (5.0%), excellent6cases(30.0%), effective10cases (50.0%)and ineffective3cases (15.0%), the total effective rate was85.0%.The two groups Ridit test:P=0.010, P<0.05, showing significant differences, efficiency of the treatment group was better than the control group.Conclusion1.Combination of Xiao Cheng Qi Tang and Zeng Ye Tang as basic herb decoctions could effectively treat Opioid-induced constipation.2.TCM was better than per os Phenolphthalein Tablets in improving Opioid-induced constipation.3.TCM could improve status of QOL in symptom fields function field and general health field at the same time when treating Opioid-induced constipation.4. TCM did not affect the analgesic effect of Opioid, and had no significant adverse reactions in the process of treating constipation, it can be a good and safety therapy.