TCM Drug Treatment Of Gastroesophageal Reflux Disease Randomized Controlled Clinical Observation

Objective:Through a randomized, controlled clinical trial, which is using the pattern identification of TCM or omeprazole in the treatment of gastroesophageal reflux disease(GERD), to observe the pattern identification of TCM in improving the clinical symptoms of GERD, the quality of life, and the safety.Method:Qualified patients were randomly assigned either treatment group using TCM treatment or control group using omeprazole. The patients of treatment group will take the appropriate Chinese medicine decoction100ml to150ml at every turn, two times per day,30minutes after the meal. The patients of control group were given omeprazole,20mg at every turn, two times per day,15to30minutes before the meal. The treatment continues8weeks. The socres of GERD symptons and36-Item Short Form Survey (SF-36) of the2groups before and after the treatment will be recorded. The main outcome measures were assessed by main symptoms of GERD, the secondary outcome measures were assessed by the secondary symptoms score of GERD and SF-36. Before and after treatment, safety inspections and adverse events were recorded during the test. After the treatment, compile all the information and establish a database for statistical analysis.Result:179cases were included in the efficacy analysis,91cases in the treatment group and88cases in the control group. There is no statistically significant difference (p>0.05) among gender, age and body mass index, hence the2groups are comparable.The main outcome measures with RDQ as the evaluation criteria, to calculate the total score and its4symptoms score. Intra-group comparison:compare the score before and after the treatment, the differences were statistically significant (p<0.05). Group comparison between them showed no significant difference (p>0.05).The secondary outcome measures were divided into two parts. The one is econdary symptoms score. Intra-group comparison:compare the score before and after the treatment, the differences were statistically significant (p<0.05). Group comparison between them showed no significant difference (p>0.05). The other one is SF-36:compare the score, the treatment group before and after treatment in eight dimensions difference had statistical significance (p<0.05); the control group had no statistical significance except "PF" outside (p=0.063>0.05), the rest had statistical significance (p<0.05). Group comparison between them showed no significant difference (p>0.05).The cured and markedly effective rate was48.35%in the treatment group and48.86%in the control group, and with no significant difference between the two groups (p>0.05).Before and after treatment found no treatment-related abnormal test items in blood routine, urine routine, stool routine, liver and kidney function and ECG. The treatment group had1case of adverse events, has nothing to do with the treatment of drugs. The control group had no adverse events.Conclusion:The pattern identification of TCM can significantly alleviate the clinical symptoms of GERD patients, particularly in terms of improving the quality of life is better than omeprazole in the treatment and it has good safety. So we can draw a conclusion that the pattern identification of TCM treatment of GERD is safe and effective, and should be widely applied.