The Wennberg Stratified Block Randomized, Parallel Subgroup Controlled, Open Trial Of Traditional Chinese And Western Medicine For Gastroesophageal Reflux Disease In Lingnan Area

Objective:The study is to compare the clinical effects of gastroesophagel reflux disease(GERD)treated by syndrome differentiation and treatment of Traditional Chinese Medicine(TCM)or western medicine based on symptoms in LingNan area when using Wennberg stratified blocked,parallel subgroups randomized controlled trial design,and then establish the evidence of evidence-based medicine and form a chinese-treated clinical protocol in LingNan area.Methods:Using Wennberg stratified blocked,parallel subgroups randomized controlled trial design,patients accorded with the inclusion criteria were distributed to 2 groups:preferred group and randomized group,they have the same simple size.Then the 2 groups were distributed to TCM group and western group respectively.TCM group included liver and stomach swelter type and spleen-deficiency and dampness-heat type.Patients of western group were given omeprazole(20mg at every turn,once a day,15 minutes before breakfast)or pantoprazole(40mg at every turn,once a day,15 minutes before breakfast).Patients of liver and stomach swelter type were asked to take Sijunzi Decoction and Zuojin pil,patients of spleen-deficiency and dampness-heat type were medicated with Si junzi Decoction.The course treatment continued 4 weeks.3 observations indexes includes Reflux Diagnostic Questionnaire(RDQ),score of electronic gastroscopy and GRED Patients Outcome(PRO)were recorded before and after treatment.Finally,analyzing all the indexes between western group and TCM group,including the 2 subgroups belong to TCM group,then to make a more objective and accurate clinical efficacy and establish an advanced clinical protocol in LingNan area.At the course of the treatment,safety inspections and adverse events will be recorded.Results:(1)The study included 129 cases who accorded with the inclusion criteria,65 cases in western group and 64 cases in TCM group,the subgroups of TCM group both had 32 cases,respectively.There was no statistically significant difference(P>0.05)among gender and age,hence all the groups were comparable.(2)The main outcome measures with RDQ as the evaluation criteria,to calculate its 4 symptoms score,all the groups were statistically significant(P<0.05)before and after treatment,there was no statistically significant difference(P>0.05)except for Chest Pain Non-Cardiac.(3)The secondary outcome measures were econdary symptoms score and GRED-PRO.As for econdary symptoms score,total effective rate of TCM group was 79.69%,total effective rate of western group was 78.46%,it was showed that the total effective rate of TCM group was higher than that of western group,but the difference was not statistically significant(P>0.05).As for GRED-PRO,intra-group comparison:comparing the score of TCM group before and after treatment,the differences were statistically significant(P<0.05)except for medicine aspect,when comparing the score of western group before and after treatment,the differences were statistically significant(P<0.05)except for spirit and form aspect,pain and discomfort aspect and medicine aspect.Group comparison between them showed no significant difference(P>0.05).(4)Before and after treatment found no abnormal test items in blood routine,urine routine,stool routine and liver and kidney function.Both groups had no adverse event.Conclutions:The study aims to evaluate the efficacy of GERD treated by syndrome differentiation and treatment of TCM or western medicine based on symptoms in Lingnan area,through the study we can draw the following conclusions:(1)From the aspect of the efficacy comparison of TCM group,western group and 2 subgroups before and after treatment,there was definite clinical effect on alleviating the symptoms,improving life quality and reducing econdary symptoms score treated by syndrome differentiation and treatment of TCM or western medicine based on symptoms under the theories of TCM and western medicine,however,both the two ways to treat GERD have their own deficiencies.(2)From the aspect of the efficacy comparison between TCM group and western group after treatment,compare with western medicine,TCM had a advantage on reducing Chest Pain Non-Cardiac,but they were equal to alleviate other symptoms and improve life quality.With regard to econdary symptoms score,the total effective rate of TCM group was higher than that of western group,but there was no evidence to prove TCM is better then western medicine,it urge us that more studies on large sample are needed to be carried out.