| Background:Gastroesophageal reflux disease (Gastroesophageal reflux disease, GERD) is defined by the stomach contents into the esophagus or above parts, into the mouth (including pharyngeal symptoms or complications or lungs), the main clinical manifestations included heartburn, reflux. Since Proton pump inhibitors (Proton pump, inhibitors, PPI) appearing, it has become the main treatment in GERD. But even high doses of PPI (2 times daily treatment for 12 weeks or 8 weeks) treatment can’t relieve all of the symptoms of GERD, there are still part of the patients, whose the symptoms relieve less than 50 percent, were reported in the literature both at home and abroad in recent years. It was known as refractory gastroesophageal reflux disease (RGERD).Because of the symptoms are difficult to recover and recidivation, it had influenced the quality of life in patientsWhene it comes to the treatment of RGERD, the Western Medicine Study focus on the optimization of PPI therapy, combining with gastric mucosal protective drugs or gastrointestinal motility drugs, and some study prove that anxiolytic drugs also play a important in the treatment of RGERD, therefore, we can’t ignore the influence between the Psychological factors and the RGERD. But the short effect, stopping to recur, the time and dose of anxiolytic drugs is unknown, long-term acid suppression therapy resulted in bad consequences, all of these trapping the western medicine treatment of RGERD. At present, a large number of clinical studies proved that traditional Chinese medicine treatment has a good curative effect for the GERD, but few reports about the RGERD. Therefore, to explore the clinical efficacy and the influence on quality of life with Chinese medicine treatment in RGERD; to observe the correlation between psychological factors and RGERD, which is very important to improve the quality of life in patients with RGERD, and has a great significance in improving the TCM treatment of RGERD.Objective:To provide the reference for the future study of TCM in the treatment of RGERD by exploring the relationship between the life quality, symptom improvement and psychological factors of RGERD patients.Methods:Outpatients aged 18-70 years old diagnosed as RGERD with stagnation heat of liver and stomach syndrome from the first affiliated hospital of Guangzhou university of Traditional Chinese Medicine, the time is from February 2015 to January 2014,were investigated by prospective cohort analysis. While entering the group, the patients were basically medicated with Sijunzi Decoction and Zuogui pill and Sini powder (mainly composed of radix pseudostellariae, atractylodes, poria cocos, liquorice, peony, fructus aurantii immaturus, bupleurum root, perilla stem, rhizoma coptidis), and clinically treated with addition and subtraction, for example:increasing ka take, bile star, talc and calamus for those with damp-heat syndrome; increasing the rhubarb, and gardenia for those with hot severe and dry stool; increasing aloes, lignum dalbergiae and odoriferae for those with heavy belch; increasing pericarpium trichosanthis and bulbus allii macrostemi for those with chest tightness; increasing pinellia and magnolia off icinalis and perilla leaf for those with throat blockage; increasing concha arcae and charcoal of gardenia for those with heavy pantothenic acid; increasing calcined magnet, yejiao vine, albizia flowers for those with insomnia. In addition, patients who were dignosed with mild, moderate anxiety were medicated with flupentixol and melitracen tablets (Dailixin) according to the standard of SAS score. The course of of treatment is 12 weeks and 4 observation indexes mainly composed of the total score of gastroesophageal reflux disease questionnaire (GerdQ) and TCM symptoms quantitative grading scale for the patients prior treatment, 4-week,8-week and 12-week treatment. The test results can be quantitatively explored by repeated measures analysis of variance, and qualitatively explored by K paired samples of non parametric test method.Results:Observations on 50 cases of RGERD patients with stagnation heat of liver and stomach syndrome were accomplished.1. The variation of GerdQ score. The GerdQ score of prior treatment,4-week treatment,8-week treatment and 12-week treatment, which was difined as no significant heartburn, reflux symptoms or significant symptoms improvement while less than 8, were analyzed by K paired samples nonparametric test method. The statistical result showed that the percentage of GerdQ scores which were less than 8 in prior treatment, 4-week,8-week and 12-week treatment were 0%,30%,48% and 80%. In the Friedman test, the mean rank were 3.29,2.69,2.33 and 1.69, and the chi-square value was 77.015, which means the results were significantly different (P<0.001, P<0.05).2. The variation of TCM symptoms grading scale score at each time point.The total scale score, the primary symptom score and the secondary symptom score were analyzed by repeated measures analysis of variance method. The total curative effects for each time point and partial symptom curative effects were analyzed by K related samples nonparametric test method.2.1 The variation of total score. Before treatment (19.06+4.714), treatment for 4 weeks (14.16+3.593), treatment for 8 weeks (10.06+3.419), treatment for 12 weeks (6.16+2.817), And the Statistics suggest that the score is different at each time point, and the difference is statistically significant (P< 0.001, P< 0.05).2.2 The variation of main symptom score.Before treatment (10.12+2.600), treatment for 4 weeks (7.30+2.375), treatment for 8 weeks (4.90+2.023), treatment for 12 weeks (2.72+21.938), And the Statistics suggest that the score is different at each time point, and the difference is statistically significant (P< 0.001, P< 0.05).2.3 The variation of Secondary symptoms score.Before treatment (8.94+2.758), treatment for 4 weeks (6.86+2.277), treatment for 8 weeks (5.16+2.074), treatment for 12 weeks (3.44+1.831), And the Statistics suggest that the the score is different at each time point, and the difference is statistically significant (P< 0.001, P< 0.05).2.4 The variation of total efficiency and main symptom efficiency.After treatment for 4 weeks,8 weeks and 12 weeks, the total effect were: 38%,96%,100%. The heartburn symptoms improvement rate were:54%,82% and 96%. c reflux symptoms improvement rate were:54%、82%、96%. The retrosternal pain symptoms improvement rate were:48%、78%、96%. And the Statistics suggest that the rate is different at each time point, and the difference is statistically significant (P< 0.001, P<0.05).3. The variation of Zung self rating anxiety scale (SAS) score.The statistical results showed that, there were 17 patients (34.0%) without obvious anxiety symptoms prior treatment (SAS score< 50),21 patients (42.0%) with mild anxiety (SAS score 50-60), and 12 patients (24%) with moderate anxiety (SAS score 61-70). After 4 weeks of treatment, the number of patients without anxiety and with mild, moderate anxiety were 20 (40.0%),19 (38.0%), 11 (22.0%), in which 3 patients were cured from mild to no anxiety, and only 1 patient were cured from moderate to mild anxiety. After 12 weeks of treatment, the number of patients without anxiety and with mild or moderate anxiety were 31 (62%),16 (32%),3 (6%). In the Friedman test, the mean rank were 2.93, 2.77,2.29 and 2.01, and the chi-square value was 46.724, which means the results were significantly different (P<0.001, P<0.05).4. The variation of scores of GERD module in spleen and stomach disease PRO scale used in evaluation of clinical efficacy of TCM.The total scores corresponding to 4 domains with 8 facets of the scale were analyzed by repeated measures analysis of variance method. Among of which, the scores aere prior treatment (52.1333+8.7807),4-week treatment (47.4888 +7.0110),8-week treatment (43.5629+5.8817) and 12-week treatment (40.8963 +4.9158), the score for each time point were significantly different (P< 0.001, P<0.05). In the mean difference comparison, values of prior treatment and 4-week treatment,4-week and 8-week treatment,8-week and 12-week treatment were 4.644,3.962,2.667, in which the maximum mean difference was between prior and 4-week treatment. The results were consistent with the variation of total score, the primary symptom score and the secondary symptom score in TCM symptom grading scale. In the variation of scores of 4 domains, apart form 8-week treatment (46.20+133.384) and 12-week treatment (46+ 12.289), which had no significant difference between scores (P=0.844, P> 0.05), the others were explored by multivariable analysis and inspection, leading to a significant difference (P=0.844, P> 0.05). In the variation of scores of 8 facets, the social relationship between prior treatment (67.8666+7.7007) and 4-week treatment (67.4666+7.9271) had no significant difference (P=0.322, P< 0.05); the medical treatment betwee prior treatment (57.9999 +16.2882) and 4-week treatment (57.5999+15.6932) had no significant difference (P=0.322 P> 0.05). The others in each time point were significantly different (P< 0.05).Conclusion:1. Chinese medicine is of great important significance in improving the symptom of heartburn, reflux and retrosternal pain in RGERD patients with stagnation heat of liver and stomach syndrome, experscially for the heartburn and retrosternal pain.2. Only partial RGERD patients are with anxiety symptom.3. The combining with Chinese medicine and Deanxit is of great important significance in treatment of RGERD patients with mild anxiety; and patients with moderate anxiety can only be relieved instead of elimination.4. Chinese medicine treatment is important to improve the life quality of patients with RGERD... |
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