| Background:Functional dyspepsia (FD) is defined by the Rome III consensus as persistent or recurrent pain or discomfort centered in the upper abdomen, without evidence of organic disease. In the past decade, our understanding of functional dyspepsia and its pathophysiology has been extended and it is now incontrovertible that the spectrum of symptoms which characterizes the disorder can be produced by numerous mechanisms. Although the cause of FD is not clear, more and more evidence showed that delayed gastric emptying and psychosocial factors were involved in FD. Successful management of functional dyspepsia remains an elusive goal for gastroenterologists because our advancing knowledge of its pathophysiology has not been paralleled by a burgeoning of appropriately targeted agents. In recent years, Traditional Chinese Medicine (TCM) showed more effective in the management of FD with medicine at the same time.Objective:The purpose of this study was to evaluate efficacy and safety of TCM differentiating treatment, the feature of gastric emptying in FD patients with different TCM Syndromes and the influence of TCM syndrome on radionuclide gastric emptying.Materials and methods:This study was a random, double-blind, multicenter, placebo-controlled clinical study.273cases of FD patients were recruited from China-Japan Friendship Hospital, Dongzhimen hospital and Peking Union Medical College Hospital on2009July to2012August. This study included93males and180females (male to female ratio:1:1.94). Mean age in male was40.1±12.3years and42±12.5years in female. According to differentiation, patients were divided into stagnation of damp-heat syndrome, spleen deficiency and qi stagnation syndrome, liver qi stagnation syndrome and stagnated heat in liver and stomach syndrome, and given corresponding traditional Chinese medicine. Evaluation of efficacy:The score of TCM and west medicine symptoms of baseline,14th day,18th day, third month,6th month was assesed. Radionuclide gastric emptying was evaluated. SPSS16.0was used to analysis intent-to-treat population, population including the per-protocol population, curative effect in the per-protocol population, safety evaluated according to the intention-to-treat population.Results:1Symptom scores evaluation1.1Compared to baseline data:All scores in the stagnation of damp-heat syndrome type in male was significantly higher than other types (P=0.000). Postprandial fullness syndrome score was significantly highest in stagnation of damp-heat syndrome and lowest in stagnated heat of liver and stomach syndrome(P<0.05); the upper abdominal pain symptoms score was highest in liver and stomach heat type compared with other types (P<0.05).1.2Symptom scores and efficiency evaluation(1) Compared symptom scores:TCM integrate score, Western medicine integrate score, postprandial fullness, early satiety, upper abdominal pain, epigastric burning sensation score in treatment group were significantly decreased after14th day(P<0.05). For28th day,3rd month,6th months, western medicine symptom score decreased in treatment group was higher than that of control group (P<0.05). For28th days and3rd month, early satiety score and upper abdominal pain symptom score in treatment group was decreased significantly than those of the control group (P<0.05). For6th month, abdominal pain integral in treatment group was decreased significantly than that in the control group (P<0.05). Efficiency comparison:for14th days of treatment, Western Medicine symptoms in treatment and control had no significant difference. For28th day of treatment,3rd month,6th month, clinical symptoms of western medicine in treatment group was significantly better than that in control (P<0.05). TCM symptom integrate in treatment and controls were14days (65.1%vs55.4%),28days (76.4%vs56.3%),3months (73.6%vs58.9%),6months (72.0%vs59.7%). After adjusting the baseline, different clinical trial centers and different symptoms by covariance analysis, we found no difference of all kinds of score between treatment group and controls in14th day. Western medicine integrate and early satiety scores of28th day and third month improved significantly, and TCM integrate score of6th month decreased significantly(P<0.05).(2) Stagnation of damp-heat syndrome:TCM score, WE score, postprandial fullness score, early satiety score, epigastric pain score, epigastric burning sensation scores were significantly decreased in treatment group after14days treatment(P<0.05). There was no significant difference between the two group and also found after28days,3months,6months(P>0.05). After adjusting the baseline, different clinical trial centers and different symptoms by covariance analysis, no difference was found for all kind of scores in14th day,28th day,3rd month and6th month(P>0.05).(3) Spleen deficiency and Qi stagnation:TCM score, WE score, postprandial fullness score, early satiety score, epigastric pain score, epigastric burning sensation scores were significantly decreased in treatment group after14days treatment(P<0.05). There was significant difference between the two group, and TCM score, WE score were significantly after28days,3months,6months(P<0.05). After adjusting the baseline, different clinical trial centers and different symptoms by covariance analysis, no difference was found for all kind of scores in14th day (P>0.05). TCM integrate score, Western medicine integrate and early satiety scores of28th day and third month improved significantly, and TCM integrate score, Western medicine integrate and upper abdominal pain scores of6th month also was found decreased significantly(P<0.05). (4) Liver qi stagnation syndrome:TCM score, WE score, postprandial fullness score, early satiety score, epigastric pain score, epigastric burning sensation scores were significantly decreased in treatment group after14days treatment(P<0.05). There was no significant difference between the two group and also found after14days,28days,3months (P>0.05). But there was significant difference between the two group, and TCM score, WE score were significantly after6months(P<0.05). Effective percentage of TCM clinical symptoms between treatment group and contr ols:14days (59.4%vs57.4%),28days (71.9%vs54.5%),3months (62.5%vs54.5%),6months (68.8%vs51.5%). After adjusting the baseline, different clinical trial centers and different symptoms by covariance analysis, no difference was found for all kind of scores in14th day,28th day,3rd month and6th month(P>0.05).(5)Stagnated heat in liver and stomach syndrome:TCM score, WE score, postprandial fullness score, early satiety score, epigastric pain score, epigastric burning sensation scores were significantly decreased in treatment group after14days treatment(P<0.05). There was no significant difference between the two group and also found after28days,3months,6months(P>0.05). Effective percentage of TCM clinical symptoms between treatment group and controls:14days (77.4%vs67.7%),28days (86.7%vs76.7%),3rd month (83.3%vs80.0%),6th month (80.0%vs86.7%). After adjusting the baseline, different clinical trial centers and different symptoms by covariance analysis, no difference was found for all kind of scores in14th day,28th day,3rd month and6th month(P>0.05).2Comparison of gastric emptying2.1Comparison of baseline data2.1.1There were46cases (54.8%) with delayed gastric emptying time,38cases (45.2%) with normal gastric emptying time among84cases.2.1.2There was significant difference among different types.(1)There was significant difference among different types in gastric half emptying time: stagnation of damp-heat type gastric half emptying time (100.8±26.7), liver qi stagnation type (140.7±55.3), spleen deficiency and qi stagnation type (134.3±64.6) and stagnation of damp-heat type (118.7±27.4).(2) There was significant difference among different types in gastric emptying rate: stagnation of damp-heat type gastric emptying rate (0.53±0.12) was significantly faster than other types(P<0.05), and there was no significant difference between the other types (P>0.05).(3) There was significant difference among different types in2hours retention rate: stagnation of damp-heat type (37.2±12.8%)was significant lower than liver and stomach qi stagnation (51%±14.7%). stagnation of liver and stomach heat syndrome (46.9%± 11.6%).2.2Comparison of28days treatment in radionuclide gastric emptying:(1) gastric half emptying time more than110min case:there were14cases in treatment group and17cases in the control group. Gastric emptying rate after treatment and2hour gasric residulal rate had significant difference in treatment group and controls (P<0.05). But it showed no significant difference between controls and treatment group (P>0.05).(2)Gastric emptying time less than110min:there were17cases in treatment group and14cases in the control group. But it showed no significant difference between controls and treatment group (P>0.05).(3) Liver qi stagnation syndrome after treatment the emptying rate significantly compared with those before treatment,2hours gastric residual rate significantly decreased than that before treatment (P<0.05).2.3The relationship between Gastric emptying and symptom score changes before and after the treatmentIn gastric half emptying time more than110min group.the changes of gastric emptying rate was associate with the changes of western medicine symptom score and postprandial full score.2hours retention rate reduced degree was associated with the declined degree of symptom score and postprandial full score.3Safety evaluation:There were no serious adverse in both groups.Conclusions:1TCM differentiating treatment on patients with functional dyspepsia was effective and safe. Treatment of spleen deficiency and qi stagnation syndrome was more effective.2. The placebo have certain efficacy to treat FD patient.3Stagnation of damp-heat type appears accelerated gastric emptying function, Spleen deficiency and qi stagnation type and Liver and stomach qi stagnation type appears delayed gastric emptying function.4.TCM differentiating treatment could improve the gastric emptying function of FD patients with delayed gastric emptying.5.Through TCM differentiating treatment, the Improvement degree of function of gastric emptying was associated with the declined degree of symptom score and postprandial fullness score. |
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