| Objective: To evaluate the efficacy of Tongfu Kuanzhong Decoction in the treatment of functional constipation(FC)of spleen deficiency and Qi stagnation syndrome complicated by anxiety and/or depression and its effect on colonic electrical activity,and to further explore the mechanism of Tongfu Kuanzhong Decoction in the treatment of FC associated with anxiety and/or depression,in order to provide a theoretical basis for the diagnosis and treatment of this disease with traditional Chinese medicine.Methods: A total of 64 patients who met the inclusion criteria of FC spleen deficiency and qi stagnation syndrome with anxiety and/or depression in the outpatient department of Spleen and Stomach Disease of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine from November 2020 to December 2021 were selected and randomly divided into the experimental group(Tongfu Kuanzhong Decoction)32 cases and control group(lactulose combined with Shugan Jieyu Capsule)32 cases.The experimental group was given Tongfu Kuanzhong Decoction orally,200 ml twice/d,the control group was given lactulose orally,20 ml once/d,combined with Shugan Jieyu Capsule orally,2 capsules per time,2 times/d.The course of treatment was4 weeks.Observation and evaluation of TCM syndrome score,Patient Assessment of Constipation Symptoms(PAC-SYM)score,7-tiem Generalized Anxiety Disorder Scale(GAD-7)score,Patient Health Questionnaire(PHQ-9)score,and the intestinal electrical activity parameters before and after treatment were detected,and the intra-group and inter-group comparisons were made.The adverse drug reactions of the two groups were observed and recorded for safety evaluation.Results: During the study,2 cases in the experimental group dropped out,a total of 30 patients completed the clinical study.2 cases in the control group dropped out,a total of 30 patients completed the clinical study.1.There is no statistical difference between two groups of patients in General information(gender,age),TCM syndrome score,PAC-SYM scale score,GAD-7 score,PHQ-9 score,colonic electrical activity parameters before treatment,(P>0.05).2.The efficacy of TCM syndromes:The total effective rates of the experimental group and the control group were 86.7% and 80%,respectively.The cure rate of the experimental group was 26.7%,the significant rate of curative effect was 70%,and the effective rate was 16.7%.The cure rate of the experimental group was 6.7%,the significant rate of curative effect was 56.7%,and the effective rate was23.3%.The cure rate of the experimental group was significantly better than that of the control group(P<0.05).There was no statistical difference in the total effective rate,significant rate and effective rate between two groups of patients(P>0.05).3.The total score of TCM syndromes:The two groups of patients after treatment were significantly decreased in terms of the total score of TCM syndromes(P<0.01).After treatment,the experimental group was significantly better than the control group(P<0.01).4.TCM main symptoms points:In terms of defecation effort,uncomfortable defecation,dry stool,and abdominal distension,the two groups of patients were significantly decreased after treatment compared with before treatment(P<0.01).There was no statistical difference in defecation effort,uncomfortable defecation,dry stool.(P>0.05).In terms of abdominal distension,the experimental group was better than the control group(P<0.05).5.TCM secondary disease points:In terms of depressed and irritable mood,fatigue after defecation,fatigue and lazy speech,lack of appetite and anorexia,and fullness in the chest and flank,the two groups of patients had different degrees of decrease after treatment compared with before treatment(P<0.01,P<0.05).The experimental group was significantly better than the control group in different degrees in depressed and irritable mood,fatigue after defecation,fatigue and lazy speech,lack of appetite and anorexia,and fullness in the chest and flank(P<0.01,P<0.05).6.PAC-SYM points:In terms of the total symptom scores and the three-dimensional scores of fecal symptom scores,abdominal symptom scores,and rectal symptom scores,the two groups of patients were significantly decreased after treatment compared with before treatment(P<0.01).There was no statistical difference between the experimental group and the control group in terms of fecal symptom scores(P>0.05).The experimental group was significantly better than the control group in different degrees in the total symptom scores,rectal symptom scores and abdominal symptom scores(P<0.01,P<0.05).The scores of the symptoms of hard feces and decreased feces were significantly decreased in both groups after treatment(P<0.01).There was no statistical difference between the experimental group and the control group after treatment in terms of hard feces and decreased feces(P>0.05).The scores of the symptoms of stomachache,abdominal pain and abdominal distention were significantly decreased in both groups after treatment(P<0.01).After treatment,the experimental group was better than the control group in terms of stomachache,abdominal pain and abdominal distention(P<0.05).The scores of decreased defecation,defecation effort,defecation pain,uncomfortable defecation,defecation intention is difficult to discharge,rectal bleeding or tearing,rectal burning sensation were decreased in different degrees after treatment in the two groups(P<0.01,P<0.05).Compared with the control group,there was no statistical difference between the experimental group and the control group in decreased defecation,defecation effort and uncomfortable defecation(P>0.05).In terms of defecation pain,defecation intention is difficult to discharge,rectal bleeding or tearing,rectal burning sensation,experimental group was better than the control group in different degrees(P<0.01,P<0.05).7.GAD-7 score,PHQ-9 score:In terms of GAD-7 and PHQ-9 scores,both of two groups were significantly decreased in both groups after treatment(P<0.01).There was no statistical difference between the experimental group and the control group in terms of PHQ-9 scores(P>0.05).In terms of GAD-7 scores,the experimental group was significantly better than the control group after treatment(P<0.05).In terms of PHQ-9 scores,there was no statistical difference between the experimental group and the control group after treatment(P>0.05).8.The average amplitude of each lead of the colon:The average amplitudes of each lead in the two groups were significantly decreased in both groups after treatment(P<0.01).There was no statistical difference of the average amplitudes of the descending colonic leads 20 minutes after meals,and the ascending colonic leads and rectal leads 30 minutes after meals between the experimental group and the control group after treatment(P>0.05).Compared with the average amplitudes of other leads at different time points,the amplitudes of the experimental group were significantly higher than those of the control group in different degrees(P<0.05,P<0.01).9.The average electrical frequency of each lead of the colon:The average frequency of each lead in the two groups were significantly increased in both groups after treatment(P<0.01).There was no statistical difference in the average frequency of each lead at each time point between the two groups after treatment(P>0.05).10.Safety assessmentThere were no allergic reactions and serious adverse events in the two groups of patients during treatment and follow-up,and it was safe.Conclusion: Tongfu Kuanzhong Decoction in the treatment of FC of spleen deficiency and qi stagnation syndrome with anxiety and/or depression has obvious clinical curative effect.Not only it strengthens spleen and qi,enhances gastrointestinal motility,improves constipation symptoms effectively and relieves spleen deficiency symptoms such as fatigue and lazy speech significantly,but also it soothes the liver,relieves depression,regulats mental activities and improves abnormal defecation sensation disturbance triggered by psycho-emotional factors in patients.It is a safe and effective method for the treatment of FC of spleen deficiency and qi stagnation syndrome with anxiety and/or depression.Its mechanism may be related to the fact that Tongfu Kuanzhong Decoction up-regulates the intestinal amplitude and intestinal frequency of each intestinal segment of the colon and promotes gastrointestinal peristalsis to adjust the electrophysiology of colonic function. |
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