The Clinical Characteristics Of Gastrointestinal Damp-heat Functional Constipation And The Curative Effect Of Light Vegetarian Intervention

BackgroundGastrointestinal damp-heat syndrome is a crucial type of functional constipation(FC),including the heat more than damp subtype(stools are characterized by dryness and hardness,which is typical constipation)and the damp more than heat subtype(stools are characterized by sticky,which is atypical constipation).So far,the clinical characteristics of FC are inconsistent due to different inclusion criteria,research methods,and the studies about atypical constipation are rather few due to insufficient recognition.Diet is closely related to functional constipation.At present,it is commonly recognized that foods of affluent dietary fiber and water are beneficial to constipation,including vegetables,fruits,whole grains and so on.Contrarily,food that is spicy and stimulated,deep-fried,barbecued,dry-fried may be involved in the pathogenesis of constipation by affecting the intestinal nervous system,intestinal flora and their metabolites,intestinal mucosal inflammatory state,etc.However,the effect of high-protein,high-fat food including meat,eggs and milk on constipation is controversial.In previous studies,our team found that light vegetarian diet combined with drugs can significantly improve the symptoms of gastrointestinal damp-heat FC and maintain curative effect.At present,the treatment of FC is still dominated by drugs.No matter in traditional Chinese medicine(TCM)or western medicine,the dependence,side effects and economic burden caused by drug treatment are serious.It’s important to change the diet!Light vegetarian diet is a set of healthy plan summarized by my tutor according to the theory of Chinese and Western medicine combined with many years of clinical experience.The plan advocates to increase the intake of vegetables,fruits and grains rich in dietary fiber and vitamins,and reduce the intake of high protein,high fat and over processed food prone to oxidative damage.In previous studies,we found that the combination of light vegetarian diet and drugs can significantly improve the symptoms of FC of gastrointestinal damp-heat syndrome,and the effect can be maintained by diet alone,but there is no more credible and objective evidence to prove it.Objectives1.To obtain the clinical characteristics of FC with gastrointestinal damp-heat syndrome and impact factors of two subtypes through analyzing relevant data2.To evaluate the effect of light vegetarian diet on FC with gastrointestinal damp-heat syndrome and the supplementary effect to the drugs.MethodsThe First Study:A total of 135 patients were included in the outpatient and inpatient of the department of Gastroenterology and the department of TCM Digestive Diseases in China-Japan Friendship Hospital,of which 87 were typically constipated and 48 were atypically constipated.All the patients enrolled have signed the informed consent form and then filled in a questionnaire to provide general information(including gender,age,etc.)and clinical data(including the history data,dietary questionnaire in the past year,Self-Rating Anxiety Scale(SAS),Self-Rating Depression Scale(SDS),Pittsburgh Sleep Quality Index(PSQI),The Patient Assessment of Constipation Quality of Life(PAC-QQL),Spontaneous Bowel Movements(SBM)and Complete Spontaneous Bowel Movements(CSBM)per week,character of stool rating scale,constipation-related symptom rating scale,TCM syndrome rating scale,gastrointestinal dynamic tests including 48-hour Gastrointestinal Transmission Time(GITT)and High Resolution Anorectal Manometry(HRAM)).All data were processed and analyzed by SAS 9.4 softwareThe Second Study:This was a randomized,placebo-controlled,clinical trial.There were 2 subtypes of gastrointestinal damp-heat FC those were typical constipation and atypical constipation.All patients enrolled had signed informed consent form and then be characterized as typical constipation subtype or atypical constipation subtype according to the classification of TCM.They were allocated randomly after completing the questionnaire and gastrointestinal dynamic tests(including 48-hour GITT and HRAM).Each subtype was divided into 4 groups at 1:1:1:1 ratio:drug(Forlax for typical constipation and the herb powder for atypical constipation)+diet intervention group,diet intervention+placebo(the Forlax placebo for typical constipation and the herb powder placebo for atypical constipation)group,drug group and placebo group(the following comparisons are in this order).The diet intervention was light vegetarian.The drugs and placebos were taken 1 bag each time,twice a day,half an hour after breakfast and dinner.All the patients recorded a designed dairy during the intervention.The treatment period lasted for 28 days,and the patients were followed up by the researchers on the 14th and 28th day respectively.The gastrointestinal dynamic tests were requested after 28 days.The primary outcome was CSBM per week,and the second outcomes were stool character score,constipation-related symptom score,TCM syndrome score and gastrointestinal motility results.In addition,safety outcome and compliance outcome were included in this study.All collected data were analyzed by SAS 9.4.This study had been approved by the Clinical Research Ethics Committee of China-Japan Friendship Hospital,No.2017-46-1ResultsThe Fisrst Study1.The gender partiality of patients with gastrointestinal damp-heat FC was mainly female(73.33%).The main age was from 41 to 60 years old(39.26%).The median duration of the disease was 10.0(5.0,20.0)years,and the duration of typical constipation was longer than that of atypical constipation.(P=0.02)2.Most of the patients with gastrointestinal damp-heat FC had a history of using laxatives in the past 3 months(74.07%).The numbers of SBM and CSBM per week are lower than normal for both two types of constipation,and there were no significant differences between the two types.The stool character score of atypical constipation was significantly lower than that of typical constipation(P<0.0001),and the incompleted evacuation score was significantly higher than that of typical constipation(P=0.00),while the scores of straining defecation,manual facilitated defecation,no sense of defecation,anorectal obstruction,anal pain or a burning sensation,anorectal dilatation had no difference compared with those of typical constipation.The score of belching in TCM syndrome of atypical constipation was higher than those of typical constipation,but there were no differences between the two types of constipation in abdominal distention,reducted diet,fatigue and weakness,nausea and vomiting,difficulty in defecation,tongue and pulse score3.Most patients of gastrointestinal damp-heat FC were mild anxious(60.00%).There was no significant difference between the two types of constipation in sleep quality and its components score,total score of constipation quality of life including physiological score,social psychological score and satisfaction score,but the anxious score of atypical constipation was higher than that of typical constipation(P=0.04)4.48-hour GITT:The barium excretion rate(%)of atypical constipation was higher than that of typical constipation[57.50(12.50,97.50)vs 10.00(0.00,55.00),P=0.00];the composition ratio of slow transit constipation was lower than that of typical constipation(70.45%vs 87.36%,P=0.02),and the residual rate(%)within rectosigmoid colon was significantly lower than that of typical constipation[5.00(0.00,37.50)vs 50.00(5.00,75.00),P<0.0001].HRAM:There was no significant difference in the results of two types of constipation.Pathophysiological classification:Mixed constipation was the most common type of both two types of constipation,and a significant difference between the two types of classification composition ratio was existed(83.91%VS 70.45%,P=0.04).5.Patients of typical constipation eat more meat and drink more water.The results of multivariate logistic regression analysis showed that the factors influencing the two types of constipation were the amount of meat intake,the score of stool character and the residual rate of barium within rectosigmoid colon,which were positively correlated with typical constipationThe Second Study1.A total of 135 patients(87 cases of typical constipation and 48 cases of atypical constipation)who met the inclusion criteria in the Department of Gastroenterology and the Department of TCM Digestive Diseases in China-Japan Friendship Hospital from January 2017 to January 2020 were selected.124 patients who agreed to be randomly allocated went into Full Analysis Set(FAS)(84 cases of typical constipation and 40 cases of atypical constipation).3 cases were withdrew and 4 cases were lost of follow-up in typical constipation subtype,while 1 case was withdrew in atypical constipation subtype.116 cases(77 cases of typical constipation and 39 cases of atypical constipation)completed the study and went into Per Protocol Set(PPS).2.The baseline data comparison of four groups in each type of constipation:There were no significant differences among the 4 groups in general information,the history data,CSBM per week,the constipation-related symptom scores and TCM syndrome scores.3.Primary outcome:The effective rate of CSBM per week for 28 days intervention of typical constipation and atypical constipation in drug(Forlax/the herb powder)+diet intervention group,diet intervention+placebo(Forlax placebo/the herb powder placebo)group and drug group(Forlax/the herb powder)group were higher than that in placebo group.The therapeutic effect of drug+diet intervention had better trends than drug or diet intervention,but there was no statistic difference among the three groups.The average number of CSBM per week in typical constipation and atypical constipation was significantly increased in the other three groups except for the placebo group after intervention4.Second outcomes:①The stool character score of the 4 groups were significantly decreased after the 28-days interventions in typical constipation;There were no differences of the scores after interventions of 4 groups in atypical constipation.②The constipation-related symptom scores of 4 groups after intervention were significantly decreased in typical constipation and those of other 3 groups except for placebo were significantly decreased in atypical constipation,and there was a significant difference among the 4 groups in improvement ratio in both two types of constipation as well.③After intervention,the TCM syndrome scores of the 4 groups in both two types of constipation were all decreased,and the improvement rate of the 4 groups showed a difference in typical constipation and at 28 days in atypical constipation.④Diet intervention+placebo group could increase the excretion rate of barium of both two types of constipation and decrease the residual rate within rectosigmoid colon of typical constipation;Forlax+diet intervention group could increase the excretion rate of barium and decrease the residual rate above the rectosigmoid colon in typical constipation;the herb powder group could increase the excretion rate of barium and decrease the residual rate of above and within rectosigmoid colon in atypical constipation.⑤Diet intervention+placebo group could increase the anal relaxation rate and anal resting pressure of atypical constipation,and increase the defecation feeling of both two types of constipation;Forlax+diet intervention group and Forlax group could increase the anal relaxation rate of typical constipation;the herb powder group could increase the anal relaxation rate of atypical constipation.5.One case of adverse event occurred in Folax+diet intervention group and Forlax group respectively,which were mild abdominal pain and diarrhea.One case of adverse event occurred in placebo group of atypical constipation,which was upper abdominal fullness.6.The composition ratio of high compliance with dietary intervention was 57.89%on 14 days and 28 days for typical constipation of PPS,53.33%on 14 days and 66.67%on 28 days for atypical constipation of PPS,respectively.Conclusions1.Most patients with gastrointestinal damp-heat FC were middle-aged,female,with mildly anxious and of mixed constipation,who had laxative in the past 3 months.There were significant differences in diet,stool character and gastrointestinal transmission function between the two types of constipation.2.Forlax and the herb powder with the effect of clearing heat and descending adverse flow of Qi have a positive effect on typical constipation and atypical constipation respectively.The light vegetarian diet can improve therapeutic effect of gastrointestinal damp-heat FC with the increase efficacy to drugs,and it has high treatment compliance,but large sample sizes are needed to verify it.