Clinical Effectiveness And Safety Of Acupuncture In The Treatment Of Diarrhea-type Irritable Bowel Syndrome

Research BackgroundIrritable Bowel Syndrome(IBS)is a common functional bowel disease characterized by frequent episodes of abdominal pain accompanied by changes of bowel habits,with a history of more than 6 months and persistent symptoms in the past 3 months.According to the Rome Ⅳ,irritable bowel syndrome is divided into four subtypes:constipation type,diarrhea type,mixed type and unclassified.The incidence of irritable bowel syndrome in China is about 15%,and IBS-D is the most common,accounting for about 74.1%of patients diagnosed with IBS.IBS-D lacks the pathological structural changes and abnormal biochemical indicators that lead to symptoms,and modern medicine has not yet defined the pathogenesis of the disease.Most scholars believe that the disease may be related to abnormal gastrointestinal motility,high-sensitivity state of internal organs,dysbacteriosis and intestinal inflammation,cerebrointestinal interaction disorders,and mental and psychological disorders.It is proposed that abnormal gastrointestinal motility is an important pathogenesis of this disease,while the high sensitivity of internal organs is at the core of the pathogenesis.There is currently a lack of specific drugs to cure the disease.Western medicine treatment is mainly for intestinal-related symptoms treatment,often can only temporarily relieve the degree of symptoms,and there is a need for an effective treatment.Evidence-based Guidelines in Europe,Denmark,Korea,the United States,and Hong Kong agree on diet and exercise therapy to improve overall symptoms in patients,but there is no agreement on specific drugs for the treatment of IBS-D.Foreign guidelines and consensus opinions recommend pitivium bromide as the commonly used antispasmodic drug for the treatment of IBS-D.However,Western medicines can only temporarily alleviate some symptoms,and long-term use has drawbacks.Therefore,there is an urgent need to explore a treatment for irritable bowel syndrome that is both safe and effective and has few adverse reactions.Diarrhea-type Irritable Bowel Syndrome(IBS-D)is very similar to "diarrhea",so it belongs to the category of "diarrhea" of traditional Chinese medicine.Traditional Chinese medicine external treatment has rich experience in the treatment of diarrhea,and has many advantages.Among them,there have been traditional Chinese medicine texts that have discussed acupuncture therapy for the treatment of diarrhea.Among them are the basic principles of the treatment of diseases and the principle of treating internal organ disease evidence.These are one of the important bases for the treatment of this disease in later generations.Chinese medicine attaches importance to the rational prescription medicine,and acupuncture attaches importance to the rational prescription points.Professor Han Biying,an old expert at Guang’anmen Hospital of China Academy of Chinese Medical Sciences,has accumulated rich clinical experience in the treatment of spleen and stomach diseases,has his own unique treatment ideas,and has achieved good clinical results.Among them,the theory of"root knot specimen" and "root slip injection" is an important idea of Professor Han Biying in the treatment of internal organ diseases,and the "combined network"acupuncture is a common acupuncture method commonly used by Professor Han Biying,and the spleen,stomach and large intestine are mainly selected in clinical practice.In the ancient texts of Traditional Chinese medicine,there are relevant acupuncture records on acupuncture treatment of diarrhea.It can be seen that in the ancient literature on acupuncture for the treatment of diarrhea,the meridians mostly involve the Foot Yang Ming Stomach Meridian,the Foot Sun Bladder Meridian,the Foot Taiyin Spleen Meridian,the Hand Yang Ming Colon Meridian,the Hand Sun Small Intestine Meridian and the Ren Pulse.And the acupuncture points are mainly concentrated in the selection of specific points.Therefore,a prospective randomized parallel control design was used to verify the effectiveness and safety of acupuncture in the treatment of diarrhea-type irritable bowel syndrome by randomized,place-based targeted photography,the blinding of patients,efficacy evaluators and statistical analysts.Research AimsTo evaluate the clinical effectiveness and safety of acupuncture in the treatment of diarrheal irritable bowel syndrome,and to evaluate the improvement of symptoms and quality of life related to irritable bowel in the two groups.Research Contents80 patients with diarrheal irritable bowel syndrome were randomly divided into two groups,namely the treatment group and the control group,40 cases in each group,respectively,were given conventional acupuncture therapy and placebo needle treatment,and the Irritable Bowel Syndrome-Symptom Severity Scale(IBS-SSS),Bristol Stool Form Scale(BSFS),stool satisfaction score,and Irritable Bowel Syndrome-Quality of Life were recorded in detail before and after treatment and follow-up of the two groups,as well as analyzing the adverse reactions and adverse events after treatment in two groups.MethodsSubjects with diarrheal irritable bowel syndrome were randomly assigned to treatment and control groups on a 1:1 ratio using a prospective randomized parallel control design.Both groups received treatment of 8 weeks and follow-up of 12 weeks without treatment.The primary outcome measure was a change in differential scores for the Irritable Bowel Syndrome-Symptom Severity Scale(IBS-SSS)at pretreatment to week 8.Secondary outcome measures were the scores and the changes of IBS-SSS,BSFS,stool satisfaction,and IBS-QOL at pre-treatment-week 4;the changes of BSFS,stool satisfaction,IBS-QOL and the score of IBS-SSS at pretreatment-week 8;the scores and the changes of IBS-SSS,BSFS,stool satisfaction,and IBS-QOL at pre-treatment-week 20.ResultsCurrently,a total of 80 eligible subjects have been included in this clinical trial,of which 74 patients have completed the collection of outcome indicators related to the treatment cycle.Before treatment,the baseline data of the two groups of patients in terms of sex,age,course,and IBS-SSS score,BSFS score,stool satisfaction score,and IBS-QOL score were balanced and comparable(all P>0.05).After treatment,IBSSSS score in the acupuncture treatment group decreased by 96.50±69.41 points compared with before treatment,and the control group decreased by 65.00±52.58 points,and the difference between the two groups was statistically significant(P=0.025,<0.05).Inter-group comparison of IBS-SSS,the difference was not statistically significant at weeks 4 and 8 between two groups(all P>0.05),and at week 20 of follow-up,the difference was statistically significant(P<0.05).The changes of the IBS-SSS scores at weeks 4 and weeks 20 was statistically significant(both P<0.05).Inter-group comparison of BSFS,the difference was not statistically significant at weeks 4 and 20 between two groups(all P>0.05),and at weeks 8,the difference was statistically significant(P<0.05).The changes of the BSFS scores at weeks 4 and weeks 8 was statistically significant(both P<0.05).The changes of the BSFS scores at weeks 20 was not statistically significant(P>0.05).Inter-group comparison of stool satisfaction,the difference was not statistically significant at weeks 4 and 8 between two groups(all P>0.05),and at weeks 20,the difference was statistically significant(P<0.05).The changes of the BSFS scores at weeks 4 was not statistically significant(P>0.05).The changes of the BSFS scores at weeks 8 and weeks 20 were statistically significant(均 P<0.05).Inter-group comparison of IBS-QOL,the difference was not statistically significant at weeks 4,weeks 8 and weeks 20 between two groups(all P>0.05).The changes of the IBS-QOL scores at weeks 4,weeks 8 and weeks 20 were not statistically significant(all P>0.05).At week 4,week 8,and week 20 of follow-up,the differences of intragroup comparison in IBS-SSS scores,stool satisfaction scores,BSFS scores,and IBS-QOL scores were statistically significant(all P<0.05).Conclusions1 Acupuncture is effective and safe in the treatment of diarrhea-type irritable bowel syndrome,and is worthy of clinical application.2 Acupuncture is effective in improving intestinal symptoms and stool satisfaction in diarrhea-type irritable bowel syndrome,and may has advantages.