Clinical Study On The Efficacy And Safety Of "BianmiTong" In Cancer Patients With Opioid-Induced Constipation

Objective: Constipation is a common adverse effect that occurs when cancer patients take opioid painkillers."BianmiTong" is a Chinese herbal compound preparation developed by the research group,which has long been used in clinical treatment of opioid-induced Constipation OIC in cancer patients.It is intended to evaluate the efficacy and safety of "BianmiTong" treatment Opioid-Induced Constipation in cancer patients through randomized control and extended study.Methods : Randomized control trials were randomized,double-blind,placebo-controlled for 2 weeks,and the extension study was an extended-label trial of 12 weeks.Randomized controlled studies will conform to the OIC diagnosis case(stable taking daily doses of opioids for 2 weeks,and OIC)according to the constipation of syndrome differentiation of traditional Chinese medicine(intestines and stomach heat,stasis and deficiency constipation,Yang deficiency,blood deficiency constipation constipation)to carry on the classification,randomized 1:1 via "BianmiTong" or placebo treatment,usage: 9:00am to give oral 1 times a day via "BianmiTong" 10 g or placebo 10 g treatment.Spontaneous bowel movement(SBM)responders(SBMs 3 or more times a week and an increase of SBMs 1 or more times a week compared to baseline)were observed.The purpose of the extended study was to observe the safety of "BianmiTong" in OIC patients..Results:(1)among the 129 patients in the randomized controlled study,65 patients took "BianmiTong" and 64 patients took placebo.The proportion of SBM responders in the "constipation" group was 72.3%(47/65,95% CI,61.5% ~ 78.5%),and the difference was statistically significant(P<0.0001)compared with 34.4%(22/64,95% CI,23.6% ~ 49.5%)in the placebo group(P<0.0001).(2)there was no statistically significant difference between the two groups in weekly SBMs baseline comparison(p=0.317),and there were statistically significant differences in weekly SBMs frequency between the two groups(4.55 vs.1.40(95%ci: 2.47 ~ 3.84,p <0.0001),CSBMs2.75 vs.0.77(95%ci: 1.42 ~ 2.55,p <0.0001),and effortless SBMs2.69 vs.1.10(95%ci: 1.93 ~ 3.22,p <0.0001).(3),TCM syndrome type distribution via "BianmiTong" group of intestines and stomach volume heat 4.6%(3/65),27.6%(18/65),qi activity stasis syndrome,qi deficiency constipation 46.1%(30/65),3.1%(2/65),Yang deficiency constipation blood deficiency constipation 18.4%(12/65),3.1% of placebo product of intestines and stomach heat(2/64),30.0%(19/64),qi activity stasis syndrome,qi deficiency constipation 48.4%(31/64),1.6%(1/64),blood deficiency constipation Yang deficiency constipation 17.2%(11/64).There was no significant difference in syndrome type distribution between the two groups(P>0.05).(4)in the "BianmiTong" group,the proportion of SBM reactivity with different syndromes was 66.7%(2/3),77.8%(14/18),80.0%(24/30),50.0%(1/2),and 50.0%(6/12).(5)Treatment-emergent effects TEAEs in the two groups were 24.6%(16/65)compared with 28.1%(18/64),and the difference was not statistically significant(P=0.842).The incidence in the extended study was 28.0%(25/89).Gastrointestinal reactions were the most frequently reported TEAE in the two studies,in which diarrhea was the most common(10 cases,accounting for 15.3%,occurred in the "BianmiTong" group in the randomized controlled trial).There were 2 cases in the placebo group,accounting for 3.0%.There were 14 cases(15.7%)in the extended study.Neither of the two groups of studies showed any non-fatal or fatal serious adverse reactions related to "BianmiTong".(6)The average scores calculated by the two groups' opioid withdrawal scale(COWS)are similar,and both are low(?2).During the randomized controlled trial,the average daily score was relatively stable,based on the digital pain scale(NRS)recording 11 points per day.Conclusion(1)"BianmiTong" treatment of cancer patients with OIC effective;(2)"BianmiTong" treatment of cancer patients OIC tolerance can.(3)cancer patients OIC TCM syndrome type to qi deficiency constipation and qi stagnation syndrome is the most common,"BianmiTong" on qi deficiency constipation and qi stagnation syndrome better efficacy.