Efficacy of mosapride citrate with polyethylene glycol solution for colonoscopy preparation

AIM:To evaluate the efficacy and safety of adjunctive mosapride citrate for bowel preparation before colonoscopy. METHODS:We conducted a randomized,double-blind, placebo-controlled study with mosapride in addition to polyethylene glycol(PEG)-electrolyte solution.Of 250 patients undergoing colonoscopy,124 were randomized to receive 2 L PEG plus 15 mg of mosapride citrate (mosapride group),and 126 received 2 L PEG plus placebo(placebo group).Patients completed a questionnaire reporting the acceptability and tolerability of the bowel preparation process.The efficacy of bowel preparation was assessed by colonoscopists using a 5-point scale based on Aronchick's criteria.The primary end point was optimal bowel preparation rates(scores of excellent/good/fair vs poor/inadequate). RESULTS:A total of 249 patients were included in the analysis.In the mosapride group,optimal bowel preparation rates were significantly higher in the left colon compared with the placebo group(78.2%vs 65.6%,P<0.05),but not in the right colon(76.5%vs 66.4%,P=0.08).After excluding patients with severe constipation,there was a significant difference in bowel preparation in both the left and right colon(82.4%vs 66.7%,80.8%vs 67.5%,P<0.05,P<0.01).The incidence of adverse events was similar in both groups. Among the subgroup who had previous colonoscopy experience,a significantly higher number of patients in the mosapride group felt that the current preparation was easier compared with patients in the placebo group(34/72 patients vs 24/74 patients,P<0.05). CONCLUSION:Mosapride citrate may be an effective and safe adjunct to PEG-electrolyte solution that leads to improved quality of bowel preparation,especially in patients without severe constipation.

Stability-indicating HPLC-DAD methods for determination of two binary mixtures:Rabeprazole sodium-mosapride citrate and rabeprazole sodium-itopride hydrochloride

Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium （RZ）-mosapride citrate （MR） and RZ-itopride hydrochloride （IO） mixturcs in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge CI 8 column using two mobile phases： the first for RZ-MR mixture consisted of acetonitrile： 0.（125 M KH,PO4 solution： TEA （30：69：1 v/v; pH 7.0）; the second for RZ-IO mixture was at ratio of 25：74：1 Iv/v： pH 9.25J. The detection wavelength was 283 nm. The two methods were validated and wdidation acceptance criteria were met in all cases. Peak purity testing using contrast angle theory, relative absorbance and log A versus the wavelengths plots were presented. The % recoveries of the intact drugs were between 99.1% and 102.2% with RSD% values less than 1.6%. Application of the proposed HPLC methods indicated that the methods could be adopted to follow the stability of their formulations.

Eficacy of Electro-acupuncture in Treatment of Functional Constipation: A Randomized Controlled Trial

Functional constipation(FC)is a chronic discasc that significantly afcts the life quality of patients.Acupuncture has been used for the treatment of FC for many years,but its effectiveness has not been scientifcally assessed.The present study aimed to evaluate the efficacy of electro-acupuncture(EA)in relieving the symptoms,mental states and quality of life(QOL)of FC patients.A total of 96 FC patients were randomly allocated into EA,mosapride&sham EA group(MS)and mosapride control group(MC).In the EA group,patients were treated with 16 sessions of needling at Quchi(LI1I)and Shangjuxu(ST37)bilaterally,5 times a week in the first 2 weeks,and 3 times a.week in the last 2 weeks.In the MC group,patients were treated with 5 mg mosapride citrate three times a day for 4 weeks.In the MS group,patients underwent sham EA and the same mosapride citrate treatment as in the MC group.The primary outcome was the number of weekly spontaneous bowel movements(SBMs).The secondary outcomes included stool consistency,intensity of defecating difficulty,36-Item Short-Form Health Survey(SF-36),Self-rating Anxiety Scale(SAS),Self-rating Depression Scale(SDS),and the validated Patient Assessment of Constipation-Quality of Life(PAC-QOL).The results showed that as compared with the baseline,EA significantly improved the weekly SBMs,stool consistency and intensity of defecating difficulty(P<0.05).It also partly ameliorated the PAC-QOL,SF-36,SDS and SAS scores when compared with MC or MS group(P<0.05).However,no significant difference was observed between MS and MC groups in bowel function outcomes and QOL scores.It was concluded that EA could effectivcly improve bowel function,mental states and QOL of FC patients.

通腑调神针法治疗便秘型肠易激综合征:随机对照试验

Objective To observe the effects of bowls-unblocking and mind-regulating acupuncture therapy on constipation,anxiety,depression and serum neuropeptide Y(NPY)content for the patients with constipation-predominant irritable bowel syndrome(IBS-C).Methods Forty-two IBS-C patients were randomly assigned either into a bowls-unblocking and mind-regulating acupuncture group(acupuncture group)or a mosapride citrate group(medication group)with 21 cases in each group.During the treatment,one patient in the medication group was excluded and 20 patients were included in final statistical analysis;while 21 patients completed the trial in the acupuncture group.Before treatment,after treatment and in follow-up(1 month after the whole treatment),the scores of the Cleveland clinical constipation scoring system(CCS),the self-rating anxiety scale(SAS),and the self-rating depression scale(SDS)were assessed in both groups.The changes in NPY content were compared before and after treatment.Results①Total score of CCS:after treatment,the total score in the acupuncture group and the medication group were(4.76±2.10)points and(5.60±1.88)points,respectively,which were significantly lower than those before treatment in both groups(both P<0.05);and the difference in the score was not significant for the between-group comparison(P>0.05).In the follow-up,the total scores were(4.19±1.69)points in the acupuncture group,and was(6.35±2.06)points in the medication group.The score in the medication group was higher than that after treatment in the same group(P<0.05),but there was no significant difference between acupuncture group and the medication group(P>0.05).②SAS score:after treatment,the SAS scores were(50.24±2.19)points and(53.45±2.46)points in the acupuncture group and the medication group,respectively,which was lower than that before treatment in the two groups(both P<0.05);and the difference in the score was significant between two groups(P<0.05).In the follow-up,the scores were(51.95±2.27)points and(54.55±1.67)points in the acupuncture group and the medication group,respectively;which was lower than that before treatment in the two groups(both P<0.05),and the difference in the score was significant between two groups(P<0.05).③SDS score:after treatment,the SDS scores were(50.71±2.70)points and(53.15±2.25)points in the acupuncture group and the medication group,respectively,which was significantly lower than that before treatment in the two groups(both P<0.05);and the difference in the score was significant between the two group(P<0.05).In the follow-up,the score of the acupuncture group was(52.57±3.72)points and it was(56.60±2.42)points in the medication group,which was significantly lower than that before treatment in the two groups(both P<0.05);and the difference in the score was significant between the two groups(P<0.05).④Comparison of serum NPY content:after treatment,the serum NPY content of the acupuncture group and the medication group were(7.08±3.02)mmol/L and(9.89±3.82)mmol/L,respectively,which was significantly lower than that before treatment within each group(both P<0.05).The difference was significant between the two groups(P<0.05).⑤Effective rate:after treatment,the total effective rate was 95.24%in the acupuncture group and 90.00%in the medication group,without statistically significant difference(P>0.05).Conclusions bowls-unblocking and mind-regulating acupuncture therapy relieved the defecation-related symptoms,anxiety,and depression in IBS-C patients;and it was more effective on abdominal pain compared with mosapride citrate.Acupuncture therapy also had some long-term effect,which may be related to its regulatory effect on the serum NPY content.