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Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial.

ABSTRACT: Background:We performed a randomized, controlled, assessor-blinded, multicenter, non-inferiority (NI) study to compare the safety and efficacy of a ready-to-drink formulation of sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) with a powder formulation (P/MC powder) for oral solution. Methods:Eligible participants (adults undergoing elective colonoscopy) were randomized 1:1 to split-dose SPMC oral solution or P/MC powder. The primary efficacy endpoint assessed overall colon-cleansing quality with the Aronchick Scale (AS), and the key secondary efficacy endpoint rated quality of right colon cleansing with the Boston Bowel Preparation Scale (BBPS). Assessments were performed by a treatment-blinded endoscopist. Tolerability was assessed using the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events and laboratory evaluations. Results:The study included 901 participants: 448 for SPMC oral solution; 453 for P/MC powder. SPMC oral solution demonstrated non-inferiority to P/MC powder {87.7% (393/448) responders versus 81.5% (369/453) responders [difference (95% confidence interval): 6.3% (1.8, 10.9)]}. The key secondary efficacy objective assessing the right colon was also met. According to the prespecified hierarchical testing, after meeting the primary and key secondary objectives, SPMC oral solution was tested for superiority to P/MC powder for the primary endpoint (p = 0.0067). SPMC oral solution was well tolerated. Most common adverse events were nausea (3.1% versus 2.9%), headache (2.7% versus 3.1%), hypermagnesemia (2.0% versus 5.1%), and vomiting (1.3% versus 0.7%) for SPMC oral solution and P/MC powder, respectively. Conclusions:Ready-to-drink SPMC oral solution showed superior efficacy of overall colon cleansing compared with P/MC powder, with similar safety and tolerability.[ClinicalTrials.gov identifier: NCT03017235.].

SUBMITTER: Hookey L

PROVIDER: S-EPMC6535705 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial.

Hookey Lawrence L Bertiger Gerald G Lee Johnson Kenneth K Ayala Julia J Seifu Yodit Y Brogadir Stuart P SP

Therapeutic advances in gastroenterology 20190519

<h4>Background</h4>We performed a randomized, controlled, assessor-blinded, multicenter, non-inferiority (NI) study to compare the safety and efficacy of a ready-to-drink formulation of sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) with a powder formulation (P/MC powder) for oral solution.<h4>Methods</h4>Eligible participants (adults undergoing elective colonoscopy) were randomized 1:1 to split-dose SPMC oral solution or P/MC powder. The primary efficacy endpoint asse ...[more]

PMID: 31205487

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Project description:BackgroundThe incidence and mortality of colorectal cancer (CRC) increase with age and, therefore, it is recommended that adults undergo regular CRC screening, ideally by colonoscopy, with some new guidelines recommending screening begin at 45 years. Effective bowel preparation is a critical step to a successful colonoscopy. Of concern is that older adults may have poorer quality of bowel preparation or reduced tolerability for the bowel preparation. Here, we performed a post hoc secondary analysis for the effect of age on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation.MethodsA phase III, randomized, assessor-blinded, multicenter, non-inferiority study was conducted comparing split-dose, low-volume SPMC oral solution with split-dose, low-volume sodium picosulfate, magnesium oxide, and citric acid powder for oral solution. A post hoc secondary analysis was performed to assess efficacy, safety, and tolerability of SPMC oral solution by age group (<50 years, 50-64 years, ⩾65 years). The prespecified primary efficacy endpoint ('responders') was the proportion of participants with 'excellent' or 'good' ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations.ResultsWithin age groups, at least 83.9% of participants were responders by the AS, and at least 91.1% of participants were responders by the BBPS in the right colon. On both scales, responder rates were highest in the youngest age group and decreased with increasing age. Greater than 88% of participants in any age group found the preparation 'easy' or 'acceptable' to ingest, with rates of 'easy' being highest in the oldest age group. No new safety signals were seen in any age group. The most commonly reported drug-related, treatment-emergent AEs were, by ascending age group, nausea (7.0%, 3.2%, 0.8%), headache (4.2%, 2.8%, 1.6%) and vomiting (2.8%, 1.2%, 0.8%).ConclusionReady-to-drink SPMC oral solution showed good efficacy of overall colon cleansing and tolerability in adults across different age groups, including those ⩾65 years.ClinicalTrials.gov identifier: NCT03017235.

Project description:Background:We performed a post hoc secondary analysis for the effect of body mass index (BMI) on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation. Methods:A phase III, randomized, assessor-blinded, multicenter, noninferiority study was conducted comparing split-dose, low-volume SPMC oral solution with a powder formulation for oral solution. A post hoc secondary analysis assessed efficacy, safety, and tolerability of SPMC oral solution stratified by BMI. BMI was classified by Centers for Disease Control and Prevention definitions (underweight and normal weight: BMI <?25?kg/m2; overweight: BMI 25-29.9?kg/m2; class?I obesity: BMI 30-34.9?kg/m2; class?II obesity: BMI 35-39.9?kg/m2; class III/severe obesity: BMI ?40?kg/m2). Prespecified primary efficacy endpoint ('responders') was the proportion of participants with 'excellent' or 'good' ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations. Results:Between 82.8% and 92.5% of participants in any BMI group were responders by AS, and between 91.3% and 100% were responders by BBPS in the right colon. Efficacy was consistent across BMI groups, with no clear trends. Greater than 83% of participants in any BMI group found the preparation 'easy' or 'acceptable' to ingest, and the majority (>58%) rated SPMC oral solution as 'better' than a prior bowel preparation. In all BMI groups, safety data were similar to the overall cohort. Commonly reported, drug-related, treatment-emergent AEs were, by ascending BMI group, nausea (1.1%, 5.3%, 1.0%, 5.7%, and 0%) and headache (1.1%, 4.1%, 1.0%, 5.7%, and 0%). Conclusions:Ready-to-drink SPMC oral solution had consistent, good quality colon cleansing, and favorable tolerability among participants of all BMI groups. ClinicalTrialsgov Registration:NCT03017235.

Project description:BACKGROUND AND AIMS:Inadequate bowel preparation (BP) is an unfavorable factor that influence the success of colonoscopy. Although standard education (SE) given to patients are proved useful to avoid inadequate BP. Studies concerning the effects of reinforced education (RE) on the quality of BP were inconsistent. The aim of this updated meta-analysis of randomized controlled trial was to compare the quality of BP between patients receiving RE in addition to SE and those receiving SE alone. METHODS:MEDLINE, EMBASE, Web of Science and the Cochrane Library were systemically searched to identify the relevant studies published through April 2019. The primary outcome was the rate of adequate BP. Subgroup analyses were conducted. Secondary outcomes included BP score, adenoma detection rate (ADR), polyp detection rate (PDR), insertion time, withdrawal time, adverse events, >80% purgative intake and diet compliance. Dichotomous variables were reported as odds ratio (OR) with 95% confidence interval (CI). Continuous data were reported as mean difference (MD) with 95%CI. Pooled estimates of OR or MD were calculated using a random-effects model. Statistical heterogeneity was accessed by calculating the I2 value. A P value less than 0.05 was considered significant. RESULTS:A total of 18 randomized controlled trails (N = 6536) were included in this meta-analysis. Patients who received RE had a better BP quality than those only receiving SE (OR 2.59, 95%CI: 2.09-3.19; P<0.001). A higher ADR (OR 1.35; 95%CI: 1.06-1.72; P = 0.020) and PDR (OR 1.24, 95%CI: 1.02-1.50; P = 0.030), shorter insertion (MD -0.76; 95%CI: -1.48-(-0.04); P = 0.040) and withdrawal time (MD -0.83; 95%CI: -1.83-(-0.28); P = 0.003), less nausea/vomiting (OR 0.78; 95%CI: 0.64-0.97; P = 0.020) and abdominal distension (OR 0.72; 95%CI: 0.68-0.92; P = 0.020) were achieved in the RE group. More patients had >80% purgative intake (OR 2.17; 95%CI, 1.09-4.32; P = 0.030) and were compliant with diet restriction (OR 2.38; 95%CI: 1.79-3.17; P<0.001) in the RE group. CONCLUSION:RE significantly improved BP quality, increased ADR and PDR, decreased insertion and withdrawal time and adverse events.

Project description:BACKGROUND:Polyethylene glycol solution (PEG) is widely used for bowel preparation prior to colonoscopies. However, patients often exhibited adverse events as nausea, vomit and distention due to its uncomfortable tastes and potential side affects. This study aimed to evaluate the effectiveness and safety of concomitant use of green tea (GT) with PEG in bowel preparation prior to colonoscopy. METHODS:This was a prospective, randomized controlled study. It was conducted at an outpatient setting of colorectal surgery in a tertiary hospital. Patients aged 18 through 80 who were scheduled to undergo colonoscopy between August 2015 and February 2016 were randomly assigned into two groups, admitting either 2?L-PEG solutions with 1?L GT liquids or 2?L-PEG solutions only for bowel preparation. Admitted doses of PEG solutions, taste evaluation, adverse reactions (nausea and vomiting, distention and abdominal pain) were investigated by questionnaires. The bowel cleanliness of each patient was evaluated according to the Aronchick indicators. RESULTS:A total of 116 patients were enrolled in this study (PEG+GT 59, PEG 57). Full compliances were achieved in 93.2% patients of group PEG+GT and 59.6% of group PEG (p?<?0.001). Mean Aronchick scale between two groups were 2.0?±?0.9 versus 2.2?±?0.7 respectively (PEG+GT vs PEG, p?=?0.296). Rates of adverse events as nausea and vomiting, abdominal pain in bowel preparation were significantly different between two groups (55.9% vs 77.2%, p?=?0.015 and 13.6% vs 33.3%, p?=?0.012). Patients in group PEG+GT who have probabilities to receive repeating colonoscopy had a higher willingness to accept PEG+GT again for bowel preparation, compared with PEG group (94.9% vs 57.9%, p?<?0.001). CONCLUSIONS:Concomitant use of green tea and polyethylene glycol may effectively reduce incidence of adverse events, increase compliances, with comparable bowel cleanliness in bowel preparation. TRIAL REGISTRATION:This trial was retrospectively registered on Feb 1st, 2019 (ChiCTR1900021178).

Dataset Information

Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial.

Publications

Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial.

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