Efficacy, safety and tolerability of oral sulphate tablet for bowel preparation in patients with inflammatory bowel disease: A multicentre randomized controlled study

Abstract

Background and Aims We evaluated the efficacy, safety and tolerability of novel oral sulphate tablets [OSTs] vs 2 L of polyethylene glycol and ascorbate [PEG/Asc] in patients with inflammatory bowel disease [IBD]. Patients and Methods A total of 110 patients with clinically inactive IBD were enrolled in this single-blind multicentre non-inferiority study. Patients were randomly assigned to the OST or 2 L PEG/Asc group and we applied a split-dose regimen. The primary efficacy endpoint was bowel cleansing success rate defined as Harefield Cleansing Scale Grade A or B. The secondary endpoints were perfect preparation rate, the presence of air bubbles, safety as assessed by laboratory abnormalities and self-reported adverse events, or IBD symptom flare-ups. Tolerability was assessed by a pre-procedural visual analog scale [VAS] interview. Results Both groups showed high cleansing success rates [98.1%] and there was no significant difference in perfect preparation rate. The proportion of a bubble score 0 was significantly higher in the OST group [94.5% vs 50.0%, p < 0.001]. There was no significant intergroup difference in vomiting or bloating. Symptom flare-ups occurred in two OST group patients. No clinically significant blood test abnormalities were noted in either group. Ease of ingestion and taste scores were significantly higher in the OST group. More patients in the OST group [94.5%] wanted to take the same preparation agent for their next colonoscopy. Conclusions Both OST and 2 L PEG/Asc demonstrated high successful cleansing and safety in patients with inactive IBD. OST achieved higher satisfaction than 2 L PEG/Asc. Our results suggest that the OST split-dose regimen is effective and safe for patients with inactive IBD.

Efficacy and safety of oral sulfate tablet vs. polyethylene glycol and ascorbate for bowel preparation in children

“…Although tablets are relatively easy to administer, children often complain of difficulty taking pills. In this study, the complete ingestion rate of the OST group was 87.1%, whereas that of adults in the OST group was 100% in a previous study (16). In addition, all patients in our study underwent bowel preparation and colonoscopy during hospitalization, which leads to problems such as school absences in school-age patients.…”

“…When the administration of a previously approved bowel preparation regimen is challenging, OST is considered a secondary option based on the voluntary intention of patients and guardians. In studies involving adults, the use of OST for bowel preparation was not inferior in efficacy and was safe and well tolerated (15)(16)(17).…”

“…To improve compliance with taking bowel preparation solutions, some tableted purgatives have been developed and used in adults (12)(13)(14)(15)(16)(17). Among them, oral sulfate tablet (OST) is an attractive agent that addresses the safety concerns of tableted sodium phosphate (NaP), such as renal toxicity, and removes the unpleasant taste of the oral sulfate solution (15)(16)(17). Despite reports on the efficacy and safety of OST in adults, no relevant data are available in children.…”

Emerging space for non-polyethene-glycol bowel preparations in inflammatory bowel disease-related colonoscopy: Veering toward better adherence and palatability

“…In a subsequent trial targeting patients with inactive IBD, Kim et al [ 19 ] reported a lower bubble score rate in the novel oral sulphate table preparations and higher palatability (including a willingness to reuse the preparation for subsequent colonoscopy) than the PEG-ascorbate comparison. The problem of bubbles is another technical aspect to consider when discussing mucosal visibility, so much so that the use of simethicone for this purpose is bleached out by European guidelines and also found beneficial for IBD[ 5 , 8 ].…”