Effectiveness of Sodium Picosulfate/Magnesium Citrate (PICO) for Colonoscopy Preparation

Song, Ki Hwan; Suh, Wu Seok; Jeong, Jin Sik; Kim, Joo Young; Kim, Sang Woo; Kwak, Dong Min; Hwang, Jong Seong; Kim, Hyun Jin; Park, Man Woo; Shim, Min Chul; Koo, Ja-Il; Kim, Jae Hwang; Shon, Dae Ho

doi:10.3393/ac.2014.30.5.222

Cited by 8 publications

(6 citation statements)

References 19 publications

(29 reference statements)

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“…The prospected randomized clinical trials to compare the preference and efficacy of sodium picosulfate in Korea proved that three sachets of sodium picosulfate regimen were as effective as conventional high volume PEG solution. And sodium picosulfate groups reported superior palatability and tolerability[ 22 - 24 ].…”

Section: Discussionmentioning

confidence: 99%

Randomized clinical trial comparing fixed-time split dosing and split dosing of oral Picosulfate regimen for bowel preparation

Jun

Han

Park

et al. 2017

WJG

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AIMTo compare the efficacy of fixed-time split dose and split dose of an oral sodium picosulfate for bowel preparation.METHODSThis is study was prospective, randomized controlled study performed at a single Institution (2013-058). A total of 204 subjects were assigned to receive one of two sodium picosulfate regimens (i.e., fixed-time split or split) prior to colonoscopy. Main outcome measurements were bowel preparation quality and subject tolerability.RESULTSThere was no statistical difference between the fixed-time split dose regimen group and the split dose regimen group (Ottawa score mean 2.57 ± 1.91 vs 2.80 ± 2.51, P = 0.457). Cecal intubation time and physician’s satisfaction of inspection were not significantly different between the two groups (P = 0.428, P = 0.489). On subgroup analysis, for afternoon procedures, the fixed-time split dose regimen was equally effective as compared with the split dose regimen (Ottawa score mean 2.56 ± 1.78 vs 2.59 ± 2.27, P = 0.932). There was no difference in tolerability or compliance between the two groups. Nausea was 21.2% in the fixed-time split dose group and 14.3% in the split dose group (P = 0.136). Vomiting was 7.1% and 2.9% (P = 0.164), abdominal discomfort 7.1% and 4.8% (P = 0.484), dizziness 1% and 4.8% (P = 0.113), cold sweating 1% and 0% (P = 0.302) and palpitation 0% and 1% (P = 0.330), respectively. Sleep disturbance was two (2%) patients in the fixed-time split dose group and zero (0%) patient in the split dose preparation (P = 0.143) group.CONCLUSIONA fixed-time split dose regimen with sodium picosulfate is not inferior to a split dose regimen for bowel preparation and equally effective for afternoon colonoscopy.

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Section: Discussionmentioning

confidence: 99%

Randomized clinical trial comparing fixed-time split dosing and split dosing of oral Picosulfate regimen for bowel preparation

Jun

Han

Park

et al. 2017

WJG

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“…Combination preparations with PEG plus SPMC may be better tolerated than high‐volume PEG alone8 and are standard practice in many Australian hospitals and endoscopy centers. Several randomized controlled trials and a meta‐analysis confirm that splitting the bowel preparation dose between the day prior and the day of the procedure results in both improved bowel cleansing and patient tolerance compared with day‐prior regimens 9, 10, 11, 12…”

Section: Introductionmentioning

confidence: 99%

White Diet with split‐dose Picosalax is preferred, better tolerated, and non‐inferior to day‐before clear fluids with polyethylene glycol plus sodium picosulfate‐magnesium citrate for morning colonoscopy: A randomized, non‐inferiority trial

et al. 2017

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Background and AimBowel preparations with polyethylene glycol (PEG) and clear fluids are often poorly tolerated. We compared an innovative low‐residue White Diet and low‐volume, split‐dose Picosalax with the standard preparation at our institution of day‐before clear fluids and combination PEG plus sodium picosulfate/magnesium citrate (SPMC).MethodsAdults undergoing morning colonoscopy were randomized to either the White Diet and split‐dose, two sachets of Picosalax (WD/PICO) or day‐before clear fluids and 1‐L PEG plus two sachets of SPMC (CF/PEG + SPMC). The primary endpoint was successful bowel preparation defined by an Ottawa bowel preparation score ≤ 6. An intention‐to‐treat analysis with a predefined non‐inferiority margin of 15% was used to compare efficacy.ResultsA total of 250 patients were randomized (125 WD/PICO and 125 CF/PEG + SPMC). WD/PICO was non‐inferior to CF/PEG + SPMC for successful bowel preparation by intention‐to‐treat analysis (58% WD/PICO vs 62% CF/PEG + SPMC, 95%CI: −14.2 to 6.2%) and per‐protocol analysis (64% WD/PICO vs 65% CF/PEG + SPMC, 95%CI: −11.3 to 9.4%). Patients in the WD/PICO group reported greater satisfaction with the diet (P < 0.001), greater ease of following the diet (P < 0.001), and improved experience compared with prior colonoscopy (P < 0.0001), less bloating (P = 0.02), less weakness (P = 0.046), less hunger (P < 0.0001), and less interference with daily activities (P = 0.001). Procedure/withdrawal times and adenoma detection rates were similar between groups.ConclusionBowel preparation with the White Diet and low‐volume, split‐dose Picosalax was preferred and better tolerated without detriment to bowel preparation success compared with clear fluids and combination PEG plus SPMC for morning colonoscopy.

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“…This reduces the time interval between the last dose and afternoon/evening colonoscopy procedure and is associated with improved quality of bowel preparation 14 15. The split-dosing regimen of PICOPREP has been shown to be efficacious, safe and well-tolerated 13 16 17 18 19 20 21, and has also been studied in children 22 23 24.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study

et al. 2017

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Background and study aims The success of any colonoscopy procedure depends upon the quality of bowel preparation. We evaluated the efficacy and safety of a new tailored dosing (TD) regimen compared with the approved PICOPREP day-before dosing regimen (DBD) in the European Union. Patient and methods Patients (≥ 18 years) undergoing colonoscopy were randomised (2:1) to TD (Dose 1, 10 – 18 hours; Dose 2, 4 – 6 hours before colonoscopy) or DBD (Dose 1 before 8:00AM on the day before colonoscopy; Dose 2, 6 – 8 hours after Dose 1). The primary endpoint of overall colon cleansing efficacy was based on total Ottawa Scale (OS) scores (0 – 14, excellent-worst). The key secondary endpoint was a binary endpoint based on the ascending colon OS (success 0 or 1, failure [≥ 2]). Convenience and satisfaction were evaluated similar to the primary and key secondary endpoints. Safety and tolerability were also evaluated. Results Use of the PICOPREP TD regimen resulted in a statistically significant reduction in the mean total Ottawa Scale score compared to the PICOPREP DBD regimen (–3.93, 95 % confidence intervals [CI]: – 4.99, – 2.97; P < 0.0001) in the intent-to-treat analysis set. The PICOPREP TD regimen also resulted in a statistically significant increase in the odds of achieving an ascending colon OS score ≤ 1, compared to the PICOPREP DBD regimen (estimated odds ratio 9.18, 95 % CI: 4.36, 19.32; P < 0.0001). There was no statistically significant difference in the overall rate of treatment-emergent adverse events (12 % (TD) and 5.7 % (DBD), respectively, P = 0.2988). The convenience and satisfaction were comparable in the two groups. Conclusion The TD regimen was superior to the DBD regimen for overall and ascending colon cleansing efficacy. ClinicalTrials.gov Identifier: NCT02239692

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Effectiveness of Sodium Picosulfate/Magnesium Citrate (PICO) for Colonoscopy Preparation

Cited by 8 publications

References 19 publications

Randomized clinical trial comparing fixed-time split dosing and split dosing of oral Picosulfate regimen for bowel preparation

Randomized clinical trial comparing fixed-time split dosing and split dosing of oral Picosulfate regimen for bowel preparation

White Diet with split‐dose Picosalax is preferred, better tolerated, and non‐inferior to day‐before clear fluids with polyethylene glycol plus sodium picosulfate‐magnesium citrate for morning colonoscopy: A randomized, non‐inferiority trial

Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study

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