Dataset Information

Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized Controlled Trial.

ABSTRACT:

Introduction

Screening colonoscopies are recommended for the detection and prevention of colon cancer. Liquid colonoscopy preparations may be poorly tolerated. We evaluated the adequacy and tolerability of a novel low-cost colonoscopy preparation consisting of magnesium citrate capsules and bisacodyl (MCCB).

Methods

This is a single-center, assessor-blinded, randomized controlled trial of 51 patients undergoing screening colonoscopies, who received a bowel preparation of either 4 liters of GoLYTELY (Braintree Laboratories, Inc., Braintree, MA) or MCCB. The primary outcome was the rate of adequate colon cleanliness, defined as a total score ≥ 6 on the Boston Bowel Preparation Scale and no colon segment with a score of zero. The secondary outcome was patient satisfaction, assessed by a validated questionnaire.

Results

A total of 100% of patients in both arms achieved adequate colon cleanliness, and the magnesium citrate arm had superior patient satisfaction (mean satisfaction score: 54.8 vs. 172.8; p < 0.001).

Conclusions

A pill-based colonoscopy preparation of MCCB may be a low-cost option for patients reluctant to consume a liquid preparation.

SUBMITTER: Eidensohn Y

PROVIDER: S-EPMC8765591 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Publications

Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized Controlled Trial.

Eidensohn Yehuda Y Mond Yisroel Y Labowitz Isaac I Greenberg Patricia P Formanowski Brielle B Eidensohn Chaya C Dutta Sudhir S Dubin Ethan E

Cureus 20211218 12

<h4>Introduction</h4>Screening colonoscopies are recommended for the detection and prevention of colon cancer. Liquid colonoscopy preparations may be poorly tolerated. We evaluated the adequacy and tolerability of a novel low-cost colonoscopy preparation consisting of magnesium citrate capsules and bisacodyl (MCCB).<h4>Methods</h4>This is a single-center, assessor-blinded, randomized controlled trial of 51 patients undergoing screening colonoscopies, who received a bowel preparation of either 4 ...[more]

PMID: 35070543

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Project description:BackgroundAdequate bowel preparation before colonoscopy is crucial. Unfortunately, 25% of colonoscopies have inadequate bowel cleansing. From a patient perspective, bowel preparation is the main obstacle to colonoscopy. Several low-volume bowel preparations have been formulated to provide more tolerable purgative solutions without loss of efficacy.ObjectivesInvestigate efficacy, safety, and tolerability of Sodium Picosulphate plus Magnesium Citrate (SPMC) vs. Polyethylene Glycol plus Ascorbic Acid (PEG-ASC) solutions in patients undergoing diagnostic colonoscopy.Materials and methodsIn this phase 4, randomized, multicenter, two-arm trial, adult outpatients received either SPMC or PEG-ASC for bowel preparation before colonoscopy. The primary aims were quality of bowel cleansing (primary endpoint scored according to Boston Bowel Preparation Scale) and patient acceptance (measured with six visual analogue scales). The study was open for treatment assignment and blinded for primary endpoint assessment. This was done independently with videotaped colonoscopies reviewed by two endoscopists unaware of study arms. A sample size of 525 patients was calculated to recognize a difference of 10% in the proportion of successes between the arms with a two-sided alpha error of 0.05 and 90% statistical power.ResultsOverall 550 subjects (279 assigned to PEG-ASC and 271 assigned to SPMC) represented the analysis population. There was no statistically significant difference in success rate according to BBPS: 94.4% with PEG-ASC and 95.7% with SPMC (P = 0.49). Acceptance and willing to repeat colonoscopy were significantly better for SPMC with all the scales. Compliance was less than full in 6.6 and 9.9% of cases with PEG-ASC and SPMC, respectively (P = 0.17). Nausea and meteorism were significantly more bothersome with PEG-ASC than SPMC. There were no serious adverse events in either group.ConclusionSPMC and PEG-ASC are not different in terms of efficacy, but SPMC is better tolerated than PEG-ASC. SPMC could be an alternative to low-volume PEG based purgative solutions for bowel preparation.Clinical trial registration[ClinicalTrials.gov], Identifier [NCT01649674 and EudraCT 2011-000587-10].

Project description:BackgroundArterial stiffness is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. Recently, we showed that magnesium citrate supplementation results in a clinically relevant improvement of arterial stiffness. It remained unclear whether the observed effect was due to magnesium or citrate, and whether other magnesium compounds may have similar effects. Therefore, we aim to study the long-term effects of magnesium citrate, magnesium oxide and magnesium sulfate on arterial stiffness. In addition, we aim to investigate possible underlying mechanisms, including changes in blood pressure and changes in gut microbiota diversity.MethodsIn this randomized, double-blind, placebo-controlled trial, a total of 162 healthy overweight and slightly obese men and women will be recruited. During a 24-week intervention, individuals will be randomized to receive: magnesium citrate; magnesium oxide; magnesium sulfate (total daily dose of magnesium for each active treatment 450 mg); or placebo. The primary outcome of the study is arterial stiffness measured by the carotid-femoral pulse wave velocity (PWVc-f), which is the gold standard for quantifying arterial stiffness. Secondary outcomes are office blood pressure, measured by a continuous blood pressure monitoring device, and gut microbiota, measured in fecal samples. Measurements will be performed at baseline and at weeks 2, 12 and 24.DiscussionThe present study is expected to provide evidence for the effects of different available magnesium formulations (organic and inorganic) on well-established cardiovascular risk markers, including arterial stiffness and blood pressure, as well as on the human gut microbiota. As such, the study may contribute to the primary prevention of cardiovascular disease in slightly obese, but otherwise healthy, individuals.Trial registrationClinicalTrials.gov, NCT03632590 . Retrospectively registered on 15 August 2018.

Dataset Information

Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized Controlled Trial.

Introduction

Methods

Results

Conclusions

Publications

Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized Controlled Trial.

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