The Acute Effect of Loperamide on Ileostomy Output: A Randomized, Double‐Blinded, Placebo‐Controlled, Crossover Study

Abstract

High stoma output is a common problem in patients with ileostomy and can lead to dehydration and electrolyte disturbances. The first drug of choice to reduce stoma output is often loperamide. The aim was to assess the acute effect of loperamide on (a) ileostomy output in g/day, (b) gastrointestinal transit time and (c) patient-reported effects. A total of 12 patients completed this double-blinded, randomized, placebo-controlled, crossover study, consisting of a 3-day treatment period with loperamide 12 mg/day or placebo followed by the reverse after a washout period of 5-7 days. Patients collected stoma output and noted food and fluid intake over 48 hr and swallowed a capsule with radiopaque markers for the determination of gastrointestinal transit time over 24 hr. At the end of the study, patients were asked to report their treatment sequence. Ileostomy output was significantly reduced during loperamide treatment (p < 0.02) with a median of 16.5% (range -5% to 46%). Transit time was reduced significantly for the passage of 10% of the markers (p = 0.02), but not for 50% and 100% of the markers. Fifty-eight per cent (N = 7) of the patients reported the correct treatment sequence (p = 0.41). Loperamide 12 mg/day reduced ileostomy output statistically significantly, but with varying effects among patients and without reaching the clinical significance of 20% set-up by this study. Dose-response studies should be performed, and standard treatment doses of loperamide should be reassessed. The study was registered at ClinicalTrials.gov - NCT02266849.

The Relationship Between High-Output Stomas, Postoperative Ileus, and Readmission After Rectal Cancer Surgery With Diverting Ileostomy

“…HOSs have been reported to occur in 16% of patients with stomas [23,27]. However, there is no agreed definition for HOSs, which have been defined as having outputs of ≥ 1000-2000 mL/day [23].…”

Ostomías de alto gasto en pacientes adultos

“…El manejo de las ostomías de alto gasto suele ser bastante retador tanto a nivel farmacológico como a nivel nutricional y su combinación con deshidratación y/o malnutrición es bastante frecuente, sobre todo en pacientes portadores de ileostomías. Entre los factores más importantes a tomar en cuenta para decidir el rumbo del tratamiento son la funcionalidad y la longitud del intestino remanente (8).…”

“…Es importante recalcar que más del 50% de los pacientes con estomas de alto débito necesitarán tratamiento médico prolongado y que hasta el 37% de estas personas podrían necesitar en algún momento nutrición parenteral y administración de fluidos (8). No obstante, previo al inicio del manejo nutricional y farmacológico, debe identificarse y tratarse la causa desencadenante del excesivo gasto (4).…”

Radiographic dose‐dependency study of loperamide effects on gastrointestinal motor function in the rat. Temporal relationship with nausea‐like behavior

“…Indeed, it is considered a safe drug and is available over the counter in several oral forms for diarrhea treatment . It also improves continence in patients with ileo‐anal pouches and reduces dehydration and malnutrition in ileostomized patients . Gastrointestinal symptoms (nausea and constipation), urinary retention, drowsiness, dizziness, and headache may occur at therapeutic doses …”

“…2,3 It also improves continence in patients with ileo-anal pouches 4 and reduces dehydration and malnutrition in ileostomized patients. 5 Gastrointestinal symptoms (nausea and constipation), urinary retention, drowsiness, dizziness, and headache may occur at therapeutic doses. 2,6 Interestingly, due to its analgesic and anti-inflammatory properties, 7 loperamide has been investigated as a possible topical analgesic for painful ulcers of the skin or mouth, 8,9 or for inflammatory cutaneous and musculoskeletal pain using local injection (in joints 7 or muscles 10 ) or nanodelivery systems, 11 although it is not as useful to reduce gut pain.…”