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Antibiotic treatment effective for most common gastrointestinal disorder in U.S., research shows 

ANN ARBOR, Jan. 6, 2011: — A ground-breaking antibiotic therapy is the first potential drug treatment to provide Irritable Bowel Syndrome (IBS) patients with long-lasting relief of their symptoms even after they stop taking the medication, according to a study published in the Jan. 6, 2011 issue of the New England Journal of Medicine.   

Unlike other traditional therapies for IBS, patients in these large studies reported relief of their symptoms for up to 10 weeks after completing treatment with rifaximin, says William D. Chey, M.D., professor in the Department of Internal Medicine at the University of Michigan.   

Rifaximin is a minimally absorbed antibiotic that stays in the gut. Specifically, patients reported improvement in overall IBS symptoms, relief from bloating, less abdominal pain and improved stool consistency for up to 10 weeks, says Chey, one of the researchers on the study and director of the Michigan Bowel Control Program

While the concept of bacteria playing a key role in this condition was controversial when first introduced a decade ago, this research confirms that bacteria in the gut, also known as the “gut microbiome,” plays a role in the symptoms of IBS, a chronic condition affecting an estimated 30 million people in the United States. The therapy was developed at Cedars-Sinai Medical Center.   

These findings show that targeted antibiotics provide safe and effective long-lasting relief for this condition, says Mark Pimentel, M.D., GI Motility Program director and principal investigator of the clinical trials at Cedars-Sinai.   

“This represents a big change in the way we think about and treat IBS,” says U-M’s Chey, adding that IBS often does not respond well to treatments currently available like dietary changes or fiber supplements alone. Patients also often see a return of symptoms once traditional medical treatments are stopped. But with this new treatment, the patients feel better and continue to feel better after stopping the drug. 

In two, 600-plus patient double-blind trials, IBS patients with mild to moderate diarrhea and bloating were randomly assigned to take a 550 milligram dose of rifaximin or placebo three times daily for two weeks. Study participants were then followed for 10 weeks more. About 40 percent of patients who took the drug reported they had significant relief from bloating, abdominal pain and loose or watery stools. Further, that relief was sustained for weeks after completing treatment with the antibiotic. 

Doctors commonly categorize IBS patients with a “constipation predominant” condition, a “diarrhea-predominant”  condition, or a mixed pattern of diarrhea and constipation. In addition, patients often experience abdominal pain or cramps, excess gas or bloating, and visible abdominal distension

Because the cause of the disease had been elusive, treatments for the disease historically have focused on relieving its symptoms with medications that either slow or speed up the digestive process. Earlier research documents a link between bloating, the most common symptom, and bacterial fermentation in the gut related to small intestine bacterial overgrowth, or SIBO. Other research has suggested that the bacteria which reside within the small and large intestines of IBS patients may be different than those inhabiting the intestines of healthy individuals. 

Rifaximin is approved by the U.S. Food and Drug Administration to treat travelers’ diarrhea and hepatic encephalopathy.   

Besides Cedars-Sinai and U-M, other centers participating in the clinical trials included Beth Israel Deaconess Medical Center in Boston, University of North Carolina at Chapel Hill, and Connecticut Gastroenterology Institute in Bristol, Conn. 

Rifaximin is marketed by Salix Pharmaceuticals Inc. Salix also provided funding for the studies. Pimentel discovered the use of rifaximin for IBS, and Cedars-Sinai holds patent rights to this discovery and has licensed rights of the invention to Salix. Dr. Pimentel is a consultant to Salix, Inc, and serves on its scientific advisory board

About the University of Michigan’s division of gastroenterology: U-M has one of the largest gastroenterology practices in the country and is a leader in the prevention, diagnosis, and treatment of diseases of the gastrointestinal tract and liver. Our 50-plus physicians are experts in the diagnosis and treatment of all diseases of the gastrointestinal system, from simple to complex, including those of the esophagus, stomach, small intestine, colon, rectum, liver, gallbladder, pancreas and biliary tract. 

In addition to being leaders in the clinic, our faculty are also leaders in their respective areas of research, which span such varied interests as the role of peptides in the brain-gut interactions in functional bowel diseases to innovative treatments of viral hepatitis and liver cancer.

Un tratamiento con antibióticos es el más eficaz para un trastorno gastrointestinal común en Estados Unidos, según una investigación

ANN ARBOR, el 6 de enero del 2011:
Una terapia innovadora con antibióticos es el primer tratamiento potencial con medicamentos que proporciona a los pacientes con el síndrome de intestino irritable (SII) un alivio duradero de sus síntomas aún después que dejan de tomar los medicamentos, según un estudio publicado en la edición del 6 de enero de la revista New England Journal of Medicine.

A diferencia de otros tratamientos tradicionales para el síndrome de intestino irritable, los pacientes en estos estudios extensos dieron cuenta de alivio de sus síntomas por hasta diez semanas después que completaron el tratamiento con Rifaximin, dijo William D. Chey, profesor en el Departamento de Medicina Interna de la Universidad de Michigan.

      Rifaximin es un antibiótico de absorción mínima que permanece en los intestinos. Específicamente los pacientes dieron cuenta de una mejoría en los síntomas generales del SII, alivio de la hinchazón, menos dolor abdominal y una mejor consistencia de la materia fecal por hasta diez semanas, dijo Chey, uno de los investigadores que participaron en el estudio y director del Programa de Control Intestinal de Michigan.

      Si bien el concepto de que las bacterias desempeñan un papel clave en esta condición era controvertido cuando se introdujo hace una década, esta investigación confirma que las bacterias en los intestinos, conocidas también como el microbioma intestinal, desempeña un papel en los síntomas del SII, una condición crónica que afecta a unos 30 millones de personas en Estados Unidos. La terapia se desarrolló en el Centro Médico Cedars Sinaí.

      Estas conclusiones muestran que los antibióticos específicos proporcionan un alivio seguro, eficaz y duradero para esta condición, dijo Mark Pimental, director del Programa de Motilidad e investigador principal de las pruebas clínicas en Cedars Sinaí.

      “Esto representa un gran cambio en la forma en que pensamos acerca del SII y la forma en que lo tratamos2, dijo Chey, de la UM, añadiendo que el SII a menudo no responde bien a los tratamientos disponibles actualmente como los cambios en la dieta o los suplementos con fibra por sí solos. Los pacientes también ven a menudo un retorno de los síntomas una vez que terminan los tratamientos médicos tradicionales. Pero con este nuevo tratamiento los pacientes se sienten mejor y continúan sintiéndose mejor después que ya no toman el medicamento.

      En dos pruebas dobles ciegas con 600 pacientes, a los pacientes de SII con diarrea de liviana a moderada e inflamación se les  asignó al azar una dosis de 550 miligramos de Rifaximin o un placebo, tres veces por día durante dos semanas. Se observó a los participantes del estudio durante diez semanas más. Aproximadamente el 40 por ciento de los pacientes que tomaron el medicamento dieron cuenta de un alivio significativo en la inflamación, el dolor abdominal y de la materia fecal floja o líquida. Además el alivio se mantuvo por semanas después que se completó el tratamiento con el antibiótico.

      Los médicos comúnmente categorizan a los pacientes de SII con una condición de “constipación (o estreñimiento) predominante” o una condición de “diarrea predominante”, o un patrón mezclado de diarrea y constipación. Además los pacientes a menudo experimentan dolores y calambres abdominales, exceso de gas o hinchazón y una distensión abdominal visible.

      Dado que no se ha podido determinar todavía la causa de la enfermedad, los tratamientos para el mal históricamente se han enfocado en el alivio de los síntomas con medicamentos que hacen más lento o aceleran el proceso digestivo. Hay documentación de investigación anterior que vincula la hinchazón, que es el síntoma más común, con la fermentación bacterial en los intestinos relacionada con un crecimiento bacterial excesivo en el intestino delgado. Otra investigación ha sugerido que las bacterias que residen en el intestino grueso y el intestino delgado de los pacientes de SII pueden ser diferentes de las que habitan en los intestinos de los individuos saludables.

      Rifaximin está aprobado por la Dirección de Alimentos y Medicamentos (FDA por su sigla en inglés) de Estados Unidos para el tratamiento en los viajeros de la diarrea y la encefalopatía hepática.

      Además de Cedars Sinaí y la UM otros centros que participaron en las pruebas clínicas incluyen el Centro Médico Beth Israel Deaconess en Boston; la Universidad de Carolina del Norte en Chapel Hill, y el Instituto Connecticut de Gastroenterología en Bristol, Connecticut.

      Rifaximin lo comercializa la firma Salix Pharmaceuticals, Inc. Salix también proporcionó los fondos para los estudios. Pimentel descubrió el uso de Rifaximin para el CII, y Cedars Sinai tiene los derechos de patente sobre este descubrimiento y ha otorgado derechos de licencia de la invención a Salix. Pimentel es un consultor de Salix y forma parte de su consejo asesor científico.

      Acerca de la división de gastroenterología de la Universidad de Michigan. La UM tiene una de las prácticas de gastroenterología más grandes del país y es pionero en la prevención, diagnóstico y tratamiento de las enfermedades del sistema gastrointestinal y el hígado. Nuestros más de 50 médicos son expertos en el diagnóstico y el tratamiento de todas las enfermedades del sistema gastrointestinal, desde las más simples a las más complejas, incluidas las enfermedades del esófago, estómago, intestino delgado, clon, recto, hígado, vesícula biliar, páncreas y tracto biliar.

      Además de ser pioneros en la clínica nuestros docentes también están en la vanguardia de sus respectivas áreas de investigación que incluyen intereses tan variados como el papel de los péptidos en las interacciones del cerebro y los intestinos en las enfermedades que afectan el funcionamiento intestinal y los tratamientos innovadores de la hepatitis viral y el cáncer de hígado.

 
 

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