NICE in the United Kingdom Gives Positive Recommendation for Eluxadoline (Truberzi) for IBS-D

July 31, 2017

Today, via the social media of the IBS Network, the U.K. charity for irritable bowel syndrome, IBS Impact received the following linked press release from Allergan, the pharmaceutical company for eluxadoline, which is known in the U.K. and throughout the European Union by the brand name Truberzi. This is the same medication which is known in the U.S. and Canada by the brand name Viberzi. It is a twice-daily oral medication for irritable bowel syndrome with diarrhea (IBS-D)

According to the press release, dated July 27, 2017, the National Institute of Health and Care Excellence, still known by its former acronym, NICE, issued a Final Appraisal Determination that the National Health Service (NHS) make eluxadoline available to adults with IBS-D who have not responded to, or for medical reasons, cannot use other IBS treatment interventions usually offered. If there is no appeal to this determination, this guidance will be published in August, and availability under the NHS is expected sometime this fall.

Eluxadoline was originally approved for use in the EU by the European Commission in September 2016, by the Food and Drug Administration (FDA) in the United States in May 2015 and by Health Canada in March 2017. It has been used successfully by many people with IBS-D throughout North America and the European Union in that time frame, but as reported by this blog on March 15, 2017, the FDA issued a warning to U.S. physicians that eluxadoline should not be prescribed to patients who do not have a gallbladder because of reports of many cases of serious pancreatitis and two deaths in that subgroup. We advise anyone considering any specific IBS medication or treatment to read available evidence-based information, to familiarize themselves with the benefits and risks, and to consult their own doctors as to if the given intervention is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular interventions, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.


NICE Guidelines in the United Kingdom for Adult Irritable Bowel Syndrome (IBS) Updated for 2015

March 6, 2015

Last month, February 2015, the National Institute for Health and Care Excellence, formerly the National Institute for Clinical Excellence and still widely known by its original acronym NICE, released revised guidelines for the diagnosis and treatment of adults with irritable bowel syndrome (IBS) in the United Kingdom. NICE’s stated goal is to provide evidence-based information to improve the overall quality of care and reduce variation in care through the National Health Service. The committees responsible for the IBS guidelines included many professionals from a variety of academic research centers and hospitals throughout the U.K.

The last update to the NICE guidelines for IBS was in 2008. In a portion of the guidelines on its website directed to the general public,  NICE cautions that these guidelines are not intended for those with IBS who are under the age of 18 or those who have other gastrointestinal disorders such as non-ulcer dyspepsia or coeliac (celiac) disease. The guidelines are primarily for use by general practitioners/primary care physicians who are the first health professionals to assess people with possible symptoms of IBS. The relevant section of the NICE website includes several additional tools, including cost information.

With a few specific country variations, the NICE guidelines are consistent with the international Rome criteria developed by leading functional gastrointestinal disorder clinicians and researchers from several countries (currently Rome III. See page 889. Rome IV was completed in December 2014 and is expected to be published in 2016.) and best practices advocated by those same IBS experts, such as patient-centered care. For example, the NICE guidelines advise primary care providers to ask open-ended questions, to be aware that many patients will not disclose incontinence without being specifically asked, and to be sensitive to individuals for whom English is not the first language or who have disabilities that may hinder effective communication.

In general, NICE advises that IBS should be considered a possible diagnosis for people who have chronic symptoms of abdominal pain and change in bowel habits  (altered frequency or stool form) and at least two of the following additional symptoms: changes in stool passage (such as straining, urgency, incomplete evacuation), bloating, symptoms worsened by eating, or passage of mucus. Additionally, NICE states that the following common non-GI or extraintestinal symptoms can further support diagnosis of IBS: lethargy, nausea, backache and bladder symptoms.

Symptoms or circumstances that are not present in irritable bowel syndrome or otherwise warrant further investigation and referral to a specialist in gastroenterology include: unintentional and unexplained weight loss (not from changes in eating habits or physical activity), rectal bleeding, family history of bowel cancer or, for women, of ovarian cancer,  chronic frequent and/or looser stools in individuals over age 60,  anaemia (anemia), rectal or abdominal masses, and or inflammatory markers for inflammatory bowel disease (IBD).

The Rome III criteria discourage extensive testing of all people with symptoms of possible IBS. As reported on this blog on October 9, 2011, IBS experts have not considered it a diagnosis of exclusion for over two decades, and state that a properly done Rome III diagnosis is 98% accurate. As there is no clinically available test specifically for IBS at this time, many IBS experts feel that absent symptoms or risk factors for disorders other than IBS, as discussed above, routine, extensive testing is time-consuming for patients and physicians, expensive and not cost-effective, stress-producing for patients and their families, and may delay appropriate IBS education and treatment for many people with IBS, who frequently spend months or years continuing to look for other statistically unlikely causes of their symptoms. In contrast, NICE guidelines do recommend certain simple blood tests to exclude other possible diagnoses: full blood count, erythrocyte sedimentation rate (ESR) or plasma viscosity, c‑reactive protein (CRP) antibody testing for coeliac (celiac) disease (endomysial antibodies [EMA] or tissue transglutaminase [TTG]), as well as serum CA 125 in women who meet NICE guidelines for possible ovarian cancer.  However, NICE guidelines also discourage procedures that are more invasive, involved, or generally not cost-effective. They specifically state that the following are generally not necessary to confirm a diagnosis of IBS for those who meet diagnostic criteria: ultrasound, rigid or flexible sigmoidoscopy, colonoscopy, barium enema, thyroid function test, faecal (fecal) ova or parasite tests, faecal (fecal) occult blood, and hydrogen breath tests for lactose intolerance or bacterial overgrowth. These details are mostly identical to the the 2008 version of the NICE guidelines.

The updates in the 2015 guidelines are concentrated in the treatment/management section, based on a review of research evidence and cost-effectiveness. Primary care physicians are encouraged by NICE to begin their advice to newly diagnosed people with IBS with general lifestyle and simple dietary measures. These include exercise and other relaxing leisure activities, regular meals that are not rushed, adequate fluid intake, reduction of caffeinated, carbonated, and alcoholic beverages, as well as adjustments in types or amounts of fiber, starches, fruit or sorbitol depending on specific symptoms. If these are not effective for particular individuals, NICE newly emphasizes this year that more extensive dietary exclusions, including the low-FODMAP diet, be tried only with the guidance of healthcare professionals with diet and nutrition expertise. For people with IBS who desire to try probiotics, NICE recommends that physicians advise them to continue for 4 weeks. This is a 2008 recommendation that has not changed.

If medications are needed, NICE recommends laxatives, except lactulose, for constipation-predominant IBS, and loperamide (Immodium) for diarrhea-predominant IBS. Among prescription medications, antispasmodics are considered by NICE to be the first line treatment. If those are not sufficiently effective, tricylic antidepressants are preferred by NICE over selective serotonin reuptake inhibitors (SSRIs) as the next line of treatment, with SSRIs only being used if tricyclics are ineffective. These 2008 recommendations were reviewed by the relevant NICE committee and unchanged for 2015. New for 2015,  NICE advises to physicians to be aware of potential side effects from both tricyclics and SSRIs, and to follow up regularly with their patients taking them, initially after 4 weeks, then every 6-12 months thereafter. NICE states that linaclotide (brand name Constella in Europe, Linzess in the United States) should be considered only for those with IBS with constipation (IBS-C) who have not had success with maximum doses of different classes of laxatives for at least 12 months. For 2015, NICE added a recommendation that physicians follow up after 3 months of use. The committee also considered  lubiprostone in this 2015 review, but did not find the evidence strong enough to make a specific recommendation regarding its use for IBS-C. Lubiprostone (Amitiza) is approved for IBS-C in the United States and is available in the United Kingdom for certain other types of constipation under specific strict conditions, but is not specifically approved in the U.K. for IBS-C at this time. Any prescription of lubiprostone for IBS in the U.K. would be off-label.

For those who do not respond adequately to medications within 12 months, NICE states referral to psychological interventions such as hypnotherapy or cognitive behavioral therapy can be considered. In 2015, NICE reviewed relaxation therapy, computerized cognitive behavioral therapy and mindfulness, but did not make specific recommendations about their use for IBS at this time. NICE recommends further research into computerized CBT and mindfulness, specifically their cost-effectiveness.

The 2008 guidelines include statements discouraging specific alternative medicine interventions. These were neither reviewed nor changed for 2015. Aloe vera, acupuncture and reflexology show insufficient evidence of effectiveness for IBS and are explicitly not recommended by NICE.

The full guidelines, 2015 supplement, addenda, tools and resources can be found on the NICE website at the following link:

NICE Guidelines (U.K.) for Adult Irritable Bowel Syndrome in Primary Care, February 2015

IBS Impact appreciates the work of all of the health care professionals involved in developing this revision to the NICE guidelines. Peer review is important to the scientific process and future advances. The availability of this document provides additional guidance to health care professionals and interested people with IBS in the most current standards of care for adults with IBS in the United Kingdom. When so many people with IBS, families and professionals continue to receive outdated or inaccurate information about basic aspects of IBS, an evidence-based document is an important tool in education and management of IBS.