Fish Oil for Ulcerative Colitis?

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A small randomized, double-blind, placebo-controlled study (E Scaioli et al. Clin Gastroenterol Hepatol 2018; 16: 1268-75) examined the use of Eicosapentaenoic acid-Free Fatty Acid Form (EPA-FFA) a component of n-3 fish oil for patients with ulcerative colitis UC).

From 2014-2016, the investigators enrolled 60 patients who had partial Mayo score <2 and fecal calprotectin >150 mcg/g who had been receiving stable therapy for at least 3 months.  Then they were randomized 1:1 to receive EPA 1000 mg BID or placebo for 6 months.

Key findings:

  • 19 of 30 (63%) EPA-FFA group compared with 4 of 30 (13.3%) of placebo-treated group had achieved the primary endpoint of a 100-point reduction in fecal calprotectin at 6 months.  OR 12.0, P<.001
  • The secondary endpoint of clinical remission was noted in 23 of 30 (77%) in the EPA-FFA group compared with 15 of 30 (50%), OR 3.29, P=.035)
  • No serious adverse effects were reported.

Limitations:

  • Small number of patients from a single center
  • Short follow-up
  • In those without clinical relapse, a followup colonoscopy was not performed

My take: In this study EPA-FFA was associated with lower calprotectin and higher rates of remaining in remission.  More data are needed.

Related blog posts:

Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

Near Banff

How to Rectify the Problem of Missed Impactions

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Blog Note: This blog site was recently upgraded such that blog followers should not see wordpress.com ads and the domain name is officially gutsandgrowth.com rather than gutsandgrowth.wordpress.com.

A recent study (S Pradhan, B Jagadisan. JPGN 2018; 67: 570-5) describes the yield of digital rectal exam (DRE) for detecting impaction in the setting of functional constipation.

Methods: In this prospective, observational study with an initial cohort of 233 (from a tertiary center) with a history of suggestive of constipation, the authors identified 169 who satisfied Rome III criteria for functional constipation.  After excluding 48 who had impactions detected without DRE and another 24 who had DRE not performed (24 due to fissures, 2 due to recent enema, and 2 due to parental preference), there were 93 who had DRE.

Key finding: “Children satisfying Rome III criteria without requiring digital rectal examination …have impaction detectable only by DRE in 30.1%” (28 of 93).

My take: Since treatment is modified in those with an impaction, DRE remains important part of the examination in children with constipation or symptoms attributed to constipation.

Related posts:

Near Banff

Avatrombopag Reduces Need for Platelet Transfusion in Patients with Chronic Liver Disease

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Briefly noted: N Terrault et al. Gastroenterol 2018; 155: 705-18. In two trials, ADAPT-1 and ADAPT-2, the use of avatrombopag, a thrombopoietin receptor agonist, was superior to placebo in increasing platelet counts and reducing need for platelet transfusion for bleeding related to procedures.

Abstract: Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia

Romaine Lettuce and E coli Outbreak

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According to the CDC update (Nov 26, 2018) –Outbreak of E. coli Infections Linked to Romaine Lettuce: “43 people infected with the outbreak strain of E. coli O157:H7 have been reported from 12 states. A list of the states and the number of cases in each can be found on the Map of Reported Cases page.

Illnesses started on dates ranging from October 8, 2018 to October 31, 2018. Ill people range in age from 1 to 84 years, with a median age of 25. Sixty-nine percent of ill people are female. Of 38 people with information available, 16 (42%) have been hospitalized, including one person who developed hemolytic uremic syndrome, a type of kidney failure. No deaths have been reported.”

“CDC is advising that U.S. consumers not eat and retailers and restaurants not serve or sell any romaine lettuce harvested from the Central Coastal growing regions of northern and central California. If you do not know where the romaine is from, do not eat it.”

Interesting Study -Detrimental Dose-Response of Screen Time

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In 1995, there was a Batman movie, “Batman Forever,” in which one of the central villains, the Riddler, places these brainwave devices over the TVs to gain control of Gotham.  The sad part, according to a recent study (J Zhao et al. J Pediatr 2018; 202; 157-62) is there is no need to add a brainwave device to a TV set.  Excessive screen time alone is quite detrimental.

In this cross-sectional survey in Shanghai with more than 20,000 children, the authors found the following:

  • Mean screen time for preschool children was 2.8 hrs per day.  78.6% exceeded 1 hour per day and 53% exceeded 2 hrs per day.
  • Every additional hour of screen time was associated with increased risk for poor psychosocial well-being; this effect on well-being had a number of mediators including reducing parent-child interaction as well as increased body mass index and reduced sleep duration.

My take: This study reinforces the consequences of excessive screen time  –now, the hard part — how to translate these findings into reduction in screen time.

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New Strategy to Overcome Severe Reactions to Peanuts

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A recent study (N Engl J Med 2018; 379:1991-2001) showed that

Link to abstract: AR101 Oral Immunotherapy for Peanut Allergy

Methods: Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic oral immunotherapy drug) or placebo in an escalating-dose program. 

Conclusions: In this phase 3 trial of oral immunotherapy in children and adolescents who were highly allergic to peanut, treatment with AR101 resulted in higher doses of peanut protein that could be ingested without dose-limiting symptoms and in lower symptom severity during peanut exposure at the exit food challenge than placebo.

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Probiotics -Lack of Efficacy for Acute Gastroenteritis (Part 2)

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This blog post highlights a second study showing a lack of efficacy of probiotics for acute gastroenteritis.  Link to 2 minute Summary: Quick Take on Probiotics for AGE

My take: While some probiotic strains have been shown to be helpful in some conditions (eg. antibiotic associated diarrhea), this study indicates that probiotics are likely ineffective in altering the course of acute gastroenteritis.

SB Freedman et al. N Engl J Med 2018; 379:2015-2026 Link to abstract: Multicenter Trial of a Combination Probiotic for Children with Gastroenteritis

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One for the Probiotic Skeptics: Lack of Efficacy in Acute Gastroenteritis (Part 1)

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My opinion has been that probiotics are generally over-hyped and are likely ineffective for many conditions in which they are commonly used (see related blog posts below).

A recent study (D Schnadower et al.N Engl J Med 2018; 379:2002-2014) provided more data to support this skeptical view when probiotics are utilized for acute gastroenteritis.  Another study in the same issue will be highlighted tomorrow and reaches a similar conclusion.

Link to Abstract: Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children

METHODS: We conducted a prospective, randomized, double-blind trial involving children 3 months to 4 years of age with acute gastroenteritis who presented to one of 10 U.S. pediatric emergency departments. Participants received a 5-day course of Lactobacillus rhamnosus GG … twice daily or matching placebo…

RESULTS Among the 971 participants, 943 (97.1%) completed the trial…There were no significant differences between the L. rhamnosus GG group and the placebo group in the duration of diarrhea (median, 49.7 hours in the L. rhamnosus GG group and 50.9 hours in the placebo group; P=0.26), duration of vomiting (median, 0 hours in both groups; P=0.17), or day-care absenteeism (median, 2 days in both groups; P=0.67) or in the rate of household transmission (10.6% and 14.1% in the two groups, respectively; P=0.16).

CONCLUSIONS Among preschool children with acute gastroenteritis, those who received a 5-day course of L. rhamnosus GG did not have better outcomes than those who received placebo

My take: While some probiotic strains have been shown to be helpful in some conditions (eg. antibiotic-associated diarrhea), this study indicates that probiotics are likely ineffective in altering the course of acute gastroenteritis.

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Low Quality Evidence for IBS Dietary Therapy

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A recent systematic review and meta-analysis (J Dionne et al. Am J Gastroenterol 2018; 113: 1290-1300) throws some shade on the effectiveness of dietary therapies for irritable bowel syndrome. Thanks to Ben Gold for this reference. The authors reviewed 1726 citations -only 9 were eligible for systematic review; two RCTs (n=111 participants) with gluten-free diet (GFD) and 7 RCTs (n=397) with low FODMAPs diet.

Key findings:

  • A GFD was associated with reduced global symptoms compared with control interventions (RR=0.42, CI 0.11-1.55) which was not statistically significant.  Thus, there is “insufficient evidence to recommend a GFD to reduce IBS symptoms.”
  • A low FODMAP diet was associated with reduced global symptoms compared with control interventions (RR=0.69, CI 0.54-0.88). The three RCTs with rigorous control diets found the least magnitude of effect. Thus, the overall quality of the data was “very low” according to the GRADE criteria.

Given the limited data supporting dietary therapy for IBS, the authors caution that in those who are placed on a low FODMAPs diet, that after a 2-6 week trial, those who “fail to improve should not continue the diet. ”

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FDA IBD Workshop -Take-Home Points

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From a previous blog lecture from Athos Bousvaros (NASPGHAN Postgraduate Course 2014)

Off-label does not equate to experimental

FDA Statement: The FD&C Act does not, however, limit the manner in which a physician may use an approved drug. Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. Such “unapproved” or, more precisely, “unlabeled” uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature.