Category Archives: Pediatric Gastroenterology Intestinal Disorder

Specific Carbohydrate Diet in Children -Ahead of Print

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Here is a link, bit.ly/1xb1kk8, (from JPGN) and the abstract to an article on the Specific Carbohydrate Diet in Children.  This study shows clinical improvement and mucosal healing, confirmed by capsule endoscopy, in response to the specific carbohydrate diet (SCN). Congratulations to my colleagues/partners from GI Care for Kids who published this study in JPGN:

Objective: To prospectively evaluate clinical and mucosal responses to the specific carbohydrate diet (SCD) in children with Crohn’s disease (CD).

Methods: Eligible patients with active CD (Pediatric Crohn’s Disease Activity Index, PCDAI >= 15) underwent a patency capsule and if passed intact, capsule endoscopy (CE) was performed. Patients were monitored on SCD for 52 weeks while maintaining all prescribed medications. Demographic, dietary and clinical information, PCDAI, Harvey Bradshaw (HB) and Lewis score (LS) were collected at 0, 12 and 52 weeks. CE’s were evaluated by an experienced reader blinded to patient clinical information and timing.

Results: Sixteen patients were screened; 10 enrolled; and 9 completed the initial 12 week trial; receiving 85 % of estimated caloric needs prior to, and 101%, on the SCD. HB significantly decreased from 3.3 + 2.0 to 0.6 + 1.3 (p = 0.007) as did PCDAI (21.1 + 5.9 to 7.8 + 7.1; p = 0.011). LS declined significantly from 2153 + 732 to 960 + 433 (p = 0.012). Seven patients continued the SCD to 52 weeks with HB (0.1 + 0.4) and PCDAI (5.4 + 5.5) remaining improved (p = 0.016 and 0.027 compared to baseline) with mean LS at 1046 + 372 and 2 patients showing sustained mucosal healing.

Impressions: Clinical and mucosal improvements were seen in children with CD using the SCD over 12 and 52 weeks. Additionally, CE can monitor mucosal improvement in treatment trials for pediatric CD. Further studies are critically needed to understand the mechanisms underlying SCD’s effectiveness in children with CD.

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Benefits of Gluten-Free Diet for “Asymptomatic” Celiac

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Here’s a link to the abstract: gastrojournal.org/article/S0016-…

Methods: “We performed a prospective trial of 3031 individuals at risk for celiac disease based on screens for EmA. Of 148 seropositive individuals, 40 fulfilled inclusion criteria and were randomly assigned to groups placed on a GFD or gluten-containing diets.”

Results: “The GFD group also had reduced indigestion (P=.006), reflux (P=.05), and anxiety (P=.025), and better health, based on the visual analog scale (P=.017), than the gluten-containing diet group.”

Take-home message: A gluten free diet improves symptoms (even in “asymptomatic” patients) with celiac disease

Comparing Biologics for Ulcerative Colitis

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A recent study has reviewed biologic therapies for ulcerative colitis (Ann Intern Med. 2014;160(10):704-711). Here’s the abstract link: bit.ly/1o5PpRX.

Data Synthesis: ..There were 7 double-blind, placebo-controlled trials that were rated as low risk of bias and showed that all biological agents (adalimumab, golimumab, infliximab, and vedolizumab) resulted in more clinical responses, clinical remissions, and mucosal healings than placebo for induction therapy. The results of network meta-analysis suggested that infliximab is more effective to induce clinical response (odds ratio, 2.36 [95% credible interval, 1.22 to 4.63]) and mucosal healing (odds ratio, 2.02 [95% credible interval, 1.13 to 3.59]) than adalimumab. No other indirect comparison reached statistical significance. For maintenance, 6 double-blind, placebo-controlled trials that were rated high risk of bias showed that all biological agents have greater clinical efficacy than placebo. The occurrence of adverse events was not different between biological agents and placebo.

Limitation: Few trials, no head-to-head comparisons, and inadequate follow-up in maintenance trials.

Conclusion: Biological agents are effective treatments for UC, but head-to-head trials are warranted to establish the best therapeutic option.

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Infliximab Compared to Adalimumab -Which is Better?

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Pharmaceutical companies are not motivated to provide a definitive answer on the title question.  A recent study (Clin Gastroenterol Hepatol 2014; 12: 811-17) states that “head-to-head clinical trials of anti-TNF therapies are unlikely to ever be undertaken because of the extreme cost to conduct such studies and the financial risk that such trials would entail for the manufacturers.”  The two most popular biologics, infliximab (IFX) and adalimumab (ADA), for inflammatory bowel disease have been incredibly successful (Multi-billion dollar biologics | gutsandgrowth).

The current study is “one of the first to directly compare the effectiveness” of IFX and ADA for Crohn’s disease.  The authors retrospectively examined a U.S. Medicare data cohort from 2006-2010 and identified new users with 1459 IFX and 871 ADA patients.  While 94% of Medicare enrollees are >65 years, this study had a range of patient ages due to those who received Medicare due to disability.  In fact, in the ADA group, ~60% were between 30-60 years and in the IFX group, ~44% were in this age group.

Key result:

  • After 26 weeks of treatment, 49% of patients receiving IFX remained on drug compared with 47% of those receiving ADA.
  • Fewer patients with IFX underwent surgery (5.5 vs 6.9 surgeries per 100 person-years) but this did not reach statistical significance.
  • Rates of hospitalization did not differ among the two groups

While persistence is an imperfect measure of effectiveness, the fact that surgeries and hospitalizations were similar indicates that the medications are likely to have similar clinical effectiveness, at least in this population.  Data on mucosal healing, more direct measures of effectiveness, and longer followup certainly would strengthen this conclusion.

My First Take: It is Hard to Save $$$ at a Rolls-Royce Dealership

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A recent article looked at a crucial issue –trying to deliver “best care at lower cost” (Inflamm Bowel Dis 2014; 20: 946-51).  “The goal of this report is to answer the primary question: What are implementable strategies and exploratory considerations for cost-efficient anti-TNF use while maintaining the highest quality of IBD care?”

The strategies that are discussed include the following:

  • Reduce costs of avoidable dose intensification of class switching by eliminating episodic anti-TNF use and improving patient education
  • Reduce over-utilization costs by accurately determining indication for escalating anti-TNF use
  • Reduce nondrug infliximab costs through shortened infusion times after initial safety is clearly established

Exploratory considerations:

  • Self-injectable anti-TNFs
  • Combination therapy
  • Monitoring anti-TNF drug levels and autoantibodies
  • Assessing mucosal healing as a clinical endpoint

The authors discuss both the exploratory issues and the strategies.  Some of each could easily increase costs, at least in the short-term, rather than reduce them.  The authors also make note of the development of an infliximab biosimilar (Inflecta) which could be approved in U.S. by 2015.

While the review article is a good read, in my opinion the authors fail to address in a meaningful way the larger context.  The costs for hospital-based care are enormous; pediatric hospitals are like Rolls-Royce dealerships; and by the way, if you have to ask how much it costs, you probably cannot afford it.  With regard to charges/costs, there is little transparency, high variability, and little accountability.  Understanding health care costs and trying to get a good deal is much harder than buying a car.

For IBD care, as an example, the authors make note of the cost of infliximab at one pediatric tertiary care center.  At this institution, “77% of the total health care cost for each infusion encounter” was for non-drug costs.  Given how expensive the drug cost is, the expense for an infusion is very high, but probably similar to many other pediatric hospitals.

If one is interested in reducing the costs of infliximab and other infusions, the first practical step would be to consider infusion outside of a hospital-based setting, such as an infusion center.  In such a setting, the patient safety would still be excellent but the costs would be less.

In Atlanta, there have been some high-profile hospital acquisitions that have increased health care costs (When doctors sell out, hospitals cash in | www.myajc.com).  In many circumstances, when a hospital acquires a physician practice, infusion center, or endoscopy center, the charges and reimbursement increase despite no change in clinical care.  In this way and many others, the current system promotes cost-inefficient care.

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AJG Celiac Practice Guidelines 2013 -Useful Link

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This full-text link to AJG Practice Guidelines for Celiac Disease 2013 (Am J Gastroenterol 2013; 108:656–676; doi:10.1038/ajg.2013.79) provides 45 evidence-based recommendations for diagnosis and management of celiac disease along with 264 references.  

Table of Contents for Article

Table of Contents for Article

Topics of particular interest

  • Whether to test first-degree relatives.  The article recommends testing in symptomatic individuals and consideration of testing in asymptomatic individuals
  • When to perform genetic testing
  • When to use tests besides tissue transglutaminase antibody (TTG IgA) (mainly in children less than 2 years)
  • Recommends against use of stool or salivary testing
  • How to approach refractory celiac disease
  • The limited circumstances which justify followup endoscopy

Potential Reasons for Genetic Testing:

Potential Reasons for Genetic Testing

Celiac vs. Gluten Sensitivity:

Celiac vs. Gluten Sensitivity

Bottomline: This practice guideline covers most of the issues dealing with celiac and gluten sensitivity –it is a useful reference.

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Understanding Idiopathic Nausea

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A recent article describes a retrospective chart review of 45 children with chronic nausea and compares them to 49 children with chronic abdominal pain (J Pediatr 2014; 164: 1104-09).

Key findings:

  • While onset of symptoms was similar, the chronic nausea cohort presented at a median age of 15 years compared with 12 years for the pain cohort.
  • Comorbid conditions like anxiety, dizziness and fatigue were common in chronic nausea cohort.
  • Family history of migraines was note in 71% of nausea cohort compared with 22% in pain cohort
  • Extensive laboratory and imaging was much more frequent in nausea cohort.  With nausea cohort, 78% had abdominal ultrasound, 60% an upper GI, 58% brain imaging with either a CT scan or MRI, 38% gastric emptying, 31% abdominal CT or MRI, and 24% had HIDA.
  • Almost all endoscopies were normal (98% of chronic nausea group and 100% of pain cohort)
  • For nausea cohort treatment, tricyclic antidepressants showed a good response (=at least 50% symptom improvement) in 44% with a mean maximal dose of 50 mg. In contrast, with proton pump inhibitors, only 22% had some improvement (=at least 25% symptom improvement).  Similarly, ondansetron showed some improvement in 50% –though none had a “good response.”
  • Twelve patients (27%) of the nausea cohort met diagnostic criteria for cyclic vomiting syndrome (CVS) (with interepisode nausea) and another nine (20%) developed chronic nausea after ‘outgrowing’ CVS.
  • Postural (orthostatic) tachycardia syndrome (POTS) was noted in 16 of 45 in the nausea cohort based on an orthostatic screen (heart rate ≥30 beats/min during positional changes from 10 minutes in supine position to standing.

As the authors note, their study, conducted between 2006-2012, had numerous limitations, particularly the relative small size and retrospective nature.  In addition, the physician expertise in nausea/vomiting at Children’s Hospital of Wisconsin predisposes to a selection bias.

Take-home message: Nausea can be a severe symptom but is often difficult to manage. Extensive workup has a low yield in absence of other complaints or physical exam findings.

An AGA technical review on nausea and vomiting was published in 2001: GASTROENTEROLOGY 2001;120:263–286 

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Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications/diets (along with potential adverse effects) should be confirmed by prescribing physician/nutritionist.  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.

 

Why I’m Not a Fan of the “1-Step” PEG

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A recent article describes a single-center retrospective review of the 1-Step Low-Profile percutaneous gastrostomy (PEG) tube (“EndoVive” from Boston Scientific) (JPGN 2014; 58: 616-20).  The potential rationale for the 1-Step PEG tubes:

  • 1-time procedure for a low-profile device

My personal experience with these devices is quite limited.  However, I did have one patient who resumed walking after placement of a 1-step dome device gastrostomy tube. He had stopped walking several months before, mainly due to some mild neurological problems.  After receiving this PEG tube, he said he was in so much pain when he was sitting down that he started walking again.  He was able to continue walking after switching to a different gastrostomy tube.  This particular ‘miracle’ explains one of the pitfalls of this device.  This patient had an embedded bolster.

In the current series, the authors’ conclusion was that the 1-step PEG “has complication rates and outcomes comparable with standard PEGs.”  However, their reported results suggest a higher rate of complications: embedded bolster occurred in 5%, cellulitis in 23% (6.6% needing IV antibiotics), and perforation occurred in 0.8%.

Given the relatively small number of patients (n=121 who met inclusion) and retrospective nature of the study, whether these complication rates are significantly higher is a matter of debate.  It should be noted that there may have been some selection bias given that there were only 31 patients less than one year in the study.

With regard to embedded PEG tubes, the authors note that this complication rate typically is 2.3% with a traditional PEG.  The authors minimize the discrepancy of their higher rate, noting the “importance of choosing the right size of the 1-step PEG.”  For those who perform this procedure, this admonition sounds easy but in practice can be problematic.  In addition, the main advantage of this procedure is the “1-step” procedure.  Yet  in Figure 2, the authors note that 67 (more than 50%) underwent a change to a balloon device.

Bottomline: The authors state that the 1-step PEG, “in our opinion, is a preferable PEG technique for children who need long-term enteral feeds.”  My opinion: I’m not a fan and think the 1-step, for initial placement, is less safe overall.

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Buckyball Recall –It’s Official

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From NASPGHAN twitter feed, 5/13/14: consumerfed.org/news/785

Consumer advocates and pediatric gastroenterologists applaud the Consumer Product Safety Commission’s announcement today that a settlement has been reached with Craig Zucker, the former CEO and President of the company that manufactured Buckyballs and Buckycubes, Maxfield and Oberton, which was dissolved in 2012.

High powered magnets, such as Buckyballs or Buckycubes, are bb-shaped smooth balls or cubes that connect to one another with a strong magnetic bond.  The magnets are individual balls or cubes that are sold in packages of many individual balls.  These products were originally sold as toys to children over 13 years of age, but after a recall in 2010, these products are sold to teens and adults age14 and older.  The new warning label that has appeared on the package of Buckyballs since the recall has not resulted in a decrease in serious injuries to children.  In November of 2011, CPSC issued a safety warning to consumers about this product but the injuries continue to occur.  In July of 2012, CPSC filed a law suit against the manufacturer of Buckyballs to issue a recall of these products. The settlement announced today is a resolution of that complaint…

Consumers will have six months to participate in the recall by requesting a refund.  The recall trust will be funded by Craig Zucker and will be overseen by the CPSC.

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Diarrhea -a Universal Experience

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To be clear, by the term “universal” I am in no way referring to a theme park.  A recent review in the NEJM (N Engl J Med 2014; 370:1532-1540) discusses acute diarrhea, http://nej.md/1l2bAIn .

“In the United States, there are approximately 179 million cases of acute diarrhea per year. This update on the diagnosis and management of acute diarrhea in immunocompetent adults gives particular attention to the roles of noroviruses and Clostridium difficile.”

This post is mainly to provide an up-to-date useful reference.