Author Archives: gutsandgrowth

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About gutsandgrowth

I am a pediatric gastroenterologist at GI Care for Kids (previously called CCDHC) in Atlanta, Georgia. The goal of my blog is to share some of my reading in my field more broadly. In addition, I wanted to provide my voice to a wide range of topics that often have inaccurate or incomplete information. Before starting this blog in 2011, I would tear out articles from journals and/or keep notes in a palm pilot. This blog helps provide an updated source of information that is easy to access and search, along with links to useful multimedia sources. I was born and raised in Chattanooga. After graduating from the University of Virginia, I attended Baylor College of Medicine. I completed residency and fellowship training at the University of Cincinnati at the Children’s Hospital Medical Center. I received funding from the National Institutes of Health for molecular biology research of the gastrointestinal tract. During my fellowship, I had the opportunity to work with some of the most amazing pediatric gastroenterologists and mentors. Some of these individuals included Mitchell Cohen, William Balistreri, James Heubi, Jorge Bezerra, Colin Rudolph, John Bucuvalas, and Michael Farrell. I am grateful for their teaching and their friendship. During my training with their help, I received a nationwide award for the best research by a GI fellow. I have authored numerous publications/presentations including original research, case reports, review articles, and textbook chapters on various pediatric gastrointestinal problems. In addition, I have been recognized by Atlanta Magazine as a "Top Doctor" in my field multiple times. Currently, I am the vice chair of the section of nutrition for the Georgia Chapter of the American Academy of Pediatrics. In addition, I am an adjunct Associate Clinical Professor of Pediatrics at Emory University School of Medicine. Other society memberships have included the North American Society for Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN), American Academy of Pediatrics, the Food Allergy Network, the American Gastroenterology Association, the American Association for the Study of Liver Diseases, and the Crohn’s and Colitis Foundation. As part of a national pediatric GI organization called NASPGHAN (and its affiliated website GIKids), I have helped develop educational materials on a wide-range of gastrointestinal and liver diseases which are used across the country. Also, I have been an invited speaker for national campaigns to improve the evaluation and treatment of gastroesophageal reflux disease, celiac disease, eosinophilic esophagitis, hepatitis C, and inflammatory bowel disease (IBD). Some information on these topics has been posted at my work website, www.gicareforkids.com, which has links to multiple other useful resources. I am fortunate to work at GI Care For Kids. Our group has 17 terrific physicians with a wide range of subspecialization, including liver diseases, feeding disorders, eosinophilic diseases, inflammatory bowel disease, cystic fibrosis, DiGeorge/22q, celiac disease, and motility disorders. Many of our physicians are recognized nationally for their achievements. Our group of physicians have worked closely together for many years. None of the physicians in our group have ever left to join other groups. I have also worked with the same nurse (Bernadette) since I moved to Atlanta in 1997. For many families, more practical matters about our office include the following: – 14 office/satellite locations – physicians who speak Spanish – cutting edge research – on-site nutritionists – on-site psychology support for abdominal pain and feeding disorders – participation in ImproveCareNow to better the outcomes for children with inflammatory bowel disease – office endoscopy suite (lower costs and easier scheduling) – office infusion center (lower costs and easier for families) – easy access to nursing advice (each physician has at least one nurse) I am married and have two sons (both adults). I like to read, walk/hike, bike, swim, and play tennis with my free time. I do not have any financial relationships with pharmaceutical companies or other financial relationships to disclose. I have helped enroll patients in industry-sponsored research studies.

“If all you have is a hammer…”

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In my training, one of my mentors would be critical of the mentality “scope first, think second.”  He was concerned that too many gastroenterologists/pediatric gastroenterologists used endoscopy as a tool simply “because if all you have is a hammer, the world looks like a nail.”

A recent publication (Clin Gastroenterol Hepatol 2014; 12: 963-69) on first glance, however, provides ammunition to the “scope first” gastroenterologists and undermines the concept that “functional” GI disorders vastly outnumber “organic” GI disorders.  The key finding was that esophagogastroduodenoscopy (EGD) provided an “accurate” diagnosis in 38%.  This included reflux esophagitis in 21%, eosinophilic esophagitis (EoE) in 5%, eosinophilic gastroenteritis (EGE) in 4%, H pylori in 2%, celiac disease 0.6%, and Crohn’s disease 0.4%. This finding is dramatically higher than previous studies.  In fact, in a recent published study (Understanding Idiopathic Nausea | gutsandgrowth) on idiopathic nausea, a control group of patients with chronic abdominal pain had a normal endoscopy in 100%!

In this prospective study of 290 children (ages 4-18 years with a mean age of 11.9 years), the primary indication for upper endoscopy was chronic abdominal pain.  Of this 290, 216 had at least 1 alarm feature and 125 had at least 2 alarm features.  Alarm features were considered to be the following:

  • Nighttime awakening 33.3%
  • Weight loss 15.6%
  • Family history of IBD 8.4%
  • Vomiting 7.8%
  • Dysphagia 6.9%
  • Nocturnal diarrhea 6.7%
  • Gastrointestinal bleed 5.8%
  • Chronic diarrhea 5.8%
  • Unexplained fever 4.4%
  • Arthralgia 4.0%
  • Growth failure 2.4%
  • Perirectal disease 0.7%
  • Delayed puberty 0.2%

There is little debate that abdominal pain in combination with true alarm symptoms (True red flags in recurrent abdominal pain | gutsandgrowth) merits further evaluation.  The aspect of this report that is worthy of close inspection is the diagnostic yield in the 74 patients without alarm symptoms.  The authors note that 25 (33.7%) had a diagnosis established with EGD including 16 with reflux esophagitis, 4 with EGE, 2 with EoE, 1 with erosive esophagitis, 1 with celiac and 1 with H pylori.  The diagnostic criteria for EGE included ≥10 eosinophils per hpf in the stomach and ≥20 eosinophils per hpf in the duodenum.

The authors note that the diagnostic yield was based on gross endoscopic findings in procedure notes or histologic changes in biopsy reports; “final pathology report on biopsies provided the data source for histologic diagnosis.”

In my opinion there are multiple flaws of this prospective study.

1. There is a very high rate of reflux esophagitis in both the alarm group and the non-alarm group patients with chronic abdominal pain.  Of the entire cohort (n=290), the authors identified reflux esophagitis in 21% and this was “primarily histologic esophagitis.”  Furthermore, the authors state that “the presence or response to PPI therapy was not predictive of esophagitis or GERD.”  So, the obvious problems:

  • Presence of histologic reflux esophagitis varies widely based on the interpreting pathologist.  In a prospective study, more than one pathologist interpreting the histology would be useful.
  • Presence of histologic reflux esophagitis does not exclude the likelihood of coexisting functional disorders (related blog post: Why didn’t patient with documented reflux get better with PPI …).  As a practical matter, “slight” or “focal” esophagitis on histology has questionable real-world relevance in pediatric gastroenterology.
  • The authors acknowledge, “current expert consensus indicates that histology has limited value in evaluating pediatric GERD.”  Yet this diagnostic finding is one of the reasons why the authors claim that EGD is so valuable.

2. In the entire cohort, the authors try to validate their findings by indicating that identification of a diagnosis led to medical therapy that was “effective in approximately 67%” of children with short-term followup. (Only 81% had short-term followup outcomes available).  Yet, there is no control group.  How many children with chronic abdominal pain will improve for a short period without an EGD-based diagnosis?  The answer: a lot of them.

3. Limitations include selection bias toward those with more severe symptoms or alarm symptoms.  In addition, this study included only a small number who were considered to have no alarm symptoms.  Finally, the short-term followup makes conclusions about the response to therapy questionable.

This study will be a useful reference for any pediatric gastroenterologist who wants to justify the need for an endoscopy.  The authors note “the majority of children in our study (93%) met criteria for functional gastrointestinal disorders, and a significant proportion (38%) still had significant histologic findings.  Therefore, we conclude the Rome III criteria alone are not sufficient to identify children who require upper endoscopy, and screening for alarm symptoms has limited utility.”

In my opinion, the reliance on histology as well as selection bias weaken the findings of this study.  If a patient with a histologic diagnosis of reflux (or several other entities) and a presentation of chronic abdominal pain does not improve, the pediatric gastroenterologist should remember that only “a poor carpenter blames his tools.”

Bottomline: EGD remains an important tool in evaluating abdominal pain.  However, I think this study substantially overestimates its utility.

Related blog posts:

 

 

 

 

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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An Inside Look at the VA: “Hidden Lists” and “Watershed Moment”

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Here’s a different view of the VA, from a practicing physician, and an excerpt:

“Nowhere else than at the VA have I felt as much that I was a part of something greater than myself. We “care for him who shall have borne the battle” in a system that, for all its woes, remains a singular presence in the confused patchwork of medical care that is American medicine. Enter the VA medical system and you know that your critical medical data are available to every provider at every VA hospital in the country in ways unimaginable in the private sector; you know that care delivered in the VA system often meets or exceeds the quality standards of the private sector.1You know, moreover, that you and the person sitting next to you in the waiting room will get the same level of care, because there is no mysterious and fickle insurer to reckon with at the end of the appointment.

I don’t know what happened in Phoenix or elsewhere, what those hidden lists hold, what grief lies there. I wish those reporting on this scandal would do more to separate issues of access to care from problems with the quality of care. I do know that, all around the country, physicians who trained at the VA or who have chosen to live out their medical career with the VA have their own hidden lists, their indelible memories of men and women who entrusted their care to us. Let us continue to work for them.”

A second article “Watershed Moment,” summarizes the current problems and what needs to be done.  Here’s an excerpt:

“Yet access to care, particularly to outpatient appointments, has been an enduring problem for the VA, as documented in multiple reports from the OIG and the Government Accountability Office (GAO)… A key reason was inconsistency in the recording and tracking of wait times according to the “desired date,” defined as the date by which a patient wants to be seen or a health care provider wants him or her to be seen.1 A preliminary VA audit showed that 13% of scheduling staff — at 64% of the 258 surveyed facilities — had been instructed to enter a different desired date than that requested by the veteran, though it remains unclear what proportion of these changes represents willful falsification.2

There is anecdotal evidence that scheduling issues led to adverse health outcomes for veterans in Phoenix and elsewhere; more systematic assessments are under way. However, there is precedent for concern, since a September 2013 OIG report concluded that delayed gastroenterology consultations for colon-cancer screening had led to delayed diagnoses for more than 50 veterans, some of whom ended up dying of colon cancer.3

Beyond access to care, health system performance should be evaluated on the basis of health outcomes, the quality and safety of the care delivered, patient satisfaction, and costs. In many of these domains, the VA has kept pace with or surpassed private-sector health systems

 

The VA is a historic institution with a long tradition of providing care to former military service members. In recent years, the agency has made progress in addressing a backlog of disability claims and in sharply reducing veterans’ homelessness. In the 1990s, VA health care, facing a similar crisis of confidence and bipartisan calls for privatization, was transformed into a more technologically advanced, decentralized, and quality-oriented system. Now it needs to protect the best elements of its infrastructure, built around longitudinal, holistic care of each veteran, while embarking on another round of reforms.“

 

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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“Do Unto Others”

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A recent article from NY Times discusses the topic of advance directives and how physicians are likely to choose a “no code” status for themselves rather than heroic measures if faced with a terminal illness.

Here’s a link:  What doctors would choose and an excerpt:

Young doctors… 88.3 percent would choose a do-not-resuscitate or “no code” status. An allow-me-to-die status, in other words.  “Doctors see a lot,” Dr. Periyakoil told me later that day. Resuscitation attempts are so aggressive — likely to break an older patient’s ribs but unlikely to restore them to their previous state of health or function —that after witnessing several, “you know too much and you’re much more wary,” she said.

Perhaps readers here remember a much-circulated web essay by Dr. Ken Murray, a retired family practitioner, called “How Doctors Die.” He claimed that his fellow physicians largely reject the sort of high-tech care they routinely dispense to their patients.

Take-home message: Physicians frequently provide high-intensity heroic measures to many of their patients which they usually would reject for themselves.  Even in pediatrics, frequently parents demand that “everything be done” when many physicians would advise otherwise.

Is Water The Best Beverage for Dieters? Maybe Not

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According to a recent study in Obesity (2014; 22: 1415-21), during the first 12 weeks of a weight loss program water is not as helpful as non-nutritive sweetened drinks (eg. diet soda) when trying to lose weight (Thanks to Jeff Schwimmer for this reference).

The study describes the findings from the 12-week weight loss phase of a 1-year randomized, clinical trial to test the hypothesis that the amount of weight lost (12 weeks) and maintained (9 months) in a behavioral weight management program will be equivalent in participants consuming beverages containing non-nutritive sweetened beverages (NNS) compared to water.

  • Demographics: n=303, mean age ~48 years, 82% female, mean BMI 33
  • Design: “Participants randomized to the NNS beverage group were asked to consume at least 24 fluid ounces of NNS beverage per day and their water consumption was not restricted. An NNS beverage qualified if it had <5 kcal per 8 ounce-serving, was pre-mixed, and contained non-nutritive sweeteners.” Similarly, in the water group, individuals were instructed to consume at least 24 fluid ounces of water per day, and not drink any NNS beverages.
  • Results: “The two treatments were not equivalent with the NNS beverage treatment group losing significantly more weight compared to the water group (5.95 kg versus 4.09 kg; P < 0.0001) after 12 weeks. Participants in the NNS beverage group reported significantly greater reductions in subjective feelings of hunger than those in the water group during 12 weeks.”
  • Conclusion: “These results show that water is not superior to NNS beverages for weight loss during a comprehensive behavioral weight loss program.”

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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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When “All-Natural” Really Isn’t

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A recent tweet from David Kessler provided this link, fooddive.com/news/the-case-…, regarding all-natural products and recent spate of lawsuits:

Here’s an excerpt from “The case against ‘all-natural’:

But how “natural” is the “natural” label? It might be a bit more misleading than you think. The U.S. Food and Drug Administration admits it doesn’t even have a hard-and-fast definition on what the term means. The agency also doesn’t object to a product being labeled as such, so long as “the food does not contain added color, artificial flavors, or synthetic substances.”

However, some consumers just aren’t buying that “all-natural” claim, and there have already been many notable court cases to prove it. Here’s a roundup of five recent lawsuits forcing food producers to cough up cash and remove labels after products didn’t live up to their farm-to-store promise.

Five recent lawsuits -highlighted in article

  • Kashi
  • Nature Valley
  • PopChips
  • Naked Juice
  • Tropicana Orange Juice

In a related post, ClarkHoward.com discusses how labels are misleading:

Here’s the link: 5 Label Tricks

“Food labels like “organic,” “free range,” “all natural,” and “multigrain” don’t necessarily mean what you think.”  He provides specific advice to avoid buying a misleading product.