Sweet Alternative to Splenda for Budesonide

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A recent article (JPGN 2014; 59: 317-20) has shown that Neocate Nutra is a good alternative to splenda as a delivery vehicle for budesonide for children with eosinophilic esophagitis.

This retrospective review of 60 children treated with oral viscous budesonide (OVB) who used either splenda (n=46) or with Neocate Nutra (n=14).  With regard to budesonide, in patients less than 10 years, the dose was 1 mg/day and older children received 2 mg/day.  For splenda patients, 10 packets were used to create a slurry whereas with Neocate Nutra powder the amount was 2.5 cm3 per milligram of budesonide.  Followup endoscopy took place at least 10 weeks after the start of treatment.

Key findings:

  • 13 of 14 Neocate Nutra patients achieved a histologic response (peak eosinophils <15/hpf) compared with 30 of 46 Splenda patients.
  • Mean eosinophil count dropped from 62 to 9 for Neocate Nutra patients and from 59.5 to 25.5 for Splenda patients.

Limitations of study: small number, retrospective study.

Take-home message: Neocate Nutra is at least as effective as Splenda as mixture with budesonide.  In addition, many parents may prefer to avoid Splenda.

Related blog posts:

Four Food Group Diet for Adults with Eosinophilic Esophagitis

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A recent study published online (here’s a link: EoE 4-food Group Diet) shows that a four food elimination diet was effective in 54% of the adults in this study.  Here’s the abstract:

Background

Eosinophilic esophagitis (EoE) is an esophageal disorder predominantly triggered by food antigens. A six-food group elimination diet (SFGED) achieves remission in more than 70% of adult patients with EoE. After individual food reintroduction, just 1 or 2 food triggers for EoE can be identified in 65% to 85% of the patients, so some dietary restrictions and endoscopies after food challenge may be unnecessary.

Objective

To evaluate the efficacy of a four-food group elimination diet (FFGED) (dairy products, wheat, egg, and legumes) for adult patients with EoE.

Methods

Prospective multicenter study. All patients were reevaluated after 6 weeks on an FFGED. Response to the FFGED was defined by clinical and histologic (<15 eos/hpf) remission. Responders underwent reintroduction of each individual food over 6 weeks followed by endoscopy and esophageal biopsies. Nonresponders were offered a rescue SFGED.

Results

A total of 52 adult patients were included, of whom 12 patients (23%) had previous failure to topical steroid therapy. Twenty-eight of the 52 patients (54%) achieved clinicopathologic remission on the FFGED and 6 of the 19 (31%) nonresponders to the FFGED were successfully rescued with the SFGED. Twenty-two of 28 responders to the FFGED (78%) finished the individual food reintroduction challenge. Milk was identified as an EoE trigger in 11 patients (50%), egg in 8 (36%), wheat in 7 (31%), and legumes in 4 (18%). All patients had just 1 or 2 food triggers, with milk being the only causative food in 27% of the patients.

Conclusions

An FFGED achieved clinicopathologic remission in 54% of adult patients with EoE. An SFGED was effective in almost a third of FFGED nonresponders, resulting in a combined efficacy of 72% of both strategies.

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What is the Role for Allergy Testing in Eosinophilic Esophagitis?

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A recent review article (Clin Gastroenterol Hepatol 2014; 12: 1216-23) summarizes the potential role of allergy testing for eosinophilic esophagitis (EoE).

The article summarizes the potential ways to use various allergy testing and reviews the literature on its effectiveness.  The article notes a couple of key points:

  • Overall, using skin prick testing (SPT) and atopy patch testing (APT), allergy testing has not proved more reliable then empirically administering a 6-food elimination diet.  Thus, “the issue remains whether food allergy testing provides a useful tool in EoE.” However, targeted testing-based diets (especially in children) may require elimination of fewer foods.
  • “Serum IgE food-specific IgE panels should not be used for EoE.”  “Testing for foods, especially IgE testing, leads to recognition of food sensitizations that may not be clinically relevant and that on elimination, could result in the loss of tolerance to the food.”
  • Testing for milk allergy is noted have a high false negative rate.
  • IgG based testing is not recommended.  In fact, IgG immunoglobulins are “associated with tolerance rather than allergy.”
  • “Only 8% of children will become tolerant to all foods that cause their EoE.”

Bottomline: While foods commonly triggers EoE, the tests to identify these foods are far from perfect. I find that families are quite uninformed about the frequent lack of correlation between allergy testing and true EoE triggers.

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Summary of article: GI & Hepatology News August 2014 Role of Allergy Testing in EoE

Elimination Diets for Eosinophilic Esophagitis in Adults

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A recent study shows that elimination diets, including a six-food group elimination diet (SFED) can be effective in adults with eosinophilic esophagitis (EoE) (Clin Gastroenterol Hepatol 2014; 12: 1272-79).

This retrospective study identified 31 adults (mean age 36 years) who underwent dietary therapy between 2006-2012.  22 had a targeted elimination diet (TED) and 9 had SFED.

Key findings:

  • Symptoms improved in 71% (68% TED, 78% SFED)
  • Endoscopic appearance improved in 54% (53% TED, 56% SFED)
  • 39% had eosinophil count drop below 15 eos/hpf (32% TED, 56% SFED).  Overall in the entire cohort, mean eosinophil count dropped from 78 eos/hpf at baseline to 43 dos/hpf.
  • Among the nine responders with food reintroduction, the most common foods identified as triggers (using food reintroduction) were milk (4), egg (4), wheat (2), shellfish (1), and legumes (1).

 

Unexpected Out-of-Network Charges ($117,000)

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A recent NY Times articles details a financial problem that really is a disgrace —unexpected out-of-network charges.

Here’s an excerpt:

Before his three-hour neck surgery for herniated disks in December, Peter Drier, 37, signed a pile of consent forms. A bank technology manager who had researched his insurance coverage, Mr. Drier was prepared when the bills started arriving…

He was blindsided, though, by a bill of about $117,000 from an “assistant surgeon,” a Queens-based neurosurgeon whom Mr. Drier did not recall meeting…

In operating rooms and on hospital wards across the country, physicians and other health providers typically help one another in patient care. But in an increasingly common practice that some medical experts call drive-by doctoring, assistants, consultants and other hospital employees are charging patients or their insurers hefty fees. They may be called in when the need for them is questionable. And patients usually do not realize they have been involved or are charging until the bill arrives…

In recent years, unexpected out-of-network charges have become the top complaint to the New York State agency that regulates insurance companies…

Out-of-Network Rates Drive Unexpected Medical Costs

When out-of-network physicians perform hospital procedures, hefty charges can be added to medical bills. Insurers often pay the full amount or large portions, which provides an incentive for doctors to include out-of-network colleagues.

Genetics of Autoimmune Hepatitis

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Briefly noted:

Recently, the first genome-wide association identified mutations associated with type 1 autoimmune hepatitis (AIH1) (Gastroenterol 2014; 147: 443-52).

Cohort: 649 Dutch adults with AIH1 and 13,436 controls

Findings: prominent association with rs2187668 (associated with variants in the major histocompatibility complex region) and with variants of SH2B3 (rs3184504) and CARD10 (rs6000782)

Interpretation (from authors): “These findings support a complex genetic basis for AIH pathogenesis and indicate that part of the genetic susceptibility overlaps with that for other immune-mediated liver diseases.”

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Adalimumab Gains FDA Approval for Use in Children

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Medications used in pediatrics often do not have a “pediatric indication” on their FDA-approved labeling.  Until recently, one of those medications included adalimumab (Humira).

Sept 25, 2014 (From MSN Money):  The Food and Drug Administration cleared Humira as a treatment for moderate to severe Crohn’s disease in children ages 6 and older when those children haven’t been helped by other treatments, AbbVie said. The North Chicago, Illinois, company said Humira can be administered at home, unlike similar drugs used to treat the condition. During the second quarter, revenue from Humira jumped 26 percent to $3.29 billion.

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NASPGHAN “Best Practices Cleanout Regimens”

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The authors of a recent report (JPGN 2014; 59: 409-16) acknowledge that “bowel regimens vary significantly” and “few clinical studies in pediatrics have evaluated the use of various bowel preparation regimens.” Furthermore, “pediatric studies did not have a common efficacy measure.”

Nevertheless, they provide a “NASPGHAN best practices cleanout regimens.”  According to Table 7:

  • Option 1: PEG-3350 (eg. Miralax) -1-day cleanout:  If less than 50 kg, then 4 g/kg/day + bisacodyl 5 mg.  If >50 kg, then 238 g in 1.5 L sports drink + bisacodyl 10 mg.   PEG-3350 administered over 4-6 hours.
  • Option 2: PEG-3350 -2-day cleanout: If <50 kg, then 2 g/kg/day + bisacodyl 5 mg; if >50 kg, then 2 g/kg/day + bisacodyl 10 mg.
  • Option 3: NG cleanout: PEG-ELS (eg. Nulytely) 25 mL/kg/h (max 450 mL/h).  NG cleanouts mainly in those with history of failed preps or other adherence problems (eg. vomiting).
  • Option 4: non-PEG cleanout: Magnesium citrate 4-6 mL/kg/day + bisacodyl 5-10 mg.

My personal opinion is that Table 7 could drop the words “best practices” since the report states “alternative dosing regimens may be entirely reasonable” and the data are quite limited.

With regard to split dosing preparations which are now recommended in adults, their role in pediatrics is a “potential area for future research.” For adults, the U.S. Multi-Society Task Force Consensus Statement on Adequate Bowel Cleansing for Colonoscopy (Johnson DA et al. Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations from the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology 2014; 147(4):903-924) recommends:

  • Use of a split-dose bowel cleansing regimen is strongly recommended for elective colonoscopy, meaning roughly half of the bowel cleansing dose is given the day of the colonoscopy.
  • The second dose of split preparation ideally should begin four to six hours before the time of colonoscopy with completion of the last dose at least two hours before the procedure time.
  • During a split-dose bowel cleansing regimen, diet recommendations can include either low-residue or full liquids until the evening on the day before colonoscopy. 

Take-home message: This NASPGHAN report summarizes the literature and provides recommendations for effective bowel preparations.

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Difficult Boundaries in Patient Care

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An interesting article in the NEJM (here’s link to full text: No Appointment Necessary?) explores the ethical and practical challenges of being asked to help in the care of friends and families.  These issues are definitely not abstract.  I would be surprised if most physicians have not received multiple requests for advice or for prescriptions.  Some of the potential problems listed include the following:

  • feeling pressured to practice outside their area of expertise
  • lack of complete information about the problem
  • not asking for sensitive information
  • emotional investment/loss of perspective
  • conflict of interest
  • potential for guilt/remorse if clinical error
  • poor documentation

The article notes that “the very first code of medical ethics drafted by the American Medical Association (AMA) in 1847 recommended against physicians treating family members, stating that “the natural anxiety and solicitude which he [the physician] experiences at the sickness of a wife, a child . . . tend to obscure his judgment, and produce timidity and irresolution in his practice.”

Yet, in practice, “a 1991 study showed that 99% of surveyed physicians reported having received requests from family members for medical advice, diagnosis, or treatment, and 83% had prescribed medications for relatives.6  Physicians cite convenience as a key reason to provide this care, but other explanations have included a wish to save the relative money as well as a belief that ‘I provide the best care.’”

Take-home message (from the authors): It is our hope that providers will think through the potential ethical conflicts before offering informal care. We also urge providers who are involved in medical education to help trainees understand the ethical boundaries of care as part of their professional role and encourage them to refrain from treating friends, family members, and themselves.

 

Brave New World: Psychotropic Manipulation & Pediatric Functional GI Disorders

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A recent review (JPGN 2014; 59: 280-87) provides helpful advice for the use of psychotropic medications in pediatric functional GI disorders.  That being said, a couple key caveats need to be stated first and foremost:

  • “A minority of psychotropic drugs has been studied in children and safety data remain inadequate.  Psychotropic drugs used for gastrointestinal symptoms in pediatric patients will be off-label for the foreseeable future.”
  • “Descriptions of individual drugs in the present review are too brief to provide accurate guidance to someone who is not already familiar with them.”

Given the limited data, the authors, in my opinion, bravely state recommendations regarding these medications.  Despite their common usage, providing explicit recommendations is quite uncommon.  The title of the blog references Aldous Huxley’s book which discusses psychological manipulation.  This book in turn is titled after a line from Shakespeare’s The Tempest, Act V, Scene I (from Wikipedia):

“O wonder!
How many goodly creatures are there here!
How beauteous mankind is! O brave new world,
That has such people in’s.”

Back to the review of psychotropic medications, the authors provide a rationale/pathophysiologic mechanism for the use of these drugs mainly for recurrent abdominal pain and chronic nausea/dyspepsia.  Table 1 lists the authors’ specific suggestions regarding first to fourth choices:

  • For abdominal pain, first choice was amitriptyline, followed by gabapentin, clonidine patch, and SSRI.
  • For nausea/dyspepsia,  first choice was amitriptyline, followed by mirtazapine, buspirone, and clonazepam.
  • For d-IBS,  first choice was amitriptyline, followed by alosetron [not a psychotropic], clonidine patch, and SSRI.
  • For c-IBS (along with polyethylene glycol),  first choice was imipramine, followed by lubiprostone [not a psychotropic], gabapentin, and SSRI.

Table 2 provides dosing suggestions, and common adverse effects.  For example, with amitriptyline, suggested dose is 10-50 mg qhs and “best to begin low dose…titrate up by response.” Other suggestions:

  • SSRIs: “should begin with low dose; titrate up by response.  With SSRIs, benefit is usually apparent after 4 to 6 wk.  Most GI adverse effects disappear in 1 to 2 wk.”
  • Mirtazapine: 7.5 mg dosing for sleep, 15-30 mg qAM for nausea/dyspepsia (higher dose is usually not sedating.  “Few drug interactions; safer than TCAs.” Weight gain is common.
  • Buspirone: 10-60 mg/day, divided twice daily; “may start with half dose in the morning.” Avoid grapefruit juice. Can “used alone or in combination with SSRIs or TCAs.”
  • Gabapentin (100 mg BID to 800 mg TID). “Rare adverse effects include drowsiness and blurred vision…Safe but only effective in about one-third of patients.”
  • Recommends that second-generation antipsychotics (quetiapine, risperidone, and olanzapine) be used only in collaboration with child psychiatry (Figure 2)

Additional pointers:

TCAs:“In RCTs, among children with functional abdominal pain, both amitriptyline and placebo were associated with an excellent therapeutic response.”  It is interesting to note the authors lack of critical comments regarding this statement.  “The usual dose of amitriptyline for chronic functional pain is 1 mg/kg/day up to a maximum of 50 mg/day.”

TCAs and EKGs: “at doses <1 mg/kg/day used to treat chronic pain and nausea, there have been no reports of death or cardiac arrhythmias in >60 years.  An EKG before starting a TCA is unnecessary in otherwise healthy children and adolescents, but may be advisable in those with a personal or family history of corrected QT interval prolongation or heart disease, or in children requiring a dose >50 mg/day.”

TCAs: some tricyclics may be less sedating and constipating including imipramine, doxepin, and nortriptyline.  The later two also come in liquid formulations.

SSRIs: “may be used in combination with TCAs in teens and adolescents…using them simultaneously may increase serum concentrations of both.” “In children there was a single RCT showing citalopram superior to placebo in IBS. Some clinicians obtain an EKG assessing corrected QT interval before initiating citalopram doses >20 mg daily.”

Clonidine has “improved diarrhea-predominant IBS…Common adverse effects include dry mouth, drowsiness, dizziness, and tiredness…checking blood pressure at each clinic visit [is recommended].” It is available as a patch (0.1-0.3 mg/wk).

Melatonin: dosed 3- to 10-mg at bedtime can promote sleep.

Take-home message: This article provides practical advice for the use of these agents.  Discussion with patients and parents regarding the role of these medications in targeting CNS arousal which perpetuates disabling chronic symptoms is crucial as well.  More studies are needed to determine conclusively their effectiveness.

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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.