Nutrition Group: OK to Continue Red Meat Consumption

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Here’s the full text study: Unprocessed Red Meat and Processed Meat Consumption: Dietary Guideline Recommendations From the Nutritional Recommendations (NutriRECS) Consortium (Published: Ann Intern Med. 2019. DOI: 10.7326/M19-1621)

In the same issue, there are several studies and an associated commentary: Meat Consumption and Health: Food for Thought by Aaron Carroll and Tiffany Doherty.

  • The recommendations from this study relate to the health effects of meat consumption.  Considerations of environmental impact or animal welfare did not bear on the recommendations.
  • “We developed the Nutritional Recommendations (NutriRECS) international consortium to produce rigorous evidence-based nutritional recommendations adhering to trustworthiness standards…”
  • “We suggest that individuals continue their current consumption of both unprocessed red meat and processed meat (both weak recommendations, low-certainty evidence).”
  • “Despite our findings from our assessment of intake studies versus dietary pattern studies suggesting that unprocessed red meat and processed meat are unlikely to be causal factors for adverse health outcomes (13, 14, 16), this does not preclude the possibility that meat has a very small causal effect.”
  • “Other dietary guidelines and position statements suggest limiting consumption of red and processed meat because of the reported association with cancer (1, 2, 44–46).”
  • “In terms of how to interpret our weak recommendation, it indicates that the panel believed that for the majority of individuals, the desirable effects (a potential lowered risk for cancer and cardiometabolic outcomes) associated with reducing meat consumption probably do not outweigh the undesirable effects (impact on quality of life, burden of modifying cultural and personal meal preparation and eating habits). The weak recommendation reflects the panel’s awareness that values and preferences differ widely, and that as a result, a minority of fully informed individuals will choose to reduce meat consumption.”**

A useful commentary from the NY Times: Eat less Red Meat, Scientists Said. Now Some Believe That Was Bad Advice.

An excerpt:

{According to the new report] If there are health benefits from eating less beef and pork, they are small, the researchers concluded. Indeed, the advantages are so faint that they can be discerned only when looking at large populations, the scientists said, and are not sufficient to tell individuals to change their meat-eating habits…

Already they have been met with fierce criticism by public health researchers. The American Heart Association, the American Cancer Society, the Harvard T.H. Chan School of Public Health and other groups have savaged the findings…

Dr. Hu, of Harvard, in a commentary published online with his colleagues. Studies of red meat as a health hazard may have been problematic, he said, but the consistency of the conclusions over years gives them credibility…

Questions of personal health do not even begin to address the environmental degradation caused worldwide by intensive meat production. Meat and dairy are big contributors to climate change, with livestock production accounting for about 14.5 percent of the greenhouse gases that humans emit worldwide each year.

My take:  Though the title says it is ‘OK to Continue Red Meat Consumption’ –overall, my suspicion is that limiting red meat is probably good for one’s health, though the effect is probably small.

**After publication of these guidelines, it was subsequently revealed that lead author had not disclosed previous research ties to meat and food industry.  See Here: Scientist Who Discredited Meat Guidelines…

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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.

What Is The Evidence That Biliary Atresia Starts in Utero?

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A good read: KR Mysore, BL Shneider, S Harpavat. JPGN 2019; 69: 396-403.

This review dissects the evidence that biliary atresia (BA) most often begins in utero.

Key points:

  • Infants with BA have elevated conjugated/direct bilirbuin at birth.
  • Infants with BA have biliary abnormalities on fetal ultrasound (eg. gallbladder abnormalities, biliary cysts).
  • Infants with BA have abnormal gamma-glutamyl transferase levels in their amniotic fluid with low levels noted at gestational age 18-19 weeks.  This finding is not specific for BA as other conditions that affect biliary tree (eg. cystic fibrosis, trisomy 21) can have low levels as well.
  • BA is more common in premature infants.
  • Early recognition is important. In U.S (from 1976-89), transplant-free survival rates were 63% for Kasai when done in 1st 30 days, 44% for 30-60 days, 40% for 60-90 days, and 29% if >90 days.
  • A diagnostic approach is given in Figure 2 but is already out of date due to the availability of MMP-7 testing (article received by JPGN in January 2019).

This review also lists numerous current investigative therapies which include probiotic, steroids, desflurane/sevoflurane (anesthetics), pentoifyline, IVIG, vancomycin, meloxicam, GCSF, Bone marrow stem cells, N-acetylcysteine, and obeticholic acid.

My take: This article shows that the clock on liver injury begins in utero in most cases of BA and this will have implications on pathogenesis and management.

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Cannon Beach, OR from Ecola State Park

Dietary Therapy for Inflammatory Bowel Disease –Useful Update

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Recently, Lindsey Albenberg, DO (from CHOP) provided an excellent update on dietary therapy for Crohn’s disease.  She was an invited speaker from CHOA as part of a nutritional support professional development series.  Thanks to Kipp Ellsworth for coordinating this.

Full Slide Set: Nutritional therapies for IBD

Key points from lecture:

  • At CHOP, exclusive enteral nutrition (EEN) is the main dietary approach for Crohn’s disease (CD) advocated due to better proof of its effectiveness
  • In children, EEN is as effective as steroids for clinical improvement and better in terms of mucosal healing
  • EEN therapy can be given regardless of CD location
  • For EEN, there is no difference in response between elemental and nonelemental formulas
  • For EEN to be effective, at least 80-90% of all calories need to be administered during induction
  • At CHOP, EEN is often administered at time of diagnosis and oral approach is tried first
  • Newer dietary approaches are being studied and may be effective.  Diets like the specific carbohydrate diet (SCD) can be considered, particularly in patients with milder disease.

 

The following slide presents SCD diet studies –mostly small studies except for 2016 survey study.

Related blog posts:

 

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

 

Improving Fatty Liver Disease Nomenclature

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Those who follow this blog regularly know that I have frequently agreed with articles suggesting improving/updating nomenclature for many conditions including the following:

A recent commentary (M Eslam et al. Gastroenterol 2019; 157: 590-3) suggests that fatty liver diseases could use a nomenclature makeover as well.

In pediatrics, the issue of alcoholic and nonalcholic fatty liver disease (NAFLD) overlap is fairly minor in many ways.  In fact, when I am seeing a young teen with NAFLD, parents will often chuckle when I tell them that ‘Johnny’ needs to lay off the booze (now and in the future).  However, it is difficult to fully differentiate nonalcoholic fatty liver disease from alcoholic fatty liver disease, especially in adults.

Full Text: Toward More Accurate Nomenclature for Fatty Liver Diseases

Key points:

  • “Light (1.0-9.9 g/d) or moderate (10.0–29.9 g/d; 10.0–19.9 g/d for women) alcohol consumption in patients with NAFLD is not uncommon…The negative impact of alcohol intake also extends to nonalcoholic steatohepatitis resolution.”
  • “it is time for clinicians to recognize that, within the spectrum of fatty liver disease, there will be patients with true alcohol-related liver disease (AFLD), those with predominant AFLD compounded by metabolic cofactors, those with true NAFLD in whom alcohol consumption is near zero and disease progression is due to metabolic factors, and perhaps a majority with fatty liver disease owing to an abnormal metabolic milieu but with alcohol intake of ≤30 g/d.”
  • ” An updated and more appropriate nomenclature and classification system is required to reflect the nuances of disease etiology within the spectrum of fatty liver disease…”
    • MPFL: metabolic dysfunction predominant fatty liver;
    • APFL, alcohol predominant fatty liver;
    • MPFL/A and MPFL/N: metabolic dysfunction predominant fatty liver with, and without alcohol intake that is anything more than ceremonial
    • APFL/M and APFL/N: alcoholic predominant fatty liver with metabolic dysfunction or with no metabolic dysfunction.

My take: The authors present a good rationale for updating fatty liver disease –will this be adopted?

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Fecal Microbial Transplantation -Evidence for Use Beyond Recurrent Clostridium Difficile

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Briefly noted: GR D’Haens, C Jobin. Gastroenterol 2019; 157: 624-36. This review sums up the emerging evidence for use of fecal microbial transplantation for conditions besides recurrent Clostridium difficile infection.

Table 2 succinctly provides list of disease, types of study/evidence, and potential effect.

  • Among gastrointestinal diseases, the authors note that there is an “overall positive” effect for ulcerative colitis, “suggestive” benefits for IBS, GVHD, post-antibiotic diarrhea, constipation, and hepatic encephalopathy.  No effect has been evident with Crohn’s disease or pouchitis.
  • Among nongastrointestinal diseases, the authors note a “suggestive” benefit in autism and metabolic syndrome and “unknown” effect with psoriasis and multiple sclerosis.

My take: The review indicates a need for more studies and the need to define which factors in fecal material mediate the therapeutic effects.

Related article: OC Aroniadis. Lancet Gastroenterology and Hepatology; 2019. https://doi.org/10.1016/S2468-1253(19)30198-0. In this double-blind, randomized, placebo-controlled crossover trial in patients aged 18–65 years with moderate-to-severe IBS-D with 48 patients, FMT (capsule study) was safe, but did not induce symptom relief at 12 weeks compared with placebo.

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Vedolizumab versus Adalimumab for Ulcerative Colitis (part 2)

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A previous blog post (Vedolizumab More Effective Than Adalimumb for Ulcerative Colitis) highlighted a preliminary report on the “VARSITY” study. The full report has now been published (BE Sands et al NEJM 2019; 381: 1215-26) and a little nuance is needed.

This double-blind, double-dummy randomized trial included 769 patients who underwent randomization to receive at least one dose of one of the study medications.

Key findings:

  • At week 52, clinical remission was higher in the vedolizumab group: 31.3% compared to 22.5% for adalimumab
  • Endoscopic improvement was better for vedolizumab: 39.7% compared to 27.7%
  • Corticosteroid-free remission was better for adalimumab: 21.8% compared to 12.6% for vedolizumab

Limitations:

  • dose escalation was not allowed during the study –this limitation likely favors vedolizumab compared to adalimumab
  • previous exposure to an anti-TNF agent was allowed in up to 25% of patients

My take:  In two of three key measures, vedolizumab outperformed adalimumab.  This study provides a rationale for vedolizumab to be considered a first-line agent.  That being said, in my clinical experience, infliximab is a much more frequently used anti-TNF agent in moderate-to-severe ulcerative colitis.  So a head-to-head study with infliximab would be of interest.

The image below shows histologic remission differences at week 52

 

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What to Tell Patients About Ranitidine From AGA

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Here’s the link: Talking to your patients about ranitidine  Thanks to John Pohl for sharing this information.

Oct. 3, 2019

Talking to your patients about ranitidine

The recent FDA safety alert might be causing concern among your patients about their heartburn treatment.

The FDA recently released several safety alerts on ranitidine formulations, including the brand-name drug Zantac, that were found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests and animal studies. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. This contaminant is similar to was recently found in losartan, an angiotensin II receptor blocker used to treat hypertension, that was recalled by the FDA.

The FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking ranitidine. 

With the voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., as well as the voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp, your patients might be asking a lot of questions about whether to continue to using their medicines and what alternatives are available. 

TALKING TO YOUR PATIENTS 

The FDA safety alerts have been covered by various media outlets since early September. This may cause your patients to question whether they should stay on or start using ranitidine products. When discussing the recall with your patients, let them know that: 

  • Ranitidine is an H2 blocker (antihistamine) — available OTC and in prescription strength — used to prevent and relieve heartburn associated with acid ingestion and sour stomach. It reduces stomach acid and works longer but not as quickly as antacids.
  • Not all ranitidine medicines marketed in the U.S. are being recalled and the FDA is not recommending individuals stop taking all ranitidine medicines at this time.
  • It might be prudent to hold off taking Zantac until a final FDA conclusion.
  • Multiple drugs are approved for the same or similar uses as ranitidine. Other treatment options are available, both prescription and OTC, for patients who are concerned about ranitidine.
  • Life-style modifications may reduce or eliminate the need for heartburn drugs for long-term use. These may include weight loss, avoiding tobacco or a change in eating patterns. Share AGA’s patient education content on gastroesophageal reflux disease (GERD) for more tips for your patients.

Related blog post: Preliminary Recommendations from NASPGHAN on Ranitidine Warnings

Gluten-Free –No Evidence It is Helpful for Healthy Individuals

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A recent study (ID Croall, et al. Gastroenterol 2019; 157: 881-3) provides additional data indicating that a gluten-free diet does not confer health benefits to healthy individuals.

A double-blind randomized placebo 2-week trial with 30 healthy adults divided subjects into two groups –some received flour sachets to consume with organic gluten (14 g) and some received a gluten-free blend (rice, potato, tapioca, maize, buckwheat flour). Both groups were instructed to take their flour sachets twice a day along with a gluten-free diet (GFD).

Key finding: The group receiving gluten did not experience any increase in gastrointestinal symptoms or fatigue compared to the placebo group.

My take: While this study lasted only 2 weeks and had a small sample size, nevertheless, it adds to the literature indicating that a GFD is unlikely to be beneficial in otherwise healthy individuals. Those who stick with a GFD should seek the help of a well-qualified dietician.

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Portland, OR. Portland aerial trams –between the city’s South Waterfront district and the main Oregon Health & Science University (OHSU) .

Ustekinumab for Ulcerative Colitis (UNIFI Trial)

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A landmark study (BE Sands et al. NEJM 2019; 381: 1201-14) shows that ustekinumab (Stelara) can be an effective therapy for moderate-to-severe ulcerative colitis (UC); it is already an approved, established therapy for Crohn’s disease. This randomized placebo-controlled study included an 8-week induction trial (n=961) followed by a 44-week maintenance trial (n=523) for patients with response.

Clinical remission was defined as a total socre of ≤2 on the Mayo scale (range 0-12) and no subscore >11 on any of the four Mayo scale components.

Key findings:

  • During induction, there was a similar clinical remission rate between those who received 130 mg fixed intravenous dose compared to those who received 6 mg/kg: 15.6% and 15.5% compared to 5.3% for placebo group.
  • During maintenance, among patients receiving 90 mg every 8 weeks the clinical remission rate at 44 weeks was 43.8%, in those with 90 mg every 12 weeks the rate was 38.4%; placebo group was 24.0%.
  • The response to ustekinumab occurred in those with or without previous treatment failure with biologic agents, though response was lower in both induction and maintenance in those with prior treatment failure.  In both phases, at least 59% of participants had failed either or both anti-TNF agents or vedolizumab.
  • In this study, there were similar serious adverse events with ustekinumab compared to placebo.  In the treatment groups, there were two deaths (one from ARDS, one from esophageal varices) and 7 cases of cancer (3 nonmelanoma skin cancer, two colon cancer, one prostate, one renal).  There was one death from testicular cancer in the placebo group. Also four patients in the ustekinumab group had opportunistic infections including CMV in two, legionella in one and HSV in one.

In terms of dosing, the authors note that there was greater improvement in calprotectin values during induction in the group who received 6 mg/kg compared to those who received 130 mg.  At week 44, using more objective and stringent end points (eg. endoscopic improvement), greater clinical benefit was observed with the every 8 week regimen.

Visual abstract from NEJM Twitter Feed:

The following image depicts patients response during the maintenance phase –the lightest color is placebo, followed by every 8 weeks, and then the darkest color is every 12 weeks.  The x-axis measures (left to right) are clinical remission, maintenance of clinical response at week 44, endoscopic improvement, corticosteroid-free remission, and remission at 44 weeks in those with remission after induction.

My take: Ustekinumab is more effective for placebo in patients with ulcerative colitis.  More experience is needed to understand its long-term safety.

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The High Toll of Sudden Infant Death

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Sudden unexpected infant death (SUID) is not frequently an issue that is addressed by pediatric gastroenterology.  However, it is very common and needs to  be considered as we see infants with reflux, irritability, diarrhea, and dyschezia.

A recent report (DR Roehler et al. J Pediatr 2019; 212: 224-7) puts the magnitude of this problem into perspective.

Key points:

  • From 2013-2015, there was an average of 3523 US infants each year who died from SUID, peaking at 1-2 months of life.
  • The average annual risk of SUID during the first year of life was more than 5 times the peak risk of mortality from firearms homicide, motor vehichle-traffic, drugs/opioid overdose, and suicide.
  • More black infants died of SUID in the first year than black children who died from firearm homicides in all of childhood through age 19 years.
  • SUID deaths from 2013-2015 (10,568) was similar to the total number of motor vehicle-traffic deaths in all of childhood (10,714) and greater than the total number of any of the other causes.
  • Rates of SUID deaths were much higher for non-hispanic blacks than non-hispanic whites or hispanics.  Peak rates reached 481 per 100,000 per month compared with 215 per 100,000 per month and 130 per 100,000 per month respectively in these three groups (Figure 1).

Related study: AB Erck Lambert et al. Pediatrics 2019; 13.pii.e20183408.  In a SUID database analysis, 14% (250) of SUID cases from 2011-2014 were due to suffocation, most commonly due to soft bedding (69%), overlay (19%), and wedging (12%).

My take: The first year of life, particularly the first 3 months, is a very dangerous time for infants.  More attention to SUID could prevent a great amount of tragedy.

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Useful website: Charlieskids.org This website has a book called “Sleep Baby Safe and Snug” which incorporates updated recommendations on safe sleep practices.

Children should sleep in the same room but on a separate surface from their parents for at least the first six months of their lives, and ideally the first year. They say that this can halve the risk of SIDS…You can read the AAP’s full guidance here. These are a few more of the pediatricians’ recommendations:

  • Infants under a year old should always sleep lying on their backs. Side sleeping “is not safe and is not advised,” the AAP says.
  • Infants should always sleep on a firm surface covered by only a flat sheet. That’s because soft mattresses “could create a pocket … and increase the chance of rebreathing or suffocation if the infant is placed in or rolls over to the prone position.”
  • Any other bedding or soft objects, like pillows or stuffed animals, could obstruct a child’s airway and increase the risk of SIDS and suffocation, according to the AAP.
  • The pediatricians say breastfeeding reduces the risk of SIDS.
  • The same goes for pacifiers at nap time and bedtime, although the doctors say the “mechanism is yet unclear.” They add that “the protective effect is observed even if the pacifier falls out of the infant’s mouth.”
  • Smoking – both during pregnancy and around the infant after birth – can increase the risk of SIDS. Alcohol and illicit drugs during pregnancy can also contribute to SIDS, and “parental alcohol and/or illicit drug use in combination with bed-sharing places the infant at particularly high risk of SIDS,” the pediatricians say.

Pittock Mansion, Portland, OR