Methods: This interview-questionnaire study used a test-negative case-control design, enrolling persons who received a positive (case-participants) or negative (control-participants) SARS-CoV-2 test result, from among all California residents, without age restriction, who received a molecular test result for SARS-CoV-2 during February 18–December 1, 2021. A total of 652 case- and 1,176 control-participants were enrolled in the study equally across nine multi-county regions in California.
Limitations included the following:
This study did not account for other preventive behaviors that could influence risk (eg distancing)
This analysis relied on an aggregate estimate of self-reported face mask or respirator use across, for some participants, multiple indoor public locations
Estimates do not account for face mask or respirator fit
Data collection occurred before the expansion of the SARS-CoV-2 B.1.1.529 (Omicron) variant
On this website: “Four presentations/lectures were released at the Nutritional Therapy for IBD Virtual Booth that provide a comprehensive review and update of the latest information regarding the use of EEN and therapeutic diets in the management of IBD”
Why Do We Need Dietary Therapies for IBD
Presenter: Lindsey Albenberg, DO
Dr. Lindsey Albenberg, a clinician and researcher from Children’s Hospital of Philadelphia, describes the rapidly increasing incidence of IBD and its relationship to diet, microbiome and the immune system. She reviews the rationale and science supporting the use of dietary therapy to compliment drug therapy as an avenue to potentially achieve higher, more sustainable and possibly safer levels of remission long term in pediatric patients.
The Crohn’s Disease Exclusion Diet Updates: December 2021
Presenter: Rotem Sigall Boneh, RD. Rotem Sigall Boneh, RD, a primary researcher and developer of CDED, provides an overview of the accumulating data with CDED in combination with PEN, including the newly published results of adult data with important endoscopic findings and further shares real world experience and application of nutritional therapy.
IBD Anti-inflammatory Diet or IBD-AID: Proof of Concept
Presenter Ana Maldonado-Contreras, MSc, PhD. Dr. Ana Maldonado-Contreras, a lead researcher in IBD-AID explains the relationship between diet, microbiome and immune function with the design and rational of IBD-AID to manipulate the microbiome. She shares the recently published data of the impact of IBD-AID on the microbiome and cytokine levels specific to food components.
At the NTforIBD Nutritional Symposium prepared for NASPGHAN2021, Professor Day provides insight into the important role of EEN, an underutilized option to both induce remission and improve outcomes in complicated and peri-operative patients.
This editorial helps provide needed context on the associated observational study by Xia et al (B Xia, M Yang et al. Gastroenterol 2021; 161: 1842-1852. Open Access. Regular use of proton pump inhibitor and the risk of inflammatory bowel disease: pooled analysis of 3 prospective cohorts) which showed a mild increase risk of IBD among PPI users. While the PPI users were at 42% increased risk of IBD compared to nonusers, if correct, “the absolute risk associated with PPI use is modest. Number needed to harm is 3770, meaning that when 3770 individuals are treated with PPIs for 1 year, 1 additional case of IBD is observed.”
Despite the efforts of the study authors to minimize confounders, the editorial focuses on the work of Austin Bradford Hill (Proc R Soc Med. 1965;58: 295-300. The environment and disease: association or causation?) who “realized making causal inferences on observational data was challenging and outlined a list of factors that would make this interpretation more or less likely….strength of association, dose response, and consistency are important and often not commented on in observational studies.”
In a previous “a double-blind, randomized clinical trial comparing pantoprazole with placebo over 3 years with more than 53,000 patient years follow-up found there was no association” with IBD identified…Interestingly, this trial reported a slightly higher risk of enteric infections, and this is the underlying mechanism proposed for how PPI therapy may increase the risk of IBD.”
My take (borrowed from editorial): “Most associations for PPI and harm are likely to be residual or unmeasured confounding, whether this is also true for IBD will only be determined by further study.”
This past month, I participated as a lecturer for the NASPGHAN Foundation’s educational campaign on Hepatitis C in Children and Adolescents. The slides highlight some tremendous advances and challenges in the field of viral hepatitis. I have copied some of the slides below (used with permission) and the full slide deck can be obtained via this link: Hepatitis C in Children and Adolescents
Gilead is a corporate sponsor for these talks. (Disclosure: I have requested that the honorarium for these lectures to be directed back to the NASPGHAN Foundation.)
Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician. Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure. 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.
Some of the reasons for America’s difficulties are well known. Despite having one of the world’s most powerful arsenals of vaccines, the country has failed to vaccinate as many people as other large, wealthy nations. Crucially, vaccination rates in older people also lag behind certain European nations.
The United States has fallen even further behind in administering booster shots, leaving large numbers of vulnerable people with fading protection as Omicron sweeps across the country...
These factors were key for pre-coronavirus rankings such as the Global Health Security Index, which in 2019 listed the United States and Britain as most prepared for a catastrophic biological event, like a pandemic — and Vietnam 74th out of 117 countries.
Instead, better outcomes appear to have gone hand in hand with high levels of trust in government and other citizens. Perception of government corruption was correlated with worse outcomes. Researchers measured trust with polling data from the World Values Survey and Gallup...
The pandemic has “eroded trust in the government,” Bang Petersen said. “It actually seems as if the pandemic has worsened the problem that this study identified.”
In this prospective study using the CCFA IBD Partners cohort, the authors examined fatigue symptoms with questionnaires (FACIT-F and MDI) at 3 timepoints over a 1 year period. There was likely a strong selection bias among participants (mean disease duration was 18 years) who chose to complete theses questionnaires. Key findings:
Persistent fatigue (at baseline and at 6 months) was the most common pattern, affecting two-thirds (65.8%) of patients
The strongest predictor of incident fatigue was sleep disturbance at baseline (odds ratio, 2.91.
Only 12.3% of those with fatigue at baseline had symptom resolution by 6 months. Resolution was more likely in patients with a diagnosis of ulcerative colitis, quiescent disease, and an absence of significant psychological comorbidity
My take: In those with fatigue, it is often persistent.
The authors retrospectively studied 7447 patients with dermatological conditions such as erythema nodosum (EN), pyoderma gangrenosum, Sweet’s syndrome, and aphthous stomatitis which can occur with inflammatory bowel disease (IBD) and are considered dermatological extraintestinal manifestations (D-EIMs).
Key findings:
131 (1.8%) subsequent IBD diagnoses in patients with D-EIMs compared with 65 (0.2%) in those without D-EIMs
Median time to IBD diagnosis was 205 days (IQR, 44-661 days) in those with D-EIMs
My take: The absolute risk if IBD is low in patients with D-EIMs but still increased 6-fold. This would probably be a good population to screen for IBD with a biomarker (eg. calprotectin)
J Shah et al. Inflamm Bowel Dis 2021; 27: 1832-1838. Ocular Manifestations of Inflammatory Bowel Disease Nice review: “ocular manifestations of IBD include keratopathy, episcleritis, scleritis, and uveitis and are among the most common extraintestinal manifestations.” Urgent referral to ophthalmology needed if deep eye pain that can awaken from sleep (?scleritis), if photosensitivity/blurry vision/headache (?anterior uveitis), or if floaters/decreased vision (?posterior uveitis)
This prospective cohort (2016-2018, n=417, mean age 13.7 y) examined the frequency of functional disorders (based on questionnaire) in children with celiac disease (CD) who were receiving a strict gluten free diet (GFD) for at least one year.
Key findings:
Functional abdominal pain disorders (FAPDs) had a higher prevalence s among patients with CD (11.5%) than controls (6.7%) (P < .05)
Irritable bowel syndrome (IBS) and functional constipation (FC) defined by the Rome IV criteria were more prevalent in patients with CD (7.2% for IBS and 19.9% for FC) than controls (3.2% for IBS and 10.5% for FC) (P < .05 and P < .001, respectively)
Younger age (P < .05) and a higher level of anti–transglutaminase IgA at diagnosis (P < .04) were associated with FAPDs (in particular for IBS) irrespective of GFD duration
A GFD did help with abdominal pain: After starting a GFD, 80% of children with celiac disease had resolution of stomach pain, whereas 9% started to complain of symptoms after starting a GFD
In the discussion, the authors speculate on the reasons for ongoing pain including inadvertent gluten exposure, intestinal inflammation/visceral hyperalgesia, altered microbiome, and refractory CD.
My take: Persistent stomach pain in CD is a common occurrence, even in those trying to adhere to a strict GFD.
“The AAP recommends COVID-19 vaccination for all children and adolescents 5 years of age and older who do not have contraindications using a COVID-19 vaccine authorized for use for their age.”
“Children with previous infection or disease with SARS-CoV-2 should receive COVID-19 vaccination, according to CDC guidelines.”
“Given the importance of routine vaccination and the need for rapid uptake of COVID-19 vaccines, the AAP supports coadministration of routine childhood and adolescent immunizations with COVID-19 vaccines (or vaccination in the days before or after).”
Also, more data on vaccine effectiveness from Eric Topol’s Twitter feed):
Vaccines reducing Covid deaths by 99% and hospitalizations by 98% with vaccination and a booster
For the past few years, when someone would ask me what I would do if I were incredibly wealthy, I would say that I wanted to start a pharmaceutical company to provide reasonably-priced medications. A good example of the problems with drug pricing was discussed earlier in the week on a prior blog post regarding insulin (Insulin: “Poster Child For Everything That’s Wrong” with U.S Drug Costs). Fortunately, I no longer need to be a billionaire:
The Mark Cuban Cost Plus Drug Company announced the opening of its online pharmacy Wednesday. The pharmacy says it will bypass health care industry “middlemen” and help consumers avoid high drug prices by charging manufacturers’ prices plus a flat 15% markup and pharmacist fee…
The pharmacy doesn’t accept health insurance but says prices will still be lower than what people would typically pay at a pharmacy….
The website currently offers 100 generic drugs to treat a variety of illnesses, including diabetes, asthma and heart conditions.
One drug for diabetes patients, metformin, sells for $3.90 for a 30-day supply, compared to a retail price of $20, the pharmacy said. A 30-count of imatinib, which is used to treat leukemia and other cancers, goes for as low as $17.10 at Cuban’s pharmacy compared with $2,502.60 at other pharmacies.
Mesalamine (Generic for Canasa) $36.90 (retail $959.07)
Mesalamine (Generic for Apriso) $36.60 (retail $122.57) ***this is only for 30 pills
Methotrexate 2.5 mg (30 capsules) $13.80
Omeprazole 40 mg capsules $4.50
Pantoprazole is priced at $4.50 (40 mg tablets) (retail $71.40)
GoodRx website also has low prices on many of these medications as well; however, some of these prices at the Mark Cuban pharmacy are terrific. For example, the cost of mesalamine suppositories at GoodRx are about three times as much.
My take: I need to talk to our Epic champion to connect our EMR to this pharmacy service.
Higher trough concentrations (TCs) (>10 mcg/mL) of anti-TNFa were not associated with higher rate of anti-TNFa-related adverse events in 135 patients & >1500 TC measurements
Out of the 30 patients who presented with elevated transaminases, 27 (90%) patients had normalized transaminases values by the end of the follow-up
Adverse events were noted in 68 of 135 patients (see below)
Forty-eight studies were included in the meta-analysis comprising 6963 patients. Key findings:
Biologic therapy in IBD pregnancies was associated with a pooled prevalence of 8% for early pregnancy loss, 9% for preterm birth, 0% for stillbirth, 8% for low birth weight, and 1% for congenital malformations.
These rates are comparable with those published in the general population.
Importantly, studies with newer biologics (eg. vedolizumab, ustekinumab) had small sample sizes. In addition, ongoing prospective multicenter registries are ongoing.
Endoscopic recurrence was 46% at 2 years (median time to recurrence: 10 months).
Histologic recurrence was present in 44% in endoscopic remission
At diagnosis and surgery, over a quarter met the criteria for growth failure.. Following surgery, height, weight and BMI z scores improved significantly both at 1 year and last followup
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