Video for Patients: Benefits and Risks of IBD Treatment & Risks of Untreated IBD

A recent study (NE Newman, KL Williams, BJ Zikmunde-Fisher, J Adler. JPGN 2020;70: e33-36) highlights work to communicate the benefits and risks of the treatment for inflammatory bowel disease (IBD) along with the risks of untreated IBD.  “We developed a simple video aid to illustrate competing risks associated with medications and underling disease in context of inflammatory bowel disease…Those who viewed the video aid had more realistic perceptions than those who did not view it.”

Here is a link to the ~13 minute online video: IBD: Risk of Disease and Treatments

Overall, the presentation is very helpful and thoughtful.  I think this would be an excellent overview for families.  For practitioners, a few points that could benefit from some nuance are noted below some screenshots.  It is worth stating that the authors had started this project a few years ago and some of the points below are related to more information that has emerged.

In the section of treatment benefits (above), the presentation suggests that thiopurines (azathioprine, 6-mercaptopurine) and methotrexate both are effective in about 50%; this is probably an overestimate; in addition, methotrexate as monotherapy is definitely less effective (if effective at all) for ulcerative colitis .  Also, it would be worthwhile to indicate that anti-TNF monotherapy with therapeutic drug monitoring may help achieve similar benefits as dual therapy.

In the section of colon cancer, the authors provide useful data that current treatments lower this risk substantially.  It is notable that more recent reports suggest that there have been improvements in the rates of colon cancer associated with IBD.

Overall, the section on lymphoma is very good.

In the section on other complications, the presentation suggests that there may be impaired wound-healing with anti-TNFs.  I think this risk is overstated in this slide. Also, I think the risk of severe infection with thiopurines is a little bit higher than stated; though, this can be mitigated with careful monitoring.

I think this summary slide could be improved by noting that the overall risk of serious cancers is likely lowered by treating IBD.  Since colon cancer is a fairly common cancer and IBD treatment reduces the risk, this likely outweighs the increased risk of other cancers (eg. lymphoma) which are much less common.

Another link to video: https://tinyurl.com/IBDTreatments

Related posts:

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.

PERSUADE Study: I Guarantee That It Will …

Peppermint oil (PO) products have been promoted for irritable bowel syndrome (IBS) for quite a long time.  When I have recommended PO as a possible treatment, I frequently say that “I guarantee that it will….give you fresh breath.  It might help your stomach symptoms.”

A recent randomized, double-blind “PERSUADE” study (Zsa Zsa R. M. Weerts et al Gastroenterol 2020; 158: 123-36) shows that PO likely has some efficacy for stomach symptoms in IBS. This trial enrolled 189 patients & 178 completed study (mean age, 34 years, 78% female) from the Netherlands.  Subjects were divided in three groups -instructed to take the study capsule 3/day for 8 weeks:

  • 182 mg small-intestinal release PO-SI
  • 182 mg ileocolonic release PO-IC
  • Placebo

The primary endpoint was at least a 30% decrease in the weekly average of worst daily abdominal pain

Key findings:

  • The primary endpoint did NOT differ significantly between the three groups: PO-SI with 46.8%, PO-IC with 41.3%, and Placebo with 34.4% response.
  • The PO-SI but not PO-IC was associated in secondary improvements compared to placebo in abdominal pain (P=.06), discomfort (P=.02), and IBS severity (P=.02).
  • Adverse events were mild with PO, but more common than placebo. Adverse events included heartburn, belching, and headache.
  • The authors calculate that the number needed to treat with PO-SI would be 8 which is higher than recent ACG monograph which suggested an NNT of 4 (Am J Gastroenterol 2018; 113: 1-18).  Even an NNT of 8 compares favorably with other treatments: linaclotide 6, plecanatide 10, and eluxadoline 12.5.

Limitations:

  • the studied population was mainly young adult, predominantly white and female; thus the findings may not be generalized to other groups
  • the peppermint smell could have undermined blinding despite presentation in capsule form
  • relatively short duration study

The associated editorial by BD Cash (pgs 36-37) notes that PO medicinal use began in 1753 by Carl Linnaeus.  PO is thought to work via smooth muscle calcium channel antagonism.  The findings of working in the small intestine and not ileocolonic release could “spur additional therapeutic development.”

My take (borrowed in part from editorial): “These results reaffirm that PO can improve viscerosensory symptoms of IBS …and is well-tolerated… [It is] clearly not a gangbuster as a monotherapy.”  While the findings show modest effect, the findings are supported by a “robust” study as this is the first randomized, double-blind placebo-controlled clinical trial of PO.

Related blog posts:

Also, fidaxomicin has received FDA approval for pediatric use for C diff infections:

The Best Information We Have To Date on the Emerging Coronavirus

The NEJM has made the information it has on the emerging coronavirus open access.  Here are the links:

An excerpt from the editorial:

For the third time in as many decades, a zoonotic coronavirus has crossed species to infect human populations. This virus, provisionally called 2019-nCoV, was first identified in Wuhan, China, in persons exposed to a seafood or wet market. The rapid response of the Chinese public health, clinical, and scientific communities facilitated recognition of the clinical disease and initial understanding of the epidemiology of the infection. First reports indicated that human-to-human transmission was limited or nonexistent, but we now know that such transmission occurs, although to what extent remains unknown. Like outbreaks caused by two other pathogenic human respiratory coronaviruses (severe acute respiratory syndrome coronavirus [SARS-CoV] and Middle East respiratory syndrome coronavirus [MERS-CoV]), 2019-nCoV causes respiratory disease that is often severe.1 As of January 24, 2020, there were more than 800 reported cases, with a mortality rate of 3%…

Both SARS-CoV and MERS-CoV infect intrapulmonary epithelial cells more than cells of the upper airways.4,6 Consequently, transmission occurs primarily from patients with recognized illness and not from patients with mild, nonspecific signs. It appears that 2019-nCoV uses the same cellular receptor as SARS-CoV (human angiotensin-converting enzyme 2 [hACE2]),3 so transmission is expected only after signs of lower respiratory tract disease develop…

It is likely that 2019-nCoV will behave more like SARS-CoV and further adapt to the human host, with enhanced binding to hACE2.

 

“Original Sin” and U.S. Health Care

Several recent articles regarding reforming our current healthcare system have been published in Annals of Internal Medicine (Jan 2020) and are open access.  Highlighted text in images below by Eric Topol, MD.

Link: Envisioning a Better U.S. Health Care System for All: Health Care Delivery and Payment System Reforms

In this position paper, the American College of Physicians (ACP) proposes strategies to address social determinants of health and reduce barriers to care in order to achieve ACP’s vision for a better U.S. health care system for all. The ACP’s vision, outlined in an accompanying call to action (1), includes 10 vision statements, 4 of which are particularly relevant to the policies discussed in this paper (Figure). The companion position papers address improving payment and delivery systems (2) and coverage and cost of care (3). Together, these papers provide a policy framework to achieve ACP’s vision for a better U.S. health care system.

Link: Envisioning a Better U.S. Health Care System for All: Coverage and Cost of Care

Link: The American College of Physician’s Endorsement of Single-Payor Reform

An excerpt:

Public choice’s second purported advantage may also be illusory. Although surveys indicate that voters value choice, it’s choice of doctor and hospital—not insurer—that they care about.
Although no reform achieves perfection, evidence indicates that a well-structured single-payer reform might resolve our nation’s coverage and affordability problems, preserve the choices patients value, and allow doctors to focus on what matters most: caring for our patients.

Link: “Original Sin” and U.S. Health Care

An excerpt:

This series of articles describes a vision and makes important recommendations to improve coverage and control costs; reform health care delivery and payment to promote person-centered; high-value primary care; and address social and environmental determinants of health…

Seen through the lens of the American College of Physicians’ recommendations, how might addressing an original sin of failure to directly finance universal coverage in the United States facilitate progress on other recommendations?…

Implementation of the American College of Physicians’ recommendations, with an emphasis on promoting transparent, direct financing of universal access, holds great promise for replacing the current system of opaque and distorting subsidies with one that better serves all Americans.

Link: A New Vision for Quality and Equity

 

Link: Health is More Than Health Care

Link: Envisioning a Better U.S. Health Care System for All: A Call to Action by the American College of Physicians

Link:  The U.S. Health Care System Is Ill and Needs a Bold New Prescription

Alcohol -More Deadly Than Opioids

NPR: U.S. Alcohol-Related Deaths Have Doubled, Study Says

An excerpt:

Death certificates spanning 2017 indicate nearly 73,000 people died in the U.S because of liver disease and other alcohol-related illnesses. That is up from just under 36,000 deaths in 1999…

Overall, researchers found men died at a higher rate than women. But when analyzing annual increases in deaths, the largest increase was among white women…

Only cigarettes are deadlier than alcohol: More than 480,000 people die each year in the U.S. because of smoking-related illnesses.

Related blog post:

Venous Thrombosis in Pediatric Inflammatory Bowel Disease

A recent “Grand Rounds” review of venous thrombosis (VT) in pediatric inflammatory bowel disease (E Mitchel, T Diamond, L Albenberg. J Pediatr 2020; 216: 213-7) provides some practical advice in an area in need of more clarity.

Risk factors for VT:

  • inflammation
  • malnutrition
  • dehydration
  • malabsorption
  • need for surgery
  • medications (eg. steroids)
  • immobilization
  • infection
  • placement of central line
  • hormonal contraceptive use
  • cigarette use
  • hereditary thrombophilia/first-degree relative with VT

Key points:

  • Pediatric patients with IBD are at increased risk for VT with an estimated incidence between 0.09% and 1.9%.  Patients hospitalized with an IBD flare have a “6-fold increased risk for pulmonary embolism and deep-vein thrombosis as compared” to hospitalized patients without IBD.  In another study, the risk was lower with a relative risk for VT of 2.37 for Crohn’s and 1.99 for ulcerative colitis (UC).
  • ESPGHAN guidelines recommend prophylactic anticoagulation in patients with acute severe colitis and at least 1 risk factor (in prepubertal children — at least 2 risk factors).  Mobilization and hydration are also recommended.
  • At the authors’ institution, “patients <12 years do not meet routine criteria” for thromboprophylaxis unless at high risk.
  • Patients >12 years who are at medium or high risk are given mechanical prophylaxis with a pneumatic compression device (if no contraindications).
  • In those at high risk and >12 years, pharmacologic prophylaxis is considered in concert with hematology service. “High risk is considered altered mobility and at least 1 risk factor.”

My take: In adolescents hospitalized with IBD, this article suggests that almost all should receive mechanical prophylaxis for VT and a subset at increased risk may benefit from pharmaccologic prophylaxis.

Related blog posts:

From a visit to Montreal

Improving Care Process in Celiac Disease

Previous studies have documented numerous deficiencies in the care of children with celiac disease, particularly with regard to followup.  A recent study (B Sparks et al. J Pediatr 2020; 216: 32-6) demonstrates that using a prospective patient registry can improve many aspects of care and allows scrutiny of other aspects for further improvement.

In this single center study with 25 pediatric gastroenterologists, the authors reviewed the experience in establishing their “Celiac Care Index.”

Key findings:

  • There was improved adherence: 77%–>89%
  • Improved rates of followup serology: 50–>90%
  • Improved completion of agreed-upon bloodwork: testing for ALT increased from 74% to 96%, Vitamin D from 36% to 83%, and checking hepatitis B immune status from 30% to 80%

When looking at their ‘smartset’ labs obtained in most of their 145 patients, the authors note that several may not be needed:

  • Iron: the authors state that serum iron is not needed in those who have had a ferritin and a CBC.
  • Thyroid testing: no patients had an abnormal free T4 and very few had an abnormal TSH (8 of 120 =7%).  In the subset with abnormal TSH, 5 were normal on repeat testing, 2 had previously recognized thyroiditis, and 1 had TSH elevation related to obesity.

Lab Findings:

  • Hepatitis B: 80 of 115 (70%) showed a lack of immunity to hepatitis B
  • Vitamin D (25-OH): 19 of 114 (17%) had values less than 20 ng/mL
  • ALT: 23 of 131 (18%) had values of ≥40 U/L

My take:

  1. This study shows that careful tracking of patients results in better adherence with established goals and allows for useful modifications.
  2. More long-term followup is needed –some abnormalities, like Vitamin D, may improve with treatment of the underlying disease even in the absence of vitamin D supplementation.
  3. Also, a majority of children lacked an adequate immune response to hepatitis B; testing is important to determine who needs repeat immunization.

Related blog posts:

Signage at a restaurant’s bathroom near Mount Tremblant

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

IBD Depression Screening

LM Mackner et al. JPGN 2020; 70: 42-47. Bonney Reed, our psychologist at GI Care for Kids is one of the authors as well.

Key points:

  • Recommendation #1: Screen adolescents with IBD ages 12 and older for depression annually.
  • Recommendation #2: Screening Measures
    Age 12 years: Moods and Feelings Questionnaire, Short Form (MFQ-SF) ; age 13: Patient Health Questionnaire-9 (PHQ-9)
  • Recommendation #3: Evaluate youth who endorse SI (eg, PHQ-9 item # 9) further
    per clinic protocol or via a suicide screener, such as the Columbia Suicide Severity Rating Scale (C-SSRS)
  • Recommendation #4: Educational Resources. Provide patients, families, and other clinicians with educational resources as needed. An additional aim of our tool kit is to give GI providers resources to assist patients, families, and other clinicians
  • Resources for modules 1-4, Supplemental Digital Content http://links.lww.com/MPG/B721

My take (borrowed from authors): “Implementing depression screening in a busy clinic may seem like a daunting task and is likely to require changes in workflow and procedures. Nonetheless, optimal IBD care treats all aspects of health, and identifying depression symptoms, that often go undetected and can affect IBD outcomes, benefits patients, families, and providers.”  In our office, we have implemented screening and there is now a smartform available in EPIC.  We are fortunate to work closely with psychologists who can help when there is an abnormal screen.

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.