Understanding the Risks of Propofol for Colonoscopy

Posted on June 2, 2016 by gutsandgrowth

A recent article & editorial (KJ Wernli et al. Gastroenterol 2016; 150: 888-94 & 801-2) shows that the use of propofol, delivered by an anesthetist, is associated with a small increase risk of adverse events. This finding goes against assumptions that there would be reduced complications with an anesthesia expert in the room who could manage resuscitation and airway problems.

The study analyzed claims data from more than 3 million colonoscopies in the U.S between 2008-2011 in 40-64 year-olds.

Key findings:

Use of anesthesia was associated with a 13% increase in the risk of any complications within 30 days.
The increased risk included perforation (OR 1.07), hemorrhage (OR 1.28), and abdominal pain (OR 1.07). Interestingly, the perforation risk was increased only in those undergoing polypectomy (OR 1.26) indicating that some confounders may have been difficult to eliminate.
Complications secondary to anesthesia were present as well (OR 1.15) and stroke (OR 1.04).

This is not the first study to associate anesthesia with increased risk of aspiration and mechanical complications (Cooper G et al. JAMA Intern Med 2013; 173: 551-6). It is certainly possible that the increased risk is due in part to patient selection, despite attempts to control for this.

It is also important to note that better sedation has not resulted in improved colonoscopy outcomes like increased polyp detection.

Will these results change anything? No.

The small increased safety risk (detectable only in studies of millions of patients), if accurate, is not going to stop the use of anesthesia services for two reasons.

Patient satisfaction
Financial incentives

Patient satisfaction. Propofol results in excellent sedation, often with complete absence of pain combined with rapid recovery and an antiemetic effect.

Financial incentives. Many endoscopists are able to employ an anesthetist and generate additional revenue by billing for sedation (in addition to the costs of the endoscopist), whereas this is not allowed with the combination of intravenous opioids/benzodiazepines used for ‘deep sedation.’ Even in the many who do not receive revenue for these services, the rapid recovery expedites patient care and room turnover.

My take: While propofol administered by anesthetists is a little less safe and more expensive, it is here to stay, at least until incentives are created to reconsider this approach.

Georgian Terrace

More on Anti-TNF Drug Levels (part 2) and a Few Mentions

Posted on June 1, 2016 by gutsandgrowth

Another study (K Papamichael et al. Clin Gastroenterol Hepatol 2016; 14: 543-9) examined therapeutic drug levels with regard to infliximab induction and mucosal healing.

In this retrospective study with 101 patients with ulcerative colitis, 54 (53.4%) achieved mucosal healing between weeks 10-14, defined by a Mayo endoscopic score of 0 or 1. 97% of patients were treated with 5 mg/kg infusions.

Key finding:

Infliximab threshold concentrations of 28.3 mcg/mL at week 2, 15 mcg/mL at week 6, and 2.1 mcg/mL at week 14 were associated with mucosal healing.

My take: While this study provides information on what type of levels to expect at 2, 6, and 14 weeks, what is really important is figuring out which patients need higher doses of infusions from the start.

Unrelated, briefly noted:

R Yadlapati et al. Clin Gastroenterol Hepatol 2016; 14: 535-42. In this prospective blinded cohort study of 59 subjects, oropharyngeal pH testing (Restech Dx-pH) and salivary pepsin analysis was not able to distinguish between healthy volunteers and subjects with a combination of laryngeal and reflux symptoms.

M Moris et al. Clin Gastroenterol Hepatol 2016; 14: 585-93. This study reports increasing findings of small pancreatic cysts with more (and better) MRI imaging.

Y Kawamura et al. Clin Gastroenterol Hepatol 2016; 14: 597-605. This retrospective study shows, among almost 10,000 patients with fatty liver disease, that alcohol consumption of ≥40 g/day is an independent risk factor for hepatocellular carcinoma.

More on Anti-TNF Drug Levels

Posted on May 31, 2016 by gutsandgrowth

B Ungar et al (Clin Gastroenterol Hepatol 2016; 14: 550-7) report median serum levels of infliximab (n=78) or adalimumab (n=67) in correlation with mucosal healing.

In this retrospective cross-sectional study of adult patients with IBD (median age ~35 years), the authors found a correlation with higher drug troughs and mucosal healing.

“Levels of infliximab above 5 mcg/mL…and levels of adalimumab above 7.1 mcg/mL identified patients with mucosal healing with 85% specificity. Increasing levels of infliximab above 8 mcg/mL produced only minimal increases in the rate of mucosal healing, whereas the association between higher level of adalimumab and increased rate of mucosal healing reached a plateau at 12 mcg/mL”

The authors propose a “therapeutic window” of 6-10 for infliximab and 8-12 for adalimumab.

Remarks from DDW

Oral Cancer and Inflammatory Bowel Disease

Posted on May 30, 2016 by gutsandgrowth

A recent study (KH Katsanos et al. Clin Gastroenterol Hepatol 2016; 14: 413-20) shows an increased risk of oral cancers in patients with inflammatory bowel disease (IBD). Because these cancers are infrequent, the absolute risk remains low. However, this study provides some further insight into why other cancers may occur more often in IBD as well.

This retrospective study collated data on 7294 patients with IBD seen at a single New York center (2000-2011). Key findings:

11 patients (7 male) developed biopsy-proven oral cancer, most commonly of the tongue (n=6). The overall oral cancer age-adjusted standardized incidence ration (SIR) was 9.77 and the SIR for tongue was 18.91. These numbers could be influenced by a referral bias.
The average age for oral cancer in this study was 44 years.
Prior treatment for IBD had occurred in 7 patients, including 4 with a thiopurine, 1 with infliximab, and 3 with combination therapy.
One patient died.

Discussion:

Traditional risk factors for oral cancer: tobacco exposure (smoking, oral tobacco) and alcohol consumption.
The authors speculate that in their population that acquiring oncogenic HPV virus may have contributed to increased risk. This is clearly a risk with cervical cancer which has been reported as increased in IBD populations as well.

Gibbs Gardens

Metronidazole –Associated Encephalopathy

Posted on May 29, 2016 by gutsandgrowth

An interesting image (D Farmakiotis, B Zeluff. NEJM 2016; 374: 1465) shows an unusual side effect from metronidazole. This individual who had cirrhosis presented with confusion after a fall.

The MRIs below show “a symmetric, enhanced fluid-attenuated inversion recovery (FLAIR) signal in the dentate nuclei of the cerebellum (Panel A, arrow), a finding consistent with encephalopathy associated with metronidazole use.” Panel B shows resolution one month later following metronidazole discontinuation.

Risk factors for metronidazole encephalopathy:

Liver dysfunction
Prolonged treatment with metronidazole (typical cumulative dose >20 g)

Know Hepatitis B Campaign

Posted on May 28, 2016 by gutsandgrowth

The CDC has launched a campaign to improve identification of Hepatitis B, particularly among Asian Americans. Here’s the link: Know Hepatitis B Campaign

There are plenty of resources on this site.

Key fact:

“While Asian Americans make up about 5% of the total U.S. population, they account for half of the 2.2 million Americans living with chronic hepatitis B. In fact, one in 12 Asian Americans has hepatitis B.”

Related blog posts:

Understanding Single-Payer Health Care: “Medicare for All”

Posted on May 27, 2016 by gutsandgrowth

A recent commentary (J Oberlander. NEJM 2016; 374: 1401-3) explains the “virtues and vices of single-payer health care.”

“In a country where nearly 30 million persons remain uninsured, even insured patients face staggering bills, and more money is spent on administration than on heart disease and cancer, it’s no surprise to hear calls for sweeping change.”

Virtues of Single-Payer System:

Based on Canadian experience, single-payer greatly reduces administrative costs and complexity.
Concentration of purchasing power
Guarantee that all residents receive care
The problems of a single-payer system “pale in comparison” to the current U.S. system

Vices of Single-Payer System:

Wait lists for some services
Public dissatisfaction
Would require increased taxes (though may improve overall finances for most)

It Does Not Matter if Single-Payer is Better:

It would face intense opposition from insurers, medical industry, and would not be adopted by Congress. “In short, single payer has no realistic path to enactment in the foreseeable future.”

My take (in agreement with author): “Preserving and strengthening the ACA [affordable care act] as well as Medicare, and addressing underinsurance and affordability of private coverage is a less utopian cause than single payer. I believe it’s also the best way forward now for U.S. medical care.”

Related blog posts:

Graphic showing association between obesity and asthma

Rome IV -Pediatric Changes

Posted on May 26, 2016 by gutsandgrowth

What are the changes in Rome IV for children and adolescents? JS Hyams, C DiLorenzo et al (Gastroenterol 2016; 150: 1456-68) provide a helpful review.

Key point:

The ‘dictum’ that there was “no evidence for organic disease” as an criteria for functional disorders has been dropped in favor of “after appropriate medical evaluation the symptoms cannot be attributed to another medical condition.” This subtle change discourages excessive investigations.

The functional disorders covered in this article include

H1 Functional nausea and vomiting disorders: H1a -cyclic vomiting syndrome, H1b -functional nausea and vomiting (NEW), H1c -rumination syndrome, H1d -aerophagia
H2 Functional abdominal pain disorders: H2a -functional dyspepsia, H2b -irritable bowel syndrome, H2c -abdominal migraine, H2d -functional abdominal pain -not otherwise specified
H3 Functional defecation disorders: H3a -functional constipation, H3b -nonretentive fecal incontinence

Other points:

“There are no published data on the treatment of isolated functional nausea and isolated functional vomiting”
“We have eliminated the requirement of pain to fulfill the criteria for FD” [functional dyspepsia]
Criteria for cyclic vomiting and abdominal migraines now require only 2 episodes in a 6 month period
Criteria for functional constipation requires only 1 month rather than 2 months (this is true for H3b as well). The authors endorsed the NASPGHAN expert guidelines which included “no role for routine use of an abdominal x-ray to diagnose FC.” The guideline discourages testing for cow’s milk allergy, hypothyroidism, celiac disease and hypercalcemia in the absence of alarm symptoms.

In a separate article, MA Benninga, S Nurko et al (Gastroenterol 2016; 150: 1443-55) describe the functional disorders affecting infants and toddlers.

In my view, the article in this special edition that incorporates the most changes regards functional disorders of the biliary tree (FGBD) (PB Cotton et al Gastroenterol 2016; 150: 1420-29). This is mainly due to data showing that sphincterotomy is no better than sham treatment for patients with post-cholecystectomy pain. “The concept of sphincter of Oddi dysfunction type III is discarded.” In addition, for biliary pain/’gallbladder dyskinesia,’ the authors also acknowledge that the role of obtaining a gallbladder ejection fraction is “controversial.” “Symptoms suggestive of FGBD often resolve spontaneously so that early intervention is unwarranted.” Ultimately, the authors state that “treatment recommendations are not firmly evidence-based.”

Related blog posts:

Owl in Our Neighborhood

Expert Review: GMOs are safe

Posted on May 25, 2016 by gutsandgrowth

Here’s a link to NBC report on National Academies of Science review of Genetically Modified & Genetically Engineered crops: Genetically Modified Crops Are Safe

Here’s an excerpt:

Here’s a website with full report and data:

National Academies of Science Genetically Engineered Crop Website

Report also covered by USATODAY:

Don’t Skip this Article -Rome IV Summary

Posted on May 24, 2016 by gutsandgrowth

When I visited MIT, one of the slogans I heard was “Getting an Education from MIT is like taking a drink from a Fire Hose.” While this is a ridiculous notion, it is also true that the amount of information to consume, not just at MIT, but in so many areas is tremendous in quantity. As such, one has to figure out what to read and what to toss. For GI physicians, a recent summary (DA Drossman. Gastroenterol 2016; 1262-80) is worth a read due to the ubiquitous nature of the problems discussed.

Here were some key points:

“The possibility that passions or emotions could lead to the development of medical disease was first proposed by the Greek physician Claudius Galen.”
“Rome IV is a compendium of knowledge accumulated since Rome III” –10 years ago.

Some of the Changes:

New diagnoses: Narcotic bowel syndrome, opioid-induced constipation, cannabinoid hyperemesis syndrome
Removal of functional terminology when possible…functional abdominal pain syndrome has been changed to centrally mediated abdominal pain syndrome
Threshold changes for diagnostic criteria
Addition of reflux hypersensitivity diagnosis.
Revision of Sphincter of Oddi dysfunction disorder… “driven by evidence that debunks the value of sphincterotomy for type III SOD.”
Emphasis that functional disorders exist on a spectrum with linked pathogenesis, particularly with regard to irritable bowel syndrome (IBS) subtypes.
Removal of the term discomfort for IBS criteria and using pain as the key criterion.

Approach to Patients with Functional GI Disorders:

The author discusses ways to engage patient to create partner-like interaction.
“Determine the immediate reason for the patient’s visit (eg. What led you to see me at this time?)” Potential reasons: exacerbating factors, concern for serious disease, stressors, emotional comorbidity, impairment in daily functioning or hidden agenda (eg. disability, narcotics, litigation)
“Determine what the patient understands of the illness…What do you think is causing your symptoms?”
Provide a thorough explanation of the disorder. “For example: ‘I understand you believe you have an infection that has been missed; as we understand it, the infection is gone but your nerves have even affected by the infection to make you feel like it is still there, similar to phantom limb.”
“Identify and respond realistically to the patient’s expectations for improvement (e.g. How do you feel I can be helpful to you?)”
Explain ways that stress can be associated. “I understand you do not see stress as causing your pain, but you have mentioned how severe and disabling your pain is. How much do you think that is causing you emotional distress?”
“Set consistent limits..narcotic medication is not indicated because it can be harmful.”
“Involve patient in treatment plan (e.g. Let me suggest some treatments for you to consider).”
With regard to use of TCAs, the author explains that antidepressants can be used “to turn down the pain, and pain benefit occurs in doses lower than that used for depression.” “Tricyclic antidepressants or the serotonin-norepinephrine reuptake inhibitors help control pain via central analgesia as well as provide relief of associated depressive symptoms. The selective serotonin reuptake inhibitors are less effective for pain but can help reduce anxiety and associated depression.”
Establish an ongoing relationship. “Whatever the result of this treatment, I am prepared to consider other options, and I will continue to work with you through this.”

My take: This summary provides a succinct update on a 6-year effort of 117 investigators/clinicians from 23 countries. After reading this article, you will probably want to glance at the other articles in the same issue.

Vik Muniz Collage

A closer look at the front wheel