Jose Garza: What’s New in Motility (Part 2)

Dr. Jose Garza joined our group in 2013 and has been providing excellent care for children throughout the South with suspected motility disorders. Recently, he gave our group a fabulous update on what’s new in motility.  My notes below may contain errors in transcription and in omission. Along with my notes, I have included many of his slides.

FLIP -How Distensible is the Esophagus

  • Distensibility index less than 2 mm2/mmHg is considered abnormal.
  • Normal FLIP (presence of RACs and normal Distensibility Index) can obviate need for high resolution esophageal manometry (HREM)
  • FLIP during anesthesia can only be done with certain medications: versed, fentanyl and propofol (no gas)
  • FLIP  is useful  in evaluating if symptoms after achalasia treatment, during achalasia treatment (dilatation or Heller), if symptoms after fundoplication, and if manometry uncertain

IB-Stim

Unable to Belch ( (Retrograde Cricopharyngeus Dysfunction)

Sitz Markers

  • Guideline published suggest single xray on day 5 (usually off treatment). Cleanout recommended (especially if impacted)
  • Useful for non-retentive fecal soiling as well

Vibrating capsule

Fecobionic

  • Emerging technology to help provide more data on defecation dysfunction

Medications:

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NY Times: “Millions Take Gabapentin for Pain. But There’s Scant Evidence It Works.”

NY Times: “Millions Take Gabapentin for Pain. But There’s Scant Evidence It Works.”

Thanks to Stan Cohen for pointing out this reference.

An excerpt:

The drug was initially approved 25 years ago to treat seizure disorders, but it is now commonly prescribed off-label to treat all kinds of pain, acute and chronic…

Two doctors recently reviewed published evidence for the benefits and risks of off-label use of gabapentin (originally sold under the trade name Neurontin) and its brand-name cousin Lyrica (pregabalin) for treating all kinds of pain…

Gabapentin and Lyrica, both sold by Pfizer, have been approved by the Food and Drug Administration to treat only four debilitating pain problems: postherpetic neuralgia, diabetic neuropathy, fibromyalgia and spinal cord injury. Even for these approved uses, the evidence for relief offered by the drugs is hardly dramatic…

In many well-controlled studies they found there was less than a one-point difference on the 10-point pain scale between patients taking the drug versus a placebo, a difference often clinically meaningless….

the number of people taking gabapentinoids more than tripled from 2002 to 2015…

Related blog post: Brave New World: Psychotropic Manipulation and Pediatric Functional GI Disorders

Near Cathedral of Barcelona

Interpreting industry-funded studies

Yesterdays’ blog entry discussed how patient selection affects the external validity of studies (According to the study which you would never qualify for…).  Today, we look at how physicians interpret studies based on a relevant article (NEJM 2012; 367: 1119-27).

In a randomized study, 269 respondents (from a pool of 503 board-certified internists)were presented with a series of three hypothetical abstracts (27 in all) and were queried about their confidence in the results.  The presumption was that “the methodologic rigor of a trial, not its funding disclosure, should be a primary determinant of its credibility.”  One of the questions that was asked was the following: “Do you think that pharmaceutical company funding is likely to influence the outcome of scientific studies…in favor of the drug in question?”

Results:

  • Physicians were more likely to identify high-rigor trials as rigorous (odds ratio, 3.95); in turn, physicians were more willing to prescribe drugs reported in high-rigor trials.
  • Physicians were less likely to view a trial as having a high level of rigor if funding source was a pharmaceutical company (odds ratio 0.63).

Both the article and the editorial (pages 1152-53) indicate a good deal of concern that industry-funded studies are “downgraded” as compared to NIH-funded studies.  Though, is it really surprising?  There have been well-publicized controversies with industry-funded research:

  • Withholding of critical data and negative results (eg. rofecoxib Alzheimer studies)
  • Ghostwritten articles (eg. promotion of gabapentin)

In addition, the perception is that industry-sponsored studies are more prone to bias due to a financial stake in the outcome.

Due to these previous problems, gaining full confidence in industry-funded studies could take a long time.  As stated by Friedrich Nietzsche:

“I’m not upset that you lied to me, I’m upset that from now on I can’t believe you”

A much more expansive discussion on the issue of industry-funded studies can be found at the following link (thanks to Jeff Lewis for this):

http://www.guardian.co.uk/business/2012/sep/21/drugs-industry-scandal-ben-goldacre

I think if the authors of the study and the NEJM editor read this link they might change their tune from “Believe the data” to “Missing data poisons the well for everybody.”  A particularly insightful example in the link includes how the industry withheld negative data on paroxetine in pediatric patients for commercial reasons.

You really should read the attached link to understand why skepticism of industry-funded studies is justified.

Additional references:

  • -Am Heart J 2012; 164: 186-93.  Rofecoxib: under-reporting of cardiovascular events in Alzheimer studies.
  • -JAMA 2008; 299: 1800-12.  Promotion of rofecoxib with guest authorship.
  • -Ann Intern Med 2006; 145: 284-93.  Promotion of gabapentin.