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Audio Therapy for Postoperative Pediatric Pain: Randomized Controlled Nonsense

For 10/10 pain I recommend two Rihannas and a Captain and Tennille!

For 10/10 pain, I recommend two Rihannas and a Captain and Tennille

In January of 2015, a study on “the effect of audio therapy to treat postoperative pain in children” performed at Lurie Children’s Hospital and published in Pediatric Surgery International made the media rounds. It was the typical story where numerous news outlets further exaggerated already exaggerated claims made in a university press release, in this case Northwestern University in Chicago. Some of the reporting was quite silly.

The study authors, the chair of pediatric anesthesiology at the hospital and his daughter, a biomedical engineering student at Northwestern who is now a fourth year medical student at Johns Hopkins, make some reasonable points in the introduction. Fear of opioid-related side effects, in particular respiratory suppression, does often result in poorly managed postoperative pain in kids. And there isn’t great data on the safety and efficacy of non-opioid medications for this purpose. (more…)

Posted in: Science and Medicine

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More drugs, more supplements, and potentially more problems

drugs and supplements

Early in my career I was fortunate to be offered a role as a hospital pharmacist, working on an inpatient ward along with physicians, nurses, and a number of other health professionals. My responsibilities included conducting a detailed medication review with each newly admitted patient. We would sit together, often with family members, going through what was sometimes a literal garbage bag full of medications, and documenting the drug, the dose, and the reason for use. I can’t remember the most medications I ever counted, but a dozen or more was normal. Some were taking medications four or five times per day, every day. Were all these drugs necessary? In many cases, no. They’d been started at different times, often by different physicians. Some drugs treated the side effects of other medications. Few had ever had a health professional document them all in a single list. There had rarely been an overall review for safety and appropriateness. Few patients knew the treatment goals of their medications. Often, they’d never been asked about their treatment preferences.

In addition to auditing every prescribed medication, I asked about vitamins, supplements and over-the-counter drugs. I usually encountered the same scenario – multiple products, often without any clear medical need. There were vitamins for “eyes”, tonics for “the blood”, and supplements believed to treat or prevent illness. There was regular (and sometimes dangerous) over-the-counter painkiller consumption. Sometimes all of these combinations were clearly antagonistic: concurrent laxatives and treatments for diarrhea, or sleeping pills taken along with stimulants. Worryingly, few had disclosed the use of many of these products to their physician beforehand.

Medication reviews were a tremendous amount of work – but enormously rewarding. It was not difficult to find one or more cases of drugs potentially causing harm, or situations with clear drug-drug or drug-supplement interaction. In some cases, it was the medications that had put them in the hospital in the first place. Working with the residents and medical staff we could usually find ways to simplify their regimen, often discontinuing one or more drugs, reducing the doses of others, and suggesting ways to cut their supplement and over-the-counter drug use – or at a minimum, reduce the risk that these products could cause problems. Not only did patients end up with simpler medication schedules, we were helping them feel better, too. Before every patient was discharged, they’d get a follow-up visit from me. I’d provide a detailed list of current medications with a simplified schedule designed to make medication use easier. We’d provide copies for them to take to the pharmacy and to any specialist. In many cases, patients were still on a long list of drugs. But we’d cleaved away the most harmful and unnecessary, trying to leave only the medications that were appropriate. (more…)

Posted in: Herbs & Supplements, Pharmaceuticals, Science and Medicine

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Zap Your Way to Learning?

halo-sport-tdcs-headphones-640x390
The company Halo Neuroscience is now offering a device, the Halo-Sport, which they claim enhances sports performance through “neuropriming.” Their website claims:

Neuropriming uses pulses of energy to increase the excitability of motor neurons, benefiting athletes in two ways: accelerated strength and skill acquisition.

Regular readers of SBM can probably see where this is going.

A proper threshold of evidence

Before I get into the details of this product, I want to back up and discuss some basic principles. There is a clear pattern that has played itself out countless times on SBM or with regular authors on SBM in their other outlets. A person, company, or industry makes a clinical medical claim. We examine the evidence and find it wanting, and state so. Believers in the claim then attack us for being shills, closed minded, and/or failing to do our research.

(more…)

Posted in: Neuroscience/Mental Health

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Testing Testosterone Treatments

hey

Whatever is in this water, it isn’t testosterone

Ponce de Leon is said to have been looking for the Fountain of Youth when he explored Florida. That’s only a myth. Now there’s a new myth, that testosterone supplements are a Fountain of Youth for aging men. Men are urged to get their testosterone levels checked if they have any of a long laundry list of vague symptoms. Anti-aging clinics promote testosterone supplementation in many forms: prescription, bioidenticals from compounding pharmacies, natural remedies, testosterone boosters, and precursors. There are highly inflated estimates of the number of men who need supplementation, often relying on broadened criteria for diagnosis or non-standard lab tests. Testimonials abound: “My depression symptoms disappeared in 20 minutes when I started using Androgel.” (That one’s particularly hard to believe. Suggestion can be powerful.)

Until recently, evidence for the benefits of testosterone supplements was scanty, and there was concern about increased cardiovascular and prostate risks and other side effects. A 2013 study found that while testosterone was clearly indicated for younger men with classic hypogonadism caused by known diseases, a general policy of testosterone replacement in all older men with age-related decline in testosterone levels was not justified. In 2003 an Institute of Medicine panel called for a set of coordinated clinical trials to determine whether testosterone would benefit older men who had low testosterone levels for no known reason other than age and who had clinical conditions to which low testosterone might contribute. The results of those trials are starting to come in. The findings to date were covered in an article in the New England Journal of Medicine in February 2016. The full text is available online.
(more…)

Posted in: Pharmaceuticals

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The hijacking of evidence-based medicine

One of our heroes at SBM: John Ioannidis.

One of our heroes at SBM: John Ioannidis.

It’s no secret that I’m a fan of John Ioannidis. So, I daresay, are pretty much all of the editors and regular contributors to this blog. (If you don’t believe me, just type Ioannidis’ name into the blog search box and see how many posts you find.) Over the last couple of decades, Ioannidis has arguably done more to reveal the shortcomings of the medical research enterprise that undergirds our treatments, revealing the weaknesses in the evidence base and how easily clinical trials can mislead, than any other researcher. Indeed, after reading what is Ioannidis’ most famous article, “Why Most Published Research Findings Are False“, back in 2005, I was hooked. I even used it for our surgical oncology journal club at the cancer center where I was faculty back then. This was long before I appreciated the difference between science-based medicine (SBM) and evidence-based medicine (EBM). So it was with much interest that I read an article by him published last week and framed as an open letter to David Sackett, the father of evidence-based medicine, entitled “Evidence-based medicine has been hijacked: a report to David Sackett.” Ioannidis is also quoted in a follow-up interview with Retraction Watch.

Before I get to Ioannidis’ latest, I can’t help but point out that, not surprisingly, quacks and proponents of pseudoscientific and unscientific medicine often latch on to Ioannidis’ work to support their quackery and pseudoscience. They’ve been doing it for years. Certainly, they’re already latching on to this article as vindication of their beliefs. After all, their reasoning—if you can call it that—seems to boil down to: If “conventional” medicine is built on such shaky science, then their pseudoscience isn’t wrong after all, given that the same scientific enterprise upon which conventional medicine is based produces the findings that reject their dubious claims and treatments. Of course, whenever I hear this line of argument, I’m reminded of Ben Goldacre’s famous adage, seen in one form on Twitter here:

The adage can be generalized to all EBM and SBM as well. Just because big pharma misbehaves, EBM has flaws, and conventional medicine practitioners don’t always use the most rigorous evidence does not mean that, for example, homeopathy, acupuncture, or energy medicine works.

Still, when Ioannidis publishes an article with a title provocatively declaring that EBM has been “hijacked,” we at SBM take notice. (more…)

Posted in: Basic Science, Clinical Trials, Medical Academia, Pharmaceuticals, Politics and Regulation

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Why Antibiotic Use Scares Me

Editor’s note: Today we present a guest post from fourth-year medical student Joshua Horton, about the looming problem of antibiotic resistance. Welcome!

Antibiotic sensitive (left) and resistant (right) bacterial colonies. They probably shouldn't be that close together.

Antibiotic sensitive (left) and resistant (right) bacterial colonies. They probably shouldn’t be that close together.

I read a study recently that alarmed me: acute bronchitis is a condition that rarely requires antibiotics, but three quarters of patients presenting with this condition receive a prescription for antibiotics. Even more worrisome, this statistic has not changed in 20 years. To those of us on the cusp of a career in medicine – I am a fourth year medical student – this is terrifying because we are going to have to deal with the consequences. Antibiotic overuse leads to:

  • Increased morbidity and mortality for patients infected with resistant bugs
  • Unnecessary and exorbitant healthcare expenditures
  • The potential to cultivate multi-resistant bacteria that could spread to pandemic proportions

We still take them for granted, but antibiotics are a finite resource. Each time we breed a bug that is resistant to a particular drug, we are forced to relinquish that gun from our armamentarium. With fiscal impetus for pharma to develop new antibiotics waning, we may have reached a point of no return. That’s why this study scared me. Hopefully, clever techniques based on behavioral theory designed to reduce antibiotic prescribing may pull us back from that edge – read on to learn more. (more…)

Posted in: Pharmaceuticals, Public Health, Science and Medicine

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Oregon Health & Science University SCAM Day

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link)

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link).  Oy.

I was looking over a recent class catalog from my alma mater, University of Oregon. I see the Astronomy Department is having a day devoted to astrology, inviting astrologers to talk about their profession. And the Chemistry department is having alchemists give an overview on how to change base metals into gold. And, to green our energy, the Physics Department, where I acquired my undergraduate degree, is having a symposium on perpetual motion machines. I am so proud.

I kid.

But not when it comes to SCAM (Supplements, Complementary and Alternative Medicine). Medicine is strange in that has no issues embracing pseudo-science. My medical school, OHSU, had an afternoon devoted to Integrative Medicine for the third year medical students, with lectures by a chiropractor, a traditional Chinese pseudomedicine practitioner, a naturopath and an integrative medicine practitioner. They also had a small group discussion of a case of irritable bowel syndrome where one of the discussion leaders was a……Qi……….Gong………..master. Really. I would be so pissed if I was going $166,000 in medical school debt and I was being taught about the approach to ANYTHING by a Qi Gong Master. It was a day to ignore that whole ‘science’ thing in the name of the school. (more…)

Posted in: Acupuncture, Chiropractic, Homeopathy, Medical Academia, Naturopathy, Science and Medicine

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American Journal of Public Health article touts “potential public health benefits” of homeopathy

Homeopathy: It's just water.

Homeopathy: It’s just water.

An article in the April, 2016 issue of the American Journal of Public Health caught my eye: “Homeopathy Use by US Adults: Results of a National Survey.” I was pleased to see that homeopathy use is actually quite low. The 2012 National Health Survey found that only 2.1% of U.S. adults used homeopathy in the last 12 months, although that was a 15% increase over 2007. Users were mostly young, white, well-educated women, the typical CAM consumer.

Even fewer saw a homeopathic practitioner (only 19% of all users), although those who did perceived a greater benefit from homeopathic remedies. This difference, speculate the authors, could be due to several factors, one of which is

a more individualized and effective homeopathic prescription by the provider.

What? Are the authors suggesting that the series of off-the-wall questions asked by homeopaths leads to a prescription of an “effective” homeopathic remedy?

They certainly seem to be. Who are these authors, anyway?

They are Michelle L. Dossett, MD, PhD, MPH, Roger B. Davis, ScD, Ted J. Kaptchuk, and Gloria Y. Yeh, MD, MPH. All are, or were, with the Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center. All are also connected with Harvard and work, in various ways, in “integrative medicine” research. The article was funded, in part, by the National Center for Complementary and Integrative Health, and in part by Harvard. (more…)

Posted in: Clinical Trials, Homeopathy, Medical Academia, Public Health, Vaccines

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Another Anti-GMO Paper Retracted

electrophoresis1

The heart of Federico Infascelli’s questionable claims.

Retraction Watch is a great website. As the name implies, it focuses on a key aspect of quality control in science, the retraction of scientific papers that have already passed peer-review and were published when serious concerns about those papers come to light.

Retracting published papers is similar to phase IV clinical trials – tracking side effects of drugs that have already been approved and are on the market so regulatory agencies can monitor for post-marketing concerns and recall the drug if necessary.

Infascelli’s woes

Recently the journal animal retracted a paper by Italian researcher, Federico Infascelli. Here is there announcement:

From late September 2015, we received several expressions of concern from third parties that the electrophoresis gels presented might have been subject to unwarranted digital manipulations (added and hidden bands or zones, including in the control samples and the DNA ladder). A detailed independent investigation was carried out by animal in accordance with the Committee on Publication Ethics (COPE) guidelines. This investigation included an analysis of the claims using the figures as submitted, and reassessment of the article by one of the original peer-reviewers in light of the results of the analysis. The authors were notified of our concerns and asked to account for the observed irregularities. In the absence of a satisfactory explanation, the institution was asked to investigate further. The University of Naples concluded that multiple heterogeneities were likely attributable to digital manipulation, raising serious doubts on the reliability of the findings.

Based on the results of all investigations, we have decided to retract the article.

(more…)

Posted in: Quality Improvement

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Cargo Cult Psychology

A cargo cult pseudo airplane. How much of psychology is like this?

A cargo cult pseudo airplane. How much of psychology is like this?

Last year I reviewed Tomasz Witkowski and Maciej Zatonski’s book Psychology Gone Wrong where they pointed out that many of psychology’s accepted beliefs and therapies were not based on good evidence. Now Witkowski has written a new book, to be published later this year, Psychology Led Astray: Cargo Cult in Science and Therapy, that is certain to ruffle a lot of feathers. He compares psychology to cargo cults. He says, “the cargo cult phenomenon is virtually absent in physics, chemistry, and mathematics, yet it runs rampant in both psychology and sociology.” He uncovers cargo cult practices in psychology, unmasking therapies that are devoid of science, dangerous, and even cruel, especially those directed at children.

Richard Feynman was the first to compare the contemporary social sciences, including psychology, to a cargo cult. For those not familiar, the term “cargo cult” originates with the natives in Melanesia, who were awestruck by the planes that landed on their islands during WWII bringing all kinds of supplies. They had no understanding of what airplanes were or where they came from. Magical thinking led them to create bamboo replicas of planes and control towers in the superstitious belief that it would attract planes and bring them material goods. Similarly, many psychology researchers have been imitating the methods of science without really understanding how science is supposed to work. They go through the motions, but their research designs are so poorly thought out and the methodology so poor that their results are meaningless. And then they use those meaningless results to guide therapy. They have been led astray, have deceived themselves, and have harmed patients. (more…)

Posted in: Neuroscience/Mental Health

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