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The need to deliver ethical placebos

Dr Placebo
Last edited 13th September 2012

Clinical practice demands doctors provide the best available care. Some patients have non-specific complaints and there is no proven ‘active’ treatment. Placebos might benefit these patients. In other cases such as relieving pain placebos are known to have beneficial effects, while ‘active’ treatments have known side-effects. A problem is regulations all but forbid placebo use. But this is perverse – why would regulations prevent doctors from helping their patients?

Fortunately there other solutions. The reason placebos are considered unethical is they supposedly involve lying to patients. For example a doctors might tell their patient “this is a real treatment” when in fact it is a sugar pill. However placebos have been known to have effects even when doctors tell patients they are mere placebos. Hence doctors could simply inform patients that the treatment they prescribe is a placebo, and avoid the ethical problem. However it is likely that telling a patient that a treatment is a ‘placebo’ will reduce its effect.

But some patients may not care whether the treatment they are going to receive is a ‘placebo’, especially if such knowledge might reduce the benefit. These patients will undoubtedly want to know the treatment is safe, but have no interest in the ingredients or the label we place on the treatment. So, doctors could ask patients how much information they wish to receive about the treatment. The doctor could say, "Good morning Mrs Jones, my name is Dr Smith. This treatment has helped people with symptoms like yours, and it is known to be safe. We don't know exactly how it works, although some studies suggest it induces the body to produce various chemicals that can have benefits. Some patients like to know a lot about the treatments they use, while others don’t care and are willing to try and judge for themselves. If you would like to know more about the treatment I’m going to depend on you to prompt me. Does that seem like an acceptable way of proceeding?” Then, if the patients prefer to know more, the doctor might say that the treatment is sometimes referred to as a ‘placebo’, and add that much confusion surrounds the term. Or, if the patient doesn’t care, the doctor could refrain from revealing any further information.

This situation is familiar to us. Some Olympic athletes may wish to know everything about their opponents and the conditions, while others will find such information distracting.

As a patient, the amount of information you wish to receive about your treatments must be taken into account. Sometimes you will want to know everything, and at other times you may merely wish to know your treatment is safe.

Evidence-based mythbusting - a foray in sports products

Peter Gill
Last edited 19th September 2012

Myths are everywhere. Haunted forests. Greek Gods. You name it and there’s probably a myth for it. But what about myths related to sports? Surely athletes and consumers would not spend millions of dollars per year purchasing sports drinks, protein shakes and energy drinks if they didn’t work?

As outlined in the previous blog post on sports performance products, the CEBM team in Oxford looked at the evidence behind sports products. While completing the systematic assessment of the evidence underpinning claims six claims continually re-emerged.

Rather than use our traditional skills of evidence-based medicine, we experimented with a foray in evidence-based mythbusting (EBMythbusting).

Did your coach ever tell you to drink more fluid if the colour of your urine was dark? If they did, they better have provided you with a “urine colour chart” as athletes are less reliable than trained investigators at distinguishing the colour of their urine. Well if not, consider yourself lucky by having avoided many unnecessary trips to the toilet. The evidence is scarce to suggest that using urine colour is a useful or accurate as a marker of hydration. Best-case scenario is that first morning urine can tell you your hydration status.

Despite sport companies wanting you to believe that “Your brain may know a lot, but it doesn’t know when your body is thirsty. You need to drink during exercise before you feel thirsty in order to get enough fluids in your body to maintain your performance level”, the evidence suggests that drinking before you are thirsty may worsen performance and puts athletes at risk of hyponatraemia (low blood sodium levels). Apparently the human body worked before sports drinks were invented.

Does Red Bull really give you wings? Well the company at least states that “in extensive studies it has been repeatedly proven that Red Bull increases performance”. In reality any caffeine slightly improves performance (not flying), but is this surprising? Why else do we drink coffee in the morning?

Surely if protein and carbohydrate combinations after working out stimulates “increased uptake of glucose by the cells, resulting in faster glycogen storage” then it must improve performance. Unfortunately EBMythbusting has revealed that the effect is inconsistent and probably no better than a well-balanced and nutritious diet. Apparently Mom was right all along.

Pure branch chain amino acids. These just sound like they must work. Apparently they, amongst other things, can “help to sustain a healthy immune system during periods of intense training and play an important role in fatigue and performance”. Maybe, at best, and only to potentially reduce muscle soreness. But isn’t feeling sore after the gym a reminder that you exercised!

Sick of your skin? Do you want a second skin? Well here is the answer for you: “this ultra-tight, second-skin fit delivers a locked-in feel that keeps your muscles fresh and your recovery time fast”. Might as well stick to a massage or hot/icy cold-water therapy as these tend to work just as well to improve recovery.

EBMythbusting has challenged these common sports myths. Maybe practicing evidence-based medicine is really just an exercise in mythbusting. Why don’t you give it a try?

*Note: this blog has also been posted on Evidence Live Blog.

A recent article published in the BMJ raises questions about the extent and type of publication bias that exists in the literature. Publication bias is the selected publication of studies based on the results, such as only publishing studies that demonstrate a drug works while not publishing studies that demonstrate harms.

The study authors, including Ben Goldacre author of the best-seller Bad Science, explore the potential implications of study funding and high reprint orders. They contacted the editors of the top general medical journals (i.e. JAMA, Lancet, NEJM, Ann Intern Med, and BMJ) and requested information on the 20 articles with the highest number of reprint orders. After matching the articles with controls, the authors evaluated whether study funding (i.e. industry, mixed, other or none) was associated with higher numbers of reprints.

The results are telling. The Lancet led the way with a median of 126,350 reprints for the top articles with a range from 24,000 to 835,100. The BMJ was a distant second with a median of 13,248 (range 1,000 to 526,650). Unfortunately JAMA, NEJM and Ann Intern Med did not provide information.

Overall, compared with controls papers with high reprint orders were considerably more likely to be funded by the pharmaceutical industry (odds ratio 8.64, 95% CI 5.09 to 14.68). In addition the cost for reprint orders ranged from £4,002 to £1,551,794: reprints are evidently a lucrative source of supplementary income for journals.

While not designed to detect publication bias, the article highlights the importance of thinking outside the box. Evidence-based medicine is filled with cutting edge issues that are continually evolving and emerging. Do you think that a paper with potentially high reprint orders may affect an editor’s decision to publish? Should journals disclose the number of reprints for each article?

If you are keen to learn more, consider attending Evidence Live, a conference unlike any other event in healthcare, bringing together the leading speakers in evidence-based medicine from all over the world. The conference will include a session dedicated to Publication Bias at Evidence Live 2013 with an international line-up of speakers including Doug Altman, An-Wen Chan, Tom Jefferson and many more.

What do you think are undiscovered sources of publication bias? Here's your chance to share your thoughts with the experts at the University of Oxford, 25-26 March 2013.

*Note: this blog has also been posted on Evidence Live Blog.

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