Tag Archives: topical

The Continuum of Evidence Based Medicine
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image002Should Pharmacists be blasted for selling what some call alternative therapies or products that are not “evidence based”? These criticisms can blindside unsuspecting Pharmacists trying to do what they can for their patients regardless of the fact that they are making a profit from it or not. What makes it more difficult is the way in which these criticisms are delivered, especially when delivered in an offensive type of online statement like most opinions are delivered today. It makes one grow thick skin if they wish to continue. As a pharmacist myself, I can reflect on the strong personal feelings we have towards our patients, especially in small community pharmacies. Not that many other health care professionals don’t have this deep feeling of ownership in their patient’s heath, it’s just that as pharmacists, the frequency we see these people is just so much higher, either in person or on the phone. We are one of the most if not the most accessible in their health care team and we answer a lot of questions from them, gladly.

Not only are we seeing these people regularly for health related concerns, but we also see them in passing when they need milk or a greeting card. In short, they feel and we feel like we see them more than some of our own family members sometimes. Couple this with the utter vastness of concerns this patient has and relies on us for.

Quite often these questions fall within the 80% of questions we hear every day. Prescription medications, interactions, side effects, screening what should go on to the doctor and what doesn’t need to, and OTC issues like supplements, cough and cold, pain relief, skin ailments, self treatable infections of all kinds, preventative measures, weight loss advice, and many more. During Med Review interviews, we uncover medical issues not being addressed fully or at all. There are medical issues that are treated in ways that the patient would prefer were treated a different way, either due to current side effects, potential side effects, interactions, or for the simple reason that they just want to be on fewer medications.

Now some may consider this an environment that sets up a scenario for a trap of giving the patient something that hasn’t been proven with studies of thousands and thousands of test subjects in randomized controlled trials. There has been no drug rep with glossy handouts showing graphs and impressive relative change overshadowing a less impressive absolute change in results. Perhaps the pharmacist has no idea of any studies that might exist for anything at their OTC disposal, no numbers needed to treat are at their fingertips (however unimpressive even Rx values for NNT are).

The truth is, a lot of these OTC treatments, even though we are taught them in Pharmacy school as recommended treatments, don’t have all that much in the way of studies to prove they work as I pointed out in a previous blog . This starts the slippery slope of evidence based to non evidence based medicine. This is a continuum rather than a conscious switch. As pharmacists who see the direct results of these recommendations daily, we begin to realize what the term “evidence based” means. It includes the evidence they see every day. Some refer only to large centre, many subject, randomized controlled trials for their definition of this term. Of course this is the basis of our scientific and medical knowledge and has extended lifespan many years. These people however may also recommend some things in what is known as off label use of some medications where the evidence is less plentiful. This is outlined in a recent blog: http://stonespharmasave.com/blog/?p=796 . The statistical method is a gift that helps us weed out chance encounters from truth (http://stonespharmasave.com/blog/?s=statistics ) . Anecdotal evidence can be notoriously prone to incorrect conclusions as it sidesteps statistics in its conclusions. Sometimes we just don’t have these studies available to us and must rely on smaller studies or a physiological basis for a recommendation.

I see this with topical pain compounding all the time. Repeated successful results with a scientific basis and numerous small studies and numerous anecdotal reports drive more recommendations and more feedback. This spreads to physicians that may be skeptical on how these products work. With one patient with a favourable results they become more comfortable in writing again. If a patient tries a prescription medication and it doesn’t work is the Doctor a quack?  Of course not.  Evidence based becomes what you see before you in your little world, regardless of what online bullies think, as long as your first priority is to keep the patient safe.

 

Graham MacKenzie Ph.C.

Stone’s Pharmasave

Baddeck N.S.

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What’s worth more? A favorable statistical p value or clinical results?
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testpostWith the recent talk of p-values and their value in scientific journals it brings to light an important interpretive tool in efficacy of therapies, clinical experience.  P value is the chance of getting a positive response in a scientific study when there is no real effect after all, also known as a false positive.  The smaller this number, the better the certainty that what you are observing is truly an effect of what you are studying.  This number often is given as p .05 meaning that only 5% of the time would you see this happen by chance, the rest of the time it is a true effect of what you are studying.  Put another way, you can say that you are rejecting the “no effect” assumption, and come to the conclusion that drug A has effect B on the body and claim that your results are statistically significant.

This has been the backbone of science forever to determine if what you are seeing is not a fluke.  On closer examination though this value may not be as strong as we first thought.  Don’t get me wrong, it is an awesome way to reduce bias in a study and the best we have to weed this out as long as we don’t play around with this p value after our calculations are done.  What if we applied this 5% theory to a supplement that was being tested for a certain condition.  If we wanted to try 100 supplements for a given condition and only one of these supplements actually did something to improve the condition, we would find 5 supplements that appeared to help (false positives) and one extra that actually did, the one effective supplement in the bunch.  Of the six supplements you came away with thinking worked for the condition, really only one worked.  This means that out of those six conclusions that claim to help the problem, only 1 in truth really does.  You are incorrect 83% of the time in your determination of effective products even though you successfully eliminated 94 ineffective products!  Imagine, a randomized, placebo controlled trial with a p value of 0.05 with this kind of result.

Retractions of published papers also appear to be on the rise and after being involved myself this past year in a scientific study, there really is a lot of pressure felt by the authors to get published in a scientific journal.  It’s almost like a final approval by the cool kids in class and seems to psychologically give a stamp of approval on your work not only to the authors that did the study, but by the public and scientific community that will read or hear about the study.  If you aren’t published, there is almost a sense of failure felt towards the whole project, regardless of how astounding the results are.

This brings us to the world of the front line where these products are actually handed out to the public, the Pharmacy.  Many times I see products written on prescription that work exactly the way they are supposed to but sometimes they fail miserably.   Regardless of how many studies were done on a drug, if a patient paid $100 for it and it didn’t work, they really don’t care how many studies were done or what the p value was; they are out $100 and they now need to fork over more money for another product.  This doesn’t mean the studies that brought this to market were bad, it’s just that they were some of the outliers in the results that didn’t respond to the drug.

When you deal with supplements you often are labeled and dare I say it with  “alternative therapy”, you are always searching for these studies.  They are often small studies but you still look for them.  The same is true for pain compounding.  It is not difficult to be labeled a quack or a charlatan when you try to help someone that doesn’t seem to fit into the regular modern medicine model or wants to try another way first.   Nothing replaces clinical experience in determination of a product’s net worth and if studies are done correctly your results should mimic the studies you originally read.  Keep in mind that this may mean a 70% success rate as determined by the studies.   It is only when you see something work before your own eye(s) that makes you comfortable suggesting it more.  Those products that showed promise in studies and it doesn’t pan out with your patients, these products fall away rather quickly.  When you deal with people that are paying out of pocket for something, you know it is working when they come back for more to spend more money on.  I have had physicians steer away from a product because of one or two bad experiences with it with their own patients.  As always, patient safety is key with any product.  Will this therapy harm this patient based on their existing meds, allergies or medical condition?   Will it cause a dangerous delay in treatment with another more proven product?  These are important questions to as when a patient looks for an alternative medication.

Clinical experience with pain compounding creams has completely change the thinking of a lot of physicians I deal with at the pharmacy level.  Many of these doctors haven’t read even one of the studies I have on the response rate of this type of therapy but when they took a leap of faith with just one patient, then another and another, they realized the value of a therapy they were not taught in school.  When I get in my car and turn the key, a lot goes on to start the car and keep it running.  I haven’t read any studies on car engines but I do it because it seemed to work for others and it works for me for the most part as well.

False positives and subjective results can happen this way as well, but when a patient that was previously addicted to hydromorphone prefers a pain cream or an addition of omega-3 with their pain medication, it helps to alleviate thoughts that they are pretending the pain went away.   As one palliative care physician said to me, “If the placebo effect is 30% on drug X, I’ll take that kind of response rate”.  When there are doubts as to the effectiveness of a well-designed trial, clinical experience acts as an effective filter to refine one’s beliefs.

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