Everything you know may be wrong. Well, not really, but reading the research of John Ioannidis does make you wonder. His work, concentrated on research about research, is a popular topic here at SBM. And that’s because he’s focused on improving the way evidence is brought to bear on decision-making. His most famous papers get to the core of questioning how we know what we know (or what we assume) to be evidence. (more…)
Is it ever ethical to provide a placebo treatment? What about when that placebo is homeopathy? Last month I blogged about the frequency of placebo prescribing by physicians. I admitted my personal discomfort, stating I’d refuse to dispense any prescription that would require me to deceive the patient. The discussion continued in the comments, where opinions seemed to range from (I’m paraphrasing) “autonomy, shmatonomy, placebos works” to the more critical who likened placebo use to “treating adults like children.” Harriet Hall noted, “We should have rules but we should be willing to break them when it would be kinder to the patient, and would do no harm.” And on reflection, Harriet’s perspective was one that I could see myself accepting should I be in a situation like the one she described. It’s far easier to be dogmatic when you don’t have a patient standing in front of you. But the comments led me to consider possible situations where a placebo might actually be the most desirable treatment option. If I find some, should I be as dogmatic about homeopathy as I am about other placebos?
Nicely, Kevin Smith, writing in the journal Bioethics, examines the ethics of placebos, based on an analysis of homeopathy. Homeopathy is the ultimate placebo in routine use — most remedies contain only sugar and water, lacking a single molecule of any potentially medicinal ingredient. Smith’s paper, Against Homeopathy — A Utilitarian Perspective, is sadly behind a paywall. So I’ll try to summarize his analysis, and add my perspective as a health care worker who regularly encounters homeopathy.
Paradoxically, the less evidence that exists to support the use of of a treatment, the more passionate its supporters seem to be. I learned this early in my career as a pharmacist. One pharmacy I worked at did a steady business in essential oils. And king of the oils was oil of oregano. Not only were there several different brands of the basic oil, they were different forms, including capsules, creams and even nasal sprays. Not aware of any therapeutic benefits, I would ask customers what they were using it for. I rarely heard the same condition described: skin infections, athlete’s foot, head lice, colds, sore throats, “parasites”, “yeasts”, diabetes, allergies and ringworm were apparently no match against the judicious use of oregano oil. Intrigued, I took a closer look.
Long before our scientific understanding of bacteria and antimicrobials, infected wounds were packed with different products in an attempt to minimize the odour, and hopefully speed healing. It’s likely that someone happened upon a fragrant herb and discovered that it seemed to help treat wounds (or at least, cover some of the smell). Given there have been some amazing drugs with powerful effects that have emerged from natural products, it’s certainly plausible that oil of oregano could have biological and therapeutic effects. Oregano (Origanum vulgare) leaves contain a wide variety of chemical compounds, including leanolic acids, ursolic acids, and phenolic glycosides. Phenolic compounds make up to 71% of the oil. Carvacrol, thymol, cymene, and terpinine and are found in oregano leaves and do appear to have biological effects. It’s these chemicals that are proposed to be the parts with beneficial effects.
The claims made by one manufacturer are unambiguous:
Oreganol P73 is the most powerful germ killer with scientifically proven results against almost every virus, bacteria, parasite, and fungi. The complexity of the phytochemical matrix in Oreganol P73 possesses a broad spectrum of antimicrobial properties that are safe for prolonged use. The oil can be used topically and internally. Oreganol P73 is the medicine chest in a bottle, especially since it is proven never to harm the internal organs, even when used daily for health maintenance.
So if we accept the manufacturer’s claims at face value, there should be evidence demonstrating oregano oil is both safe and effective when used internally and externally. There is apparently also adequate long-term safety data to demonstrate that it can be safely used on a daily basis.
Whether it’s acupuncture, homeopathy or the latest supplement, placebo effects can be difficult to distinguish from real effects. Today’s post sets aside the challenge of identifying placebo effects and look at how placebos are used in routine medical practice. I’ve been a pharmacist for almost 20 years, and have never seen a placebo in practice, where the patient was actively deceived by the physician and the pharmacist. So I was quite surprised to see some placebo usage figures cited by Tom Blackwell, writing in the National Post last week:
The practice is discouraged by major medical groups, considered unethical by many doctors and with uncertain benefit, but one in five Canadian physicians prescribes or hands out some kind of placebo to their often-unknowing patients, a new study suggests.
The article references a paper in the Canadian Journal of Psychiatry which, sadly, does not have much of a web presence. The article continues:
Calcium is good for us, right? Milk products are great sources of calcium, and we’re told to emphasize milk products in our diets. Don’t (or can’t) eat enough dairy? Calcium supplements are very popular, especially among women seeking to minimize their risk of osteoporosis. Osteoporosis prevention and treatment guidelines recommend calcium and vitamin D as an important measure in preserving bone density and reducing the risk of fractures. For those who don’t like dairy products, even products like orange juice and Vitamin Water are fortified with calcium. The general perception seemed to be that calcium consumption was a good thing – the more, the better. Until recently. (more…)
Despite the variety of health systems across hundreds of different countries, one feature is near-universal: We all depend on private industry to commercialize and market drug products. And because drugs are such an integral part of our health care system, that industry is generally heavily regulated. Yet despite this regulation, little is publicly known about drug development costs. But aggregate research and development (R&D) data are available, and the pharmaceutical industry spends billions per year.
Could a vitamin with proven benefits in one group cause harm to another? That’s the growing concern with folic acid, the vitamin that dramatically reduces the risk of neural tube birth defects such a spina bifida. Studies designed to explore the possible benefits of folic acid for heart disease, stroke and cancer are giving out some worrying signs: At best, folic acid is ineffective, and at worst it may be increasing the risks of some cancers. So what does this say about routine supplementation for the typical healthy individual, and its overall risk and benefit?
Folate (vitamin B9) is an essential nutrient found green, leafy vegetables, broccoli, peas, corn, oranges, grains, cereals, and meats. Folate has important roles in the synthesis of DNA, and consequently cell division. Significant folate deficiency can lead to macrocytic anemia. Folic acid, a synthetic form of folate, is used in multivitamins supplements because it is better absorbed.
Folic acid’s benefits in pregnancy are well documented. Supplementation before conception, and in the first few weeks of pregnancy, significantly and substantially lower the risk of several different birth defects, including neural tube defects (NTDs). The neural tube is the embryonic precursor to the brain and spinal column. NTDs include very serious defects like spinal bifida and anencephaly, birth without part of the brain.
I have a mental basket of drugs that I suspect may be placebos. In that basket were the topical versions of non-steroidal anti-inflammatory drugs (NSAIDs). When the first products were commercially marketed over a decade ago, I found the clinical evidence unconvincing, and I suspected that the modestly positive effects were probably due to simply rubbing the affected area, or possibly due to the effects of the cream or vehicle itself. Frankly, I didn’t think these products worked. So when I recently noticed a topical NSAID appear for sale as an over-the-counter treatment for muscle aches and pains (seemingly only in Canada, for now), I was confident it would make a good case study in bad science.
It’s not that I’m partial to the oral NSAIDs. Yes, they’re among the most versatile, and probably most well-loved drugs in our modern medicine cabinet. They offer good pain control, reduce inflammation and can eliminate fever. We start using it in our sick and feverish infants, through childhood and adulthood for the aches and pains of modern life, and into our later years for the treatment of degenerative disease like osteoarthritis, which affects pretty much everyone as we age. An astonishing 17 million Americans use NSAIDs on a daily basis, and this number is expected to grow as the population ages. In the running groups I frequent, ibuprofen has the affectionate nickname “Vitamin I”, where it’s perceived as an essential ingredient for dealing with the consequences of training.
But NSAIDs have a long list of side effects. Not only do they cause stomach ulcers and bleeding by damaging the gastrointestinal mucosa, there are heart risks, too. It was the arrival (and departure) of the drugs Bextra and Vioxx that led to documentation of the potential for cardiovascular toxicity. And now there’s data to suggest that these effects are not limited to the “COX-2″ drugs – almost all NSAIDs, including the old standbys we have used for years, seem capable of raising the risks of heart attacks and strokes.
So despite my initial skepticism, I took another look at the topical NSAIDs. The data were not what I expected.
As a pharmacist, when I dispense medication, it’s my responsibility to ensure that the medication is safe and appropriate for the patient. There are numerous checks we go through including verifying the dose, ensuring there are no interactions with other drugs, and verifying the patient has no history of allergy to the product prescribed. Asking about allergies is a mandatory question for every new patient.
Penicillin is one of the oldest antibiotics still in use despite widespread bacterial resistance. Multiple analogs of penicillin have been developed to change its effectiveness, or improve its tolerability. And other classes of antibiotics (e.g., cephalosporins) share some structural features with penicillin. These products are widely used for both routine and serious bacterial infections. Unfortunately, allergies to penicillin are widely reported. Statistically, one in ten of you reading this post will respond that you’re allergic to penicillin. Yet the incidence of anaphylaxis to penicillin is estimated to be only 1 to 5 per 10,000. So why do so many people believe they’re allergic to penicillin? Much of it comes down to how we define “allergy.”
Working in pharmacies where supplements are sold alongside traditional (over-the-counter) medications, I’m regularly astonished at the different perceptions consumers can have about the relative efficacy and safety of different types of products. Once, speaking with a customer about a medical condition she wanted to treat, I indicated that there were no effective non-prescription therapies — she needed to see a physician for access to an effective treatment by prescription — and I gestured behind the counter. “Back there?!” she pointed. “That’s where you keep the stuff that kills people! I want something natural!” Suggesting that my patients with heart disease or HIV had a somewhat different perspective, I tried (unsuccessfully) to talk her out of a questionable-looking supplement (Hint: avoid anything from a company with a P.O. box as a mailing address.) This appeal to nature, combined with a perception that natural products are safe, and conventional drugs are unsafe, is pervasive. (more…)