Rethinking Placebos

Placebo. I love the word; it comes from the Latin verb placere: to please, and in the first person future indicative –placebo– translates as ‘I will please’. Wonderful.

I’ve been thinking about it a lot lately, probably since rereading a Dec. 31/14 article in Medscape entitled ‘Should Doctors Use More Placebos?’ http://www.medscape.com/viewarticle/835197 The answer, of course, is ambiguous –no one seems to want to commit to the use of a technique favoured in the days when there were few other options; times when there were no antibiotics, no condition-specific medications –no detailed knowledge of the physiology of the body, let alone diseases. Those were times when naming the problem and being able to give a likely prognosis was an important part of Medicine. I suppose it still is. But the other, equally important component nowadays, of course, is solving the problem so named –solving, as well as hopefully curing it with specifically targeted medications or therapies.

Placebos have usually been construed as inert, essentially harmless substances with little or no known properties that might otherwise be helpful in restoring bodily health. No pharmacological effect… So why would anyone wish to use them anymore? Or do we?

In this informed era of medical ethics –and of course, social media- would it even be possible to use placebo treatment, except, maybe, in a study where a treatment is being compared to no -or likely ineffective- treatment (placebo treatment) and where the participants are unaware which substance they are receiving (so as not to bias the results) and have understood and accepted this? Not something likely to occur in the average visit to a doctor’s office for an illness.

And the ethics that need to be considered? Well, amongst others, the concept of autonomy –the right of an individual to make both their own treatment decision and an informed choice. And then, of course, there is the ethical requirement for Informed Consent. How can you give someone a treatment without telling her that you may well end up using something that is pharmacologically inert? A non-medication, as it were.

A placebo is usually a trick –you think you have been given something specifically designed to help; you take it on trust; you have faith in the doctor… If you found out that what you had been given –lied to about, in fact- was inert, wouldn’t that undermine your confidence, and especially your trust, in that doctor? Even if it worked? Or maybe especially if it worked –it would mean he thought your condition was more psychological than physiological –i.e. ‘all in your head’. Not very likely to foster a continuing relationship.

But what if the doctor told you he was going to use a placebo for your condition? Would it work if you knew? Well, here’s where it can get interesting; there is a difference between using a placebo and using the placebo effect: the approach to the patient matters as well as what is given to attack the problem. Such things as actually hearing the patient –listening to what they have to say- rather than immediately reaching for the prescription pad; being reassuring and sympathetic. Friendly. Understanding. The demeanour and hope with which any treatment is administered has been shown to effect the results –the art of Medicine.

But nowadays, we all know about this. The fact that there is some theatre to medicine, and a play of characters is not a secret –although I suspect that most of us prefer not to think about it when we ourselves have an illness. The play within the play…

It got me thinking about placebos in my specialty, though. Are there any placebos in gynaecology, for instance, and do we ever use them? We certainly use the placebo effect in obstetrics –we are constantly reassuring our patients about the never-ending and always-changing symptoms occasioned by their growing bodies. Most of them don’t need investigations or tests- nor do they need any specific medication -just an acknowledgment by the doctor that whatever the patient has noticed is not something to be worried about. It is not something malevolent, nor likely to affect the baby, but merely something that happens in pregnancy –part of the spectrum. Something to be expected. It’s a trust issue. That’s why they came to you after all.

And what about gynaecology? All medicine involves placebo effects –we’ve just discussed that- but what about placebos? Are we kidding ourselves to think that gyaecology is exempt from their use? I suppose it depends on how you define a placebo. As we’ve already seen, a placebo is classically defined as a substance that is not likely to have any measurable pharmacological effects and so is considered inert. But what about a substance that is not yet proven by scientists to have an effect –for example by well-designed studies that compare various treatments? Of course, it may simply be that no one has actually studied the substance so far; there are many complementary and alternative medicines that Western Medicine has not subjected to analysis. So their use by the doctor would not necessarily be as a therapy, but maybe as an acquiescence to a patient’s request, in the absence, perhaps, of any other recognized treatment options.

How about a substance that has some effects, and yet likely not enough, nor sufficiently consistently to be considered a mainstay treatment, but which might be sold, say, in a health food store? Some of the phytoestrogens found in materials like clover or soy have estrogenic effects, but may attach weakly or ineffectively to certain estrogen receptors -and in some organs but not others…

And then there are medications that are useful for other conditions –perhaps related, but not necessarily so- but are re-packaged for a new life. The use of ovulation inducers in infertility treatment, even when the patient is known to be ovulating –a just-in-case therapy. Or an antibiotic for a new-onset, ultrasound negative –but as yet undiagnosed- pelvic pain in a woman when she shows up in a busy emergency department. Maybe it’s an infection… Or vitamin pill use for the busy woman who doesn’t have time for a healthy diet every day. It can’t hurt and it may help… Surely these are placebos.

Or substances that have switched their roles over the years –were they inadvertent placebos that have been since promoted? Acetylsalicylic acid (ASA) was once only considered a pain reliever and was used for menstrual cramps. It seemed to help patients cope with the period but this was assumed to be only because of the pain relief. So it was a placebo for coping, a therapy for pain. Then, because it was later discovered to be an anti-prostaglandin –which is a chemical mediator of inflammation and has a direct effect on the flow through blood vessels (and hence one cause for increased bleeding and cramping with periods because of dilated blood vessels in the area)- ASA, or at least more modern analogues of antiprostaglandins such as ibuprofen, was reassigned to a new function. A new, non-placebo job, as it were. So, although it did one job at first, was it an unsuspecting placebo that actually did two jobs? Is that a temporal placebo? An interesting philosophical conundrum –but I suspect I am stretching the concept beyond any useful application.

Maybe we’re looking at the whole idea of placebos the wrong way. In our data-glutted age where information is conflated with knowledge perhaps we need a concept that defies mere illumination and transcends erudition. Something that is so embedded in the weft of context that it disappears in the very act of searching for it –an unsolvable Where’s Waldo. Sometimes our need for elucidation of every aspect of the world we live in is self-defeating. Maybe –just maybe- we don’t need to know where the geese go when they disappear through clouds that gird the mountain tops. Just that they come back every year. ..Somehow.

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Pelvic Exams

Medicine has been my life, and over the years I have seen my specialty of obstetrics and gynaecology break free of many of the traditions that shackled it to the past. Obstetrics was once a superstition-clad field -a world unto itself; gynaecology was mired in taboo and cultural sensitivities that often precluded open-minded and unbiased research and therapy.

To a variable extent, both managed to disentangle themselves from the constraining mesh of gendered folklore and even sexual politics by embracing a non-discriminatory and objective multidisciplinary approach to the problems surrounding each domain: what a pregnant woman had in common with her non-pregnant counterpart, for example. A recognition that gestational diabetes, say, could be engendered by the stresses of pregnancy and that its diagnosis and management had much in common with type 2 diabetes in both sexes. That not only did conditions -diseases, anomalies, medical and surgical abnormalities- have an effect on pregnancy, but that pregnancy had an effect on them as well. Treatment had to be contextualized. Tailored.

An awareness that one of the most common and devastating cancers of women had preliminary and treatable forms that could be detected by scraping the surface cells of the uterine cervix led to the development by Papanicolau of his eponymous pap smear in the early part of the last century. This mainstay of Women’s Health required some education, of course: although readily accessible physically, the cervix occupied an understandably personal and intimate region hitherto guarded by powerful societal norms -not to mention feminine propriety.

And yet, despite the obvious progress and benefits accruing to this approach, there remain other elements equally important to success. To ignore these, is to forget that there is more to personhood than meets the eye. We are more than the sum total of our parts.

I can’t help but feel that Medicine has sometimes capitulated to the Scientific Method -surrendered its mandate. Forgotten its purpose: to help and reassure. Even my own specialty, despite its undeniable progress, occasionally mistakes a valuable stand of trees for a forest and seems to be in a hurry to log them all to ground level -to the bottom, if you’ll pardon the mixed metaphor- in its haste to discover what might be hidden. There are tides of change that buffet us all, but are they sweeping baby, bathwater and flotsam out to some nebulous Sargasso place beyond the horizon? A place unreachable by the rest of us. Unusable. Unauditable. In our dash to embrace what has been called evidence-based care, have we thrown reality-based care overboard to lighten the load? The bureaucratic equivalent of jetsam: cargo thrown overboard to save the ship -a word derived from jettison.

We must be sensitive to changing times and evidence, of course; new data require new approaches. We must be aware of public opinion and evolving mores because sensibilities wander, expectations mutate. We are not the same people we were even a decade ago. We are an ever-simmering melange as new customs merge with established ones, and religions stir several pots at once.

So there is no one center around which things revolve; we are many circles, each overlapping. We are a stochastic society: a kaleidoscopic stew of boiling colours and tastes.

But just because there are many variables that resist easy classification, this does not necessitate ill-considered solutions. Some things in Medicine are important -worth preserving even if they require more work than in the past. More patience. More understanding.

Think, for example, of vaccinations. Who would have thought there would be any resistance to these life-saving measures a generation ago when polio, smallpox, diphtheria, tetanus –even measles- were reeking havoc across the world? Nowadays it’s not the doctors who are suspicious, but the public: ‘Why vaccinate my child and subject her to risks of side effects for something that nobody gets anymore?’

I hear this occasionally from my pregnant patients. So, I have to make the time to counsel them and attempt to answer their pre-printed Google inquiries. And by and large they understand. What they have been seeking is not so much a detailed data-ridden explication with appended references, but an empathetic hearing and discussion of their concerns. People are sensible, by and large. They simply want what’s best for themselves and their families. They want to be participants in health related issues –and why not?

But to come to the point of this essay: http://annals.org/article.aspx?articleid=1884537

Some patients have readily discoverable problems -an enlarging mole on their skin that worries them, say. But some areas are hidden –both from the world and the person herself. The vagina was not designed as a shop window, and what hides at its end in the pelvis –like the uterus, ovaries, Fallopian tubes, for example- are not subject to casual interrogation. Tests like ultrasounds or CT scans are only done when symptoms arise –and like everything else, that is often too late. This is a worry.

Most women are resigned to interval pap smears (and soon, no doubt, to interval HPV testing from the same area). It seems to be accepted by most people in the community that pap smears can detect abnormal cells arising on the surface of the cervix long before –years before- any noticeable symptoms appear. And the fact that the rest of the pelvis can be assessed at the same time as the pap smear is reassuring to most women. Expected, actually -especially since their doctor is already focussed on the area. In the neighbourhood, as it were.

So it came as a surprise to me that a recent guideline from the American College of Physicians suggested that a pelvic exam should not be done routinely with pap smears. Only if symptoms arise that are suggestive of pelvic pathology could one justify its performance… Where’s the reassurance in that?

http://www.2minutemedicine.com/new-acp-guidelines-recommend-against-regular-pelvic-exams/

There are harms associated with it apparently. Evaluated harms ‘included fear, anxiety, embarrassment, pain, and discomfort. Physical harms may include urinary tract infections, and symptoms such as dysuria, and frequent urination.’ Wow! I wonder who is doing the pelvic exams for their studies.

And I wonder if any of the examiners actually discussed the examination with the patient beforehand. Or, more importantly, asked her permission. Her arrival at the office for the pap smear was voluntary (one hopes) and so she must be an active and willing participant in any medical investigations performed on her –including a pelvic examination, obviously. If possible, she should be able to choose her examiner –a female doctor, for example, or someone she trusts and with whom she feels at ease. As for my part, if she should choose not to be examined at the time of the pap, I certainly do not object; but I always ask.

Sometimes, there are cultural differences where the patient would feel awkward being examined by a male and if I suspect that is the case, I do not insist or make her feel uncomfortable about having to make a choice. I also offer to have another woman (her friend, my secretary, or her husband if she so chooses) to be present in the examination room.

Examination is as much for her reassurance as to discover something. The choice is hers, not mine. But there is usually an expectation that it will be done –or at least offered. I don’t think that we should make a big production about it. I don’t enjoy going to the dentist –childhood memories of pain and discomfort, I suppose- but when I do go, I expect her to check more in my mouth than just my teeth. Even if it is just my regular dental checkup I am willing to have my tongue palpated and my gums poked and prodded… especially if it is just a check up. I want to prevent problems as well as solve them. And the more thorough the examination, the more reassured I feel when it is normal. Am I alone in this?

Let’s face it, there are some things that, like it or not, we need to do for our own benefit. In the long march of Time, they might not amount to much, but nonetheless we may put them off in anticipation of discomfort or embarrassment. Autonomy –choice- is paramount.

But let me paraphrase (para-sex) Shakespeare:

She that outlives this day, and comes safe home,                                                                         

Will stand a’ tiptoe when this day is named.

Kind of makes one proud to have participated, don’t you think..?