This post is a part of our Bioethics in the News series

By Robyn Bluhm, PhD

It’s something we’ve all been told: be sure to finish taking your antibiotic prescription. Don’t just stop when you begin to feel better. Doing so, we’re warned, may mean that the bacteria causing the infection have not been completely eradicated. Once treatment stops, they will begin to multiply again, causing a relapse. Worse, it may result in the development of antibiotic-resistant bacteria, which is dangerous both to the individual taking the medication and to the public as a whole.

But a recent article in The BMJ argues against this common wisdom, saying that advice to “complete the course” is not evidence-based—and that doing so may actually have the opposite effect of increasing, rather than decreasing, the risk of antibiotic resistance.

I find this piece—and reactions to it in on the journal’s website—interesting for bioethics because it illuminates the complex relationship between evidence and patient care. The article recommends changing treatment practices because of evidence that they may do more harm than good, but doesn’t really have a plan for what to change them to. This conundrum leads the authors of the article to make some interesting, but incomplete, suggestions related to physician-patient communication and shared decision-making. The commentaries on the paper challenge both the authors’ claims about the available evidence and their suggestions about sharing doubts about current practice with patients.

Changing Clinical Practice?
The randomized controlled trial (RCT) is currently thought to be the “gold standard” of evidence in medicine. It is not uncommon for discussions of medical evidence to cite examples of treatments that were in common use before an RCT was conducted, that were then shown by the trial to be useless or even harmful. This time last year, I blogged about a report that suggested that there is no evidence that flossing your teeth has any benefits. In response to this report, a number of people suggested that we should just stop flossing. In the late 1980s, a large RCT showed that two drugs commonly used to treat arrhythmia actually increase the risk of cardiac death and the authors recommended that their use be discontinued.

The question addressed in the BMJ paper is more complex than either of these cases. The recommendation is not to stop using antibiotics altogether, but to change the way that they are used. And the recommendation is not based on RCTs, but on the lack of evidence for current practice; on the flawed reasoning that linked early discontinuation with antibiotic resistance; and on evidence that overuse of antibiotics is actually the most important causal factor in the development of resistance. The authors identify only seven conditions for which researchers have conducted RCTs that directly compared a shorter with a longer course of treatment. Moreover, even in cases where the shortest effective course of an antibiotic treatment for a health condition has been identified, it’s not possible to extrapolate from this situation to the use of other antibiotics, or the use of that antibiotic for other diseases.

The authors of the BMJ paper do emphasize that more evidence is needed. But until that research has been done (if it ever is done), it’s not clear how doctors should change their current prescribing habits. As the discussion in the article makes clear, the answer to this question will depend on a number of factors, including the kind of infection and the specific antibiotic being used. Moreover, it will depend on the individual patient, as “patients may respond differently to the same antibiotic, depending on diverse patient and disease factors” (p. 2).

Talking with Patients
Given the number of factors that might affect patient outcomes, it would not be surprising if the authors of the article were unwilling to make specific recommendations for clinical practice. In fact, they don’t make a recommendation in terms of what doctors should prescribe for their patients. Instead, they end their paper with a section titled “How should we advise patients?” While prescribing a medication regimen certainly counts as giving a patient advice (at least implicitly), they couch their discussion in terms of general communication strategies, rather than of specific practice guidelines. In this section of the paper, they suggest that part of the reason that the traditional advice to “complete the course” has been so resilient is that “it is simple and unambiguous, and the behavior it advocates is clearly defined and easy to carry out” (p. 3). In addition to recommending further research on the appropriate dose of antibiotic, the authors also recommend research to identify “the most appropriate simple alternative messages” (p. 3). One possibility is to tell patients to stop when they feel better–exactly the opposite of what we have generally been told. More immediately, however, they say that doctors should begin to educate patients about the problems with the traditional advice, telling them that antibiotic overuse is the real problem that leads to antibiotic resistance. They suggest that honesty about our current lack of knowledge is better than “simply substituting subtle alternatives” such as the instruction to “take exactly as prescribed” (p. 3).

Take as directed…
A number of the commentaries on the BMJ website express frustration with the article–and with the situation it describes. Some of the commentaries emphasize that the article title is misleading or that the article itself overstates the conclusion that can be drawn based on the available evidence. Others worry that patients will take this article (and the media coverage that suggests that they should stop taking their antibiotics when they feel better) as license to ignore their doctor’s recommendations. One commenter even suggests that patient-centered decision-making is dangerous, and an illusion, when there is still medical debate on a topic. Yet many also agree that there is a problem with current practice.

The problem is that, if Llewelyn et al. are even close to correct, there is no clear direction for physicians or for patients. Confusingly, this seems like a case in which the growing evidence leave us knowing less, rather than more.

Robyn Bluhm, PhD, is an Associate Professor in the Department of Philosophy and Lyman Briggs College at Michigan State University.

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