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Editor's note: Although clinicians have effective, evidence-based treatment options for bipolar disorder at their disposal, many patients have poor functional outcomes and frequent relapses. Poor treatment adherence is often related to poor outcome. To find out the latest thinking on enhancing adherence in treatment of bipolar disorder, Medscape's Randall F. White, MD, interviewed Gary S. Sachs, MD. Dr. Sachs is the director of the Bipolar Clinic and Research Program at the Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School.
Medscape: Diagnosis and treatment of patients with bipolar disorder present many challenges. Once a patient has achieved a stable mood, the next task is to maintain treatment gains. Nonadherence to therapy is a leading cause of relapse.[1] What are patient correlates of nonadherence to treatment?
Dr. Sachs: The biggest correlate is the belief that a mood disorder is more like pneumonia than like heart disease, which means that people have a bias toward an acute treatment model as opposed to a chronic-illness treatment model for managing their condition. That brings us into the realm of what we call concordance, the degree to which the doctor and patient are in agreement about what it makes sense to do.
Medscape: I want to come back to that. Can you mention any other patient correlates, for example, demographic factors or comorbidities that contribute to nonadherence?
Dr. Sachs: Among mental disorders, bipolar disorder has the most associated comorbidities.[2] A number of psychiatric and general medical conditions frequently co-occur with bipolar disorder compared with other psychiatric and medical conditions. Bipolar patients have a lot of anxiety disorders; they have a lot of problems with substance abuse and misuse. They also may have high blood pressure, high cholesterol, and be overweight. All of these conditions may make the disorder more cumbersome to manage successfully.
Medscape: Do you think that those conditions can contribute to nonadherence?
Dr. Sachs: Yes. The more complicated the circumstances, the more likely a patient is to say, "Forget it, I can't manage all of that, so I may as well do none of it."
Medscape: I ran across some research that suggested that patients who have a minority ethnic status are more likely to be nonadherent.[3] What do you think?
Dr. Sachs: Investigators talk a lot about those demographic issues. I see them as proxies for concordance. The tradeoffs made by whites in healthcare decisions are different from those that might be made among Latinos, Asians, or African Americans. For example, what you're willing to tolerate in treatment for your headaches or your vision problems will cause you to decide how often you are going to wear your glasses, or whether you're going to get LASIK surgery. Those decisions may differ among ethnic groups, and it's not so much that people are simply not adherent, it's that nobody has bothered to establish that they were interested in the treatment to begin with.
Medscape: Let's go back to what you were mentioning about concordance. Can you explain that?
Dr. Sachs: Concordance is an idea that takes into account agreement between a care provider and a patient about what is the most appropriate thing to do. If my primary care doctor thinks that it's necessary to treat my high blood pressure and recommends that I take medication, I might see the value in treatment but I might prefer diet change and exercise. If my primary care doctor is terrific, she will be happy for me to try diet and exercise, and when I succeed she will acknowledge that and say, "Keep at it, but if you find that you can't keep this up, you can always take medication." She has encouraged me to work on diet and exercise so that I don't need medication to manage high blood pressure, and we're in agreement that bringing the blood pressure down is the right thing.
However, if I were trying to use diet and exercise, but after 3 months it's not working, and despite redoubling my efforts it's still not working to reduce my blood pressure, I will probably become concordant with her recommendation. I will try a medication, and when that works I will continue it. This is a process that tends to produce wise agreements amicably, and that's what we're in this game to do. It's not a process to persuade, not a process to demand, not a process that's one-way in either direction.
Medscape: This seems to me related to research showing that therapeutic alliance is one of the most important correlates of adherence to treatment.[3]
Dr. Sachs: That's exactly right. If patients have a good working relationship with care providers, they are likely to be concordant about the treatment. If despite concordance patients are nonadherent, they may be open to having external supports to help them stick with therapy; whereas without concordance, when a clinician proposes external supports, the proposal may seem insulting. Whenever a patient is nonadherent, clinicians should address the concordance issue and find out what agreement can be reached.
Medscape: Patients who are manic may lack insight into their illness, and according to research, poor insight correlates with reluctance to remain in treatment or to take medication.[4] What interventions can promote insight in such patients?
Dr. Sachs: Remember the premise that we started with: the patient has become well, and the time for enhancing insight is during that time. If you're talking about someone who is manic and doesn't have insight, that's an entirely different situation. In our program, we create a written treatment plan and have patients anticipate that they may become manic or terribly depressed, and that other people should be empowered to help them during those times.
Of course, sometimes patients change their mind and don't want to go along with their plan, but as we work with patients over time, we come up with interventions that can be tested out in those circumstances and find what works for an individual.
Medscape: You were involved in an NIMH-sponsored multicenter trial, the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)[5]; what lessons came out of that investigation regarding improving treatment adherence?
Dr. Sachs: We learned several things. STEP-BD used a disease management model in which we promised patients excellent care in exchange for known results. We trained the doctors to be comfortable using proven treatments first, to use negotiation techniques as described in the book Getting to Yes,[6] and to integrate measurements directly into the management. There were some concerns that patients might not be willing or able to consider numerical measurements in their care, but that turned out not to be the case.
In an analysis of the data, our team found that 80% of patients were guideline concordant both in terms of choice of medications and dosing.[7] So that's quite an accomplishment when you think about it.
Medscape: Do you think that the negotiation paradigm can play a role in general psychiatric practice?
Dr. Sachs: I think it can play a role beyond general psychiatric practice, in all of medicine. Coming up with negotiation strategies that are positional is often the stumbling block that prevents us from getting along with people, whereas I think that a principled negotiation can more often help people agree.
Medscape: Now I want to talk about pharmacotherapy. Do specific choices of medication or using multiple medications affect adherence in bipolar disorder?
Dr. Sachs: The more complicated the regimen, the harder it is for patients to follow. As a field, we psychiatrists have embraced the idea of polypharmacy for what started out as good reasons. Relatively few patients have a perfect response to any 1 treatment, and a second treatment can be beneficial. If you look at all of the acute mania trials, the data show benefits of an active drug over placebo, and that increment of benefit is the same when you add a second drug. However, no evidence exists for adding a third, fourth, fifth, sixth, or seventh drug.
Medscape: Is that because the trials haven't been carried out or that the evidence is negative?
Dr. Sachs: The trials haven't been carried out. I know of no line beyond which you can say that treatment has gone from rational to potentially toxic polypharmacy, but often it is in a range that is confusing to patients and care providers. As a rule, you can improve adherence by simplifying people's treatment regimens, by not using multiple drugs of the same class, and by discontinuing medications that haven't worked. So as you manage by subtraction, you may improve outcomes as well as cost and quality of life for patients.
Medscape: Manage by subtraction?
Dr. Sachs: We have a study going on in our clinic called "Interventions for Ineffective Complex Chronic Care," with patients who are taking 5 or more medications for 6 or more months without getting better. We expected that these would be difficult cases to manage, but it turned out that many of them were on 9, 10, or 11 drugs simply because the clinician and the patient were afraid to stop something.
Medscape: Do you have any publications from that work?
Dr. Sachs: No, we haven't yet reached a point where we can analyze the data. But I can tell you that it's often easy to eliminate 2 or 3 drugs within the first 4-6 weeks.
Medscape: If you have a patient who is taking , for example, an antipsychotic, an antidepressant, and 2 mood stabilizers, how would you decide which to remove first?
Dr. Sachs: We have a discussion with the patient to evaluate every trial they've had, and we categorize them:
The medications to eliminate are those that are associated with no particular benefit and that have side effects that impair the patient's functioning.
For example, if a patient found that an evening medication was sedating but didn't improve sleep, and caused lethargy through the next day, and the patient was therefore taking a stimulant in the morning, you really have 2 drugs to take away. I also recommend gradually tapering medications as opposed to abruptly stopping them.
Medscape: Can you discuss any evidence that exists on specific psychosocial interventions that can enhance adherence in patients with bipolar disorder?
Dr. Sachs: Yes. Colom and Vieta have conducted a very nice study that, instead of just measuring self-reported adherence rates, measured lithium levels.[8] They found that lithium levels were more often therapeutic in subjects who received a group psychoeducational intervention in a Barcelona clinic than in patients who did not receive the intervention.
Medscape: It sounds as though it could be very cost effective.
Dr. Sachs: And the extra cost to do cognitive-behavior therapy, psychoeducational programs, or family-focused therapy is effective because these interventions not only enhance response rates, but they tend to bring improvement sooner than in people who don't receive those interventions.[9] Furthermore, it appears that the most likely candidates are those who are early in the course of their treatment.
Medscape: It's similar in concept to early psychosis intervention.
Dr. Sachs: That's right, so the earlier we do this, the most cost effective it's likely to be.
Supported by an independent educational grant from Abbott.
