Wednesday, 5 December 2007

Clinical Research

Commonly I'm asked to help manage Behavioural and Psychological Symptoms of Dementia (BPSD).

Usually this involves stopping medication that's making things worse and changing the environment to reduce ambiguity and distress then psychoeducation to guide carers on what to expect, how to de-escalate distress and what interventions can be effective to minimise disturbed behavioural repetoires without compromising personal care.

For example, a wife recently struggled to bath her dementing husband because he assertively resisted each time she tried. Removing unnecessary medication made him much more content more of the time anyway, then guidance with her meant she'd cracked it and was able to use a mix of ongoing reality orientation and reassaurance to bath him without any problems.

Still, for some folk, medication for BPSD is useful. I don't like older antipsychotics, I won't sedate anyone to "make things more manageable" and I'll only use medication as part of the process of care (rather than being seen as the solution itself). At best, medication then is something that helps the patient and carers manage behavioural disturbance better, allowing the patient to engage with the carer in the techniques they can use. Medication, then, is just a tiny part of the solution, helping the carer do the high quality dementia care we teach and advocate.

With that in mind, it's not often I find myself using olanzapine or risperidone in the treatment of BPSD. Just a couple times a year, that I can recall. But there's a snag.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) said that they shouldn't be used.

Letters in the British Medical Journal criticised the authority/strength of direction, saying these drugs shouldn't be used, since they're clinically helpful and risks were low.

A more objective observational study didn't find the level of risk and concern the MHRA described concluding, "Perhaps the best we can say is that on the basis of this good observational study, the risk of increased strokes from atypical antipsychotics in dementia is less than the trials indicate."

The MHRA say that background risk of stroke is about 1% a year in this patient group. Patients on olanzapine or risperidone have an annual risk of about 3%. Many of the strokes are small (and arising in people with a degree of vascular dementia already).

The MHRA conceded that it's not likely to be a problem with these specific drugs, it's just that there's evidence about them. So alternatives aren't known to be any safer.

These patients with dementia and behavioural disturbance often can't and don't have capacity to give valid consent to treatment with a difficult risk/benefit ratio to consider. As the medics in the BMJ wrote, who is advocating that they should get the care they need and deserve?

Studies tell us about general risks and trends and effects. They don't tell us about our specific patient in front of us. Curtailing clinical freedom so the individual's care is overly influenecd by "average" statistical trial outcomes is harmful.

Much badness.

2 comments:

the little medic said...

Reading your posts has reconfirmed that I could NEVER do psychiatry. It scares me too much, the unpredictability and illogicalness of it all.

Never-the-less its an important job so well done.

The Shrink said...

Ah, it's scary, true.

We manage uncertainty and risk all the time, so it's unpredictable, true.

Illogical? I'd challenge that. I reckon that good mental health work is more structured and logical and methodical than physical health/medicine is.
Patient presentations, formulation/diagnosis, interventions, all very logical. More so that in general medicine, no?