Friday, March 30, 2012

Lyrica Helps Patients With Fibromyalgia Sleep

The diagnosis of fibromyalgia is topic of frustration among many clinicians. This is a legitimate diagnosis with very specific criteria, but it also often becomes the diagnosis-of-exclusion after a thorough workup for a person's symptoms does not reveal the elusive cause. Often that cause, in those particular cases, actually ends up being less directly tangible, something involving stress, anxiety, frustrations, mood disturbance expressing itself as physical symptoms... something someone might see a psychologist or psychiatrist for.

So that is frustrating, because when I see a patient with that diagnosis, I have to figure out if they have the definitive diagnosis, made by an outside clinician utilizing the specific criteria, or if it ended up being the diagnosis given to the patient by the outside clinician's benign-intentioned frustration at not finding a more fitting diagnosis even after a hopefully excellent workup.

BUT because fibromyalgia IS a real diagnosis, with specific criteria, we would expect a trend of predictable changes, right? And we do.

One of those changes I see is a variant sleep brain waveform pattern called alpha-delta variant in many individuals with this diagnosis and we aren't sure what it actually represents in the brain. I also see quite a bit of insomnia in these individuals and other changes in the parameters of their sleep study like frequent spontaneous arousals ("elevated spontaneous arousal index" is what I call it in my reports).

I liked this study (published:

In it, they took 119 patients with a carefully-discerned fibromyalgia diagnosis and treated them with doses of Lyrica (pregabalin), either 300mg or 450mg a day, versus placebo (fake pill). It was double-blinded, which means the doctor asked them if they wanted to be in the study, and if the patient did, then neither the doctor nor the patient knew what dose they were being given or if they were even given the real drug versus the fake pill. This was to minimize the chance of a placebo affect. They followed them for 4 weeks of treatment. They then spent two nights back-to-back in the sleep lab followed by an actual overnight, diagnostic in-lab sleep study. There are other interesting twists and turns of the study, but the condensed summary of the results:

The Lyrica group got 6.6 hours of sleep versus 6.2 in the fake pill group.
The Lyrica group took 34.5 minutes to fall asleep versus 41.6 minutes in the fake pill group.
The Lyrica group had an improved sleep efficiency of 82.6% versus 77.2% in the fake pill group.
The Lyrica group had more deep slow-wave sleep at 17.2% versus 15% in the fake pill group.
When the Lyrica group woke up during the night (for greater than 1 minute), it happened 8.63 times versus 10.2 nights in the fake pill group.

On first glance, these may not seem so profound, but keep in mind that it was a foreign sleeping condition (not home), and these results are cumulative. They add up over time in regards to their benefit. They may not make a difference in a day, but 0.4 hours more of sleep each night, adds up to almost 3 hours hours of sleep for the week. I could use that, especially when I think about how much I love hitting the snooze button in the morning for just 10 more glorious minutes.

This is also important since frequent awakenings and decreased slow-wave sleep is thought to make the symptoms of fibromyalgia during the day worse, or as the researchers more eloquently put it, "These are common in [fibromyalgia] and may have an influence on bodily hypersensitivity and pain."

Lastly... the dreaded side effects. I wouldn't be a good doc if I didn't scare you with these, right?
Half the patients in the treatment group had at least some degree of the following side effects (% noted too):
dizziness (28.6%), somnolence--sleepiness that continued into the day (20.5%), nausea (6.3%), and headache (7.1%).
Even more interesting was that in the fake pill group, 9.9% had dizziness, 4.5% had somnolence, 1.8% had nausea, and 6.3% had headache.... a seemingly "anti-placebo" affect one could argue.