University School of Medicine in Baltimore and lead author of the study, the updated practice parameters were less complicated to develop than many similar parameters in sleep medicine due to the strength and amount of evidence available, particularly the data related to the dopaminergic agents used to treat RLS. “The number and quality of studies looking at therapies for RLS is better than what we see for other sleep disorders,” she said. “Often, studies in the sleep medicine literature are small or of limited quality because sleep medicine is still a young and evolving field.”
Explore this issue:December 2012
Seth Schwartz, MD, the current chair of the AAO-HNS Guideline Development Task Force, thinks the practice parameter provides a nice review of the evidence on using a methodology that is presently considered state of the art. “The recommendations are evidence-based and pretty clear cut,” he said.
The study used principles of evidence-based medicine to develop three main levels of recommendations based on the quality of the evidence. Recommendations based on the highest quality of evidence are labeled “standard,” those based on clear evidence but not the highest quality are labeled “guideline” and recommendations based on data that is not of very high quality but is thought to be reasonable are labeled “optional.” To further clarify the strength of the recommendation, the AASM committee provided a data-based benefit/harm/burden assessment of each agent indicating the committee’s confidence that the true effectiveness of the drug is close to its estimated effectiveness.
Based on the current evidence, the dopamine agonists pramipexole and ropinirole are the two main treatments for movement disorders. See “Current Recommendations for the Treatment of Restless Legs Syndrome,” below.
Along with these recommendations, the practice parameters list a number of agents for which no recommendations are given. One of these agents, rotigotine, was taken off the market in 2008 due to inconsistent dosing. However, rotigotine has been upgraded from a “no recommendation” to a “guideline” recommendation based on the availability of a new formulation of the patch that now meets FDA approval (Sleep. 2012;35:1037).
Caution with Long-Term Use of Dopamine Agonists
According to Dr. Shangold, the main differences between the 2004 and 2012 updated practice parameters is the shift in the level of recommendation given to the medications used to treat RLS. He emphasized that although the evidence accumulated over the past eight years shows that the medications with a standard recommendation—the dopaminergic agents—have a high benefit with minor risks, they do still carry risks. “This is our dilemma,” he said. “How many otolaryngologists are comfortable prescribing dopamine-agonists, which are neurological drugs? I’m not sure many of us will be using these commonly.”