A task force consisting of six authors reviewed the published literature on
the therapy of the restless legs syndrome or periodic limb movements in sl
eep available in indices through April, 1998. They selected the 45 articles
for detailed review which presented original investigations of therapeutic
impact on the restless legs syndrome (RLS) or periodic limb movements (PLM
) and which met minimal standards. These articles dealt with a range of pha
rmacological and other treatment modalities, although most dealt with medic
ations and almost half of those concentrated on dopaminergic agents, especi
ally levodopa in various formulations. Almost half of the articles reviewed
used controlled methodologies, most commonly cross-over methodologies with
randomized allocation of subjects. Multi-center studies with large numbers
of subjects and long-term controlled studies were not found. Information w
as extracted from the articles and study design, clinical definition, evalu
ative measures, side effects, and outcomes were tabulated in 6 evidence tab
les and summarized in the accompanying text. This literature was evaluated
for the nature of the studies performed and its coverage of potential thera
pies. The review concludes with comments on possible future directions for
therapeutic investigation based on the current state of the literature.