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QUESTION: In patients with restless legs syndrome (RLS), is gabapentin more effective than placebo for improving sensory and motor symptoms?
Design
13 week randomised (allocation concealed*), blinded (clinicians and patients),* placebo controlled, crossover trial.
Setting
Madrid, Spain.
Patients
24 patients who were 33–75 years of age (mean age 55 y, 67% women) and were diagnosed with idiopathic RLS (established by the International RLS Study Group). Patients with ferritin concentrations <20 μg/ml were excluded. 21 patients (88%) completed the study.
Intervention
Patients were allocated to sequence 1 (gabapentin followed by placebo) or sequence 2 (placebo followed by gabapentin). Gabapentin was given at an initial dose of 600 mg/day, up to a maximum dose of 2400 mg/day. The sequences lasted 6 weeks with a 1 week washout period, and then patients …