Comment: The quality of evidence is downgraded by study quality (high drop-out rate), indirectness (short follow-up, which may exclude potentially serious adverse events) and imprecise results (one study).
A Cochrane review [Abstract] 1 included one study with a total of 276 subjects with idiopathic restless legs syndrome (RLS). The studies evaluated opioids (prolonged release oxycodone/naloxone) vs. placebo. Only 174 patients completed the 12 week study. After 12 weeks, RSL symptoms had improved more in the drug group than in the placebo group (using the IRLSSS: MD -7.0, 95% CI -9.69 to -4.31 and the CGI: MD -1.11; 95% CI -1.49 to -0.73). More patients in the drug group than in the placebo group were drug responders (using the International RLS Severity Scale (IRLSSS): RR 1.82; 95% CI 1.37 to 2.42 and the Clinical Global Impression (CGI): RR1.92, 95% ICI 1.49 to 2.48). The proportion of remitters was greater in the drug group than in the placebo group (using the IRLSSS: RR 2.14; 95% CI 1.45 to 3.16). Quality of life scores also improved more in the drug group than in the placebo group (MD -0.73; 95% CI -1.1 to -0.36). Quality of sleep was improved more in the drug group measured by sleep adequacy (MD -0.74; 95% CI -1.15 to -0.33), and sleep quantity (MD 0.89; 95% CI 0.52 to 1.26).There was no difference between groups for daytime somnolence, trouble staying awake during the day, or naps during the day. More adverse events were reported in the drug group (RR 1.22; 95% CI 1.07 to 1.39). The major adverse events were gastrointestinal problems, fatigue, and headache.
The high drop-out rate precludes prediction of the entire range of possible adverse events for the opioid treatment, which is an important issue when opioids are used.
Date of latest search:
Primary/Secondary Keywords