Comparative Efficacy and Safety of Clonazepam versus Nortriptyline in Restless Leg Syndrome among Forty Plus Women: A Prospective, Open-Label Randomized Study.

AIMS AND OBJECTIVES: The aim of this study is to compare the effect of clonazepam and nortriptyline on rate, frequency, and severity of restless leg syndrome (RLS) in above 40 years women suffering from RLS. MATERIALS AND METHODS: A prospective, randomized, open-label comparative study was conducted at a tertiary care teaching hospital for 1 year. Restless legs syndrome (RLS) diagnosis was based on four essential clinical criteria established by the International RLS Study Group in 2003. Patients were randomized into two groups. Group 1 received tablet clonazepam 0.5 mg bedtime orally daily. Group 2 received tablet nortriptyline 25 mg bedtime orally daily. The primary efficacy endpoints by the International Restless leg Syndrome Scale (IRLS) were evaluated at 0, 4, and 8 weeks. Adverse drug events and safety assessment for vital signs such as blood pressure, pulse, heart rate, waist circumference, and body mass index were compared between two groups. RESULTS: Effect on mean IRLSS was statistically more in clonazepam group in comparison to nortriptyline group with comparable results at 8 weeks (P < 0.001), but at 4 weeks, nortriptyline showed less improvement (P < 0.01) versus P < 0.001 in nortriptyline group. Thus, nortriptyline reported relatively more improvement on IRLSS numerically in comparison to clonazepam. Nortriptyline proved to be statistically better in improving the frequency of RLS with comparison to clonazepam, whereas the results were comparable with regard to rate and the severity of RLS. Both the groups were relatively safe and did not produce any change in biochemical parameters and were free from any serious or severe adverse events and overall, both the treatments were well tolerated. CONCLUSION: Both the drugs provided clinically and statistical significant effect on RLS when compared with their respective baselines. However, nortriptyline proved to be statistically better in improving the frequency of RLS in comparison to clonazepam, whereas the results were comparable with regard to rate and the severity of RLS on intergroup comparison. Both the drugs were well tolerated.