J Midlife Health. 2019 Oct-Dec;10(4):197-203. doi: 10.4103/jmh.JMH_26_18.
Comparative Efficacy and Safety of Clonazepam versus Nortriptyline in Restless Leg Syndrome among Forty Plus Women: A Prospective, Open-Label Randomized Study.
Journal of mid-life health
Roshi, Vishal R Tandon, Annil Mahajan, Sudhaa Sharma, Vijay Khajuria
Affiliations
Affiliations
- Department of Pharmacology and Therapeutic, Government Medical College, Jammu, Jammu and Kashmir, India.
- Department of General Medicine, Government Medical College, Jammu, Jammu and Kashmir, India.
- Department of Obstetrics and Gynecology, Government Medical College, Jammu, Jammu and Kashmir, India.
PMID: 31942156
PMCID: PMC6947720 DOI: 10.4103/jmh.JMH_26_18
Abstract
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 (
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.
Copyright: © 2019 Journal of Mid-life Health.
Keywords: Plus forty age; restless leg syndrome; treatment drugs; women
Conflict of interest statement
There are no conflicts of interest.
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