N N Singh1, S Misra. 1. Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Abstract
OBJECTIVES: To study the effect of Sertraline, a selective serotonin reuptake inhibitor in chronic tension type headache (CTTH) in a double blind placebo controlled randomized trial. MATERIAL AND METHODS: The study design was a double blind placebo controlled randomized study of 50 patients, over a period of 10 weeks including run-in period of two weeks, treatment period four weeks, and follow-up four weeks. The diagnosis of CTTH was based on criteria given by International Headache Society (IHS). The overall response was graded in terms of headache index, analgesic intake per week and percentage reduction in headache frequency using chi-square and 't' test. Anxiety and depression was assessed using Hamilton Rating Scale. RESULTS: The mean analgesic intake per week declined from 4.34 +/- 0.736 tab/week to 1.07 +/- 0.592 tab/week in sertraline group (p < 0.01) while reduction in placebo group was not significant (3.98 +/- 0.729 tab/week to 2.94 +/- 0.665 tab/week) (p > 0.05). The reduction in headache index and percentage reduction in frequency of headache was not significant in drug treatment group. Side effects were seen in 24.4% of patients nausea, nervousness and dizziness being the commonest. CONCLUSION: The drug treatment group showed a significant decline in analgesic intake per week. The study result shows that sertraline can be a useful alternative to amitryptiline in those patients who fail to respond or cannot tolerate it.
RCT Entities:
OBJECTIVES: To study the effect of Sertraline, a selective serotonin reuptake inhibitor in chronic tension type headache (CTTH) in a double blind placebo controlled randomized trial. MATERIAL AND METHODS: The study design was a double blind placebo controlled randomized study of 50 patients, over a period of 10 weeks including run-in period of two weeks, treatment period four weeks, and follow-up four weeks. The diagnosis of CTTH was based on criteria given by International Headache Society (IHS). The overall response was graded in terms of headache index, analgesic intake per week and percentage reduction in headache frequency using chi-square and 't' test. Anxiety and depression was assessed using Hamilton Rating Scale. RESULTS: The mean analgesic intake per week declined from 4.34 +/- 0.736 tab/week to 1.07 +/- 0.592 tab/week in sertraline group (p < 0.01) while reduction in placebo group was not significant (3.98 +/- 0.729 tab/week to 2.94 +/- 0.665 tab/week) (p > 0.05). The reduction in headache index and percentage reduction in frequency of headache was not significant in drug treatment group. Side effects were seen in 24.4% of patientsnausea, nervousness and dizziness being the commonest. CONCLUSION: The drug treatment group showed a significant decline in analgesic intake per week. The study result shows that sertraline can be a useful alternative to amitryptiline in those patients who fail to respond or cannot tolerate it.