Medicine
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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
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Item Low-dose melatonin for sleep disturbances in early-stage cirrhosis: A randomized, placebo-controlled, cross-over trial(John Wiley & Sons Australia Ltd, 2020) de Silva, A.P.; Niriella, M.A.; Ediriweera, D.S.; de Alwis, J.P.N.; Liyanage, I.K.; Ettickan, U.; Liyanapathirana, K.V.; Undugodage, C.; de Silva, H.A.; de Silva, H.J.BACKGROUND AND AIM: Melatonin is used to treat sleep disturbances (SDs). The aim of this study was to investigate the safety and efficacy of low-dose melatonin for SDs in early-stage cirrhosis. METHODS: In a single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial, patients with early-stage (Child-Turcotte-Pugh [CTP] class A or B) cirrhosis with SDs, without hepatic encephalopathy, were randomized to placebo or 3 mg of melatonin for 2 weeks. After 2 weeks, the patients were given a washout period of 1 week and crossed over to melatonin or placebo for a further 2 weeks. The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) were used to measure sleep quality and daytime sleepiness, respectively. Analysis of results was based on intention to treat, and linear mixed-effect models were used to evaluate the effect of melatonin. Analysis was conducted using R-programming language 3.5.1. RESULTS: Seventy-one patients were recruited (mean age: 61.9 ± 8.7 years, males: 46 [64.8%], and CTP Class A = 52 [73.2%] and Class B = 19 [26.8%]). Sixty patients completed the study (mean age: 61.7 ± 8.8 years, males: 40 [66.6%], and CTP Class A = 45 [75.0%] and Class-B = 15 [25.0%]). Two patients dropped out due to adverse events. Nine patients were lost to follow up. Patients given melatonin had a significantly lower PSQI and ESS compared to both pretreatment (P < 0.001) and postplacebo scores (P < 0.001). Incidence of adverse events was similar (two each of abdominal pain, one each of headache, one each of dizziness) in both groups. CONCLUSION: Melatonin seems safe and effective for use in patients with SDs in early-stage cirrhosis in the short term. However, larger and longer-term studies to assess efficacy and safety are required before its clinical use can be recommended. KEYWORDS: cirrhosis; clinical trial; melatonin; sleep disturbances; treatment.Item Efficacy of rivastigmine on activities of daily living in Sri Lankan patients with Alzheimer disease and on improving caregiver burden: a prospective study(Sri Lanka Medical Association, 2005) de Silva, H.A.; Pathmeswaran, A.; Gunatilake, S.B.OBJECTIVE: This open label, parallel group, prospective cohort study investigated the efficacy of rivastigmine treatment on activities of dailyliving (ADL) in patients with mild to moderate Alzheimer's disease (AD) and the possible benefits of this therapy on caregiver stress levels. METHODS: Thirty eight consecutive patients with mild to moderate AD were recruited; 22 received rivastigmine 3-6 mg twice daily (treatment group) for 20 weeks. Sixteen patients who did not receive rivastigmine served as the control group. The 17-item ADL Index was used to assess ADL and to determine the presence of functional deterioration. Caregivers were evaluated with the Caregiver Stress Scale (CSS). Each patient was required to have a committed caregiver and all caregivers were interviewed and administered the ADL Index and the Caregiver Stress Scale (CSS) at the start of treatment (week 0) and at the end of 20 weeks of treatment (week 20). RESULTS: Patients in the control group showed a significant decline in ADL Index score at 20 weeks compared to rivastigmine-treatedpatients (difference in mean ADL Index score = 8.5; p < 0.001). At week 20, mean change from baseline scores for CSS total and individual domain scores were better for caregivers in the treatment group than those in the control group (CSS total mean difference = 19.2). CONCLUSION: We conclude that treatment of AD patients with rivastigmine for 20 weeks produces a significant improvement in patient ADL functioning, and lower levels of caregiver stress.