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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty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 Reduced efficacy of blood pressure lowering drugs in the presence of diabetes mellitus-results from the TRIUMPH randomised controlled trial(Nature Publishing Group, 2023) Gnanenthiran, S.R.; Webster, R.; de Silva, A.; Maulik, P.K.; Salam, A.; Selak, V.; Guggilla, R.K.; Schutte, A.E.; Patel, A.; Rodgers, A.; TRIUMPH Study GroupWe investigated whether diabetes mellitus (DM) affects the efficacy of a low-dose triple combination pill and usual care among people with mild-moderate hypertension. TRIUMPH (TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension) was a randomised controlled open-label trial of patients requiring initiation or escalation of antihypertensive therapy. Patients were randomised to a once-daily low-dose triple combination polypill (telmisartan-20mg/amlodipine-2.5 mg/chlorthalidone-12.5 mg) or usual care. This analysis compared BP reduction in people with and without DM, both in the intervention and control groups over 24-week follow-up. Predicted efficacy of prescribed therapy was calculated (estimation methods of Law et al.). The trial randomised 700 patients (56 ± 11 yrs, 31% DM). There was no difference in the number of drugs prescribed or predicted efficacy of therapy between people with DM and without DM. However, the observed BP reduction from baseline to week 24 was lower in those with DM compared to non-diabetics in both the triple pill (25/11 vs 31/15 mmHg, p ≤ 0.01) and usual care (17/7 vs 22/11 mmHg, p ≤ 0.01) groups, and these differences remained after multivariable adjustment. DM was a negative predictor of change in BP (β-coefficient -0.08, p = 0.02). In conclusion, patients with DM experienced reduced efficacy of BP lowering therapies as compared to patients without DM, irrespective of the type of BP lowering therapy received.Item Therapeutic effects of domperidone on abdominal pain-predominant functional gastrointestinal disorders: randomized, double-blind, placebo- controlled trial.(Lippincott Williams & Wilkins, 2015) Karunanayake, A.; Devanarayana, N.M.; Rajindrajith, S.; de Silva, A.INTRODUCTION: The therapeutic effect of domperidone on abdominal pain-predominant functional gastrointestinal diseases (AP-FGIDs) was assessed on children in 5-12 year age group at the Gastroenterology Research Laboratory of Faculty of Medicine, University of Kelaniya, Sri Lanka. METHODS: Children fulfilling Rome III criteria for AP-FGIDs were recruited from the out-patient clinic of the University Paediatric Unit, North Colombo Teaching Hospital, Ragama, Sri Lanka, after obtaining parental consent. They were randomized in to 8 weeks of placebo or Domperidone (Motillium 10 mg, 3 times per day, before meals) groups, using computer generated random numbers. Placebo was a specially prepared dummy tablet without any active ingredients, had the same colour, size, shape and taste of domperidone tablet and were packaged similarly. Primary outcomes defined were cure (abdominal pain less than 25 mm on the visual analogue scale and no impact on daily activities) and improvement (pain relief and sense of improvement recorded on global assessment scale). Secondary outcomes were significant improvement in symptoms, gastric motility, quality of life (QoL) and family impact. Both patients and investigators who assessed primary and secondary outcomes before and after intervention were blind to inventions administered. Symptom severity was recorded on a validated 100 mm visual analogue scale. Translated and validated PedQL Generic Score Scale version 4.0 and Family Impact Module were used. Gastric motility was assessed using a validated ultrasound method. RESULTS: One hundred children were enrolled and 89 completed the trial [Placebo 42 (22 girls), Domperidone 47(33 girls)]. While comparing primary outcomes, domperidone group had significant improvement [37 (78.7%) vs. 25 (59.5%) in placebo group, p = 0.04], while no such difference was observed in cure. When assessing secondary outcomes, domperidone group reported significant reduction in abdominal pain severity (70.84% vs. 48.18% p = 0.03) and improvement in motility index (29.3% vs. 8.6% p = 0.04) after intervention. No such difference was seen in improvement of QoL and family impact (p > 0.05). CONCLUSIONS: Domperidone has a favorable therapeutic effect on improvement AP-FGIDs in children aged 5-12 years. It causes significant reduction in abdominal pain and improvement in motility of the gastric antrum. However, it has no significant effect on improvement of QoL and family impact.