Journal/Magazine Articles

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This collection contains original research articles, review articles and case reports published in local and international peer reviewed journals by the staff members of the Faculty of Medicine

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    Duplication errors due to brand name confusion; It is not always the name-Short case series
    (John Wiley & Sons, 2023) Mamunuwa, N.; Jayamanne, S.; Wijekoon, N.; Coombes, J.; Perera, D.; Shanika, T.; Mohamed, F.; Lynch, C.; de Silva, A.; Dawson, A.
    Confusion of drug names has been identified as a leading cause of medication errors and potential iatrogenic harm. Most of these errors occur because of look-alike or sound-alike drugs. This case series gives examples of duplication errors due to brand confusion, where there are no similarities in the names.
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    Efficacy and safety of low-dose triple and quadruple combination pills vs monotherapy, usual care, or placebo for the initial management of hypertension: A systematic review and meta-analysis
    (American Medical Association, 2023) Wang, N.; Rueter, P.; Atkins, E.; Webster, R.; Huffman, M.; de Silva, A.; Chow, C.; Patel, A.; Rodgers, A.
    IMPORTANCE: Low-dose combination (LDC) antihypertensives consisting of 3 or 4 blood pressure (BP)-lowering drugs have emerged as a potentially important therapy for the initial management of hypertension. OBJECTIVE: To assess the efficacy and safety of LDC therapies for the management of hypertension. DATA SOURCES: PubMed and Medline were searched from date of inception until September 2022. STUDY SELECTION: Randomized clinical trials comparing LDC consisting of 3 or 4 BP-lowering drugs compared to either monotherapy, usual care, or placebo. DATA EXTRACTION AND SYNTHESIS: Data were extracted by 2 independent authors and synthesized using both random and fixed-effects models using risk ratios (RR) for binary outcomes and mean differences for continuous outcomes. MAIN OUTCOMES AND MEASURES: The primary outcome was mean reduction in systolic BP (SBP) between LDC and monotherapy, usual care, or placebo. Other outcomes of interest included the proportion of patients achieving BP less than 140/90 mm Hg, rates of adverse effects, and treatment withdrawal. RESULTS: Seven trials with a total of 1918 patients (mean [mean range] age, 59 [50-70] years; 739 [38%] female) were included. Four trials involved triple-component LDC and 3 involved quadruple-component LDC. At 4 to 12 weeks follow-up, LDC was associated with a greater mean reduction in SBP than initial monotherapy or usual care (mean reduction, 7.4 mm Hg; 95% CI, 4.3-10.5) and placebo (mean reduction, 18.0 mm Hg; 95% CI, 15.1-20.8). LDC was associated with a higher proportion of participants achieving BP less than 140/90 mm Hg at 4 to 12 weeks compared to both monotherapy or usual care (66% vs 46%; RR, 1.40; 95% CI, 1.27-1.52) and placebo (54% vs 18%; RR, 3.03; 95% CI, 1.93-4.77). There was no significant heterogeneity between trials enrolling patients with and without baseline BP-lowering therapy. Results from 2 trials indicated LDC remained superior to monotherapy or usual care at 6 to 12 months. LDC was associated with more dizziness (14% vs 11%; RR 1.28, 95% CI 1.00-1.63) but no other adverse effects nor treatment withdrawal. CONCLUSIONS AND RELEVANCE: The findings in the study showed that LDCs with 3 or 4 antihypertensives were an effective and well-tolerated BP-lowering treatment option for the initial or early management of hypertension.
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    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 Group
    We 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.
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    The use of personal protective equipment in endoscopy: what should the endoscopist wear during a pandemic?
    (Taylor & Francis, 2021) Jayasena, H.; Abeynayake, D.; Niriella, M.; de Silva, H.J.; de Silva, A.
    Endoscopists are at high risk of exposure and nosocomial transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus) when performing endoscopic procedures due to the highly aerosol generating nature of these procedures. At present, there is still no consensus among endoscopists with regards to the type of protective equipment to be worn by healthcare workers, when performing endoscopy during the coronavirus 2019 (COVID-19) pandemic. This review encompasses a summary of currently published guidelines related to the use of personal protective equipment (PPE) when performing endoscopic procedures during the COVID-19 pandemic. With increasing calls to rationalize the use of PPE due to shortages in global supply chains, the review offers a concise summary on the most appropriate and adequate use of PPE when performing endoscopy during the pandemic. It is expected that these adaptations in the use of PPE during the pandemic will help to improve standards of care and safety of healthcare workers.
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    Effect of a multicomponent intervention on antihypertensive medication intensification in rural South Asia: post-hoc analysis of a cluster RCT
    (Oxford University Press, 2021) Feng, L.; Jehan, I.; de Silva, A.; Naheed, A.; Khan, H.A.H.; Kasturiratne, A.; Clemens, J.D.; Lim, C.W.; Hughes, A.D.; Chaturvedi, N.; Jafar, T.H.; COBRA-BPS Study Group.
    BACKGROUND: Inadequate treatment of hypertension is a widespread problem, especially in South Asian countries where cardiovascular disease mortality rates are high. We aimed to explore the effect of a multicomponent intervention (MCI) on antihypertensive medication intensification among rural South Asians with hypertension. METHODS: A post-hoc analysis of a two-year cluster-randomized controlled trial including 2645 hypertensives aged≥ 40 years from 30 rural communities, 10 each, in Bangladesh, Pakistan, and Sri Lanka. Independent assessors collected information on participants' self-reports and physical inspection of medications. The main outcomes were the changes from baseline to 24 months in the following: 1) the therapeutic intensity score (TIS) for all (and class specific) antihypertensive medications; 2) the number of antihypertensive medications in all trial participants. RESULTS: At 24 months, the mean increase in the TIS score of all antihypertensive medications was 0.11 in the MCI group and 0.03 in the control group, with a between-group difference in the increase of 0.08 (95% CI (0.03, 0.12); P=0.002). In MCI compared to controls, a greater increase in the TIS of renin angiotensin-aldosterone system blockers (0.05; 95% CI (0.02, 0.07); P<0.001) and calcium channel blockers (0.03; 95% CI (0.00, 0.05);p=0.031) , and in the number of antihypertensive medications (0.11, 95% CI (0.02, 0.19);P=0.016) was observed. CONCLUSIONS: In rural communities in Bangladesh, Pakistan, and Sri Lanka, MCI led to a greater increase in antihypertensive medication intensification compared to the usual care among adults with hypertension. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02657746. KEYWORDS: South Asia; community health workers; hypertension; medications intensification; multicomponent intervention; physicians.
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    Association of low-dose triple combination therapy with therapeutic inertia and prescribing patterns in patients with hypertension: A Secondary analysis of the TRIUMPH trial
    (American Medical Association., 2020) Wang, N.; Salam, A.; Webster, R.; de Silva, A.; Guggilla, R.; Stepien, S.; Mysore, J.; Billot, L.; Jan, S.; Maulik, P. K.; Naik, N.; Selak, V.; Thom, S.; Prabhakaran, D.; Patel, A.; Rodgers, A.; TRIUMPH Study Group
    IMPORTANCE: Fixed-dose combination (FDC) therapies are being increasingly recommended for initial or early management of patients with hypertension, as they reduce treatment complexity and potentially reduce therapeutic inertia. OBJECTIVE: To investigate the association of antihypertensive triple drug FDC therapy with therapeutic inertia and prescribing patterns compared with usual care. DESIGN, SETTING, AND PARTICIPANTS: A post hoc analysis of the Triple Pill vs Usual Care Management for Patients With Mild-to-Moderate Hypertension (TRIUMPH) study, a randomized clinical trial of 700 patients with hypertension, was conducted. Patients were enrolled from 11 urban hospital clinics in Sri Lanka from February 2016 to May 2017; follow-up ended in October 2017. Data were analyzed from September to November 2019. INTERVENTIONS: Once-daily FDC antihypertensive pill (telmisartan, 20 mg; amlodipine, 2.5 mg; and chlorthalidone, 12.5 mg) or usual care. MAIN OUTCOMES AND MEASURES: Therapeutic inertia, defined as not intensifying therapy in those with blood pressure (BP) above target, was assessed at baseline and during follow-up visits. Prescribing patterns were characterized by BP-lowering drug class and treatment regimen potency. Predictors of therapeutic inertia were assessed with binomial logistic regression. RESULTS: Of the 700 included patients, 403 (57.6%) were female, and the mean (SD) age was 56 (11) years. Among patients who did not reach the BP target, therapeutic inertia was more common in the triple pill group compared with the usual care group at the week 6 visit (92 of 106 [86.8%] vs 124 of 194 [63.9%]; P < .001) and week 12 visit (81 of 90 [90%] vs 116 of 179 [64.8%]; P < .001). At the end of the study, 221 of 318 patients in the triple pill group (69.5%) and 182 of 329 patients in the usual care group (55.3%) reached BP targets. Among those who received treatment intensification, the increase in estimated regimen potency was greater in the triple pill group compared with the usual care group at baseline (predicted mean [SD] increase in regimen potency: triple pill, 15 [6] mm Hg; usual care, 10 [5] mm Hg; P < .001), whereas there were no significant differences at the week 6 or at week 12 visit. Clinic systolic BP level was the only consistent predictor of treatment intensification during follow-up. During follow-up, there were 23 vs 54 unique treatment regimens per 100 treated patients in the triple pill vs usual care groups, respectively (P < .001). CONCLUSIONS AND RELEVANCE: Triple pill FDC therapy was associated with greater rates of therapeutic inertia compared with usual care. Despite this, triple pill FDC therapy substantially simplified prescribing patterns and improved 6-month BP control rates compared with usual care. Further improvements in hypertension control could be achieved by addressing therapeutic inertia among the minority of patients who do not achieve BP control after initial FDC therapy.
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    Randomized controlled clinical trial on value of domperidone in functional abdominal pain in children
    (Lippincott Williams & Wilkins, 2018) Karunanayake, A.; Devanarayana, N.M.; de Silva, A.; Gunawardena, S.; Rajindrajith, S.
    OBJECTIVES: The aim of the study was to evaluate the therapeutic effect of domperidone on children with abdominal pain predominant functional gastrointestinal disorders (AP-FGIDs). METHODS: One hundred children (aged 5-12 years) fulfilling Rome III criteria for AP-FGIDs were randomized into 8 weeks of domperidone or placebo treatment. Primary outcomes defined were cure and patient-reported general improvement. Secondary outcomes were reduction in the severity of abdominal pain and increase in gastric motility. Patients were followed up for 6 months. RESULTS: Eighty-nine (42 in placebo group, 47 in domperidone group) completed the trial at 8 weeks. Seventy-nine completed the 6-month follow-up. When primary outcomes were assessed at 8 weeks, 37 (74%) in the domperidone group and 25 (50%) in the placebo group showed patient-reported general improvement (P = 0.013), whereas no significant difference was observed in cure (22 [44%] vs 14 [28%] P = 0.09). At 6-month follow-up 30 (60%) in the domperidone group and 19 (38%) in the placebo group reported cure (P = 0.028), whereas 44 (88%) in the domperidone group and 33 (66%) in the placebo group showed patient-reported general improvement (P = 0.009). When assessing secondary outcomes at 8 weeks, the domperidone group reported significant reduction in the severity of abdominal pain (54.1% vs 24.7%, P = 0.008) and an increase in the antral motility index (27.5% vs 7.2%, P = 0.029). None of the patients reported intervention-related adverse effects. CONCLUSIONS: Domperidone may be a safe and effective therapeutic modality to achieve a lasting remission of symptoms in children with AP-FGIDs.
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    Route of feeding as a proxy for dysphagia after stroke and the effect of transdermal Glyceryl Trinitrate: Data from the efficacy of nitric oxide in stroke randomised controlled trial
    (Springer, 2018) Woodhouse, L.J.; Scutt, P.; Hamdy, S.; Smithard, D.G.; Cohen, D.L.; Roffe, C.; Bereczki, D.; Berge, E.; Bladin, C.F.; Caso, V.; Christensen, H.K.; Collins, R.; Czlonkowska, A.; de Silva, A.; Etribi, A.; Laska, A.C.; Ntaios, G.; Ozturk, S.; Phillips, S.J.; Prasad, K.; Szatmari, S.; Sprigg, N.; Bath, P.M.
    Post-stroke dysphagia is common, associated with poor outcome and often requires non-oral feeding/fluids. The relationship between routeof feeding and outcome, as well as treatment with glyceryl trinitrate (GTN), was studied prospectively. The Efficacy of Nitric Oxide in Stroke(ENOS) trial assessed transdermal GTN (5 mg versus none for 7 days) in 4011 patients with acute stroke and high blood pressure. Feedingroute (oral = normal or soft diet; non-oral = nasogastric tube, percutaneous endoscopic gastrostomy tube, parenteral fluids, no fluids) was assessed at baseline and day 7. The primary outcome was the modified Rankin Scale (mRS) measured at day 90. At baseline, 1331 (33.2%) patients had non-oral feeding, were older, had more severe stroke and more were female, than 2680 (66.8%) patients with oral feeding. By day 7, 756 patients had improved from non-oral to oral feeding, and 119 had deteriorated. Non-oral feeding at baseline was associated with more impairment at day 7 (Scandinavian Stroke Scale 29.0 versus 43.7; 2p < 0.001), and worse mRS (4.0 versus 2.7; 2p < 0.001) and death (23.6 versus 6.8%; 2p = 0.014) at day 90. Although GTN did not modify route of feeding overall, randomisation ≤6 h of stroke was associated with a move to more oral feeding at day 7 (odds ratio = 0.61, 95% confidence intervals 0.38, 0.98; 2p = 0.040). As a proxy for dysphagia, non-oral feeding is present in 33% of patients with acute stroke and associated with more impairment, dependency and death. GTN moved feeding route towards oral intake if given very early after stroke. Clinical Trial Registration Clinical Trial Registration-URL: http://www.controlled-trials.com . Unique identifier: ISRCTN99414122.
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    Control of blood pressure and risk attenuation: a public health intervention in rural Bangladesh, Pakistan, and Sri Lanka: feasibility trial results
    (Lippincott Williams & Wilkins, 2016) Jafar, T.H.; de Silva, A.; Naheed, A.; Jehan, I.; Liang, F.; Assam, P.N.; Legido-Quigley, H.; Finkelstein, E.A.; Ebrahim, S.; Wickremasinghe, R.; Alam, D.; Khan, A.H.; COBRA-BPS Study Group
    BACKGROUND: High blood pressure (BP) is the leading attributable risk for cardiovascular disease globally. There is little information on effective and sustainable public health system strategies for managing hypertension in South Asian countries. We conducted a feasibility study to gather preliminary data to optimize BP-lowering strategies for a public health intervention in rural communities in Bangladesh, Pakistan, and Sri Lanka. METHODS: A mixed method feasibility study comprised a 3-month pre and postevaluation of a multicomponent intervention (MCI), including BP screening and home health education by trained government community health worker (CHW); providers trained in hypertension management, and compensation of CHW for additional services. Checklists were used to document care. Stakeholder interviews were also conducted. Individuals aged 40 years and above with high BP (systolic ≥140 mmHg or diastolic ≥90 mmHg based on two readings from 2 separate days, or receiving antihypertensive medications) were enrolled from rural communities in Bangladesh, Pakistan, and Sri Lanka. BP was measured at baseline and 3 months postintervention. RESULTS: A total of 412 (90%) of the 454 eligible individuals were recruited. Of those recruited, 90% received home health education session by trained CHWs, 80% were referred to trained providers, of whom 83% completed the management checklist. A follow-up rate of 95.6% was achieved. The mean SBP declined significantly by 4.5 mmHg 95% confidence interval (2.3, 6.7) mmHg (P < 0.001) in the overall pooled analysis in three countries; however, it varied among countries. BP decline was 10.5 mmHg (8.1, 13.0 mmHg) (P < 0.001) in the pooled analysis of individuals with uncontrolled hypertension at baseline, and was also significant each of the three countries. All 98 stakeholders strongly supported upscaling the proposed MCI strategies. CONCLUSION: The proposed MCI is feasible for implementation and requires long-term, large-scale evaluation in the rural public health infrastructure in South Asian countries to determine sustainability of health system changes and BP control. If these long-term effects are confirmed, MCI may be a long-term strategy for tackling rising rates of cardiovascular disease in low-resourced countries.Clintrial.govNCT02341651.
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    Methylene Blue induced bluish discoloration mimicking cyanosis, at diagnostic laparoscopy
    (International Publisher of Science, Technology and Medicine, 2014) Herath, R.P.; Warnakulasuriya, T.; de Silva, A.; Wijesinghe, P.S.
    BACKGROUND: Methylene blue is commonly used to check patency of Fallopian tubes and tracking fistulae. Intraversation of methylene blue is a recognized complication of diagnostic laparoscopy and dye test. Although a case of cyanosis due to methaemoglobinaemia following methylene blue use is a known complication, cyanosis without methaemoglobinaemia is unknown. CASE PRESENTATION: A 31 year old healthy female, being investigated for primary subfertility for 3 years underwent a diagnostic laparoscopy for evaluation of her fallopian tubes under general anaesthesia. Methylene blue 20 ml was injected to see the patency of the tubes. The patient became centrally cyanosed soon after dye ingestion. Her oxygen saturation dropped to 10% whilst her partial pressure of oxygen remained normal. CONCLUSION: Bluish discoloration of the body can occur in the absence of methaemoglobinaemia in patients undergoing laparoscopy following dye ingestion for evaluation of fallopian tubes using methylene blue. Recognizing this complication will help in avoiding unnecessary intervention to the patient. CASE PRESENTATION: A 31 year old healthy female, being investigated for primary subfertility for 3 years underwent a diagnostic laparoscopy for evaluation of her fallopian tubes under general anaesthesia. Methylene blue 20 ml was injected to see the patency of the tubes. The patient became centrally cyanosed soon after dye ingestion. Her oxygen saturation dropped to 10% whilst her partial pressure of oxygen remained normal.