Displaying publications 61 - 80 of 364 in total

Abstract:
Sort:
  1. Lau AS, Yanagisawa N, Hor YY, Lew LC, Ong JS, Chuah LO, et al.
    Benef Microbes, 2018 Jan 29;9(1):61-70.
    PMID: 29065707 DOI: 10.3920/BM2017.0063
    This 10-months randomised, double-blind, parallel and placebo-controlled study evaluated the effects of Bifidobacterium longum BB536 on diarrhoea and/or upper respiratory illnesses in 520 healthy Malaysian pre-school children aged 2-6 years old. The subjects randomly received a one-gram sachet containing either BB536 (5×109 cfu) or placebo daily. Data analysis was performed on 219 subjects who fully complied over 10-months (placebo n=110, BB536 n=109). While BB536 did not exert significant effects against diarrhoea in children, Poisson regression with generalised estimating equations model indicated significant intergroup difference in the mean number of times of respiratory illnesses over 10 months. The duration of sore throat was reduced by 46% (P=0.018), with marginal reduction for duration of fever (reduced by 27%, P=0.084), runny nose (reduced by 15%, P=0.087) and cough (reduced by 16%, P=0.087) as compared to the placebo. Principal coordinate analysis at genus level of the gut microbiota revealed significant differences between 0 and 10 months in the BB536 group (P<0.01) but not in placebo group (P>0.05). The abundance of the genus Faecalibacterium which is associated with anti-inflammatory and immuno-modulatory properties was significantly higher in the BB536 group (P<0.05) compared to the placebo group. Altogether, our present study illustrated the potential protective effects of BB536 against upper respiratory illnesses in pre-school Malaysian children, with gut microbiota modulating properties.
    Matched MeSH terms: Double-Blind Method
  2. Bukhari NI, Zafar A, Shamsi Wu, Bashir MA, Mirza AA
    Therapie, 2005 Mar-Apr;60(2):167-73.
    PMID: 15969319
    AIM: The bioequivalence of aspirin from two enteric-coated brands, Nu-seals and Loprin, identified as the reference (R) and test (T) products, respectively, was assessed.

    METHODS: A two-period randomised crossover design with a washout interval of 15 days was used in this study. The study results were determined in 16 healthy volunteers, all males with ages ranging from 19-28 (23.33 +/- 3.74) years and bodyweights of 52-92 (65.89 +/- 11.39) kg. After oral ingestion of 150mg of the either brand with 200 mL of water, serial blood samples were obtained over a period of 24 hours. Plasma, harvested from blood was analysed for the concentration of salicylic acid, a deacetylated metabolite of aspirin, by a validated high performance liquid chromatography (HPLC) method. Pharmacokinetic parameters were determined for both formulations by an interactive computer-assisted PK II procedure. A general linear model for repeated measures and 90% confidence intervals (CI) was employed to assess the sequence of treatment effects and to exclude differences between the parameters due to the product and period of administration, respectively.

    RESULTS: The observed 90% CI ratios (Loprin/Nu-seals) for peak concentration, time to reach the peak and area under the plasma-concentration time curve from zero to infinity of 1.03,1.08; 1.04,1.05 and 1.01,1.15, respectively, were within the bioequivalence range (0.80,1.25) stipulated by the US Food and Drug Administration.

    CONCLUSION: On the basis of the findings, the test (Loprin) and reference drug (Nu-seals) were deemed bioequivalent.
    Matched MeSH terms: Double-Blind Method
  3. Hassan Y, Alfadly SO, Azmin MN, Peh KK, Tan TF, Noorizan AA, et al.
    Singapore Med J, 2007 Sep;48(9):819-23.
    PMID: 17728962
    A bioequivalence study of two oral formulations of 500 mg tablets of ciprofloxacin (RAZA Pharmaniaga, Malaysia) as test and Ciprobay (Bayer AG, Germany) as reference, was carried out in 24 healthy human volunteers. Each volunteer received a single dose of ciprofloxacin.
    Matched MeSH terms: Double-Blind Method
  4. Efferth T, Banerjee M, Abu-Darwish MS, Abdelfatah S, Böckers M, Bhakta-Guha D, et al.
    Phytomedicine, 2019 Feb;53:319-331.
    PMID: 30190231 DOI: 10.1016/j.phymed.2018.06.007
    BACKGROUND: Practices of biopiracy to use genetic resources and indigenous knowledge by Western companies without benefit-sharing of those, who generated the traditional knowledge, can be understood as form of neocolonialism.

    HYPOTHESIS: The One-World Medicine concept attempts to merge the best of traditional medicine from developing countries and conventional Western medicine for the sake of patients around the globe.

    STUDY DESIGN: Based on literature searches in several databases, a concept paper has been written. Legislative initiatives of the United Nations culminated in the Nagoya protocol aim to protect traditional knowledge and regulate benefit-sharing with indigenous communities. The European community adopted the Nagoya protocol, and the corresponding regulations will be implemented into national legislation among the member states. Despite pleasing progress, infrastructural problems of the health care systems in developing countries still remain. Current approaches to secure primary health care offer only fragmentary solutions at best. Conventional medicine from industrialized countries cannot be afforded by the impoverished population in the Third World. Confronted with exploding costs, even health systems in Western countries are endangered to burst. Complementary and alternative medicine (CAM) is popular among the general public in industrialized countries, although the efficacy is not sufficiently proven according to the standards of evidence-based medicine. CAM is often available without prescription as over-the-counter products with non-calculated risks concerning erroneous self-medication and safety/toxicity issues. The concept of integrative medicine attempts to combine holistic CAM approaches with evidence-based principles of conventional medicine.

    CONCLUSION: To realize the concept of One-World Medicine, a number of standards have to be set to assure safety, efficacy and applicability of traditional medicine, e.g. sustainable production and quality control of herbal products, performance of placebo-controlled, double-blind, randomized clinical trials, phytovigilance, as well as education of health professionals and patients.

    Matched MeSH terms: Double-Blind Method
  5. Yusuf S, Lonn E, Pais P, Bosch J, López-Jaramillo P, Zhu J, et al.
    N Engl J Med, 2016 May 26;374(21):2032-43.
    PMID: 27039945 DOI: 10.1056/NEJMoa1600177
    BACKGROUND: Elevated blood pressure and elevated low-density lipoprotein (LDL) cholesterol increase the risk of cardiovascular disease. Lowering both should reduce the risk of cardiovascular events substantially.
    METHODS: In a trial with 2-by-2 factorial design, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to rosuvastatin (10 mg per day) or placebo and to candesartan (16 mg per day) plus hydrochlorothiazide (12.5 mg per day) or placebo. In the analyses reported here, we compared the 3180 participants assigned to combined therapy (with rosuvastatin and the two antihypertensive agents) with the 3168 participants assigned to dual placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, and the second coprimary outcome additionally included heart failure, cardiac arrest, or revascularization. The median follow-up was 5.6 years.
    RESULTS: The decrease in the LDL cholesterol level was 33.7 mg per deciliter (0.87 mmol per liter) greater in the combined-therapy group than in the dual-placebo group, and the decrease in systolic blood pressure was 6.2 mm Hg greater with combined therapy than with dual placebo. The first coprimary outcome occurred in 113 participants (3.6%) in the combined-therapy group and in 157 (5.0%) in the dual-placebo group (hazard ratio, 0.71; 95% confidence interval [CI], 0.56 to 0.90; P=0.005). The second coprimary outcome occurred in 136 participants (4.3%) and 187 participants (5.9%), respectively (hazard ratio, 0.72; 95% CI, 0.57 to 0.89; P=0.003). Muscle weakness and dizziness were more common in the combined-therapy group than in the dual-placebo group, but the overall rate of discontinuation of the trial regimen was similar in the two groups.
    CONCLUSIONS: The combination of rosuvastatin (10 mg per day), candesartan (16 mg per day), and hydrochlorothiazide (12.5 mg per day) was associated with a significantly lower rate of cardiovascular events than dual placebo among persons at intermediate risk who did not have cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; ClinicalTrials.gov number, NCT00468923.).
    Note: Malaysia is a study site (Author: Yusoff K)
    Matched MeSH terms: Double-Blind Method
  6. Lonn EM, Bosch J, López-Jaramillo P, Zhu J, Liu L, Pais P, et al.
    N Engl J Med, 2016 May 26;374(21):2009-20.
    PMID: 27041480 DOI: 10.1056/NEJMoa1600175
    BACKGROUND: Antihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher, but its role in persons at intermediate risk and with lower blood pressure is unclear.
    METHODS: In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization. The median follow-up was 5.6 years.
    RESULTS: The mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group. The first coprimary outcome occurred in 260 participants (4.1%) in the active-treatment group and in 279 (4.4%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P=0.40); the second coprimary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%), respectively (hazard ratio, 0.95; 95% CI, 0.81 to 1.11; P=0.51). In one of the three prespecified hypothesis-based subgroups, participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg) who were in the active-treatment group had significantly lower rates of the first and second coprimary outcomes than those in the placebo group; effects were neutral in the middle and lower thirds (P=0.02 and P=0.009, respectively, for trend in the two outcomes).
    CONCLUSIONS: Therapy with candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascular events than placebo among persons at intermediate risk who did not have cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; ClinicalTrials.gov number, NCT00468923.).
    Note: Malaysia is a study site (Author: Yusoff K)
    Matched MeSH terms: Double-Blind Method
  7. Manaf FA, Peiffer JJ, Maker GL, Fairchild TJ
    J Sci Med Sport, 2021 Apr;24(4):412-417.
    PMID: 33162329 DOI: 10.1016/j.jsams.2020.10.014
    OBJECTIVES: To investigate the effects of acute branched-chain amino acid (BCAA) supplementation on cycling performance and neuromuscular fatigue during a prolonged, self-paced cycling time-trial.

    DESIGN: Randomised double-blind counterbalanced crossover.

    METHODS: Eighteen recreationally active men (mean±SD; age: 24.7±4.8 years old; body-weight, BW: 67.1±6.1kg; height: 171.7±4.9cm) performed a cycling time-trial on an electromagnetically-braked cycle ergometer. Participants were instructed to complete the individualised total work in the shortest time possible, while ingesting either BCAAs (pre-exercise: 0.084gkg-1 BW; during exercise: 0.056gkg-1h-1) or a non-caloric placebo solution. Rating of perceived exertion, power, cadence and heart rate were recorded throughout, while maximal voluntary contraction, muscle voluntary activation level and electrically evoked torque using single and doublet stimulations were assessed at baseline, immediately post-exercise and 20-min post-exercise.

    RESULTS: Supplementation with BCAA reduced (287.9±549.7s; p=0.04) time-to-completion and ratings of perceived exertion (p≤0.01), while concomitantly increasing heart rate (p=0.02). There were no between-group differences (BCAA vs placebo) in any of the neuromuscular parameters, but significant decreases (All p≤0.01) in maximal voluntary contraction, muscle voluntary activation level and electrically evoked torque (single and doublet stimulations) were recorded immediately following the trial, and these did not recover to pre-exercise values by the 20min recovery time-point.

    CONCLUSIONS: Compared to a non-caloric placebo, acute BCAA supplementation significantly improved performance in cycling time-trial among recreationally active individuals without any notable changes in either central or peripheral factors. This improved performance with acute BCAA supplementation was associated with a reduced rating of perceived exertion.

    Matched MeSH terms: Double-Blind Method
  8. Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, et al.
    Arthritis Rheumatol, 2018 07;70(7):1071-1076.
    PMID: 29513931 DOI: 10.1002/art.40479
    OBJECTIVE: To evaluate the safety and potential efficacy of AMG 557, a fully human antibody directed against the inducible T cell costimulator ligand (ICOSL) in patients with systemic lupus erythematosus (SLE) with arthritis.

    METHODS: In this phase Ib, randomized, double-blind, placebo-controlled study, patients received AMG 557 210 mg (n = 10) or placebo (n = 10) weekly for 3 weeks, then every other week for 10 additional doses. The corticosteroid dosage was tapered to ≤7.5 mg/day by day 85, and immunosuppressants were discontinued by day 29. Primary end points on day 169 were safety, immunogenicity, the Lupus Arthritis Response Index (LARI; defined by a reduction in the tender and swollen joint counts), ≥1-letter improvement in the musculoskeletal domain of the British Isles Lupus Assessment Group (BILAG) index, and medication discontinuation. The secondary/exploratory end points were changes in the tender and swollen joint counts, BILAG index scores (musculoskeletal, global), and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI).

    RESULTS: The incidence of adverse events, most of which were mild, was similar between groups. LARI responses occurred in 3 of 10 patients receiving AMG 557 and 1 of 10 patients receiving placebo (P = 0.58). More patients in the AMG 557 group achieved a ≥4-point improvement in the SLEDAI score on day 169 (7 of 10 patients) compared with the placebo group (2 of 10 patients) (P = 0.07). Patients treated with AMG 557 (versus placebo) had greater improvements from baseline in the global BILAG index scores (-36.3% versus -24.7%) and the SLEDAI score (-47.8% versus -10.7%) and in tender (-22.8% versus -13.5%) and swollen (-62.1% versus -7.8%) joint counts on day 169.

    CONCLUSION: AMG 557 showed safety and potential efficacy, supporting further evaluation of the clinical efficacy of ICOSL blockade in patients with SLE.

    Matched MeSH terms: Double-Blind Method
  9. Ji L, Han P, Liu Y, Yang G, Dieu Van NK, Vijapurkar U, et al.
    Diabetes Obes Metab, 2015 Jan;17(1):23-31.
    PMID: 25175734 DOI: 10.1111/dom.12385
    To evaluate the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin or metformin in combination with sulphonylurea.
    Matched MeSH terms: Double-Blind Method
  10. Razali N, Md Latar IL, Chan YK, Omar SZ, Tan PC
    PMID: 26773246 DOI: 10.1016/j.ejogrb.2015.12.017
    OBJECTIVE: To evaluate the uterotonic effect of carbetocin compared with oxytocin in emergency cesarean delivery.

    STUDY DESIGN: Participants were randomized to intravenous bolus injection of 100mcg carbetocin or 10IU oxytocin after cesarean delivery of the baby. The primary outcome is any additional uterotonic which may be administered by the blinded provider for perceived inadequate uterine tone with or without hemorrhage in the first 24hours after delivery. Secondary outcomes include operating time, perioperative blood loss, change in hemoglobin and hematocrit levels, blood transfusion and reoperation for postpartum hemorrhage.

    RESULTS: Additional uterotonic rates were 107/276 (38.8%) vs. 155/271 (57.2%) [RR 0.68 95% CI 0.57-0.81 p<0.001; NNTb 6 95% CI 3.8-9.8], mean operating time 45.9±16.0 vs. 44.5±13.1minutes p=0.26, mean blood loss 458±258 vs. 446±281ml p=0.6, severe postpartum hemorrhage (≥1000ml) rates 15/276 (5.4%) vs. 10/271 (3.7%) p=0.33 and blood transfusion rates 6/276 (2.2%) vs. 10/271 (3.7%); p=0.30 for carbetocin and oxytocin arms respectively. There was only one case of re-operation (oxytocin arm). In the cases that needed additional uterotonic 98% (257/262) was started intraoperatively and in 89% (234/262) the only additional uterotonic administered was an oxytocin infusion over 6hours.

    CONCLUSION: Fewer women in the carbetocin arm needed additional uterotonics but perioperative blood loss, severe postpartum hemorrhage, blood transfusion and operating time were not different.

    Matched MeSH terms: Double-Blind Method
  11. Liew KB, Tan YT, Peh KK
    AAPS PharmSciTech, 2012 Mar;13(1):134-42.
    PMID: 22167416 DOI: 10.1208/s12249-011-9729-4
    The aim of this study was to develop a taste-masked oral disintegrating film (ODF) containing donepezil, with fast disintegration time and suitable mechanical strength, for the treatment of Alzheimer's disease. Hydroxypropyl methylcellulose, corn starch, polyethylene glycol, lactose monohydrate and crosspovidone served as the hydrophilic polymeric bases of the ODF. The uniformity, in vitro disintegration time, drug release and the folding endurance of the ODF were examined. The in vitro results showed that 80% of donepezil hydrochloride was released within 5 minutes with mean disintegration time of 44 seconds. The result of the film flexibility test showed that the number of folding time to crack the film was 40 times, an indication of sufficient mechanical property for patient use. A single-dose, fasting, four-period, eight-treatment, double-blind study involving 16 healthy adult volunteers was performed to evaluate the in situ disintegration time and palatability of ODF. Five parameters, namely taste, aftertaste, mouthfeel, ease of handling and acceptance were evaluated. The mean in situ disintegration time of ODF was 49 seconds. ODF containing 7 mg of sucralose were more superior than saccharin and aspartame in terms of taste, aftertaste, mouthfeel and acceptance. Furthermore, the ODF was stable for at least 6 months when stored at 40°C and 75% relative humidity.
    Matched MeSH terms: Double-Blind Method
  12. Yusuf S, Bosch J, Dagenais G, Zhu J, Xavier D, Liu L, et al.
    N Engl J Med, 2016 May 26;374(21):2021-31.
    PMID: 27040132 DOI: 10.1056/NEJMoa1600176
    BACKGROUND: Previous trials have shown that the use of statins to lower cholesterol reduces the risk of cardiovascular events among persons without cardiovascular disease. Those trials have involved persons with elevated lipid levels or inflammatory markers and involved mainly white persons. It is unclear whether the benefits of statins can be extended to an intermediate-risk, ethnically diverse population without cardiovascular disease.
    METHODS: In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants in 21 countries who did not have cardiovascular disease and were at intermediate risk to receive rosuvastatin at a dose of 10 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, and the second coprimary outcome additionally included revascularization, heart failure, and resuscitated cardiac arrest. The median follow-up was 5.6 years.
    RESULTS: The overall mean low-density lipoprotein cholesterol level was 26.5% lower in the rosuvastatin group than in the placebo group. The first coprimary outcome occurred in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.64 to 0.91; P=0.002). The results for the second coprimary outcome were consistent with the results for the first (occurring in 277 participants [4.4%] in the rosuvastatin group and in 363 participants [5.7%] in the placebo group; hazard ratio, 0.75; 95% CI, 0.64 to 0.88; P<0.001). The results were also consistent in subgroups defined according to cardiovascular risk at baseline, lipid level, C-reactive protein level, blood pressure, and race or ethnic group. In the rosuvastatin group, there was no excess of diabetes or cancers, but there was an excess of cataract surgery (in 3.8% of the participants, vs. 3.1% in the placebo group; P=0.02) and muscle symptoms (in 5.8% of the participants, vs. 4.7% in the placebo group; P=0.005).
    CONCLUSIONS: Treatment with rosuvastatin at a dose of 10 mg per day resulted in a significantly lower risk of cardiovascular events than placebo in an intermediate-risk, ethnically diverse population without cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; HOPE-3 ClinicalTrials.gov number, NCT00468923.).
    Note: Malaysia is a study site (Author: Yusoff K)
    Matched MeSH terms: Double-Blind Method
  13. Carpentier P, van Bellen B, Karetova D, Hanafiah H, Enriquez-Vega E, Kirienko A, et al.
    Int Angiol, 2017 Oct;36(5):402-409.
    PMID: 28206732 DOI: 10.23736/S0392-9590.17.03801-9
    BACKGROUND: Chronic venous disorders (CVD) is estimated to affect 30% to 50% of women and 10% to 30% of men. The most widely prescribed treatment for CVD worldwide is micronized purified flavonoid fraction 500 mg (MPFF). The aim of this clinical trial was to develop a new once daily 1000-mg oral suspension of MPFF.

    METHODS: In an international, randomized, double-blind, parallel-group study, symptomatic individuals classified CEAP C0s to C4s were randomized in either treatment arm and treated for 8 weeks. Lower limb symptoms (discomfort, pain and heaviness) were assessed using Visual Analog Scales (VAS), and quality of life (QoL) was measured with the CIVIQ-20 Questionnaire.

    RESULTS: A total of 1139 patients were included in the study. Both MPFF treatment regimens were well tolerated and associated with a significant reduction in lower limb symptoms. A non-inferiority of MPFF 1000-mg oral suspension once daily compared to MPFF 500-mg tablet twice daily (P<0.0001) was found for lower limb discomfort (-3.33 cm for MPFF 1000 mg and -3.37 cm for MPFF 500 mg), leg pain (-3.27 cm for MPFF 1000 mg and -3.31 cm for MPFF 500 mg) and leg heaviness (-3.41 cm for MPFF 1000 mg and -3.46 cm for MPFF 500 mg). The patients' QoL was improved by about 20 points on the CIVIQ scale in both groups (19.33 points for MPFF 1000 mg and 20.28 points for MPFF 500 mg).

    CONCLUSIONS: MPFF 1000-mg oral suspension and MPFF 500-mg tablets treatments were associated with similar reductions in lower limb symptoms and QoL improvement. The new once daily MPFF1000-mg oral suspension has a similar safety profile to two tablets of MPFF 500 mg, with the advantage of one daily intake, potentially associated with improved patient adherence and easier CVD management.

    Matched MeSH terms: Double-Blind Method
  14. Lim PH, Ng FC, Cheng CW, Wong MY, Chee CT, Moorthy P, et al.
    J Int Med Res, 2002 Mar-Apr;30(2):137-43.
    PMID: 12025521 DOI: 10.1177/147323000203000206
    Safety and tolerability of sildenafil citrate was assessed in a population subset of 60 Singaporean men with erectile dysfunction taken from the Asian Sildenafil Efficacy and Safety Study (ASSESS-I), a double-blind, placebo-controlled, flexible-dose study. The men, from two centres, with > or = 6 months' history of erectile dysfunction, were randomized to two treatment arms for 12 weeks. One group (30 patients) received sildenafil (initial dose 50 mg taken 1 h before sexual activity for the first 2 weeks, increased to 100 mg or decreased to 25 mg, according to efficacy and/or tolerability). The remaining 30 patients received a matching placebo. Incidence and type of adverse effects were evaluated at 2, 4, 8 and 12 weeks. Nine patients (30.0%) on sildenafil (33.1% in the full ASSESS-I study) and one patient (3.3%) on placebo (22.8% in the full ASSESS-I study) experienced treatment-related adverse events, the most frequent being headache in the sildenafil group (reported by five patients [16.7%]; 11.0% in the full ASSESS-I study). Flushing, visual disturbance, dizziness, insomnia, myalgia and back pain each occurred in one patient in the sildenafil group (3.3%); in the placebo group, one patient (3.3%) had headache. Importantly, the incidence of cardiovascular and respiratory system adverse events were relatively less than in the full ASSESS-I population (cardiovascular 3.3% in the present study versus 10.2% in the full ASSESS-I population; respiratory 3.3% versus 5.5%). All adverse events were transient and mild, and did not lead to treatment withdrawal. There was no effect on sitting blood pressure, heart rate or standard laboratory parameters; more importantly, there was no incidence of myocardial infarction, stroke or priapism. These results should reassure Singaporean patients and their physicians of the safety of sildenafil for erectile dysfunction.
    Matched MeSH terms: Double-Blind Method
  15. Goh KL, Parasakthi N, Chuah SY, Toetsch M
    Eur J Gastroenterol Hepatol, 1997 Nov;9(11):1091-5.
    PMID: 9431900
    OBJECTIVES: To determine the efficacy of a three times daily (t.i.d.) versus a twice daily (b.i.d.) regimen of combination amoxycillin and metronidazole and famotidine in the eradication of Helicobacter pylori and the influence of metronidazole resistance on the outcome of treatment.

    PATIENTS: Patients selected had unequivocal evidence of H. pylori infection based on the urease test, culture and histology and had either peptic ulcer disease or non-ulcer dyspepsia.

    DESIGN: The study was a comparative and double-blind study and patients were randomized to receive either amoxycillin 750 mg t.i.d. and metronidazole 500 mg t.i.d. for 12 days or amoxycillin 1000 mg b.i.d. and metronidazole 500 mg b.i.d. for 12 days. Both groups also received famotidine 40 mg for 6 weeks.

    MAIN OUTCOME MEASURE: Patients were assessed for successful eradication, defined as absence of bacteria in all tests, at least 4 weeks after completion of antibiotic therapy by repeat gastroscopy.

    RESULTS: One hundred and twenty-nine patients were recruited for the study. Two patients defaulted follow-up, two patients were withdrawn from the study and six patients were found to be non-compliant with medications. The eradication rates of the t.i.d. regimen was higher than the b.i.d. regimen (per protocol (PP) analysis: 83.3% (50/60) vs. 76.3% (45/59), P=0.337; intention-to-treat (ITT) analysis: 78.5% (51/65) vs. 75.0% (48/64), P=0.642). Seventy-five patients had pre-treatment cultures checked for metronidazole resistance, 33 (44.0%) were found to be resistant. Acquired resistance occurred in 3/40 (7.5%) patients. Eradication rates of metronidazole-sensitive and metronidazole-resistant patients: t.i.d. regimen - 100% (17/17) and 88.2% (15/17), b.i.d. regimen - 19/21 (90.5%) and 11/15 (73.3%). Side effects were reported in up to 70% of patients but were mild and tolerable in the majority. Two patients were withdrawn from the study because of a fixed drug eruption in one and generalized macular rash in the other.

    CONCLUSION: Combination amoxycillin and metronidazole is effective in eradicating H. pylori. There was a tendency for the t.i.d. regimen to be better than the b.i.d. regimen and for metronidazole-resistant infections to be associated with a lower eradication rate but these differences did not reach statistical significance.

    Matched MeSH terms: Double-Blind Method
  16. Ghosh AK, Rahaman AA, Singh R
    Int J Sport Nutr Exerc Metab, 2010 Jun;20(3):216-23.
    PMID: 20601739
    The purpose of the study was to investigate whether a combination of sago and soy protein ingested during moderate-intensity cycling exercise can improve subsequent high-intensity endurance capacity compared with a carbohydrate in the form of sago and with a placebo. The participants were 8 male recreational cyclists with age, weight, and VO2max of 21.5 +/- 1.1 yr, 63.3 +/- 2.4 kg, and 39.9 +/- 1.1 ml . kg(-1) . min(-1), respectively. The design of the study was a randomized, double-blind placebo-controlled crossover comprising 60 min of exercise on a cycle ergometer at 60% VO2max followed by a time-to-exhaustion ride at 90% VO2max. The sago feeding provided 60 g of carbohydrate, and the sago-soy combination provided 52.5 g of carbohydrate and 15 g of protein, both at 20-min intervals during exercise. Times to exhaustion for the placebo, sago, and sago-soy supplementations were 4.09 +/- 1.28, 5.49 +/- 1.20, and 7.53 +/- 2.02 min, respectively. Sago-soy supplementation increased endurance by 84% (44-140%; p < .001) and by 37% (15-63%; p < .05) relative to placebo and sago, respectively. The plasma insulin response was elevated above that with placebo during sago and sago-soy supplementations. The authors conclude that a combination of sago and soy protein can delay fatigue during high-intensity cycling.
    Matched MeSH terms: Double-Blind Method
  17. Shu L, Sulaiman AH, Huang YS, Fones Soon Leng C, Crutel VS, Kim YS
    Asian J Psychiatr, 2014 Apr;8:26-32.
    PMID: 24655622 DOI: 10.1016/j.ajp.2013.09.009
    OBJECTIVE: This randomized, double-blind study evaluates the efficacy and tolerability of agomelatine, using fluoxetine as an active comparator, in Asian patients suffering from moderate to severe major depressive disorder (MDD).
    METHOD: Patients were randomly assigned to receive either agomelatine (25-50mg/day, n=314) or fluoxetine (20-40mg/day, n=314) during an 8-week treatment period. The main outcome measure was the change in Hamilton Depression Rating Scale 17 items (HAM-D17) scores. Secondary efficacy criteria included scores on Clinical Global Impression Severity of illness (CGI-S) and Improvement of illness (CGI-I), patient sleeping improvement using the self-rating Leeds Sleep Evaluation Questionnaire (LSEQ) and anxiety using the Hamilton Anxiety Rating Scale (HAM-A) scores. Tolerability and safety evaluations were based on emergent adverse events.
    RESULTS: Agomelatine and fluoxetine exert a comparable antidepressant efficacy in the Asian population. Mean changes over 8 weeks were clinically relevant and similar in both groups (-14.8±7.3 and -15.0±8.1 on HAM-D17 scale in agomelatine and fluoxetine groups, respectively). The between-group difference reached statistical significance on non-inferiority test (p=0.015). Clinically relevant decreases in CGI-S and CGI-I scores were observed over the treatment period in both groups. The two treatments were equally effective on the symptoms of both anxiety and sleep. The good tolerability profile and safety of both doses of agomelatine was confirmed in the Asian population.
    CONCLUSIONS: Agomelatine and fluoxetine are equally effective in the treatment of MDD-associated symptoms in Asian depressed patients.
    KEYWORDS: Agomelatine; Antidepressant; Asian population; Fluoxetine
    Study site in Malaysia: Psychiatric clinic, University Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia
    Matched MeSH terms: Double-Blind Method
  18. Yusoff K, Razak TA, Yusof N, Rafee NM
    Int J Clin Pract, 1999 Jun;53(4):277-80.
    PMID: 10563072
    ACE inhibitors are important therapeutic agents in controlling hypertension, correcting some of its pathophysiological derangement and improving its prognosis. While there are many such agents, there may be some important differences between them. This placebo run-in, double blind, crossover study, using 24-hour ambulatory blood pressure monitoring, compares the efficacy of perindopril 4-8 mg and enalapril 10-20 mg as once daily antihypertensive agents on 32 patients. For diastolic blood pressure (DBP), perindopril had a placebo-corrected peak (P) reduction of blood pressure (BP) of -6.4 +/- 1.3 mmHg vs its placebo-corrected trough (T) of -5.2 +/- 1.7 mmHg. Enalapril had a reduction in DBP of -8.5 +/- 1.3 mmHg (P) and -5.7 +/- 1.7 mmHg (T). For systolic blood pressure (SBP), perindopril had a reduction of -7.5 +/- 1.6 mmHg (P) vs -7.3 +/- 2.2 mmHg (T) compared to enalapril with -10.8 +/- 1.6 mmHg (P) vs -8.3 +/- 2.3 mmHg (T). Placebo-corrected trough-to-peak ratio (SBP/DBP) for perindopril was 0.97/0.81 vs 0.77/0.67 for enalapril. There was no difference noted in 24-hour mean BP, area under the curve or post-dose casual BP measurements. Both perindopril and enalapril were well tolerated and the two treatment groups had similar safety profiles. Perindopril thus had a predictable and sustained blood pressure effect giving a 24-hour cover for the patient without excessive peak effect or poor trough effect.
    Matched MeSH terms: Double-Blind Method
  19. Karupaiah T, Chuah KA, Chinna K, Matsuoka R, Masuda Y, Sundram K, et al.
    Lipids Health Dis, 2016 Aug 17;15(1):131.
    PMID: 27535127 DOI: 10.1186/s12944-016-0301-9
    BACKGROUND: Mayonnaise is used widely in contemporary human diet with widespread use as a salad dressing or spread on breads. Vegetable oils used in its formulation may be a rich source of ω-6 PUFAs and the higher-PUFA content of mayonnaise may be beneficial in mediating a hypocholesterolemic effect. This study, therefore, evaluated the functionality of mayonnaise on cardiometabolic risk within a regular human consumption scenario.

    METHODS: Subjects underwent a randomized double-blind crossover trial, consuming diets supplemented with 20 g/day of either soybean oil-based mayonnaise (SB-mayo) or palm olein-based mayonnaise (PO-mayo) for 4 weeks each with a 2-week wash-out period. The magnitude of changes for metabolic outcomes between dietary treatments was compared with PO-mayo serving as the control. The data was analyzed by ANCOVA using the GLM model. Analysis was adjusted for weight changes.

    RESULTS: Treatments resulted in significant reductions in TC (diff = -0.25 mmol/L; P = 0.001), LDL-C (diff = -0.17 mmol/L; P = 0.016) and HDL-C (diff = -0.12 mmol/L; P  0.05). Lipoprotein particle change was significant with large LDL particles increasing after PO-mayo (diff = +63.2 nmol/L; P = 0.007) compared to SB-mayo but small LDL particles remained unaffected. Plasma glucose, apolipoproteins and oxidative stress markers remained unchanged.

    CONCLUSIONS: Daily use with 20 g of linoleic acid-rich SB-mayo elicited reductions in TC and LDL-C concentrations without significantly changing LDL-C:HDL-C ratio or small LDL particle distributions compared to the PO-mayo diet.

    TRIAL REGISTRATION: This clinical trial was retrospectively registered with the National Medical Research Register, National Institute of Health, Ministry of Health Malaysia, (NMRR-15-40-24035; registered on 29/01/2015; https://www.nmrr.gov.my/fwbPage.jsp?fwbPageId=ResearchISRForm&fwbAction=Update&fwbStep=10&pk.researchID=24035&fwbVMenu=3&fwbResearchAction=Update ). Ethical approval was obtained from the National University of Malaysia's Medical Ethics Committee (UKM 1.5.3.5/244/SPP/NN-054-2011, approved on 25/05/2011).

    Matched MeSH terms: Double-Blind Method
  20. Nagendrababu V, Abbott PV, Pulikkotil SJ, Veettil SK, Dummer PMH
    Int Endod J, 2021 Mar;54(3):331-342.
    PMID: 33040335 DOI: 10.1111/iej.13428
    BACKGROUND: The scientific literature is contradictory in relation to selecting the appropriate volume of local anaesthetic solution for inferior alveolar nerve blocks (IANB) when attempting to anaesthetize mandibular teeth with irreversible pulpitis.

    OBJECTIVES: To compare the efficacy of 1.8 and 3.6 mL of the same anaesthetic solution for IANBs when treating mandibular teeth with irreversible pulpitis.

    METHODS: A literature search was performed in PubMed, Scopus and EBSCOhost databases until May 2020. Randomized clinical trials published in English, comparing 1.8 with 3.6 mL of the same anaesthetic solution for IANBs in permanent mandibular teeth with irreversible pulpitis, were included. The risk of bias of the included trials was appraised using the revised Cochrane risk of bias tool. A meta-analysis was performed using the random-effects model. The effect of random errors on the results of the meta-analysis was evaluated by trial sequential analysis and the quality of evidence was appraised using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

    RESULTS: Four clinical trials involving 280 teeth from patients with ages ranging from 18 to 65 years were included. Among the four trials, three were categorized as having a 'low' risk of bias and one was categorized as having 'some concerns'. The primary meta-analysis revealed that 3.6 mL of anaesthetic solution when administered for IANBs was associated with significantly greater success rates compared with 1.8 mL (RR = 1.94; 95% CI, 1.07, 3.52; I2  = 77%). Similarly, the results of the sensitivity analysis (restricting trials only to those that used the Heft-Parker visual analogue pain scale) revealed that the use of 3.6 mL significantly increased the success of IANBs compared with 1.8 mL. The trial sequential analysis confirmed the evidence for the beneficial effect of 3.6 mL to achieve success for IANBs was 'conclusive'. The quality of evidence was graded as 'high'.

    CONCLUSION: Increasing the volume of anaesthetic solution from 1.8 to 3.6 mL improved the success rate for IANBs in mandibular molars with irreversible pulpitis. The quality of the evidence was 'high'. Future high-quality clinical trials are required with different types of anaesthetic solutions and other types of teeth.

    Matched MeSH terms: Double-Blind Method
Filters
Contact Us

Please provide feedback to Administrator (afdal@afpm.org.my)

External Links