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.
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.
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.
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.
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.
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.
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).
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.