Displaying publications 321 - 340 of 387 in total

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  1. 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
  2. Sow YL, Tang IP, Kho JPY, Prepageran N
    Med J Malaysia, 2018 08;73(4):244-248.
    PMID: 30121688
    INTRODUCTION: Endoscopic sinus surgery (ESS) is the mainstay for treatment of chronic rhinosinusitis versus maximal medical therapy. We propose a more economical option, by using steroid-impregnated Gelfoam instead of Nasopore post ESS, as it is less expensive and has showed effectiveness in preventing post-operative bleeding.

    MATERIALS AND METHODS: A randomised, double-blinded, placebo-controlled trial was carried out in eight patients with chronic rhinosinusitis or nasal polyposis who were planned for bilateral endoscopic sinus surgery. A Peri-operative Sinus Endoscopy (POSE) Score and Lund-Kennedy Endoscopic Score (LKES) were recorded. The use of hydrocortisone-impregnated Gelfoam dressing versus normal saline-impregnated Gelfoam dressing were compared. Scores were repeated post-operatively at one week, three weeks and three months interval.

    RESULTS: For LKES, at the end of three months, 50% of the patients had the same score difference, 37.5% had better results on the study side while 12.5% had better results on the control side. Meanwhile, for POSE Score, at the end of three months, 75% of the patients had better score difference on the study side while 12.5% had better results on the control side.

    CONCLUSION: Gelfoam can be used as nasal packing material to deliver topical steroid after endoscopic sinus surgery. Steroid-impregnated nasal dressing after endoscopic sinus surgery may not provide better long-term outcome.

    Matched MeSH terms: Double-Blind Method
  3. Inoue Y, Kaneko S, Hsieh PF, Meshram C, Lee SA, Aziz ZA, et al.
    Epilepsia, 2019 03;60 Suppl 1:60-67.
    PMID: 30869167 DOI: 10.1111/epi.14645
    This post hoc analysis assessed the long-term safety, tolerability, and efficacy of perampanel in Asian patients with refractory focal seizures; an additional analysis assessed the effect of perampanel on focal impaired awareness seizures (FIAS) with focal to bilateral tonic-clonic (FBTC) seizures. In this subanalysis, data from Asian patients ≥12 years of age who had focal seizures with FBTC seizures despite taking one to 3 concomitant antiepileptic drugs at baseline, and who had entered either the long-term extension phase of 3 phase-3 perampanel trials (study 307) or the 10-week extension phase of study 335, were analyzed for the effect of perampanel on duration of exposure, safety, and seizure outcomes. Of 874 Asian patients included in the analysis, 205 had previously received placebo during the double-blind phase-3 trials and 669 had previously received perampanel 2-12 mg/day; 313 had FIAS with FBTC seizures at core study baseline. The median duration of exposure to perampanel was 385.0 days, and the retention rate at one year was 62.6%. Overall, during the first 52 weeks of perampanel treatment, 777 patients (88.9%) had treatment-emergent adverse events (TEAEs), most of which were mild to moderate in severity. The most frequent TEAEs were dizziness (47.1%), somnolence (22.3%), and nasopharyngitis (17.4%). During the first 52 weeks of perampanel treatment, median percent change in seizure frequency per 28 days from pre-perampanel baseline for all focal seizures was -28.1%, and -51.7% for FIAS with FBTC seizures. The 50% responder rate relative to pre-perampanel baseline for all focal seizures was 33.8%, and 51.1% for FIAS with FBTC seizures. Long-term treatment with perampanel in Asian patients had safety, tolerability, and efficacy similar to that of the global population in the phase-3 trials and extension study 307. The safety profile and response rate suggest benefit for an Asian population of patients with refractory epilepsy.
    Matched MeSH terms: Double-Blind Method
  4. Hall DA, Ray J, Watson J, Sharman A, Hutchison J, Harris P, et al.
    Hear Res, 2019 06;377:153-166.
    PMID: 30939361 DOI: 10.1016/j.heares.2019.03.018
    AUT00063 is an experimental new medicine that has been demonstrated to suppress spontaneous hyperactivity by modulating the action of voltage-gated potassium-channels in central auditory cortical neurons of a rodent model. This neurobiological property makes it a good candidate for treating the central component of subjective tinnitus but this has not yet been tested in humans. The main purpose of the QUIET-1 (QUest In Eliminating Tinnitus) trial was to examine the effect of AUT00063 on the severity of tinnitus symptoms in people with subjective tinnitus. The trial was a randomised, placebo-controlled, observer, physician and participant blinded multi-centre superiority trial with two parallel groups and a primary endpoint of functional impact on tinnitus 28 days after the first drug dosing day. The trial design overcame the scale and logistical challenges of delivering a scientifically robust, statistically powered multi-centre study for subjective tinnitus within the National Health Service in England. The trial was terminated early for futility. Overall, 212 participants consented across 18 sites with 91 participants randomised to groups using age, gender, tinnitus symptom severity and hearing status as minimisation factors. While the pharmacokinetic markers confirm the uptake of AUT00063 in the body, within the expected therapeutic range, with respect to clinical benefit findings indicated that AUT00063 was not effective in alleviating tinnitus symptoms (1.56 point change in Tinnitus Functional Index). In terms of clinical harms, results indicated that a daily dose of 800 mg capsules of AUT00063 taken for 28 days was safe and well tolerated. These findings provide significant advances in the drug development field for hearing sciences, but raise questions about the predictive validity of certain rodent models of noise-induced hearing loss and tinnitus, as least for the mechanism evaluated in the present study. Trial Registration: (EudraCT) 2014-002179-27; NCT02315508.
    Matched MeSH terms: Double-Blind Method
  5. George A, Udani JK, Yusof A
    Pharm Biol, 2019 Dec;57(1):145-153.
    PMID: 30922154 DOI: 10.1080/13880209.2019.1585460
    CONTEXT: Phyllanthus amarus Schumach. and Thonn. (Euphorbiaceae) is traditionally known to improve general liver health. However, its effect on hangover is unknown.

    OBJECTIVE: This study evaluated PHYLLPRO™, a standardized ethanol extract of P. amarus leaves for protection against oxidative stress and recovery from hangover symptoms.

    MATERIAL AND METHODS: Ten days daily oral supplementation of 750 mg/day followed by intoxication was evaluated in a randomized placebo-controlled (containing only excipient), crossover study in 15 subjects (21-50 years old), for oxidative stress, liver damage, alleviating hangover symptoms (Hangover Severity Score: HSS) and mood improvement (Profile-of-Mood-Scores: POMS).

    RESULTS: PHYLLPRO™ was able to remove blood alcohol in the active group while the placebo group still had 0.05% at 12 h post-intoxication (p  0.05) from baseline to hour 22 was reported in the placebo group using POMS. Significant anti-inflammatory group effect favouring the active group, by the upregulation of cytokines IL-8 (p = 0.0014) and IL-10 (p = 0.0492) and immunomodulatory effects via IL-12p70 (p = 0.0304) were observed. The incidence of adverse events was similar between groups indicating the safety of PHYLLPRO™.

    DISCUSSION AND CONCLUSION: Preliminary findings of PHYLLPRO™ in managing hangover, inflammation and liver functions following intoxication, is demonstrated. Future studies on PHYLLPRO™ in protecting against oxidative stress and hangover in larger populations is warranted.

    Matched MeSH terms: Double-Blind Method
  6. Assiry AA, Karobari MI, Bhavikatti SK, Marya A
    Biomed Res Int, 2021;2021:5510174.
    PMID: 34195261 DOI: 10.1155/2021/5510174
    Introduction: Illicium verum commonly known as star anise has been widely used in many Asian countries for pharmaceutical treatment for many diseases. The aim of the present study was to investigate the anti-inflammatory, astringent, and antimicrobial properties of an Illicium verum mouthwash.

    Methods: The present double blinded randomized clinical trial was conducted on fifty subjects, divided into groups A and B. Illicium verum mouthwash (group A) and placebo (group B) were provided to subjects for 21 days; after 14 days, washout period mouthwashes were switched as per crossover design between groups for 21 days. The gingival index (GI), papillary bleeding index (PBI), and oral microbial count were recorded at each stage of study.

    Results: The significant intragroup difference was observed, before crossover in group A and after crossover in group B for GI, PBI, and oral microbial count at different stages of study. On comparing both group A and group B at the first and second follow-up for GI, PBI, and oral microbial count, a statistically significant difference (p < 0.05) was observed. A statistically highly significant mean intergroup and intragroup difference was seen for all the clinical parameters at different stages of study.

    Conclusion: The study revealed that the Illicium verum/star anise has potent antibacterial, anti-inflammatory, and astringent properties.

    Matched MeSH terms: Double-Blind Method
  7. Toussaint ND, Pedagogos E, Lioufas NM, Elder GJ, Pascoe EM, Badve SV, et al.
    J Am Soc Nephrol, 2020 11;31(11):2653-2666.
    PMID: 32917784 DOI: 10.1681/ASN.2020040411
    BACKGROUND: Hyperphosphatemia is associated with increased fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality. Effects of phosphate-lowering medication on vascular calcification and arterial stiffness in CKD remain uncertain.

    METHODS: To assess the effects of non-calcium-based phosphate binders on intermediate cardiovascular markers, we conducted a multicenter, double-blind trial, randomizing 278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg lanthanum carbonate or matched placebo thrice daily for 96 weeks. We analyzed the primary outcome, carotid-femoral pulse wave velocity, using a linear mixed effects model for repeated measures. Secondary outcomes included abdominal aortic calcification and serum and urine markers of mineral metabolism.

    RESULTS: A total of 138 participants received lanthanum and 140 received placebo (mean age 63.1 years; 69% male, 64% White). Mean eGFR was 26.6 ml/min per 1.73 m2; 45% of participants had diabetes and 32% had cardiovascular disease. Mean serum phosphate was 1.25 mmol/L (3.87 mg/dl), mean pulse wave velocity was 10.8 m/s, and 81.3% had abdominal aortic calcification at baseline. At 96 weeks, pulse wave velocity did not differ significantly between groups, nor did abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate. Serious adverse events occurred in 63 (46%) participants prescribed lanthanum and 66 (47%) prescribed placebo. Although recruitment to target was not achieved, additional analysis suggested this was unlikely to have significantly affected the principle findings.

    CONCLUSIONS: In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo. These findings do not support the role of intestinal phosphate binders to reduce cardiovascular risk in patients with CKD who have normophosphatemia.

    CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Australian Clinical Trials Registry, ACTRN12610000650099.

    Matched MeSH terms: Double-Blind Method
  8. Goh KL, Peh SC, Parasakthi N, Wong NW, Tan KK, Lo YL
    Am J Gastroenterol, 1994 Oct;89(10):1789-92.
    PMID: 7942668
    OBJECTIVES: Our objectives were to determine the effect of dual therapy with omeprazole and amoxicillin and of triple therapy with omeprazole, amoxicillin, and metronidazole in the eradication of Helicobacter pylori (HP) and to study the long-term results of eradication in these patients.
    METHODS: A prospective, randomized, controlled trial was performed. Patients who were recruited had unequivocal evidence of HP infection based on culture, histology, rapid urease test, and Gram's stain of a tissue smear. Eradication was defined as the absence of bacteria in all tests performed on both corpus and antral biopsies.
    RESULTS: The infection was eradicated in 15 of 19 (78.9%) patients randomized to receive dual therapy and in 19 of 22 (86.4%) patients who received triple therapy. We followed the course of 30 patients in whom HP had been eradicated for a prolonged term (up to 12 months). All remained clear of HP. Twenty-five of 28 patients (89.3%) with duodenal ulcers in whom HP was successfully eradicated remained healed at 12 months. Fewer side effects were reported among patients who received the dual therapy.
    CONCLUSIONS: Combination therapy with omeprazole and amoxicillin with or without metronidazole is effective in the eradication of HP. In particular, the dual therapy regimen with amoxicillin is not only effective but is also well tolerated by patients.
    Matched MeSH terms: Double-Blind Method
  9. Wong SM, Ng TG, Baba R
    J Dermatol, 2013 Nov;40(11):874-80.
    PMID: 24111816 DOI: 10.1111/1346-8138.12265
    Staphylococcus aureus is frequently found in patients with atopic dermatitis (AD) and contributes to disease exacerbation. The objective of this study was to evaluate the efficacy and safety of bleach baths as an adjunctive treatment in AD patients. Patients between 2 and 30 years old with moderate to severe AD were enrolled in a prospective, randomized, placebo-controlled study. Patients soaked in diluted bleach or distilled water baths for 10 min, twice a week for 2 months. Efficacy assessments included the Eczema Area and Severity Index (EASI) scores and S. aureus density was determined using quantitative bacterial cultures. Patients in the treatment group showed significant reductions in EASI scores. A 41.9% reduction in S. aureus density from baseline was seen at 1 month further reducing to 53.3% at 2 months. Equal numbers of patients in both groups experienced mild side-effects. This study demonstrates that diluted bleach baths clinically improved AD in as little as 1 month. No patient withdrew from the treatment arm because of intolerance to the baths.
    Matched MeSH terms: Double-Blind Method
  10. P S L, Miskan MM, Y Z C, Zaki RA
    BMC Anesthesiol, 2017 Oct 11;17(1):137.
    PMID: 29020936 DOI: 10.1186/s12871-017-0430-3
    BACKGROUND: Cough on emergence has been reported as a common adverse reaction with sugammadex reversal. We investigated if staggering the dose of sugammadex will reduce emergence cough in a single-center, randomized, double-blinded study.

    METHODS: A hundred and twenty ASA 1-3 adults were randomly reversed with 1 mg/kg sugammadex prior to extubation followed by another 1 mg/kg immediately after extubation (staggered group), single dose of 2 mg/kg sugammadex (single bolus group) or neostigmine 0.02 mg/kg with glycopyrrolate (neostigmine group).

    RESULTS: We found 70% of patients (n = 28) reversed with single boluses of sugammadex had Grade 3 emergence cough compared to 12.5% (n = 5) in the staggered sugammadex group and 17.5% (n = 7) in the neostigmine group (p 

    Matched MeSH terms: Double-Blind Method
  11. Blair GW, Appleton JP, Law ZK, Doubal F, Flaherty K, Dooley R, et al.
    Int J Stroke, 2018 07;13(5):530-538.
    PMID: 28906205 DOI: 10.1177/1747493017731947
    Rationale The pathophysiology of most lacunar stroke, a form of small vessel disease, is thought to differ from large artery atherothrombo- or cardio-embolic stroke. Licensed drugs, isosorbide mononitrate and cilostazol, have promising mechanisms of action to support their testing to prevent stroke recurrence, cognitive impairment, or radiological progression after lacunar stroke. Aim LACI-1 will assess the tolerability, safety, and efficacy, by dose, of isosorbide mononitrate and cilostazol, alone and in combination, in patients with ischemic lacunar stroke. Sample size A sample of 60 provides 80+% power (significance 0.05) to detect a difference of 35% (90% versus 55%) between those reaching target dose on one versus both drugs. Methods and design LACI-1 is a phase IIa partial factorial, dose-escalation, prospective, randomized, open label, blinded endpoint trial. Participants are randomized to isosorbide mononitrate and/or cilostazol for 11 weeks with dose escalation to target as tolerated in two centers (Edinburgh, Nottingham). At three visits, tolerability, safety, blood pressure, pulse wave velocity, and platelet function are assessed, plus magnetic resonance imaging to assess cerebrovascular reactivity in a subgroup. Study outcomes Primary: proportion of patients completing study achieving target maximum dose. Secondary symptoms whilst taking medications; safety (hemorrhage, recurrent vascular events, falls); blood pressure, platelet function, arterial stiffness, and cerebrovascular reactivity. Discussion This study will inform the design of a larger phase III trial of isosorbide mononitrate and cilostazol in lacunar stroke, whilst providing data on the drugs' effects on vascular and platelet function. Trial registration ISRCTN (ISRCTN12580546) and EudraCT (2015-001953-33).
    Matched MeSH terms: Double-Blind Method
  12. Siddique MI, Katas H, Jamil A, Mohd Amin MCI, Ng SF, Zulfakar MH, et al.
    Drug Deliv Transl Res, 2019 04;9(2):469-481.
    PMID: 29159691 DOI: 10.1007/s13346-017-0439-7
    Hydrocortisone (HC), topical glucocorticoid along with hydroxytyrosol (HT), and anti-microbial- and anti-oxidant-loaded chitosan nanoparticles (CSNPs) were prepared in large scale and analyzed for their adverse effects on healthy human skin followed by repeated applications. Ten subjects were randomized to receive test (HC-HT CSNPs) and vehicle samples (aqueous (AQ) cream). They were applied on the arms for 28 days, and transepidermal water loss (TEWL), erythema intensity, and irritation score were measured. Blood samples were analyzed for blood hematology, blood biochemistry, and adrenal cortico-thyroid hormone (ACTH) levels. Skin biopsy was obtained to assess histopathological changes in the skin. HC-HT CSNP AQ cream was stored at 4, 25, and 45 °C for a period of 1 year, and its stability was assessed by monitoring their physical appearances, particle size, and pH. Spherical-shaped NPs were successfully upscaled using spinning-disc technology, with insignificant changes in particle size, zeta potential, and incorporation of drugs as compared to the well-established laboratory method. Particle size of HC-HT CSNPs was
    Matched MeSH terms: Double-Blind Method
  13. Stein EA, Dann EJ, Wiegman A, Skovby F, Gaudet D, Sokal E, et al.
    J Am Coll Cardiol, 2017 Aug 29;70(9):1162-1170.
    PMID: 28838366 DOI: 10.1016/j.jacc.2017.06.058
    BACKGROUND: Homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder, is characterized by extremely elevated levels of low-density lipoprotein cholesterol (LDL-C) and accelerated atherosclerotic cardiovascular disease. Statin treatment starts at diagnosis, but no statin has been formally evaluated in, or approved for, HoFH children.

    OBJECTIVES: The authors sought to assess the LDL-C efficacy of rosuvastatin versus placebo in HoFH children, and the relationship with underlying genetic mutations.

    METHODS: This was a randomized, double-blind, 12-week, crossover study of rosuvastatin 20 mg versus placebo, followed by 12 weeks of open-label rosuvastatin. Patients discontinued all lipid-lowering treatment except ezetimibe and/or apheresis. Clinical and laboratory assessments were performed every 6 weeks. The relationship between LDL-C response and genetic mutations was assessed by adding children and adults from a prior HoFH rosuvastatin trial.

    RESULTS: Twenty patients were screened, 14 randomized, and 13 completed the study. The mean age was 10.9 years; 8 patients were on ezetimibe and 7 on apheresis. Mean LDL-C was 481 mg/dl (range: 229 to 742 mg/dl) on placebo and 396 mg/dl (range: 130 to 700 mg/dl) on rosuvastatin, producing a mean 85.4 mg/dl (22.3%) difference (p = 0.005). Efficacy was similar regardless of age or use of ezetimibe or apheresis, and was maintained for 12 weeks. Adverse events were few and not serious. Patients with 2 defective versus 2 negative LDL receptor mutations had mean LDL-C reductions of 23.5% (p = 0.0044) and 14% (p = 0.038), respectively.

    CONCLUSIONS: This first-ever pediatric HoFH statin trial demonstrated safe and effective LDL-C reduction with rosuvastatin 20 mg alone or added to ezetimibe and/or apheresis. The LDL-C response in children and adults was related to underlying genetic mutations. (A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia [HYDRA]; NCT02226198).

    Matched MeSH terms: Double-Blind Method
  14. Shariffuddin II, Teoh WH, Wahab S, Wang CY
    BMC Anesthesiol, 2018 01 05;18(1):3.
    PMID: 29304735 DOI: 10.1186/s12871-017-0464-6
    BACKGROUND: Ambulatory surgery has recently gain popularity, as it is a good method of optimizinghospital resources utilization. To support ambulatory surgery, anaesthetic goals nowrevolve around patients' early recovery with minimal pain and nausea, expedientdischarge home and prompt resumption of activities of daily living. In this study, weevaluated the effect of a single pre-induction dose of dexmedetomidine on anaestheticrequirements, postoperative pain and clinical recovery after ambulatory ureteroscopy andureteric stenting under general anaesthesia.

    METHODS: Sixty patients were randomised to receive IV dexmedetomidine 0.5 μg.kg-1 (Group DEX, n = 30) or IV saline (Group P, n = 30). General anaesthesia was maintained with Sevoflurane: oxygen: air, titrated to BIS 40-60. Pain intensity, sedation, rescue analgesics, nausea/vomiting and resumption of daily activities were recorded at 1 h, and postoperative day (POD) 1-5.

    RESULTS: Group DEX patients had significant reduction in sevoflurane minimum alveolar concentration (MAC), mean (SD) DEX vs. Placebo 0.6 (0.2) vs. 0.9 (0.1), p = 0.037; reduced postoperative resting pain at 1 h (VAS 0-10) (mean (SD) 1.00 (1.84) vs. 2.63 (2.78), p = 0.004), POD 1 (mean (SD) 1.50 (1.48) vs. 2.87 (2.72), p = 0.002), POD 2 (0.53 (0.97) vs. 1.73 (1.96), p = 0.001) and POD 3 (0.30 (0.75) vs. 0.89 (1.49), p = 0.001). DEX patients also had less pain on movement POD 1 (3.00 (2.12) vs. 4.30 (3.10), p = 0.043) and POD 2 (2.10 (1.98) vs. 3.10 (2.46), p = 0.040), with higher resumption of daily activities by 48 h compared to placebo, 87% vs. 63%, p = 0.04.

    CONCLUSIONS: We conclude that a single dose of dexmedetomidine was a useful adjuvant in reducing MAC and postoperative pain (at 1 h and POD 1-3), facilitating faster return to daily activities by 48 h.

    TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617001120369 , 31st July 2017, retrospectively registered.

    Matched MeSH terms: Double-Blind Method
  15. Ahmad N, Choy CY, Aris EA, Balan S
    Anesth Analg, 2005 Apr;100(4):987-990.
    PMID: 15781511 DOI: 10.1213/01.ANE.0000147790.76114.3A
    We compared the efficacy of IV fentanyl with IV lidocaine as pretreatment for the prevention of withdrawal response after rocuronium injection. For this prospective, randomized, placebo-controlled, double-blind study we recruited 90 patients aged between 18 and 65 yr, ASA physical status I or II, who had undergone elective surgery requiring general anesthesia and positive pressure ventilation. Patients were randomly allocated to 1 of 3 groups: group F received 2 mL IV fentanyl 50 microg/mL (100 microg), group L received 2 mL of preservative-free lidocaine 2% (40 mg), and group P (placebo) received 2 mL of normal saline. The incidence of withdrawal response after rocuronium was 57%, 30%, and 7% in the placebo, lidocaine, and fentanyl groups, respectively. We found a significant reduction in incidence of withdrawal response in both the fentanyl and lidocaine groups when compared with the placebo group (P < 0.05), with the fentanyl group being most effective (P < 0.05). In conclusion, both fentanyl and lidocaine are effective clinical treatments to alleviate the withdrawal response associated with rocuronium injection, with fentanyl being more effective.
    Matched MeSH terms: Double-Blind Method
  16. 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
  17. Goh KL, Benamouzig R, Sander P, Schwan T, EMANCIPATE
    Eur J Gastroenterol Hepatol, 2007 Mar;19(3):205-11.
    PMID: 17301646
    To compare the efficacy and tolerability of pantoprazole 20 mg once daily with that of esomeprazole 20 mg once daily for 6 months as maintenance therapy in patients with previously healed gastroesophageal reflux disease.
    Matched MeSH terms: Double-Blind Method
  18. Sharma S, Abdullah N
    Singapore Med J, 2000 Apr;41(4):147-50.
    PMID: 11063177
    Prospective, randomized, double-blind, placebo-controlled study involving one hundred ASA I-II patients undergoing major gynaecological surgery.
    Matched MeSH terms: Double-Blind Method
  19. Chiu CK, Low TH, Tey YS, Singh VA, Shong HK
    Singapore Med J, 2011 Dec;52(12):868-73.
    PMID: 22159928
    INTRODUCTION: Chronic, nonspecific low back pain is a difficult ailment to treat and poses an economic burden in terms of medical expenses and productivity loss. The aim of this study was to determine the efficacy and safety of intramuscular metylcobalamin in the treatment of chronic nonspecific low back pain.
    METHODS: This was a double-blinded, randomised, controlled experimental study. 60 patients were assigned to either the methylcobalamin group or the placebo group. The former received intramuscular injections of 500 mcg parenteral methylcobalamin in 1 ml solution three times a week for two weeks, and the placebo group received 1 ml normal saline. Patients were assessed with Oswestry Disability Index questionnaire Version 2.0 and Visual Analogue Scale pain score. They were scored before commencement of the injections and at two months interval.
    RESULTS: Of the 60 patients, 27 received the placebo injections and 33 were given methylcobalamin injections. A total of 58 patients were available for review at two months (placebo: n is 26; methylcobalamin: n is 32). There was a significant improvement in the Oswestry Disability Index and Visual Analogue Scale pain scores in the methylcobalamin group as compared with the placebo group (p-value less than 0.05). Only minor adverse reactions such as pain and haematoma at the injection sites were reported by some patients.
    CONCLUSION: Intramuscular methylcobalamin is both an effective and safe method of treatment for patients with nonspecific low back pain, both singly or in combination with other forms of treatment.
    Study site: Orthopaedic Clinic, Hospital Tuanku Jaafar, Seremban, Negeri Sembilan, Malaysia
    Matched MeSH terms: Double-Blind Method
  20. Zangrillo A, Alvaro G, Pisano A, Guarracino F, Lobreglio R, Bradic N, et al.
    Am Heart J, 2016 Jul;177:66-73.
    PMID: 27297851 DOI: 10.1016/j.ahj.2016.03.021
    OBJECTIVE: Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes.

    DESIGN: Double-blind, placebo-controlled, multicenter randomized trial.

    SETTING: Tertiary care hospitals.

    INTERVENTIONS: Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours.

    MEASUREMENTS AND MAIN RESULTS: The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction.

    CONCLUSIONS: This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.

    Matched MeSH terms: Double-Blind Method
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