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1541. Insufficient evidence for garlic in prevention or treatment of the common cold

that looked at whether taking garlic for symptoms of the cold reduces its severity or duration. However, in the included study, the number of days to recover from a cold was similar for both groups. Context Garlic is alleged to have antimicrobial and antiviral properties that relieve the common cold, among other beneficial effects. There is widespread usage of garlic supplements. The common cold is associated with significant morbidity and economic consequences. On average, children have 6 to 8 colds per

2011 Cochrane PEARLS

1542. Topical treatments are effective for acute otitis externa

Topical treatments are effective for acute otitis externa PEARLS Practical Evidence About Real Life Situations PEARLS are succinct summaries of Cochrane Systematic Reviews for primary care practitioners. They Topical treatments are effective for acute otitis externa Clinical question How effective are interventions for acute otitis externa? Bottom line Topical treatments alone were effective in treating acute otitis externa. Topical treatments in the review included antiseptic, antibiotic (...) , steroid, antibiotic/steroid, antiseptic/steroid, antiseptic/antibiotic/steroid, antibiotic/steroid/antifungal and antiseptic/astringent treatments. There was little to choose between these treatments in terms of effectiveness. Additional oral antibiotics were not required. However, when treatment needed to be extended beyond 1 week, acetic acid drops appeared to be less effective than antibiotic/steroid drops. In addition, symptoms persisted for 2 days longer in those treated with acetic acid. More

2011 Cochrane PEARLS

1543. Insufficient evidence for effectiveness of probiotics for bacterial vaginosis

for the treatment of bacterial vaginosis. In addition, there is no conclusive evidence to recommend the use of probiotics either before, during or after antibiotic treatment as a means of ensuring successful treatment or reducing recurrence. An analysis of odds ratios and confidence intervals for individual studies for the outcomes of microbiological cure was suggestive of a beneficial effect only for the augmentation of oral metronidazole with an oral probiotics regimen and for the probiotic/oestriol regimen (...) vaginal microorganisms, with depletion of the dominant lactobacilli and overgrowth of other types of bacteria. Treatment of this condition using recommended antibiotics is often associated with failure and high rates of recurrence. This has led to the concept of replacing the depleted lactobacilli using probiotics, defined as live microorganisms which, when administered in adequate amounts, confer a beneficial health effect on the host. Cochrane Systematic Review Senok AC et al. Probiotics

2011 Cochrane PEARLS

1544. Rapid viral testing may be beneficial in the emergency department

and respiratory symptoms, RVT reduced the use of chest x-rays; there was a trend toward less antibiotic usage but this was not statistically significant. No effect on length of ED visits, blood or urine testing was seen. Caveat The combined number of participants from the few available studies was not large enough to statistically detect a significant effect of RVT on the primary outcome (antibiotic prescribing) and most of the secondary outcomes (length of ED stay, rate of ancillary tests, rate of physician (...) visit within 2 weeks after discharge, hospital admission rate, and acceptability of nasal specimen collection sampling). Context Paediatric acute respiratory infections represent a significant burden on EDs and families. Most of these illnesses are due to viruses. However, investigations (radiography, blood and urine testing) to rule out bacterial infections and antibiotics are often ordered because of diagnostic uncertainties. This results in prolonged ED visits and unnecessary antibiotic use

2011 Cochrane PEARLS

1545. Some evidence shows that certain mouthrinses can reduce halitosis

Kumar DDS, MDSc . Overview Systematic Review Conclusion Mouthrinses containing antibacterial agents (chlorhexidine and cetylpyridinium chloride) or those containing chlorine dioxide and zinc can reduce halitosis to some extent. Critical Summary Assessment Although antibacterial mouthrinses can reduce halitosis, the extent of effectiveness is uncertain owing to incomplete reporting, possible study and variation in patients’ characteristics and assessment methods. Evidence Quality Rating Limited

2010 ADA Center for Evidence-Based Dentistry

1546. Glycemic control of diabetics may improve slightly with periodontal treatment

levels. Main Results: The review included three RCTs and two CCTs, both of which totaled 199 treated patients and 183 control patients. All patients had type 2 diabetes and periodontitis. Periodontal treatment was scaling and root planning, with or without antibiotic therapy. All studies reported absolute change in A1C. A1C levels of 8 percent and less are considered good and 10 percent and above are considered poor. All studies showed an improved (decreased) A1C level in treated patients ranging (...) a lack of precision in the estimate of effect. The lacked robustness due to significant among the studies. The CCTs introduced by placing treatment avoiders in the control groups. Baseline A1C levels generally reflected poor glycemic control. However, some subjects in two of the RCTs had good control, which may have affected their treatment results. The studies used different or unstated definitions of periodontitis. When antibiotics were used, the protocols changed. Only two studies reported

2010 ADA Center for Evidence-Based Dentistry

1547. Limited evidence suggests no difference in denture cleaning methods

information. The inclusion criteria were limited to randomized clinical trials (RCTs) comparing any mechanical method or chemical in adults over age 18 wearing removable partial or complete dentures. Studies were excluded if participants had implant-retained prostheses or a history of corticosteroid or antimicrobial use within 3 months. Primary outcomes considered included health of denture bearing areas and patient satisfaction and preference. Secondary outcomes included denture plaque coverage area

2010 ADA Center for Evidence-Based Dentistry

1548. Effectiveness of different treatment regimens for peri-implantitis

complex and expensive therapies for peri-implantitis Candice G. McMullan-Vogel DDS . Overview Systematic Review Conclusion Local antibiotics, bone augmentation and subgingival débridement all may be effective in treating peri-implantitis. Critical Summary Assessment There is a need for properly designed studies to identify which treatments are most effective for peri-implantitis. Evidence Quality Rating Limited Evidence This summary is published in the Journal of the American Dental Association

2010 ADA Center for Evidence-Based Dentistry

1549. Patients may not need to stop oral anticoagulant therapy for simple oral surgical procedures

focused on clinically relevant outcomes of the studies, principally differences in postoperative bleeding rates and the control of any bleeding that did occur. Although the title implies that the dealt with the influence of OAT on oral implant therapy, all data provided relate only to simple oral surgical procedures. The authors recommended that drugs that may increase bleeding tendencies, aspirin and other NSAIDs, and antibiotics that can potentiate the anticoagulant effect of OAT be avoided prior

2010 ADA Center for Evidence-Based Dentistry

1551. Exenatide (Byetta) subcutaneous injection

is not an antimicrobial agent. 6.1.6 Efficacy Conclusions • The primary objective was to determine if glycemic control as measured by the change in HbA1c from baseline to endpoint with exenatide twice daily (BID) was superior to placebo BID after 24 wks treatment in patients with T2D who had inadequate control with diet and exercise. Only the exenatide groups experienced a statistically significant improvement in HbA1c compared to baseline. The LS mean treatment difference (exenatide – placebo) at endpoint was -0.5

2009 FDA - Drug Approval Package

1552. Cefepime for Injection USP and Dextrose Injection USP in the Duplex® Container

prescribing decisions based upon the meta analysis? Taken without critical examination, the meta analysis published by Yahav and colleagues seems to implicate cefepime as the cause of higher mortality compared with that among patients treated with other beta lactam antibiotics. In an era with limited development of new antimicrobials for resistant Gram-negative organisms, agents like cefepime have a very important role. Losing cefepime as a major antimicrobial for the treatment and prophylaxis (...) in Pseudomonas aeruginosa: About 24 cases at Rouen University Hospital.] Pathol Biol (Paris). 2008 Nov-Dec;56(7-8):429-34. Epub 2008 Oct 4. French. 15. Matyar F, Kaya A, Dinçer S. Antibacterial agents and heavy metal resistance in Gram negative bacteria isolated from seawater, shrimp and sediment in Iskenderun Bay,Turkey.Sci Total Environ. 2008 Dec 15;407(1):279-85. Epub 2008 Sep 19. 16. Sauermann R, Schwameis R, Fille M, Ligios ML, Zeitlinger M. Antimicrobial activity of cefepime and rifampicin

2009 FDA - Drug Approval Package

1553. Kombiglyze XR (saxagliptin/metformin extended release) fixed dose combination tablets

diamide hydrochloride) is a biguanide. Metformin hydrochloride is a white crystalline with a molecular formula of C4H11N5•HCl. Figure 2 The structural formula of metformin metformin hydrochloride (b) (4) (b) (4)Clinical Review Arlet V. Nedeltcheva, M.D. NDA 200678 saxagliptin/metformin XR FDC 13 See the CMC review for a discussion of the characteristics of the FDC tablet. 4.2 Clinical Microbiology Not applicable- saxagliptin is not an antimicrobial. 4.3 Preclinical Pharmacology/Toxicology The sponsor

2009 FDA - Drug Approval Package

1554. Rilutek - riluzole

attributes. In this case series, drug-related attributes included a strong temporal drug relationship and a correlation between inadequate responses to an antibiotic challenge and in turn a favorable response to riluzole 3 withdrawal and steroid pulse therapy. Based on this correlation of events, 14 healthcare professionals reported and assessed the drug-event relationship as probable or likely. In our case series, two cases reported a constellation of adverse events including features of or a diagnosis (...) . d Death was due to the progression of ALS A representative case of ILD with riluzole follows: ISR#4454417/MFR#200413969JP/2005 A 62 year old male patient had been on riluzole 100 mg daily for the treatment of amyotrophic lateral sclerosis (ALS) since 20Oct03. On 10Nov03, cough and pyrexia developed. The symptoms didn’t improve with antibiotics and dyspnea developed. The patient was hospitalized on 18Nov03

2009 FDA - Drug Approval Package

1555. Glycemic control of diabetics may improve slightly with periodontal treatment

levels. Main Results: The review included three RCTs and two CCTs, both of which totaled 199 treated patients and 183 control patients. All patients had type 2 diabetes and periodontitis. Periodontal treatment was scaling and root planning, with or without antibiotic therapy. All studies reported absolute change in A1C. A1C levels of 8 percent and less are considered good and 10 percent and above are considered poor. All studies showed an improved (decreased) A1C level in treated patients ranging (...) a lack of precision in the estimate of effect. The lacked robustness due to significant among the studies. The CCTs introduced by placing treatment avoiders in the control groups. Baseline A1C levels generally reflected poor glycemic control. However, some subjects in two of the RCTs had good control, which may have affected their treatment results. The studies used different or unstated definitions of periodontitis. When antibiotics were used, the protocols changed. Only two studies reported

2010 ADA Center for Evidence-Based Dentistry

1556. Limited evidence suggests no difference in denture cleaning methods

information. The inclusion criteria were limited to randomized clinical trials (RCTs) comparing any mechanical method or chemical in adults over age 18 wearing removable partial or complete dentures. Studies were excluded if participants had implant-retained prostheses or a history of corticosteroid or antimicrobial use within 3 months. Primary outcomes considered included health of denture bearing areas and patient satisfaction and preference. Secondary outcomes included denture plaque coverage area

2010 ADA Center for Evidence-Based Dentistry

1557. Effectiveness of different treatment regimens for peri-implantitis

complex and expensive therapies for peri-implantitis Candice G. McMullan-Vogel DDS . Overview Systematic Review Conclusion Local antibiotics, bone augmentation and subgingival débridement all may be effective in treating peri-implantitis. Critical Summary Assessment There is a need for properly designed studies to identify which treatments are most effective for peri-implantitis. Evidence Quality Rating Limited Evidence This summary is published in the Journal of the American Dental Association

2010 ADA Center for Evidence-Based Dentistry

1558. Patients may not need to stop oral anticoagulant therapy for simple oral surgical procedures

focused on clinically relevant outcomes of the studies, principally differences in postoperative bleeding rates and the control of any bleeding that did occur. Although the title implies that the dealt with the influence of OAT on oral implant therapy, all data provided relate only to simple oral surgical procedures. The authors recommended that drugs that may increase bleeding tendencies, aspirin and other NSAIDs, and antibiotics that can potentiate the anticoagulant effect of OAT be avoided prior

2010 ADA Center for Evidence-Based Dentistry

1559. Some evidence shows that certain mouthrinses can reduce halitosis

Kumar DDS, MDSc . Overview Systematic Review Conclusion Mouthrinses containing antibacterial agents (chlorhexidine and cetylpyridinium chloride) or those containing chlorine dioxide and zinc can reduce halitosis to some extent. Critical Summary Assessment Although antibacterial mouthrinses can reduce halitosis, the extent of effectiveness is uncertain owing to incomplete reporting, possible study and variation in patients’ characteristics and assessment methods. Evidence Quality Rating Limited

2010 ADA Center for Evidence-Based Dentistry

1560. Helping former smokers stay on the wagon: insufficient evidence regarding relapse prevention interventions for smoking cessation

are the strongest resources to aid dental professionals in clinical decision making and help incorporate evidence gained through scientific investigation into patient care. Guidelines include recommendation statements intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options. Antibiotics for Dental Pain and Swelling Guideline A panel of experts convened by the ADA Council on Scientific Affairs presents clinical (...) recommendations concerning the use of antibiotics for the urgent management of pulpal- and periapical-related dental pain and intra-oral swelling. This guideline updates the 1997 recommendations by the American Heart Association for the prevention of infective endocarditis (IE). The committee concluded that IE prophylaxis for dental procedures should be recommended only for patients with underlying cardiac conditions associated with the highest risk of adverse outcomes from IE. A panel of experts convened

2010 ADA Center for Evidence-Based Dentistry

Evidence-based Synopses

Synopses are typically easily digested, critical commentaries of articles e.g. critically appraised topics.