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At least 613 records · Page 34Linked to original sources
PubMed1998

Adjunctive systemic and locally delivered metronidazole in the treatment of periodontitis: a controlled clinical study.

OBJECTIVE: To compare clinical and microbiological responses following non-surgical treatment of moderate to advanced adult periodontitis using subgingival scaling with and without adjunctive topical or systemic metronidazole. DESIGN: A single blind randomised clinical trial of 90 subjects, stratified for periodontitis disease severity and smoking status, divided into three treatment groups: 1. Subgingival scaling using ultrasonic scalers and local anaesthesia; 2. Subgingival scaling using ultrasonic scalers and local anaesthesia plus seven days of systemic metronidazole (200 mg tds); 3. Subgingival scaling using ultrasonic scalers and local anaesthesia plus two applications of 25% metronidazole gel one week apart in all sites with probing depths more than 4 mm. Evaluations were made before treatment, and 8 weeks and 24 weeks post treatment. MAIN OUTCOME MEASURES: Probing depths, probing attachment levels and bleeding on probing were measured using a Florida probe. Bacterial morphotypes were evaluated with darkfield microscopy. Results were analysed for all sites with baseline probing depths equal to or greater than Florida probe recordings of 4.6 mm using analysis of variance. RESULTS: 84 subjects completed the trial and the three treatment groups did not differ at baseline for any clinical parameter. Mean probing depths were reduced following treatment by greater than 1.6 mm (Group 1 = 1.68 mm, Group 2 = 1.62 mm, Group 3 = 1.74 mm at six months post treatment) but no significant differences were detected between treatment groups at any time point. Similarly, no significant differences were detectable between treatments for changes in mean probing attachment levels, bleeding on probing, plaque scores or proportions of bacterial morphotypes. CONCLUSIONS: This study does not support the routine use of adjunctive metronidazole in the non-surgical treatment of periodontitis.

Administration, Oral↗
PubMed2004

Docosanol: a topical antiviral for herpes labialis.

Recurrent herpes labialis is a painful and potentially disfiguring infection affecting an estimated 40 million people in the US alone. The majority of recurrences are caused by herpes simplex virus type 1. Various oral and topical formulations of nucleoside analogues have demonstrated efficacy for this indication. Over-the-counter treatments are palliative in nature and do not reduce time to healing. Docosanol is a compound with a unique mechanism of action involving viral fusion inhibition. In randomised, clinical trials, a 10% docosanol cream formulation, initiated within 12 h of symptoms onset, demonstrated efficacy in reduction of time-to-healing compared with a polyethylene glycol control. Despite its potential to be a mild irritant, this novel antiviral was well-tolerated in clinical trials. Docosanol is the first topical antiviral approved for over-the-counter use in recurrent herpes labialis.

Administration, Topical↗
PubMed2001

The cost effectiveness of tapered versus abrupt discontinuation of oral cyclosporin microemulsion for the treatment of psoriasis.

OBJECTIVE: To assess the cost effectiveness of tapered versus abrupt discontinuation of a microemulsion formulation of cyclosporin in patients with chronic plaque psoriasis. METHODS: A cost-effectiveness analysis was performed in parallel with a non-blind, multicentre, international clinical trial of the safety and efficacy of intermittent short courses of cyclosporin. Direct and indirect costs were considered within a 1-year period following randomisation. PATIENTS: Patients with chronic plaque psoriasis inadequately controlled with topical treatment. STUDY PERSPECTIVE: The study was conducted from a societal perspective and was performed using data from Canada, Spain, Turkey and the UK. MAIN OUTCOMES MEASURES: The health outcome used was the total number of systemic therapy-free days (STFDs) over the first year. The mean incremental cost-effectiveness ratio (ICER) was determined by dividing the differences in average cost per patient by the differences in average STFDs per patient. RESULTS: The overall ICER was dominant because tapered discontinuation was associated with both lower costs and improved efficacy in comparison with abrupt discontinuation. Further analyses showed that tapered discontinuation was a cost-effective alternative to abrupt discontinuation therapy, even when a conservative definition for cost effectiveness was adopted. CONCLUSION: This cost-effectiveness analysis demonstrated that tapering cyclosporin was more cost effective than abruptly stopping cyclosporin in patients with chronic plaque psoriasis.

Administration, Oral↗
PubMed1999

Evidence-based medicine and critical care.

Applying the best available scientific evidence to selecting the most appropriate action for the care of individual patients is not a novel concept. Nevertheless, in these times of exponential growth in medical literature, heavy time constraints on clinicians and increasing health care costs, this approach needed to be reemphasised. The promoters of evidence-based medicine have contributed significantly to this task, by making explicit the steps from the search for the best evidence (randomised controlled trials and meta-analyses) to its application to clinical practice. Moreover, they have developed and made available several invaluable tools for critical appraisal of the medical literature. To illustrate the usefulness of evidence-based medicine, we applied this approach to two clinical situations: (1) the decision whether to use NPPV instead of conventional ventilation in a patient with acute respiratory failure due to severe pneumonia; and (2) whether to administer albumin to critically ill patients with hypovolaemia, burns or hypoalbuninaemia. Finally, the limitations of evidence-based medicine and its main instruments, i.e. randomised controlled trials and meta-analyses, are briefly discussed.

Aged↗
PubMed2001

Internal fixation implants for intracapsular proximal femoral fractures in adults.

BACKGROUND: Numerous different implants with screws, pins and side plates have been used for the internal fixation of intracapsular hip fractures. OBJECTIVES: To determine from randomised trials which implant is superior for the internal fixation of intracapsular proximal femoral fractures. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register. The date of the most recent search was December 2000. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing different implants for the internal fixation of intracapsular hip fractures in adults. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, by use of a ten item scale, and extracted data. Additional information was sought from trialists. After grouping by implant type, comparable groups of trials were subgrouped and where appropriate, data were pooled using the fixed effects model. MAIN RESULTS: Twenty-seven studies involving 5269 participants (5274 fractures) were included in the study. Considerable variation in the quality of methodology between studies was found and biases due to familiarity with some of the implants were noted. None of the implants tested were found to be significantly superior for any of the outcome measures related to fracture healing complications or mortality. The sliding hip screw was found to take longer to insert and to have an increased operative blood loss compared with multiple screws or pins. REVIEWER'S CONCLUSIONS: No clear conclusions can be made on the choice of implant for internal fixation of intracapsular fractures from the available evidence within randomised trials.

Bone Nails↗
PubMed2004

Radiofrequency thermal ablation versus other interventions for hepatocellular carcinoma.

BACKGROUND: Hepatocellular carcinoma is one of the most common malignant diseases worldwide. A potential curative option is surgical resection. Due to impaired liver function and/or anatomical reasons only few patients can be treated surgically. For the majority of patients, several interventions have been developed. Among these, local radiofrequency inducing heat production has been used to coagulate the cancer. OBJECTIVES: To evaluate the effects of radiofrequency thermal ablation in hepatocellular carcinoma patients with respect to clinically relevant outcomes (mortality, rate of recurrences, adverse events, quality of life, and duration of hospital stay) versus sham intervention, no intervention, or other interventions. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library, MEDLINE, EMBASE, CancerLit, and Current Contents until October 2003. Handsearches were also conducted. Reference lists of the identified articles were checked for further trials. SELECTION CRITERIA: All randomised trials investigating radiofrequency thermal ablation versus placebo, no intervention, or any other therapeutic approach were considered for inclusion, regardless of blinding, language, and publication status. DATA COLLECTION AND ANALYSIS: Trial inclusion, quality assessment, and data extraction were performed independently by two reviewers. Principal investigators were contacted for further information. MAIN RESULTS: Only two randomised clinical trials were identified. One trial including 102 patients compared radiofrequency thermal ablation versus percutaneous ethanol injection for small hepatocellular carcinoma. Radiofrequency thermal ablation significantly increased recurrence-free survival (hazard ratio 0.48, 95% confidence interval (CI) 0.27 to 0.85) but did not significantly influence overall survival (hazard ratio 0.20, 95% CI 0.02 to 1.69). The rate of complications and side effects did not differ significantly between the two groups. Another trial with methodological flaws compared radiofrequency thermal ablation versus percutaneous microwave coagulation for 72 patients with 94 hepatocellular carcinoma lesions. The main outcome criterion was the rate of recurrences in both groups; no significant difference was detected. The rate of side effects did not differ significantly, but significantly more treatment sessions were needed with percutaneous microwave coagulation to achieve complete tumour ablation. REVIEWERS' CONCLUSIONS: Radiofrequency thermal ablation seems a potentially promising technique for the treatment of small hepatocellular carcinoma. However, more randomised clinical trials are needed.

Carcinoma, Hepatocellular↗
PubMed2004

Dopaminergic agonists for hepatic encephalopathy.

BACKGROUND: Hepatic encephalopathy may be associated with an impairment of the dopaminergic neurotransmission. Dopaminergic agonists may therefore have a beneficial effect on patients with hepatic encephalopathy. OBJECTIVES: To evaluate the beneficial and harmful effects of dopaminergic agonists for patients with hepatic encephalopathy. SEARCH STRATEGY: Trials were identified through The Cochrane Hepato-Biliary Group Controlled Trials Register (July 2004), The Cochrane Central Register of Controlled Trials (Issue 3, 2004), MEDLINE (1966-2004/07), EMBASE (1980-2004/07), manual searches of bibliographies and journals, authors of trials, and pharmaceutical companies. SELECTION CRITERIA: All randomised trials comparing dopaminergic agonists versus placebo or no intervention for hepatic encephalopathy. DATA COLLECTION AND ANALYSIS: Trial inclusion and data extraction were made independently by two reviewers. Binary outcomes are reported as odds ratios (OR) with 95% confidence intervals (CI) based on a random effects model. The presence of statistical heterogeneity was explored by the chi-squared test with significance set at P < 0.1. Potential sources of heterogeneity were explored through subgroup analyses with regard to the type of hepatic encephalopathy and type of dopaminergic agonist. MAIN RESULTS: Five trials were included. Four trials had low methodological quality. Compared with placebo or no treatment, dopaminergic agonists had no significant effect on the risk of no improvement (OR 0.33, 95% CI 0.01 to 11.25, two trials, 80 patients) or mortality (OR 1.11, 95% CI 0.34 to 3.54, four trials, 139 patients). There was significant heterogeneity (P = 0.09) among trial results on the risk of no improvement, but not on mortality (P = 0.19). The treatment response was not significantly different with regard to the type of hepatic encephalopathy or dopaminergic agonist, but the analyses had very low power to detect potential differences. There was a nonsignificant trend that dopaminergic agonists may be associated with adverse events (OR 8.33, 95% CI 0.37 to 187.74, 2 trials, 13 patients). All adverse events (n = 7) occurred in the experimental group. REVIEWERS' CONCLUSIONS: This review does not provide evidence that dopaminergic agonists are of benefit to patients with acute or chronic hepatic encephalopathy, or fulminant hepatic failure. The review is limited by the small number of trials performed within this field, the low number of patients randomised in each trial, and the low methodological quality of included trials. Accordingly, there is also insufficient evidence to exclude a potential beneficial effect. Dopaminergic agonists should not be used for hepatic encephalopathy, but may be assessed in future randomised clinical trials.

Dopamine Agonists↗
PubMed2001

Medicinal herbs for hepatitis C virus infection.

BACKGROUND: Hepatitis C virus (HCV) infection is a serious health problem world-wide. Medicinal herbs are increasingly being used for hepatitis C. OBJECTIVES: To assess the efficacy and safety of medicinal herbs for hepatitis C virus infection. SEARCH STRATEGY: Searches were applied to The Controlled Trial Registers of The Cochrane Hepato-Biliary Group, The Cochrane Complementary Medicine Field, and The Cochrane Library as well as MEDLINE, EMBASE, BIOSIS, Chinese and Japanese databases. Five Chinese journals and one Japanese journal were handsearched. No language restriction was used. SELECTION CRITERIA: Randomised clinical trials comparing medicinal herbs (single herb or compound of herbs) versus placebo, no intervention, general non-specific treatment, other herbal medicine, or interferon and/or ribavirin treatment. Trials of medicinal herbs plus interferon and/or ribavirin versus interferon and/or ribavirin alone were also included. Trials could be double-blind, single-blind, or unblinded. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers. The methodological quality of the trials was evaluated using the generation of allocation sequence, allocation concealment, double blinding, and the Jadad-scale. The outcomes were presented as relative risk or weighted mean difference, both with 95% confidence interval. MAIN RESULTS: Ten randomised trials, including 517 patients with mainly chronic hepatitis C, evaluated ten different medicinal herbs versus various control interventions (four placebo, four interferon, two other herbs). The methodological quality was considered adequate in four trials and inadequate in six trials. Compared with placebo in four trials, none of the medicinal herbs showed positive effects on clearance of serum HCV RNA or anti-HCV antibody or on serum liver enzymes, except one short-term trial in which a silybin preparation showed a significant effect on reducing serum aspartate aminotransferase and gamma-glutamyltranspeptidase activities. The herbal compound Bing Gan Tang combined with interferon-alpha showed significantly better effects on clearance of serum HCV RNA (relative risk 2.54; 95% confidence interval 1.43 to 4.49) and on normalisation of serum alanine aminotransferase activity (relative risk 2.54; 95% confidence interval 1.43 to 4.49) than interferon-alpha monotherapy. The herbal compound Yi Zhu decoction showed a significant effect on clearance of serum HCV RNA and normalisation of ALT levels compared to glycyrrhizin plus ribavirin. Yi Er Gan Tang showed a significant effect on normalising serum alanine aminotransferase compared to silymarin plus glucurolactone. There was no significant efficacy of the other examined herbs. The herbs were associated with adverse events. REVIEWER'S CONCLUSIONS: There is no firm evidence of efficacy of any medicinal herbs for HCV infection. Medicinal herbs for HCV infection should not be used outside randomised clinical trials.

Hepatitis C, Chronic↗
PubMed2002

Generation of allocation sequences in randomised trials: chance, not choice.

The randomised controlled trial sets the gold standard of clinical research. However, randomisation persists as perhaps the least-understood aspect of a trial. Moreover, anything short of proper randomisation courts selection and confounding biases. Researchers should spurn all systematic, non-random methods of allocation. Trial participants should be assigned to comparison groups based on a random process. Simple (unrestricted) randomisation, analogous to repeated fair coin-tossing, is the most basic of sequence generation approaches. Furthermore, no other approach, irrespective of its complexity and sophistication, surpasses simple randomisation for prevention of bias. Investigators should, therefore, use this method more often than they do, and readers should expect and accept disparities in group sizes. Several other complicated restricted randomisation procedures limit the likelihood of undesirable sample size imbalances in the intervention groups. The most frequently used restricted sequence generation procedure is blocked randomisation. If this method is used, investigators should randomly vary the block sizes and use larger block sizes, particularly in an unblinded trial. Other restricted procedures, such as urn randomisation, combine beneficial attributes of simple and restricted randomisation by preserving most of the unpredictability while achieving some balance. The effectiveness of stratified randomisation depends on use of a restricted randomisation approach to balance the allocation sequences for each stratum. Generation of a proper randomisation sequence takes little time and effort but affords big rewards in scientific accuracy and credibility. Investigators should devote appropriate resources to the generation of properly randomised trials and reporting their methods clearly.

Epidemiology↗
PubMed1989

A controlled, prospective, randomised trial of adjuvant chemotherapy or radiotherapy in resectable gastric cancer: interim report. British Stomach Cancer Group.

A prospective, randomised controlled trial of surgery, surgery with adjuvant radiotherapy and surgery with adjuvant chemotherapy (5-fluorouracil, adriamycin and mitomycin C) in operable gastric cancer is described. Four hundred and thirty-six patients were randomly allocated to one of three treatment groups. With 12 months' minimum follow-up, 334 patients have died, 292 from recurrent cancer. The median survival for all patients was 15 months. Neither form of adjuvant therapy provides any survival advantage. Surgery remains the principal treatment for operable gastric cancer. Care should be taken to standardise surgical treatment and any adjuvant treatments must be compared within the confines of controlled, randomised trials.

Adenocarcinoma↗