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PubMed1996

A randomised trial of fibrin sealant in peripheral vascular surgery.

In a prospective randomised trial 39 patients undergoing either arterial bypass surgery with a polytetrafluoroethylene (PTFE) bypass graft (n = 18) or aortic aneurysm repair with a woven Dacron graft (n = 21) were randomised either to receive fibrin sealant as a topical haemostatic agent at the arterial anastomosis or to act as control. The main outcome measure was the time taken to achieve haemostasis at the suture line. The median time to achieve haemostasis was 0.5 min (range 0-11 min) in the treatment group and 4 min (range 0-21 min) in the control group. This difference was statistically significant p < 0.014 by the Mann-Whitney test. Immediate haemostasis on release of the clamps was achieved in 13/21 patients in the treatment group and in 4/18 patients in the control group (p = 0.023 by Fisher's exact test). There was no difference in total operative time or operative blood loss. No patients in the treatment group suffered any perioperative thromboembolic event and 1 patient in the control group suffered an early graft occlusion. There was no evidence of transmission of hepatitis B or C, or parvovirus B19. In conclusion, fibrin sealant is an effective topical haemostatic agent for arterial suture lines involving PTFE or woven Dacron.

Aged↗
PubMed1985

The effect of a prostacyclin analogue (Iloprost) on skin temperature.

Skin temperature was measured in the forearms of 8 healthy volunteers to study the effect of transdermal application of a stable prostacyclin analogue (Iloprost). Local skin temperature was significantly increased 24 hours and 48 hours after application of the drug when compared with an area of control skin. The effect had worn off by 72 hours. At a dose of 25 micrograms there were no systemic effects of vasodilatation or antiplatelet behaviour, but when the dose was increased to 75 micrograms there was a decreased rate of platelet aggregation for 24 hours. Histology of a skin biopsy suggested that the increase in skin temperature was due to vasodilatation and not acute inflammatory reaction. The results of this pilot study suggest that transdermal application of Iloprost is a suitable vehicle for administration of the drug and a prospective randomised trial is proposed for patients with Raynaud's Syndrome.

Administration, Topical↗
PubMed2000

Randomised clinical trials in the Scandinavian Journal of Rheumatology.

OBJECTIVE: To identify all reports of randomised clinical trials in the Journal and compare our findings with reports available in Medline. METHODS: We handsearched the Scandinavian Journal of Rheumatology with supplements for the years 1955-1997 to identify reports of randomised clinical trials and controlled clinical trials. RESULTS: We identified 445 trial reports. In Medline, 134 of these trials (30%) were indexed as randomised or controlled trials; an additional 50 trials (11%) were available in Medline but were indexed differently. Thus, 261 of the trials (59%) we identified were not indexed in Medline; most of these trials were published in supplements to the Journal. CONCLUSION: Handsearching of medical journals for randomised trials can be a worthwhile effort. Clinicians and patients will become better informed about the value of different treatment options and researchers will reduce their risk of performing trials that are unnecessary.

Humans↗
PubMed2004

Arthroplasties (with and without bone cement) for proximal femoral fractures in adults.

BACKGROUND: Numerous types of arthroplasties may be used in the surgical treatment of a hip fracture (proximal femoral fracture). The main differences between the implants are the design of the stems, whether the stem is fixed in place with or without cement, whether a second articulating joint is included within the prosthesis (bipolar prosthesis) or whether the whole hip joint is replaced. OBJECTIVES: To review all randomised trials that have compared different arthroplasties for the treatment of hip fractures in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register which is compiled by regular searches of the Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE and CINAHL. Additional trials were identified by searching reference lists of relevant articles, conference proceedings, and contact with trialists. Date of most recent search: October 2003. SELECTION CRITERIA: All randomised and quasi-randomised trials comparing different arthroplasties (and/or cement), for the treatment of hip fractures. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, by use of a ten-item checklist and extracted data. MAIN RESULTS: Fifteen trials involving 1670 patients were included. One trial involved two comparisons. Cemented prostheses, when compared with uncemented (five trials, 482 participants) were associated with a lower risk of failure to regain mobility (relative risk (RR) 0.60; 95% confidence interval (CI) 0.44 to 0.82) and of post-operation pain at a year or later (RR 0.51, 95% CI 0.31 to 0.81). For this comparison, there were no significant differences in any other outcome. Comparison of unipolar hemiarthroplasty with bipolar hemiarthroplasty (seven trials, 857 participants) showed no significant differences between the two types of implant. Two trials of 269 patients compared different types of hemiarthroplasty with a total hip replacement and two trials of 151 patients compared either different types of prosthesis head or different bipolar prostheses. Because of the limited number of cases and the use of different prostheses, no definite conclusions could be made from these four studies. REVIEWERS' CONCLUSIONS: Cementing prostheses in place seems to reduce pain post-operatively and results in better mobility, but because of the under-reporting of outcomes and the small number of patients involved, no definite conclusions can be made. The role of bipolar prostheses and total hip replacement is uncertain. Further well-conducted randomised trials are required.

Adult↗
PubMed2006

Arthroplasties (with and without bone cement) for proximal femoral fractures in adults.

BACKGROUND: Numerous types of arthroplasties may be used in the surgical treatment of a hip fracture (proximal femoral fracture). The main differences between the implants are in the design of the stems, whether the stem is fixed in place with or without cement, whether a second articulating joint is included within the prosthesis (bipolar prosthesis) or whether a partial (hemiarthroplasty) or total whole hip replacement is used. OBJECTIVES: To review all randomised controlled trials that have compared different arthroplasties for the treatment of hip fractures in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2005), MEDLINE, EMBASE, the UK National Research Register, several orthopaedic journals, conference proceedings and reference lists of articles. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials comparing different arthroplasties and their insertion with or without cement, for the treatment of hip fractures. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality, by use of a ten-item checklist, and extracted data. MAIN RESULTS: Seventeen trials involving 1920 patients were included. One trial involved two comparisons. Cemented prostheses, when compared with uncemented (six trials, 549 participants) were associated with less pain at a year or later (16/52 versus 28/52; RR 0.51, 95% CI 0.31 to 0.81) and a tendency to better mobility. No significant difference in surgical complications was found. Comparison of unipolar hemiarthroplasty with bipolar hemiarthroplasty (seven trials, 857 participants, 863 fractures) showed no significant differences between the two types of implant. Two trials involving 232 patients compared uncemented hemiarthroplasty with a total hip replacement. Both studies reported increased pain for the uncemented prosthesis and one study found better mobility and a lower long-term revision rate for those treated with a THR. Two trials involving 214 participants compared cemented hemiarthroplasty versus total hip replacement. Both trials generally found little difference between prostheses. THR was associated with a slightly longer surgical time but a tendency to better functional outcome in one trial. AUTHORS' CONCLUSIONS: There is limited evidence that cementing a prosthesis in place may reduce post-operative pain and lead to better mobility. There is insufficient evidence to determine the roles of bipolar prostheses and total hip replacement. Further well-conducted randomised trials are required.

Adult↗
PubMed2006

S-adenosyl-L-methionine for alcoholic liver diseases.

BACKGROUND: Alcohol is a major cause of liver disease and disrupts methionine and oxidative balances. S-adenosyl-L-methionine (SAMe) acts as a methyl donor for methylation reactions and participates in the synthesis of glutathione, the main cellular antioxidant. Randomised clinical trials have addressed the question whether SAMe may benefit patients with alcoholic liver diseases. OBJECTIVES: To evaluate the beneficial and harmful effects of SAMe for patients with alcoholic liver diseases. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (May 2005), The Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 2, 2005), MEDLINE (1950 to May 2005), EMBASE (1980 to May 2005), and Science Citation Index Expanded (searched May 2005). SELECTION CRITERIA: We included randomised clinical trials studying patients with alcoholic liver diseases. Interventions encompassed per oral or parenteral administration of SAMe at any dose versus placebo or no intervention. DATA COLLECTION AND ANALYSIS: We performed all analyses according to the intention-to-treat method using RevMan Analyses provided by the Cochrane Collaboration. We evaluated the methodological quality of the randomised clinical trials by quality components. MAIN RESULTS: We identified nine randomised clinical trials including a heterogeneous sample of 434 patients with alcoholic liver diseases. The methodological quality regarding randomisation was generally low, but 8 out of 9 trials were placebo controlled. Only one trial including 123 patients with alcoholic cirrhosis used adequate methodology and reported clearly on all-cause mortality and liver transplantation. We found no significant effects of SAMe on all-cause mortality (relative risks (RR) 0.62, 95% confidence interval (CI) 0.30 to 1.26), liver-related mortality (RR 0.68, 95% CI 0.31 to 1.48), all-cause mortality or liver transplantation (RR 0.55; 95% CI 0.27 to 1.09), or complications (RR 1.35, 95% CI 0.84 to 2.16), but the analysis is based mostly on one trial only. SAMe was not significantly associated with non-serious adverse events (RR 4.92; 95% CI 0.59 to 40.89) and no serious adverse events were reported. AUTHORS' CONCLUSIONS: We could not find evidence supporting or refuting the use of SAMe for patients with alcoholic liver diseases. We need more long-term, high-quality randomised trials on SAMe for these patients before SAMe may be recommended for clinical practice.

Humans↗
PubMed2004

Nonabsorbable disaccharides for hepatic encephalopathy.

BACKGROUND: Nonabsorbable disaccharides (lactulose or lactitol) are considered the treatment of choice for hepatic encephalopathy. OBJECTIVES: To assess the beneficial and harmful effects of nonabsorbable disaccharides for patients with hepatic encephalopathy. SEARCH STRATEGY: Trials were identified through The Cochrane Hepato-Biliary Group Controlled Trials Register (March 2003), The Cochrane Central Register of Controlled Trials (Issue 1, 2003), MEDLINE (1966 to 2003/03), EMBASE (1980 to 2003/03), manual searches of bibliographies and journals, authors of trials, and pharmaceutical companies. SELECTION CRITERIA: Randomised trials comparing lactulose or lactitol versus no intervention, placebo, or antibiotics and trials comparing lactulose versus lactitol for hepatic encephalopathy. DATA COLLECTION AND ANALYSIS: The primary outcome measures included no improvement of hepatic encephalopathy and all-cause mortality. Binary outcomes are reported as relative risks (RR) based on a random effects model. Subgroup analyses were performed with regard to methodological quality and form of hepatic encephalopathy. MAIN RESULTS: Thirty trials assessed nonabsorbable disaccharides versus placebo, no intervention, or antibiotics or assessed lactulose versus lactitol. We could not extract data from all trials. Compared with placebo or no intervention, nonabsorbable disaccharides had no statistically significant effect on mortality (RR 0.41, 95% CI 0.02 to 8.68, four trials), but appeared to reduce the risk of no improvement of hepatic encephalopathy (RR 0.62, 95% CI 0.46 to 0.84, six trials). However, this result may reflect bias due to low methodological quality of the majority of included trials. Trials of high methodological quality found no significant effect of nonabsorbable disaccharides on the risk of no improvement (RR 0.92, 95% CI 0.42 to 2.04, two trials). We found no statistically significant difference between lactulose and lactitol on mortality (two trials) or risk of no improvement (four trials). However, our meta-analyses were underpowered to establish whether these treatments have comparable effect. Nonabsorbable disaccharides appeared to be inferior to antibiotics on reducing the risk of no improvement (RR 1.24, 95% CI 1.02 to 1.50, 10 trials). REVIEWERS' CONCLUSIONS: This systematic review questions the beneficial effects of nonabsorbable disaccharides and highlights that there is insufficient high-quality evidence to support this treatment. We found that antibiotics appeared to be superior to nonabsorbable disaccharides in improving hepatic encephalopathy, but it is unclear whether this difference in treatment effect is clinically important to patients. Nonabsorbable disaccharides should not serve as comparator in randomised trials on hepatic encephalopathy.

Anti-Bacterial Agents↗
PubMed2002

Benperidol for schizophrenia.

BACKGROUND: Benperidol is a relatively old antipsychotic drug, marketed since 1966, used in Germany for 30 years, but also available in Belgium, Greece, Italy, the Netherlands and the UK. Benperidol is a butyrophenone antipsychotic, with the highest neuroleptic potency in terms of D2 receptor blockade. Those taking it are, therefore, reputed to be at high risk of extrapyramidal side effects, but benperidol's unusual profile may render it of value to subgroups of people with schizophrenia. OBJECTIVES: To examine the clinical effects and safety of benperidol for those with schizophrenia and schizophrenia-like psychoses. SEARCH STRATEGY: The reviewers searched the Cochrane Schizophrenia Group's register (January 2001) which includes relevant randomised controlled trials from the bibliographic databases Biological Abstracts, CINAHL, The Cochrane Library, EMBASE, MEDLINE, PsycLIT, LILACS, PSYNDEX, Sociological Abstracts and Sociofile. We also searched the references of all included studies and contacted pharmaceutical companies and authors of included studies in order to identify further trials. SELECTION CRITERIA: Randomised controlled trials that compared benperidol with other treatments for people with schizophrenia and/or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: Citations and, where possible, abstracts were independently inspected by two reviewers and papers were ordered, re-inspected and quality assessed. We independently extracted data but excluded data if loss to follow up was greater than 50%. For homogeneous dichotomous data, we calculated the relative risk (RR), the 95% confidence interval (CI) and, where appropriate, the number needed to treat/harm (NNT/H), on an intention-to-treat basis. MAIN RESULTS: We identified only one unpublished poorly randomised controlled trial (N=40, duration 30 days, comparison perphenazine). Although benperidol was inferior to perphenazine (1 RCT, N=40, global state no better or worse RR 8.0 CI 2.1 to 30, NNH 1.4 CI 1 to 2) poor reporting suggests that an overestimate of effect is likely. It was not possible to report other outcomes. REVIEWER'S CONCLUSIONS: Currently, there are insufficient data from randomised trials to assess the clinical effects of benperidol. This interesting compound merits further research.

Antipsychotic Agents↗
PubMed2005

Benperidol for schizophrenia.

BACKGROUND: Benperidol is a relatively old antipsychotic drug that has been marketed since 1966. It has been used in Germany for 30 years, but is also available in Belgium, Greece, Italy, the Netherlands and the UK. Benperidol is a butyrophenone antipsychotic, with the highest neuroleptic potency in terms of D2 receptor blockade. Those taking it are therefore reputed to be at high risk of extrapyramidal side effects, but benperidol's unusual profile may render it valuable to subgroups of people with schizophrenia. OBJECTIVES: To examine the clinical effects and safety of benperidol for those with schizophrenia and schizophrenia-like psychoses. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's register (November 2004) for this update. SELECTION CRITERIA: We included all randomised controlled trials that compared benperidol with other treatments for people with schizophrenia, or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: We reliably selected studies, quality rated them and extracted data. We independently extracted data but excluded data if loss to follow up was greater than 50%. For dichotomous data, we estimated relative risks (RR), with the 95% confidence intervals (CI). Where possible, we calculated the number needed to treat/harm statistic (NNT/H) and used intention-to-treat analysis. MAIN RESULTS: The update yielded no further studies for inclusion in the review. We identified only one unpublished poorly randomised controlled trial (N=40, duration 30 days, comparison perphenazine). Although benperidol was inferior to perphenazine (1 RCT, N=40, global state no better or worse RR 8.0 CI 2.1 to 30, NNH 1.4 CI 1 to 2) poor reporting suggests that an overestimate of effect is likely. It was not possible to report other outcomes. AUTHORS' CONCLUSIONS: Currently, there are insufficient data from randomised trials to assess the clinical effects of benperidol. This compound merits further research interest.

Antipsychotic Agents↗
PubMed2006

Auricular acupuncture for cocaine dependence.

BACKGROUND: Auricular acupuncture (insertion of acupuncture into a number, usually five, of specific points in the ear) is a widely-used treatment for cocaine dependence. OBJECTIVES: To determine whether auricular acupuncture is an effective treatment for cocaine dependence, and to investigate whether its effectiveness is influenced by the treatment regimen. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2004); MEDLINE (January 1966 to October 2004) , EMBASE (January 1988 to October 2004); PsycInfo (1985 to October 2004); CINAHL (1982 to October 2004); SIGLE (1980 to October 2004) and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials comparing a therapeutic regimen of auricular acupuncture with sham acupuncture or no treatment for reduction of cocaine use in cocaine dependents. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from published reports and assessed study quality using the Drug and Alcohol CRG checklist. All authors were contacted for additional information; two provided data. Separate meta-analyses were conducted for studies comparing auricular acupuncture with sham acupuncture, and with no treatment. For the main cocaine use outcomes, analyses were conducted by intention to treat, assuming that missing data were treatment failures. Available case analyses, using only individuals who provided data, were also conducted. MAIN RESULTS: Seven studies with a total of 1,433 participants were included. All were of generally low methodological quality. No differences between acupuncture and sham acupuncture were found for attition RR 1.05 (95% CI 0.89 to 1.23) or acupuncture and no acupuncture: RR 1.06 (95% CI 0.90 to 1.26) neither for any measure of cocaine or other drug use. However, the number of participants included in meta-analyses was low, and power was limited. Moderate benefit or harm is not ruled out by these results. Methodological limitations of the included studies may have also made the results open to bias. AUTHORS' CONCLUSIONS: There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.

Acupuncture, Ear↗
PubMed2006

Lamotrigine for schizophrenia.

BACKGROUND: Treating the 20-30% of people with schizophrenia whose symptoms are resistant to treatment can be problematic. Adding lamotrigine to ongoing antipsychotic treatment has shown to be of benefit in preliminary studies. OBJECTIVES: To evaluate the effects of adjuvant lamotrigine for people with schizophrenia and schizophrenia-like psychoses. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's Register (February 2006) and inspected references of all identified studies for further trials. We contacted relevant authors of trials for additional information. SELECTION CRITERIA: We included all clinical randomised trials comparing lamotrigine with placebo or other antipsychotic augmentation strategies. DATA COLLECTION AND ANALYSIS: We extracted data independently. For homogenous dichotomous data we calculated random effects relative risk (RR), 95% confidence intervals (CI) and, where appropriate, numbers needed to treat (NNT) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). MAIN RESULTS: We found five relevant trials (total n=537), but no usable data on service outcomes, general functioning, behaviour, engagement with services, satisfaction with treatment or economic outcomes. Overall, reporting of data was poor. Those data we were able to use suggested that equal proportions of people allocated lamotrigine or placebo had no global response (n=208, 1 RCT, RR 1.06 CI 0.73 to 1.54). There was no significant difference between groups in the proportions of people whose mental state did not improve (n=297, 3 RCT, RR 1.26 CI 0.81 to 1.97). There was, however, a significant reduction in the PANSS total scores (n=67, 2 RCT, WMD -16.88 CI -8.57 to -25.18, p=0.0001), positive symptom sub-scale scores (n=65, 2 RCTs, WMD -5.10 CI -8.86 to -1.34) and negative symptom sub-scale scores (n=67, 2 RCTs, WMD -5.25, CI -7.07 to -3.43). Most cognitive measures showed no differences (n=329, 2 RCTs, RR not attaining BACS composite score of 0.5 1.10 CI 0.59 to 2.04). The proportion of participants leaving studies was about 25% at 12 weeks (n=537, 5 RCTs, RR 0.96 CI 0.71 to 1.29). The lamotrigine group did experience the outcome of any adverse effects significantly more frequent than people allocated placebo (n=429, 2 RCTs, RR 1.19 CI 1.02 to 1.38, NNH 10 CI 5 to 90). Among the many effects listed, only nausea was found to be significantly more (9%) in the lamotrigine group compared with placebo (n=465, 3 RCTs, RR 2.26 CI 1.05 to 4.88). AUTHORS' CONCLUSIONS: Evidence for use of lamotrigine as an adjuvant for people with schizophrenia is not robust and large well-designed, conducted and reported real-world randomised trials are needed to determine its place in everyday clinical practice.

Antipsychotic Agents↗