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PubMed2002

Propylthiouracil for alcoholic liver disease.

BACKGROUND: Alcohol is the most common cause of liver disease in the Western world today. Randomised clinical trials have addressed the question whether propylthiouracil has any efficacy in patients with alcoholic liver disease. OBJECTIVES: The objectives were to assess the efficacy of propylthiouracil on mortality, clinical symptoms and complications, liver biochemistry, and liver histology in patients with alcoholic liver disease. Adverse events were also analysed. SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register (searched July 2001), The Cochrane Controlled Trials Register (Cochrane Library Issue 3, 2001), MEDLINE (January 1966 to July 2001), EMBASE (January 1985 to July 2001) were searched. These electronic searches were combined with full text searches. Manufacturers and researchers in the field were also contacted. SELECTION CRITERIA: Randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included. Interventions encompassed propylthiouracil at any dose versus placebo or no intervention. The trials could be double-blind, single-blind, or unblinded. The trials could be unpublished or published as an article, an abstract, or a letter and no language limitations were applied. DATA COLLECTION AND ANALYSIS: All analyses were performed according to the intention-to-treat method. The statistical package (RevMan and MetaView) provided by the Cochrane Collaboration was used. The methodological quality of the randomised clinical trials was evaluated by components of quality and the Jadad-scale. MAIN RESULTS: Combining the results of six randomised clinical trials including 710 patients demonstrated no significant effects of propylthiouracil versus placebo on mortality (Peto odds ratio (OR) 0.91, 95% confidence interval (CI) 0.59 to 1.40), liver related mortality (OR 0.78, 95% CI 0.45 to 1.33), complications of the liver disease (OR 1.14, 95% CI 0.58 to 2.24), or liver histology. Propylthiouracil was associated with a non significant trend towards an increased risk of non-serious adverse events (OR 1.49, 95% CI 0.74 to 2.99) and with the seldom occurrence of serious adverse events (leukopenia). REVIEWER'S CONCLUSIONS: This systematic review could not demonstrate any significant efficacy of propylthiouracil on any clinically important outcomes (mortality, liver related mortality, liver complications, and liver histology) of patients with alcoholic liver disease and propylthiouracil was associated with adverse events. Accordingly, there is no evidence for using propylthiouracil for alcoholic liver disease outside randomised clinical trials.

Antimetabolites↗
PubMed2004

The value of systematic reviews as research activities in medical education.

Medical residents and postdoctoral fellows are often required to conduct and publish original research as part of their medical education. However, their relative lack of experience, time, money, and sometimes supervision in conducting original research often results in research of modest quality on topics of limited importance. Such research may also consume scarce resources from the sponsoring institution. Manuscripts describing such research are often unremarkable, although most are submitted for publication, where editors and peer reviewers will spend time evaluating them. Systematic reviews of the literature, however, offer similar training in the scientific method, are relatively inexpensive to conduct, teach critical appraisal of the literature, give trainees a thorough command of the topic studied, and provide even new investigators the opportunity to make important contributions to the literature. Systematic reviews of the literature should thus be acceptable alternatives to original research assignments for most trainees in medical education programs. The author reviews the characteristics of systematic reviews, outlines the steps in conducting them, identifies the lessons learned from completing each step, and compares the advantages and disadvantages of systematic reviews with those of conducting original research.

Biomedical Research↗
PubMed2000

Cognitive behaviour therapy for schizophrenia.

BACKGROUND: Although medication is the mainstay of treatment for schizophrenia, always, some sort of informal or formal talking therapy is indicated. In cognitive behavioural therapy (CBT) links are made between the person's feelings and patterns of thinking which underpin their distress. OBJECTIVES: To review the effects of cognitive behaviour therapy (CBT) for those with schizophrenia compared to standard care, specific medication and non-intervention; also to review the effects of CBT for those with schizophrenia who are concurrently receiving standard care compared to no additional intervention to standard care, specific medication, additional drug interventions to standard care and other additional psychosocial interventions to standard care. SEARCH STRATEGY: Electronic searches of Biological Abstracts (1980-1998), CINAHL (1982-1998), The Cochrane Library (Issue 2, 1998), The Cochrane Schizophrenia Group's Register of Trials (August 1998), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1887-1998), SIGLE (1990-1998), and Sociofile (1980-1998) were undertaken. All references of articles selected were searched for further relevant trials. SELECTION CRITERIA: Randomised trials of cognitive behaviour therapy for people with a diagnosis of schizophrenia, possible schizophrenia or mental illnesses where specific diagnoses have not been employed. Outcomes such as death, metal state, relapse, psychological well-being and acceptability of treatment were sought. DATA COLLECTION AND ANALYSIS: Studies were reliably selected and assessed for methodological quality. Data were extracted by two reviewers working independently. Dichotomous data were analysed on an intention-to-treat basis and continuous data with 70% completion rate are presented. MAIN RESULTS: Four small trials were identified. All presented data suggested that there was a difference favouring CBT plus standard care over standard care alone in terms of reducing relapse rates (short term OR 0.31 CI 0.1-0.98; medium term OR 0.38 CI 0.17-0.83; long term OR 0.46 CI 0.26-0.83, NNT 6 CI 3-30). These findings were supported within the trials by scale-derived data. CBT, however, did not keep more people in care than a standard approach and there is no data relating to the effect of CBT on compliance with medication. One study also presented data on the effects of CBT when compared to supportive psychotherapy. No effect statistically significantly favoured either group but all were suggestive that the trial may have been underpowered to find an effect in favour of CBT. REVIEWER'S CONCLUSIONS: The results of well conducted and reported ongoing trials are eagerly awaited. Currently, for those with schizophrenia willing to receive CBT, access to this treatment approach is associated with a substantially reduced risk of relapse. However, at present CBT is a fairly scarce commodity, often provided by highly skilled and experienced therapists. Therefore, its application in day to day practice may be restricted by the availability of suitable practitioners. Similarly, the present data provides little indication of how effective CBT procedures might be when they are applied by less experienced practitioners.

Cognitive Behavioral Therapy↗
PubMed2004

Nutritional supplementation for hip fracture aftercare in the elderly.

BACKGROUND: Fractures of the hip are an important cause of later ill health and mortality in elderly people. People with hip fractures are often malnourished at the time of fracture, and have poor food intake in hospital. OBJECTIVES: This review assesses the effects of nutritional interventions in elderly people recovering from hip fracture. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register, the Cochrane Central Register of Controlled Trials (The Cochrane Library issue 2, 2003), MEDLINE (1966 to July 2003), Nutrition Abstracts and Reviews (1984 to March 2003), EMBASE (1980 to week 29 2003), BIOSIS (1985 to July 2003), CINAHL (1982 to July 2003), HEALTHSTAR (1975 to March 2002), the National Research Register and reference lists. We contacted investigators, and handsearched the American Journal of Clinical Nutrition, Proceedings of the Nutrition Society, Clinical Nutrition and the Journal of Parenteral and Enteral Nutrition. SELECTION CRITERIA: Randomised and quasi-randomised trials of nutritional interventions of mainly older patients (aged over 65 years) with hip fracture. DATA COLLECTION AND ANALYSIS: Trial allocation to included, excluded and awaiting assessment categories, was by consensus. Both reviewers independently extracted data and assessed trial quality. Additional information was sought from all trialists. Pooling of data for primary outcomes and select exploratory analyses were undertaken. MAIN RESULTS: Seventeen randomised trials involving 1266 participants were included. Overall the quality of trials was poor; specifically in terms of allocation concealment, assessor blinding and intention to treat analysis. This, and the limited availability of outcome data, mean that the following results must be interpreted with caution. Oral multinutrient feeds (providing non-protein energy, protein, some vitamins and minerals), evaluated by seven trials, may reduce unfavourable outcome (death or complications) (14/66 versus 26/73; relative risk 0.52, 95% confidence interval 0.32 to 0.84), but did not demonstrate an effect on mortality (12/91 versus 14/97; relative risk 0.85, 95% confidence interval 0.42 to 1.70). Four trials, examining nasogastric multinutrient feeding, showed no evidence for an effect on mortality (relative risk 0.99, 95% confidence interval 0.50 to 1.97), but the studies were heterogeneous regarding case-mix. Insufficient information was provided to evaluate unfavourable outcome. The effect of protein in an oral feed, tested in three trials, showed no evidence for an effect on mortality (relative risk 1.38, 95% confidence interval 0.82 to 2.34). It may have reduced the number of long term complications and days spent in rehabilitation wards. Two trials, testing intravenous thiamin (vitamin B1) and other water soluble vitamins, or 1-alpha-hydroxycholecalciferol (an active form of vitamin D) respectively, produced no evidence of benefit for either vitamin supplement. REVIEWER'S CONCLUSIONS: The strongest evidence for the effectiveness of nutritional supplementation exists for oral protein and energy feeds, but the evidence is still very weak. Future trials are required which overcome the defects of the reviewed studies, particularly inadequate size, methodology and outcome assessment.

Aftercare↗
PubMed2005

Nutritional supplementation for hip fracture aftercare in older people.

BACKGROUND: Fractures of the hip are an important cause of later ill health and mortality in older people. People with hip fractures are often malnourished at the time of fracture, and have poor food intake in hospital. OBJECTIVES: This review assesses the effects of nutritional interventions in older people recovering from hip fracture. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group Specialised Register, the Cochrane Central Register of Controlled Trials (The Cochrane Library issue 3, 2004), MEDLINE (1966 to October week 1 2004), Nutrition Abstracts and Reviews, EMBASE, BIOSIS, CINAHL, HEALTHSTAR, the National Research Register and reference lists. We contacted investigators and handsearched four nutrition journals. SELECTION CRITERIA: Randomised and quasi-randomised trials of nutritional interventions for mainly older people (aged over 65 years) with hip fracture. DATA COLLECTION AND ANALYSIS: Both authors independently selected trials, extracted data and assessed trial quality. We sought additional information from all trialists, and pooled data for primary outcomes. MAIN RESULTS: Eighteen randomised trials involving 1306 participants were included. Overall trial quality was poor; specifically in terms of allocation concealment, assessor blinding and intention-to-treat analysis. This, and the limited availability of outcome data, mean that the following results must be interpreted with caution. Eight trials evaluated oral multinutrient feeds: these provided non-protein energy, protein, some vitamins and minerals. Oral feeds had no statistically significant effect on mortality (15/161 versus 17/176; relative risk (RR) 0.89, 95% confidence interval (CI) 0.47 to 1.68) but may reduce 'unfavourable outcome' (combined outcome of mortality and survivors with complications) (14/66 versus 26/73; RR 0.52, 95% CI 0.32 to 0.84). Four trials examining nasogastric multinutrient feeding showed no evidence of an effect on mortality (RR 0.99, 95% CI 0.50 to 1.97), but the studies were heterogeneous regarding case mix. There was insufficient information for other outcomes. The specific effect of protein given in an oral feed was tested in three trials. There was no evidence for an effect on mortality (RR 1.38, 95% CI 0.82 to 2.34). Protein supplementation may have reduced the number of long term complications and days spent in rehabilitation wards. Two trials, testing intravenous thiamin (vitamin B1) and other water soluble vitamins, or 1-alpha-hydroxycholecalciferol (an active form of vitamin D) respectively, produced no evidence of effect for either vitamin supplement. AUTHORS' CONCLUSIONS: While some evidence exists for the effectiveness of oral protein and energy feeds, overall the evidence for the effectiveness of nutritional supplementation remains weak. Future trials are required which overcome the defects of the reviewed studies, particularly inadequate size, methodology and outcome assessment.

Aftercare↗
PubMed2000

Mycobacterium vaccae immunotherapy for treating tuberculosis.

BACKGROUND: Mycobacterium vaccae has been advocated for immunotherapy in the treatment of tuberculosis and other infections caused by mycobacteria. OBJECTIVES: The objective of this review was to assess the effects of Mycobacterium vaccae for treating tuberculosis. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group trials register, the Cochrane Controlled Trials register, Medline, Embase and reference lists of articles. We also contacted organisations and individuals working in the field. SELECTION CRITERIA: Randomised and quasi-randomised trials of preparations of whole, killed Mycobacterium vaccae in patients with tuberculosis. DATA COLLECTION AND ANALYSIS: One reviewer assessed trial quality and extracted data. MAIN RESULTS: Four trials met the inclusion criteria. There was no effect on mortality (2 trials, RR 1.01, 95% CI 0.50 to 2.04); no consistent effect on sputum negativity or sputum culture; and a high level of adverse reactions. REVIEWER'S CONCLUSIONS: Immunotherapy with Mycobacterium vaccae does not appear to benefit patients with tuberculosis.

Humans↗
PubMed2004

Hyperbaric oxygen therapy for thermal burns.

BACKGROUND: Hyperbaric oxygen therapy (HBOT) consists of intermittently administering 100% oxygen at pressures greater than 1 atmosphere in a pressure vessel. This technology has been used to treat a variety of disease states and has been described as helping patients who have sustained burns. OBJECTIVES: The aim of this review was to assess the evidence for the benefit of hyperbaric oxygen treatment (HBOT) for the treatment of thermal burns. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2002), MEDLINE (Ovid 1966 to November Week 2, 2003), CINAHL (Ovid 1982 to December Week 2 2003), EMBASE (Ovid 1980 to September 2003), DORCTHIM (Database of Randomised Controlled Trials in Hyperbaric Medicine) from inception to 2003, and reference lists of articles. SELECTION CRITERIA: We included all randomised controlled trials that compared the effect of HBOT with no HBOT (no treatment or sham). DATA COLLECTION AND ANALYSIS: Two authors using standardised forms extracted the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data was extracted and entered into RevMan 4.2.3. MAIN RESULTS: Four randomised controlled trials were identified, of which two satisfied the inclusion criteria. The trials were of poor methodological quality. As a result, it was difficult to have confidence in the individual results and it would not have been appropriate to attempt to pool the data. One trial reported no difference in length of stay, mortality, or number of surgeries between the control and HBO-treated groups once these variables were adjusted for the patient's condition. The second trial reported mean healing times that were shorter in patients exposed to HBOT (mean: 19.7 days versus 43.8 days). REVIEWERS' CONCLUSIONS: This systematic review has not found sufficient evidence to support or refute the effectiveness of HBOT for the management of thermal burns. Evidence from the two randomised controlled trials is insufficient to provide clear guidelines for practice. Further research is needed to better define the role of HBOT in the treatment of thermal burns.

Burns↗
PubMed2005

[Treatment of thoracic malignancy--results of meta-analyses].

Meta-analyses dealing with the treatment of thoracic malignancy (non-small cell lung cancer, small cell lung cancer and mesothelioma) were reviewed including isolated ones, based on individual data from clinical trials, or conducted in the context of a systematic review of the literature Their results have changed clinical practice, notably by validating radiochemotherapy for patients with unresectable limited diseases, adjuvant chemotherapy for resectable non-small cell lung cancer and by identifying the most active drugs. However it is important to understand the limits of their methodology in order to avoid inappropriate interpretations.

Carcinoma, Non-Small-Cell Lung↗
PubMed2003

Nurse specialist care for bronchiectasis.

BACKGROUND: Nurses have expanded and developed their roles to meet the needs of patients. This review evaluates the safety, effectiveness and health outcomes of nurses practising in autonomous roles, using advanced practice skills, within the context of a dedicated bronchiectasis clinic. OBJECTIVES: To determine the effectiveness of nurse-led care in the management of bronchiectasis. SEARCH STRATEGY: The Cochrane Airways Group specialised register was searched on 12/06/02. SELECTION CRITERIA: Randomised controlled trials were eligible for inclusion in the review. DATA COLLECTION AND ANALYSIS: Two reviewers extracted and entered data from included studies. MAIN RESULTS: One study was included in the review. No statistically significant changes were observed in infective exacerbations, lung function, exercise capacity, quality of life and hospital admissions. More healthcare resources were utilised by nurse-treated participants during the first arm of the study. REVIEWER'S CONCLUSIONS: This review has found one trial that does not demonstrate significant differences in clinical outcomes between nurse led care and doctor led care within the setting of a specialist clinic is, but there may be increased cost implications. Further research is required to review whether nurse led care provides the same outcomes in the community or secondary care setting.

Adult↗
PubMed2000

Bromocriptine versus levodopa in early Parkinson's disease.

BACKGROUND: Drugs that mimic dopamine as bromocriptine were introduced as monotherapy or in a combination with LD in the hope that this approach would prevent or delay the onset of motor complications in patients with Parkinson's disease (PD). However, hitherto, the role of bromocriptine (BR) in this issue has remained controversial. The present study is a systematic review of all randomized controlled trials of bromocriptine monotherapy compared with levodopa (LD) monotherapy in PD. OBJECTIVES: To assess the efficacy and safety of bromocriptine (BR) monotherapy for delaying the onset of motor complications associated with levodopa (LD) therapy in patients with Parkinson's disease (PD). SEARCH STRATEGY: Sources including the Cochrane Library, the search strategy of the Movement Disorders Group (includes computerised searches of MEDLINE and EMBASE and hand searching of appropriate neurology journals), reference lists of the reviews found by the MEDLINE and EMBASE search-strategy, Sandoz -now Novartis- (manufacturer of BR), symposia reports, PD handbooks, contacts with colleagues who had co-ordinated trials on BR and reference lists of all included studies were used to identify randomized controlled trials (RCTs) of interest. SELECTION CRITERIA: Randomized trials were eligible for inclusion if they evaluated the efficacy of BR monotherapy for delaying the onset of motor complications compared to LD therapy in PD patients. Outcome measures that were evaluated included occurrence and severity of motor complications, changes in impairment and disability, and the occurrence of side effects. DATA COLLECTION AND ANALYSIS: To determine the feasibility of a quantitative systematic review two independent reviewers evaluated the methodological quality of identified trials. MAIN RESULTS: Over the period of 1974 to January 1999 we identified six studies randomizing more than 850 patients to a BR or a LD regimen. The majority of the studies lacked sample size calculations and randomization procedure remained unclear in three trials. Only two trials were performed according to a double-blind design. Important differences between studies concerning the duration of trials, the BR titration phase, the achieved mean dose of LD or BR, and the applied outcomes were found. Because of these differences, we could not pool the data from the different trials in an attempt to perform a meta-analysis. Therefore, the available data of the individual trials was re-analysed. Subsequently, the results were interpreted against the background of the sources of heterogeneity between the studies. The occurrence of dyskinesias in three short trials was too low to allow any conclusion. The results of the longer trials indicate a lower occurrence of dyskinesias in the BR tier. In five trials that evaluated dystonia, this motor complication occurred less frequent in the BR tier. However, for both dyskinesias and dystonia a statistically significant difference in favour of BR emerged only in the largest trial. There was a trend for wearing-off and on-off fluctuations to occur less frequently in the BR group. Although all trials evaluated patients at the impairment level, only the largest trial reported a significantly larger improvement for the LD tier during the first year of therapy. Concerning disability, which was evaluated by five trials no statistically significant differences were found. Overall, a statistically larger number of dropouts occurred in the BR group because of an inadequate therapeutic response or intolerable side effects. REVIEWER'S CONCLUSIONS: This systematic review identified important sources of heterogeneity between trials. Inadequate powering of the studies and clinically relevant differences in trial duration, applied outcomes, and trial design may explain the different results and why many findings failed to reach a statistically significant level. Nevertheless, based on qualitative review of available data we conclude that in the treatment of early Parkinson's disease, bromocriptine may be beneficial in delaying motor complications and dyskinesias with comparable effects on impairment and disability in those patients that tolerate the drug.

Antiparkinson Agents↗
PubMed2005

Heroin maintenance for chronic heroin dependents.

BACKGROUND: Many medications have been used for stabilizing heroin users: Methadone, Buprenorphine and LAAM. The present review focus on the prescription of heroin to heroin dependents. OBJECTIVES: To assess the efficacy and acceptability of heroin maintenance versus methadone or other substitution treatments for opioid dependence, in retaining patients in treatment; reducing the use of illicit substances and improving health and social functioning. SEARCH STRATEGY: The Cochrane Central Register of Trials (CENTRAL) issue 1, 2005; MEDLINE 1966-2005, EMBASE 1980-2005 and CINAHL till 2005 (on OVID) were searched. There was no language or publication year restrictions. Many researchers were contacted for information. SELECTION CRITERIA: Randomised controlled trials of heroin (alone or combined with methadone) maintenance treatment compared with any other pharmacological treatments for heroin dependents. DATA COLLECTION AND ANALYSIS: The trials were independently assessed for inclusion and methodological quality by the reviewers. Data were extracted independently and double checked. Studies were not pooled together because of heterogeneity. MAIN RESULTS: 2400 references were obtained and 20 studies were eligible, 4 met the inclusion criteria for a total of 577 patients. The studies could not be analysed cumulatively because of heterogeneity of interventions and outcomes. Retention in treatment: no groups difference was found in two studies; one study (N=96) found RR=2.82 (95% CI 1.70-4.68) favouring heroin; one study (N=235) found RR 0.79 (95%CI 0.68-0.90) favouring methadone. Relapse to illegal heroin use (self- reported): in one study people using heroin in treatment was 64% (heroin group)and 59% (methadone group); in the other study the RR of heroin use was 0.33 (95%CI 0.15-0.72) favouring heroin. Criminal offence: one study showed the potential of heroin prescription in reducing the risk of being charged RR 0.32 (95% CI 0.14-0.78). Social functioning: two studies did not show statistical difference between intervention groups, and two studies considered criminal offence and social functioning as part of a multidomain outcome measure showing improvements among those treated with heroin plus methadone over those on methadone only. AUTHORS' CONCLUSIONS: No definitive conclusions about the overall effectiveness of heroin prescription is possible. Results favouring heroin treatment come from studies conducted in countries where easily accessible Methadone Maintenance Treatment at effective dosages is available. In those studies heroin prescription was addressed to patients who had failed previous methadone treatments. The present review contains information about ongoing trials which results will be integrated as soon as available.

Heroin↗
PubMed2000

Systematic review of randomized trials of the effect of exercise on bone mass in pre- and postmenopausal women.

Studies of the effect of exercise programs on bone mass appear inconsistent. Our objective was to systematically review and meta-analyze randomized trials of the effect of exercise on bone mass in pre- and postmenopausal women. A computerized MEDLINE search was conducted for the years 1966-1997. Thirty-five randomized trials were identified. Meta-analytic methods were used to statistically pool results of studies of the effect of impact (e.g., aerobics) and non-impact (e.g., weight training) exercise on the lumbar spine and femoral neck. The most studied bone site was the lumbar spine in postmenopausal women (15 studies), where both impact [1.6% bone loss prevented, 95% confidence intervals (CI): 1.0%-2.2%] and non-impact (1.0%, 95% CI: 0.4%-1.6%) exercise programs had a positive effect. Results for the lumbar spine in premenopausal women (eight studies) were similar: 1.5% (95% CI: 0.6%-2.4%) less bone loss (or net gain) after impact exercise and 1.2% (95% CI: 0.7%-1.7%) after non-impact exercise. Impact exercise programs appeared to have a positive effect at the femoral neck in postmenopausal women (five studies), 1.0% (95% CI: 0.4%-1.6%) bone loss prevented, and possibly in premenopausal women, 0.9% (95% CI: -0.2%-2.0%) bone loss prevented. There were too few trials to draw conclusions from meta-analyses of the effect of non-impact exercise on the neck of femur. This systematic review of randomized trials shows that both impact and non-impact exercise have a positive effect at the lumbar spine in pre- and postmenopausal women. Impact exercise probably has a positive effect at the femoral neck. More studies are required to determine the optimal intensity and type of exercise.

Animals↗
PubMed2002

Rofecoxib for the treatment of rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) is a systemic auto-immune disorder, in which the synovial lining of many joints and tendon sheaths are persistently inflamed. OBJECTIVES: To assess the efficacy and toxicity of rofecoxib for treating RA. SEARCH STRATEGY: We searched the following databases up to December 2000: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, National Research Register, NHS Economic Evaluation Database, Health Technology Assessment database. The bibliographies of retrieved papers were scanned for additional references. The manufacturers of rofecoxib, MSD, were also approached by the UK National Institue for Clincal Excellence to submit additional evidence to inform it's appraisal on the use of cyclo-oxygenase inibitors for arthritis. SELECTION CRITERIA: Relevant studies were randomised controlled trials of parallel group design evaluating the efficacy and/or toxicity of rofecoxib in RA, both placebo based and comparative trials were eligible. Relevant outcome criteria had to be available to evaluate efficacy and/or toxicity, such as the OMERACT outcomes. DATA COLLECTION AND ANALYSIS: Data were abstracted independently by two reviewers and the results were compared for the degree of agreement. A validated tool (Jadad 1995) was used to score the quality of the randomised controlled trials. The planned analysis was to pool, where appropriate, continuous outcome measures using mean or standardized mean differences, and dichotomous outcome measures using relative risk ratios. MAIN RESULTS: Two randomised controlled trials evaluating the efficacy and toxicity of rofecoxib in RA were identified and met the criteria. One compared rofecoxib to placebo and the other compared rofecoxib to naproxen. The overall number of ACR 20 responders who had received 25mg (82/ 171 = 48%) or 50mg (86/161 = 53%) was statistically significantly more than those receiving placebo (58/168 = 35% ) (RR 1.39 CI: 1.07, 1.80 and RR 1.55 CI: 1.20, 1.99 respectively) with no statistically significant differences between the 25 and 50 mg doses. The safety profile of rofecoxib was similar to that of placebo. In the comparative trial, rofecoxib at a dosage of 50 mg/day demonstrated similar efficacy to naproxen at a dosage of 500 mg twice daily. However, the combined rate of clinically significant complicated gastro-intestinal events (GI) (perforations, ulcers, bleeds, or obstructions) was lower with rofecoxib than with naproxen (RR 0.46, 95% CI, 0.34 to 0.63) due to a reduction in the number of ulcers and bleeds. Patients taking rofecoxib had a greater risk of having a myocardial infarction (MI) than patients taking naproxen (RR 4.03, 95% CI, 2.86 to 5.68). REVIEWER'S CONCLUSIONS: In patients with RA, rofecoxib demonstrates a greater degree of efficacy than placebo, while having a comparable safety profile. Rofecoxib demonstrates a similar degree of efficacy as naproxen, but with a significantly lower rate of ulceration and gastrointestinal bleeding. Rofecoxib was associated with a greater risk for MI, but the exact significance and pathophysiology of this possible relationship is unclear.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2004

Giving women their own case notes to carry during pregnancy.

BACKGROUND: In many countries women are given their own case notes to carry during pregnancy so as to increase their sense of control and satisfaction with their care. OBJECTIVES: To evaluate the effects of giving women their own case notes to carry during pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (January 2004). SELECTION CRITERIA: Randomised controlled trials of women given their own case notes to carry during pregnancy. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied the inclusion criteria and assessed study quality. One reviewer extracted data from the included studies using a standard form (checked by second reviewer). We assessed estimates of effect using relative risk with 95% confidence intervals. MAIN RESULTS: Three trials were included (n = 675 women). Women carrying their own notes were more likely to feel in control (relative risk (RR) 1.56, 95% confidence interval (CI) 1.18 to 2.06). Women's satisfaction: one trial reported more women in the case notes group (66/95) were satisfied with their care than the control group (58/102) (RR 1.22, 95% CI 0.99 to 1.52); two trials reported no difference in women's satisfaction (one trial provided no data and one trial used a 17 point satisfaction scale). More women in the case notes group wanted to carry their own notes in a subsequent pregnancy (RR 1.79, 95% CI 1.43 to 2.24). Overall, the pooled estimate of the two trials (n = 347) that reported on the risk of notes lost or left at home was not significant (RR 0.38, 95% CI 0.04 to 3.84). There was no difference for health related behaviours (cigarette smoking and breastfeeding), analgesia needs during labour, miscarriage, stillbirth and neonatal deaths. More women in the case notes group had operative deliveries (RR 1.83, 95% CI 1.08 to 3.12). REVIEWERS' CONCLUSIONS: The three trials are small, and not all of them reported on all outcomes. The results suggest that there are both potential benefits (increased maternal control and satisfaction during pregnancy, increased availability of antenatal records during hospital attendance) and harms (more operative deliveries). Importantly, all of the trials report that more women in the case notes group would prefer to hold their antenatal records in another pregnancy. There is insufficient evidence on health related behaviours (smoking and breastfeeding) and clinical outcomes. It is important to emphasise that this review shows a lack of evidence of benefit rather than evidence of no benefit.

Female↗
PubMed2000

Lamotrigine add-on for drug-resistant partial epilepsy.

BACKGROUND: Epilepsy is a common neurological disorder, affecting almost 0.5 to 1% of the population. Nearly 30% of patients with epilepsy are refractory to currently available drugs. Lamotrigine is one of the newer antiepileptic drugs and is the topic of this review. OBJECTIVES: To examine the effects of lamotrigine on seizures, side effects, cognition and quality of life, when used as an add-on treatment for patients with drug-resistant partial epilepsy. SEARCH STRATEGY: We searched the Cochrane Epilepsy Group trials register, the Cochrane Controlled Trials Register (Cochrane Library Issue 1, 2000), MEDLINE (January 1966 to December 1999) and reference lists of articles. We also contacted the manufacturers of lamotrigine (Glaxo-Wellcome). SELECTION CRITERIA: Randomized placebo controlled trials, of patients with drug-resistant partial epilepsy of any age, in which an adequate method of concealment of randomization was used. The studies may be double, single or unblinded. For crossover studies, the first treatment period was treated as a parallel trial. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the trials for inclusion and extracted data. Primary analyses were by intention to treat. Outcomes included 50% or greater reduction in seizure frequency, treatment withdrawal (any reason), side effects, effects on cognition, and quality of life. MAIN RESULTS: We found three parallel add-on studies and eight cross-over studies, which included 1243 patients (199 children and 1044 adults). The overall Peto's Odds Ratio (OR) and 95% confidence intervals (CIs) across all studies for 50% or greater reduction in seizure frequency was 2.71 (1.87, 3.91) indicating that lamotrigine is significantly more effective than placebo in reducing seizure frequency. The overall OR (95%CI) for treatment withdrawal (for any reason) is 1.12 (0.78, 1. 61). The 99% CIs for ataxia, dizziness, nausea, and diplopia do not include unity, indicating that they are significantly associated with lamotrigine. The limited data available preclude any conclusions about effects on cognition and quality of life, though there may be minor benefits in affect balance (happiness) and mastery. REVIEWER'S CONCLUSIONS: Lamotrigine add-on therapy is effective in reducing the seizure frequency, in patients with drug-resistant partial epilepsy. Further trials are needed to assess the long term effects of lamotrigine, and to compare it with other add-on drugs.

Anticonvulsants↗
PubMed2003

Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA).

The Medical Dictionary for Regulatory Activities (MedDRA) is a unified standard terminology for recording and reporting adverse drug event data. Its introduction is widely seen as a significant improvement on the previous situation, where a multitude of terminologies of widely varying scope and quality were in use. However, there are some complexities that may cause difficulties, and these will form the focus for this paper. Two methods of searching MedDRA-coded databases are described: searching based on term selection from all of MedDRA and searching based on terms in the safety database. There are several potential traps for the unwary in safety searches. There may be multiple locations of relevant terms within a system organ class (SOC) and lack of recognition of appropriate group terms; the user may think that group terms are more inclusive than is the case. MedDRA may distribute terms relevant to one medical condition across several primary SOCs. If the database supports the MedDRA model, it is possible to perform multiaxial searching: while this may help find terms that might have been missed, it is still necessary to consider the entire contents of the SOCs to find all relevant terms and there are many instances of incomplete secondary linkages. It is important to adjust for multiaxiality if data are presented using primary and secondary locations. Other sources for errors in searching are non-intuitive placement and the selection of terms as preferred terms (PTs) that may not be widely recognised. Some MedDRA rules could also result in errors in data retrieval if the individual is unaware of these: in particular, the lack of multiaxial linkages for the Investigations SOC, Social circumstances SOC and Surgical and medical procedures SOC and the requirement that a PT may only be present under one High Level Term (HLT) and one High Level Group Term (HLGT) within any single SOC. Special Search Categories (collections of PTs assembled from various SOCs by searching all of MedDRA) are limited by the small number available and by lack of clarity about criteria applied in their construction. Difficulties in database searching may be addressed by suitable user training and experience, and by central reporting of detected deficiencies in MedDRA. Other remedies may include regulatory guidance on implementation and use of MedDRA. Further systematic review of MedDRA is needed and generation of standardised searches that may be used 'off the shelf' will help, particularly where the same search is performed repeatedly on multiple data sets. Until these enhancements are widely available, MedDRA users should take great care when searching a safety database to ensure that cases are not inadvertently missed.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

[Laser epilation. A systematic review of evidence-based clinical results].

Unwanted hair growth remains a therapeutic challenge and an effective treatment modality without side effects is needed. Today, hair removal is offered with lasers and light sources and patients may expect long-lasting or permanent hair removal. Evidence-based clinical results have been considerably examined for ruby and alexandrite lasers, whereas there is little documentation on Nd:YAG and diode lasers. The results with the diode laser are, however, promising. No controlled clinical studies have been published with intense pulsed light sources. We conclude that there is scientific evidence of a short-term effect after hair removal with ruby, alexandrite, Nd:YAG, and diode lasers (three, six months). Ruby and diode lasers may have a long-lasting effect (one year), but this, however, must be further clarified. No studies have examined whether laser hair removal may be permanent. The occurrence of postoperative side effects is reported to be low for all laser systems. From this review of the literature, we conclude that laser hair removal does not at the moment have a permanent or convincing long-lasting effectiveness.

Controlled Clinical Trials as Topic↗
PubMed2006

A quality assessment tool to evaluate tocolytic studies.

Over the past 15 years, the use of beta-agonists has declined worldwide. Following the Royal College of Obstetricians and Gynaecologists guidelines in 2002, clinicians in the UK and beyond were faced with the dilemma of continuing to use beta-agonists, desist from using tocolytic therapy completely or choosing to change to atosiban or calcium channel blockers (CCBs). While grade A level 1 evidence exists to show that atosiban is significantly more efficacious than placebo and significantly safer than beta-agonists for the treatment of spontaneous preterm labour, the evidence for CCBs, such as nifedipine, is much less robust and no placebo-controlled trials have been performed. Published studies on nifedipine are largely investigator-led studies of small sample size, which lack sufficient power. As a result, most of the evidence has been based on meta-analyses of these studies, which look retrospectively at pooled data and are only as good as the quality of the studies included. In light of this, a tool was developed to produce a systematic review of studies on tocolytic effectiveness, which can and should be applied to all tocolytics and which considered both method- and topic-specific markers of quality. In the process of applying this tool to nifedipine, an extensive literature search identified 31 studies for a systematic review of the quality of nifedipine studies assessed by eight paired reviewers with wide experience in the subject of spontaneous preterm labour and preterm birth. Forty topic- and method-specific items of quality were assessed. The paucity of good quality studies of nifedipine used for the treatment of spontaneous preterm labour should be highlighted in meta-analyses or systematic reviews, which measure efficacy and should limit and influence the degree to which recommendations and guidelines are made on the basis of such studies.

Adrenergic beta-Agonists↗