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PubMed2000

The effects of emotion-oriented approaches in the care for persons suffering from dementia: a review of the literature.

OBJECTIVE: This article presents an overview of the results of intervention studies in various emotion-oriented approaches in the care for people suffering from dementia. Recommendations are made with regard to clinical practice and future research. DATA SOURCES: We searched for references (1990-99) in several bibliographical databases, i.e. Medline, PsycLit, Embase, Sociofile and Current Contents. The terms 'dementia' and 'Alzheimer's disease' were linked separately to the search terms: emotion-oriented, validation (therapy), sensory integration/sensory stimulation/snoezelen, simulated presence therapy and reminiscence (therapy)/life-review. Based on references in the articles found, other publications were traced. STUDY SELECTION: We started from the 'emotion-oriented' approaches used in 24-hour care distinguished by the American Psychiatric Association (1997) i.e. validation, sensory stimulation/integration, simulated presence therapy and reminiscence. We selected research articles that describe intervention, design, measuring instruments and results. DATA EXTRACTION: The articles were analyzed with regard to research group, setting, design, effect variables, intervention, measuring instruments, statistical analyses and results. DATA SYNTHESIS: It is shown that mainly positive results (including increased social interaction and decrease of behavior problems) are achieved with these emotion-oriented approaches. Unfortunately many studies have methodological limitations and are done independently, which makes comparison difficult. CONCLUSIONS: Despite the limited cogency of the studies we traced, the results are promising. Emotion-oriented care approaches offer the opportunity to tailor the care to the individual needs of dementing elderly and can be complemented with other psychosocial approaches (e.g. psychomotor therapy and music therapy) when necessary. The challenge for the care sector is to develop guidelines to determine which approach should be applied to whom and when. Scientific research can contribute by examining which emotion-oriented approaches, possibly in combination with each other or with psychosocial therapies, effect an increase in the well-being and improve functioning in which patients.

Aged↗

PubMed2005

Budesonide for induction of remission in Crohn's disease.

BACKGROUND: Corticosteroids continue to play a central role in induction of remission in active Crohn's disease. However, their use comes at a price of significant adverse effects when used repeatedly or for extended periods. Newer corticosteroid agents with limited systemic bioavailability offer a tantalizing option, if they can be shown to be efficacious and safer than conventional corticosteroids. Budesonide is the main alternative corticosteroid currently available in an enteric formulation. OBJECTIVES: To evaluate the effectiveness of oral budesonide for the treatment of acute flares of Crohn's disease. A secondary but important endpoint was to evaluate the adverse effect profile. SEARCH STRATEGY: The following sources were used to search the literature for potentially relevant papers and trials. 1. A computer-assisted search of the on-line bibliographic database MEDLINE from 1986 onwards. 2. Hand searching the reference lists of trials and review articles identified by means of the computer- assisted search. 3. Proceedings from major gastrointestinal meetings were manually searched from 1990 onwards. 4. Contact with the relevant pharmaceutical companies that have been involved in the development of budesonide. SELECTION CRITERIA: Potentially relevant articles were reviewed in an independent unblinded fashion by two authors to determine if they met the criteria specified below: 1) STUDY POPULATION: Patients of any age with acutely active Crohn's disease, as defined by a CDAI > 150. 2) METHODOLOGY: Randomized double blind controlled trials comparing budesonide to a control treatment. Patients in the control arm may have received placebo, conventional corticosteroids, 5-aminosalicylic acid or sulfasalazine. 3) OUTCOME MEASURES: Clinical remission was the outcome measure of interest. The definition of remission was usually a CDAI < 150 by 8 to 16 weeks of therapy. DATA COLLECTION AND ANALYSIS: Eligible articles were reviewed in duplicate and the results of the primary research trials were abstracted onto specially designed data extraction forms. The proportion of patients achieving remission in the active treatment and control groups of each study were derived from the data provided in the original research papers. Where possible, data were broken down based on site of disease or other strata used by the individual trials. STATISTICAL ANALYSIS: Data extracted from the original research articles were converted, where necessary, into individual 2 x 2 tables (remission versus no remission x budesonide versus control) for each of the individual studies. Where available, individual 2 x 2 tables for strata within studies were also used. The presence of significant heterogeneity among studies was tested for using the chi-square test. Because this is a relatively insensitive test for the presence of heterogeneity, a p-value of 0.10 was regarded as statistically significant. Where p < 0.10 the data from the individual studies were still combined but the pooled results were interpreted with caution. The 2 x 2 tables were synthesized into a summary test statistic using the pooled odds ratio and 95% confidence intervals as described by Cochran and Mantel and Haenszel. A fixed effects model was used for the pooling of data. The analysis was performed initially by combining data from all trials to estimate the response rate to budesonide therapy. The analysis was also performed by combining only studies with comparable control groups. MAIN RESULTS: Eight studies were deemed eligible for review. EFFICACY: Budesonide was superior to placebo for induction of remission with a pooled odds ratio for the two placebo-controlled trials of 2.85 (95% CI 1.67 - 4.87). A single trial comparing budesonide with mesalamine demonstrated an odds ratio of 2.80 (95% CI 1.50 - 5.20) in favour of budesonide over mesalamine for induction of remission in active Crohn's disease. However, budesonide was inferior to conventional corticosteroids (prednisone or prednisolone) for induction of remission with a pooled odds ratio for the five trials of 0.69 (95% CI 0.51 - 0.95). SAFETY: The two trials comparing budesonide versus placebo (Greenberg 1994; Tremaine 2002) showed no difference between study groups for proportion of reported corticosteroid-related adverse effects with the pooled odds ratio for both trials of 0.98 (95% CI 0.58 - 1.67). Five trials comparing budesonide versus prednisone showed the budesonide study group had fewer reported corticosteroid-related adverse effects than the prednisone study group (pooled odds ratio was 0.38 (95% CI 0.28 - 0.53). AUTHORS' CONCLUSIONS: With disease in the ileum or ascending colon, budesonide offers an effective therapy which is somewhat less efficacious but with fewer adverse effects than conventional corticosteroids (e.g. prednisone, prednisolone, or 6-methylprednisolone).

Administration, Oral↗

PubMed2005

Cyclosporine for induction of remission in Crohn's disease.

BACKGROUND: Cyclosporine was first found to be an effective and well-tolerated immunosuppressive agent in organ transplant recipients, and subsequently in several autoimmune diseases. It was reported in open studies that cyclosporine is effective for induction of remission in Crohn's disease. Four randomized controlled trials have been performed to determine whether the results observed in these open studies were valid. This systematic review summarizes the evidence on the use of oral cyclosporine for the induction of remission in Crohn's disease. OBJECTIVES: To evaluate the effectiveness of oral cyclosporine for induction of remission in patients with active Crohn's disease in the presence and absence of concomitant steroid therapy. Secondary objectives were to evaluate clinical response rates and adverse events associated with cyclosporine. SEARCH STRATEGY: Computer-assisted searches of the on-line bibliographic databases MEDLINE and EMBASE were performed to identify potentially relevant publications between 1980 and July 2004. The MeSH terms "Crohn Disease" or "Inflammatory Bowel disease" and "Cyclosporin" (exploded) were used to perform key word searches of the databases. Manual searches of reference lists from potentially relevant papers were performed in order to identify additional studies that may have been missed. Abstracts from major gastroenterological meetings, The Cochrane Central Register of Controlled Trials and the Cochrane Inflammatory Bowel Disease Group Specialized Trials Register were also searched for relevant studies. Appropriate officials at Sandoz Corporation were contacted to seek information on any unpublished trials. SELECTION CRITERIA: Prospective, randomized, double-blinded, placebo-controlled trials of parallel design with treatment duration of a minimum 12 weeks comparing oral cyclosporine therapy with placebo for treatment of patients with active Crohn's disease were eligible for inclusion. DATA COLLECTION AND ANALYSIS: All data were analyzed on an intention-to-treat basis. Data were extracted from the original research articles and converted into 2x2 tables (cyclosporine vs. placebo). Where available, individual 2x2 tables for strata within studies were also used. Heterogeneity was assessed using the chi-square test (p < 0.10 was regarded as statistically significant). For non-pooled data, p-values were derived using the chi-square test. For pooled data, summary test statistics were derived using the Peto odds ratio and 95% confidence intervals. A fixed effects model was used for pooling of data. For continuous data, summary test statistics were derived using the weighted mean difference and 95% confidence intervals. The definitions of treatment success, remission and clinical improvement were set by the authors of each paper, and the data were combined for analysis only if these definitions were sufficiently similar. MAIN RESULTS: Brynskov 1989a found that patients receiving high dose cyclosporine (median 7.6 mg/kg/day) had statistically significant clinical improvement at 12 weeks compared to placebo patients. None of the other studies found any statistically significant benefit for clinical improvement or induction of remission for low dose cyclosporine treatment (5 mg/kg/day) used by itself or in combination with corticosteroids compared to placebo. Cyclosporine was associated with a significantly higher proportion of adverse events and withdrawals due to adverse events relative to placebo. AUTHORS' CONCLUSIONS: Brynskov 1989a enrolled a small number of patients and the modified clinical grading scale used in the study has not been validated in other studies. Furthermore, statistically significant clinical improvement does not imply induction of clinical remission. Indeed, Brynskov 1989a found no statistically significant differences in the mean Crohn's Disease Activity Index score at 12 weeks indicating that cyclosporine was no more effective than placebo for induction of remission in Crohn's disease. The results of this review demonstrate that low dose (5 mg/kg/day) oral cyclosporine is not effective for the induction of remission in Crohn's disease. Patients treated with low dose oral cyclosporine are more likely than placebo treated patients to experience adverse events including renal dysfunction. The use of low dose oral cyclosporine for the treatment of chronic active Crohn's disease does not appear to be justified. Oral dosing at higher levels or parenteral administration of cyclosporine have not been adequately evaluated in controlled clinical trials. Higher doses of cyclosporine are not likely to be useful for the long-term management of Crohn's disease because of the risk of nephrotoxicity and the availability of other proven interventions.

Crohn Disease↗

PubMed2004

Percutaneous transluminal angioplasty and stenting for carotid artery stenosis.

BACKGROUND: Carotid artery stenosis may be treated endovascularly by percutaneous transluminal balloon angioplasty with or without stent insertion or by primary stenting. Endovascular treatment may be a useful alternative to carotid endarterectomy (CEA), particularly for lesions not suitable for surgery. OBJECTIVES: The objective of this review was to assess the benefits and risks of endovascular treatments compared with carotid endarterectomy (in patients suitable for surgery) or medical therapy (in patients not suitable for surgery). SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register (last searched 1 September 2003). In addition we searched the following bibliographic databases: Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2002), MEDLINE (1966 to June 2003), EMBASE (1980 to June 2003) and Science Citation Index (1981 to June 2003). We also contacted researchers in the field and balloon catheter and stent manufacturers. SELECTION CRITERIA: We selected randomised trials of carotid endovascular treatment compared with carotid endarterectomy, or endovascular treatment plus best medical therapy compared with best medical therapy alone, in patients with symptomatic or asymptomatic carotid artery stenosis. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied the inclusion criteria, extracted data and assessed trial quality. MAIN RESULTS: Two completed trials comparing endovascular treatment with carotid endarterectomy involving 608 patients were found. In addition there were two trials which fulfilled the inclusion criteria and which were stopped early (242 patients), and a third trial which has completed randomisation and 30 day follow up of 307 patients. Four trials are ongoing. Meta analysis of the data from the included studies found no significant difference between the odds of death or any stroke at 30 days post procedure (Odds Ratio [OR] endovascular:surgery 1.26, 95% Confidence Interval [CI] 0.82 to 1.94). The odds of death or disabling stroke at 30 days were similar in the endovascular and surgical group (OR 1.22, CI 0.61 to 2.41). At one year following procedure, there was no significant difference between the two groups in preventing any stroke or death (OR 1.36,CI 0.87 to 2.13). Endovascular treatment significantly reduced the risk of cranial neuropathy (OR 0.12, CI 0.06 to 0.25). There was no significant difference between the two groups when the risk of death, any stroke or myocardial infarction was considered (OR 0.99, CI 0.66 to 1.48). There was substantial heterogeneity between the trials for four of the five outcomes. REVIEWERS' CONCLUSIONS: Data from randomised trials comparing endovascular treatment for carotid artery stenosis with carotid endarterectomy suggest that the two treatments have similar early risks of death or stroke and similar long term benefits. However, the substantial heterogeneity renders the overall estimates of effect somewhat unreliable. Furthermore, two trials were stopped early because of safety concerns, so perhaps leading to an over-estimate of the risks of endovascular treatment. On the other hand, endovascular treatment appears to avoid completely the risk of cranial neuropathy. There is also uncertainty about the potential for restenosis to develop and cause recurrent stroke after endovascular treatment. The current evidence does not support a widespread change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis. There is a strong case to continue recruitment in the current randomised trials comparing carotid stenting with endarterectomy.

Angioplasty, Balloon↗

PubMed2005

Percutaneous transluminal angioplasty and stenting for vertebral artery stenosis.

BACKGROUND: Surgery for vertebral artery stenosis is technically difficult, potentially hazardous and is not considered in most centres. There is growing evidence from case series that vertebral artery stenosis may be treated endovascularly by percutaneous transluminal angioplasty and stenting. This may be a feasible alternative to surgery to relieve symptoms caused by significant stenosis. OBJECTIVES: The objective of this review was to assess the safety and efficacy of vertebral artery percutaneous transluminal angioplasty, with or without stenting, combined with medical care, compared to medical care alone, in patients with vertebral artery stenosis. SEARCH STRATEGY: We searched the Cochrane Stroke Group's trials register (last searched 28 July 2004). In addition we searched the following bibliographic databases: Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2002), MEDLINE (1966 to July 2004), EMBASE (1980 to July 2004), and Science Citation Index (1981 to July 2004). We also contacted researchers in the field, and balloon catheter and stent manufacturers. SELECTION CRITERIA: We selected randomised trials of endovascular treatment of vertebral artery stenosis combined with best medical therapy, compared with best medical therapy alone, in patients with symptomatic or asymptomatic vertebral artery stenosis. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied the inclusion criteria, extracted data and assessed trial quality. MAIN RESULTS: One completed randomised trial was found. In one subgroup of this trial, 16 patients with symptomatic severe vertebral artery stenosis were randomised to endovascular treatment (n = 8) or medical treatment alone (n = 8). There were no strokes in any arterial territory or deaths from any cause in either group within 30 days of treatment (endovascular group) or 30 days of randomisation (medical group). In the endovascular group, two patients had a posterior circulation TIA at the time of the procedure. In the endovascular group, the mean vessel stenosis at follow up was 47% (range 0% to 80%). Patients were followed up for a mean of 4.5 years in the endovascular group and 4.9 years in the medical group. There were no further vertebrobasilar territory strokes in either group for the duration of follow up. Morbidity and mortality was related to carotid and coronary artery disease in this study. AUTHORS' CONCLUSIONS: There is currently insufficient evidence to assess the effects of percutaneous transluminal angioplasty with or without stenting or primary stenting for vertebral artery stenosis.

Angioplasty, Balloon↗

PubMed2001

Enteral nutritional therapy for inducing remission of Crohn's disease.

BACKGROUND: The role of enteral nutrition in Crohn's disease is controversial. Increasing research on the mechanisms by which nutritional therapy improves the clinical well being of patients with Crohn's disease has led to novel formula design and trials comparing two different forms of enteral nutrition. This systematic review aims to provide an update on the existing efficacy data for both corticosteroids versus enteral nutrition and for one form of enteral nutrition versus another for inducing remission of active Crohn's disease. OBJECTIVES: To evaluate the efficacy of exclusive enteral nutrition as primary therapy to induce remission in Crohn's disease and to examine the importance of formula composition on efficacy. SEARCH STRATEGY: Studies were selected using a computer-assisted search of the on-line bibliographic databases MEDLINE (1966-2000) and EMBASE (1984-2000), as well as the Science Citation Index on Web of Science. Additional citations were sought by manual search of references of articles retrieved from the computerized search, abstracts submitted to major gastroenterologic meetings and published in the journals: Gut, Gastroenterology, Journal of Pediatric Gastroenterology and Nutrition, and Journal of Parenteral and Enteral Nutrition, and from the reviewers' personal files or contact with leaders in the field. SELECTION CRITERIA: All randomized and quasi-randomized controlled trials involving patients with active Crohn's disease defined by a clinical disease activity index were considered for review. Studies evaluating the administration of one type of enteral nutrition to one group of patients and another type of enteral nutrition or conventional corticosteroids to the other group were selected for review. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers and any discrepancies were resolved by rereading and discussion. For the dichotomous variable, achievement of remission, individual and pooled trial statistics were calculated as odds ratios (OR) with 95% confidence intervals (CI); both fixed and random effect models were used. The results for each analysis were tested for heterogeneity using the chi square statistic. The studies were separated into two groups: A. one form of enteral nutrition compared with another form of enteral nutrition and B. one form of enteral nutrition compared with corticosteroids. Subgroup analyses were conducted on the basis of clinical or disease criteria and formula composition. Sensitivity analyses were conducted on the basis of the inclusion of abstracts of studies not yet fully published, methodologic quality and by random or fixed effects models. MAIN RESULTS: In part A, of the 11 trials (one abstract) comparing different formulations of enteral nutrition ten compared one [or more (Middleton (a)1995)] elemental formulas to a non-elemental diet. The eleventh study (Akobeng 2000) compared two non-elemental diets differing only by glutamine enrichment in one group. This study was therefore not included in the primary analysis but was part of the subgroup analyses. Meta-analysis of nine studies which included 170 patients treated with an elemental diet and 128 patients treated with a non-elemental diet for active Crohn's disease demonstrated no significant difference among diet formulations [OR 1.15 (95% CI: 0.64, 2.08)]. Significant heterogeneity was not present [chi-square 9.77 (df=8)]. Subgroup and sensitivity analyses had no significant effect on the results. In part B, six trials (two abstracts) comparing enteral nutrition to steroid therapy met the inclusion criteria for review. Meta-analysis of four trials that included 130 patients treated with enteral nutrition and 123 treated with steroids yielded a pooled OR of 0.30 favouring steroid therapy (95% CI: 0.17, 0.52). Heterogeneity was not demonstrated [chi-square 0.43 (df=3)]. The risk difference calculated from this meta-analysis was 0.26, and the NNT (number of patients needed to treat with steroids rather than enteral nutrition to achieve one remission) was four. The same result was found in a sensitivity analysis that included abstracts. The inclusion of abstracts resulted in an increase in the number of participants to 150 in the enteral nutrition group and 142 in the steroid group but the meta-analysis yielded a similar result [OR 0.34 (95% CI: 0.20, 0.56)]. There were inadequate data from full publications to perform further subgroup analyses by age, disease duration and disease location. REVIEWER'S CONCLUSIONS: Corticosteroid therapy is more effective than enteral nutrition for inducing remission of active Crohn's disease as was found in past meta-analyses. There is no significant difference in the efficacy of elemental and non-elemental diets for induction of remission of Crohn's disease.

Adrenal Cortex Hormones↗

PubMed2000

Piracetam for dementia or cognitive impairment.

OBJECTIVES: To determine the clinical efficacy of piracetam for the features of dementia or cognitive impairment, classified according to the major subtypes of dementia: vascular, Alzheimer's disease or mixed vascular and Alzheimer's disease or unclassified dementia or cognitive impairment not fulfilling the criteria for dementia. SEARCH STRATEGY: The Cochrane Dementia and Cognitive Impairment Group Register of Clinical Trials was searched using the terms "piracetam", "nootropic" and "2-oxo-l-pyrrolidine acetamide". Electronic bibliographic databases including Medline, Embase, PychLit, Current Contents, Sociofile were searched back to 1966 with the terms piracetam, nootropics, 2-oxo-1-pyrrolidine and trials. In addition the pharmaceutical company responsible for marketing most of the piracetam worldwide, UCB Pharma, provided a comprehensive list of abstracts, which included many unpublished studies. As many of these unpublished, placebo control studies will be reviewed as possible. SELECTION CRITERIA: All unconfounded trials specified as randomised in which treatment with piracetam was administered for more than a day and compared with placebo in patients with dementia of the Alzheimer's type, vascular dementia or mixed vascular and Alzheimer's disease or uncalssified dementia or cognitive impairment not fulfilling the criteria for dementia. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers. Each study was independently verified as fulfilling the inclusion criteria. Studies were rated for methodological quality by assessment of blinding and loss before analysis as described by Jadad et al. (1996). Studies were pooled if appropriate and possible, and the pooled odds ratios (95%CI) or the average differences (95%CI) were estimated. Where possible, intention-to-treat data were used. Sensitivity analyses were performed to determine if successive elimination of those studies performing most poorly on these quality criteria changed the effect estimate. MAIN RESULTS: Unfortunately, many of these studies were crossover in design and data were unavailable from the first period. In many other studies data were not able to be extracted from the first period. From the data that were pooled there was only one outcome where significant amounts of evidence were available, Global Impression of Change. There was evidence of heterogeneity in the results from the individual studies, Chi squared test = 20.8 (df=5). Using a fixed effects model the odds ratio for improvement in the Piracetem group compared with the Placebo group was 3.55, [95% CI][2.45, 5.16]. If a random effects model was used the odds ratio was 3.47 [1.29, 9.30]. If one single-blind study was excluded, the fixed effects model yielded an odds ratio of 3.36 [2.29, 4.99] and if a random effects model was applied then the odds ratio was 2.89 [1.01, 8.24]. The evidence of effects on cognition and other measures, was inconclusive. REVIEWER'S CONCLUSIONS: At this stage the evidence available from the published literature does not support the use of Piracetem in the treatment of people with dementia or cognitive impairment because effects were found only on global impression of change but not on any of the more specific measures. There is a need for further evaluation of piracetam by : 1) Obtaining the data from these studies for an individual patient database review, 2) Performing a randomised trial of Piracetam in patients with diagnoses made by currently accepted diagnostic criteria. Piracetam should be trialled for a period of at least 6 months and preferably longer. Specific cognitive instruments which are sensitive to change, Clinician Global Impression of Change, levels of dependency and caregiver quality of life scales should also be incorporated in such a study.

Alzheimer Disease↗

PubMed2000

Cognitive behaviour therapy for adults with chronic fatigue syndrome.

OBJECTIVES: 1. To systematically review all randomised controlled trials of cognitive-behaviour therapy (CBT) for adults with chronic fatigue syndrome (CFS); 2. To test the hypothesis that CBT is more effective than orthodox medical management or other interventions in adults with CFS. SEARCH STRATEGY: 1. Electronic searching of bibliographic databases, including Medline, PsycLIT, Biological Abstracts, Embase, SIGLE, Index to Theses, Index to Scientific and Technical Proceedings, and Science Citation Index, using multiple search terms in order to perform a highly sensitive search. 2. Electronic searching of the Trials Register of the Depression, Anxiety and Neurosis group. 3. Citation lists of relevant studies and reviews were perused for other relevant trials. 4. Contact with the principal authors of relevant studies, and with researchers in the field. SELECTION CRITERIA: All randomised controlled trials were included in which - adult patients with CFS; - received CBT or a control intervention, being either orthodox medical management or another intervention; - and whose outcomes were assessed in an appropriate way. CBT could be either type 'A' (encouraging return to 'normal' levels of rest and activity) or type 'B' (encouraging rest and activity which were within levels imposed by the disorder). DATA COLLECTION AND ANALYSIS: The two reviewers worked independently throughout the selection of trials and data extraction, comparing findings only when there was disagreement. Relevant trials were allocated to one of three quality categories. Full data extraction, using a standardised data extraction sheet, was performed on studies which were of high or moderate quality. Trials of low quality were excluded from the review. The comparisons made to test the review hypothesis were of type 'A' CBT versus other intervention(s), and of type 'B' CBT versus other intervention(s). Functional outcome was used as the main outcome for comparison, but other appropriate outcomes were compared where possible. Results were synthesised using the Review Manager software. For dichotomous data, the odds ratio was calculated for each study. For continuous data, effect sizes were obtained and the standardised mean difference, with 95% confidence intervals, was calculated. MAIN RESULTS: Only three relevant trials of adequate quality were found. These trials demonstrated that CBT significantly benefits physical functioning in adult out-patients with CFS when compared to orthodox medical management or relaxation. It is necessary to treat about two patients to prevent one additional unsatisfactory physical outcome about six months after treatment end. CBT appeared highly acceptable to the patients in these trials. There is no satisfactory evidence for the effectiveness of CBT in patients with the milder forms of CFS found in primary care or in patients who are so disabled that they are unable to attend out-patients. Additionally, there is no satisfactory evidence for the effectiveness of group CBT. REVIEWER'S CONCLUSIONS: Cognitive behaviour therapy appears to be an effective and acceptable treatment for adult out-patients with chronic fatigue syndrome. CFS is a common and disabling disorder. Its sufferers deserve the medical profession to be more aware of the potential of this therapy to bring lasting functional benefit, and health service managers to increase its availability. Further research is needed in this important area. Trials should conform to accepted standards of reporting and methodology. The effectiveness of CBT in more and less severely disabled patients than those usually seen in out-patient clinics needs to be assessed. Trials of group CBT and in-patient CBT compared to orthodox medical management, and of CBT compared to graded activity alone, also need to be conducted.

Adult↗

PubMed2000

Chemotherapy for advanced ovarian cancer. Advanced Ovarian Cancer Trialists Group.

BACKGROUND: Ovarian carcinoma is the seventh most common cancer of women in the world and is responsible for the greatest number of deaths from gynaecological malignancy in Europe and North America. Although many studies have explored the use of chemotherapy in this disease, most individual trials have been too small to show clear benefit of one type of chemotherapy over another. OBJECTIVES: The type and intensity of chemotherapy used routinely for women with advanced ovarian cancer has varied because of uncertainty about the effectiveness of the different regimens. The objective of this review was to compare single drugs versus combinations of drugs, platinum versus non-platinum, and carboplatin versus cisplatin-based chemotherapy in women with advanced ovarian cancer. SEARCH STRATEGY: Search strategy: We searched MEDLINE, and CancerLit bibliographic databases and the National Cancer Institute and the UK Co-ordinating Committee on Cancer Research registers of trials. We also handsearched the proceedings of meetings and contacted experts in the field and drug companies. SELECTION CRITERIA: Randomised trials of: (1) single non-platinum versus non-platinum combination chemotherapy (2) single non-platinum versus platinum combination chemotherapy (3) non-platinum regimen versus the same regimen plus cisplatin (4) single platinum versus platinum combination chemotherapy (5) cisplatin versus carboplatin-based chemotherapy in women with advanced ovarian cancer. DATA COLLECTION AND ANALYSIS: Individual patient data were obtained from the trial investigators, checked by the reviewers and finally verified by the trial investigator. MAIN RESULTS: Main results: 49 trials involving 8763 women were included. The data were combined to calculate hazard ratios (HR) for survival on an intention-to-treat basis. For single non-platinum versus platinum combination chemotherapy the overall HR for survival was 0.93, 95% confidence interval (CI) 0.83-1.05 in favour of platinum-based combination chemotherapy. For non-platinum regimens compared with the same regimen plus cisplatin the survival HR was 0.88, 95% CI 0.79- 0.98 in favour of the addition of platinum to drug regimens. Single platinum compared with platinum combination therapy gave a HR of 0.91, 95% CI 0.79-1.05 in favour of combination chemotherapy. Cisplatin versus carboplatin gave a HR of 1.02, 95% CI 0.93-1.12. Sub-group analyses for age, stage, grade, histology, resection, bulk of residual tumour and performance status were undertaken for cisplatin versus carboplatin only. No difference in effect was found. REVIEWER'S CONCLUSIONS: The available evidence, although not conclusive, suggests that platinum-based chemotherapy is better than non-platinum therapy. There is some evidence that combination therapy improves survival compared with platinum alone. No difference in effect has been shown between cisplatin and carboplatin.

Antineoplastic Agents↗

PubMed2002

Surgery for varicose veins: use of tourniquet.

BACKGROUND: Varicose vein surgery is a common surgical procedure but there is no consensus regarding the best surgical technique. The use of tourniquets during varicose vein surgery has been advocated as a means of reducing the potential for blood loss during the operation. OBJECTIVES: To identify whether the use of a tourniquet should be recommended when undertaking surgery for the management of primary varicose veins. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group trials register (last searched November 2001), thirteen electronic bibliographic databases, including the Cochrane Controlled Trials Register (CCTR) (last searched Issue 3, 2001), covering biomedical science, social science, health economic and grey literature (including current research). In addition, the reference lists of relevant articles were checked and various health services research related resources were consulted via the Internet. These included health economics and HTA organisations, guideline producing agencies, generic research and trials registers, and specialist sites. SELECTION CRITERIA: All studies described as randomised controlled trials that examined the use of tourniquets during surgery for patients with primary varicose veins were included. DATA COLLECTION AND ANALYSIS: Data from eligible studies were extracted and summarised independently by two reviewers. All studies were cross-checked independently by the reviewers. MAIN RESULTS: A total of twenty published papers and nineteen studies were identified. Only three of these were randomised controlled trials and were included in the review. Sixteen studies were excluded as they were non-randomised and one was a duplicate study. All three trials had a small sample size and reported the trial design, outcome measures and analysis poorly. There were also variations in the outcome measures used between the trials. In addition, there was no consistency on the reporting of mean and medians for blood loss during the operation. It was therefore not possible to pool the data to perform meta-analysis. However, the reported blood loss when using a tourniquet was between 0 and 16mls compared to between 107 to 133mls when not using a tourniquet (p<0.01). REVIEWER'S CONCLUSIONS: Although there were significant quality issues with the available evidence, the use of a tourniquet would appear to reduce blood loss during surgery. There were no reported differences between the use or non-use of a tourniquet in terms of complications and morbidity. However, the available trials were not of sufficient size to detect rarer complications such as nerve damage.

Blood Loss, Surgical↗

PubMed2000

Peripheral retinal ablation for threshold retinopathy of prematurity in preterm infants.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: In premature infants with threshold retinopathy of prematurity (ROP) does peripheral retinal ablation, by any means, reduce the incidence of adverse ophthalmic outcome? SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group was used. This included a search of the Cochrane Neonatal Group Register of Clinical Trials, MEDLINE, EMBASE, previous reviews including cross references, abstracts from pediatric and ophthalmologic meetings, letters and expert informants. Search terms included "Retinopathy of Prematurity" [MeSH Terms], "Retrolental Fibroplasia" [All Fields] and "Lightcoagulation" [All Fields] or "Cryosurgery" [All Fields]. In addition, a personal bibliographic database was used as a cross-reference. SELECTION CRITERIA: All trials in human premature infants with threshold ROP utilizing random or quasi random allocation to either peripheral retinal ablation of the avascular retina, by any means, or concurrent control group with independent outcome assessment were initially selected for review. Following methodologic review, only studies using random allocation were selected for data extraction. DATA COLLECTION AND ANALYSIS: Relevance and validity were assessed by the two authors and consensus reached. Each author extracted clinical outcomes from valid reports independently. Data analysis was conducted according to the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Two randomised trials were identified. Data from these studies show that peripheral retinal ablation reduces the risk of (1) early unfavorable retinal structure from 47. 9% to 28.1% (absolute risk reduction 19.8% [95% CI 27.9 - 11.8%]), (2) unfavorable retinal structure in early childhood from 44.3% to 26.3% (absolute risk reduction 18% [95% CI 27.0 - 9.1%]) and (3) unfavorable visual acuity in early childhood from 63% to 50.6% (absolute risk reduction 12.2% [95% CI 21.2 - 3.1]). In addition, visual fields in sighted eyes were slightly smaller in the treated (51.3 degrees +/- 11.8 degrees ) group as compared to the control (58.2 degrees +/- 14.5 degrees ) group. REVIEWER'S CONCLUSIONS: Peripheral retinal ablation reduces the incidence of adverse ophthalmic outcome in premature infants with threshold ROP. In sighted eyes, peripheral retinal ablation may reduce the size of the visual field. At this stage, long term outcomes remain unknown.

Cryosurgery↗

PubMed2000

SSRIs versus other antidepressants for depressive disorder.

OBJECTIVES: To examine the relative efficacy of selective serotonin reuptake inhibitors (SSRIs) compared to other antidepressants. SEARCH STRATEGY: The search strategy included a search of (a) Electronic bibliographic databases (MEDLINE, EMBASE); (b) reference lists of related reviews (c) reference lists of all located studies (d) contact with the manufacturer and (e) the Cochrane Group register of controlled trials SELECTION CRITERIA: Randomised controlled trials comparing selective serotonin reuptake inhibitors with other kinds of antidepressants in the treatment of patients with depressive disorders. The outcome measures assessed included measures of the severity of depression. DATA COLLECTION AND ANALYSIS: Data were collected from each study the main outcome measurefrom each study. These included: mean Hamilton depression rating scale, mean Montgomery & Asberg depression rating scale, Clinical Global Impression rating scale. An analysis of standardised mean difference of these scales was performed using Review Manager 3. 1 software. The presence of heterogeneity of treatment effect was assessed MAIN RESULTS: Ninety-eight trials contributed data to the analysis of the relative efficacy of SSRIs and related drugs with comparator antidepressants (Figure 3 & Appendix 3). Analysis of efficacy was based upon 5044 patients treated with an SSRI or related drug, and 4510 treated with an alternative antidepressant. The standardised effect size for SSRIs and related drugs together versus alternative antidepressants using a fixed effects model was 0. 035 (95% CI -0.006 to 0.076; Q = 149.25, df = 97, p < 0.001). REVIEWER'S CONCLUSIONS: There are no clinically significant differences in effectiveness between selective serotonin reuptake inhibitors and tricyclic antidepressants. Treatment decisions need to be based on considerations of relative patient acceptability, toxicity and cost.

Antidepressive Agents↗

PubMed2002

Physical methods for preventing deep vein thrombosis in stroke.

BACKGROUND: Deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) are uncommon but important complications of stroke. There is good evidence that anticoagulants can reduce the risk of DVT and PE after stroke, but this benefit is offset by a small but definite risk of serious haemorrhages. Physical methods to prevent DVT and PE (such as compression stockings applied to the legs) are not associated with any bleeding risk and are effective in some categories of medical and surgical patients. We sought to assess their effects in stroke patients. OBJECTIVES: To assess the effectiveness and safety of physical methods of preventing the onset of deep vein thrombosis and fatal or non fatal pulmonary embolism in patients with recent stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched October 2001). In addition we searched the following electronic bibliographic databases: Cochrane Controlled Trials Register (1999, Issue 3), MEDLINE (1966- Jan 2001), EMBASE (1980- Jan 2001) and CINAHL (1982-May 1999). The reference lists of all relevant papers were screened for additional trials. SELECTION CRITERIA: All completed randomised unconfounded trials or controlled clinical trials comparing physical methods in patients allocated to receive physical methods, applied within one week of onset of stroke, with patients allocated to no physical methods. DATA COLLECTION AND ANALYSIS: Two reviewers independently searched for relevant trials and three others independently checked the results. MAIN RESULTS: We identified two small trials which included 123 patients. In one trial of 97 patients, compression stockings were associated with a non significant trend towards a reduction in DVT detected by Doppler ultrasound. In one trial of 26 patients, an intermittent pneumatic compression device was not associated with a significant reduction in DVT detected by 125-I-fibrinogen scanning. Overall, physical methods were not associated with a significant reduction in DVT (Odds ratio 0.59, 95%.CI 0.24-1.48) or death (Odds ratio 5.06, 95% CI 0.96-26.78). REVIEWER'S CONCLUSIONS: There is insufficient evidence from randomised trials to support the routine use of physical methods for preventing DVT in acute stroke.

Bandages↗

PubMed2004

Physical methods for preventing deep vein thrombosis in stroke.

BACKGROUND: Deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) are uncommon but important complications of stroke. There is good evidence that anticoagulants can reduce the risk of DVT and PE after stroke, but this benefit is offset by a small but definite risk of serious haemorrhages. Physical methods to prevent DVT and PE (such as compression stockings applied to the legs) are not associated with any bleeding risk and are effective in some categories of medical and surgical patients. We sought to assess their effects in stroke patients. OBJECTIVES: To assess the effectiveness and safety of physical methods of preventing the onset of deep vein thrombosis and fatal or non fatal pulmonary embolism in patients with recent stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register (last searched June 2003). In addition we searched the following electronic bibliographic databases: Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2003), MEDLINE (1966 to June 2003), EMBASE (1980 to June 2003) and CINAHL (1982 to June 2003). The reference lists of all relevant papers were screened for additional trials. SELECTION CRITERIA: Unconfounded randomised controlled trials comparing physical methods for the prevention of DVT with control, in which prophylaxis was started within seven days of the onset of stroke. DATA COLLECTION AND ANALYSIS: Two reviewers independently searched for relevant trials and three others independently checked the results. MAIN RESULTS: We identified two small trials which included 123 patients. In one trial of 97 patients, compression stockings were associated with a non significant trend towards a reduction in DVT detected by Doppler ultrasound. In one trial of 26 patients, an intermittent pneumatic compression device was not associated with a significant reduction in DVT detected by 125-I-fibrinogen scanning. Overall, physical methods were not associated with a significant reduction in DVT during the treatment period in survivors (Odds ratio (OR) 0.54, 95% Confidence Interval (CI) 0.18 to 1.57) or death (OR 1.54, 95% CI 0.5 to 4.77). REVIEWERS' CONCLUSIONS: There is insufficient evidence from randomised trials to support the routine use of physical methods for preventing DVT in acute stroke.

Bandages↗

PubMed2000

Multidisciplinary biopsychosocial rehabilitation for subacute low back pain among working age adults.

BACKGROUND: Multidisciplinary biopsychosocial rehabilitation programs are widely applied for chronic low back pain patients. The biopsychosocial approach for low back pain could also be considered to prevent chronicity by carrying out the rehabilitation if the acute pain is prolonged. Nevertheless multidisciplinary treatment programmes are often laborious and long processes and require good collaboration between the patient, the rehabilitation team and the work place. By workplace visits and close relationship with occupational health care one might expect results in terms of patients working ability. OBJECTIVES: The objective of this systematic review was to determine the effectiveness of multidisciplinary rehabilitation for subacute low back pain among working age adults. SEARCH STRATEGY: The reviewed studies for this structured Cochrane review were identified from electronic bibliographic databases, the Science Citation Index, reference checking and consulting experts in the rehabilitation field. The original search was planned and performed for more broad area of musculoskeletal disorders. Trials on subacute low back pain were separated afterwards. SELECTION CRITERIA: From all references found in our original search we selected randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). Trials had to assess the effectiveness of multidisciplinary rehabilitation for working age patients suffering from subacute low back pain (more than 4 weeks but less than 3 months). The rehabilitation program was required to be multidisciplinary, i.e.; it had to consist of a physician's consultation plus either a psychological, social or vocational intervention, or a combination of these. DATA COLLECTION AND ANALYSIS: Four blinded reviewers selected the randomized controlled trials and controlled trials that met the specified inclusion criteria. Two experts in the field of rehabilitation evaluated the clinical relevance and applicability of the findings of the selected studies to actual clinical use. Two other blinded reviewers extracted the data and assessed the main results and the methodological quality of the studies using standardized forms. Finally, a qualitative analysis was performed to evaluate the level of scientific evidence for the effectiveness of multidisciplinary rehabilitation. MAIN RESULTS: After screening 1808 abstracts, and the references of 65 reviews, we found only 2 relevant studies that satisfied our criteria on subacute low back pain. They were both considered to be methodologically low quality randomized controlled trials. The clinical relevance of included studies was sufficient. The level of scientific evidence for the effectiveness of multidisciplinary rehabilitation was moderate on subacute low back pain showing that multidisciplinary rehabilitation which includes workplace visit or more comprehensive occupational health care intervention helps patients to return to work faster, makes sick leaves less and alleviates subjective disability. REVIEWER'S CONCLUSIONS: We conclude that there is moderate evidence of positive effectiveness of multidisciplinary rehabilitation for subacute low back pain and workplace visit increases the effectiveness. But because this evidence is based on the trials that had some methodological shortcomings and several expensive multidisciplinary rehabilitation programmes are commonly used for common subacute low back problems, there is an obvious need for high quality trials in this field.

Acute Disease↗

PubMed2000

Multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain among working age adults.

BACKGROUND: Multidisciplinary biopsychosocial rehabilitation programs for neck and shoulder pain require substantial staff and financial resources. Despite questionable scientific evidence of their effectiveness, they are widely used. Neck and shoulder complaints are common among working age adults and they are often associated with physical work load and stress. Pain in the neck and shoulder area cause biopsychosocial difficulties for the patient especially if disability due to pain is prolonged. To help patients with biopsychosocial problems or to prevent their development, multidisciplinary biopsychosocial programs are applied on rehabilitation for neck and shoulder pain patients. Nevertheless multidisciplinary treatment programmes are often laborious and rather long processes and require good collaboration between the patient, the rehabilitation team and the work place. OBJECTIVES: The objective of this systematic review was to determine the effectiveness of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain among working age adults. SEARCH STRATEGY: The reviewed studies for this structured Cochrane review were identified from electronic bibliographic databases, the Science Citation Index, reference checking and consulting experts in the rehabilitation field. The original search was planned and performed for more broad area of musculoskeletal disorders. Trials on neck and shoulder pain were separated afterwards. SELECTION CRITERIA: From all references found in our original search we selected randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). Trials had to assess the effectiveness of biopsychosocial rehabilitation for patients suffering from neck and shoulder pain among working age adults. The rehabilitation program was required to be multidisciplinary, i.e.; it had to consist of a physician's consultation plus either a psychological, social or vocational intervention, or a combination of these. DATA COLLECTION AND ANALYSIS: Four blinded reviewers selected the randomized controlled trials and controlled trials that met the specified inclusion criteria. Two experts in the field of rehabilitation evaluated the clinical relevance and applicability of the findings of the selected studies to actual clinical use. Two other blinded reviewers extracted the data and assessed the main results and the methodological quality of the studies using standardized forms. Finally, a qualitative analysis was performed to evaluate the level of scientific evidence for the effectiveness of multidisciplinary biopsychosocial rehabilitation. MAIN RESULTS: After screening 1808 abstracts, and the references of 65 reviews, we found only 2 relevant studies that satisfied our criteria. One of these was considered methodologically low quality randomized controlled trial and the other one was a methodologically low quality controlled clinical trial. The clinical relevance of included studies was satisfactory. The level of scientific evidence for the effectiveness of multidisciplinary biopsychosocial rehabilitation was limited for neck and shoulder pain. REVIEWER'S CONCLUSIONS: We conclude that there appears to be little scientific evidence for the effectiveness of multidisciplinary biopsychosocial rehabilitation compared with other rehabilitation facilities on neck and shoulder pain. Multidisciplinary rehabilitation is a commonly used intervention for chronic neck and shoulder complaints, therefore we see an urgent need for high quality trials in this field.

Adult↗

PubMed2000

Biopsychosocial rehabilitation for upper limb repetitive strain injuries in working age adults.

BACKGROUND: Upper limb repetitive strain injury is a common problem in western countries, causing human suffering and huge economical losses. Patients with prolonged pain associated with repetitive tasks in the work place can face both psychological and physical difficulties. Different treatment programmes, physical, psychological, behavioural, social and occupational treatments have been developed and used to help these patients. OBJECTIVES: The objective of this systematic review is to determine the effectiveness of biopsychosocial rehabilitation for upper limb repetitive strain injuries among working age adults. SEARCH STRATEGY: The reviewed studies for this structured Cochrane review were identified from electronic bibliographic databases, the Science Citation Index, reference checking and consulting experts in the rehabilitation field. The original search was planned and performed for a more broad area of musculoskeletal disorders. Trials on repetitive strain injuries were separated afterwards. SELECTION CRITERIA: Randomised controlled trials and controlled trials comparing biopsychosocial measures for the treatment of repetitive upper limb strain injury in working age adults DATA COLLECTION AND ANALYSIS: Two experts in the field of rehabilitation evaluated the clinical relevance and applicability of the findings of the selected studies to actual clinical use. Two other blinded reviewers extracted the data and assessed the main results and the methodological quality of the studies using standardized forms. Finally, a qualitative analysis was performed to evaluate the level of scientific evidence for the effectiveness of biopsychosocial rehabilitation. MAIN RESULTS: We found only two relevant studies that satisfied our criteria. They assessed the effectiveness of two specific interventions and were both considered as low quality trials. The clinical relevance of the included studies was also unsatisfactory. The level of scientific evidence for the effectiveness of biopsychosocial rehabilitation for repetitive strain injuries was limited. One small trial found that hypnosis supplementary to comprehensive treatment can decrease the intensity of pain for acute RSI in six weeks follow-up. REVIEWER'S CONCLUSIONS: We conclude that presently there appears to be little scientific evidence for the effectiveness of biopsychosocial rehabilitation on repetitive strain injuries. As RCTs on more intensive and comprehensive biopsychosocial treatment programmes for RSI are lacking, there does not seem to be reliable data for these interventions. There is a need for high quality trials in this field.

Adult↗

PubMed2001

Second-line chemotherapy for non-small cell lung cancer.

BACKGROUND: The role of second-line chemotherapy for the treatment of patients with non-small cell lung cancer (NSCLC) who have relapsed or failed to respond to first-line treatment was unclear. OBJECTIVES: To determine the effectiveness of any second-line chemotherapy in patients with NSCLC. SEARCH STRATEGY: Bibliographic databases were searched. Handsearching and contact with experts was also performed. SELECTION CRITERIA: Randomised controlled clinical trials in which any second-line chemotherapy was compared with BSC in patients with NSCLC who had previously failed to any previous chemotherapy regimen. DATA COLLECTION AND ANALYSIS: Data was extracted by 2 independent reviewers and revised by all authors. MAIN RESULTS: Only one study was included. It randomised 204 patients to receive either doxetaxel or BSC. Following an unacceptably high toxic death rate the dose of doxetaxel was reduced from 100 mg/m(2) to 75 mg/m(2). Doxetaxel gave an extra 2.4 months of survival - an average of 7.0 months vs 4.6 months on BSC. At 1 year after diagnosis 29% of doxetaxel treated patients were alive compared with 19% of the BSC group. REVIEWER'S CONCLUSIONS: Definitive recommendations cannot be made since evidence is only available from one randomised controlled trial which, though of reasonable quality, had a number of limitations. There is currently no evidence to support second-line treatment of patients with poor performance status. Larger, well-designed controlled trials are needed to further evaluate whether the benefits of second-line chemotherapy to patients with NSCLC outweigh its risks and costs.

Antineoplastic Agents, Phytogenic↗