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PubMed2001

Speech and language therapy for dysarthria due to non-progressive brain damage.

BACKGROUND: Dysarthria is a common sequel of non-progressive brain damage (typically stroke and traumatic brain damage). Impairment-based therapy and a wide variety of compensatory management strategies are undertaken by speech and language therapists with this patient population. OBJECTIVES: To determine the efficacy of speech and language therapy interventions for adults with dysarthria following non-progressive brain damage. SEARCH STRATEGY: This review has drawn on the search strategies developed for the following Cochrane Groups as a whole: Stroke, Injuries, and Infectious Diseases. Relevant trials were identified in the Specialised Registers of Controlled Trials (see Review Group Details for more information). We also searched the trials register of the Cochrane Rehabilitation and Related Therapies Field. The Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL, PsycLIT, and Linguistics and Language Behavior Abstracts were electronically searched. Hand-searching of The International Journal of Language and Communication Disorders and of reference lists from relevant articles and conference proceedings was also undertaken. Colleagues were approached to identify other possible published and unpublished studies. Date of most recent searches: May 2000. SELECTION CRITERIA: Unconfounded randomised controlled trials. DATA COLLECTION AND ANALYSIS: One reviewer assessed trial quality. Two co-reviewers were available to examine any potential trials for possible inclusion in the review. MAIN RESULTS: No trials of the required standard were identified. REVIEWER'S CONCLUSIONS: There is no evidence of the quality required by this review to support or refute the effectiveness of Speech and Language Therapy interventions for dysarthria following non-progressive brain damage. There is an urgent need for good quality research in this area.

Adult↗
PubMed2000

Long-chain polyunsaturated fatty acid supplementation in infants born at term.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: The n-3 and n-6 essential fatty acids alpha linolenic acid and linoleic acid are the precursors of the n-3 and n-6 longchain polyunsaturated fatty acids (LCPUFA). Controversy exists over whether LCPUFA are essential nutrients during infancy. The aim of this review is to assess whether supplementation of formula with LCPUFA is safe and of benefit to term infants. SEARCH STRATEGY: Trials were identified by MEDLINE, checking reference lists of articles and conference proceedings, and by personal communication. SELECTION CRITERIA: All randomised trials of formula supplemented with LCPUFA and with clinical endpoints were reviewed. DATA COLLECTION AND ANALYSIS: Eight randomised studies were identified. One of these studies was excluded due to supplementation commencing after three weeks of age, and one is awaiting assessment. The remaining six trials were assessed to be of good quality. MAIN RESULTS: Visual acuity was assessed by visual evoked potentials at 4 and 7-8 months in the studies of Makrides et al (1995 & 1996). The supplemented infants had an improved rate of visual maturation at both time points in the first study, but no difference was found between the groups at 4 months in the second study. Visual acuity was assessed by Teller acuity cards in the study of Carlson et al (1996), Clausen et al (1996) and Austed et al (1997). Supplementation had no consistent effect on visual acuity over the first year of life. General development was measured in five studies, all with small numbers. Two suggested a benefit of supplementation. One reported a benefit with supplementation at 4 months ( developmental quotient, DQ measured with the Brunet Lezine test, Agostini et al 1995), but when the groups were reassessed with the same test at 1 and 2 years, no differences were found in DQ (Agostini et al 1997). The other study reported a benefit with supplementation at 9 months (novelty preference measured by Fagan Infantest, Clausen et al 1996). The Adelaide studies showed no effect of supplementation on DQ at one year (Bayley Scales of Infant Development (BSID), Makrides et al 1995 &1996). The Portland study showed no effect of supplementation on development at one year (BSID) or at three years (Stanford Binet IQ test). The Portland study showed no effect of supplementation on language development at one year (McArthur Communicative Development Inventory, Janowsky et al 1995) or at three years (Peabody Picture Vocabulary Test, Scott et al 1997). Growth was measured in a small number of infants in the studies of Makrides et al (1995 & 1996) and Austed et al (1997). There was no suggestion that LCPUFA supplementation reduced the growth of term infants. REVIEWER'S CONCLUSIONS: At present there is little evidence from randomised trials of LCPUFA supplementation to support the hypothesis that LCPUFA supplementation confers any benefit on visual or cognitive development. There are no data from the randomised trials presently available to indicate that LCPUFA supplements influence the growth of term infants.

Dietary Supplements↗
PubMed2000

Psychological therapies for sickle cell disease and pain.

BACKGROUND: Sickle cell disease comprises of a group of genetic blood disorders, and occurs when the sickle cell haemoglobin gene is inherited from both parents. The effects of the condition are: varying degrees of anaemia which if severe reduce the capacity for mobility; predisposition to obstruction of small blood capillaries causing pain in muscle and bone known as "crises"; damage to major organs such as the spleen, liver, kidneys, and lungs; and increased vulnerability to severe infections. There are both medical and non-medical complications, and treatment is usually symptomatic and palliative in nature. Psychological intervention for individuals with sickle cell disease seems viable in complementing current medical treatment, and studies examining their efficacy appear to have also yielded encouraging results. OBJECTIVES: To examine the evidence that in patients with sickle cell disease, psychological treatment improves the ability to cope with the condition. SEARCH STRATEGY: The Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. Also, searches on the Internet were performed. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing the use of psychological intervention to no (psychological) intervention in patients with sickle cell disease. DATA COLLECTION AND ANALYSIS: The following outcomes were assessed: pain, mood, coping, health service utilisation, general health, quality of life, and life satisfaction. MAIN RESULTS: Four trials which reported results were all found to be unsuitable for inclusion at the present time, owing to incomplete data in the published papers. REVIEWER'S CONCLUSIONS: Psychological approaches are commonly used in an attempt to improve coping ability in patients with sickle cell disease. No conclusions can be made about the use of specific psychological therapies in sickle cell disease from the information currently available. This systematic review has clearly identified the need for well designed, adequately-powered, multicentre, RCTs assessing the effectiveness of specific interventions in sickle cell disease.

Adaptation, Psychological↗
PubMed2000

Reminiscence therapy for dementia.

BACKGROUND: Reminiscence Therapy (RT) has been defined as vocal or silent recall of events in a person's life, either alone, or with another person or group of people. It typically involves group meetings, at least once a week. in which participants are encouraged to talk about past events, often assisted by aids such as photos, music, objects and videos of the past. There is, often, little consistent application of psychological therapies in dementia services. A number of these 'therapies' were greeted with enthusiasm by health care practitioners in understimulating care environments. They were expected to work miracles and their 'failure' to do this has led to their widespread disuse. A systematic review of the available evidence is important in order to identify the effectiveness of the different therapies. Subsequently, guidelines for their use can be made on a sound evidence base. OBJECTIVES: RT involves groups of elderly people talking of past events, assisted by aids such as videos, pictures and archives, as a means of communicating and reflecting upon their life experiences. The objective of the review is to assess the effects of RT for dementia. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, MEDLINE, PSYCHLIT, EMBASE, OMNI, BIDS, Dissertation Abstracts International, SIGLE and reference lists of relevant articles up to 1998, and we contacted specialists in the field. We also searched relevant internet sites and we handsearched Aging and Mental Health, the Gerontologist, Journal of Gerontology, Current Opinion in Psychiatry, Current Research in Britain: Social Sciences, British Psychological Society conference proceedings and Reminiscence database. SELECTION CRITERIA: Randomised controlled trials and quasi-randomised trials of RT for dementia in elderly people. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: Two trials are included in the review, but only one trial with 15 participants had extractable data. The results were statistically non-significant for both cognition and behaviour. REVIEWER'S CONCLUSIONS: No firm conclusions could be reached regarding the effectiveness of RT for dementia. The review highlighted the urgent need for more systematic research in the area.

Dementia↗
PubMed2001

Interventions for herpes simplex virus epithelial keratitis.

BACKGROUND: Many clinical trials have been performed on the acute treatment of dendritic epithelial keratitis. Surveys of antiviral pharmacology and of herpes simplex virus eye disease have evaluated different commercially available agents, but a systematic review of all comparative clinical studies has not previously been undertaken. OBJECTIVES: The objective of this review is to compare the effects of various treatments for dendritic or geographic herpes simplex virus epithelial keratitis. SEARCH STRATEGY: Sources searched for relevant studies were the Cochrane Eyes and Vision Group specialized register, The Cochrane Controlled Trials Register - CENTRAL, MEDLINE, EMBASE, Index Medicus, Excerpta Medica Ophthalmology, reference lists of primary reports, review articles, and corneal textbooks and conference proceedings pertaining to ocular virology. SELECTION CRITERIA: This review includes comparative clinical trials that assessed oral or topical ophthalmic antiviral agents, or physical or chemical debridement in people with active epithelial keratitis. DATA COLLECTION AND ANALYSIS: The reviewer extracted data and assessed trial quality. Interventions were compared by the proportions of participants healed at seven days and at fourteen days after trial enrollment. MAIN RESULTS: This review includes data from 96 trials which randomised a total of 4991 participants. Compared to idoxuridine, the topical application of vidarabine, trifluridine, or acyclovir generally resulted in a significantly greater proportion of participants healing within one week of treatment. Among these three antiviral agents, no treatment emerged as significantly better for the therapy of dendritic epithelial keratitis. Insufficient placebo-controlled studies were available to assess debridement and other physical and physicochemical methods of treatment. Interferon monotherapy had a slight beneficial effect on dendritic epithelial keratitis, but not better than other antiviral agents, and was useful with debridement. REVIEWER'S CONCLUSIONS: Currently available and investigational antiviral agents are effective and nearly equivalent, but the combination of an antiviral nucleoside and interferon seems to speed healing. Future trials of the acute treatment of herpes simplex virus epithelial keratitis must aim to achieve adequate statistical power for assessing the primary outcome and should consider the effect of lesion size and other characteristics on treatment response.

Administration, Oral↗
PubMed2002

Artemether-lumefantrine for treating uncomplicated falciparum malaria.

BACKGROUND: Artemether-lumefantrine is being promoted by the World Health Organization for treating uncomplicated malaria. It is expensive. We sought evidence of its superiority over existing treatment regimens. OBJECTIVES: To compare artemether-lumefantrine with other antimalarial drugs for treating uncomplicated falciparum malaria. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group specialized trials register (April 2002), the Cochrane Controlled Trials Register (Issue 2, 2002), MEDLINE (1966 to April 2002), EMBASE (1988 to April 2002), conference proceedings, and reference lists of articles. We contacted experts in malaria research and the pharmaceutical company that manufactures artemether-lumefantrine. SELECTION CRITERIA: Randomized and quasi-randomized trials comparing artemether-lumefantrine administered orally with standard treatment regimens (single drug or combination). DATA COLLECTION AND ANALYSIS: Two reviewers independently applied inclusion criteria to potentially relevant trials, assessed trial quality, and extracted data. Parasitaemia on day 28 (day 42 for sulfadoxine-pyrimethamine and day 63 for mefloquine) was the primary outcome. Adverse event information was collected from the studies. MAIN RESULTS: Eight trials (2117 participants) met the inclusion criteria. In the four studies against single agents, failure rates for artemether-lumefantrine tended to be higher in comparisons against sulfadoxine-pyrimethamine, halofantrine, and mefloquine. This difference was statistically significant for mefloquine. When compared with chloroquine, artemether-lumefantrine was better in two studies, but the failure rate for chloroquine at these sites was over 50%. All single agent studies used four doses of artemether-lumefantrine. In comparisons against combination treatment, three trials tested artemether-lumefantrine against mefloquine-artesunate and showed that artemether-lumefantrine was inferior for day 28 cure (Relative Risk 6.33, 95% confidence interval 3.08 to 13.01). If this comparison is confined to the two trials where participants received six doses, artemether-lumefantrine was associated with higher cure rates, but this was not statistically significant (Relative Risk 4.20, 95% confidence interval 0.55 to 31.93). REVIEWER'S CONCLUSIONS: Artemether-lumefantrine is more effective than chloroquine in chloroquine resistant areas. Artemether-lumefantrine is less effective than mefloquine or mefloquine combined with artesunate. We found no evidence to confirm or refute whether artemether-lumefantrine was better than sulfadoxine-pyrimethamine.

Antimalarials↗
PubMed2000

Interventions for psoriatic arthritis.

OBJECTIVES: To assess the effects of salazopyrin, auranofin, etretinate, fumaric acid, IMI gold, azathioprine, and methotrexate, in psoriatic arthritis. SEARCH STRATEGY: We searched Medline up to 1995, and Excerpta Medica (June 1974-95). Search terms were psoriasis, arthritis, therapy and/or controlled trial. This was supplemented by manually searching bibliographies of previously published reviews, conference proceedings and contacting drug companies. All languages were included in the initial search. SELECTION CRITERIA: All randomized trials comparing salazopyrin, auranofin, etretinate, fumaric acid, IMI gold, azathioprine, and methotrexate, in psoriatic arthritis. The main outcome measures included individual component variables derived from Outcome Measures in Rheumatology Clinical Trials (OMERACT). These include Acute Phase Reactants, Disability, Pain, Patient Global Assessment, Physician Global Assessment, Swollen joint count, Tender joint count and radiographic changes of joints in any trial of 1 year or longer [Tugwell 1993], and the change in pooled disease index. Only English trials were included in the review. DATA COLLECTION AND ANALYSIS: Data were independently extracted from the published reports by two of the reviewers. An independent blinded quality assessment was also performed. MAIN RESULTS: Nineteen randomized trials were identified of which eleven were included in the quantitative analysis with data from 777 subjects. Although all agents were better than placebo, parenteral high dose methotrexate (not included), salazopyrin, azathioprine and etretinate were the agents that achieved statistical significance in a global index of disease activity (although it should be noted that only one component variable was available for azathioprine and only one trial was available for etretinate suggesting some caution is necessary in interpreting these results). Analysis of response in individual disease activity markers was more variable with considerable differences between different medications and responses. In all trials the placebo group improved over baseline (pooled improvement 0.43 DI units, 95% CI 0. 28-0.59). There was insufficient data to examine toxicity. REVIEWER'S CONCLUSIONS: Parenteral high dose methotrexate and salazopyrin are the only two agents with well demonstrated published efficacy in psoriatic arthritis. The magnitude of the effect seen with azathioprine, etretinate, oral low dose methotrexate and perhaps colchicine suggests that they may be effective but that further multicentre clinical trials are required to establish their efficacy. Furthermore, the magnitude of the improvement observed in the placebo group strongly suggests that uncontrolled trials should not be used to guide management decisions in this condition.

Antirheumatic Agents↗
PubMed2001

Dietary advice given by a dietitian versus other health professional or self-help resources to reduce blood cholesterol.

BACKGROUND: The average level of blood cholesterol is an important determinant of the risk of coronary heart disease. Blood cholesterol can be reduced by dietary means. Although dietitians are trained to provide dietary advice, for practical reasons it is also given by other health professionals and occasionally through the use of self-help resources. OBJECTIVES: To assess the effects of dietary advice given by a dietitian compared with another health professional, or the use of self-help resources, in reducing blood cholesterol in adults. SEARCH STRATEGY: We searched The Cochrane Library (to Issue 2 1999), MEDLINE (1966 to January 1999), EMBASE (1980 to December 1998), Cinahl (1982 to December 1998), Human Nutrition (1991 to 1998), Science Citation Index, Social Sciences Citation Index, hand searched conference proceedings on nutrition and heart disease, and contacted experts in the field. SELECTION CRITERIA: Randomised trials of dietary advice given by a dietitian compared with another health professional or self-help resources. The main outcome was difference in blood cholesterol between dietitian groups compared with other intervention groups. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Eleven studies with 12 comparisons were included, involving 704 people receiving advice from dietitians, 486 from other health professionals and 551 people using self-help leaflets. Four studies compared dietitian with doctor, seven with self-help resources, and one compared dietitian with nurse. Participants receiving advice from dietitians experienced a greater reduction in blood cholesterol than those receiving advice only from doctors (-0.25 mmol/L (95% CI -0.37, -0.12 mmol/L)). There was no statistically significant difference in change in blood cholesterol between dietitians and self-help resources (-0.10 mmol/L (95% CI -0.22, 0.03 mmol/L)). No statistically significant differences were detected for secondary outcome measures between any of the comparisons with the exception of dietitian versus nurse for HDLc, where the dietitian groups showed a greater reduction (-0.06 mmol/L (95% CI -0.11, -0.01)). No significant heterogeneity between the studies was detected. REVIEWER'S CONCLUSIONS: Dietitians were better than doctors at lowering blood cholesterol in the short to medium term, but there was no evidence that they were better than self-help resources. The results should be interpreted with caution as the studies were not of good quality and the analysis was based on a limited number of trials. More evidence is required to assess whether change can be maintained in the longer term. There was no evidence that dietitians provided better outcomes than nurses.

Cholesterol↗
PubMed2002

Supported housing for people with severe mental disorders.

BACKGROUND: There has been a significant reduction in the number of people with severe mental illness who spend extended periods in long-stay hospitals. Psychiatric and social services, both statutory and voluntary, aim to assist these people to stay in their local community. District health authorities, local authorities, housing associations and voluntary organisations are jointly expected to provide support for people with severe mental disorder/s. This 'support' may well involve some sort of special housing. OBJECTIVES: To determine the effects of supported housing schemes compared with outreach support schemes or 'standard care' for people with severe mental disorder/s living in the community. SEARCH STRATEGY: Cochrane Schizophrenia Group's Register of trials (February 2001) and the Cochrane Library (Issue 1, 2001) were searched using relevant phrases. These databases are compiled by methodical searches of BIOSIS, CINAHL, Dissertation abstracts, EMBASE, LILACS, MEDLINE, PSYNDEX, PsycINFO, RUSSMED, Sociofile, supplemented with hand searching of relevant journals and numerous conference proceedings. Reference list screening of relevant papers was performed. SELECTION CRITERIA: Relevant randomised, or quasi-randomised, trials dealing with people with 'severe mental disorder/s' allocated to supported housing, outreach support schemes or standard care focusing on outcomes of service utilisation, mental state, satisfaction with care, social functioning, quality of life, and economic data, were sought. DATA COLLECTION AND ANALYSIS: Studies were reliably selected, quality rated and data extracted. For dichotomous data, relative risks (RR) would have been estimated, with the 95% confidence intervals (CI). Where possible, the number needed to treat statistic (NNT) was to have been calculated. Analysis would have been by intention-to-treat. Normal continuous data were to have been summated using the weighted mean difference (WMD). Scale data were to have been presented for only those tools that had attained pre-specified levels of quality. Tests of heterogeneity and for publication bias were to have been undertaken. MAIN RESULTS: No studies met the inclusion criteria although 139 citations were acquired from the searches. REVIEWER'S CONCLUSIONS: Dedicated schemes whereby people with severe mental illness are located within one site or building with assistance from professional workers have potential for great benefit as they provide a 'safe haven' for people in need of stability and support. This, however, may be at the risk of increasing dependence on professionals and prolonging exclusion from the community. Whether or not the benefits outweigh the risks can only be a matter of opinion in the absence of reliable evidence. There is an urgent need to investigate the effects of supported housing on people with severe mental illness within a randomised trial.

Group Homes↗
PubMed2000

Mobilisation strategies after hip fracture surgery in adults.

BACKGROUND: Post-operative care programmes after hip fracture surgery include strategies for mobilisation, such as early weight bearing, gait retraining and other physical therapy interventions. OBJECTIVES: To evaluate the effects of different mobilisation strategies and programmes after hip fracture surgery. SEARCH STRATEGY: The Cochrane Musculoskeletal Injuries Group trials register, Medline, and reference lists of relevant articles were searched. Date of the most recent search: August 1999. SELECTION CRITERIA: All randomised or quasi-randomised trials comparing different mobilisation strategies/programmes after hip fracture surgery. DATA COLLECTION AND ANALYSIS: All reviewers independently assessed trial quality, using a ten item scale, and extracted data. Wherever appropriate and possible, the data are presented graphically. MAIN RESULTS: Each of the four included trials evaluated a different intervention. All had poor and / or poorly reported trial methodology. One trial of 100 patients compared twice daily with once daily physiotherapy. Only limited outcome data were available for checking the claims in the trial report that there was no demonstrable difference in recovery of the two patient groups at nine weeks follow-up. A treadmill gait retraining programme was compared with a conventional gait retraining programme in one trial of 40 patients. More patients in the treadmill group had recovered their pre-fracture level of mobility by the time of hospital discharge, which tended to happen earlier than for the control group. Neither of these differences were statistically significant. One trial of 24 patients compared neuromuscular stimulation of the quadriceps muscle with placebo stimulation. No data were available to test the claims that neuromuscular stimulation improved the recovery of mobility, assessed up to 13 weeks. One trial involving 273 patients with a displaced intracapsular fracture treated by internal fixation compared weight bearing at two weeks after surgery with delayed weight bearing at 12 weeks after surgery. From the limited data available, there were no statistically significant differences between the two methods of treatment for the outcomes of non-union, mortality and overall unfavourable outcome at one year (42/141 versus 50/132; relative risk = 0.79, 95%confidence interval = 0.56 to 1.10). REVIEWER'S CONCLUSIONS: There is insufficient evidence from randomised trials to determine the effects of more frequent physiotherapy, treadmill gait retraining, or neuromuscular stimulation after hip fracture surgery. There is also insufficient evidence to determine the effects of early weight bearing after the internal fixation of an intracapsular proximal femoral fracture.

Adult↗
PubMed2000

General versus spinal/epidural anaesthesia for surgery for hip fractures in adults.

BACKGROUND: The majority of hip fracture patients are treated surgically, requiring anaesthesia. OBJECTIVES: To compare different types of anaesthesia for surgical repair of hip fractures (proximal femoral fractures) in adults. This is primarily regional (spinal or epidural) anaesthesia versus inhalation general anaesthesia, but also includes ketamine anaesthesia versus inhalation general anaesthesia. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register, Medline, selected orthopaedic and anaesthetic journals and conference proceedings, and reference lists of relevant articles. Date of the most recent search: August 1998. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing different methods of anaesthesia for hip fracture surgery in skeletally mature persons. Trials comparing the use of local nerve blocks are not considered in this review. Neither are trials using different types of drugs or techniques with one type of anaesthesia. The primary outcome was mortality. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, using a nine item scale, and extracted data. The other two reviewers independently checked these results. Wherever appropriate and possible, results were pooled. MAIN RESULTS: Fifteen trials, involving 2162 patients, which compared regional anaesthesia with general anaesthesia, were included. All trials had methodological flaws. Regional anaesthesia was associated with a decreased mortality at one month (49/766 (6.4%) versus 76/812 (9.4%)) of borderline statistical significance (Peto odds ratio 0.66, 95% confidence interval 0.46 to 0.96)). The results for three month mortality were not statistically significant, although the confidence interval does not exclude the possibility of a clinically relevant reduction (86/726 (11.8%) versus 98/765 (12.8%), Peto odds ratio 0.91, 95% confidence interval 0.67 to 1.24). The reduced numbers at one year, coming exclusively from two studies, preclude any useful conclusions for long term mortality (80/354 (22.6%) versus 78/372 (21.0%), Peto odds ratio 1.10, 95% confidence interval 0.77 to 1.57). Regional anaesthesia was associated with a tendency to a longer operation (weighted mean difference 4.8 minutes, 95% confidence interval 1.1 to 8.6 minutes), and a reduced risk of deep venous thrombosis (39/129 (30%) versus 61/37(76%); Peto odds ratio 0. 41, 95% confidence interval 0.23 to 0.72), although this conclusion is insecure due to possible selection bias in the subgroups in whom this outcome was measured. No other statistically significant differences in outcome were identified. There was insufficient evidence to draw any conclusions from a further two included trials, involving a total of 100 patients, which compared other types of anaesthesia. REVIEWER'S CONCLUSIONS: Regional anaesthesia and general anaesthesia appear to produce comparable results for most of the outcomes studied. Regional anaesthesia may reduce short-term mortality but no conclusions can be drawn for longer term mortality.

Adult↗
PubMed2002

Beta-lactam versus beta-lactam-aminoglycoside combination therapy in cancer patients with neutropaenia.

BACKGROUND: Chemotherapy treated cancer patients are prone to neutropaenia and life-threatening infections. Early, empirical antibiotic treatment is therefore administered routinely to febrile neutropaenic patients. Currently, either beta-lactam-aminoglycoside combination treatment or beta-lactam monotherapy are recommended. OBJECTIVES: We compared beta-lactam monotherapy versus beta-lactam-aminoglycoside combination therapy for cancer patients with fever and neutroepaenia. SEARCH STRATEGY: Cochrane Library (Issue 4,2001), the Cochrane Cancer Network Register of trials (July 2000), EMBASE (January 1980-2000), MEDLINE (1966-8/2001), and ICAAC conference proceedings (1995 onwards). We scanned references of all included studies, pertinent reviews, and contacted the first author of each included trial and the pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials comparing any beta-lactam antibiotic monotherapy to any combination of a beta-lactam and an aminoglycoside antibiotic, for the initial, empirical treatment of febrile neutropaenic cancer patients. DATA COLLECTION AND ANALYSIS: Data concerning mortality, treatment failure (including treatment modifications), superinfections, adverse effects and study quality measures were extracted independently by two reviewers. Relative risks with their 95% confidence intervals (CI) were estimated. Outcomes were extracted by intention-to-treat analysis whenever possible. MAIN RESULTS: Forty-six trials and 7642 patients were included. All cause mortality was the primary outcome assessed. For all mortality comparisons, no significant difference between monotherapy and combination therapy was seen, relative risk 0.85 (95% CI 0.72-1.02) for all studies combined. Treatment failure was the outcome reported in all included trials. No significant difference between study groups was shown for studies comparing the same beta-lactam, relative risk 1.12 (95% CI 0.96-1.29). A significant advantage to monotherapy was observed for studies comparing different beta-lactams, relative risk 0.86 (95% CI 0.80-0.93). Bacterial and fungal superinfections developed with similar frequencies in the monotherapy and combination treatment groups. Adverse events were significantly more common in the combination treatment group, relative risk 0.83, (95% CI 0.72-0.97). These included events associated with significant morbidity, primarily renal toxicity. Results were consistent for subgroup and sensitivity analyses. REVIEWER'S CONCLUSIONS: We have shown an advantage to broad-spectrum beta-lactam monotherapy over beta-lactam-aminoglycoside combination therapy for febrile neutropaenia. This advantage comprises of 1) a similar, if not better, survival, 2) a significantly lower treatment failure rate, 3) comparable probability for secondary infections and, 4) most importantly, a lower rate of adverse events associated with significant morbidity. Monotherapy can be regarded, therefore, as the standard of care for febrile neutropaenic patients.

Aminoglycosides↗
PubMed2000

Oral pentoxifylline for treatment of venous leg ulcers.

BACKGROUND: Healing of venous leg ulcers is improved by the use of compression bandaging but some venous ulcers do not respond to compression therapy. Pentoxifylline, a drug which helps blood flow, has been used to treat venous leg ulcers but to date there has been no systematic review. OBJECTIVES: To assess the effects of pentoxifylline ('Trental 400') for treating venous leg ulcers, when compared with placebo, or in comparison with other therapies, in the presence or absence of compression therapy. SEARCH STRATEGY: We searched the Cochrane Peripheral Vascular Diseases and Wounds Groups specialised registers (date of search August 1999), and reference lists of relevant articles. We hand searched relevant journals and conference proceedings, and contacted Hoechst (the manufacturer of the drug) and experts in the field. SELECTION CRITERIA: Randomised trials comparing pentoxifylline with placebo or other therapy in the presence or absence of compression, in patients with venous leg ulcers. DATA COLLECTION AND ANALYSIS: Details from eligible trials were extracted and summarised by one reviewer using a coding sheet. Data extraction was independently verified by one other reviewer. MAIN RESULTS: Nine trials involving 572 adults were included. The quality of trials was variable. Eight trials compared pentoxifylline with placebo; in five of these trials patients received compression therapy. In one trial pentoxifylline was compared with defibrotide in patients who also received compression. By pooling eight trials that compared pentoxifylline with placebo (with or without compression) it was found pentoxifylline was more effective than placebo in terms of complete healing or significant improvement (relative risk for healing with pentoxifylline compared with placebo 1.41, 95% confidence interval 1.19 -1.66). Pentoxifylline and compression was more effective than placebo and compression (relative risk for healing with pentoxifylline 1.30, 95% confidence interval 1.10-1.54). Combination of similar trials using compression obtained a number needed to treat (NNT) of 7 (95%confidence interval 4-17). A comparison between pentoxifylline and defibrotide found no difference in healing rates. More adverse effects were reported in the pentoxifylline group, although this was not statistically significant (relative risk for adverse effects with pentoxifylline 1. 25, 95% confidence interval 0.87-1.80). Nearly half of the adverse effects were reported to be gastro-intestinal. REVIEWER'S CONCLUSIONS: Pentoxifylline appears to be an effective adjunct to compression bandaging for treating venous ulcers. There was no cost effectiveness data available and healthcare commissioners may therefore conclude that it not be considered a routine adjunct. Pentoxifylline in the absence of compression may be effective for treating venous ulcers in the absence of compression, although the evidence should be cautiously interpreted. The majority of adverse effects are likely to be tolerated by patients, and gastrointestinal disturbances (indigestion, diarrhoea and nausea) are the most frequent adverse effect.

Administration, Oral↗
PubMed2000

Therapeutic hypothermia for head injury.

BACKGROUND: Mild to moderate induced hypothermia has been used in the treatment of head injury for over 50 years, although few randomised controlled trials have been performed. Recent encouraging results from small, single-centre trials and consistent findings of a cerebral protection effect of cooling in laboratory models of global ischaemia has led to a renewed interest in the area. OBJECTIVES: To determine whether the use of mild therapeutic hypothermia in the treatment of moderate and severe head injury improves short-term control of intracranial pressure (ICP) and long-term functional outcome. SEARCH STRATEGY: Electronic searches of the Injuries Group trial registry and EMBASE for any relevant randomised trials, supplemented by hand searching of conference proceedings and reference lists of relevant articles. SELECTION CRITERIA: All randomised controlled trials of mild hypothermia versus control (open or normothermia) in the treatment of patients with any closed head injury requiring hospitalisation. Mild hypothermia was defined as local or systemic cooling to a target temperature of at most 34-35 degrees Celsius for a period of at least 12 hours. Outcome was all-cause mortality and death or severe disability at the end of the scheduled follow-up period. All trials were assessed by two reviewers, and included or excluded on a consensus basis. DATA COLLECTION AND ANALYSIS: Eleven potential trials of therapeutic hypothermia for head injury were found, of which two are ongoing and one is awaiting assessment. The eight remaining trials were included in the systematic review. Data on death, GOS score at final follow-up, complications and ICP were sought and extracted, either from published material or by contact with the investigators. Mantel-Haenzel odds ratios and 95% confidence intervals were calculated for death and death and severe disability for each trial on an intention-to-treat basis. No quantitative synthesis of data on either complications or ICP was attempted. Trials of immediate and deferred hypothermia were analysed separately. MAIN RESULTS: Active immediate hypothermic treatment was associated with a 33% non-significant (p=0.16) reduction in the odds of death at the end of treatment or final follow-up, (OR 0.67, 95% confidence interval 0.38 to 1.17), and a 61% reduction (p=0.004) in the odds of being dead or severely disabled, (OR 0.39, 95% confidence interval 0.20 to 0.74). Similar effect sizes were found for delayed hypothermia. These results are, however, based on a few small trials each of less than 100 patients. A multi-centre trials of hypothermia versus control in 392 patients will be reporting results in 1999, providing substantially more evidence than is currently available. REVIEWER'S CONCLUSIONS: Although this review would suggest a strong positive effect of therapeutic hypothermia, the results are based on several small trials carried out in single, specialist centres. The results of a large multi-centre trial are expected in 1999 and will more than treble the available evidence. Until these results have been released, it would be inappropriate to make any short-term recommendations for clinical practice or research.

Craniocerebral Trauma↗
PubMed2000

Tricyclic drugs for depression in children and adolescents.

BACKGROUND: There is a need to identify effective and safe treatments for depression in children and adolescents. While tricyclic drugs have proven effectiveness in the treatment of depression in adults, individual studies involving children and adolescent have been equivocal. OBJECTIVES: To examine whether orally administered tricyclic antidepressants are superior to placebo in the treatment of child and adolescent depression SEARCH STRATEGY: We searched the literature using CD ROM Silver Platter and On-Line MEDLINE (1966-1997) and Excerpta Medica (June 1974-1997) data bases. Terms used for the search were: the exploded terms child and depression; the Medical Subject Headings of antidepressant drugs, tricyclic and affective disorders; individual tricyclic drugs by name; names of well-known researchers in the field; and school phobia. We searched the trials database of the Cochrane Collaboration Depression, Anxiety and Neurosis Group. Abstracts in English (of English and non-English papers) were reviewed. Bibliographies of previously published reviews and papers describing original research were cross-checked. Current Contents was screened for recent publications. We contacted authors of abstracts describing "work in progress" identified in conference proceedings of the American Academy of Child and Adolescent Psychiatry to determine whether they held data which could be included in the meta-analysis. We have hand searched the Journal of the American Academy of Child and Adolescent Psychiatry to identify randomized controlled trials. SELECTION CRITERIA: Randomized controlled trials comparing the efficacy of orally administered tricyclic medication with placebo in depressed subjects aged 6-18 years. DATA COLLECTION AND ANALYSIS: Most studies reported multiple outcome measures including depression scales and clinical global impression scales. For each study the best available depression measure was taken as the index measure of depression outcome. Predetermined criteria were established to assist in the ranking of measures. Where authors reported categorical outcomes we calculated individual and pooled odds ratios for the odds of improvement in treated compared with control subjects. For continuous outcomes pooled effect sizes were calculated as the number of standard deviations by which the change in depression scores for the treatment group exceeded those for the control groups. MAIN RESULTS: Twelve studies fulfilled the criteria for inclusion in the review, eight from which dichotomous outcome data could be extracted, and eleven from which continuous outcome data could be extracted. Pooled odds ratios calculated from the dichotomous data indicated no advantage of treatment over placebo for children or adolescents (odds ratio = 0.83, 95% confidence interval 0.48 to 1.42). Effect size calculations from the continuous data suggested a statistically significant but small benefit of treatment over placebo in reducing symptoms for the aggregate sample (effect size = -0.38, 95% confidence interval -0.74 to -0.02) with subgroup analyses suggesting a larger benefit among adolescents (effect size = -0.59, 95% confidence interval -1.12 to -0.06), and no benefit among children (effect size = 0.15, 95% confidence interval -0.34 to 0.64). Treatment with a tricyclic antidepressant caused more vertigo (odds ratio = 8.47, 95% confidence interval 1.40 to 51.0), orthostatic hypotension (odds ratio = 4.77, 95% confidence interval 1.11 to 20.49) and dry mouth (odds ratio = 5.19, 95% confidence interval 1.15 to 23.51) than did placebo, but there was no statistically significant difference in other possible adverse effects. REVIEWER'S CONCLUSIONS: Data suggest tricyclic antidepressants are of unlikely benefit in the treatment of depression in pre pubertal children. There is marginal evidence to support the use of tricyclic antidepressants in the treatment of depression in adolescents, although the magnitude of effect is likely to be moderate at best.

Administration, Oral↗
PubMed2000

Quetiapine for schizophrenia.

BACKGROUND: Quetiapine is a novel atypical antipsychotic with low propensity for movement disorder adverse effects. It is used for treatment of schizophrenia and other psychoses. OBJECTIVES: To determine the effects of quetiapine for schizophrenia in comparison to placebo, classical and other atypical antipsychotics. SEARCH STRATEGY: Electronic searches of Biological Abstracts (1982-1997), CINAHL (1982-1997), the Cochrane Library (1998, Issue 1), the Cochrane Schizophrenia Group's Register of trials (1998), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1974-1997), SocioFile (1974-1997) and many conference proceedings and hand searches of specific journals were undertaken. Zeneca Pharmaceuticals was contacted for information regarding unpublished trials. SELECTION CRITERIA: All controlled trials where adults with schizophrenia or similar illnesses were randomised to quetiapine, placebo or other neuroleptic drugs and where clinically relevant outcomes were reported. DATA COLLECTION AND ANALYSIS: Citations and, where possible, abstracts were independently inspected by reviewers, papers ordered, re-inspected and quality assessed. Data were also independently extracted. For homogeneous dichotomous data the Peto odds ratio (OR), 95% confidence interval (CI) and, where appropriate, the number needed to treat (NNT) was calculated on an intention-to-treat basis. MAIN RESULTS: Seven trials of short duration are included (31 reports) and seven are excluded (15 reports). Apart from that of 'leaving the study early', all other results may be prone to bias and should be viewed with caution since dropout rates are high (48-61%) in each arm of all studies. There are data suggesting less people allocated quetiapine leave the study early (53%) than those in the placebo group (61%) (OR 0.67 CI 0.48-0. 95). Data incorporating considerable assumptions about the many people who left early suggest that global state and psychotic symptoms - both positive and negative - may be more helped by quetiapine than placebo. Although some of these data reach statistical significance their clinical importance is difficult to interpret. While the incidences of extrapyramidal side effects are not different between quetiapine and placebo, side effects such as dizziness and dry mouth are more prevalent in the quetiapine treated group. High proportions of trial participants also leave when quetiapine is compared to chlorpromazine or haloperidol (57% by six weeks). Quetiapine is as potent as chlorpromazine and haloperidol as regards global and mental state but it may cause higher incidences of dry mouth and sleepiness. Extrapyramidal side effects are the same as those of chlorpromazine but may be less than haloperidol. High dose quetiapine is better than low dose quetiapine with regard to leaving the study early, and limited data suggest that the higher dose is also better at marginally improving global state (n = 1, OR 0.70, CI 0.50-0.99, NNT 11). There are no clear differences between high and low dose groups in respect of extrapyramidal side effects. REVIEWER'S CONCLUSIONS: The high dropout rates are a large problem in interpreting any results other than 'leaving the study early' since about half the data were not available at the end of studies. Before quetiapine's use can be recommended, we need more large, well conducted trials that provide short, medium and long term outcomes relevant to carers and clinicians.

Adult↗
PubMed2000

Newborn screening for cystic fibrosis.

BACKGROUND: This review was performed to test the hypothesis that presymptomatic diagnosis, for example by newborn screening, and early treatment may prevent or reduce irreversible organ damage and thereby improve outcome and quality of life in patients with cystic fibrosis. OBJECTIVES: To determine whether there is evidence that early diagnosis of cystic fibrosis by means of neonatal screening, followed by current treatment, improves survival and long term morbidity, without unacceptable adverse effects. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Trials Register. Additional studies were identified by one of the reviewers from handsearching conference proceedings not included in the Cochrane Register. Pharmaceutical companies manufacturing screening tests for cystic fibrosis were also contacted to identify any trials of neonatal screening for cystic fibrosis. Date of the most recent search of the Group's specialised register: November 1999. SELECTION CRITERIA: All randomised or pseudorandomised controlled trials, published and unpublished, comparing screening followed by early treatment to clinical diagnosis and later treatment in patients with cystic fibrosis. DATA COLLECTION AND ANALYSIS: Four reviewers independently assessed trial eligibility and methodological quality and two of these reviewers independently extracted data. MAIN RESULTS: Two trials involving a total of 1,124,483 neonates met inclusion criteria. A total of 210 patients with cystic fibrosis aged from zero to 11 years with a maximum follow-up of eleven years are included. Concealment of allocation was unclear in both studies. Sequence generation was adequate in one study and unclear in the other. Method to ascertain cases was similar in one study and not similar in the other. An intention-to-screen-analysis was possible in one study, but could not be made due to lack of data and was not performed in the other. Differences in study design, variation in outcomes reported and their summary measures precluded calculation of pooled screening estimates. Only data from one study could be analysed in this review. This study reported a reduced risk of weight and height below the fifth percentile among screened patients (odds ratio control compared with screened group for: weight 6.16, 95% Confidence Interval (CI) 2.44, 15.57 and height 5.03, 95% CI 1. 63, 15.63). Adverse effects among parents in the screened and control populations were examined, but it is difficult to assess how meaningful these results are as the timing of the administration of the questionnaire to each group was not clear. Estimation of direct medical costs of screening suggested it was cheaper to diagnose cystic fibrosis by screening rather than other methods. The costing methods used however were not fully described and costs have not been related to effect. REVIEWER'S CONCLUSIONS: There are few randomised controlled trials assessing the effectiveness of neonatal screening in cystic fibrosis. From the data available at this time, there is little evidence suggesting benefit from screening for cystic fibrosis in the neonatal period, although there is similarly little evidence of harm. This systematic review has identified the need for individual patient data from both included studies. Although we have not been able to perform a meta-analysis, this review provides a summary of all the information currently available from randomised controlled trials on the effectiveness of neonatal screening for cystic fibrosis.

Cystic Fibrosis↗
PubMed2000

Sucrose for analgesia in newborn infants undergoing painful procedures.

BACKGROUND: Management of pain for neonates is less than optimal. The administration of sucrose with and without non-nutritive sucking (pacifiers) has been the most frequently studied non-pharmacological intervention for relief of procedural pain in neonates. OBJECTIVES: To determine the efficacy, effect of dose, and safety of sucrose for relieving procedural pain as assessed by physiologic and/or behavioural indicators. SEARCH STRATEGY: Standard methods as per the Neonatal Collaborative Review Group. A MEDLINE search was carried out for relevant randomized controlled trials (RCTs) published from January 1966 - November 1, 1997; EMBASE from 1993-1997; Reference Update search on November 11, 1997 and search of the Cochrane Library Issue 4 on November 11, 1997. Key words and (MeSH) terms included, infant/newborn, pain, analgesia and sucrose. Personal files, bibliographies, the most recent relevant neonatal and pain journals and conference proceedings were searched manually. Unpublished studies were not included. Language restrictions were not imposed. SELECTION CRITERIA: RCTs in which term and/or preterm neonates undergoing heel lance, venepuncture or intramuscular injection (immunization) received sucrose or water/placebo or no intervention. DATA COLLECTION AND ANALYSIS: Trial quality was assessed according to the methods of the Neonatal Collaborative Review Group. Quality measures included; blinding of randomization, blinding of intervention, completeness of follow up and blinding of outcome measurement. Data were abstracted and independently checked for accuracy by the two investigators. The inconsistency in outcome measures and differences in the statistical reporting of results made meta-analysis impossible. We were not able to identify two studies in which the same physiologic and/or behavioral outcomes following a noxious stimulus (heel-lance, venepuncture, intramuscular injection) were measured and reported in an identical fashion using means and standard deviations (or standard errors). The results are therefore reported for each accepted study separately. MAIN RESULTS: Fifteen studies were identified for possible inclusion in this systematic review. Five studies were excluded; three RCTs were excluded as in these trials the number of infants randomized to treatment vs. placebo groups were not reported; one study was not an RCT, and in one RCT the neonates did not undergo a painful procedure. Ten RCTs were included in this review. Sucrose in a wide range of dosages was generally found to decrease univariate physiologic (heart rate) and behavioural (the mean percent time crying, total cry duration, duration of first cry, and facial action) pain indicators and multivariate [Premature Infant Pain Profile (PIPP)] pain outcomes in neonates undergoing heelstick or venepuncture. An optimal dose of sucrose to reduce pain associated with procedures in preterm and term neonates could not be identified through this systematic review. REVIEWER'S CONCLUSIONS: Sucrose reduces physiologic and/or behavioral indicators of stress/pain in neonates following procedural pain stimuli (heel lance, venepuncture, immunization). There was inconsistency in the dose of sucrose that was effective and an optimal dose to be used in preterm and/or term infants could not be identified. Considerations for future research are to describe the painful procedure and intervention in detail, to use appropriate sample size to show a statistically significant reduction in pain, to use a multidimensional conceptualization of pain, to select outcome measures that are reliable and valid pain indicators and to account for the variation in the infant's response and context in which the pain is experienced. The use of repeated administrations of sucrose in neonates needs to be investigated. Use of sucrose in neonates that are very low birth weight, unstable and/or ventilated also needs to be addressed. (ABSTRACT TRUNCATED)

Analgesics↗