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PubMed2004

Valproate for schizophrenia.

BACKGROUND: Many people with schizophrenia do not achieve a satisfactory treatment response with ordinary antipsychotic drug treatment. In these cases, various add-on medications are used, among them valproate. OBJECTIVES: To review the effects of valproate for the treatment of schizophrenia and schizophrenia-like psychoses. SEARCH STRATEGY: The reviewers searched the Cochrane Schizophrenia Group's register (July 2002). This register is compiled of 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. We also contacted a pharmaceutical company and authors of relevant studies in order to identify further trials. SELECTION CRITERIA: All randomised controlled trials comparing valproate to antipsychotics or to placebo (or no intervention), whether as the sole agent or as an adjunct to antipsychotic medication for the treatment of schizophrenia and/or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: Citations and, where possible, abstracts were independently inspected by reviewers, papers ordered, re-inspected and quality assessed. Data were extracted independently by at least two reviewers. Dichotomous data were analysed using relative risks (RR) and the 95% confidence intervals (CI). Continuous data were analysed using weighted mean differences. Where possible the number needed to treat (NNT) or number needed to harm statistics were calculated. MAIN RESULTS: Five studies with a total of 379 participants were included. All trials examined the effectiveness of valproate as an adjunct to antipsychotics. With one exception the studies were small, short-term and incompletely reported. Adding valproate was as acceptable as adding placebo to antipsychotic drugs (n=130, RR leaving the study early 1.6 CI 0.8 to 3.1). No significant effect of using valproate as an adjunct to antipsychotic medication on the participants' global state or general mental state at the endpoint studies was evident. However, one study showed a quicker onset of action in the combination group. Participants receiving valproate more frequently experienced sedation than those in the placebo group. The effects of valproate on important subgroups such as those with schizophrenia and aggressive behaviour or those with schizoaffective disorder are unknown. REVIEWER'S CONCLUSIONS: Based on randomised trial-derived evidence which is currently available, there are no data to support or to refute the use of valproate as a sole agent for schizophrenia. There is some evidence for a more rapid improvement with valproate augmentation, but this effect vanished over time. Given this limited evidence, further large, simple well-designed and reported trials are necessary. These might focus on people with schizophrenia and violent episodes, on those with treatment resistant forms of the disorder and on people with schizoaffective disorders.

Antimanic Agents↗
PubMed2004

Light therapy for non-seasonal depression.

BACKGROUND: Efficacy of light therapy for non-seasonal depression has been studied without any consensus on its efficacy. OBJECTIVES: To evaluate clinical effects of bright light therapy in comparison to the inactive placebo treatment for non-seasonal depression. SEARCH STRATEGY: We searched the Depression Anxiety & Neurosis Controlled Trials register (CCDANCTR January 2003), comprising the results of searches of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 -), EMBASE (1980 -), CINAHL (1982 -), LILACS (1982 -), National Research Register, PsycINFO/PsycLIT (1974 -), PSYNDEX (1977 -), and SIGLE (1982 - ) using the group search strategy and the following terms: #30 = phototherapy or ("light therapy" or light-therapy). We also sought trials from conference proceedings and references of included papers, and contacted the first author of each study as well as leading researchers in the field. SELECTION CRITERIA: Randomized controlled trials comparing bright light with inactive placebo treatments for non-seasonal depression. DATA COLLECTION AND ANALYSIS: Data were extracted and quality assessment was made independently by two reviewers. The authors were contacted to obtain additional information. MAIN RESULTS: Twenty studies (49 reports) were included in the review. Most of the studies applied bright light as adjunctive treatment to drug therapy, sleep deprivation, or both. In general, the quality of reporting was poor, and many reviews did not report adverse effects systematically. The treatment response in the bright light group was better than in the control treatment group, but did not reach statistical significance. The result was mainly based on studies of less than 8 days of treatment. The response to bright light was significantly better than to control treatment in high-quality studies (standardized mean difference (SMD) -0.90, 95% confidence interval (CI) -1.50 to -0.31), in studies applying morning light treatment (SMD -0.38, CI -0.62 to -0.14), and in sleep deprivation responders (SMD -1.02, CI -1.60 to -0.45). Hypomania was more common in the bright light group compared to the control treatment group (risk ratio 4.91, CI 1.66 to 14.46, number needed to harm 8, CI 5 to 20). Twenty studies (49 reports) were included in the review. Most of the studies applied bright light as adjunctive treatment to drug therapy, sleep deprivation, or both. Treatment REVIEWERS' CONCLUSIONS: For patients suffering from non-seasonal depression, bright light therapy offers modest though promising antidepressive efficacy, especially when administered during the first week of treatment, in the morning, and as an adjunctive treatment to sleep deprivation responders. Hypomania as a potential adverse effect needs to be considered. Due to limited data and heterogeneity of studies these results need to be interpreted with caution.

Depression↗
PubMed2006

Chemotherapy for metastatic carcinoma of the esophagus and gastro-esophageal junction.

BACKGROUND: More than 50% of patients with esophageal cancer have metastatic disease at presentation. The use of chemotherapy for this patient group is increasing with the intention of local and distant tumor control, improving quality of life and prolongation of survival. OBJECTIVES: To assess the effectiveness of a) chemotherapy versus best supportive care or b) different chemotherapy regimes against each other, in metastatic esophageal carcinoma. SEARCH STRATEGY: Searches were conducted on the Cochrane Central register of Controlled Trials--CENTRAL (which includes the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register) on The Cochrane Library (Issue 1 2004) MEDLINE (1966 to February 2004), EMBASE (1980 to February 2004) and Cancerlit. Reference lists from trials selected by electronic searching were handsearched to identify further relevant trials. Published abstracts from conference proceedings from the United European Gastroenterology Week (published in Gut) and Digestive Disease Week (published in Gastroenterology) were handsearched. The search was updated in February 2005 and February 2006. Members of the Cochrane UGPD Group, and experts in the field were contacted and asked to provide details of outstanding clinical trials and any relevant unpublished materials SELECTION CRITERIA: Randomized controlled trials comparing chemotherapy versus best supportive care, or different chemotherapy regimes against each other in patients with metastatic carcinoma of the esophagus or gastro-esophageal junction. DATA COLLECTION AND ANALYSIS: Two authors (MYVH/EJK) extracted data and assessed trial quality. Study authors were contacted to obtain subgroup results of patients with metastatic esophageal carcinoma. MAIN RESULTS: Only two RCTs with a total of 42 participants compared chemotherapy with best supportive care for metastatic esophageal cancer. No survival benefit was shown for chemotherapy treatment in these RCTs. Five RCTs with a total of 1242 participants compared different chemotherapy regimes. Due to variation in patient population and chemotherapy regimes, it was not possible to perform a formal pooled analysis. There was no consistent benefit of any specific chemotherapy regimen. AUTHORS' CONCLUSIONS: There is a need for well designed, adequately powered, phase III trials comparing chemotherapy versus best supportive care for patients with metastatic esophageal cancer. Chemotherapy agents with promising response rates and tolerable toxicity are cisplatin, 5-fluorouracil (5-FU), paclitaxel and antracyclins. Future trials comparing palliative treatment modalities should assess quality of life with validated quality of life measures.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2003

Totally implantable vascular access devices for cystic fibrosis.

BACKGROUND: Totally implantable vascular access devices are widely used in people with cystic fibrosis to provide intermittent venous access for therapeutic infusions. Their use is associated with some complications such as thrombosis, embolism and infection. OBJECTIVES: To assess if totally implantable venous access devices are a safe and effective route for providing venous access for intermittent administration of intravenous antibiotics in people with cystic fibrosis, also to assess strategies to reduce possible complications of totally implantable venous access devices (e.g. anticoagulants to reduce the risk of thrombosis). SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register which comprises references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings. Date of the most recent search: May 2003. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials which compared the use of totally implantable venous access devices in people with cystic fibrosis to other means of vascular access, trials which compared the different types of these devices against each other and trials which assessed strategies to reduce complications of these devices. DATA COLLECTION AND ANALYSIS: No relevant trials were identified. MAIN RESULTS: No trials were included in this review. REVIEWER'S CONCLUSIONS: Totally implantable vascular access devices are widely used in people with cystic fibrosis to provide intermittent venous access for therapeutic infusions. Reports of their use in people with cystic fibrosis suggest that they are safe and effective. These reports also suggest that certain interventions might reduce the risk of complications; however, it is disappointing that these reports have not been assessed by randomised controlled trials. This systematic review identifies the need for a multicentre randomised controlled trial assessing both efficacy and possible adverse effects of totally implantable venous access devices in cystic fibrosis.

Catheters, Indwelling↗
PubMed2006

Herbal medicines for treatment of irritable bowel syndrome.

BACKGROUND: Traditional herbal therapies have been used for a long time to treat gastrointestinal disorders including irritable bowel syndrome, and their effectiveness from clinical research evidence needs to be systematically reviewed. OBJECTIVES: To assess the effectiveness and safety of herbal medicines in patients with irritable bowel syndrome. SEARCH STRATEGY: We searched the following electronic databases till July 2004: The Cochrane Library (CENTRAL), MEDLINE, EMBASE, AMED, LILACS, the Chinese Biomedical Database, combined with hand searches of Chinese journals and conference proceedings till end of 2003. No language restriction was used. SELECTION CRITERIA: Randomised controlled trials of herbal medicines compared with no treatment, placebo, pharmacological interventions were included. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two authors. The methodological quality of trials was evaluated using the components of randomisation, allocation concealment, double blinding, and inclusion of randomised participants. MAIN RESULTS: Seventy-five randomised trials, involving 7957 participants with irritable bowel syndrome, met the inclusion criteria. The methodological quality of three double-blind, placebo-controlled trials was high, but the quality of remaining trials was generally low. Seventy-one different herbal medicines were tested in the included trials, in which herbal medicines were compared with placebo or conventional pharmacologic therapy. Herbal medicines were also combined with conventional therapy and compared to conventional therapy alone.Compared with placebo, a Standard Chinese herbal formula, individualised Chinese herbal medicine, STW 5 and STW 5-II, Tibetan herbal medicine Padma Lax, traditional Chinese formula Tongxie Yaofang, and Ayurvedic preparation showed significantly improvement of global symptoms. Compared with conventional therapy in 65 trials testing 51 different herbal medicines, 22 herbal medicines demonstrated a statistically significant benefit for symptom improvement, and 29 herbal medicines were not significantly different than conventional therapy. In nine trials that evaluated herbal medicine combined with conventional therapy, six tested herbal preparations showed additional benefit from the combination therapy compared with conventional monotherapy. No serious adverse events from the herbal medicines were reported. AUTHORS' CONCLUSIONS: Some herbal medicines may improve the symptoms of irritable bowel syndrome. However, positive findings from less rigorous trials should be interpreted with caution due to inadequate methodology, small sample sizes, and lack of confirming data. Some herbal medicines deserve further examination in high-quality trials.

Drugs, Chinese Herbal↗
PubMed2006

Preoperative hair removal to reduce surgical site infection.

BACKGROUND: The preparation of people for surgery has traditionally included the routine removal of body hair from the intended surgical wound site. However, there are studies which claim that pre-operative hair removal is deleterious to patients, perhaps by causing surgical site infections (SSIs), and should not be carried out. OBJECTIVES: The primary objective of this review was to determine if routine pre-operative hair removal results in fewer SSIs than not removing hair. SEARCH STRATEGY: The reviewers searched the Cochrane Wounds Group Specialised Register (October 2005), The Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 2005), EMBASE (1980 to 2005), CINAHL (1982 to 2005), and the ZETOC database of conference proceedings (1993 to 2005). We also contacted manufacturers of hair removal products. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing hair removal with no hair removal, different methods of hair removal, hair removal conducted at different times prior to surgery and hair removal carried out in different settings. DATA COLLECTION AND ANALYSIS: Three authors independently assessed the relevance and quality of each trial. Data was extracted independently by one author and cross checked for accuracy by a second author. MAIN RESULTS: Eleven RCTs were included in this review. Three trials involving 625 people compared hair removal using either depilatory cream or razors with no hair removal and found no statistically significant difference between the groups in terms of surgical site infections. No trials were identified which compared clipping with no hair removal. Three trials involving 3193 people compared shaving with clipping and found that there were statistically significantly more SSIs when people were shaved rather than clipped (RR 2.02, 95%CI 1.21 to 3.36). Seven trials involving 1420 people compared shaving with removing hair using a depilatory cream but found no statistically significant difference between the two groups in SSI rates. No trials were found that compared clipping with a depilatory cream.One trial involving 537 people compared shaving on the day of surgery with shaving the day before surgery and one trial compared clipping on the day of surgery with clipping the day before surgery; neither trial found a statistically significant difference in the number of SSIs. No trials were found that compared depilatory cream at different times or that compared hair removal in different settings. AUTHORS' CONCLUSIONS: The evidence finds no difference in SSIs among patients who have had hair removed prior to surgery and those who have not. If it is necessary to remove hair then clipping results in fewer SSIs than shaving using a razor. There is insufficient evidence regarding depilatory cream compared with shaving using a razor. There is no difference in SSIs when patients are shaved or clipped one day before surgery or on the day of surgery.

Hair Removal↗
PubMed2006

Preoperative hair removal to reduce surgical site infection.

BACKGROUND: The preparation of people for surgery has traditionally included the routine removal of body hair from the intended surgical wound site. However, there are studies which claim that pre-operative hair removal is deleterious to patients, perhaps by causing surgical site infections (SSIs), and should not be carried out. OBJECTIVES: The primary objective of this review was to determine if routine pre-operative hair removal results in fewer SSIs than not removing hair. SEARCH STRATEGY: The reviewers searched the Cochrane Wounds Group Specialised Register (October 2005), The Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 2005), EMBASE (1980 to 2005), CINAHL (1982 to 2005), and the ZETOC database of conference proceedings (1993 to 2005). We also contacted manufacturers of hair removal products. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing hair removal with no hair removal, different methods of hair removal, hair removal conducted at different times prior to surgery and hair removal carried out in different settings. DATA COLLECTION AND ANALYSIS: Three authors independently assessed the relevance and quality of each trial. Data was extracted independently by one author and cross checked for accuracy by a second author. MAIN RESULTS: Eleven RCTs were included in this review. Three trials involving 625 people compared hair removal using either depilatory cream or razors with no hair removal and found no statistically significant difference between the groups in terms of surgical site infections. No trials were identified which compared clipping with no hair removal. Three trials involving 3193 people compared shaving with clipping and found that there were statistically significantly more SSIs when people were shaved rather than clipped (RR 2.02, 95%CI 1.21 to 3.36). Seven trials involving 1213 people compared shaving with removing hair using a depilatory cream and found that there were statistically significantly more SSIs when people were shaved than when a cream was used (RR 1.54, 95%CI 1.05 to 2.24). No trials were found that compared clipping with a depilatory cream. One trial compared shaving on the day of surgery with shaving the day before surgery and one trial compared clipping on the day of surgery with clipping the day before surgery; neither trial found a statistically significant difference in the number of SSIs. No trials were found that compared depilatory cream at different times or that compared hair removal in different settings. AUTHORS' CONCLUSIONS: The evidence finds no difference in SSIs among patients who have had hair removed prior to surgery and those who have not. If it is necessary to remove hair then both clipping and depilatory creams results in fewer SSIs than shaving using a razor. There is no difference in SSIs when patients are shaved or clipped one day before surgery or on the day of surgery.

Hair Removal↗
PubMed2003

Noninvasive positive pressure ventilation as a weaning strategy for intubated adults with respiratory failure.

BACKGROUND: Noninvasive positive pressure ventilation (NPPV) provides ventilatory support without the need for an invasive airway. Interest has emerged in using NPPV to facilitate earlier removal of the endotracheal tube and decrease complications associated with prolonged intubation. OBJECTIVES: To summarize the evidence comparing NPPV and invasive positive pressure ventilation (IPPV) weaning on clinical outcomes in intubated adults with respiratory failure. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, issue 2, 2003), MEDLINE (January 1966 to July 2003) and EMBASE (January 1980 to July 2003) for randomized controlled trials comparing NPPV and IPPV weaning. Additional data sources included personal files, conference proceedings and author contact. SELECTION CRITERIA: Randomized and quasi-randomized studies comparing early extubation with immediate application of NPPV to IPPV weaning in intubated adults with respiratory failure. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and abstracted data according to prespecified criteria. Sensitivity and subgroup analyses were planned to assess the impact of (i) excluding quasi-randomized trials and (ii) the etiology of respiratory failure on outcomes. MAIN RESULTS: We identified eleven trials, of which five were included, involving 171 participants with predominantly chronic obstructive pulmonary disease. Overall, the included studies were of moderate to good quality. Compared to the IPPV strategy, the NPPV strategy decreased mortality (RR 0.41, 95% CI 0.22 to 0.76), the incidence of ventilator associated pneumonia (RR 0.28, 95% CI 0.09 to 0.85), intensive care unit length of stay (WMD -6.88 days, 95% CI -12.60 to -1.15), hospital length of stay (WMD -7.33 days, 95%CI -14.05 to -0.61), total duration of mechanical support (WMD -7.33 days, 95% CI -11.45 to -3.22) and the duration of endotracheal mechanical ventilation (WMD -6.79 days, 95% CI -11.70 to -1.87). There was no effect of NPPV on weaning failures or the duration of mechanical support related to weaning and insufficient data to pool adverse events or quality of life. Excluding a single quasi-randomized trial maintained the significant reduction in mortality and ventilator associated pneumonia. Subgroup analyses suggested that the mortality benefit of the NPPV approach is greater in patients with chronic obstructive pulmonary disease. REVIEWER'S CONCLUSIONS: Summary estimates from five studies of moderate to good quality demonstrated a consistent positive effect on overall mortality. At present, use of NPPV to facilitate weaning in mechanically ventilated patients, with predominantly chronic obstructive lung disease, is associated with promising, although insufficient, evidence of net clinical benefit.

Adult↗
PubMed2005

Antihypertensive agents for preventing diabetic kidney disease.

BACKGROUND: Twenty to sixty percent of diabetic patients are affected by hypertension and antihypertensive agents are used to treat this condition. These agents are also used to prevent the onset of kidney disease both in normotensive and hypertensive diabetics. OBJECTIVES: To evaluate the comparative effects of antihypertensive agents in patients with diabetes and normoalbuminuria. SEARCH STRATEGY: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, conference proceedings, and contact with investigators were used to identify relevant trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing any antihypertensive agent with placebo or another agent in hypertensive or normotensive patients with diabetes and no kidney disease (albumin excretion rate < 30 mg/d) were included. DATA COLLECTION AND ANALYSIS: Two investigators independently extracted data on renal outcomes and other patient relevant outcomes (all-cause mortality, serious cardiovascular events), and assessed quality of trials. Analysis was by a random effects model and results expressed as relative risk (RR) and 95% confidence intervals (CI). MAIN RESULTS: Sixteen trials (7603 patients) were identified, six of angiotensin converting enzyme inhibitors (ACEi) versus placebo, six of ACEi versus calcium channel blockers (CCBs), one of ACEi versus CCBs or combined ACEi and CCBs and three of ACEi versus other agents. Compared to placebo, ACEi significantly reduced the development of microalbuminuria (six trials, 3840 patients: RR 0.60, 95% CI 0.43 to 0.84) but not doubling of creatinine (three trials, 2683 patients: RR 0.81, 95% CI 0.24 to 2.71) or all-cause mortality (four trials, 3284 patients: RR 0.81, 95% CI 0.64 to 1.03). Compared to CCBs, ACEi significantly reduced progression to microalbuminuria (four trials, 1210 patients: RR 0.58, 95% CI 0.40 to 0.84). AUTHORS' CONCLUSIONS: A significant reduction in the risk of developing microalbuminuria in normoalbuminuric patients with diabetes has been demonstrated for ACEi only. It appears that the effect of ACEi is independent of baseline blood pressure, renal function and type of diabetes, but data is too sparse to be confident that these are not important effect modifiers and an individual patient data meta-analysis is required.

Albuminuria↗
PubMed2005

Colony stimulating factors for prevention of myelosupressive therapy induced febrile neutropenia in children with acute lymphoblastic leukaemia.

BACKGROUND: Acute lymphoblastic leukaemia (ALL) is the most common cancer in childhood and febrile neutropenia is a potentially life-threatening side effect of its treatment. Current treatment consists of supportive care plus antibiotics. Clinical trials have attempted to evaluate the use of colony-stimulating factors (CSF) as additional therapy to prevent febrile neutropenia in children with ALL. The individual trials do not show whether there is significant benefit or not. Systematic review provides the most reliable assessment and the best recommendations for practice. OBJECTIVES: To evaluate the safety and effectiveness of the addition of G-CSF or GM-CSF to myelosuppressive chemotherapy in children with ALL, in an effort to prevent the development of febrile neutropenia. Evaluation of number of febrile neutropenia episodes, length to neutrophil count recovery, incidence and length of hospitalisation, number of infectious disease episodes, incidence and length of treatment delays, side effects (flu-like syndrome, bone pain and allergic reaction), relapse and overall mortality (death). SEARCH STRATEGY: The search covered the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CANCERLIT, LILACS, and SciElo. We manually searched records of conference proceedings of ASCO and ASH from 1985 to 2003 as well as databases of ongoing trials. We consulted experts and scanned references from the relevant articles. SELECTION CRITERIA: We looked for randomised controlled trials (RCTs) comparing CSF with placebo or no treatment as primary or secondary prophylaxis to prevent febrile neutropenia in children with ALL. DATA COLLECTION AND ANALYSIS: Two authors independently selected, critically appraised studies and extracted relevant data. The end points of interest were:* Primary end points: number of febrile neutropenia episodes and overall mortality (death) * Secondary end points: time to neutrophil count recovery, incidence and length of hospitalisation, number of infectious diseases episodes, incidence and length of treatment delays, side effects (flu-like syndrome, bone pain and allergic reaction) and relapse. We conducted a meta-analysis of these end points and expressed the results as Peto odds ratios. For continuous outcomes we calculated a weighted mean difference and a standardised mean difference. For count data, meta-analysis of the logarithms of the rate ratios using generic inverse variance was employed. MAIN RESULTS: We scanned more than 5500 citations and included six studies with a total of 332 participants in the analysis. There were insufficient data to assess the effect on survival. The use of CSF significantly reduced the number of episodes of febrile neutropenia episodes (Rate Ratio = 0.63; 95% confidence interval (CI) 0.46 to 0.85; p =0.003, with substantial heterogeneity), the length of hospitalisation (weighted mean difference (WMD) = -1.58; 95% CI -3.00 to -0.15; p = 0.03), and number of infectious diseases episodes (Rate Ratio=0.44; 95%CI 0.24 to 0.80; p=0.002). In spite of these results, CSF did not influence the length of episodes of neutropenia (WMD = -1.11; 95% CI -3.55 to 1.32; p = 0.4) or delays in chemotherapy courses (Rate Ratio=0.77; 95%CI 0.49 to 1,23; p=0.28) . AUTHORS' CONCLUSIONS: Children with ALL treated with CSF benefit from shorter hospitalisation and fewer infections. However, there was no evidence for a shortened duration of neutropenia nor fewer treatment delays, and no useful information about survival. The role of CSF regarding febrile neutropenia episodes is still uncertain. Although current data shows statistical benefit for CSF use, substantial heterogeneity between included trials does not allow this conclusion.

Child↗
PubMed2005

Treatment for methaqualone dependence in adults.

BACKGROUND: Methaqualone is a potent quinazoline, a class of sedative-hypnotics, that has a high potential for abuse. While the oral use of methaqualone (Quaalude, Mandrax) has waned in western countries since the mid-late 1980's, the practice of smoking methaqualone is a serious public health problem in South Africa, other parts of Africa and India. In the context of diminishing resources devoted to substance abuse treatment in regions affected by methaqualone abuse, it would be desirable to base treatment on the best evidence available. This review aimed to provide health care workers, policy-makers and consumers with the necessary information to make decisions regarding effective treatment of this highly dependence-producing drug. OBJECTIVES: To compare the effectiveness of any type of pharmacological or behavioural treatment administered in either an in-patient or out-patient setting compared with either a placebo or no treatment or a waiting list, or with another form of treatment administered in either an in- or out-patient setting. SEARCH STRATEGY: The authors searched the following databases: Cochrane Drugs and Alcohol Group'Register of Trials (February 2004); Cochrane Central Register of Controlled Trials (CENTRAL-The Cochrane Library, Issue 2, 2004); MEDLINE (OVID - January 1966 to february 2004), PsycInfo (OVID - January 1967 to february 2004). Relevant conference proceedings and reference lists of relevant articles were hand-searched. Broad internet searches were conducted and contact made with experts in the field. SELECTION CRITERIA: All randomised controlled trials and quasi-randomised trials of the effectiveness of treatment programmes (in- or out-patient) for methaqualone dependence and abuse were considered for inclusion in this review. DATA COLLECTION AND ANALYSIS: The authors independently assessed study eligibility and quality. MAIN RESULTS: No studies were found that met the inclusion criteria. AUTHORS' CONCLUSIONS: To date, no randomized controlled trials appear to have been conducted. Consequently, the effectiveness of inpatient versus outpatient treatment, psychosocial treatment versus no treatment, and pharmacological treatments versus placebo for methaqualone abuse or dependence has yet to be established.

Adult↗
PubMed2003

Antipsychotic drug treatment for elderly people with late-onset schizophrenia.

BACKGROUND: At least 0.1% of the world's elderly population have a diagnosis of schizophrenia that started late in life and prognosis may be made worse by delay and avoidance of treatment. OBJECTIVES: To assess the effects of antipsychotic drugs for elderly people with late-onset schizophrenia. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group trials register (September 2002). This register is compiled by methodical searches of BIOSIS, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Dissertation Abstracts, EMBASE, LILACS, MEDLINE, PSYNDEX, PsycINFO, RUSSMED, Sociofile, supplemented with hand searching of relevant journals and numerous conference proceedings. References of all identified studies were also inspected for more trials. SELECTION CRITERIA: All relevant randomised controlled trials that compared atypical antipsychotic drugs with other treatments for elderly people (at least 80% of whom should be over 65 years of age) with a recent (within five years) diagnosis of schizophrenia or schizophrenia like illnesses such as delusional disorder, schizoaffective disorder, schizophreniform psychosis or paraphrenia. DATA COLLECTION AND ANALYSIS: All citations were inspected by the principal reviewer (SA) and papers ordered and re-inspected (by IA, NAQ, SP) to ensure reliable selection. Methodological quality of trials would have been assessed using the Cochrane Reviewers' Handbook criteria and data would have been independently extracted. Data were to have been excluded if loss to follow up was greater than 50%. For homogeneous dichotomous data the relative risk (RR), 95% confidence interval (CI), and the number needed to treat (NNT) and number needed to harm (NNH), were to have been calculated based on an intention-to-treat basis. MAIN RESULTS: Electronic searching produced 119 references, 65 of which were selected for examination of the full text. These referred to 38 studies. Not one study met the entry criteria for this review. Most were randomised but involved elderly people with chronic schizophrenia. Four trials involved people with schizophrenia, and did include a minority who suffered from paraphrenia. Outcomes for this sub-group, however, were not reported. One randomised study (n=18) did focus on late onset schizophrenia, but unfortunately the two treatments under evaluation, remoxipride and thioridazine, have both been withdrawn from use. REVIEWER'S CONCLUSIONS: There is no trial-based evidence upon which to base guidelines for the treatment of late onset schizophrenia. This review highlights the need for good quality controlled clinical trials to address the effects of antipsychotic drugs for this group. Such trials are possible. Until they are undertaken people with late onset schizophrenia will be treated by doctors using clinical judgement and habit to guide prescribing.

Age of Onset↗
PubMed2003

Compression therapy for treating stage I and II (Widmer) post-thrombotic syndrome.

BACKGROUND: Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis characterised by chronic complaints, swelling, and skin changes in the affected limb. One in every three patients with deep vein thrombosis develops post-thrombotic complications within five years. OBJECTIVES: To assess the effectiveness of compression therapy in patients with stage I and II post-thrombotic syndrome according to the classification of Widmer. Interventions of interest included elastic compression stockings and mechanical devices, compared with no intervention and with each other. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Specialised Trials Register (last searched April 2003), and the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched Issue 1, 2003). In addition, journals, conference proceedings and bibliographies were hand searched. Personal contact with other investigators involved in the clinical area was sought to get information about missed or unpublished studies. SELECTION CRITERIA: Trials that evaluated compression therapy for stage I and II (Widmer) post-thrombotic syndrome. Primary outcomes were leg ulceration, or deterioration of post-thrombotic syndrome. There were no restrictions on date or language. One reviewer (DNK) assessed titles and abstracts for relevance. This was verified independently by a second reviewer (MWCS). DATA COLLECTION AND ANALYSIS: Details of eligible studies were extracted and summarised using data extraction sheets. Data extraction was undertaken by one reviewer (DNK) and verified by a second reviewer (MHP). MAIN RESULTS: Only two trials were identified that addressed physical treatment of post-thrombotic syndrome. Both trials were initiated by the same group of investigators. A cross-over study lasting two months compared low and high pressure with intermittent compression units for severe post-thrombotic syndrome. This showed a beneficial effect of higher pressures. The second study, in patients with mild to moderate post-thrombotic symptoms, showed no effect of elastic compression stockings (30-40 mm Hg at the ankle region) when compared to 'placebo' stockings that were one to two sizes too large. REVIEWER'S CONCLUSIONS: There is some evidence of a beneficial effect of intermittent pneumatic compression units, but the study was too small and of too short a duration to draw strong conclusions. Further research is needed in order to assess whether intermittent pneumatic compression units give long term reduction and relief of the symptoms caused by post-thrombotic syndrome, and prevent deterioration and leg ulceration. The use of elastic compression stockings to treat post-thrombotic syndrome cannot be supported on the basis of the currently available data.

Bandages↗
PubMed2006

Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis.

BACKGROUND: Lower respiratory tract infection with Pseudomonas aeruginosa (P. aeruginosa) occurs in most people with cystic fibrosis. Once chronic infection is established, P. aeruginosa is virtually impossible to eradicate and is associated with increased mortality and morbidity. Early infection may be easier to eradicate. OBJECTIVES: To determine whether antibiotic treatment of early P. aeruginosa infection in children and adults with cystic fibrosis eradicates the organism and improves clinical and microbiological outcome. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of most recent search: May 2004 SELECTION CRITERIA: We included randomised controlled trials of people with cystic fibrosis, in whom P. aeruginosa had recently been isolated from respiratory secretions. We compared combinations of inhaled, oral or intravenous antibiotics with placebo or usual treatment (or both) or other combinations of inhaled, oral or intravenous antibiotics. We excluded non-randomised trials, cross-over trials, and those utilising historical controls. DATA COLLECTION AND ANALYSIS: Both authors independently assessed selected trials, assessed methodological quality and extracted data. MAIN RESULTS: The search identified 15 trials. Three trials (69 participants) were eligible for inclusion. There is evidence from two randomised controlled trials, of questionable methodological quality, that treatment of early P. aeruginosa infection with inhaled tobramycin results in microbiological eradication of the organism from respiratory secretions more often than placebo and that this effect may persist for up to 12 months, however incomplete data from one of the trials precludes an accurate analysis. One randomised controlled trial of oral ciprofloxacin and nebulised colisitin versus usual treatment was identified. This trial was of poor methodological quality. The results suggested treatment of early infection results in microbiological eradication of P. aeruginosa more often than usual treatment, after two years, RR 0.24 (95% CI 0.06 to 0.96). There is insufficient evidence to determine whether antibiotic strategies for the eradication of early P. aeruginosa decrease mortality or morbidity, improve quality of life, or are associated with adverse effects compared to placebo or standard treatment. AUTHORS' CONCLUSIONS: From the three trials included in this review, there is some evidence that antibiotic treatment of early P. aeruginosa results in short-term eradication but it remains uncertain whether there is clinical benefit to people with cystic fibrosis.

Anti-Bacterial Agents↗
PubMed2004

Treatments for priapism in boys and men with sickle cell disease.

BACKGROUND: Sickle cell disease comprises a group of genetic haemoglobin disorders. The predominant symptom associated with sickle cell disease is pain resulting from the occlusion of small blood vessels by abnormally 'sickle-shaped' red blood cells. There are other complications, including chronic organ damage and prolonged painful erection of the penis, known as priapism. Severity of sickle cell disease is variable, and treatment is usually symptomatic. Priapism affects up to half of all men with sickle cell disease, however there is no consistency in treatment. We therefore need to know the best way of treating this complication in order to offer an effective interventional approach to all affected individuals. OBJECTIVES: To assess the benefits and risks of different treatments for stuttering (repeated short episodes) and fulminant (lasting for six hours or more) priapism in sickle cell disease. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register, which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched the internet for further references. Date of the most recent search of the Group's trials register: August 2004. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing non-surgical or surgical treatment with placebo or no treatment, or with another intervention for stuttering or fulminant priapism. DATA COLLECTION AND ANALYSIS: The reviewers independently extracted data and assessed study quality. MAIN RESULTS: Only one study of 11 participants was identified and met the criteria for inclusion in this review. This study compared stilboestrol to placebo. The only outcome specified in this review, which was assessed in the study, was reduction in frequency of stuttering priapism and there was no difference between the groups, relative risk 0.18 (95%CI 0.01 to 2.54). REVIEWERS' CONCLUSIONS: There is no evidence for the benefits or risks of the different treatments for both stuttering and fulminant priapism in sickle cell disease. This systematic review has clearly identified the need for well-designed, adequately-powered, multicentre randomised controlled trials assessing the effectiveness of specific interventions for priapism in sickle cell disease.

Anemia, Sickle Cell↗
PubMed2004

Percutaneous central venous catheters versus peripheral cannulae for delivery of parenteral nutrition in neonates.

BACKGROUND: Parenteral nutrition for newborn infants may be delivered via short peripheral cannulae or central venous catheters, which are usually sited percutaneously. The method of delivery may affect nutrient input, and consequently growth and development. Although potentially more difficult to site, percutaneous central venous catheters may be more stable than peripheral cannulae, and need less frequent replacement. These methods may also be associated with different risks of adverse events, including acquired systemic infection and extravasation injury. OBJECTIVES: To review the evidence from randomised controlled trials that, in newborn infants who require parenteral nutrition, infusion via a percutaneous central venous catheter versus a peripheral cannula improves nutrient input, and growth and development, without increasing adverse consequences including systemic infection, or extravasation injuries. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2003), MEDLINE (1966 - October 2003), EMBASE (1980 - October 2003), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised controlled trials that compared the effect of delivering parenteral nutrition via percutaneous central venous catheters versus peripheral cannulae in newborn infants. DATA COLLECTION AND ANALYSIS: We extracted the data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by each author, and synthesis of data using relative risk, risk difference and mean difference. MAIN RESULTS: We found three trials eligible for inclusion. These recruited a total of 262 infants and reported a number of different outcomes. One study showed that the use of a percutaneous central venous catheter was associated with a decreased risk of cumulative nutritional deficit during the trial period: Mean difference in the percentage of the prescribed nutritional intake actually received: -7.1% (95% confidence interval -11.2, -3.2). In another trial, infants in the percutaneous central venous catheter group needed significantly fewer catheters/cannulae per infant during the trial period: Mean difference in the number of catheters/cannulae per infant: -3.2 (95% confidence interval -5.13, -1.27). Meta-analysis of data from two trials did not find any evidence of an effect on the incidence of systemic infection: Typical relative risk: 0.90 (95% confidence interval 0.62, 1.32); typical risk difference: -0.04 (95% confidence interval -0.17, 0.10). REVIEWERS' CONCLUSIONS: Data from one small study suggest that the use of percutaneous central venous catheters to deliver parenteral nutrition in newborn infants improves nutrient input. The significance of this in relation to longer-term growth and developmental outcomes is unclear. Another study suggested that the use of percutaneous central venous catheters rather than peripheral cannulae decreases the number of catheters/cannulae needed to deliver the nutrition. We have not found any evidence that percutaneous central venous catheter use increases the risk of adverse events, particularly systemic infection.

Catheterization, Central Venous↗
PubMed2006

Purine antagonists for chronic lymphocytic leukaemia.

BACKGROUND: Recent trials suggest improved response rates for purine antagonists compared to alkylator-based regimens in the treatment of B-CLL. However, none was able to show a survival advantage. OBJECTIVES: To determine if there is any advantage of purine antagonists compared to alkylating agents (alone or in combination) in the treatment of patients with previously untreated B-CLL. SEARCH STRATEGY: Medical databases (Cochrane Library, MEDLINE, EMBASE), conference proceedings and internet-based trial registers were searched electronically and/or by hand (1990-2003). All references were checked for further trial information. We also contacted experts in the field and pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials comparing purine antagonists as single agents with alkylator-based regimens in patients with previously untreated B-CLL were included. We included full-text and abstract publications as well as unpublished data. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment were done in duplicate by two independent reviewers. Missing data were obtained from original authors. Endpoints included overall survival, overall response rate, rate of complete remissions, progression-free survival, treatment-related morbidity and mortality. MAIN RESULTS: Five trials with 1838 randomised patients were included. There is some evidence for improved overall survival after treatment with purine antagonists compared to alkylators, but statistical significance was not reached (HR 0.89 [95% CI 0.78-1.01], 4 trials, n=1638). However, the relative risk for achieving an overall response (RR 1.22 [95% CI 1.13-1.31], 5 trials, n=1751) and complete remission (RR 1.94 [95% CI 1.65-2.28], 5 trials, n=1751) was significantly higher, resulting in a longer progression-free survival (HR 0.70 [95% CI 0.61-0.82], 4 trials, n=1638). Incidence of grade III/IV infections was significantly higher in patients receiving treatment with purine antagonists (RR 1.83 [95% 1.30-2.58], 4 trials, n=1620). There was no significant difference concerning the relative risk for grade III/IV neutropenia (RR 1.14 [95% CI 0.98-1.34], 4 trials, n=1620) and therapy-related mortality (RR 0.94 [95% CI 0.45-1.95]). Overall incidence of hemolytic anemia was low, but significantly increased in the purine antagonist group (RR 3.36 [95% CI 1.27-8.91], 3 trials, n=1258). AUTHORS' CONCLUSIONS: Despite significantly increased overall response and complete remission rates and longer progression-free survival with first-line treatment of B-CLL patients with single-agent purine antagonists, we were not able to detect a statistically significant improvement of overall survival compared to alkylator-based regimens. Furthermore, the use of purine antagonists also augments the risk for grade III/IV infections and hemolytic anemia.

Antineoplastic Agents↗
PubMed2006

Endoscopic mucosal resection for early gastric cancer.

BACKGROUND: The treatment of early gastric cancer (EGC) using an endoscopy, namely, endoscopic mucosal resection (EMR), has been adopted for about 20 years, but the effectiveness and the safety of the modality are still controversial. The quality of these trials has not been assessed systematically. OBJECTIVES: The purpose of this review was to compare the effectiveness and the safety of EMR with gastrectomy for the treatment of EGC. SEARCH STRATEGY: Searches were conducted on the Cochrane Central Register of Controlled Trials - CENTRAL (which includes the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register) on The Cochrane Library (Issue 1 2005) MEDLINE (1966 to March 2005) and EMBASE (1980 to March 2005), CINAHL (1985-March 2005) and CBM (Chinese BioMedical Database 1982 -2002). Reference lists from trials selected by electronic searching were handsearched to identify further relevant trials. Published abstracts from conference proceedings from the United European Gastroenterology Week (published in Gut) and Digestive Disease Week (published in Gastroenterology) were handsearched. Members of the Cochrane UGPD Group, and experts in the field were contacted and asked to provide details of outstanding clinical trials and any relevant unpublished materials SELECTION CRITERIA: All randomised controlled trials of EGC patients involving a treatment arm of EMR and a comparison arm of gastrectomy were to be included, but no RCTs were found. DATA COLLECTION AND ANALYSIS: Three reviewers (YP Wang, C Bennett and T Pan) independently assessed the eligibility of potential trials and extracted the data. MAIN RESULTS: There are no included randomised control trials for the systematic review. Available evidence derived from non-randomised controlled trials is discussed in the main text of this review. AUTHORS' CONCLUSIONS: There is a lack of randomised controlled trials in which EMR is compared with gastrectomy for EGC. There is a need for well designed randomised controlled trials to determine the effects of EMR compared to gastrectomy.

Gastrectomy↗