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PubMed2005

Surgery for thumb (trapeziometacarpal joint) osteoarthritis.

BACKGROUND: Surgery has been used to treat persistent pain and dysfunction at the base of the thumb. However, there is no evidence to suggest that any one surgical procedure is superior to another. OBJECTIVES: To investigate the effect of surgery in reducing pain and improving physical function, patient global assessment, range of motion, and strength in people with trapeziometacarpal osteoarthritis at 12 months. Additionally, it was the reviewers intention to investigate whether there was any improvement or deterioration in outcomes between the 12 months review and a 5 year follow-up. SEARCH STRATEGY: We searched the the following databases in the Cochrane Library 2004, Issue 4: Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects (DARE) as well as MEDLINE (1966-Dec 2004), CINAHL (1982-Dec 2004), AMED (1985-Dec 2004), and EMBASE (1974-Dec 2004). Database searches were supplemented by hand searching conference proceedings and reference lists from reviews and papers. SELECTION CRITERIA: Studies were included if they were: randomised, quasi-randomised or controlled trials; intervention was surgery; and pain, physical function, patient global assessment, range of motion, or strength was measured as an outcome. DATA COLLECTION AND ANALYSIS: Two independent reviewers examined the identified studies according to the inclusion criteria. Included studies were assessed for methodological quality and then data, including adverse effects, was extracted and cross-checked. Authors were contacted to provide missing information. MAIN RESULTS: Seven studies involving 384 participants were included. Studies of five surgical procedures were identified (trapeziectomy, trapeziectomy with interpositional arthroplasty, trapeziectomy with ligament reconstruction, trapeziectomy with ligament reconstruction and tendon interposition (LRTI), and joint replacement). All studies reported results of a mixed group of participants with Stage II-IV osteoarthritis, with a range of improvement across all stages of 27 to 57 mm on a 0-100 VAS scale for pain and 18-24 mm on a 0-100 VAS scale for physical function. No procedure demonstrated any superiority over another in terms of pain, physical function, patient global assessment, range of motion or strength. However, participants who underwent trapeziectomy had 16% fewer adverse effects (p=0<.001) than the other commonly-used procedures studied in this review; conversely, those who underwent trapeziectomy with ligament reconstruction and tendon interposition had 11% more (p=0.03) (including scar tenderness, tendon adhesion or rupture, sensory change, or Complex Regional Pain Syndrome (Type 1). AUTHORS' CONCLUSIONS: No one procedure produced greater strength than any other. Although this also appears to be the case for pain and physical function, there was insufficient evidence to be conclusive. Trapeziectomy is safer and has fewer complications than the other procedures studied in this review, and conversely trapeziectomy with LRTI has more.

Hand Joints↗
PubMed2005

Laxatives for the treatment of hemorrhoids.

BACKGROUND: Symptomatic hemorrhoids are a common medical condition, which increase in prevalence in women during pregnancy and postpartum. Although the evidence appears to be inconclusive, narrative reviews and clinical practice guidelines recommend the use of laxatives (and fiber) for the treatment of hemorrhoids and relief of symptoms. This is due to their safety and low cost. OBJECTIVES: To evaluate the impact of laxatives on a wide range of symptoms in people with symptomatic hemorrhoids. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2005), MEDLINE (1966 to 2005), EMBASE (1980 to 2005), CINAHL (1982 to 2005), BIOSIS, and AMED (Allied and Alternative Medicine Database), for eligible trials (including conference proceedings). We sought missing and additional information from authors, industry, and experts in the field. SELECTION CRITERIA: We selected all published and unpublished randomised controlled trials that compared any type of laxative to placebo or no therapy in any patient population. DATA COLLECTION AND ANALYSIS: Two authors independently screened studies for inclusion and retrieved all potentially relevant studies. Data were extracted from studies that met our selection criteria on study population, intervention used, pre-specified outcomes, and methodology. We extracted methodological information for the assessment of internal validity: existence and method of generation of the randomization schedule, and method of allocation concealment; blinding of caregivers and outcomes assessors; numbers of and reasons for participants lost to follow up; and use of validated outcome measures. MAIN RESULTS: Seven randomised trials enrolling a total of 378 participants to fiber or a non-fiber control were identified. Meta-analyses using random-effects models showed that laxatives in the form of fiber had a beneficial effect in the treatment of symptomatic hemorrhoids. The risk of not improving hemorrhoids and having persisting symptoms decreased by 53% in the fiber group (risk reduction (RR) 0.47, 95% CI 0.32 to 0.68). These results are compatible with large treatment effects regarding prolapse, pain, itching, although the pooled analyses showed a tendency toward no-effect for these parametres. The effect on bleeding showed a significant difference in favour of the fiber (RR 0.50, 95% CI 0.28 to 0.89). Studies including data on multiple follow ups (usually after six weeks and three months) showed consistent results over time. However, we have to stress two possible limitations of this review: the risk of publication bias, and only moderate study quality. AUTHORS' CONCLUSIONS: The use of fiber shows a consistent beneficial effect for relieving overall symptoms and bleeding in the treatment of symptomatic hemorrhoids.

Cathartics↗
PubMed2006

Tiagabine in the treatment of acute affective episodes in bipolar disorder: efficacy and acceptability.

BACKGROUND: Bipolar disorder is a common recurrent illness with high levels of chronicity. Treatment resistance persists despite the use of established medications, such as lithium and valproate. New medications are required for the treatment of refractory cases. Some open-label reports have suggested that the anticonvulsant tiagabine may be efficacious in bipolar disorder. There is a need to clarify the evidence available, in the form of randomised controlled trials, for its use in the treatment of acute affective episodes in bipolar disorder OBJECTIVES: To review the evidence for the efficacy and acceptability of tiagabine in the treatment of acute mood episodes in bipolar disorder. SEARCH STRATEGY: The following databases were searched on 13-10-2005. The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Registers (CCDANCTR-Studies and CCDANCTR-References),The Cochrane Controlled Clinical Trials Register (CCCTR),EMBASE,MEDLINE,LILACS,PsycLIT andPsyndex. Reference lists of relevant papers and major textbooks of mood disorder were searched. Handsearches were done (specialist journals and conference proceedings). Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable published or unpublished trials. SELECTION CRITERIA: Randomised controlled trials, which compared tiagabine with placebo or with active agents in the treatment of any acute mood episodes in bipolar disorder, were selected. Studies of participants with bipolar disorder were to be included. Subjects could be of either sex and of all ages. DATA COLLECTION AND ANALYSIS: Data extraction and methodological quality assessment were performed independently by two reviewers. For analysis, relative risk was used for binary efficacy outcomes and the weighted mean difference or standardised mean differerence was used for continuously distributed outcomes MAIN RESULTS: We did not find any studies which fulfilled the Cochrane criteria of randomised controlled trials. However, one uncontrolled open label study and one case series were found. There were also three case reports/series of acute treatment which were continued into maintenance therapy, and one open non-randomised study with this design. The results of these studies are inconsistent. AUTHORS' CONCLUSIONS: We found no randomised controlled trials of tiagabine in bipolar disorder. In the reported cases, a significant proportion of patients suffered episodes of syncope or seizure. There is a need for randomised controlled trials examining the efficacy and acceptability of tiagabine in the acute treatment of bipolar disorder, after the nature of these episodes has been clarified.

Antimanic Agents↗
PubMed2005

Calorie and protein-enriched formula versus standard term formula for improving growth and development in preterm or low birth weight infants following hospital discharge.

BACKGROUND: Preterm and low birth weight infants are often growth-restricted at hospital discharge. Feeding infants post-hospital discharge with calorie and protein-enriched formula milk might facilitate "catch-up" growth and improve development. OBJECTIVES: To review the evidence from randomised controlled trials that feeding following hospital discharge with calorie and protein-enriched formula compared with standard term formula improves growth and development for preterm or low birth weight infants. 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, 2004), MEDLINE (1966 - December 2004), EMBASE (1980 - December 2004), CINAHL (1982 - December 2004), conference proceedings, and previous reviews. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that compared the effect of feeding preterm or low birth weight infants post-hospital discharge with calorie and protein-enriched formula compared with standard term formula. DATA COLLECTION AND ANALYSIS: We extracted data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two authors, and synthesis of data using weighted mean difference and a fixed effects model for meta-analysis. MAIN RESULTS: We found six trials that were eligible for inclusion. These recruited a total of 424 infants and were generally of good methodological quality. These trials found little evidence that feeding with calorie and protein-enriched formula milk affected growth and development. Because of differences in the way individual trials measured and presented outcomes, data synthesis was limited. Meta-analysis of data from two trials found a statistically significant effect on crown-heel length at 18 months post-term (weighted mean difference 9.7 millimetres (95% confidence interval 3.2 to 16.2)), but not on weight or head circumference. Meta-analysis of data from the two trials that assessed neurodevelopment at 18 months post-term did not reveal a statistically significant difference in either Bayley Mental Development Index (weighted mean difference 0.23 (95% confidence interval -2.99 to 3.45)) or Psychomotor Development Index (weighted mean difference 0.56 (95% confidence interval -1.95 to 3.07)). There are not yet any data on growth or development through later childhood. AUTHORS' CONCLUSIONS: The limited available data do not provide strong evidence that feeding preterm or low birth weight infants following hospital discharge with calorie and protein-enriched formula compared with standard term formula affects growth rates or development up to 18 months post-term.

Child Development↗
PubMed2005

Early versus late chest radiotherapy for limited stage small cell lung cancer.

BACKGROUND: It is standard clinical practice to combine chemotherapy and chest radiotherapy in treating patients with limited-stage small cell lung cancer. However, the best way to integrate both modalities is unclear. OBJECTIVES: To establish the most effective way of combining chest radiotherapy with chemotherapy for patients with limited-stage small cell lung cancer in order to improve long-term survival. SEARCH STRATEGY: The electronic databases MEDLINE, EMBASE, Cancerlit and the Cochrane Central Register of Controlled Trials (CENTRAL), reference lists, handsearching of journals and conference proceedings, and discussion with experts were used to identify potentially eligible trials, published and unpublished. SELECTION CRITERIA: Randomised controlled clinical trials comparing different timing of chest radiotherapy in patients with limited-stage small cell lung cancer. DATA COLLECTION AND ANALYSIS: Seven randomised trials were reviewed. There were differences in the timing and the overall treatment time of chest radiotherapy, the overall treatment time of , and the type of chemotherapy used. MAIN RESULTS: No significant differences in the 2-year and the 5-year survival were found, whether chest radiotherapy was delivered within 30 days after the start of chemotherapy or later. When the only study that delivered chest radiotherapy during cycles of non-platinum chemotherapy was excluded, a trend for the 5-year survival was observed (RR:0.93, p=0.07) in favour of early radiation, but not for the 2-year survival. Survival at 5 years, but not at 2 years, was significantly better for those having early chest radiotherapy delivered in an overall treatment time of less than 30 days compared with a longer treatment time (RR: 0.90, p=0.006). These results, however, should be interpreted with caution because the largest trial has follow-up data at three years, but not later. It remains to be seen what the effect of longer follow up will be for 5-year survival rates. Local tumour control was not significantly different between early and late chest radiotherapy. The incidence of severe pneumonitis or severe oesophagitis was not significantly different for early versus late thoracic radiotherapy. However, a trend for a higher chance to develop pneumonitis when early chest radiotherapy was delivered during non-platinum based chemotherapy was observed. AUTHORS' CONCLUSIONS: At present, it is uncertain whether the timing of chest radiotherapy as such is important for survival. The optimal integration of chemotherapy and chest radiotherapy in patients with limited-stage small cell lung cancer is unknown. Therefore, further research is needed to establish the most effective combination of radiotherapy and chemotherapy in this disease.

Carcinoma, Small Cell↗
PubMed2005

Transabdominal pre-peritoneal (TAPP) vs totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair.

BACKGROUND: The choice of approach to the laparoscopic repair of inguinal hernia is controversial. There is a scarcity of data comparing the laparoscopic transabdominal preperitoneal (TAPP) approach with the laparoscopic totally extraperitoneal (TEP) approach and questions remain about their relative merits and risks. OBJECTIVES: To compare the clinical effectiveness and relative efficiency of laparoscopic TAPP and laparoscopic TEP for inguinal hernia repair. SEARCH STRATEGY: We searched Medline Extra, Embase, Biosis, Science Citation Index, Cochrane Central Register of Controlled Trials (CENTRAL), Journals@ Ovid Full Text and the electronic version of the journal, Surgical Endoscopy. Recent conference proceedings by the following organisations were hand searched: Association of Endoscopic Surgeons of Great Britain & Ireland; International Congress of the European Association for Endoscopic Surgery; Scientific Session of the Society of American Gastrointestinal & Endoscopic Surgeons (SAGES); and the Italian Society of Endoscopic Surgery. In addition, specialists involved in research on the repair of inguinal hernia were contacted to ask for information about any further completed and ongoing trials, relevant websites were searched and reference lists of the all included studies were checked for additional reports. SELECTION CRITERIA: All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic TAPP with laparoscopic TEP for inguinal hernia repair were eligible for inclusion. Non-randomised prospective studies were also eligible for inclusion to provide further comparative evidence of complications and adverse events. DATA COLLECTION AND ANALYSIS: Statistical analyses were performed using the fixed effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes with 95% confidence intervals (CI). MAIN RESULTS: The search identified one RCT which reported no statistical difference between TAPP and TEP when considering duration of operation, haematoma, length of stay, time to return to usual activity and recurrence. The eight non-randomised studies suggest that TAPP is associated with higher rates of port-site hernias and visceral injuries whilst there appear to be more conversions with TEP. Vascular injuries and deep/mesh infections were rare and there was no obvious difference between the groups. No studies reporting economic evidence were identified. Very limited data were available on learning effects but these data suggest that operators become experienced at between 30 and 100 procedures. AUTHORS' CONCLUSIONS: There is insufficient data to allow conclusions to be drawn about the relative effectiveness of TEP compared with TAPP. Efforts should be made to start and complete adequately powered RCTs, which compare the different methods of laparoscopic repair.

Hernia, Inguinal↗
PubMed2004

Palliation of metastatic bone pain: single fraction versus multifraction radiotherapy - a systematic review of the randomised trials.

BACKGROUND: Recent randomised studies reported that single fraction radiotherapy was as effective as multifraction radiotherapy in relieving pain due to bone metastasis. However, there are concerns about the higher re-treatment rates and the efficacy of preventing future complications such as pathological fracture and spinal cord compression by single fraction radiotherapy. OBJECTIVES: To undertake a systematic review and meta-analysis of single fraction radiotherapy versus multifraction radiotherapy for metastatic bone pain relief and prevention of bone complications. SEARCH STRATEGY: Trials were identified through MEDLINE, EMBASE, Cancerlit, reference lists of relevant articles and conference proceedings. Relevant data was extracted. SELECTION CRITERIA: Randomised studies comparing single fraction radiotherapy with multifraction radiotherapy on metastatic bone pain DATA COLLECTION AND ANALYSIS: The analyses were performed using intention-to-treat principle. The results were pooled using meta-analysis to estimate the effect of treatment on pain response, re-treatment rate, pathological fracture rate and spinal cord compression rate. MAIN RESULTS: Eleven trials that involved 3435 patients were identified. Of 3435 patients, 52 patients were randomised more than once for different painful bone metastasis sites. Altogether, 3487 painful sites were randomised. The trials included patients with painful bone metastases of any primary sites, but were mainly prostate, breast and lung. The overall pain response rates for single fraction radiotherapy and multifraction radiotherapy were 60% (1059/1779) and 59% (1038/1769) respectively, giving an odds ratio of 1.03 (95% confidence interval [CI], 0.89 - 1.19) indicating no difference between the two radiotherapy schedules. There was also no difference in complete pain response rates for single fraction radiotherapy (34% [497/1441]) and multifraction radiotherapy (32% [463/1435]) with an odds ratio of 1.11 (95%CI 0.94-1.30). Patients treated by single fraction radiotherapy had a higher re-treatment rate with 21.5% (267/1240) requiring re-treatment compared to 7.4% (91/1236) of patients in the multifraction radiotherapy arm (odds ratio 3.44 [95%CI 2.67-4.43]). The pathological fracture rate was also higher in single fraction radiotherapy arm patients. Three percent (37/1240) of patients treated by single fraction radiotherapy developed pathological fracture compared to 1.6% (20/1236) for those treated by multifraction radiotherapy (odds ratio 1.82 [95%CI 1.06-3.11]). The spinal cord compression rates were similar for both arms (odds ratio 1.41 [95%CI 0.72-2.75]). Repeated analyses excluding dropout patients gave similar results. REVIEWERS' CONCLUSIONS: Single fraction radiotherapy was as effective as multifraction radiotherapy in relieving metastatic bone pain. However, the re-treatment rate and pathological fracture rates were higher after single fraction radiotherapy. Studies with quality of life and health economic end points are warranted to find out the optimal treatment option.

Bone Neoplasms↗
PubMed2005

Protein substitute for children and adults with phenylketonuria.

BACKGROUND: Phenylketonuria is an inherited disease characterised by an absence or deficiency of the enzyme phenylalanine hydroxylase. The aim of treatment is to lower blood phenylalanine concentrations to prevent developmental delay. Current treatment is based on a low phenylalanine diet in combination with a protein substitute (mixtures of amino acids free from or low in phenylalanine). Guidance regarding the dosage and distribution of this protein substitute, over a 24-hour period, is unclear and there is variation in recommendation between treatment centres. OBJECTIVES: To assess in children and adults with phenylketonuria, who are adhering to a low phenylalanine diet, the benefits and adverse effects of protein substitute, its dosage and distribution of dose. 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. We also contacted manufacturers of the phenylalanine-free and low phenylalanine protein substitutes for any data from published and unpublished randomised controlled trials. Date of the most recent search of the Group's Trials Register: August 2005. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing: any dose of protein substitute with no protein substitute; an alternative dosage; or the same dose, but given as frequent small doses throughout the day compared with the same total daily dose given as larger boluses less frequently. DATA COLLECTION AND ANALYSIS: Both authors independently extracted data and assessed trial quality. MAIN RESULTS: The searches identified 20 trials, of which one, including a total of 28 participants, was eligible for inclusion in the review. This was a two-phase trial, with only phase one being a randomised controlled trial. As data from both phases were combined in the analysis presented in the published paper, we are currently unable to include any data from the randomised controlled trial in the analysis of this review. AUTHORS' CONCLUSIONS: No conclusions could be made about the short- or long-term use of protein substitute in phenylketonuria due to the lack of adequate trial data. A randomised controlled trial is needed to investigate the use of protein substitute in phenylketonuria. Until further evidence is available current practice in the use of protein substitute should continue to be observed and monitored with care.

Adult↗
PubMed2006

Patching for corneal abrasion.

BACKGROUND: Recent audits show that corneal abrasion is a common presenting eye complaint. Eye patches are often recommended for treating corneal abrasions despite the lack of evidence for their use. This systematic review was conducted to determine the effects of the eye patch when used to treat corneal abrasions. OBJECTIVES: The objective of this review was to test the hypothesis that patching an eye following a corneal abrasion improves healing or provides pain relief. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) on The Cochrane Library (2005, Issue 2), MEDLINE (1966 to April 2005), EMBASE (1980 to April 2005), LILACS (13 April 2005), NRR (2005, Issue 2) and SIGLE (December 2004). There were no language or date restrictions in the searches. We also searched the reference lists of included studies, unpublished 'grey' literature and conference proceedings and contacted pharmaceutical companies for details of unpublished trials. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials that compared patching the eye with no patching to treat simple corneal abrasions. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted investigators for further information regarding quality of trials. The primary outcome was healing of the corneal epithelium and secondary outcomes were related to pain. MAIN RESULTS: Eleven trials, which randomised a total of 1014 participants, were included in the review. Meta-analysis of seven studies with dichotomous healing outcomes favoured no patching on the first day of healing (risk ratio (RR) 0.89, 95% Confidence Interval (CI) 0.79 to 0.99). For days two and three there was no significant difference between the two groups. Of the nine trials that measured pain scores two favoured no patching and none favoured patching. Complication rates were low and no differences were noted in these between the two groups. No-patch groups generally received more adjuvant treatment with antibiotics and/or cycloplegics than the patch group which is an important confounding factor. AUTHORS' CONCLUSIONS: Treating simple corneal abrasions with a patch does not improve healing rates on the first day post-injury and does not reduce pain. In addition, use of patches results in a loss of binocular vision. Therefore it is recommended that patches should not be used for simple corneal abrasions. Further research should focus on large (greater than 10 mm(2)) abrasions.

Corneal Injuries↗
PubMed2005

Vitamin K for upper gastrointestinal bleeding in patients with liver diseases.

BACKGROUND: Upper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. Several treatments are used for upper gastrointestinal bleeding in patients with liver diseases. However, supplementary interventions are often used as well. One of them is vitamin K administration, but it is unknown whether it benefits or harms patients with liver disease and upper gastrointestinal bleeding. OBJECTIVES: To assess the beneficial and harmful effects of vitamin K for patients with liver disease and upper gastrointestinal bleeding. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (February 2004), which comprises references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings, The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 1, 2004), MEDLINE (1966 to March 2004), EMBASE (1988 to March 2004), and LILACS (1982 to March 2004). Additional randomised trials were sought from the reference lists of the trials found and reviews identified by the electronic searches. SELECTION CRITERIA: We intended to include randomised clinical trials. DATA COLLECTION AND ANALYSIS: We intended to summarise data by standard Cochrane Collaboration methodologies. MAIN RESULTS: We could not find any randomised trials on vitamin K for upper gastrointestinal bleeding in patients with liver diseases. AUTHORS' CONCLUSIONS: We were unable to identify randomised trials on the safety and efficacy of vitamin K for upper gastrointestinal bleeding in patients with liver diseases. The effects of vitamin K need to be tested in randomised clinical trials.

Antifibrinolytic Agents↗
PubMed2006

Interventions to improve water quality for preventing diarrhoea.

BACKGROUND: Diarrhoeal diseases are a leading cause of mortality and morbidity, especially among young children in developing countries. While many of the infectious agents associated with diarrhoeal disease are potentially waterborne, the evidence for reducing diarrhoea in settings where it is endemic by improving the microbiological quality of drinking water has been equivocal. OBJECTIVES: To assess the effectiveness of interventions to improve water quality for preventing diarrhoea. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (December 2005), CENTRAL (The Cochrane Library 2005, Issue 4), MEDLINE (December 2005), EMBASE (December 2005), and LILACS (December 2005). We also handsearched relevant conference proceedings, contacted researchers and organizations working in the field, and checked references from identified studies. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials comparing interventions aimed at improving the microbiological quality of drinking water with no intervention in children and adults living in settings where diarrhoeal disease is endemic. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We used meta-analyses to estimate pooled measures of effect, where appropriate, and investigated potential sources of heterogeneity using subgroup analyses. MAIN RESULTS: Thirty trials (including 38 independent comparisons) covering over 53,000 participants met the inclusion criteria. Differences between the trials limited the comparability of results and pooling by meta-analysis. In general, the evidence suggests that interventions to improve the microbiological quality of drinking water are effective in preventing diarrhoea both for populations of all ages and children less than five years old. Subgroup analyses suggest that household interventions are more effective in preventing diarrhoea than interventions at the water source. Effectiveness was positively associated with compliance. Effectiveness was not conditioned on the presence of improved water supplies or sanitation in the study setting, and was not enhanced by combining the intervention to improve water quality with other common environmental interventions intended to prevent diarrhoea. AUTHORS' CONCLUSIONS: Interventions to improve water quality are generally effective in preventing diarrhoea, and interventions to improve water quality at the household level are more effective than those at the source. Significant heterogeneity among the trials suggests that the actual level of effectiveness may depend on a variety of conditions that research to date cannot fully explain. Rigorous, blinded, multi-arm randomized controlled trials conducted over a longer duration in a variety if settings may help clarify the potential effectiveness.

Adult↗
PubMed2006

Sodium bicarbonate infusion during resuscitation of infants at birth.

BACKGROUND: For many years, intravenous sodium bicarbonate has been used to reverse acidosis during newborn resuscitation. However, controversy surrounds its use. Most of the evidence has been derived from studies in animals, adult humans, or in uncontrolled, descriptive experiments. Despite the lack of evidence from the human neonatal population and concerns about its safety, some international resuscitation guidelines still recommend the use of sodium bicarbonate in resuscitation of the newborn. OBJECTIVES: To determine whether an intravenous infusion of sodium bicarbonate, compared to placebo or no treatment, reduces mortality and morbidity (in particular regarding neurodevelopmental outcome) in infants receiving resuscitation in the delivery room at birth. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. Searches were conducted of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2005), MEDLINE (1966 - September 2005), EMBASE (1980 - September 2005) and CINAHL (1982 - September 2005) and Pediatric Research (1987 - September 2005). Unpublished trials were sought by handsearching the conference proceedings of American Pediatric Society/Society for Pediatric Research (1990 - 2005) and European Society for Paediatric Research (1993 - 2005). SELECTION CRITERIA: Randomised or quasi-randomised controlled trials of newborn infants receiving sodium bicarbonate infusion during any resuscitation in the delivery room at birth. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: We found one randomised controlled trial that fulfilled the eligibility criteria (Lokesh 2004) that compared treating asphyxiated newborn infants (infants continuing to need positive pressure ventilation at 5 minutes after birth) with sodium bicarbonate infusion (N = 27) versus 5% dextrose (N = 28). They found no evidence of an effect on mortality prior to discharge [Relative risk 1.04 (95% confidence interval 0.49 to 2.21)], abnormal neurological examination at discharge [Relative risk 0.86 (95% confidence interval 0.30 to 2.50)] or a composite outcome of death or abnormal neurological examination at discharge [Relative risk 0.97 (95% confidence interval 0.59 to 1.60)]. There was no statistically significant difference in the incidence of encephalopathy [Relative risk 1.30 (95% confidence interval 0.88 to 1.92)], intraventricular haemorrhage [Relative risk 1.04 (95% confidence interval 0.23 to 4.70)] and neonatal seizures [Relative risk 1.19 (95% confidence interval 0.50 to 2.82)]. No long term neurodevelopmental outcomes were assessed. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials to determine whether the infusion of sodium bicarbonate reduces mortality and morbidity in infants receiving resuscitation in the delivery room at birth.

Asphyxia Neonatorum↗
PubMed2005

Anticonvulsants for preventing seizures in patients with chronic subdural haematoma.

BACKGROUND: Anticonvulsant therapy is sometimes used prophylactically in patients with chronic subdural haematoma, although the benefit is unclear. OBJECTIVES: To establish the effectiveness of prophylactic anticonvulsants in patients with chronic subdural haematoma, for both pre- and post-operative periods. SEARCH STRATEGY: We searched the Cochrane Injuries Group Specialised Register, Cochrane Controlled Trials Register, MEDLINE, EMBASE, LILACS, the American Association of Neurological Surgeons Database and abstract books of conference proceedings of the European Association of Neurosurgical Societies. We also searched the references of all identified studies. SELECTION CRITERIA: Randomised controlled trials comparing any anticonvulsant versus placebo or no intervention. DATA COLLECTION AND ANALYSIS: No trials met the inclusion criteria for the review. MAIN RESULTS: No randomised, controlled trials were identified. AUTHORS' CONCLUSIONS: No formal recommendations can be made about the use of prophylactic anticonvulsants in patients with chronic subdural haematoma based on the literature currently available. Non-controlled studies came up with conflicting results. There is an urgent need for well-designed randomised controlled trials.

Anticonvulsants↗
PubMed2005

Monoamine oxidase B inhibitors for early Parkinson's disease.

BACKGROUND: It has been postulated that monoamine oxidase B (MAO-B) inhibitors alter disease progression in Parkinson's disease (PD). Clinical trials have produced conflicting results. OBJECTIVES: To assess the evidence from randomized controlled trials for the effectiveness and safety of long-term use of MAO-B inhibitors in early PD. SEARCH STRATEGY: We searched the following electronic databases: Cochrane Central Register of Controlled trials (CENTRAL) (The Cochrane Library Issue 2, 2004), MEDLINE (last searched 18th August 2004) and EMBASE (last searched 18th August 2004). We also handsearched neurology and movement disorders conference proceedings, checked reference lists of relevant studies and contacted other researchers. SELECTION CRITERIA: We sought to include all unconfounded randomized controlled trials that compared a MAO-B inhibitor with control, in the presence or absence of levodopa or dopamine agonists, in patients with early PD and where treatment and follow up lasted at least one year. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed the methodological quality, and extracted the data. A small amount of additional data was provided by the original authors. Random-effects models were used to analyse results, where appropriate. MAIN RESULTS: Ten trials were included (a total of 2422 patients), nine using selegiline, one using lazabemide. The methodological quality was reasonable although concealment of allocation was definitely adequate in only four trials. The mean follow up was for 5.8 years. MAO-B inhibitors were not associated with a significant increase in deaths (odds ratio (OR) 1.15; 95% confidence interval (CI) 0.92 to 1.44). They provided small benefits over control in impairment (weighted mean difference (WMD) for change in motor UPDRS score was 3.81 points less with MAO-B inhibitors; 95% CI 2.27 to 5.36) and disability (WMD for change in UPDRS ADL score was 1.50 less; 95% CI 0.48 to 2.53) at one year which, although statistically significant, were not clinically significant. There was a marked levodopa-sparing effect with MAO-B inhibitors which was associated with a significant reduction in motor fluctuations (OR 0.75; 95% CI 0.59 to 0.94) but not dyskinesia (OR 0.97; 95% CI 0.76 to 1.25). The reduction in motor fluctuations was, however, not robust in sensitivity analyses. Although adverse events were generally mild and infrequent, withdrawals due to side-effects were higher (OR 2.36; 95% CI 1.32 to 4.20) with MAO-B inhibitors. AUTHORS' CONCLUSIONS: MAO-B inhibitors do not appear to delay disease progression but may have a beneficial effect on motor fluctuations. There was no statistically significant effect on deaths although the confidence interval does not exclude a small increase with MAO-B inhibitors. At present we do not feel these drugs can be recommended for routine use in the treatment of early Parkinson's disease but further randomized controlled trials should be carried out to clarify, in particular, their effect on deaths and motor complications.

Antiparkinson Agents↗
PubMed2005

Interventions for infantile esotropia.

BACKGROUND: Various aspects of the clinical management of infantile esotropia (IE) are unclear - mainly, the most effective type of intervention and the age at intervention. OBJECTIVES: The objective of this review was to assess the effectiveness of various surgical and non-surgical interventions for IE and to determine the significance of age at treatment with respect to outcome. SEARCH STRATEGY: Trials were identified from the Cochrane Central Register of Controlled Trials - CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) in The Cochrane Library (Issue 3 2004), MEDLINE (1966 to July 2004), EMBASE (1980 to August 2004) and LILACS (July 2004). We manually searched the conference proceedings of the European Strabismological Association (ESA) (1975-1997, 1999-2002), International Strabismological Association (ISA) (1994) and American Academy of Paediatric Ophthalmology and Strabismus meeting (AAPOS) (1995-2003). Efforts were made to contact researchers who are active in the field for information about further published or unpublished studies. SELECTION CRITERIA: Randomised trials comparing any surgical or non-surgical intervention for infantile esotropia. DATA COLLECTION AND ANALYSIS: Each reviewer independently assessed study abstracts identified from the electronic and manual searches. MAIN RESULTS: No studies were found that met our selection criteria and therefore none were included for analysis. AUTHORS' CONCLUSIONS: The main body of literature on interventions for IE are either retrospective studies or prospective cohort studies. It has not been possible through this review to resolve the controversies regarding type of surgery, non-surgical intervention and age of intervention. There is clearly a need for good quality trials to be conducted in these areas to improve the evidence base for the management of IE.

Esotropia↗
PubMed2006

Antifungal agents for preventing fungal infections in non-neutropenic critically ill patients.

BACKGROUND: Invasive fungal infections, important causes of morbidity and mortality in critically ill patients, may be preventable with the prophylactic administration of antifungal agents. OBJECTIVES: This study aims to systematically identify and summarize the effects of antifungal prophylaxis in non-neutropenic critically ill adult patients on all-cause mortality and the incidence of invasive fungal infections. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library, Issue 3, 2005), MEDLINE (1966 to 2 September 2005), and EMBASE (1980 to week 36, 2005). We also handsearched reference lists, abstracts of conference proceedings and scientific meetings (1998 to 2004), and contacted authors of included studies and pharmaceutical manufacturers. SELECTION CRITERIA: We included randomized controlled trials in all languages comparing the prophylactic use of any antifungal agent or regimen with placebo, no antifungal, or another antifungal agent or regimen in non-neutropenic critically ill adult patients. DATA COLLECTION AND ANALYSIS: Two authors independently applied selection criteria, performed quality assessment, and extracted data using an intention-to-treat approach. We resolved differences by discussion. We synthesized data using the random effects model and expressed results as relative risk with 95% confidence intervals. MAIN RESULTS: We included 12 unique trials (eight comparing fluconazole and four ketoconazole with no antifungal or a nonabsorbable agent) involving 1606 randomized patients. For both outcomes of total mortality and invasive fungal infections, almost all trials of fluconazole and ketoconazole separately showed a non-significant risk reduction with prophylaxis. When combined, fluconazole/ketoconazole reduced total mortality by about 25% (relative risk 0.76, 95% confidence interval 0.59 to 0.97) and invasive fungal infections by about 50% (relative risk 0.46, 95% confidence interval 0.31 to 0.68). We identified no significant increase in the incidence of infection or colonization with the azole-resistant fungal pathogens Candida glabrata or C. krusei, although the confidence intervals of the summary effect measures were wide. Adverse effects were not more common amongst patients receiving prophylaxis. Results across all trials were homogeneous despite considerable heterogeneity in clinical and methodological characteristics. AUTHORS' CONCLUSIONS: Prophylaxis with fluconazole or ketoconazole in critically ill patients reduces invasive fungal infections by one half and total mortality by one quarter. Although no significant increase in azole-resistant Candida species associated with prophylaxis was demonstrated, trials were not powered to exclude such an effect. In patients at increased risk of invasive fungal infections, antifungal prophylaxis with fluconazole should be considered.

Adult↗
PubMed2006

Breastfeeding or breast milk for procedural pain in neonates.

BACKGROUND: Physiological changes brought about by pain may contribute to the development of morbidity in neonates. Clinical studies have shown reduction in the changes in physiological parameters and pain score measurements following pre-emptive analgesic administration in situations where the neonate is experiencing pain or stress. Nonpharmacological measures (such as holding, swaddling, breastfeeding) and pharmacological measures (such as acetaminophen, sucrose and opioids) have been used for this purpose. OBJECTIVES: The primary objective of this review was to evaluate the effectiveness of breastfeeding or supplemental breast milk in reducing procedural pain in neonates. The secondary objective was to conduct subgroup analyses based on the type of control intervention, type of painful procedure, gestational age and the amount of supplemental breast milk given. SEARCH STRATEGY: A literature search was performed using MEDLINE (1966 - Feb 2006), EMBASE (1980 - Feb 2006), CINAHL (1982 - Feb 2006), Cochrane Central Register of Controlled Trials (Issue 4, 2005 of Cochrane Library), abstracts from the annual meetings of the Society for Pediatric Research (1994 - 2006) and major pediatric pain conference proceedings. No language restrictions were applied. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials of breastfeeding or supplemental breast milk versus no treatment/other measures in neonates were eligible for inclusion in this review. The study must have reported on either physiologic markers of pain or validated pain scores. DATA COLLECTION AND ANALYSIS: The methodological quality of the trials was assessed using the information provided in the studies and by personal communication with the authors. Data on relevant outcomes were extracted and the effect size was estimated and reported as relative risk (RR), risk difference (RD) and weighted mean difference (MD) as appropriate. MAIN RESULTS: Eleven eligible studies were identified. Marked heterogeneity in terms of control intervention and pain assessment measures were noted among the studies. Neonates in the breastfeeding group had statistically significantly less increase in the heart rate, reduced proportion of crying time and reduced duration of crying compared to swaddled group or pacifier group. Neonates in the breastfeeding group had a significant reduction in duration of crying compared to fasting (no intervention) group, but there was no significant difference when compared to glucose group. Premature Infant Pain Profile scores were significantly different between the breastfeeding group when compared to placebo group and the group positioned in mother's arms. However, these scores were not statistically significantly different in the breastfeeding group when compared to the no treatment group and the glucose group. Douleur Aigue Nouveau-ne scores were significantly different in the breastfeeding group when compared to the placebo group and the group positioned in mother's arms, but not when compared to the glucose group. Neonates in the supplemental breast milk group had significantly less increase in the heart rate and Neonatal Facial Coding Score compared to the placebo group. The differences in the duration of crying time and oxygen saturation change between supplemental breast milk group and the placebo group were not statistically significant. Neonates in the supplemental breast milk group had significantly higher increase in the heart rate changes and duration of crying time compared to glucose/sucrose group. No study was identified that has evaluated safety/effectiveness of repeated administration of breastfeeding or supplemental breast milk for pain relief. AUTHORS' CONCLUSIONS: If available, breastfeeding or breast milk should be used to alleviate procedural pain in neonates undergoing a single painful procedure compared to placebo, positioning or no intervention. Administration of glucose/sucrose had similar effectiveness as breastfeeding for reducing pain. The effectiveness of breast milk for repeated painful procedures is not established and further research is needed. These studies should include various control interventions including glucose/ sucrose and should target preterm neonates.

Breast Feeding↗
PubMed2005

Hyperbaric oxygen therapy for acute ischaemic stroke.

BACKGROUND: Most cases of stroke are caused by impairment of blood flow to the brain (ischaemia) which results in a reduction in oxygen available and subsequent cell death. It has been postulated that hyperbaric oxygen therapy (HBOT) may reduce the volume of brain that will die by greatly increasing the oxygen available, and it may further improve outcome by reducing brain swelling. Some centres are using HBOT routinely to treat stroke. OBJECTIVES: To assess the effectiveness and safety of adjunctive HBOT in the treatment of acute ischaemic stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched 9 January 2004), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 3, 2004), MEDLINE (1966 to July 2004), EMBASE (1980 to July 2004), CINAHL (1982 to July 2004), and DORCTHIM (Database of Randomised Controlled Trials in Hyperbaric Medicine) (from inception to 2004). We handsearched journals and conference proceedings, searched reference lists of articles, and contacted researchers in an effort to identify additional published and unpublished studies. SELECTION CRITERIA: We included all randomised controlled trials that compared the effect of adjunctive HBOT with no HBOT (no treatment or sham). DATA COLLECTION AND ANALYSIS: Two authors used standardised forms to extract the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data were extracted and entered into RevMan 4.2. MAIN RESULTS: Three randomised controlled trials (106 participants) satisfied the inclusion criteria. The methodological quality of the trials varied but was generally high. Data could be pooled for a limited number of clinically important outcomes. There were no significant differences in mortality rate at six months in those receiving HBOT compared to the control group (relative risk 0.61, 95% confidence interval (CI) 0.17 to 2.2, P value 0.45). Two of 15 scale measures of disability and functional indicated an improvement following HBOT, both at one year follow up: the mean Trouillas Disability Scale was lower with HBOT (mean difference (MD) 2.2 points reduction with HBOT, 95% CI 0.15 to 4.3, P value 0.04) and the mean Orgogozo Scale was higher (MD 27.9 points, 95% CI 4.0 to 51.8, P value 0.02). These improvements were not reflected in other trials or functional scales. AUTHORS' CONCLUSIONS: This systematic review has not found evidence to show that HBOT improves clinical outcomes when applied during the acute presentation of ischaemic stroke. While evidence from the three randomised controlled trials is insufficient to provide clear guidelines for practice, clinical benefit does not seem likely. Further research is required to better define the role of HBOT in this condition.

Brain Ischemia↗