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PubMed2005

Interventions for the treatment of burning mouth syndrome.

BACKGROUND: The complaint of a burning sensation in the mouth can be said to be a symptom of other disease or a syndrome in its own right of unknown aetiology. In patients where no underlying dental or medical causes are identified and no oral signs are found, the term burning mouth syndrome (BMS) should be used. The prominent feature is the symptom of burning pain which can be localised just to the tongue and/or lips but can be more widespread and involve the whole of the oral cavity. Reported prevalence rates in general populations vary from 0.7% to 15%. Many of these patients show evidence of anxiety, depression and personality disorders. OBJECTIVES: The objectives of this review are to determine the effectiveness and safety of any intervention versus placebo for relief of symptoms and improvement in quality of life and to assess the quality of the studies. SEARCH STRATEGY: We searched the Cochrane Oral Health Group Trials Register (20 October 2004), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2004), MEDLINE (January 1966 to October 2004), EMBASE (January 1980 to October). Clinical Evidence Issue No. 10 2004, conference proceedings and bibliographies of identified publications were searched to identify the relevant literature, irrespective of language of publication. SELECTION CRITERIA: Studies were selected if they met the following criteria: study design - randomised controlled trials (RCTs) and controlled clinical trials (CCTs) which compared a placebo against one or more treatments; participants - patients with burning mouth syndrome, that is, oral mucosal pain with no dental or medical cause for such symptoms; interventions - all treatments that were evaluated in placebo-controlled trials; primary outcome - relief of burning/discomfort. DATA COLLECTION AND ANALYSIS: Articles were screened independently by two reviewers to confirm eligibility and extract data. The reviewers were not blinded to the identity of the studies. The quality of the included trials was assessed independently by two reviewers, with particular attention given to allocation concealment, blinding and the handling of withdrawals and drop outs. Due to both clinical and statistical heterogeneity statistical pooling of the data was inappropriate. MAIN RESULTS: Nine trials were included in the review. The interventions examined were antidepressants (two trials), cognitive behavioural therapy (one trial), analgesics (one trial), hormone replacement therapy (one trial), alpha-lipoic acid (three trials) and anticonvulsants (one trial). Diagnostic criteria were not always clearly reported. Out of the nine trials included in the review, only three interventions demonstrated a reduction in BMS symptoms: alpha-lipoic acid (three trials), the anticonvulsant clonazepam (one trial) and cognitive behavioural therapy (one trial). Only two of these studies reported using blind outcome assessment. Although none of the other treatments examined in the included studies demonstrated a significant reduction in BMS symptoms, this may be due to methodological flaws in the trial design, or small sample size, rather than a true lack of effect. AUTHORS' CONCLUSIONS: Given the chronic nature of BMS, the need to identify an effective mode of treatment for sufferers is vital. However, there is little research evidence that provides clear guidance for those treating patients with BMS. Further trials, of high methodological quality, need to be undertaken in order to establish effective forms of treatment for patients suffering from BMS.

Analgesics↗
PubMed2004

Habit retraining for the management of urinary incontinence in adults.

BACKGROUND: Habit retraining is toileting assistance given by a caregiver to adults with urinary incontinence. It involves the identification of an incontinent person's natural voiding pattern and the development of an individualised toileting schedule which pre-empts involuntary bladder emptying. OBJECTIVES: To assess the effects of habit retraining for the management of urinary incontinence in adults. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised register (9 May 2002), MEDLINE (January 1966 to December 2002), EMBASE (January 1980 to Week 18 2002), CINAHL (January 1982 to February 2001), PsycINFO (January 1972 to current), Biological Abstracts (January 1980 to December 2000), Current Contents (January 1993 to December 2001) and the reference lists of relevant articles. We also contacted experts in the field, searched relevant websites and hand searched journals and conference proceedings. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing habit retraining delivered either alone or in conjunction with another intervention for urinary incontinence in adults. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment were undertaken by at least two people working independently of each other. Any differences were resolved by discussion. The relative risks for dichotomous data were calculated with 95% confidence intervals. Where data were insufficient for a quantitative analysis, a narrative overview was undertaken. MAIN RESULTS: Three trials with a total of 337 participants met the inclusion criteria, describing habit retraining combined with other approaches compared with usual care. Participants were primarily care-dependent elderly women with concurrent cognitive and/or physical impairment, residing in either a residential aged-care facility or in their own home. Outcomes included incidence and/or severity of urinary incontinence, the prevalences of urinary tract infection, skin rash and skin breakdown, cost and caregiver preparedness, role strain and burden. Caregivers found it difficult to maintain voiding records and to implement the toileting program. A 61% compliance rate was reported in one trial. There were no statistically significant differences in the incidence and in the volume of incontinence between groups. Within group analyses did however show improvements on these measures. Reductions were also reported for the intervention group in one study for skin rash, skin breakdown and in caregivers' perceptions of their level of stress. Descriptive data on the intervention suggests that habit retraining is a labour-intense activity. Electronic loggers, used as an adjunct to caregiver-delivered wet/dry checks, were reported as providing more accurate data than that from caregiver conducted wet/dry checks. To date, no analysis of the time and resources associated with these comparisons is available. REVIEWERS' CONCLUSIONS: Data on habit retraining are few and of insufficient quality to provide a firm basis for practice.

Habits↗
PubMed2004

Timed voiding for the management of urinary incontinence in adults.

BACKGROUND: Timed voiding is a fixed time interval toileting assistance program that has been promoted for the management of people with urinary incontinence who cannot participate in independent toileting. For this reason, it is commonly assumed to represent current practice in residential aged care settings. OBJECTIVES: To assess the effects of timed voiding for the management of urinary incontinence in adults who cannot participate in independent toileting. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised register (9 May 2002), MEDLINE (January 1966 to December 2002), EMBASE (January 1980 to Week 18 2002), CINAHL (January 1982 to February 2001), PsycINFO (January 1972 to current), Biological Abstracts (January 1980 to December 2000), Current Contents (January 1993 to December 2001) and the reference lists of relevant articles. We also contacted experts in the field, searched relevant websites and handsearched journals and conference proceedings. SELECTION CRITERIA: We selected all randomised and quasi-randomised trials that addressed timed voiding in an adult population and that had an alteration in continence status as a primary outcome. We included those trials that had assessed timed voiding delivered either alone or in combination with another intervention and compared it with either usual care, or no timed voiding, or another intervention. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment were undertaken by at least two people working independently of each other. Any differences were resolved by discussion until agreement was reached. The relative risk for dichotomous data were calculated with 95% confidence intervals. Where data were insufficient to support a quantitative analysis, a narrative overview was undertaken. MAIN RESULTS: Two trials with a total of 298 participants met the inclusion criteria. Both compared timed voiding plus additional intervention with usual care. In one of these timed voiding was combined with continence products, placement of a bedside commode for each participant, education to staff on transfer techniques, feedback and encouragement to staff, praise to participants for "successful responses" and administration of oxybutynin in small doses. The mean percentage who were incontinent when checked daily was 20% in the intervention group compared with 80% in the control group. No further between group analysis was possible from the data reported. The other trial combined timed voiding with a medical assessment and individualised medical management that was based on clinical data. Reduction in the number of participants with daytime and night-time incontinence was greater in the intervention group but this difference was statistically significant only for night-time wetting. There was no difference in the volume of urine lost as determined by pad weighing. The methodological quality of these trials was not high based on the quality appraisal criteria of the Cochrane Incontinence Group. In particular, there was a lack of clarity regarding levels of blinding. It was not possible to combine data from trials. In both trials, the fixed schedule of toileting was combined with other interventions. The extent to which the results reflect the contribution of timed voiding is unknown because the trials' design did not allow assessment of the effects of the fixed schedule of toileting separately from other components of the interventions. REVIEWER'S CONCLUSIONS: The data were too few and of insufficient quality to provide empirical support for or against the intervention of timed voiding.

Adult↗
PubMed2003

Treadmill training and body weight support for walking after stroke.

BACKGROUND: Treadmill training, with some body weight supported using a harness, is a method of treating walking after stroke. Systematic review is required to assess the cost, effectiveness and acceptance of this treatment. OBJECTIVES: To assess the effectiveness of treadmill training and/or body weight support in the treatment of walking after stroke. The primary outcomes investigated were walking speed and walking dependency. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched 21 March 2003), the Cochrane Central Register of Controlled Trials (Cochrane Library, Issue 1 2003), MEDLINE (1966-March 2003), EMBASE (1980-March 2003), CINAHL (1982-February 2003) and PEDro (last searched 21 March 2003). In addition, we handsearched relevant conference proceedings, screened reference lists and contacted trialists to identify further published and unpublished trials. SELECTION CRITERIA: Randomised, or quasi-randomised, controlled and cross-over trials of treadmill training and/or body weight support for the treatment of walking after stroke were eligible. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials and extracted data. Trialists were contacted for additional information. A fixed effects model was used for analysis, but if heterogeneity existed (Chi squared statistic) a random effects model was used. Results were analysed as weighted mean differences (WMD) for continuous variables and relative risk (RR) for dichotomous variables. The main outcome variables were walking speed and dependency. MAIN RESULTS: Eleven trials (458 participants) were included. There were no statistically significant differences between treadmill training, with or without body weight support, and other interventions for walking speed or dependence. There was a small trend toward the effectiveness of treadmill training with body weight support for participants who could walk independently (WMD: 0.24 m/sec, 95% CI: -0.19 to 0.66 for speed; random effects). The one trial which compared treadmill training with and without body weight support showed benefit at the end of follow-up (mean difference: 0.22 m/sec, 95% CI: 0.05 to 0.39). Adverse events occurred slightly more frequently in participants receiving treadmill training, although statistically there were no differences. REVIEWER'S CONCLUSIONS: Overall, no statistically significant effect of treadmill training and body weight support was detected. However, among people who could walk independently, treadmill training with body weight support appeared to be more effective than other interventions at improving walking speed, but this conclusion was not robust.

Body Weight↗
PubMed2005

Treadmill training and body weight support for walking after stroke.

BACKGROUND: Treadmill training, with or without some body weight supported using a harness, is a method of treating walking after stroke. A systematic review is required to assess the cost, effectiveness, and acceptability of this treatment. OBJECTIVES: To assess the effectiveness of treadmill training and body weight support, individually or in combination, in the treatment of walking after stroke. The primary outcomes investigated were walking speed, endurance and dependency. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched 2 March 2005), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to January 2005), EMBASE (1980 to February 2005), CINAHL (1982 to February 2005) and PEDro (last searched 2 March 2005). In addition, we handsearched relevant conference proceedings, screened reference lists and contacted trialists to identify further published and unpublished trials. SELECTION CRITERIA: Randomised or quasi-randomised controlled and cross-over trials of treadmill training and body weight support, individually or in combination, for the treatment of walking after stroke were eligible. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, extracted data, and assessed quality. We contacted trialists for additional information. We used a fixed-effect model for analysis, but if heterogeneity existed a random-effects model was used. We analysed the results as weighted mean differences (WMD) for continuous variables and relative risk (RR) for dichotomous variables. MAIN RESULTS: Fifteen trials (622 participants) were included. There were no statistically significant differences between treadmill training, with or without body weight support, and other interventions for walking speed or dependence. Among participants who could walk independently at the start of treatment, treadmill training with body weight support tended to produce higher walking speeds (WMD 0.09 m/s, 95% confidence interval (CI) -0.02 to 0.20 for speed; fixed-effect), but this result was not statistically significant. An individual trial tended to support the use of treadmill training with body weight support for dependent walkers as compared to treadmill training alone. One of three individual trials indicated that independent walkers may benefit from treadmill training combined with other task-orientated exercise. However, data are very limited. Adverse events occurred more frequently in participants receiving treadmill training but these were not judged to be clinically serious events. AUTHORS' CONCLUSIONS: Overall no statistically significant effect of treadmill training with or without body weight support was detected. Although individual studies suggested that treadmill training with body weight support may be more effective than treadmill training alone and that treadmill training plus task-oriented exercise may be more effective than sham exercises, further trials are required to confirm these findings.

Body Weight↗
PubMed2005

Prevention of recurrent miscarriage for women with antiphospholipid antibody or lupus anticoagulant.

BACKGROUND: A range of treatments have been proposed to improve pregnancy outcome in recurrent pregnancy loss associated with antiphospholipid antibody (APL). Small studies have not resolved uncertainty about benefits and risks. OBJECTIVES: To examine outcomes of all treatments given to maintain pregnancy in women with prior miscarriage and APL. SEARCH STRATEGY: We searched the Pregnancy and Childbirth Group's Trials Register (30 May 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2003), MEDLINE (1966 to June 2003), EMBASE (1988 to June 2003), Lupus (volume one to eight, 1991 to 1999) and conference proceedings from the International Symposium on APL up to 1999. SELECTION CRITERIA: Randomised or quasi-randomised, controlled trials of interventions in pregnant women with a history of pregnancy loss and APL. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed quality and extracted data for studies up to December 1999. One review author performed this for studies after 1999. MAIN RESULTS: Thirteen studies were found (849 participants). The quality was not high; 50% had clear evidence of allocation concealment. Participant characteristics varied between trials. Unfractionated heparin combined with aspirin (two trials; n = 140) significantly reduced pregnancy loss compared to aspirin alone (relative risk (RR) 0.46, 95% confidence interval (CI) 0.29 to 0.71). Low molecular weight heparin (LMWH) combined with aspirin compared to aspirin (one trial; n = 98) did not significantly reduce pregnancy loss (RR 0.78, 95% CI 0.39 to 1.57). There was no advantage in high-dose, over low-dose, unfractionated heparin (one trial; n = 50). Three trials of aspirin alone (n = 135) showed no significant reduction in pregnancy loss (RR 1.05, 95% CI 0.66 to 1.68). Prednisone and aspirin (three trials; n = 286) resulted in a significant increase in prematurity when compared to placebo, aspirin, and heparin combined with aspirin, and an increase in gestational diabetes, but no significant benefit. Intravenous immunoglobulin +/- unfractionated heparin and aspirin (two trials; n = 58) was associated with an increased risk of pregnancy loss or premature birth when compared to unfractionated heparin or LMWH combined with aspirin (RR 2.51, 95% CI 1.27 to 4.95). When compared to prednisone and aspirin, intravenous immunoglobulin (one trial; n = 82) was not significantly different in outcomes. AUTHORS' CONCLUSIONS: Combined unfractionated heparin and aspirin may reduce pregnancy loss by 54%. Large, randomised controlled trials with adequate allocation concealment are needed to explore potential differences between unfractionated heparin and LMWH.

Abortion, Habitual↗
PubMed2006

Methods of repair for obstetric anal sphincter injury.

BACKGROUND: Anal sphincter injury during childbirth - obstetric anal sphincter injuries (OASIS) - is associated with significant maternal morbidity including perineal pain, dyspareunia and anal incontinence. Anal incontinence affects women psychologically and physically. Many do not seek medical attention because of embarrassment. The two recognised methods for the repair of damaged external anal sphincter (EAS): are end-to-end (approximation) repair and overlap repair. OBJECTIVES: To compare the effectiveness of overlap repair versus end-to-end repair following OASIS in reducing subsequent anal incontinence, perineal pain, dyspareunia and improving quality of life. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 January 2006), MEDLINE (January 1966 to 31 January 2006), EMBASE (January 1974 to 31 January 2006), SciSearch (January 1974 to 31 January 2006) and conference proceedings of obstetrics and gynaecology, surgery and coloproctology. SELECTION CRITERIA: Randomised controlled trials comparing different techniques of immediate primary repair of EAS following OASIS. DATA COLLECTION AND ANALYSIS: Trial quality was assessed independently by all authors. MAIN RESULTS: Three eligible trials, of grade A quality, involving 279 women, were included. There was considerable heterogeneity in the outcome measures, time points and reported results. Meta-analyses showed that there was no statistically significant difference in perineal pain (relative risk (RR) 0.08, 95% confidence interval (CI) 0.00 to 1.45, one trial, 52 women), dyspareunia (RR 0.62, 95% CI 0.11 to 3.39, one trial, 52 women), flatus incontinence (RR 0.93, 95% CI 0.26 to 3.31, one trial, 52 women) and faecal incontinence (RR 0.07, 95% CI 0.00 to 1.21, one trial, 52 women) between the two repair techniques at 12 months but showed a statistically significantly lower incidence in faecal urgency (RR 0.12, 95% CI 0.02 to 0.86, one trial, 52 women) and lower anal incontinence score (weighted mean difference -1.70, 95% CI -3.03 to -0.37) in the overlap group. Overlap technique was also associated with a statistically significant lower risk of deterioration of anal incontinence symptoms over 12 months (RR 0.26, 95% CI 0.09 to 0.79, one trial, 41 women). There was no significant difference in quality of life. AUTHORS' CONCLUSIONS: The limited data available show that compared to immediate primary end-to-end repair of OASIS, early primary overlap repair appears to be associated with lower risks for faecal urgency and anal incontinence symptoms. As the experience of the surgeon is not addressed in the three studies reviewed, it woudl be inappropriate to recommend one type of repair in favour of another.

Anal Canal↗
PubMed2001

Psychological therapies for thalassaemia.

BACKGROUND: Thalassaemia is a group of genetic blood disorders characterised by the absence or reduction in the production of haemoglobin. Severity is variable from less severe anaemia, through thalassaemia intermedia, to profound severe anaemia (thalassaemia major). In thalassaemia major other complications include growth retardation, bone deformation, and enlarged spleen. Blood transfusion is required to treat severe forms of thalassaemia, but this results in excessive accumulation of iron in the body (iron overload), removed mostly by a drug called desferrioxamine through 'chelation therapy'. Non-routine treatments are bone marrow transplantation (which is age restricted), and possibly hydroxyurea, designed to raise foetal haemoglobin level, thus reducing anaemia. In addition, psychological therapies seem appropriate to improving outcome and adherence to medical treatment. OBJECTIVES: To examine the evidence that in patients with thalassaemia, psychological treatments improve the ability to cope with the condition, and improve both medical and psychosocial outcome. SEARCH STRATEGY: The Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references from comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. Also, searches on the Internet were performed. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing the use of psychological intervention to no (psychological) intervention in patients with thalassaemia. DATA COLLECTION AND ANALYSIS: No trials of psychological therapies were found in the literature for inclusion at the present time. MAIN RESULTS: There are no results to be reported at present. REVIEWER'S CONCLUSIONS: As a chronic disease with a considerable role for self-management, psychological support seems appropriate for managing thalassaemia. However, no conclusions can be made about the use of specific psychological therapies in thalassaemia from the information currently available. This systematic review has clearly identified the need for well designed, adequately-powered, multicentre, randomised controlled trials assessing the effectiveness of specific psychological interventions for thalassaemia.

Adaptation, Psychological↗
PubMed2002

Nutrition support for bone marrow transplant patients.

BACKGROUND: Bone marrow transplantation involves the administration of toxic chemotherapy and infusion of marrow cells. After treatment, patients can develop a poor appetite, mucositis and gastrointestinal failure, leading to malnutrition. To prevent this, parenteral nutrition (PN) support is the first choice but is associated with an increased risk of infection. Enteral nutrition (EN) is an alternative, as is the addition of substrates e.g. glutamine to enteral and parenteral solutions. However, the relative effectiveness of these treatments is not clear. OBJECTIVES: To determine the efficacy of EN or PN support for patients receiving a bone marrow transplant. SEARCH STRATEGY: Trials were identified by searching the Cochrane Library (Issue 4, 2000 ), MEDLINE (1966-2000), EMBASE (1988-2000) and CINAHL (1982-2000 ). Reference lists of identified trials and conference proceedings were searched for relevant reports. Date of the most recent search: 2000. SELECTION CRITERIA: RCTs that compared one form of nutrition support with another, or control, for bone marrow transplant patients were included. DATA COLLECTION AND ANALYSIS: Thirty five reports were identified, 11 were excluded. Two reviewers extracted data from 24 studies; 16 were allocated to four interventions: oral glutamine versus placebo; PN and glutamine versus standard PN; PN versus IV hydration; PN versus EN. Eight studies were other interventions. Data were collected on participants' characteristics; adverse effects; neutropaenia; % change in body weight; graft versus host disease; and survival. Trialists were contacted for unreported data. MAIN RESULTS: Two studies (82 subjects) found that glutamine mouthwash reduced days of neutropaenia (6.82 days, 95% CI (1.67-11.98) p=0.009) compared with placebo. Three studies (103 subjects) showed that patients receiving PN with glutamine had a reduced hospital stay, 6.62 d (95% CI 3.47, 9.77, P=0.00004) compared with patients receiving standard PN. Two studies (73 subjects) indicated that patients receiving PN plus glutamine had a reduced incidence of positive blood cultures (OR 0.23, 95% CI 0.08-0.65, p=0.006) compared to those receiving standard PN. One study, (25 subjects) showed patients receiving PN had a higher incidence of line infections (odds ratio 21.23, 95% CI 4.15,108.73, P=0.0002) compared to those receiving standard IV fluids. There were no evaluable data to compare PN with EN. REVIEWER'S CONCLUSIONS: Lack of evaluable data means that the relative effectiveness of EN versus PN cannot be evaluated. Further studies and missing data from completed trials need to be retrieved. Studies comparing PN with glutamine versus standard PN suggest that patients leave hospital earlier, and experience a reduced incidence of positive blood cultures, than those receiving standard PN. Patients with gastrointestinal failure should consider PN with the addition of glutamine if enteral feeding is not possible.

Bone Marrow Transplantation↗
PubMed2006

Antibiotic therapy for prophylaxis against infection of pancreatic necrosis in acute pancreatitis.

BACKGROUND: Acute pancreatitis is a common abdominal emergency with no specific treatment. Pancreatic necrosis may complicate severe attacks, detectable by computed tomography (CT). Necrosis can become infected, making surgical intervention necessary and increasing mortality to more than 40%. Experimental studies suggest that antibiotic therapy may prevent infection, but could promote resistance and fungal infection. OBJECTIVES: To determine the effectiveness and safety of prophylactic antibiotics in acute pancreatitis complicated by pancreatic necrosis. SEARCH STRATEGY: The Cochrane Library (Issue 1, 2006), MEDLINE (January 1966-December 2005), EMBASE (January 1980-December 2005) and CINAHL (January 1982-December 2005) were searched. We also examined Conference proceedings. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing antibiotics versus placebo in acute pancreatitis with CT proven necrosis were sought using a detailed search strategy without linguistic limitation. RCTs. Initial searching was undertaken in November 2001. Latest update: December 2005. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data independently for rates of primary end-points: mortality and pancreatic infection rates. Secondary end-points included: non pancreatic infection and operative rates. Adverse events: antibiotic resistance and fungal infections. Subgroup analyses: antibiotic regimen. MAIN RESULTS: Five evaluable studies randomised 294 patients. Analysis suggested significantly less mortality with therapy (6%) versus controls (15.3%), odds ratio 0.37 (95% CI 0.17, 0.83). Infected pancreatic necrosis rates were not significantly different (therapy 20%, controls 27.8%), odds ratio 0.62 (95% CI 0.35, 1.09), and neither were operative treatment rates or non-pancreatic infection rates. Fungal infections were not significantly different at 4% with therapy versus 4.9% in controls, odds ratio 0.83 (95% CI 0.30, 2.27). There were no evaluable data on antibiotic resistance. Sub-group analysis was performed for antibiotic regimen: beta lactam (192 patients), and quinolone plus imidazole (102 patients). With beta lactam prophylaxis there was significantly less mortality (6.3%) versus controls (16.7%), odds ratio 0.34 (95% CI 0.13, 0.91), and infected pancreatic necrosis (15.6%) versus (29.2%) in controls, odds ratio 0.41 (95% CI 0.20, 0.85), but there were no significant differences in operative treatment rates or non-pancreatic infections. No significant differences were seen with quinolone plus imidazole. AUTHORS' CONCLUSIONS: Antibiotic prophylaxis appeared to be associated with significantly decreased mortality but not infected pancreatic necrosis. Beta lactams were associated with significantly decreased mortality and infected pancreatic necrosis, but quinolone plus imidazole regimens were not. There were variations in methodological quality, treatment regimens, and a lack of data on adverse effects. Further better designed studies are needed to support antibiotic prophylaxis and, should these prove beneficial, to compare beta-lactams with quinolones directly.

Acute Disease↗
PubMed2003

Hyaluronate for temporomandibular joint disorders.

BACKGROUND: Temporomandibular joint disorders (TMD) refer to a group of heterogeneous pain and dysfunction conditions involving the masticatory system, reducing life quality of the sufferers. Intra-articular injection of hyaluronate for TMD has been used for nearly two decades but the clinical effectiveness of the agent has not been summarized in the form of a systematic review. OBJECTIVES: To assess the effectiveness of intra-articular injection of hyaluronate both alone and in combination with other remedies on temporomandibular joint disorders. SEARCH STRATEGY: Intensive electronic and handsearches were carried out. The Oral Health Group's Trials Register (September 2001), The Cochrane Library CENTRAL database (Issue 3, 2001), MEDLINE (1966- May 2001), PubMed ( up to March 2002), EMBASE (1974 - August 2001), SIGLE (1980 - December 2001), CBMdisc (1983 - July 2001, in Chinese) and Chinese Medical Library were searched. All the Chinese professional journals in the oral health field were handsearched and conference proceedings consulted. There was no language restriction. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials (RCTs), with single or double blind, design testing the effectiveness of hyaluronate for patients with temporomandibular joint disorders. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data, and three reviewers independently assessed the quality of included studies. The first authors of the selected articles were contacted for additional information. MAIN RESULTS: Seven studies were included in the review. Three studies, including 109 patients with temporomandibular disorders, compared hyaluronate with placebo. Long term effects (three months or longer) are in favour of hyaluronate for the improvement of clinical signs/overall improvement of TMD (RR=1.71, 95%CI: 1.05, 2.77) from two of the studies (n=71). However, this conclusion was not stable enough at sensitivity analysis. Three studies provided data from 124 patients for the comparison of hyaluronate with glucocorticoids (one study also included a placebo group). Hyaluronate had the same short term and long term effects on the improvement of symptoms, clinical signs or overall conditions of the disorders as glucocorticoids. When comparing the effect of arthroscopy or arthrocentesis with and without hyaluronate, results were inconsistent. Hyaluronate had a potential in improving arthroscopic evaluation scores. Mild and transient adverse reactions such as discomfort or pain at the injection site were reported in the hyaluronate groups. No quality of life data were reported REVIEWER'S CONCLUSIONS: There is insufficient, consistent evidence to either support or refute the use of hyaluronate for treating patients with TMD. Further high quality RCTs of hyaluronate need to be conducted before firm conclusions with regard to its effectiveness can be drawn.

Glucocorticoids↗
PubMed2002

Devices and pressure sources for administration of nasal continuous positive airway pressure (NCPAP) in preterm neonates.

BACKGROUND: Nasal continuous positive airway pressure (NCPAP) is used to support preterm infants recently extubated, those experiencing significant apnoea of prematurity and those with respiratory distress soon after birth as an alternative to intubation and ventilation. This review will focus exclusively on identifying the most effective pressure source and interface for NCPAP delivery in preterm infants. OBJECTIVES: In preterm infants extubated to NCPAP following intermittent positive pressure ventilation (IPPV) for respiratory distress syndrome (RDS) or in those treated with NCPAP soon after birth, which technique of pressure generation and which type of nasal interface for NCPAP delivery most effectively reduces the need for additional respiratory support? SEARCH STRATEGY: The strategy included searches of MEDLINE (1966-2002), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002), CINAHL, abstracts from conference proceedings, cross-referencing of previous reviews and the use of expert informants. SELECTION CRITERIA: Randomised or quasi-randomised trials comparing different techniques of NCPAP pressure generation and/or nasal interfaces in preterm infants extubated to NCPAP following IPPV for RDS or treated with NCPAP soon after birth. DATA COLLECTION AND ANALYSIS: Data was extracted and analysed by the first three authors. Dichotomous results were analysed using the relative risk (RR), risk difference (RD) and number needed to treat (NNT). MAIN RESULTS: 1. Preterm infants being extubated to NCPAP following a period of IPPV for RDS: Meta-analysis of the results from Davis 2001 and Roukema 1999a demonstrated that short binasal prongs are more effective at preventing re-intubation than single nasal or nasopharyngeal prongs [typical RR 0.59 (CI: 0.41, 0.85), typical RD -0.21 (CI: -0.35, -0.07), NNT 5 (CI: 3, 14)]. In the single study comparing short binasal prong devices (Sun 1999) the re-intubation rate was significantly lower with the Infant Flow Driver than with the Medicorp prong [RR 0.33 (CI: 0.17, 0.67), RD -0.32 (CI: -0.49, -0.15), NNT 3 (CI: 2, 7)]. 2. Preterm infants primarily treated with NCPAP soon after birth: The one trial identified, Mazzella 2001, found a significantly lower oxygen requirement and respiratory rate in those randomised to short binasal prongs when compared with CPAP delivered via nasopharyngeal prong. The requirement for intubation beyond 48 hours from randomisation was not assessed. No studies comparing different techniques of pressure generation were identified. REVIEWER'S CONCLUSIONS: Short binasal prong devices are more effective than single prongs in reducing the rate of re-intubation. Although the Infant Flow Driver appears more effective than Medicorp prongs the most effective short binasal prong device remains to be determined. The improvement in respiratory parameters with short binasal prongs suggests they are more effective than nasopharyngeal CPAP in the treatment of early RDS. Further studies incorporating longer-term outcomes are required. Studies are also needed to determine the optimal pressure source for the delivery of NCPAP.

Humans↗
PubMed2004

Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes.

BACKGROUND: Hot flushes and night sweats are common symptoms experienced by menopausal women. Hormone therapy (HT), containing oestrogens alone or oestrogens together with progestogens in a cyclic or continuous regimen, is often recommended for their alleviation. OBJECTIVES: To examine the effect of oral HT compared to placebo on these vasomotor symptoms and the risk of early onset side-effects. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders Group and Subfertility Group trials register (searched May 2002). This register is based on regular searches of MEDLINE, EMBASE, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, the handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. We also contacted all relevant pharmaceutical companies, The Journal of the International Menopause Society and Climacteric. SELECTION CRITERIA: Double-blind, randomised, placebo-controlled trials of oral HT for at least three months duration. DATA COLLECTION AND ANALYSIS: Study quality and outcome data were assessed independently. Random effects models were considered appropriate due to the variety of trial methodologies. The meta-analyses were explored for sensitivity to trial quality and therapy duration. Symptom frequency and severity were assessed separately, together with withdrawals and side-effects. Frequency data were analysed using the Weighted Mean Difference (WMD) between treatment and placebo outcomes. For severity data, odds ratios were estimated from the proportional odds model. From 115 references originally identified, 24 trials meeting the selection criteria were included in the review. Study participants totaled 3,329. Trial duration ranged from three months to three years. MAIN RESULTS: There was a significant reduction in the weekly hot flush frequency for HT compared to placebo (WMD -17.92, 95% CI -22.86 to -12.99). This was equivalent to a 75% reduction in frequency (95% CI 64.3 to 82.3) for HT relative to placebo. Symptom severity was also significantly reduced compared to placebo (OR 0.13, 95% CI 0.07 to 0.23). Withdrawal for lack of efficacy occurred significantly more often on placebo therapy (OR 10.51, 95% CI 5.00 to 22.09). Withdrawal for adverse events, commonly breast tenderness, oedema, joint pain and psychological symptoms, was not significantly increased (OR 1.25, 95% CI 0.83 to 1.90), although the occurrence of any adverse events was significantly increased for HT (OR 1.41, 95% CI 1.00 to 1.99). In women who were randomised to placebo treatment, a 57.7% (95% CI 45.1 to 67.7) reduction in hot flushes was observed between baseline and end of study. REVIEWERS' CONCLUSIONS: Oral HT is highly effective in alleviating hot flushes and night sweats. Therapies purported to reduce such symptoms must be assessed in blinded trials against a placebo or a validated therapy because of the large placebo effect seen in well conducted randomised controlled trials, and also because during menopause symptoms may fluctuate and after menopause symptoms often decline. Withdrawals due to side-effects were only marginally increased in the HT groups despite the inability to tailor HT in these fixed dose trials. Comparisons of hormonal doses, product types or regimens require analysis of trials with these specific "within study" comparisons.

Administration, Oral↗
PubMed2002

Macrolides for chronic asthma.

BACKGROUND: Asthma is a chronic disease of the airways in which inflammation of the respiratory mucosa plays a crucial role. The mechanisms responsible for the maintaining of this inflammatory response are only partially known and there is evidence that a role could be paid by chronic infection by intracellular pathogens (such as Chlamydia pneumoniae). Macrolides are antibiotics with both antimicrobial and anti-inflammatory activities and thus their use in asthmatic patients could lead to reduction of the airways inflammation and therefore improvement of symptoms and pulmonary function. OBJECTIVES: To determine whether macrolides are effective in the management of patients with chronic asthma. SEARCH STRATEGY: We searched MEDLINE, EMBASE and CINAHL up to May 2001. This was also supplemented by manually searching bibliographies of previously published reviews, conference proceedings, and contacting study authors. All languages were included in the initial search. SELECTION CRITERIA: Randomised, controlled clinical trials involving both children and adult patients with chronic asthma treated with macrolides for more than 4 weeks, versus placebo. DATA COLLECTION AND ANALYSIS: Two reviewers independently examined all identified articles. Two reviewers reviewed the full text of any potentially relevant article independently. MAIN RESULTS: The initial search retrieved 95 studies. Preliminary evaluation identified 20 studies that were potentially eligible. Five (357 patients) met the entry criteria. The entry criteria for the primary trials differed, but all recruited a specific subgroup of patients (eg severe oral steroid dependent, aspirin intolerant or evidence of Chlamydia pnuemoniae infection). There was a positive effect on symptoms (Standardised Mean Difference -1.25, 95% Confidence Intervals (CI) -1.80, -0.70) and markers of eosinophilic inflammation; eg sputum eosinophils Weighted Mean difference -78.5, 95%CI -90.8, -66.1). Tests of oral corticosteroid-sparing effects have not yet been performed on the newer agents such as roxithromycin and clarithromycin. REVIEWER'S CONCLUSIONS: Considering the small number of patients studied, there is insufficient evidence to support or to refute the use of macrolides in patients with chronic asthma. Further studies are needed in particular to clarify the potential role of macrolides in some subgroups of asthmatics such as those with evidence of chronic bacterial infection.

Anti-Bacterial Agents↗
PubMed2005

Macrolides for chronic asthma.

BACKGROUND: Asthma is a chronic disease of the airways in which inflammation of the respiratory mucosa plays a crucial role. The mechanisms responsible for the maintaining of this inflammatory response are only partially known and there is evidence that a role could be paid by chronic infection by intracellular pathogens (such as Chlamydia pneumoniae). Macrolides are antibiotics with both antimicrobic and antiinflammatory activities and thus their use in asthmatic patients could lead to reduction of the airways inflammation and therefore improvement of symptoms and pulmonary function. OBJECTIVES: To determine whether macrolides are effective in the management of patients with chronic asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group Specialised Register of trials up to May 2004. This was also supplemented by manually searching bibliographies of previously published reviews, conference proceedings, and contacting study authors. All languages were included in the initial search. SELECTION CRITERIA: Randomised, controlled clinical trials involving both children and adult patients with chronic asthma treated with macrolides for more than 4 weeks, versus placebo. DATA COLLECTION AND ANALYSIS: Two reviewers independently examined all identified articles. The full text of any potentially relevant article was reviewed independently by two reviewers. MAIN RESULTS: Seven studies recruiting a total of 416 participants met the inclusion criteria. The quality of reporting of study methodology was generally low. We assembled findings from studies comparing macrolide treatment for at least 4 weeks in adult and pediatric patients treated for chronic asthma. Four studies showed a positive effect on symptoms of macrolides in different types of asthmatic patients. There were limited data available for meta-analysis. There was no significant difference in FEV1 for either parallel or crossover trials. However, there were significant differences in eosinophilic inflammation and symptoms. One large parallel group trial reported significant differences in peak flow but these differences abated within six months of treatment. AUTHORS' CONCLUSIONS: Considering the small number of patients studied, there is insufficient evidence to support or to refute the use of macrolides in patients with chronic asthma. Further studies are needed in particular to clarify the potential role of macrolides in some subgroups of asthmatics such as those with evidence of chronic bacterial infection.

Anti-Bacterial Agents↗
PubMed2005

Macrolides for chronic asthma.

BACKGROUND: Asthma is a chronic disease of the airways in which inflammation of the respiratory mucosa plays a crucial role. The mechanisms responsible for the maintaining of this inflammatory response are only partially known and there is evidence that a role could be paid by chronic infection by intracellular pathogens (such as Chlamydia pneumoniae). Macrolides are antibiotics with both antimicrobic and antiinflammatory activities and thus their use in asthmatic patients could lead to reduction of the airways inflammation and therefore improvement of symptoms and pulmonary function. OBJECTIVES: To determine whether macrolides are effective in the management of patients with chronic asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group Specialised Register of trials up to May 2005. This was also supplemented by manually searching bibliographies of previously published reviews, conference proceedings, and contacting study authors. All languages were included in the initial search. SELECTION CRITERIA: Randomised, controlled clinical trials involving both children and adult patients with chronic asthma treated with macrolides for more than 4 weeks, versus placebo. DATA COLLECTION AND ANALYSIS: Two reviewers independently examined all identified articles. The full text of any potentially relevant article was reviewed independently by two reviewers. MAIN RESULTS: Seven studies recruiting a total of 416 participants met the inclusion criteria. The quality of reporting of study methodology was generally low. We assembled findings from studies comparing macrolide treatment for at least 4 weeks in adult and pediatric patients treated for chronic asthma. Four studies showed a positive effect on symptoms of macrolides in different types of asthmatic patients. There were limited data available for meta-analysis. There was no significant difference in FEV1 for either parallel or crossover trials. However, there were significant differences in eosinophilic inflammation and symptoms. One large parallel group trial reported significant differences in peak flow but these differences abated within six months of treatment. AUTHORS' CONCLUSIONS: Considering the small number of patients studied, there is insufficient evidence to support or to refute the use of macrolides in patients with chronic asthma. Further studies are needed in particular to clarify the potential role of macrolides in some subgroups of asthmatics such as those with evidence of chronic bacterial infection.

Anti-Bacterial Agents↗
PubMed2002

Perioperative fluid volume optimization following proximal femoral fracture.

BACKGROUND: Proximal Femoral Fracture (PFF) or 'hip fracture' is a frequent injury, and adverse outcomes are common. Many patients are elderly, with significant comorbidity. Several factors suggest the importance of developing appropriate techniques to optimize intravascular fluid volume. These may include protocols that enhance the efficacy of clinicians' assessments, invasive techniques such as oesophageal Doppler or central venous pressure monitoring, or advanced non-invasive techniques such as plethysmographic pulse volume determination. OBJECTIVES: To determine the optimal method of fluid volume optimization for adult patients undergoing surgical repair of hip fracture. Comparisons of fluid types (e.g. crystalloid vs. colloid) or of blood transfusion strategies or of other pharmacological interventions (e.g. inotropes) are not considered in this review. SEARCH STRATEGY: Randomized controlled trials (RCTs) since 1985 were identified by searching MEDLINE, EMBASE, the Cochrane Library, the Cochrane Anaesthesia Group's specialized Controlled Trials Register and bibliographies of retrieved articles. Relevant journals and conference proceedings were handsearched. SELECTION CRITERIA: RCTs comparing a fluid optimization intervention with normal practice (control) or with another fluid optimization intervention, in patients following PFF undergoing surgery of any type under anaesthesia of any type. DATA COLLECTION AND ANALYSIS: Searches and exclusion of clearly irrelevant articles were performed by one reviewer. Two reviewers examined independently the remaining studies, extracting study quality and results data. A wide range of short- and long-term outcome data was sought. Study quality was assessed using a ten-point instrument and studies were excluded if they did not meet the study criteria or if results were likely to be biased. Due to a lack of consistency in reporting, combination of data was not generally possible. MAIN RESULTS: Searches identified only four trials, of which two studies, randomizing a total of 130 patients, were of adequate quality and addressed the review question. Both studies were of invasive advanced haemodynamic monitoring during the intraoperative period only. One study randomized patients to 'normal care' or optimization using oesophageal Doppler; the second study randomized patients to 'normal care', oesophageal Doppler or central venous pressure monitoring. In each study, invasive monitoring led to a significant increase in volume of fluid infused and a reduction in length of hospital stay. The pooled Peto odds ratio for in-hospital fatality was 1.44 (95% confidence interval 0.45-4.62). Neither study followed patients beyond hospital discharge or assessed functional outcomes (for example return to previous accommodation). No serious complications were reported to be directly attributable to the monitoring interventions. There were no studies of protocol-guided fluid optimization or of advanced non-invasive techniques. REVIEWER'S CONCLUSIONS: Invasive methods of fluid optimization during surgery may shorten hospital stay, but their effects on other important, patient-centred, longer-term outcomes are uncertain. An adverse effect on fatality cannot be excluded. Other fluid optimization techniques have not been evaluated. The lack of randomized studies of adequate quality addressing this important question is disappointing given the high incidence and frequently adverse outcome of PFF. More research is needed.

Blood Volume↗
PubMed2004

Perioperative fluid volume optimization following proximal femoral fracture.

BACKGROUND: Proximal Femoral Fracture (PFF) or 'hip fracture' is a frequent injury, and adverse outcomes are common. Several factors suggest the importance of developing techniques to optimize intravascular fluid volume. These may include protocols that enhance the efficacy of clinicians' assessments, invasive techniques such as oesophageal Doppler or central venous pressure monitoring, or advanced non-invasive techniques such as plethysmographic pulse volume determination. OBJECTIVES: To determine the optimal method of fluid volume optimization for adult patients undergoing surgical repair of PFF. Comparisons of fluid types, of blood transfusion strategies or of pharmacological interventions are not considered in this review. SEARCH STRATEGY: We searched CENTRAL (The Cochrane Library, issue 4, 2003), MEDLINE (1985 to 2003), EMBASE (1985 to 2003), and bibliographies of retrieved articles. Relevant journals and conference proceedings were handsearched. SELECTION CRITERIA: Randomized controlled studies comparing a fluid optimization intervention with normal practice or with another fluid optimization intervention, in patients following PFF undergoing surgery of any type under anaesthesia of any type. DATA COLLECTION AND ANALYSIS: Searches and exclusion of clearly irrelevant articles were performed by one reviewer. Two reviewers examined independently the remaining studies, extracting study quality and results data. A wide range of short- and long-term outcome data were sought. Studies were excluded if they did not meet selection criteria or if results were likely to be biased. Due to inconsistent data reporting, combination of data was not generally possible. MAIN RESULTS: Searches identified four trials, of which two studies, randomizing a total of 130 patients, were of adequate quality and addressed the review question. Both studies were of invasive advanced haemodynamic monitoring, either oesophageal Doppler ultrasonography or central venous pressure monitoring, during the intraoperative period only. In both, invasive monitoring led to significant increases in fluid volumes infused and reductions in length of hospital stay. The pooled Peto odds ratio for in-hospital fatality was 1.44 (95% confidence interval 0.45-4.62). Neither study followed patients beyond hospital discharge or assessed functional outcomes. No serious complications were directly attributable to the interventions. There were no studies of protocol-guided fluid optimization or of advanced non-invasive techniques. REVIEWER'S CONCLUSIONS: Invasive methods of fluid optimization during surgery may shorten hospital stay, but their effects on other important, patient-centred, longer-term outcomes are uncertain. Adverse effects on fatality cannot be excluded. Other fluid optimization techniques have not been evaluated. The lack of randomized studies of adequate quality addressing this important question is disappointing. More research is needed.

Femoral Fractures↗