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PubMed2004

Combinations of topical fluoride (toothpastes, mouthrinses, gels, varnishes) versus single topical fluoride for preventing dental caries in children and adolescents.

BACKGROUND: Topical fluoride therapy (TFT) in the form of toothpastes, mouthrinses, varnishes and gels are effective caries preventive measures. However, there is uncertainty about the relative value of these interventions when used together. OBJECTIVES: To compare the effectiveness of two TFT modalities combined with one of them alone (mainly toothpaste) when used for the prevention of dental caries in children. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register (May 2000), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2000), MEDLINE (1966 to January 2000), plus several other databases. We handsearched journals, reference lists of articles and contacted selected authors and manufacturers. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish, gel, mouthrinse, or toothpaste in combination with each other in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). DATA COLLECTION AND ANALYSIS: Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF) that is the difference in mean caries increments between the 'treatment' and 'control' groups expressed as a percentage of the mean increment in the control group. Random effects meta-analyses were performed where data could be pooled. MAIN RESULTS: Eleven of the 12 included studies contributed data for the meta-analyses. For the nine trials that provided data for the main meta-analysis on the effect of fluoride mouthrinses, gels or varnishes used in combination with toothpaste (involving 4026 children) the D(M)FS pooled PF was 10% (95% CI, 2% to 17%; p = 0.01) in favour of the combined regimens. Heterogeneity was not substantial in these results (I square = 32%). The separate meta-analyses of fluoride gel or mouthrinse combined with toothpaste versus toothpaste alone favour the combined regimens, but differences were not statistically significant; the significant difference in favour of the combined use of fluoride varnish and toothpaste accrues from a very small trial and appears likely to be a spurious result. Not all other combinations of possible practical value were tested in the included studies. The only other statistically significant result was in favour of the combined use of fluoride gel and mouthrinse in comparison to gel alone (pooled DMFS PF 23%; 95% CI, 4% to 43%; p = 0.02), based on two trials. No other combinations of TFT were consistently superior to a single TFT. REVIEWER'S CONCLUSIONS: Topical fluorides (mouthrinses, gels, or varnishes) used in addition to fluoride toothpaste achieve a modest reduction in caries compared to toothpaste used alone. No conclusions about any adverse effects could be reached, because data were scarcely reported in the trials.

Adolescent↗
PubMed2003

Topical fluoride (toothpastes, mouthrinses, gels or varnishes) for preventing dental caries in children and adolescents.

BACKGROUND: Topical fluoride therapy (TFT) in the form of varnish, gel, mouthrinse or toothpaste has been used extensively as a caries-preventive intervention for over three decades. OBJECTIVES: To determine the effectiveness and safety of fluoride varnishes, gels, mouthrinses, and toothpastes in the prevention of dental caries in children and to examine factors potentially modifying their effect. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register (May 2000), CENTRAL (The Cochrane Library Issue 2, 2000), MEDLINE (1966 to January 2000), plus several other databases. We handsearched journals, reference lists of articles and contacted selected authors and manufacturers. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish, gel, mouthrinse, or toothpaste with placebo or no treatment in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). DATA COLLECTION AND ANALYSIS: Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF) that is the difference in mean caries increments between the treatment and control groups expressed as a percentage of the mean increment in the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects metaregression analyses. MAIN RESULTS: There were 144 studies included. For the 133 that contributed data for meta-analysis (involving 65,169 children) the D(M)FS pooled prevented fraction estimate was 26% (95% CI, 24% to 29%; p < 0.0001). There was substantial heterogeneity, confirmed statistically (p < 0.0001), but the direction of effect was consistent. The effect of topical fluoride varied according to type of control group used, type of TFT used, mode/setting of TFT use, initial caries levels and intensity of TFT application, but was not influenced by exposure to water fluoridation or other fluoride sources. D(M)FS PF was on average 14% (95% CI, 5% to 23%; p = 0.002) higher in non-placebo controlled trials, 14% (95% CI, 2% to 26%; p = 0.25) higher in fluoride varnish trials compared with all others, and 10% (95% CI, -17% to -3%; p = 0.003) lower in trials of unsupervised home use compared with self applied supervised and operator-applied. There was a 0.7% increase in the PF per unit increase in baseline caries (95% CI, 0.2% to 1.2%; p = 0.004). REVIEWER'S CONCLUSIONS: The benefits of topical fluorides have been firmly established on a sizeable body of evidence from randomized controlled trials. While the formal examination of sources of heterogeneity between studies has been important in the overall conclusions reached, these should be interpreted with caution. We were unable to reach definite conclusions about any adverse effects that might result from the use of topical fluorides, because data reported in the trials are scarce.

Adolescent↗
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↗
PubMed2005

Acupuncture for acute stroke.

BACKGROUND: Acupuncture-like sensory stimulation activates multiple efferent (nerve) pathways leading to altered activity in numerous neural systems. Acupuncture is widely accepted by Chinese people and it is increasingly requested by patients and their relatives in Western countries. OBJECTIVES: To assess the effectiveness and safety of acupuncture in patients with acute stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register (last searched August 2003), the Chinese Stroke Trials Register (August 2003) and the Chinese Acupuncture Trials Register (August 2003). Electronic searches were performed in the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2003), MEDLINE (1966 to 2003), EMBASE (1980 to 2003), Alternative Medicine Database (1985 to 2003), CINAHL (1982 to 2003) and the Chinese Biological Medicine Database (1981 to 2003). Reference lists of systematic reviews and identified trials were handsearched. SELECTION CRITERIA: Randomised and quasi-randomised trials of acupuncture started within 30 days of stroke onset, compared with placebo/sham acupuncture or open control in patients with acute ischaemic and/or haemorrhagic stroke. Needling into skin was required for acupuncture. DATA COLLECTION AND ANALYSIS: Two reviewers selected trials for inclusion, assessed trial quality, and extracted the data independently. Authors of trials were contacted for missing data. MAIN RESULTS: Fourteen trials involving 1208 patients were included. Ten trials included patients with only ischaemic stroke. When acupuncture was compared with sham acupuncture or open control, there was a borderline significant trend towards fewer patients being dead or dependent (Odds ratio (OR) 0.66, 95% confidence interval (CI) 0.43 to 0.99), and significantly fewer being dead or needing institutional care (OR 0.58, 95% CI 0.35 to 0.96) in the acupuncture group after three months or more. There was also a significant difference favouring acupuncture in the mean change of global neurological deficit score during the treatment period (standardized mean difference (SMD) 1.17, 95% CI 0.30 to 2.04). Comparison of acupuncture with sham acupuncture only showed a statistically significant difference on death or requiring institutional care (OR 0.49, 95% CI 0.25 to 0.96), but not on death or dependency (OR 0.67, 95% CI 0.40 to 1.12), or change of global neurological deficit score (SMD 0.01, 95% CI -0.55 to 0.57). Severe adverse events with acupuncture (dizziness, intolerable pain and infection of acupoints) were rare (6/386, 1.55%). AUTHORS' CONCLUSIONS: Acupuncture appeared to be safe but without clear evidence of benefit. The number of patients is too small to be certain whether acupuncture is effective for treatment of acute ischaemic or haemorrhagic stroke. Larger, methodologically-sound trials are required.

Acupuncture Therapy↗
PubMed2006

Rehabilitation for distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. OBJECTIVES: To examine the effects of rehabilitation interventions in adults with conservatively or surgically treated distal radial fractures. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2005), MEDLINE, EMBASE, CINAHL, AMED, PEDro, OTseeker and other databases, conference proceedings and reference lists of articles. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials evaluating rehabilitation as part of the management of fractures of the distal radius sustained by adults. Rehabilitation interventions such as active and passive mobilisation exercises, and training for activities of daily living, could be used on their own or in combination, and be applied in various ways by various clinicians. DATA COLLECTION AND ANALYSIS: The authors independently selected and reviewed trials. Study authors were contacted for additional information. No data pooling was done. MAIN RESULTS: Fifteen trials, involving 746 mainly female and older patients, were included. Initial treatment was conservative, involving plaster cast immobilisation, in all but 27 participants whose fractures were fixed surgically. Though some trials were well conducted, others were methodologically compromised. For interventions started during immobilisation, there was weak evidence of improved hand function for hand therapy in the days after plaster cast removal, with some beneficial effects continuing one month later (one trial). There was weak evidence of improved hand function in the short term, but not in the longer term (three months), for early occupational therapy (one trial), and of a lack of differences in outcome between supervised and unsupervised exercises (one trial). For interventions started post-immobilisation, there was weak evidence of a lack of clinically significant differences in outcome in patients receiving formal rehabilitation therapy (four trials), passive mobilisation (two trials), ice or pulsed electromagnetic field (one trial), or whirlpool immersion (one trial) compared with no intervention. There was weak evidence of a short-term benefit of continuous passive motion (post external fixation) (one trial), intermittent pneumatic compression (one trial) and ultrasound (one trial). There was weak evidence of better short-term hand function in participants given physiotherapy than in those given instructions for home exercises by a surgeon (one trial). AUTHORS' CONCLUSIONS: The available evidence from randomised controlled trials is insufficient to establish the relative effectiveness of the various interventions used in the rehabilitation of adults with fractures of the distal radius.

Adult↗
PubMed2002

Trypanocidal drugs for chronic asymptomatic Trypanosoma cruzi infection.

BACKGROUND: Prior guidelines stated that trypanocidal therapy should not be used for treating chronic asymptomatic Trypanosoma cruzi infections. However, the recent availability of clinical trials reporting high rates of parasitologic cure in children with early chronic T. cruzi infection have produced changes of these recommendations in some countries. Because of the uncertainty regarding best treatment for this stage of T. cruzi infections, the literature was reviewed systematically for a synthesis of the available evidence. OBJECTIVES: To assess the effects of trypanocidal therapy for chronic asymptomatic T. cruzi infection. SEARCH STRATEGY: We searched The Cochrane Controlled Trials Register (Issue 1, 2000), MEDLINE (start-Nov 1999), EMBASE (start - Feb 2000), LILACS (start - Feb 2000) and the Tropical Diseases Research Division of WHO database (Start - Feb 2000). Reference lists of articles were searched for relevant material. SELECTION CRITERIA: Published RCTs of trypanocidal therapy for people with chronic, asymptomatic T. cruzi infections DATA COLLECTION AND ANALYSIS: Two reviewers independently screened papers for inclusion criteria, quality assessment and data extraction. Forms were used to collect data. Reviewers resolved differences by discussion then a third reviewer if necessary. MAIN RESULTS: Of 43 papers assessed for inclusion, five RCTs (total population=756) met the inclusion criteria. The quality of the trials was rated as low (n=3) or intermediate (n=2). Two RCTs tested benznidazole in school children and three tested different agents in adults. The Odds Ratios and their 95%CI (Fixed models) were: Incidence of ECG abnormalities: 0.41 (0.09, 1.85); Negative seroconversion (AT ELISA): 10.91 (6.07, 19.58); Negative xenodiagnosis during the follow up: 5.37 (3.34, 8.64); Standardised mean reduction of antibody titres: 0.54 (0.31, 0.84). Nitroimidazolic derivatives substantially and significantly modified parasite-related outcomes compared to placebo. Other agents showed borderline or not significant effect. REVIEWER'S CONCLUSIONS: Despite major public health importance, trypanocidal.therapy for chronic asymptomatic T. cruzi infection has been tested in few, small size RCTs which were designed to assess parasitic-related, but not clinical outcomes. Therefore, the potential of trypanocidal therapy to prevent Chagas' disease among asymptomatic, chronically infected subjects is promising, but remains to be evaluated. trypanocidal therapy, particularly nitroimidazolic derivatives given to children or adults with positive xenodiagnosis improve parasite-related outcomes. The large contrast between the burden of Chagas disease and the existing evidence on its prevention points the need to test these or newer agents in more and larger RCTs that include clinical endpoints.

Animals↗
PubMed2006

Complete or ultraconservative removal of decayed tissue in unfilled teeth.

BACKGROUND: The treatment of deep dental decay has traditionally involved removal of all the soft demineralised dentine before a filling is placed. However this has been challenged in three groups of studies which involve sealing soft caries into the tooth. The three main groups either remove no caries and seal the decay into the tooth, remove minimal (ultraconservative) caries at the entrance to a cavity and seal the remaining caries in, or remove caries in stages over two visits some months apart to allow the pulp time to lay down reparative dentine (the stepwise excavation technique). OBJECTIVES: To test the null hypothesis of no difference in the incidence of damage or disease of the nerve of the tooth (pulp), progression of decay and longevity of restorations irrespective of whether the removal of decay had been minimal (ultraconservative) or complete. SEARCH STRATEGY: The Cochrane Oral Health Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PubMed and EMBASE databases were searched. The reference lists in relevant papers were checked. SELECTION CRITERIA: Randomised controlled trials and controlled clinical trials comparing minimal (ultraconservative) caries removal with complete caries removal in unrestored permanent and deciduous teeth. DATA COLLECTION AND ANALYSIS: Outcome measures recorded were exposure of the nerve of the tooth (pulp) during caries removal, patient experience of symptoms of pulpal inflammation or necrosis, progression of caries under the filling, time until the filling was lost or replaced. Due to the heterogeneity of the included studies the overall estimate of effect was calculated using a random-effects model. MAIN RESULTS: Four studies met the inclusion criteria; two stepwise excavation studies and two ultraconservative caries removal studies. Partial caries removal in symptomless, primary or permanent teeth reduces the risk of pulp exposure. We found no detriment to the patient in terms of pulpal symptoms in this procedure and no reported premature loss or deterioration of the restoration. AUTHORS' CONCLUSIONS: The results of this systematic review reject the null hypothesis of no difference in the incidence of damage or disease of the nerve of the tooth (pulp) irrespective of whether the removal of decay had been minimal (ultraconservative) or complete and accepts the null hypothesis of no difference in the progression of decay and longevity of restorations. However, the number of included studies is small and differ considerably. Partial caries removal is therefore preferable to complete caries removal in the deep lesion, in order to reduce the risk of carious exposure. However, there is insufficient evidence to know whether it is necessary to re-enter and excavate further but studies that have not re-entered do not report adverse consequences.

Cariostatic Agents↗
PubMed2003

Ventilation with lower tidal volumes versus traditional tidal volumes in adults for acute lung injury and acute respiratory distress syndrome.

BACKGROUND: Patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) require mechanical ventilatory support. ALI/ARDS is further complicated by ventilator-induced lung injury. Lung-protective ventilation strategies may lead to improved survival. OBJECTIVES: To assess the effects of ventilation with lower tidal volume (Vt) on morbidity and mortality in adults patients affected by ALI/ARDS. A secondary objective was to determine whether the comparison between low and conventional Vt is different if a plateau airway pressure of greater than 30 to 35 cm H20 was used. SEARCH STRATEGY: We searched The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library issue 3, 2002; MEDLINE (1966 to June 2002); EMBASE and CINAHL (1982 to June 2002); intensive care journals and conference proceedings; databases of ongoing research, reference lists and 'grey literature'. SELECTION CRITERIA: Randomized trials comparing ventilation using lower Vt and/or low airway driving pressure (plateau pressure 30 cm H2O or less), resulting in Vt of 7 ml/kg or less versus ventilation that uses Vt in the range of 10 to 15 ml/kg, in adults (16 year-old or greater). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Wherever appropriate, results were pooled. Fixed and random effects models were applied. MAIN RESULTS: Five trials, involving 1202 patients, were eligible. The test for heterogeneity gave a P-value of 0.12. Ventilation with lower Vt was associated with a decreased mortality at the end of the follow up period for each trial: 216/605 (35.7%) versus 249/597 (41.7%), relative risk (RR) 0.85 (CI 0.74 to 0.98). The effect of the intervention was not statistically significant when a random effects model was used: RR 0.91 (CI 0.72 to 1.14). Mortality at day 28 was significantly reduced by lung-protective ventilation: RR 0.74 (CI 0.61 to 0.88). The comparison between low and conventional Vt was not significantly different if a plateau pressure less than or equal to 31 cm H2O in control group was used: RR 1.13 (CI 0.88 to 1.45). There was insufficient evidence about morbidity and long term outcomes. REVIEWER'S CONCLUSIONS: Clinical heterogeneity, such as different lengths of follow up and higher plateau pressure in control arms in two trials make the interpretation of the combined results difficult. Mortality is significantly reduced at day 28 and the effects on long term mortality are uncertain, although the possibility of a clinically relevant benefit cannot be excluded. There is no evidence that low Vt ventilation is beneficial in patients where hypercapnia is potentially harmful.

Adult↗
PubMed2004

Ventilation with lower tidal volumes versus traditional tidal volumes in adults for acute lung injury and acute respiratory distress syndrome.

BACKGROUND: Patients with acute respiratory distress syndrome and acute lung injury require mechanical ventilatory support. Acute respiratory distress syndrome and acute lung injury are further complicated by ventilator-induced lung injury. Lung-protective ventilation strategies may lead to improved survival. OBJECTIVES: To assess the effects of ventilation with lower tidal volume on morbidity and mortality in patients aged 16 years or older affected by acute respiratory distress syndrome and acute lung injury. A secondary objective was to determine whether the comparison between low and conventional tidal volume was different if a plateau airway pressure of greater than 30 to 35 cm H20 was used. SEARCH STRATEGY: We searched The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library issue 4, 2003; MEDLINE (1966 to October 2003); EMBASE and CINAHL (1982 to October 2003); intensive care journals and conference proceedings; databases of ongoing research, reference lists and 'grey literature'. SELECTION CRITERIA: Randomized trials comparing ventilation using either lower tidal volume or low airway driving pressure (plateau pressure 30 cm H(2)O or less), resulting in tidal volume of 7 ml/kg or less versus ventilation that uses Vt in the range of 10 to 15 ml/kg, in adults (aged 16 years or older). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Wherever appropriate, results were pooled. Fixed and random effects models were applied. MAIN RESULTS: Five trials, involving 1202 patients, were eligible. Mortality at day 28 was significantly reduced by lung-protective ventilation: relative risk 0.74 (confidence interval 0.61 to 0.88), whereas beneficial effect on long-term mortality was uncertain: relative risk 0.84 (confidence interval 0.68 to 1.05). The comparison between low and conventional tidal volume was not significantly different if a plateau pressure less than or equal to 31 cm H2O in control group was used: relative risk 1.13 (confidence interval 0.88 to 1.45). There was insufficient evidence about morbidity and long term outcomes. REVIEWERS' CONCLUSIONS: Clinical heterogeneity, such as different lengths of follow up and higher plateau pressure in control arms in two trials make the interpretation of the combined results difficult. Mortality is significantly reduced at day 28 and the effects on long term mortality are uncertain, although the possibility of a clinically relevant benefit cannot be excluded.

Adult↗
PubMed2006

In vitro fertilisation versus tubal reanastomosis (sterilisation reversal) for subfertility after tubal sterilisation.

BACKGROUND: Tubal sterilisation is the most popular contraceptive method in the world. Approximately 138 million women of reproductive age have had tubal sterilisation and there is evidence that increasingly younger women are being sterilized. With such large numbers of women choosing this option of birth control, it is clear that even if a small percentage of women later regret the decision, large numbers of women will seek counselling regarding reversal from their physicians. OBJECTIVES: To compare the efficacy of surgical tubal reanastomosis and in vitro fertilisation in terms of live birth rates. The morbidity and cost-effectiveness of both techniques were also to be compared. SEARCH STRATEGY: The following databases were searched: Cochrane Menstrual Disorders and Subfertility Review Group Specialised Register, MEDLINE (1966 to 2005), EMBASE (1980 to 2005), and other electronic databases. We handsearched the reference lists of trials, reviews and relevant textbooks; searched abstracts from relevant conferences, and personally communicated with experts in the field. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing surgical reversal of tubal sterilisation with in vitro fertilisation (IVF). The method of allocation will be assessed and results subgrouped according to whether the trials were randomised or quasi-randomised. DATA COLLECTION AND ANALYSIS: No trials were found that met the selection criteria. MAIN RESULTS: No data exist on which to report. AUTHORS' CONCLUSIONS: There is a need for well-designed controlled clinical trials to compare the efficacy and safety of surgical reversal of tubal sterilisation and IVF in restoring fertility in women seeking pregnancy following tubal sterilisation.

Female↗
PubMed2004

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

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

Anemia, Sickle Cell↗
PubMed2003

Preoperative fasting for adults to prevent perioperative complications.

BACKGROUND: Fasting before general anaesthesia aims to reduce the volume and acidity of stomach contents during surgery, thus reducing the risk of regurgitation/aspiration. Recent guidelines have recommended a shift in fasting policy from the standard 'nil by mouth from midnight' approach to more relaxed policies which permit a period of restricted fluid intake up to a few hours before surgery. The evidence underpinning these guidelines however, was scattered across a range of journals, in a variety of languages, used a variety of outcome measures and methodologies to evaluate fasting regimens that differed in duration and the type and volume of intake permitted during a restricted fasting period. Practice has been slow to change. OBJECTIVES: To systematically review the effect of different preoperative fasting regimens (duration, type and volume of permitted intake) on perioperative complications and patient wellbeing (including aspiration, regurgitation and related morbidity, thirst, hunger, pain, nausea, vomiting, anxiety) in different adult populations. SEARCH STRATEGY: Electronic databases, conference proceedings and reference lists from relevant articles were searched for studies of preoperative fasting in August 2003 and experts in the area were consulted. SELECTION CRITERIA: Randomised controlled trials which compared the effect on postoperative complications of different preoperative fasting regimens on adults were included. DATA COLLECTION AND ANALYSIS: Details of the eligible studies were independently extracted by two reviewers and where relevant information was unavailable from the text attempts were made to contact the authors. MAIN RESULTS: Thirty eight randomised controlled comparisons (made within 22 trials) were identified. Most were based on 'healthy' adult participants who were not considered to be at increased risk of regurgitation or aspiration during anaesthesia. Few trials reported the incidence of aspiration/regurgitation or related morbidity but relied on indirect measures of patient safety i.e. intra-operative gastric volume and pH. There was no evidence that the volume or pH of participants' gastric contents differed significantly depending on whether the groups were permitted a shortened preoperative fluid fast or continued a standard fast. Fluids evaluated included water, coffee, fruit juice, clear fluids and other drinks (e.g. isotonic drink, carbohydrate drink). Participants given a drink of water preoperatively were found to have a significantly lower volume of gastric contents than the groups that followed a standard fasting regimen. This difference was modest and clinically insignificant. There was no indication that the volume of fluid permitted during the preoperative period (i.e. low or high) resulted in a difference in outcomes from those participants that followed a standard fast. Few trials specifically investigated the preoperative fasting regimen for patient populations considered to be at increased risk during anaesthesia of regurgitation/aspiration and related morbidity. REVIEWER'S CONCLUSIONS: There was no evidence to suggest a shortened fluid fast results in an increased risk of aspiration, regurgitation or related morbidity compared with the standard 'nil by mouth from midnight' fasting policy. Permitting patients to drink water preoperatively resulted in significantly lower gastric volumes. Clinicians should be encouraged to appraise this evidence for themselves and when necessary adjust any remaining standard fasting policies (nil-by-mouth from midnight) for patients that are not considered 'at-risk' during anaesthesia.

Adult↗
PubMed2005

Laparoscopy versus laparotomy for benign ovarian tumours.

BACKGROUND: Over the last ten years laparoscopy has become an increasingly common approach for the surgical removal of benign ovarian tumours. There remains uncertainty as to the value of this intervention. This review has been undertaken to assess the available evidence for the benefits and harms of laparoscopic surgery for benign ovarian tumours compared to laparotomy. OBJECTIVES: To determine the efficacy, safety and cost of laparoscopic surgery compared with laparotomy in women with ovarian tumours assumed to be benign. SEARCH STRATEGY: We searched electronic databases, trials registers and reference lists of published trial reports. Review articles were also searched. SELECTION CRITERIA: All randomised controlled trials comparing laparoscopy versus laparotomy for benign ovarian tumours. DATA COLLECTION AND ANALYSIS: Three reviewers independently assessed each study's eligibility and quality and extracted data. MAIN RESULTS: Six randomised controlled trials were identified involving 324 patients. Three subgroups of ovarian tumours were considered: any histological type of benign ovarian tumour, dermoid cysts and endometriomata. Surgical outcomes: The mean duration of surgery was longer in the laparoscopy group compared to the laparotomy group overall (WMD 11.39; 95% CI 0.57 to 22.22). However, heterogeneity was present with substantial inconsistency (I(2)=87%) . The heterogeneity found in these analyses was likely to reflect differences in the patient populations. Adverse effects of surgery: The pooled estimate for febrile morbidity decreased for laparoscopy compared to laparotomy (Peto OR 0.34; 95% CI 0.13 to 0.88). The odds of any adverse effect of surgery (total number of complications - surgical injury and/or post operative complications) were decreased after laparoscopic procedures (Peto OR 0.26; 95% CI 0.12 to 0.55). Short-term recovery: VAS pain scores favoured laparoscopy (WMD -2.36; 95% CI -2.07 to -2.03) andt he odds of being pain free were significantly greater for the laparoscopy group compared to laparotomy (Peto OR 7.35; 95% CI 4.3 to 12.56). Mean length of hospital stay was shorter in the laparoscopy group with reduction 2.79 days (95% CI -2.95 to -2.62) compared to laparotomy. Economic outcomes: There was a significant reduction of US$1045 (95% CI -1361 to -726.97) in the laparoscopy group compared to the laparotomy group in one trial of women with any type of benign ovarian tumour. AUTHORS' CONCLUSIONS: In women undergoing surgery for benign ovarian tumours, laparoscopy is associated with a reduction in the following; febrile morbidity, urinary tract infection, post operative complications, post operative pain, days in hospital and total cost. These findings should be interpreted with caution as only a small number of studies were identified including a total of only 324 women and not all of the important outcomes were reported in each study.

Female↗
PubMed2006

Interventions for cutaneous molluscum contagiosum.

BACKGROUND: Molluscum contagiosum is a common skin infection, caused by a virus, which will usually resolve within months in people with a normal immune system. Many treatments have been promoted for molluscum contagiosum but a clear evidence base supporting them is lacking. OBJECTIVES: To assess the effects of management strategies (including waiting for natural resolution) for cutaneous, non-genital molluscum contagiosum in healthy people. SEARCH STRATEGY: We searched the Skin Group Specialised Register (March 2004), the Cochrane Central Register of Controlled Trials (2004, Issue 2), MEDLINE (from 1966 to March 2004), EMBASE (from 1980 to March 2004) and LILACS (from 1982 to March 2004) databases. We also searched reference lists and contacted pharmaceutical companies and experts in the field. SELECTION CRITERIA: Randomised controlled trials for treatment of molluscum contagiosum were investigated. Trials on sexually transmitted molluscum contagiosum and in people with lowered immunity (including those with HIV infection) were excluded. DATA COLLECTION AND ANALYSIS: Study selection and assessment of methodological quality were carried out by two independent authors. As similar comparisons between two interventions were not made in more than one study, statistical pooling was not performed. MAIN RESULTS: Five studies, with a total number of 137 participants, examined the effects of topical (three studies), systemic and homoeopathic interventions (one study each). Limited evidence was found for sodium nitrite co-applied with salicylic acid compared to salicylic acid alone (risk ratio (RR) 3.50, 95% confidence interval (CI) 1.23 to 9.92). No statistically significant differences were found for topical povidone iodine plus salicylic acid compared to povidone iodine alone (RR of cure 1.67, 95% CI 0.81 to 3.41) or compared to salicylic acid alone. Also no statistically significant differences were found for potassium hydroxide compared to placebo; systemic treatment with cimetidine versus placebo or systemic treatment with calcarea carbonica, a homoeopathic drug, versus placebo (RR 5.57, 95% CI 0.93 to 33.54). Study limitations included no blinding (two studies), many dropouts (three studies) and no intention-to-treat analysis (two studies); small study sizes may have led to important differences being missed. None of the evaluated treatment options were associated with serious adverse effects. AUTHORS' CONCLUSIONS: No single intervention has been shown to be convincingly effective in treating molluscum contagiosum.

Anti-Infective Agents, Local↗
PubMed2005

Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults.

BACKGROUND: Cough is a very common symptom presenting to medical practitioners. Gastroesophageal reflux disease (GORD) is said to be the causative factor in up to 41% of adults with chronic cough. However cough and GORD are common ailments and their co-existence by chance is high. Also cough can induce reflux episodes. Treatment for GORD includes conservative measures (diet manipulation), pharmaceutical therapy (motility or prokinetic agents, H(2) antagonist and proton pump inhibitors (PPI)) and fundoplication. OBJECTIVES: To evaluate the efficacy of GORD treatment on chronic cough in children and adults with GORD and prolonged cough that is not related to an underlying respiratory disease i.e. non-specific chronic cough. SEARCH STRATEGY: The Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register Collaboration and Cochrane Airways Group, MEDLINE and EMBASE databases, review articles and reference lists of relevant articles were searched. The date of last search was 4th April 2004. SELECTION CRITERIA: All randomised controlled trials on GORD treatment for cough in children and adults without primary lung disease. DATA COLLECTION AND ANALYSIS: Results of searches were reviewed against pre-determined criteria for inclusion. Two independent reviewers selected, extracted and assessed data for inclusion. Authors were contacted for further information. Data was analysed as "intention to treat" as well as "treatment received". Paediatric and adults data were considered separately. Sensitivity analyses were performed. MAIN RESULTS: 11 studies (3 paediatric, 8 adults; 383 participants) were included. None of the paediatric studies could be included in meta-analysis. In adults, analysis on use of H(2) antagonist, motility agents and conservative treatment for GORD were not possible (from lack of data) and there were no controlled studies on fundoplication as an intervention. Five adult studies comparing PPI (2-3 months) to placebo were analysed for various outcomes in the meta-analysis. Enrollment of subjects for two studies were primarily from medical clinics and another three studies were otolaryngeal clinic patients. Using "intention to treat", pooled data from three studies resulted in no significant difference between treatment and placebo in total resolution of cough. Pooled data revealed no significant improvement in cough outcomes (end of trial or change in cough scores). Significant differences were only found in sensitivity analysis. A significant improvement in change of cough scores was found in end of intervention (2-3 months) in those receiving PPI with a standardised mean difference of -0.41 (95%CI -0.75, -0.07) using GIV analysis on cross over trials. Two studies reported improvement in cough after 5 days to 2 weeks of treatment. Significant heterogeneity was found between studies using omeprazole and other PPIs. AUTHORS' CONCLUSIONS: There is insufficient evidence to definitely conclude that GORD treatment with PPI is beneficial for cough associated with GORD in adults. The beneficial effect was only seen in sub-analysis and its effect was small. The optimal duration of such a trial of therapy to evaluate response could not be ascertained in the meta-analysis although two RCTs reported significant change by two weeks of therapy. Clinicians should be cognisant of a period (natural resolution with time) and placebo effect in studies that utilise cough as an outcome measure. Data in children are inconclusive. Future paediatric and adult studies are needed whereby studies should be double blind, randomised controlled, parallel design, using treatments for at least two months, with validated subjective and objective cough outcomes and include ascertainment of time to respond as well as assessment of acid and/or non acid reflux whilst on therapy.

Adult↗
PubMed2006

Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults.

BACKGROUND: Cough is a very common symptom presenting to medical practitioners. Gastroesophageal reflux disease (GORD) is said to be the causative factor in up to 41% of adults with chronic cough. However cough and GORD are common ailments and their co-existence by chance is high. Also cough can induce reflux episodes. Treatment for GORD includes conservative measures (diet manipulation), pharmaceutical therapy (motility or prokinetic agents, H(2) antagonist and proton pump inhibitors (PPI)) and fundoplication. OBJECTIVES: To evaluate the efficacy of GORD treatment on chronic cough in children and adults with GORD and prolonged cough that is not related to an underlying respiratory disease i.e. non-specific chronic cough. SEARCH STRATEGY: The Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register Collaboration and Cochrane Airways Group, MEDLINE and EMBASE databases, review articles and reference lists of relevant articles were searched. The date of last search was 7th April 2006. SELECTION CRITERIA: All randomised controlled trials on GORD treatment for cough in children and adults without primary lung disease. DATA COLLECTION AND ANALYSIS: Results of searches were reviewed against pre-determined criteria for inclusion. Two independent reviewers selected, extracted and assessed data for inclusion. Authors were contacted for further information. Data was analysed as "intention to treat" as well as "treatment received". Paediatric and adults data were considered separately. Sensitivity analyses were performed. MAIN RESULTS: Thirteen studies (3 paediatric, 10 adults) were included. Data from six were available for analysis. None of the paediatric studies could be included in meta-analysis. In adults, analysis on use of H(2) antagonist, motility agents and conservative treatment for GORD were not possible (from lack of data) and there were no controlled studies on fundoplication as an intervention. Six adult studies comparing PPI (2-3 months) to placebo were analysed for various outcomes in the meta-analysis. Enrolment of subjects for two studies were primarily from medical clinics and another 4 studies were otolaryngology clinic patients or patients with laryngitis. Using "intention to treat", pooled data from 4 studies resulted in no significant difference between treatment and placebo in total resolution of cough, Odds Ratio 0.46 (95% CI 0.19 to 1.15). Pooled data revealed no overall significant improvement in cough outcomes (end of trial or change in cough scores). Significant differences were only found in sensitivity analyses. A significant improvement in change of cough scores was found in end of intervention (2-3 months) in those receiving PPI with a standardised mean difference of -0.41 (95%CI -0.75, -0.07) using GIV analysis on cross over trials. Two studies reported improvement in cough after 5 days to 2 weeks of treatment. AUTHORS' CONCLUSIONS: There is insufficient evidence to definitely conclude that GORD treatment with PPI is universally beneficial for cough associated with GORD in adults. The beneficial effect was only seen in sub-analysis and its effect was small. The optimal duration of such a trial of therapy to evaluate response could not be ascertained in the meta-analysis although two RCTs reported significant change by 2 weeks of therapy. Clinicians should be cognisant of a period (natural resolution with time) and placebo effect in studies that utilise cough as an outcome measure. Data in children are inconclusive. Future paediatric and adult studies are needed whereby studies should be double blind, randomised controlled, parallel design, using treatments for at least two months, with validated subjective and objective cough outcomes and include ascertainment of time to respond as well as assessment of acid and/or non acid reflux whilst on therapy.

Adult↗
PubMed2006

Alpha-glucosidase inhibitors for people with impaired glucose tolerance or impaired fasting blood glucose.

BACKGROUND: Alpha-glucosidase inhibitors (AGIs) reduce blood glucose levels and may thus prevent type 2 diabetes and cardiovascular disease in patients with impaired glucose tolerance. These possible effects, and the effects on quality of life, plasma lipids and body weight, have never been investigated in a systematic literature review and meta-analysis. OBJECTIVES: To assess the effects of alpha-glucosidase inhibitors in patients with impaired glucose tolerance (IGT) or impaired fasting blood glucose (IFBG), or both. SEARCH STRATEGY: We searched The Cochrane Library (Clinical Trials database, formerly known as CENTRAL), PUBMED, EMBASE, Web of Science, LILACS, databases of ongoing trials, reference lists of relevant reviews, and we contacted experts and manufacturers. Date of last search was February 2006. SELECTION CRITERIA: Randomised controlled trials of at least one-year duration in patients with IGT or IFBG, or both, comparing AGI monotherapy with any other intervention. DATA COLLECTION AND ANALYSIS: Two reviewers read all abstracts, assessed quality and extracted data independently. Discrepancies were resolved by consensus or by the judgement of a third reviewer. MAIN RESULTS: We included five trials (2360 participants), all investigating acarbose, that included patients with IGT or patients 'at increased risk for diabetes' (n = 1). Study duration was one, three (n = 2), five and six years. One study was at low risk of bias and four studies at high risk of bias. Except for the outcome incidence of type 2 diabetes in acarbose versus no treatment (two studies), meta-analyses were not possible. Data from the study at low risk of bias suggests that acarbose decreases the occurrence of type 2 diabetes (NNT = 10), cardiovascular events (NNT = 50, based on 47 events, study not initially powered for this outcome), post-load blood glucose (-0.6 mmol/L, 95% CI -1.0 to -0.3) and body mass index (0.3 kg/m(2), 95% CI -0.1 to -0.5). No statistically significant effects were observed on mortality, other morbidity, glycated haemoglobin, fasting blood glucose, lipids and blood pressure. The effects on the incidence of type 2 diabetes were confirmed in two studies at high risk of bias (OR 0.2, 95% CI 0.1 to 0.6). Adverse effects were mostly of gastro-intestinal origin (OR 3.5, 95% CI 2.7 to 4.4). AUTHORS' CONCLUSIONS: There is evidence that acarbose reduces the incidence of type 2 diabetes in patients with IGT. However, it is unclear whether this should be seen as prevention, delay or masking of diabetes. Acarbose may prevent the occurrence of cardiovascular events, but this finding needs to be confirmed in more studies.

Acarbose↗
PubMed2005

Efficacy and safety of cesarean delivery for prevention of mother-to-child transmission of HIV-1.

BACKGROUND: Cesarean section before labor and before ruptured membranes ("elective cesarean section", or ECS) has been introduced as an intervention for the prevention of mother-to-child transmission (MTCT) of HIV-1. The role of mode of delivery in the management of HIV-1-infected women should be assessed in light of risks as well as benefits, since HIV-1-infected pregnant women must be provided with available information with which to make informed decisions regarding cesarean section and other options to prevent transmission of infection to their children. OBJECTIVES: Our objectives were to assess the efficacy (for prevention of MTCT of HIV-1) and the safety of ECS among HIV-1-infected women. SEARCH STRATEGY: Electronic searches were undertaken using MEDLINE and other databases. Hand searches of reference lists of pertinent reviews and studies, as well as abstracts from relevant conferences, were also conducted. Experts in the field were contacted to locate any other studies. The search strategy was iterative. SELECTION CRITERIA: Randomized clinical trials assessing the efficacy and safety of ECS for prevention of MTCT of HIV-1 were included in the analysis, as were observational studies with relevant data. DATA COLLECTION AND ANALYSIS: Data regarding HIV-1 infection status of infants born to HIV-1-infected women according to mode of delivery were extracted from the reports of the studies. Similarly, data regarding postpartum morbidity (PPM) (including minor (e.g., febrile morbidity, urinary tract infection) and major (e.g., endometritis, thromboembolism) morbidity) of the HIV-1-infected women, and infant morbidity, according to mode of delivery were extracted. MAIN RESULTS: One randomized clinical trial of the efficacy of ECS for prevention of MTCT of HIV-1 was identified. No data regarding infant morbidity according to the HIV-1-infected mother's mode of delivery were available. Data regarding PPM according to mode of delivery were available from this clinical trial as well as from five observational studies. Among HIV-1-infected women not taking antiretrovirals (ARVs) during pregnancy or taking only zidovudine, ECS was found to be efficacious for prevention of MTCT of HIV-1. PPM is generally higher among HIV-1-infected women who undergo cesarean as compared to vaginal delivery, with the risk with ECS being intermediate between that of vaginal delivery and NECS (including emergency procedures). Other factors associated with the risk of PPM among HIV-1-infected women include HIV-1 disease stage (more advanced disease, as manifested by lower CD4 counts and higher viral loads, being associated with a greater risk of PPM) and co-morbid conditions (e.g., diabetes). AUTHORS' CONCLUSIONS: ECS is an efficacious intervention for the prevention of MTCT among HIV-1-infected women not taking ARVs or taking only zidovudine. The risk of PPM with ECS is higher than that associated with vaginal delivery, yet lower than with NECS. Among HIV-1-infected women, more advanced maternal HIV-1 disease stage and concomitant medical conditions (e.g., diabetes) are independent risk factors for PPM. The risk of MTCT of HIV-1 according to mode of delivery among HIV-1-infected women with low viral loads (low either because the woman's HIV-1 disease is not advanced, or because her HIV-1 disease is well-controlled with ARVs) is unclear. Therefore, an important issue to be addressed in one or more large studies (individual studies or an individual patient data meta-analysis combining data from more than one study) is assessment of the effectiveness of ECS for prevention of MTCT of HIV-1 among HIV-1-infected women with undetectable viral loads (with or without receipt of highly active ARV therapy (HAART)).

Cesarean Section↗