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PubMed2005

Hip protectors for preventing hip fractures in older people.

BACKGROUND: Hip fracture in older people usually results from a fall on the hip. Hip protectors have been advocated as a means to reduce the risk of sustaining a hip fracture. OBJECTIVES: To determine if external hip protectors reduce the incidence of hip fractures in older people following a fall. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register (January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to January Week 2, 2005), EMBASE (1988 to 2005 Week 02), CINAHL (1982 to December Week 2 2004), other databases and reference lists of relevant articles. We also contacted trialists. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing the use of hip protectors with a control group. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We sought additional information from trialists. Pooling of uncorrected data from cluster-randomised trials was only done on an exploratory basis. MAIN RESULTS: Fifteen included trials contributed data to this updated review. One trial, which was a study of compliance (adherence) lasting 12 weeks, contributed no fracture outcome data. Pooling of data from eleven trials conducted in nursing or residential care settings, including six cluster-randomised studies, showed evidence of a marginally statistically significant reduction in hip fracture incidence (relative risk (RR) 0.77, 95% confidence interval (CI) 0.62 to 0.97). This analysis showed significant statistical heterogeneity. Pooling of data from three individually randomised trials involving 5135 community dwelling participants, showed no reduction in hip fracture incidence from the provision of hip protectors (RR 1.16, 95% CI 0.85 to 1.59). There was no evidence of any significant effect of hip protectors on incidence of pelvic or other fractures. No important adverse effects of the hip protectors were reported but compliance, particularly in the long term, was poor. AUTHORS' CONCLUSIONS: Accumulating evidence casts some doubt on the effectiveness of the provision of hip protectors in reducing the incidence of hip in older people. Acceptance and adherence by users of the protectors remain poor due to discomfort and practicality.

Aged↗
PubMed2001

Interventions for educating children who have attended the emergency room for asthma.

BACKGROUND: Asthma is one of the most common reasons for paediatric admissions to hospital, with substantial cost to the community. There is some evidence to suggest that many hospital admissions could be prevented with effective education about asthma and its management. OBJECTIVES: To conduct a systematic review of the literature in order to identify whether asthma education leads to improved health outcomes in children who have attended the emergency department for asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register, including Medline, Embase, and Cinahl databases, and reference lists of trials and review articles. SELECTION CRITERIA: Randomised controlled trials or controlled clinical trials of asthma education for children who had attended the emergency department for asthma, with or without hospitalisation, within the previous 12 months. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: Eight trials involving 1407 patients were included, in all the education was provided by nurses or researchers. Compared to control (usual care or lower intensity education) education did not reduce subsequent emergency department (ED) visits [4 trials; relative risk (RR)= 0.87, 95% confidence interval (CI) 0.37 to 2.08], hospital admissions [5 trials; RR=0.74, 95% CI 0.38 to 1.46] and unscheduled doctor visits [5 trials; RR= 0.74, 95% CI 0.49 to 1.12). Each analysis showed evidence of heterogeneity among the studies (P<0.01). Subgroup analyses by the overall difference in scale of intervention between treatment and control groups (comprehensive programme versus information only) or the timing of the intervention/recruitment (early versus delayed) gave similar results to the main analysis and still revealed significant heterogeneity between trials. REVIEWER'S CONCLUSIONS: On the basis of the published trials, there is no firm evidence to support the use of asthma education for children who have attended the emergency department for asthma as a means of reducing subsequent ED visits, hospital admissions or unscheduled doctor visits. Some trials appeared to show clear evidence of benefit, but reasons for differences between these and the negative studies is not clear. More research is required

Asthma↗
PubMed2001

Hormonally impregnated intrauterine systems (IUSs), versus other forms of reversible contraceptives as effective methods of preventing pregnancy.

OBJECTIVES: To assess the contraceptive efficacy, tolerability and acceptability of hormonally impregnated intrauterine systems (IUSs) in comparison to other reversible contraceptive methods. SEARCH STRATEGY: Literature was identified through database searches, reference lists and individuals/organisations working in the field. SELECTION CRITERIA: All randomised controlled trials comparing IUSs with other forms of reversible contraceptives and reporting on pre-determined outcomes in women of reproductive years. The primary outcomes were pregnancy due to method/user failure and continuation rate. DATA COLLECTION AND ANALYSIS: The quality assessment of studies and data extraction were completed independently by two blinded reviewers. A quality checklist was designed to identify general methodological and contraceptive specific factors which could bias results. Events per women months and single decrement life table rates were extracted where possible for pregnancy, continuation, adverse events and reasons for discontinuation. Events per total number of women at follow up were collected for hormonal side effects and menstrual disturbance. When appropriate, data were pooled at the same points of follow up to calculate rate ratios in order to determine the relative effectiveness of one method compared to another. For the single decrement life table rates, the rate differences were pooled to determine the absolute difference in effectiveness of one method compared to another. Interventions were only combined if the contraceptive methods were similar. Non-hormonal IUDs were divided into three categories for the purpose of comparison with IUSs: IUDs >250mm2 (i.e. CuT 380A IUD and CuT 380 Ag IUD), IUDs <=250mm2 (i.e. Nova-T, Multiload, CuT 200 and CuT 220 IUDs) and non-medicated IUDs. MAIN RESULTS: Nineteen RCTs comparing hormonally impregnated IUSs to a reversible contraceptive method met the inclusion criteria and it was possible to include eight of these in the meta-analyses, four comparing LNG-20 IUSs with non-hormonal IUDs, one comparing the LNG-20 IUS with Norplant-2 and three comparing Progestasert with non-hormonal IUDs. No significant difference was observed between the pregnancy rates for the LNG-20 users and those for the IUD >250mm2 users. However, women using the LNG-20 IUS were significantly less likely to become pregnant than those using the IUD <=250mm2. Women using the LNG-20 IUS were more likely to experience amenorrhoea and device expulsion than women using IUDs >250mm2. LNG-20 users were significantly more likely than all the IUD users to discontinue because of hormonal side effects and menstrual disturbance, which on further breakdown of the data was due to amenorrhoea. When the LNG-20 IUS was compared to Norplant-2, the LNG-20 users were significantly more likely to experience amenorrhoea and oligomenorrhoea, but significantly less likely to experience prolonged bleeding and spotting. No other significant differences were observed. Progestasert users were significantly less likely to become pregnant and less likely to continue on the method than non-medicated IUD users after one year, but no significant differences was noted for these two outcomes when Progestasert users were compared to IUD<=250mm2 users. The only other significant differences found in the meta-analyses were that Progestasert users were less likely to expel the device and more likely to discontinue the method because of menstrual bleeding and pain than users of IUDs <=250mm2. REVIEWER'S CONCLUSIONS: Current evidence suggests LNG-20 IUS users are no more or less likely to have unwanted pregnancies than IUD >250mm2 and Norplant-2 users. The LNG-20 IUS was more effective in preventing either intrauterine or extrauterine pregnancies than IUDs <=250mm2. The contraceptive effectiveness of Progestasert was significantly better than non-medicated IUDs, but no difference was observed when compared to IUDs<=250mm2. Continuation of LNG-20 IUS use was similar to continuation of the non-hormonal IUDs and Norplant-2. Amenorrhoea was the main reason for the discontinuation for the LNG-20 IUS and women should be informed of this prior to starting this method.

Contraceptive Agents, Female↗
PubMed2004

Hormonally impregnated intrauterine systems (IUSs) versus other forms of reversible contraceptives as effective methods of preventing pregnancy.

BACKGROUND: In the 1970s a new approach to the delivery of hormonal contraception was researched and developed. It was suggested that the addition of a progestogen to a non-medicated contraceptive device improved its contraceptive action. An advantage of these hormonally impregnated intrauterine systems (IUS) is that they are relatively maintenance free, with users having to consciously discontinue using them to become pregnant rather than taking a proactive daily decision to avoid conception. OBJECTIVES: To assess the contraceptive efficacy, tolerability and acceptability of hormonally impregnated intrauterine systems (IUSs) in comparison to other reversible contraceptive methods. SEARCH STRATEGY: Literature was identified through database searches, reference lists and individuals/organisations working in the field. Searches covered the period from 1972 to November 2003. SELECTION CRITERIA: All randomised controlled trials comparing IUSs with other forms of reversible contraceptives and reporting on pre-determined outcomes in women of reproductive years. The primary outcomes were pregnancy due to method/user failure and continuation rate. DATA COLLECTION AND ANALYSIS: The quality assessment of studies and data extraction were completed independently by two blinded reviewers. A quality checklist was designed to identify general methodological and contraceptive specific factors which could bias results. Events per women months and single decrement life table rates were extracted where possible for pregnancy, continuation, adverse events and reasons for discontinuation. Events per total number of women at follow up were collected for hormonal side effects and menstrual disturbance. When appropriate, data were pooled at the same points of follow up to calculate rate ratios in order to determine the relative effectiveness of one method compared to another. For the single decrement life table rates, the rate differences were pooled to determine the absolute difference in effectiveness of one method compared to another. Interventions were only combined if the contraceptive methods were similar. Non-hormonal IUDs were divided into three categories for the purpose of comparison with IUSs: IUDs >250mm2 (i.e. CuT 380A IUD and CuT 380 Ag IUD), IUDs <=250mm2 (i.e. Nova-T, Multiload, CuT 200 and CuT 220 IUDs) and non-medicated IUDs. MAIN RESULTS: Twenty-one RCTs comparing hormonally impregnated IUSs to a reversible contraceptive method met the inclusion criteria and it was possible to include eight of these in the meta-analyses, four comparing LNG-20 IUSs with non-hormonal IUDs, one comparing the LNG-20 IUS with Norplant-2 and three comparing Progestasert with non-hormonal IUDs. No significant difference was observed between the pregnancy rates for the LNG-20 users and those for the IUD >250mm2 users. However, women using the LNG-20 IUS were significantly less likely to become pregnant than those using the IUD <=250mm2. Women using the LNG-20 IUS were more likely to experience amenorrhoea and device expulsion than women using IUDs >250mm2. LNG-20 users were significantly more likely than all the IUD users to discontinue because of hormonal side effects and menstrual disturbance, which on further breakdown of the data was due to amenorrhoea. When the LNG-20 IUS was compared to Norplant-2, the LNG-20 users were significantly more likely to experience amenorrhoea and oligomenorrhoea, but significantly less likely to experience prolonged bleeding and spotting. No other significant differences were observed. Progestasert users were significantly less likely to become pregnant and less likely to continue on the method than non-medicated IUD users after one year, but no significant difference was noted for these two outcomes when Progestasert users were compared to IUD<=250mm2 users. The only other significant differences found in the meta-analyses were that Progestasert users were less likely to expel the device and more likely to discontinue the method because of menstrual bleeding and pain than users of IUDs <=250mm2. REVIEWERS' CONCLUSIONl the device and more likely to discontinue the method because of menstrual bleeding and pain than users of IUDs <=250mm2. REVIEWERS' CONCLUSIONS: Current evidence suggests LNG-20 IUS users are no more or less likely to have unwanted pregnancies than IUD >250mm2 and Norplant-2 users. The LNG-20 IUS was more effective in preventing either intrauterine or extrauterine pregnancies than IUDs <=250mm2. The contraceptive effectiveness of Progestasert was significantly better than non-medicated IUDs, but no difference was observed when compared to IUDs<=250mm2. Continuation of LNG-20 IUS use was similar to continuation of the non-hormonal IUDs and Norplant-2. Amenorrhoea was the main reason for the discontinuation for the LNG-20 IUS and women should be informed of this prior to starting this method.

Contraceptive Agents, Female↗
PubMed2006

Topical treatments for cutaneous warts.

BACKGROUND: Viral warts are common and usually harmless but very troublesome. A very wide range of local treatments are used. OBJECTIVES: To assess the effects of different local treatments for cutaneous, non-genital warts in healthy people. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (March 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to March 2005), EMBASE (1980 to March 2005) and a number of other biomedical databases. The references of all trials and selected review articles were also searched. In addition, we contacted pharmaceutical companies involved in local treatments for warts and experts in the field SELECTION CRITERIA: Randomised controlled trials of local treatments for cutaneous non-genital viral warts in immunocompetent (healthy) people. DATA COLLECTION AND ANALYSIS: Data was extracted and two authors independently selected the trials and assessed methodological quality. MAIN RESULTS: Sixty trials were identified that fulfilled the criteria for inclusion. The evidence provided by these studies was generally weak due to poor methodology and reporting. In 21 trials with placebo groups that used participants as the unit of analysis, the average cure rate of placebo preparations was 27% (range 0 to 73%) after an average period of 15 weeks (range 4 to 24 weeks). The best available evidence was for simple topical treatments containing salicylic acid, which were clearly better than placebo. Data pooled from five placebo-controlled trials showed a cure rate of 117/160 (73%) compared with 78/162 (48%) in controls, which translates to a risk ratio of 1.60 (95% confidence interval 1.16 to 2.23), using a random effects model. Evidence for the absolute efficacy of cryotherapy was surprisingly lacking. Two trials comparing cryotherapy with salicylic acid and one comparing duct tape with cryotherapy showed no significant difference in efficacy. Evidence for the efficacy of the remaining treatments reviewed was limited. AUTHORS' CONCLUSIONS: There is a considerable lack of evidence on which to base the rational use of topical treatments for common warts. The reviewed trials are highly variable in method and quality. Cure rates with placebo preparations are variable but nevertheless considerable. There is certainly evidence that simple topical treatments containing salicylic acid have a therapeutic effect. There is less evidence for the efficacy of cryotherapy, but reasonable evidence that it is only of equivalent efficacy to simpler and safer treatments. The benefits and risks of topical dinitrochlorobenzene and 5-fluorouracil, intralesional bleomycin and interferons, photodynamic therapy and other miscellaneous treatments remain to be determined.

Administration, Topical↗
PubMed2006

Nutritional supplementation for hip fracture aftercare in older people.

BACKGROUND: Older people with hip fractures are often malnourished at the time of fracture, and have poor food intake subsequently. OBJECTIVES: To review the effects of nutritional interventions in older people recovering from hip fracture. 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 2006, Issue 1), MEDLINE, six other databases and reference lists. We contacted investigators and handsearched journals. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of nutritional interventions for people aged over 65 years with hip fracture. DATA COLLECTION AND ANALYSIS: Both authors independently selected trials, extracted data and assessed trial quality. We sought additional information from trialists, and pooled data for primary outcomes. MAIN RESULTS: Twenty-one randomised trials involving 1727 participants were included. Overall trial quality was poor, specifically regarding allocation concealment, assessor blinding and intention-to-treat analysis, and limited availability of outcome data. Eight trials evaluated oral multinutrient feeds: providing non-protein energy, protein, some vitamins and minerals. Oral feeds had no statistically significant effect on mortality (15/161 versus 17/176; relative risk (RR) 0.89, 95% confidence interval (CI) 0.47 to 1.68) but may reduce 'unfavourable outcome' (combined outcome of mortality and survivors with medical complications) (14/66 versus 26/73; RR 0.52, 95% CI 0.32 to 0.84). Four trials examining nasogastric multinutrient feeding showed no evidence of an effect on mortality (RR 0.99, 95% CI 0.50 to 1.97) but the studies were heterogeneous regarding case mix. Nasogastric feeding was poorly tolerated. There was insufficient information for other outcomes. Increasing protein intake in an oral feed was tested in four trials. There was no evidence for an effect on mortality (RR 1.42, 95% CI 0.85 to 2.37). Protein supplementation may have reduced the number of long term medical complications. Two trials, testing intravenous vitamin B1 and other water soluble vitamins, or 1-alpha-hydroxycholecalciferol (an active form of vitamin D) respectively, produced no evidence of effect for either supplement. One trial, evaluating dietetic assistants to help with feeding, showed a trend for a reduction in mortality (RR 0.57, 99% CI 0.29 to 1.11). AUTHORS' CONCLUSIONS: Some evidence exists for the effectiveness of oral protein and energy feeds, but overall the evidence for the effectiveness of nutritional supplementation remains weak. Adequately sized trials are required which overcome the methodological defects of the reviewed studies. In particular, the role of dietetic assistants requires further evaluation.

Aftercare↗
PubMed2004

Parent-training programmes for improving maternal psychosocial health.

BACKGROUND: Mental health problems are common and there is evidence to suggest that the origins of such problems lie in infancy and childhood. In particular, there is evidence from a range of studies to suggest that maternal psychosocial health can have a significant effect on the mother-infant relationship, and that this in turn can have consequences for both the short and long-term psychological health of the child. The use of parenting programmes is increasing in the UK and elsewhere and evidence of their effectiveness in improving outcomes for children has been provided. Evidence is now required of their effectiveness in improving outcomes for mothers. OBJECTIVES: The objective of this review is to address whether group-based parenting programmes are effective in improving maternal psychosocial health including anxiety, depression, and self-esteem. SEARCH STRATEGY: A range of biomedical, social science, educational and general reference electronic databases were searched including MEDLINE, EMBASE CINAHL, PsychLIT, ERIC, ASSIA, Sociofile and the Social Science Citation Index. Other sources of information included the Cochrane Library (SPECTR, CENTRAL), and the National Research Register (NRR). SELECTION CRITERIA: Only randomised controlled trials were included in which participants had been randomly allocated to an experimental and a control group, the latter being a waiting-list, no-treatment or a placebo control group. Studies had to include at least one group-based parenting programme, and one standardised instrument measuring maternal psychosocial health. DATA COLLECTION AND ANALYSIS: A systematic critical appraisal of all included studies was undertaken using a modified version of the Journal of the American Medical Association (JAMA) published criteria. The treatment effect for each outcome in each study was standardised by dividing the mean difference in post-intervention scores for the intervention and treatment group, by the pooled standard deviation, to produce an effect size. Where appropriate the results were then combined in a meta-analysis using a fixed-effect model, and 95% confidence intervals were used to assess the significance of the findings. MAIN RESULTS: A total of 23 studies were included in the original review which was increased to 26 at the first udate (2003). Of these 20 provided sufficient data to calculate effect sizes. The 20 studies provided a total of 64 assessments of outcome on a range of aspects of psychosocial functioning including depression, anxiety, stress, self-esteem, social competence, social support, guilt, mood, automatic thoughts, dyadic adjustment, psychiatric morbidity, irrationality, anger and aggression, mood, attitude, personality, and beliefs. Data sufficient to combine in a meta-analysis existed for only five outcomes (depression; anxiety/stress; self-esteem; social support; and relationship with spouse/marital adjustment). The results of the meta-analyses show statistically significant results favouring the intervention group for depression; anxiety/stress; self-esteem; and relationship with spouse/marital adjustment. The meta-analysis of the social support data showed no evidence of effectiveness. Of the remaining data that it was not possible to combine in a meta-analysis, approximately 22% of the outcomes measured, showed significant differences between the intervention group and the control group. A further 40% showed non-significant differences favouring the intervention group. Approximately one-third of outcomes showed no evidence of effectiveness.A meta-analysis of the follow-up data on three outcomes was also conducted - depression, self-esteem and relationship with spouse/marital adjustment. The results show that there was a continued improvement in self-esteem, depression, and marital adjustment at follow-up, although the latter two findings were not statistically significant. This review has been updated (2003) with the addition of 3 new included studies. A number of additional excluded studies have also been added. There is one additional study awaiting 03) with the addition of 3 new included studies. A number of additional excluded studies have also been added. There is one additional study awaiting assessment and 2 ongoing studies listed for inclusion at a future update of this review. The size of effect for the main outcomes has not been substantially altered by this update. Additional sensitivity analyses to assess the impact of quasi randomised studies on the result have also been added. Where the quasi randomised studies are excluded from the analysis, the result was found to be slightly more conservative. REVIEWER'S CONCLUSIONS: It is suggested that parenting programmes can make a significant contribution to the short-term psychosocial health of mothers. However, there is currently a paucity of evidence concerning whether these results are maintained over time, and the limited follow-up data which are available show equivocal results. This points to the need for further evidence concerning the long-term effectiveness of parenting programmes on maternal mental health. Whilst the results of this review are positive overall, some studies showed no effect. Further research is needed to assess which factors contribute to successful outcomes in these programmes with particular attention being paid to the quality of delivery.These results suggest that parenting programmes have a potential role to play in the promotion of mental health.

Anxiety↗
PubMed2001

Opioids for the palliation of breathlessness in terminal illness.

BACKGROUND: Breathlessness is a common symptom in people with advanced disease. The most effective treatments are aimed at treating the underlying cause of the breathlessness but this may not be possible and symptomatic treatment is often necessary. Strategies for the symptomatic treatment of breathlessness have never been systematically evaluated. Opioids are commonly used to treat breathlessness: the mechanisms underlying their effectiveness are not completely clear and there have been few good-sized trials in this area. OBJECTIVES: To determine the effectiveness of opioid drugs given by any route in relieving the symptom of breathlessness in patients who are being treated palliatively. SEARCH STRATEGY: An electronic search was carried out of Medline, Embase, Cinahl, the Cochrane library, Dissertation Abstracts, Cancercd and SIGLE. Review articles and reference lists of retrieved articles were hand searched. Date of most recent search: May 1999 SELECTION CRITERIA: Randomised double-blind, controlled trials comparing the use of any opioid drug against placebo for the relief of breathlessness were included. Patients with any illness suffering from breathlessness were included and the intervention was any opioid, given by any route, in any dose. DATA COLLECTION AND ANALYSIS: Studies identified by the search were imported into a reference manager database. The full texts of the relevant studies were retrieved and data were independently extracted by two reviewers. Studies were quality scored according to the Jadad scale. The primary outcome measure used was breathlessness and the secondary outcome measure was exercise tolerance. Studies were divided into non-nebulised and nebulised and were analysed both separately and together. A qualitative analysis was carried out of adverse effects of opioids. Where appropriate, meta-analysis was carried out. MAIN RESULTS: Eighteen studies were identified of which nine involved the non-nebulised route of administration and nine the nebulised route. A small but statistically significant positive effect of opioids was seen on breathlessness in the analysis of studies using non-nebulised opioids. There was no statistically significant positive effect seen for exercise tolerance in either group of studies or for breathlessness in the studies using nebulised opioids. REVIEWER'S CONCLUSIONS: There is evidence to support the use of oral or parenteral opioids to palliate breathlessness although numbers of patients involved in the studies were small. No evidence was found to support the use of nebulised opioids. Further research with larger numbers of patients, using standardised protocols and with quality of life measures is needed.

Apnea↗
PubMed2002

Fluoride varnishes for preventing dental caries in children and adolescents.

BACKGROUND: Topically applied fluoride varnishes have been used extensively as an operator-applied caries-preventive intervention for over two decades. OBJECTIVES: To determine the effectiveness and safety of fluoride varnishes in the prevention of dental caries in children and to examine factors potentially modifying their effect. SEARCH STRATEGY: Multiple electronic database searches, reference lists of articles, journal handsearch, selected authors and manufacturers. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish with placebo or no treatment in children up to 16 years during at least one 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. Study authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF), that is the difference in caries increments between the treatment and control groups expressed as a percentage of the 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 meta-regression analyses. MAIN RESULTS: Nine studies were included, involving 2709 children. For the seven that contributed data for the main meta-analysis, the D(M)FS pooled prevented fraction estimate was 46% (95% CI, 30% to 63%; p<0.0001). There was substantial heterogeneity, confirmed statistically (p<0.0001). The pooled d(e/m)fs prevented fraction estimate was 33% (95% CI, 19% to 48%; p<0.0001). No significant association between estimates of D(M)FS prevented fractions and baseline caries severity or background exposure to fluorides was found in meta-regression, and a funnel plot of the seven studies indicated no relationship between prevented fraction and study precision. In both methods, power is limited when only a few trials are included. REVIEWER'S CONCLUSIONS: The review suggests a substantial caries-inhibiting effect of fluoride varnish in both the permanent and the deciduous dentitions based largely on trials with no treatment controls. There is little information concerning acceptability of treatment or possible side effects in the included trials. Given the relatively poor quality of most of the included studies and the wide confidence intervals around the estimates of effect, there remains a need for further trials. It is important that these trials should be of high quality and include assessment of potential adverse effects.

Adolescent↗
PubMed2002

Fluoride gels for preventing dental caries in children and adolescents.

BACKGROUND: Topically applied fluoride gels have been widely used as a caries-preventive intervention in dental surgeries and school-based programs for over two decades. OBJECTIVES: To determine the effectiveness and safety of fluoride gels in the prevention of dental caries in children and to examine factors potentially modifying their effect. SEARCH STRATEGY: Multiple electronic database searches, reference lists of articles, journal handsearch, selected authors and manufacturers. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride gel with placebo or no treatment in children up to 16 years during at least one 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. Study authors were contacted for missing data. The primary outcome measure was the prevented fraction (PF), that is the caries increment in the treatment group expressed as a percentage of the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects meta-regression analyses. MAIN RESULTS: Twenty-five studies were included, involving 7747 children. For the 23 that contributed data for meta-analysis, the D(M)FS pooled prevented fraction estimate was 28% (95% CI, 19% to 37%; p<0.0001). There was clear heterogeneity, confirmed statistically (p<0.0001). The effect of fluoride gel varied according to type of control group used, with D(M)FS PF on average being 19% (95% CI, 5% to 33%; p<0.009) higher in non-placebo controlled trials. A funnel plot of the 23 studies indicated a relationship between prevented fraction and study precision. Only two trials reported on adverse events. REVIEWER'S CONCLUSIONS: There is clear evidence of a caries-inhibiting effect of fluoride gel. The best estimate of the magnitude of this effect, based on the 14 placebo-controlled trials, is a 21% reduction (95% CI, 14 to 28%) in D(M)FS. This corresponds to an NNT of 2 (95% CI, 1 to 3) to avoid 1 D(M)FS in a population with a caries increment of 2.2 D(M)FS/year, or an NNT of 24 (95% CI, 18 to 36) based on an increment of 0.2 D(M)FS/year. There is little information concerning deciduous dentition, on adverse effects or on acceptability of treatment. Future trials should include assessment of potential adverse effects.

Adolescent↗
PubMed2000

Cognitive rehabilitation for memory deficits following stroke.

BACKGROUND: Memory problems occur following stroke. Cognitive rehabilitation programmes are provided to retrain memory function or to teach patients strategies to cope despite memory impairment. OBJECTIVES: To determine the effects of cognitive rehabilitation for memory problems following stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register, Medline, EMBASE, CINHAL and CLIN PSYCH databases and reference lists from relevant articles. Date of most recent searches: December 1998. SELECTION CRITERIA: Controlled trials of memory retraining in stroke. Studies with mixed aetiology groups were excluded unless they had more than 75% of stroke patients or separate data were available for the stroke patients. DATA COLLECTION AND ANALYSIS: Two reviewers extracted trial data and assessed trial quality. Reviewers contacted investigators for further details of trials. MAIN RESULTS: One trial was identified with 12 participants. This showed memory strategy training had no significant effect on memory impairment or subjective memory complaints. REVIEWER'S CONCLUSIONS: There is insufficient evidence to support or refute the effectiveness of cognitive rehabilitation for memory problems after stroke.

Attention↗
PubMed2000

Cognitive rehabilitation for attention deficits following stroke.

BACKGROUND: Attention problems occur following stroke and are treated using computerised activities or paper and pencil tasks. OBJECTIVES: To determine the effects of cognitive rehabilitation for attention deficits following stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register, Medline, EMBASE, CINHAL and CLIN PSYCH databases and reference lists from relevant articles. Date of most recent searches: December 1998 SELECTION CRITERIA: Controlled trials of attention training in stroke. Studies with mixed aetiology groups were excluded unless they included more than 75% of stroke patients or separate data were available for the stroke patients. DATA COLLECTION AND ANALYSIS: Two reviewers extracted trial data and assessed trial quality. Reviewers contacted investigators for further details of trials. MAIN RESULTS: Two trials were identified with 56 participants. The two trials showed a benefit of training on measures of alertness and sustained attention. Only one trial included a measure of functional independence and this showed no significant effect of training. REVIEWER'S CONCLUSIONS: There is some indication that training improves alertness and sustained attention but no evidence to support or refute the use of cognitive rehabilitation for attention deficits to improve functional independence following stroke.

Attention↗
PubMed2004

Erythropoietin for patients with malignant disease.

BACKGROUND: Anaemia associated with cancer and cancer therapy is an important clinical factor in the treatment of malignant diseases. Therapeutic alternatives are recombinant human erythropoietin (EPO) and red blood cell transfusions. OBJECTIVES: The aim of this systematic review was to assess the effect of erythropoietin to either prevent or treat anaemia in cancer patients. SEARCH STRATEGY: We searched the Central Register of Controlled Trials, MEDLINE (01/1985 to 12/2001), EMBASE (01/1985 to 12/2001), other databases and reference lists of articles. We also contacted experts in the field and pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials comparing the use of recombinant human erythropoietin (plus transfusion if needed) with red blood cell transfusions alone for the treatment or prevention of anaemia in cancer patients. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. All authors from included studies were contacted for additional information. MAIN RESULTS: Twenty seven trials with 3,287 adults were included. Use of erythropoietin significantly reduced the relative risk of red blood cell transfusions (RR 0.67; 95% CI 0.62 to 0.73, 25 trials, n = 3,069). On average participants in the erythropoietin group received one unit of blood less than the control group (WMD -1.00; 95% CI-1.31 to -0.70, 13 trials, n = 2,056). For participants with baseline haemoglobin below 10 g/dL haematological response was observed more often in participants receiving EPO (RR 3.60; 95% CI 3.07 to 4.23, 14 trials, n = 2,347). There was inconclusive evidence whether EPO improves tumour response (fixed effect RR 1.36; 95% CI 1.07 to 1.72, seven trials, n = 1,150; random effects: RR 1.21; 95% CI 0.92 to 1.59) and overall survival (adjusted data: HR 0.81; 95% CI 0.67 to 0.99; unadjusted data: HR 0.84; 95% CI 0.69 to 1.02, 19 trials, n = 2,865). There were no statistically significant adverse effects. Evidence was inconclusive with respect to quality of life and fatigue. REVIEWERS' CONCLUSIONS: There is consistent evidence that the administration of erythropoietin reduces the risk for blood transfusions and the number of units transfused in cancer patients. For patients with baseline haemoglobin below 10 g/dL there is strong evidence that erythropoietin improves haematological response. There is inconclusive evidence whether erythropoietin improves tumour response and overall survival. Research on side effects is inconclusive.

Anemia↗
PubMed2006

Neoadjuvant chemoradiation for advanced primary vulvar cancer.

BACKGROUND: In advanced stage primary vulvar cancer, treatment is tailored to individual patient needs. Combined treatment modalities have been developed, using chemotherapy, radiotherapy and surgery. OBJECTIVES: To determine whether the combined treatment strategy using concurrent neoadjuvant chemoradiation therapy followed by surgery is effective and safe in vulvar cancer patients with advanced primary disease. Main outcomes of interest were: types of surgical intervention following chemoradiation and survival, recurrence and complication rates. SEARCH STRATEGY: We searched the Cochrane Gynaecological Cancer Review Group Specialised Register. The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE (PubMed), EMBASE, CANCERLIT, other databases and reference lists of articles. The latest search was conducted on 12 March 2005. SELECTION CRITERIA: Studies of curative treatment of patients with advanced, primary squamous cell carcinoma of the vulva were included. Treatment included concurrent radiotherapy and chemotherapy, followed by surgery. DATA COLLECTION AND ANALYSIS: Twenty-eight abstracts and papers were selected either by the search strategy or by checking the cross references. Randomised controlled trials (RCTs) were not available. Five studies met the inclusion criteria. (Eifel 1995; Landoni 1996; Montana 2000; Moore 1998; Scheistroen 1993). Two authors (HCvD, MV-L) independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials. MAIN RESULTS: Chemotherapy was given uniformly within each of the five selected studies. However, four different chemoradiation schedules were applied. Radiotherapy dose fractionation techniques, fields and target definitions varied. Skin toxicity was observed in nearly all patients. Wound breakdown, infection, lymphedema, lymphorrhea and lymphoceles were also common. Operability was achieved in 63 to 92% of cases in the four studies using 5FU and CDDP or 5FU and MMC. In contrast, only 20% of the patients who received Bleomycin were operable after chemoradiation. After a follow up of 5 to 125 months, 26 to 63% of participants were alive and well. A total of 27 to 85% of participants died due to treatment related causes or disease. The five studies included in this review show that preoperative chemoradiotherapy reduces tumour size and improves operability. However, complications of treatment are considerable and information on the effects of quality of life (QOL) is not available. Furthermore, treatment results of the respective studies diverge considerably. AUTHORS' CONCLUSIONS: Patients with inoperable primary tumours or lymph nodes benefit from chemoradiation if an operation can be performed. In patients with large tumours that can only be treated with anterior and/or posterior exenteration complications of neoadjuvant therapy might outweigh complications of exenterative surgery. With the current knowledge neoadjuvant therapy is not justified in patients with tumours that can be adequately treated with radical vulvectomy and bilateral groin node dissection alone.

Carcinoma, Squamous Cell↗
PubMed2004

Iodine supplementation for preventing iodine deficiency disorders in children.

BACKGROUND: Iodine deficiency is the main cause of potentially preventable mental retardation in childhood, as well as causing goitre and hypothyroidism in people of all ages. It is still prevalent in large parts of the world. OBJECTIVES: To assess the effects of iodine supplementation overall, and of different forms and dosages of iodine supplementation separately, in the prevention of iodine deficiency disorders in children. SEARCH STRATEGY: The Cochrane Library, MEDLINE, EMBASE and reference lists, databases of ongoing trials and the Internet were searched. Date of latest search: October 2003. SELECTION CRITERIA: We included randomised controlled trials and prospective controlled trials not using randomisation of iodine supplementation in children living in areas of iodine deficiency. DATA COLLECTION AND ANALYSIS: Two reviewers did the initial data selection and quality assessment of trials independently. As the studies identified were not sufficiently similar and not of sufficient quality, we did not do a meta-analysis but summarised the data in a narrative format. MAIN RESULTS: Twenty-six prospective controlled trials were related to our question, assessing a total of 29613 children. Twenty of them were classified as being of low quality, six of moderate quality. Most studies used iodised oil as a supplement, but other supplements were also used. The intervention groups were compared to a non-supplemented control group, different doses or different forms of iodine supplementation. There was a clear tendency towards goitre reduction with iodine supplementation; this was significant in several studies. Significant differences in physical development were not seen, except in one study. Results for differences in cognitive and psychomotor measures were mixed, with only few studies showing a positive intervention effect. One study suggested that infant mortality was lowered after iodine supplementation. Most studies showed a significant increase in urinary iodine excretion and levels recommended by the WHO were reached in most cases after supplementation. Thyroid-stimulating hormone (TSH) levels were significantly reduced in one study. In 1.8% of the children investigated, adverse effects were found, most of them were minor and transient. REVIEWERS' CONCLUSIONS: Despite most of the included studies being of low quality, the results suggest that iodine supplementation, especially iodised oil, is an effective means of decreasing goitre rates and improving iodine status in children. Indications of positive effects on physical and mental development and mortality were seen, although results were not always significant. Adverse effects were generally minor and transient. Insufficient evidence was available on non-oil supplements. High quality controlled studies investigating relevant long term outcome measures are needed to address the question of the best form of iodine supplementation in different population groups and settings.

Child↗
PubMed2004

Dan Shen agents for acute ischaemic stroke.

BACKGROUND: Based mainly on experimental data which indicates improvement to the cerebral microcirculation, Dan Shen, a form of herbal medicine, is widely used in the treatment of acute ischaemic stroke in China. We aimed to assess the evidence from randomised controlled trials of their effects. OBJECTIVES: To review the randomised or quasi-randomised controlled trials of Dan Shen agents for acute ischaemic stroke. The primary objective was to determine whether Dan Shen agents improve functional outcome without causing undue harm in patients with acute ischaemic stroke. Secondary objectives were to assess the effect of Dan Shen agents on impairment and on quality of life. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched September 2003), the register of the Cochrane Complementary Field (last searched September 2003) and the Chinese Stroke Trials Register (last searched September 2003). In addition we searched the following bibliographic databases: The Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2002), MEDLINE (1996 to December 2002), EMBASE (1980 to December 2002), CINAHL (1982 to December 2002), AMED (1985 to December 2002) and China Biological Medicine Database (CBM-disc 1979 to December 2002). We handsearched 10 Chinese journals, searched clinical trials and research databases, scanned reference lists and contacted the pharmaceutical company manufacturing Dan Shen. SELECTION CRITERIA: Randomised controlled trials or quasi-randomised controlled clinical trials comparing Dan Shen agents with placebo or open control (no placebo) in patients with acute ischaemic stroke. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed trial quality and extracted the data. MAIN RESULTS: Eight potentially eligible trials were identified, of which three trials (304 patients) were included. Two trials were excluded and three trials are awaiting assessment. Numbers of deaths and dependent patients at the end of follow-up of at least three months were not reported in the three included trials. Only one trial reported adverse events. Three trials measured the outcome "significant improvement in neurological deficit at the end of treatment". Compound Dan Shen agents were associated with a significant increase in the number of patients with the outcome (Peto Odds Ratio (OR) 2.72, 95% Confidence Interval (CI) 1.10 to 6.72). No deaths were reported within the first two weeks of treatment or during the whole follow-up period (21 to 28 days). The trials did not include any assessment of quality of life. REVIEWERS' CONCLUSIONS: There were too few patients and outcome events to draw reliable conclusions from the present data. The methodological qualities of all included studies were poor. Further high-quality randomised controlled trials should be performed.

Acute Disease↗
PubMed2005

Megestrol acetate for the treatment of anorexia-cachexia syndrome.

BACKGROUND: Megestrol acetate (MA) is currently used to improve appetite and to increase weight in cancer-associated anorexia. In 1993 MA was approved by the USA's Federal Drug Administration for the treatment of anorexia, cachexia, or unexplained weight loss in patients with AIDS. The mechanism by which MA increases appetite is unknown, and its effectiveness for anorexia and cachexia in neoplastic and AIDS patients is under investigation. OBJECTIVES: To evaluate the efficacy, effectiveness and safety of MA in palliating anorexia-cachexia syndrome in patients with cancer, AIDS and other underlying pathologies. SEARCH STRATEGY: Studies were sought thorough an extensive search of the electronic databases, journals, reference lists, contact with investigators and other search strategies outlined in the methods. The most recent search was carried out on October 2002. SELECTION CRITERIA: Studies were included in the review if they assessed megestrol acetate compared to placebo or other drug treatments in randomized controlled trials of patients with a clinical diagnosis of anorexia-cachexia related to cancer, AIDS or another underlying pathology. DATA COLLECTION AND ANALYSIS: Data extraction was conducted by two independent authors, and methodological quality evaluated. Quantitative analyses were performed using appetite and quality of life as a dichotomous variable, and weight gain was analysed as continuous and dichotomous variables. Studies with more than 50% of patients lost to follow-up were excluded from the analysis. MAIN RESULTS: Thirty trials met the inclusion criteria (4123 patients). Twenty-one trials compared MA at different doses with placebo; four compared different doses of MA versus other drugs; two compared MA with other drugs and placebo; and three compared different doses of MA. For all patient conditions, meta-analysis showed a benefit of MA compared with placebo, particularly with regard to appetite improvement and weight gain in cancer patients. Analysing quality of life, clinical and statistical heterogeneity was found and discussed. There was insufficient information to define the optimal dose of MA. AUTHORS' CONCLUSIONS: This review demonstrates that MA improves appetite and weight gain in patients with cancer. No overall conclusion about quality of life (QOL) could be drawn due to heterogeneity. The small number of patients, methodological shortcomings and poor reporting have not allowed us to recommend megestrol acetate in AIDS patients or with other underlying pathologies.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Interventions for promoting booster seat use in four to eight year olds traveling in motor vehicles.

BACKGROUND: Public health and traffic safety agencies recommend use of booster seats in motor vehicles for children aged four to eight years, and various interventions have been implemented to increase their use by individuals who transport children in motor vehicles. There is little evidence regarding the effectiveness of these interventions, hence the need to examine what works and what does not. OBJECTIVES: To assess the effectiveness of interventions intended to increase acquisition and use of booster seats in motor vehicles among four to eight year olds. SEARCH STRATEGY: We searched the Cochrane Injuries Group's Specialized Register, the Cochrane Central Register of Controlled Trials, MEDLINE (January 1966 to April 2005), EMBASE (1980 to April 2005), LILACS, Transport Research Databases (1988 to April 2005), Australian Transport Index (1976 to April 2005), additional databases and reference lists of relevant articles. We also contacted experts in the field. SELECTION CRITERIA: We included randomized and controlled before-and-after trials that investigated the effects of interventions to promote booster seat use. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: Five studies involving 3,070 individuals met the criteria for inclusion in the meta-analysis. All interventions for promoting use of booster seats among 4 to 8 year olds demonstrated a positive effect (relative risk (RR) 1.43; 95% confidence intervals (CI) 1.05 to 1.96). Incentives combined with education demonstrated a beneficial effect (RR 1.32, 95% CI 1.12 to 1.55; n = 1,898). Distribution of free booster seats combined with education also had a beneficial effect (RR 2.34; 95% CI 1.50 to 3.63; n = 380) as did education-only interventions (RR 1.32; 95% CI 1.16 to 1.49; n = 563). One study which evaluated enforcement of booster seat law met the criteria for inclusion in the meta-analysis, but demonstrated no marked beneficial effect. AUTHORS' CONCLUSIONS: Available evidence suggests that interventions to increase use of booster seats among children age four to eight years are effective. Combining incentives (booster seat discount coupons or gift certificates) or distribution of free booster seats with education demonstrated marked beneficial outcomes for acquisition and use of booster seats for four to eight year olds. There is some evidence of beneficial effect of legislation on acquisition and use of booster seats but this was mainly from uncontrolled before-and-after studies, which did not meet the criteria for inclusion in the meta-analysis.

Automobiles↗