OBJECTIVES: To assess the effects of interventions for the management of patients with taste disturbances.
SEARCH METHODS: We searched the Cochrane Oral Health Group Trials Register (to 5 March 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2014), MEDLINE via OVID (1948 to 5 March 2014), EMBASE via OVID (1980 to 5 March 2014), CINAHL via EBSCO (1980 to 5 March 2014) and AMED via OVID (1985 to 5 March 2014). We also searched the relevant clinical trial registries and conference proceedings from the International Association of Dental Research/American Association of Dental Research (to 5 March 2014), Association for Research in Otolaryngology (to 5 March 2014), the US National Institutes of Health Trials Register (to 5 March 2014), metaRegister of Controlled Trials (mRCT) (to 5 March 2014), World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) (to 5 March 2014) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Clinical Trials Portal (to 5 March 2014).
SELECTION CRITERIA: We included all randomised controlled trials (RCTs) comparing any pharmacological agent with a control intervention or any non-pharmacological agent with a control intervention. We also included cross-over trials in the review.
DATA COLLECTION AND ANALYSIS: Two authors independently, and in duplicate, assessed the quality of trials and extracted data. Wherever possible, we contacted study authors for additional information. We collected adverse events information from the trials.
MAIN RESULTS: We included nine trials (seven parallel and two cross-over RCTs) with 566 participants. We assessed three trials (33.3%) as having a low risk of bias, four trials (44.5%) at high risk of bias and two trials (22.2%) as having an unclear risk of bias. We only included studies on taste disorders in this review that were either idiopathic, or resulting from zinc deficiency or chronic renal failure.Of these, eight trials with 529 people compared zinc supplements to placebo for patients with taste disorders. The participants in two trials were children and adolescents with respective mean ages of 10 and 11.2 years and the other six trials had adult participants. Out of these eight, two trials assessed the patient reported outcome for improvement in taste acuity using zinc supplements (RR 1.45, 95% CI 1.0 to 2.1; very low quality evidence). We included three trials in the meta-analysis for overall taste improvement (effect size 0.44, 95% CI 0.23 to 0.65; moderate quality evidence). Two other trials described the results as taste acuity improvement and we conducted subgroup analyses due to clinical heterogeneity. One trial described the results as taste recognition improvement for each taste sensation and we analysed this separately. We also analysed one cross-over trial separately using the first half of the results. None of the zinc trials tested taste discrimination. Only one trial tested taste discrimination using acupuncture (effect size 2.80, 95% CI -1.18 to 6.78; low quality evidence).Out of the eight trials using zinc supplementation, four reported adverse events like eczema, nausea, abdominal pain, diarrhoea, constipation, decrease in blood iron, increase in blood alkaline phosphatase, and minor increase in blood triglycerides. No adverse events were reported in the acupuncture trial.None of the included trials could be included in the meta-analysis for health-related quality of life in taste disorder patients.
AUTHORS' CONCLUSIONS: We found very low quality evidence that was insufficient to conclude on the role of zinc supplements to improve taste perception by patients, however we found moderate quality evidence that zinc supplements improve overall taste improvement in patients with zinc deficiency/idiopathic taste disorders. We also found low quality evidence that zinc supplements improve taste acuity in zinc deficient/idiopathic taste disorders and very low quality evidence for taste recognition improvement in children with taste disorders secondary to chronic renal failure. We did not find any evidence to conclude the role of zinc supplements for improving taste discrimination, or any evidence addressing health-related quality of life due to taste disorders.We found low quality evidence that is not sufficient to conclude on the role of acupuncture for improving taste discrimination in cases of idiopathic dysgeusia (distortion of taste) and hypogeusia (reduced ability to taste). We were unable to draw any conclusions regarding the superiority of zinc supplements or acupuncture as none of the trials compared these interventions.
OBJECTIVES: To compare manual and powered toothbrushes in everyday use, by people of any age, in relation to the removal of plaque, the health of the gingivae, staining and calculus, dependability, adverse effects and cost.
SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 23 January 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 1), MEDLINE via OVID (1946 to 23 January 2014), EMBASE via OVID (1980 to 23 January 2014) and CINAHL via EBSCO (1980 to 23 January 2014). We searched the US National Institutes of Health Trials Register and the WHO Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.
SELECTION CRITERIA: Randomised controlled trials of at least four weeks of unsupervised powered toothbrushing versus manual toothbrushing for oral health in children and adults.
DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by The Cochrane Collaboration. Random-effects models were used provided there were four or more studies included in the meta-analysis, otherwise fixed-effect models were used. Data were classed as short term (one to three months) and long term (greater than three months).
MAIN RESULTS: Fifty-six trials met the inclusion criteria; 51 trials involving 4624 participants provided data for meta-analysis. Five trials were at low risk of bias, five at high and 46 at unclear risk of bias.There is moderate quality evidence that powered toothbrushes provide a statistically significant benefit compared with manual toothbrushes with regard to the reduction of plaque in both the short term (standardised mean difference (SMD) -0.50 (95% confidence interval (CI) -0.70 to -0.31); 40 trials, n = 2871) and long term (SMD -0.47 (95% CI -0.82 to -0.11; 14 trials, n = 978). These results correspond to an 11% reduction in plaque for the Quigley Hein index (Turesky) in the short term and 21% reduction long term. Both meta-analyses showed high levels of heterogeneity (I(2) = 83% and 86% respectively) that was not explained by the different powered toothbrush type subgroups.With regard to gingivitis, there is moderate quality evidence that powered toothbrushes again provide a statistically significant benefit when compared with manual toothbrushes both in the short term (SMD -0.43 (95% CI -0.60 to -0.25); 44 trials, n = 3345) and long term (SMD -0.21 (95% CI -0.31 to -0.12); 16 trials, n = 1645). This corresponds to a 6% and 11% reduction in gingivitis for the Löe and Silness index respectively. Both meta-analyses showed high levels of heterogeneity (I(2) = 82% and 51% respectively) that was not explained by the different powered toothbrush type subgroups.The number of trials for each type of powered toothbrush varied: side to side (10 trials), counter oscillation (five trials), rotation oscillation (27 trials), circular (two trials), ultrasonic (seven trials), ionic (four trials) and unknown (five trials). The greatest body of evidence was for rotation oscillation brushes which demonstrated a statistically significant reduction in plaque and gingivitis at both time points.
AUTHORS' CONCLUSIONS: Powered toothbrushes reduce plaque and gingivitis more than manual toothbrushing in the short and long term. The clinical importance of these findings remains unclear. Observation of methodological guidelines and greater standardisation of design would benefit both future trials and meta-analyses.Cost, reliability and side effects were inconsistently reported. Any reported side effects were localised and only temporary.
OBJECTIVES: To assess the effects of sweet potato for type 2 diabetes mellitus.
SEARCH METHODS: We searched several electronic databases, including The Cochrane Library (2013, Issue 1), MEDLINE, EMBASE, CINAHL, SIGLE and LILACS (all up to February 2013), combined with handsearches. No language restrictions were used.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared sweet potato with a placebo or a comparator intervention, with or without pharmacological or non-pharmacological interventions.
DATA COLLECTION AND ANALYSIS: Two authors independently selected the trials and extracted the data. We evaluated risk of bias by assessing randomisation, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias.
MAIN RESULTS: Three RCTs met our inclusion criteria: these investigated a total of 140 participants and ranged from six weeks to five months in duration. All three studies were performed by the same trialist. Overall, the risk of bias of these trials was unclear or high. All RCTs compared the effect of sweet potato preparations with placebo on glycaemic control in type 2 diabetes mellitus. There was a statistically significant improvement in glycosylated haemoglobin A1c (HbA1c) at three to five months with 4 g/day sweet potato preparation compared to placebo (mean difference -0.3% (95% confidence interval -0.6 to -0.04); P = 0.02; 122 participants; 2 trials). No serious adverse effects were reported. Diabetic complications and morbidity, death from any cause, health-related quality of life, well-being, functional outcomes and costs were not investigated.
AUTHORS' CONCLUSIONS: There is insufficient evidence about the use of sweet potato for type 2 diabetes mellitus. In addition to improvement in trial methodology, issues of standardization and quality control of preparations - including other varieties of sweet potato - need to be addressed. Further observational trials and RCTs evaluating the effects of sweet potato are needed to guide any recommendations in clinical practice.
OBJECTIVES: To assess the effectiveness of centralisation of care for patients with gynaecological cancer.
SEARCH METHODS: We searched the Cochrane Gynaecological Cancer Group Trials Register, CENTRAL (The Cochrane Library, Issue 4, 2010), MEDLINE, and EMBASE up to November 2010. We also searched registers of clinical trials, abstracts of scientific meetings, and reference lists of included studies.
SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs, controlled before-and-after studies, interrupted time series studies, and observational studies that examined centralisation of services for gynaecological cancer, and used multivariable analysis to adjust for baseline case mix.
DATA COLLECTION AND ANALYSIS: Three review authors independently extracted data, and two assessed risk of bias. Where possible, we synthesised the data on survival in a meta-analysis.
MAIN RESULTS: Five studies met our inclusion criteria; all were retrospective observational studies and therefore at high risk of bias.Meta-analysis of three studies assessing over 9000 women suggested that institutions with gynaecologic oncologists on site may prolong survival in women with ovarian cancer, compared to community or general hospitals: hazard ratio (HR) of death was 0.90 (95% confidence interval (CI) 0.82 to 0.99). Similarly, another meta-analysis of three studies assessing over 50,000 women, found that teaching centres or regional cancer centres may prolong survival in women with any gynaecological cancer compared to community or general hospitals (HR 0.91; 95% CI 0.84 to 0.99). The largest of these studies included all gynaecological malignancies and assessed 48,981 women, so the findings extend beyond ovarian cancer. One study compared community hospitals with semi-specialised gynaecologists versus general hospitals and reported non-significantly better disease-specific survival in women with ovarian cancer (HR 0.89; 95% CI 0.78 to 1.01). The findings of included studies were highly consistent. Adverse event data were not reported in any of the studies.
AUTHORS' CONCLUSIONS: We found low quality, but consistent evidence to suggest that women with gynaecological cancer who received treatment in specialised centres had longer survival than those managed elsewhere. The evidence was stronger for ovarian cancer than for other gynaecological cancers.Further studies of survival are needed, with more robust designs than retrospective observational studies. Research should also assess the quality of life associated with centralisation of gynaecological cancer care. Most of the available evidence addresses ovarian cancer in developed countries; future studies should be extended to other gynaecological cancers within different healthcare systems.
OBJECTIVES: To assess the effects of workplace ergonomic design or training interventions, or both, for the prevention of work-related upper limb and neck MSDs in adults.
SEARCH METHODS: We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, AMED, Web of Science (Science Citation Index), SPORTDiscus, Cochrane Occupational Safety and Health Review Group Database and Cochrane Bone, Joint and Muscle Trauma Group Specialised Register to July 2010, and Physiotherapy Evidence Database, US Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health database, and International Occupational Safety and Health Information Centre database to November 2010.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) of ergonomic workplace interventions for preventing work-related upper limb and neck MSDs. We included only studies with a baseline prevalence of MSDs of the upper limb or neck, or both, of less than 25%.
DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias. We included studies with relevant data that we judged to be sufficiently homogeneous regarding the intervention and outcome in the meta-analysis. We assessed the overall quality of the evidence for each comparison using the GRADE approach.
MAIN RESULTS: We included 13 RCTs (2397 workers). Eleven studies were conducted in an office environment and two in a healthcare setting. We judged one study to have a low risk of bias. The 13 studies evaluated effectiveness of ergonomic equipment, supplementary breaks or reduced work hours, ergonomic training, a combination of ergonomic training and equipment, and patient lifting interventions for preventing work-related MSDs of the upper limb and neck in adults.Overall, there was moderate-quality evidence that arm support with alternative mouse reduced the incidence of neck/shoulder disorders (risk ratio (RR) 0.52; 95% confidence interval (CI) 0.27 to 0.99) but not the incidence of right upper limb MSDs (RR 0.73; 95% CI 0.32 to 1.66); and low-quality evidence that this intervention reduced neck/shoulder discomfort (standardised mean difference (SMD) -0.41; 95% CI -0.69 to -0.12) and right upper limb discomfort (SMD -0.34; 95% CI -0.63 to -0.06).There was also moderate-quality evidence that the incidence of neck/shoulder and right upper limb disorders were not reduced when comparing alternative mouse and conventional mouse (neck/shoulder RR 0.62; 95% CI 0.19 to 2.00; right upper limb RR 0.91; 95% CI 0.48 to 1.72), arm support and no arm support with conventional mouse (neck/shoulder RR 0.67; 95% CI 0.36 to 1.24; right upper limb RR 1.09; 95% CI 0.51 to 2.29), and alternative mouse with arm support and conventional mouse with arm support (neck/shoulder RR 0.58; 95% CI 0.30 to 1.12; right upper limb RR 0.92; 95% CI 0.36 to 2.36).There was low-quality evidence that using an alternative mouse with arm support compared to conventional mouse with arm support reduced neck/shoulder discomfort (SMD -0.39; 95% CI -0.67 to -0.10). There was low- to very low-quality evidence that other interventions were not effective in reducing work-related upper limb and neck MSDs in adults.
AUTHORS' CONCLUSIONS: We found moderate-quality evidence to suggest that the use of arm support with alternative mouse may reduce the incidence of neck/shoulder MSDs, but not right upper limb MSDs. Moreover, we found moderate-quality evidence to suggest that the incidence of neck/shoulder and right upper limb MSDs is not reduced when comparing alternative and conventional mouse with and without arm support. However, given there were multiple comparisons made involving a number of interventions and outcomes, high-quality evidence is needed to determine the effectiveness of these interventions clearly. While we found very-low- to low-quality evidence to suggest that other ergonomic interventions do not prevent work-related MSDs of the upper limb and neck, this was limited by the paucity and heterogeneity of available studies. This review highlights the need for high-quality RCTs examining the prevention of MSDs of the upper limb and neck.
OBJECTIVES: To assess the effect of restricted versus unrestricted pacifier use in healthy full-term newborns whose mothers have initiated breastfeeding and intend to exclusively breastfeed, on the duration of breastfeeding, other breastfeeding outcomes and infant health.
SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2016) and reference lists of retrieved studies.
SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing restricted versus unrestricted pacifier use in healthy full-term newborns who have initiated breastfeeding.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. The quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS: We found three trials (involving 1915 babies) for inclusion in the review, but have included only two trials (involving 1302 healthy full-term breastfeeding infants) in the analysis. Meta-analysis of the two combined studies showed that pacifier use in healthy breastfeeding infants had no significant effect on the proportion of infants exclusively breastfed at three months (risk ratio (RR) 1.01; 95% confidence interval (CI) 0.96 to 1.07, two studies, 1228 infants), and at four months of age (RR 1.01; 95% CI 0.94 to 1.09, one study, 970 infants, moderate-quality evidence), and also had no effect on the proportion of infants partially breastfed at three months (RR 1.00; 95% CI 0.98 to 1.02, two studies, 1228 infants), and at four months of age (RR 0.99; 95% CI 0.97 to 1.02, one study, 970 infants). None of the included trials reported data on the other primary outcomes, i.e. duration of partial or exclusive breastfeeding, or secondary outcomes: breastfeeding difficulties (mastitis, cracked nipples, breast engorgement); infant's health (dental malocclusion, otitis media, oral candidiasis; sudden infant death syndrome (SIDS)); maternal satisfaction and level of confidence in parenting. One study reported that avoidance of pacifiers had no effect on cry/fuss behavior at ages four, six, or nine weeks and also reported no effect on the risk of weaning before age three months, however the data were incomplete and so could not be included for analysis.
AUTHORS' CONCLUSIONS: Pacifier use in healthy term breastfeeding infants, started from birth or after lactation is established, did not significantly affect the prevalence or duration of exclusive and partial breastfeeding up to four months of age. Evidence to assess the short-term breastfeeding difficulties faced by mothers and long-term effect of pacifiers on infants' health is lacking.
OBJECTIVES: To assess the effectiveness of carbohydrates in improving cognitive function in older adults.
SEARCH STRATEGY: We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register on 22 June 2010 using the terms: carbohydrates OR carbohydrate OR monosaccharides OR disaccharides OR oligosaccharides OR polysaccharides OR CARBS. ALOIS contains records from all major healthcare databases (The Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, LILACS) as well as from many trial databases and grey literature sources.
SELECTION CRITERIA: All randomised controlled trials (RCT) that have examined the efficacy of any form of carbohydrates in normal cognition and MCI.
DATA COLLECTION AND ANALYSIS: One review author selected and retrieved relevant articles for further assessment. The remaining authors independently assessed whether any of the retrieved trials should be included. Disagreements were resolved by discussion.
MAIN RESULTS: There is no suitable RCT of any form of carbohydrates involving independent-living older adults with normal cognition or mild cognitive impairment.
AUTHORS' CONCLUSIONS: There are no suitable RCTs on which to base any recommendations about the use of any form of carbohydrate for enhancing cognitive performance in older adults with normal cognition or mild cognitive impairment. More studies of many different carbohydrates are needed to tease out complex nutritional issues and further evaluate memory improvement.
OBJECTIVES: To ascertain whether therapy-based rehabilitation services can influence outcome one year or more after stroke.
SEARCH STRATEGY: We searched the trials registers of the following Cochrane Review Groups: Stroke Group (last searched September 2007), Effective Practice and Organisation of Care Group (last searched October 2006) and Dementia and Cognitive Improvement Group (last searched October 2006). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2006), MEDLINE (1966 to October 2006), EMBASE (1980 to October 2006), CINAHL (1982 to October 2006), AMED (1985 to October 2006), PEDro (1952 to October 2006), British Nursing Index (1993 to October 2006), DARE (1994 to October 2006), HMIC (1979 to October 2006) and NHS EED (1991 to October 2006). We also searched dissertation databases and ongoing trials and research registers, scanned reference lists and contacted researchers and experts in the field.
SELECTION CRITERIA: All randomised controlled trials of community-based stroke patients, in which at least 75% were recruited one year after stroke and received a therapy-based rehabilitation intervention that was compared with conventional care.
DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials and extracted data on a number of pre-specified outcomes. The primary outcomes were the proportion of participants who had deteriorated or were dependent in personal activities of daily living at the end of scheduled follow up.
MAIN RESULTS: We identified five trials of 487 participants that were eligible for the review. Overall, there was inconclusive evidence as to whether therapy-based rehabilitation intervention one year after stroke was able to influence any relevant patient or carer outcome. Trials varied in design, type of interventions provided, quality, and outcomes assessed.
AUTHORS' CONCLUSIONS: This review highlights the dearth of evidence investigating long-term therapy-based rehabilitation interventions for patients with stroke.
OBJECTIVES: To assess the effects of colesevelam for type 2 diabetes mellitus.
SEARCH METHODS: Several electronic databases were searched, among these The Cochrane Library (Issue 1, 2012), MEDLINE, EMBASE, CINAHL, LILACS, OpenGrey and Proquest Dissertations and Theses database (all up to January 2012), combined with handsearches. No language restriction was used.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared colesevelam with or without other oral hypoglycaemic agents with a placebo or a control intervention with or without oral hypoglycaemic agents.
DATA COLLECTION AND ANALYSIS: Two review authors independently selected the trials and extracted the data. We evaluated risk of bias of trials using the parameters of randomisation, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias.
MAIN RESULTS: Six RCTs ranging from 8 to 26 weeks investigating 1450 participants met the inclusion criteria. Overall, the risk of bias of these trials was unclear or high. All RCTs compared the effects of colesevelam with or without other antidiabetic drug treatments with placebo only (one study) or combined with antidiabetic drug treatments. Colesevelam with add-on antidiabetic agents demonstrated a statistically significant reduction in fasting blood glucose with a mean difference (MD) of -15 mg/dL (95% confidence interval (CI) -22 to - 8), P < 0.0001; 1075 participants, 4 trials, no trial with low risk of bias in all domains. There was also a reduction in glycosylated haemoglobin A1c (HbA1c) in favour of colesevelam (MD -0.5% (95% CI -0.6 to -0.4), P < 0.00001; 1315 participants, 5 trials, no trial with low risk of bias in all domains. However, the single trial comparing colesevelam to placebo only (33 participants) did not reveal a statistically significant difference between the two arms - in fact, in both arms HbA1c increased. Colesevelam with add-on antidiabetic agents demonstrated a statistical significant reduction in low-density lipoprotein (LDL)-cholesterol with a MD of -13 mg/dL (95% CI -17 to - 9), P < 0.00001; 886 participants, 4 trials, no trial with low risk of bias in all domains. Non-severe hypoglycaemic episodes were infrequently observed. No other serious adverse effects were reported. There was no documentation of complications of the disease, morbidity, mortality, health-related quality of life and costs.
AUTHORS' CONCLUSIONS: Colesevelam added on to antidiabetic agents showed significant effects on glycaemic control. However, there is a limited number of studies with the different colesevelam/antidiabetic agent combinations. More information on the benefit-risk ratio of colesevelam treatment is necessary to assess the long-term effects, particularly in the management of cardiovascular risks as well as the reduction in micro- and macrovascular complications of type 2 diabetes mellitus. Furthermore, long-term data on health-related quality of life and all-cause mortality also need to be investigated.