Die 5 Minuten Evidenz - Cochrane Ausgabe 1/2010

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Ausgabe 1/2010 der Cochrane Library

 


Bitte wählen Sie Ihr Thema aus:

Herz, Kreislauf, CVD Infektion Kinder
Diabetes Augen Krebs
Exercise Atmung Urologie
Frauen Chirurgie Neurologie/Psychiatrie
Schmerz Zahn Diverses 



Ausgewählte Updates mit veränderter klinischer Konsequenz:

 


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Herz, Kreislauf, CVD 

20 Studien (n= 3744)
Addition of a beta-blocker to diuretics or calcium-channel blockers reduces BP by 6/4mmHg at 1 times the starting dose and by 8/6 mmHg at 2 times the starting dose. When the blood pressure lowering effect of beta-blockers from this review was compared to that of thiazide diuretics from our previous review (Chen 2009), second-line beta-blockers reduce systolic BP to the same extent as second-line thiazide diuretics, but reduce diastolic BP to a greater degree. The different effect on diastolic BP means that beta-blockers have little or no effect on pulse pressure whereas thiazides cause a significant dose-related decrease in pulse pressure. This difference in the pattern of BP lowering with beta-blockers as compared to thiazides might be the explanation for the fact that beta-blockers appear to be less effective at reducing adverse cardiovascular outcomes than thiazide diuretics, particularly in older individuals. 

Blood pressure lowering efficacy of potassium-sparing diuretics (that block the epithelial sodium channel) for primary hypertension    
ENaC blockers do not have a statistically or clinically significant BP lowering effect at low doses but trials at higher doses are not available. The review did not provide a good estimate of the incidence of harms associated with ENaC blockers.

17 Studien
Cyclosporine statistically significantly increases blood pressure compared to placebo in a dose-related fashion. The magnitude of increase in blood pressure is clinically significant and increases the risk of stroke, myocardial infarction, heart failure and other adverse cardiovascular events associated with elevated BP. Consequently prescribers should try to find the lowest effective dose in all patients receiving cyclosporine chronically. 

Roselle for hypertension in adults 
Keine geeigneten Studien
There is insufficient evidence to support the benefit of Roselle for either controlling or lowering blood pressure in patients with hypertension. Based on the information of this review, there is a clear need to develop well-designed studies to assess the efficacy of Roselle on hypertensive patients.

Blood transfusions for treating acute chest syndrome in people with sickle cell disease  
Keine geeigneten Studien
There is currently no reliable evidence to support or refute the effectiveness of blood transfusions as treatment options for acute chest syndrome in people with sickle cell disease. Well-designed, adequately-powered randomised controlled trials are now required to assess the benefits and risks of this form of treatment.

Erythropoiesis-stimulating agents for anaemia in chronic heart failure patients   
11 Studien (n= 794)
Meta-analysis of small RCTs suggests that ESA treatment in patients with symptomatic CHF and mild anaemia (haemoglobin more than 10g/dL) can improve anaemia and exercise tolerance, reduce symptoms and have benefits on clinical outcomes. Confirmation requires well-designed studies with careful attention to dose, haemoglobin treatment target and associated iron therapy.

3 Studien (n= 5042)
Nao-an capsule may be a choice for the primary prevention of stroke. However, the design of the study providing this evidence means that there was potential for results to have been affected by bias from the way participants may have been selected, or from investigators' conflicts of interests. There was a lack of description of the methodology in the two other studies therefore evidence from these was considered too weak to draw any firm conclusions.

Home-based versus centre-based cardiac rehabilitation  
12 Studien (n=1.938)
Home- and centre-based cardiac rehabilitation appear to be equally effective in improving the clinical and health-related quality of life outcomes in acute MI and revascularisation patients. This finding, together with an absence of evidence of difference in healthcare costs between the two approaches, would support the extension of home-based cardiac rehabilitation programmes such as the Heart Manual to give patients a choice in line with their preferences, which may have an impact on uptake of cardiac rehabilitation in the individual case.

Hydroxyethyl starch (HES) versus other fluid therapies: effects on kidney function  
34 Studien (n=2607)
Potential for increased risk of AKI should be considered when weighing the risks and benefits of HES for volume resuscitation, particularly in septic patients. Large studies with adequate follow-up are required to evaluate the renal safety of HES products in non-septic patient populations. RIFLE criteria should be applied to evaluate kidney function in future studies of HES and, where data is available, to re-analyse those studies already published. There is inadequate clinical data to address the claim that safety differences exist between different HES products.  

Nutritional support for acute kidney injury   
8 Studien (n=257)
There is not enough evidence to support the effectiveness of nutritional support for AKI. Further high quality studies are required to provide reliable evidence of the effect and safety of nutritional support.

Prostanoids for critical limb ischaemia  
20 Studien
Despite some positive results regarding rest-pain relief, ulcer healing and amputations, there is no conclusive evidence based on this meta-analysis of the long-term effectiveness and safety of different prostanoids in patients with CLI. Further well-conducted, high quality randomised double-blinded trials should be performed.

Enhanced external counterpulsation for chronic angina pectoris  
We found one relevant trial which failed to address the characteristics of interest satisfactorily, in terms of severity of angina, for the participants in this review. Participants with the most severe symptoms of angina were excluded, therefore the results of this study represent only a subsection of the broader population with the disorder, are not generalizable and provide inconclusive evidence for the effectiveness of enhanced external counterpulsation therapy for chronic angina pectoris.

Extracranial-intracranial arterial bypass surgery for occlusive carotid artery disease   
2 RCT (n=2591)
EC/IC bypass surgery in patients with sCAO disease was neither superior nor inferior to medical care alone. However, most studies included patients irrespective of their cerebral haemodynamics. Participation in an ongoing RCT, which is restricted to patients with impaired haemodynamics, is recommended as these patients might benefit from bypass surgery.

Tirilazad for aneurysmal subarachnoid haemorrhage 
5 Studien (n=3821)
There is no evidence that tirilazad, in addition to nimodipine, reduces mortality or improves poor outcome in patients with aneurysmal SAH.

 

 

Diabetes

Complex interventions for preventing diabetic foot ulceration   
5 Studien mit hohem Risiko des Bias
There is no high quality research evidence evaluating complex interventions for preventing diabetic foot ulceration and insufficient evidence of benefit.

Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus  
23 Studien (n=976)
There is some evidence to suggest that CSII may be better than MI for glycaemic control in people with type 1 diabetes. Non-severe hypoglycaemic events do not appear to be reduced with CSII. There is insufficient evidence regarding adverse events, mortality, morbidity and costs.

 

There is insufficient evidence to recommend momordica charantia for type 2 diabetes mellitus. Further studies are therefore required to address the issues of standardization and the quality control of preparations. For medical nutritional therapy, further observational trials evaluating the effects of momordica charantia are needed before RCTs are established to guide any recommendations in clinical practice.

 

 

 

Infektion

14 Studien (n=2269)
Peginterferon plus ribavirin may be considered a treatment for patients with chronic hepatitis C and stable HIV who have not received treatment for hepatitis C as the intervention may clear the blood of HCV RNA. Supporting evidence comes mainly from the analysis of this non-validated surrogate outcome assessed in comparisons against other antiviral treatments. There is no evidence on treatment of patients who have relapsed or did not respond to previous therapy. Careful monitoring of adverse events is warranted. 

10 Studien
Studies were generally small and very few studies were done in developing countries. There was a lack of studies truly looking at the effect of home based care itself or looking at significant end points (death and progression to AIDS). However, the range of interventions and HBC models evaluated can assist in making evidence-based decisions about HIV care and support. 

19 Studien (n=3382)
The findings of the review may not be wholly relevant to primary care as most of the trials were conducted in a hospital setting and over half involved ear cleaning as part of the treatment (this is generally not available in primary care). However, the review does demonstrate that topical treatments alone are effective at treating acute otitis externa.

Interventions for preventing infectious complications in haemodialysis patients with central venous catheters   
10 Studien (n=786)
Mupirocin ointment appears effective in reducing the risk of catheter-related bacteraemia. Insufficient reporting on mupirocin resistance was noted and needs to be considered in future studies. A lack of high quality data on the routine use of povidone-iodine ointment, polysporin ointment and topical honey warrant larger RCTs. Insufficient data were available to determine which dressing type (transparent polyurethane or dry gauze dressing) has the lowest risk of catheter-related infections. 

4 Studien
There is some evidence to support the use of massage therapy to improve quality of life for people living with HIV/AIDS (PLWHA), particularly in combination with other stress-management modalities, and that massage therapy may have a positive effect on immunological function. The trials are small, however, and at moderate risk of bias. Further studies are needed using larger sample sizes and rigorous design/reporting before massage therapy can be strongly recommended for PLWHA. 

35 Studien (n=11.867)
There is limited support for the widespread use of formal multi-session psychosocial interventions for reducing injection and sexual risk behaviour. Brief standard education interventions appear to be a more cost-effective option. Further research is required to assess if there are particular groups of drug users more likely to respond to such interventions. 

6 Studien (n=434)
Based on current limited evidence, chest physiotherapy might not be recommended as routine adjunctive treatment for pneumonia in adults.

 

 

 

Kinder

Adenoidectomy for otitis media in children  
14 Studien (n=2712)
Our review shows a significant benefit of adenoidectomy as far as the resolution of middle ear effusion in children with OME is concerned. However, the benefit to hearing is small and the effects on changes in the tympanic membrane are unknown. The risks of operating should be weighed against these potential benefits.
The absence of a significant benefit of adenoidectomy on AOM suggests that routine surgery for this indication is not warranted.    

10 Studien
Evidence on whether zinc supplementation can reduce the incidence of otitis media in healthy children under the age of five years living in low- and middle-income countries is mixed. There is some evidence of benefit in children being treated for marasmus, but this is based on one small trial and should therefore be treated with caution.

1 Studie
Current evidence regarding the effect of adenoidectomy on recurrent or chronic nasal symptoms or nasal obstruction alone is sparse, inconclusive and has a significant risk of bias.
High quality trials assessing the effectiveness of adenoidectomy in children with recurrent or chronic nasal symptoms should be initiated.

Ethamsylate for the prevention of morbidity and mortality in preterm or very low birth weight infants 
8 Studien (n=1410)
Preterm infants treated with ethamsylate showed no reductions in mortality or neurodevelopmental impairment despite the reduction in any grade of intraventricular haemorrhage seen in infants < 35 weeks gestation. 

Honey for acute cough in children  
Eine Studie (n=108)
We found insufficient evidence to advise for or against the use of honey for acute cough in children.

Interventions for bone disease in children with chronic kidney disease  
15 Studien (n=369)
Bone disease, assessed by changes in PTH levels, is improved by all vitamin D preparations. However no consistent differences between routes of administration, frequencies of dosing or vitamin D preparations have been demonstrated. Though fewer episodes of high calcium levels occurred with the non calcium-containing binder, sevelamer, compared with calcium-containing binders, there were no differences in serum phosphorus and calcium overall and phosphorus values were reduced to similar extents. All RCTs were small with few data available on patient-centred outcomes (growth, bone deformities) and limited data on biochemical parameters resulting in considerable imprecision of results thus limiting the applicability to care of children with CKD. 

7 Studien
There are no proven clinically significant short or long-term benefits of PET in polycythemic newborn infants who are clinically well or who have minor symptoms related to hyperviscosity. PET may lead to an increase in the risk of NEC. The data regarding developmental follow-up is extremely imprecise due to the large number of surviving infants who were not assessed and, therefore, the true risks and benefits of PET are unclear. 

4 Studien
Limited paediatric data are available comparing antifungal agents in children with proven, probable or suspected invasive fungal infection. No differences in mortality or treatment efficacy were observed when antifungal agents were compared. Children are less likely to develop nephrotoxicity with a lipid preparation of amphotericin B compared with conventional amphotericin B. Further comparative paediatric antifungal drug trials and epidemiological and pharmacological studies are required highlighting the differences between neonates, children and adults with invasive fungal infections.

Heliox for croup in children  
2 Studien (n=44)
At present there is a lack of evidence to establish the effect of heliox inhalation in the treatment of croup in children. A methodologically well-designed and adequately powered RCT is needed to assess whether there is a role for heliox therapy in the management of children with croup. 

Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis  
1 Studien (n=186)
We identified one randomised controlled trial comparing five monthly doses of palivizumab to placebo in infants up to two years old with CF. While the overall incidence of adverse events was similar in both groups, it is not possible to draw conclusions on the safety and tolerability of RSV prophylaxis with palivizumab in infants with CF because the trial did not specify how adverse events were classified. Six months after treatment, the authors reported no clinically meaningful differences in outcomes; however no data were provided. Additional randomised studies are needed to establish the safety and efficacy of palivizumab in children with CF. 

Singing for children and adults with bronchiectasis  
In the absence of data, we cannot draw any conclusion to support or refute the adoption of singing as an intervention for people with bronchiectasis. Given the simplicity of the potentially beneficial intervention, future randomised controlled trials are required to evaluate singing therapy for people with bronchiectasis.

 

 

 

Augen

16 Studien (n=3498)
Sham-controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre-defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. Waiting list-controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects.

Braces for idiopathic scoliosis in adolescents  
2 Studien
There is very low quality evidence in favour of using braces, making generalization very difficult. Further research could change the actual results and our confidence in them; in the meantime, patients' choices should be informed by multidisciplinary discussion.  

4 Studien
There is low quality evidence that an oral herbal medication, Compound Qishe Tablet, reduced pain more than placebo or Jingfukang and a topical herbal medicine, Compound Extractum Nucis Vomicae, reduced pain more than Diclofenac Diethylamine Emulgel. Further research is very likely to change both the effect size and our confidence in the results.

Exercises for prevention of recurrences of low-back pain 
9 Studien (n=1520)
There is moderate quality evidence that post-treatment exercise programmes can prevent recurrences of back pain but conflicting evidence was found for treatment exercise. Studies into the validity of measurement of recurrences and the effectiveness of post-treatment exercise are needed.

Golimumab for rheumatoid arthritis  
4 Studien (n=1714)
With an overall high grade of evidence, at the FDA-approved dose, golimumab is significantly more efficacious than placebo in treatment of patients with active RA , when used in combination with methotrexate. The short-term safety profile, based on short-term RCTs, is reasonable with no differences in total adverse events, serious infections, cancer, tuberculosis or deaths. Long-term surveillance studies are needed for safety assessment.

Rehabilitation interventions for improving physical and psychosocial functioning after hip fracture in older people
9 Studien (n=1400)
Some outcomes may be amenable to psychosocial treatments; however, there is insufficient evidence to recommend practice changes. Further research on interventions described in this review is required, including attention to timing, duration, setting and administering discipline(s), as well as treatment across care settings. To facilitate future evaluations, a core outcome set, including patient-reported outcomes such as quality of life and compliance, should be established for hip fracture trials. 

When used in isolation, current evidence indicates poor diagnostic performance of most physical tests used to identify lumbar disc herniation. However, most findings arise from surgical populations and may not apply to primary care or non-selected populations. Better performance may be obtained when tests are combined.

 

 

 

Krebs  

55 Studien (n= 5261)
This review did not provide assured evidence concerning the effectiveness of TCMHs in improving the quality of life or rate of remission, alleviating the toxic and side effects caused by the chemotherapy, or reducing short-term mortality. Limited and weak evidence showed that Huachansu, when used together with chemotherapy, improved leukopenia caused by chemotherapy, but did not improve rate of short-term remission. Large, well designed clinical trials are required urgently before any confident conclusions can be drawn about the value of TCMHs for advanced or late gastric cancer.

Interferon-alpha for maintenance of follicular lymphoma   
8 Studien (n=1563)
There is evidence that addition of IFN as maintenance therapy for FL improves progression-free survival. A net benefit for overall survival is less evident. In the included studies, IFN was associated with significant toxicities that may have a major impact on a patient's quality of life.

Duration of adjuvant chemotherapy for patients with non-metastatic colorectal cancer  
The present meta-analysis confirmed that adjuvant chemotherapy of CRC should not last for more than 6 months. Prolonged duration would result in lower benefit to risk ratio. However, the results do not make it possible to favour either 3 or 6 month durations. They should help design a future RCT comparing different durations of continuous treatment.

Serotonin receptor antagonists for highly emetogenic chemotherapy in adults  
16 Studien (n=7808)
Ondansetron and granisetron appear to be equivalent drugs for the prevention of acute and delayed emesis following the use of highly emetogenic chemotherapy.
According to one single trial the combination of palonosetron and dexamethasone was superior to granisetron and dexamethasone in controlling delayed emesis. However, more evidence is needed before palonosetron could become the candidate 5-HT3 RA for the control of delayed emesis induced by highly emetogenic chemotherapy.

Cyclophosphamide versus ifosfamide for paediatric and young adult bone and soft tissue sarcoma patients 
No RCTs or CCTs comparing the effectiveness of cyclophosphamide and ifosfamide in the treatment of bone and soft tissue sarcoma in children and young adults were identified. Therefore no definitive conclusions can be made about the effects of cyclophosphamide and ifosfamide in these patients. Based on the currently available evidence we are not able to give recommendations for clinical practice. More high quality research is needed.

 

 

Knochen 

Acupuncture for peripheral joint osteoarthritis
16 Studien (n=3498)
Sham-controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre-defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. Waiting list-controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects.

Braces for idiopathic scoliosis in adolescents
2 Studien
There is very low quality evidence in favour of using braces, making generalization very difficult. Further research could change the actual results and our confidence in them; in the meantime, patients' choices should be informed by multidisciplinary discussion. 

Chinese herbal medicine for chronic neck pain due to cervical degenerative disc disease 
4 Studien
There is low quality evidence that an oral herbal medication, Compound Qishe Tablet, reduced pain more than placebo or Jingfukang and a topical herbal medicine, Compound Extractum Nucis Vomicae, reduced pain more than Diclofenac Diethylamine Emulgel. Further research is very likely to change both the effect size and our confidence in the results.

Exercises for prevention of recurrences of low-back pain 
9 Studien (n=1520)
There is moderate quality evidence that post-treatment exercise programmes can prevent recurrences of back pain but conflicting evidence was found for treatment exercise. Studies into the validity of measurement of recurrences and the effectiveness of post-treatment exercise are needed.

Golimumab for rheumatoid arthritis  
4 Studien (n=1714)
With an overall high grade of evidence, at the FDA-approved dose, golimumab is significantly more efficacious than placebo in treatment of patients with active RA , when used in combination with methotrexate. The short-term safety profile, based on short-term RCTs, is reasonable with no differences in total adverse events, serious infections, cancer, tuberculosis or deaths. Long-term surveillance studies are needed for safety assessment.

Rehabilitation interventions for improving physical and psychosocial functioning after hip fracture in older people
9 Studien (n=1400)
Some outcomes may be amenable to psychosocial treatments; however, there is insufficient evidence to recommend practice changes. Further research on interventions described in this review is required, including attention to timing, duration, setting and administering discipline(s), as well as treatment across care settings. To facilitate future evaluations, a core outcome set, including patient-reported outcomes such as quality of life and compliance, should be established for hip fracture trials.

Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain
When used in isolation, current evidence indicates poor diagnostic performance of most physical tests used to identify lumbar disc herniation. However, most findings arise from surgical populations and may not apply to primary care or non-selected populations. Better performance may be obtained when tests are combined.

 

 

Atmung

Benzodiazepines for the relief of breathlessness in advanced malignant and non-malignant diseases in adults 
7 Studien (n=200)
There is no evidence for a beneficial effect of benzodiazepines for the relief of breathlessness in patients with advanced cancer and COPD. There is a slight but non-significant trend towards a beneficial effect but the overall effect size is small. Benzodiazepines caused more drowsiness as an adverse effect compared to placebo, but less compared to morphine. These results justify considering benzodiazepines as a second or third-line treatment within an individual therapeutic trial, when opioids and non-pharmacological measures have failed to control breathlessness. Although a few good quality studies were included in this review, there is still a further need for well-conducted and adequately powered studies.

Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events 
8 Studien (n= 6163)
The seven identified studies in adults did not show any significant difference in safety between formoterol and budesonide in comparison with salmeterol and fluticasone. Asthma-related serious adverse events were rare, and there were no reported asthma-related deaths. There was a single small study comparing formoterol and beclomethasone to salmeterol and fluticasone in adults, but no serious adverse events occurred in this study. No studies were found in children.
Overall there is insufficient evidence to decide whether regular formoterol and budesonide or beclomethasone have equivalent or different safety profiles from salmeterol and fluticasone.

 

 

Neurologie/Psychiatrie

Amisulpride versus other atypical antipsychotics for schizophrenia    
10 Studien (n= 1549)
There is little randomised evidence comparing amisulpride with other second generation antipsychotic drugs. We could only find trials comparing amisulpride with olanzapine, risperidone and ziprasidone. We found amisulpride may be somewhat more effective than ziprasidone, and more tolerable in terms of weight gain and other associated problems than olanzapine and risperidone. These data, however, are based on only ten short to medium term studies and therefore too limited to allow for firm conclusions. 

Quetiapine versus other atypical antipsychotics for schizophrenia  
21 Studien (n= 4101)
Best available evidence from trials suggests that most people who start quetiapine stop taking it within a few weeks. Comparisons with amisulpride, aripiprazole, sertindole and zotepine do not exist. Most data that has been reported within existing comparisons are of very limited value because of assumptions and biases within them. There is much scope for further research into the effects of this widely used drug.

Risperidone versus placebo for schizophrenia 
Risperidone appears to have a marginal benefit in terms of clinical improvement compared with placebo in the first few weeks of treatment but data are limited, poorly reported and probably biased in favour of risperidone. The margin of improvement chosen by the researchers as their outcome may not be clinically meaningful. Even after so much use of this drug, we feel that further independent trials can be justified.

Sulpiride augmentation for schizophrenia    
4 Studien (n= 221)
Sulpiride plus clozapine is probably more effective than clozapine alone in producing clinical improvement in some people whose illness has been resistant to other antipsychotic drugs including clozapine. However, much more robust data are needed.

Zotepine versus other atypical antipsychotics for schizophrenia 
2 Studien (n=109)
Zotepine may be less effective than clozapine and associated with more movement disorders and higher prolactin levels, but the evidence base is too small and prone to bias, making any practical recommendations impossible. There is no randomised evidence on the effects of zotepine compared to second generation antipsychotic drugs other than clozapine. More studies are possible to justify.

Antiepileptic drugs for the primary and secondary prevention of seizures after stroke 
3 Studien
Currently, there is insufficient evidence to support the routine use of antiepileptic drugs for the primary or secondary prevention of seizures after stroke. Further well-conducted research is needed for this important clinical problem.

Disulfiram for the treatment of cocaine dependence  
7 Studien (n= 492)
There is low evidence, at the present, supporting the clinical use of disulfiram for the treatment of cocaine dependence. Larger randomised investigations are needed investigating relevant outcomes and reporting data to allow comparisons of results between studies. Results from ongoing studies will be added as soon as their results will be available.

Haemostatic drugs for traumatic brain injury  
2 Studien
There is no reliable evidence from randomised controlled trials to support the effectiveness of haemostatic drugs in reducing mortality or disability in patients with TBI. New randomised controlled trials assessing the effects of haemostatic drugs in TBI patients should be conducted. These trials should be large enough to detect clinically plausible treatment effects.

Immediate-release versus controlled-release carbamazepine in the treatment of epilepsy   
10 Studien
At present, data from trials do not confirm or refute an advantage for CR CBZ over IR CBZ for seizure frequency or adverse events in patients with newly diagnosed epilepsy.

Shared decision making interventions for people with mental health conditions 
2 Studien (n= 518)
No firm conclusions can be drawn at present about the effects of shared decision making interventions for people with mental health conditions. There is no evidence of harm, but there is an urgent need for further research in this area.

Efficacy of Psychostimulant Drugs for Cocaine Dependence   
16 Studien (n= 1.345)
This review found mixed results, therefore evidence of the efficacy of psychostimulants for cocaine dependence is inconclusive. Nevertheless promising results exist for methadone maintained dual heroin-cocaine addicts and for some specific drugs such as dexamphetamine and bupropion.

Gamma-hydroxybutyrate (GHB) for treatment of alcohol withdrawal and prevention of relapses   
13 Studien
GHB 50mg is effective compared to placebo in the treatment of AWS, and in preventing relapses in previously detoxified alcoholics at 3 months follow-up, but the results of this review do not provide sufficient evidence in favour of GHB compared to benzodiazepines and Chlormethiazole for AWS prevention. GHB is better than NTX and Disulfiram in maintaining abstinence and it has a better effect on craving than placebo and Disulfiram. Side effects of GHB are not statistically different from those with BZD, NTX or Disulfiram. However, concern has been raised regarding the risk of developing addiction, misuse or abuse, especially in polydrug abusers.

Sports and games for post-traumatic stress disorder (PTSD)  
No studies met the inclusion criteria. More research is therefore required before a fair assessment can be made of the effectiveness of sports and games in alleviating symptoms of PTSD.

Surface neuromuscular electrical stimulation for quadriceps strengthening pre and post total knee replacement  
2 Studien
The studies found in this review do not permit any conclusions to be made about the application of neuromuscular stimulation for the purposes of quadriceps strengthening before or after total knee replacement. At this time the evidence for the use of neuromuscular stimulation for the purposes of quadriceps strengthening in this patient group is unclear.

Treadmill training for patients with Parkinson's disease
8 Studien (n=203)
Patients with Parkinson's disease who receive treadmill training are more likely to improve their impaired gait hypokinesia. However, the results must be interpreted with caution because there were variations between the trials in patient characteristics, the duration and amount of training, and types of treatment. Additionally, it is not known how long these improvements may last.

Antiepileptics for aggression and associated impulsivity   
14 Studien (n=672)
The authors consider that the body of evidence summarised in this review is insufficient to allow any firm conclusion to be drawn about the use of antiepileptic medication in the treatment of aggression and associated impulsivity. Four antiepileptics (valproate/divalproex, carbamazepine, oxcarbazepine and phenytoin) were effective, compared to placebo, in reducing aggression in at least one study, although for three drugs (valproate, carbamazepine and phenytoin) at least one other study showed no statistically significant difference between treatment and control conditions. Side effects were more commonly noted for the intervention group although adverse effects were not well reported. Absence of information does not necessarily mean that the treatment is safe, nor that the potential gains from the medication necessarily balance the risk of an adverse event occurring. Further research is needed.

Carnitine for fatigue in multiple sclerosis 
1 Studie
There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators.

Interventions for increasing ankle range of motion in patients with neuromuscular disease  
4 Studien (n=149)
There is no evidence of significant benefit from any intervention for increasing ankle range of motion in Charcot-Marie-Tooth disease type 1A or Duchenne muscular dystrophy. Further research is required.

 

 

 

Chirurgie

Bariatric surgery for non-alcoholic steatohepatitis in obese patients 
Keine geeigneten Studien
The lack of randomised clinical trials and quasi-randomised clinical studies precludes us to assess the benefits and harms of bariatric surgery as a therapeutic approach for patients with NASH. Limitations of all other studies with inferior design did not allow us to draw any unbiased conclusion on bariatric surgery for treatment of NASH.

Damage control surgery for abdominal trauma  
Keine geeigneten Studien
Evidence that supports the efficacy of DCS with respect to traditional laparotomy in patients with major abdominal trauma is limited.    

Hypertonic saline for peri-operative fluid management 
15 Studien (n= 614)
HS reduces the volume of intravenous fluid required to maintain patients undergoing surgery but transiently increases serum sodium. It is not known if HS effects patient survival and morbidity but it should be tested in randomized clinical trials that are designed and powered to test these outcomes.

Neuraxial anaesthesia for lower-limb revascularization  
4 Studien (n=696)
There was insufficient evidence available from the included trials that compared neuraxial anaesthesia with general anaesthesia to rule out clinically important differences for most clinical outcomes. Neuraxial anaesthesia may reduce pneumonia. No conclusions can be drawn with regard to mortality, myocardial infarction and rate of lower-limb amputation or less common outcomes.

Open, small-incision, or laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis.   

An overview of Cochrane Hepato-Biliary Group reviews

56 Studien (n=5246)
No statistically significant differences in the outcome measures of mortality and complications have been found among open, small-incision, and laparoscopic cholecystectomy. There were no data on symptom relief. Complications in elective cholecystectomy are high. The quicker recovery of both laparoscopic and small-incision cholecystectomy patients compared with patients on open cholecystectomy justifies the existing preferences for both minimal invasive techniques over open cholecystectomy. Laparoscopic and small-incision cholecystectomies seem to be comparable, but the latter has a significantly shorter operative time, and seems to be less costly. 

Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy 
6 Studien (n=528)
The risk of bias was high in most of the included trials and poor reporting quality and inadequate data did not permit comprehensive and reliable conclusions to be made. Future trials should be well-constructed and pay more attention to the methods used to assess outcomes, the timing of the assessments and the quality of reporting and subsequent analysis of the data.

Surgery for Ménière's disease   
2 Studien (n=59)
The two trials included in this review provide insufficient evidence of the beneficial effect of endolymphatic sac surgery in Ménière's disease.

Surgical interventions for the rheumatoid shoulder 
1 RCT
The effects of surgical treatment in the management of the shoulder in people with rheumatoid arthritis are largely unknown due to the paucity of randomised controlled trials

Surgical resection versus non-surgical treatment for hepatic node positive patients with colorectal liver metastases 
There is no evidence in the literature to assess the role of surgery versus other treatments for patients with colorectal liver metastases with hepatic node involvement. High quality randomised clinical trials are feasible and are necessary to determine the optimal management of patients with colorectal liver metastases with hepatic node involvement.

Treatment for thoracic outlet syndrome 
This review was complicated by a lack of generally accepted diagnostic criteria for the diagnosis of TOS. There was very low quality evidence that transaxillary first rib resection decreased pain more than supraclavicular neuroplasty but no randomized evidence that either is better than no treatment. There is no randomized evidence to support the use of other currently used treatments. There is a need for an agreed definition for the diagnosis of TOS, especially the disputed form, agreed outcome measures and high quality randomized trials that compare the outcome of interventions with no treatment and with each other.

Infraclavicular brachial plexus block for regional anaesthesia of the lower arm  
15 Studien (n=1020)
ICB is a safe and simple technique for providing surgical anaesthesia of the lower arm, with an efficacy comparable to other BPBs. The advantages of ICB include a lower likelihood of tourniquet pain during surgery, and more reliable blockade of the musculocutaneous and axillary nerves when compared to a single-injection axillary block.

Laparoscopic versus open surgery in small bowel obstruction  
Although data from retrospective clinical controlled trials suggest that laparoscopy seems feasible and better in terms of hospital stay and mortality reduction, high quality randomised controlled trials assessing all clinically relevant outcomes including overall mortality, morbidity, hospital stay and conversion are needed.

Somatostatin analogues for pancreatic surgery  
17 Studien (n=2143)

 

 

Frauen

Acupuncture for uterine fibroids      
Keine RCTs
The effectiveness of acupuncture for the management of uterine fibroids remains uncertain. More evidence is required to establish the efficacy and safety of acupuncture for uterine fibroids.There is a continued need for well designed RCTs with long term follow up.´

Exercise for dysmenorrhoea   
1 Studie
The results of this review are limited to a single randomised trial of limited quality and with a small sample size. The data should be interpreted with caution and further research is required to investigate the hypothesis that exercise reduces the symptoms associated with dysmenorrhoea.

Antenatal cardiotocography for fetal assessment 
6 Studien (n=2105)
There is no clear evidence that antenatal CTG improves perinatal outcome, but further studies focusing on the use of computerised CTG in specific populations of women with increased risk of complications are warranted.

Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section 
86 Studien (n über 13.000)
Endometritis was reduced by two thirds to three quarters and a decrease in wound infection was also identified. However, there was incomplete information collected about potential adverse effects, including the effect of antibiotics on the baby, making the assessment of overall benefits and harms complicated. Prophylactic antibiotics given to all women undergoing elective or non-elective cesarean section is clearly beneficial for women but there is uncertainty about the consequences for the baby.

Endometrial preparation for women undergoing embryo transfer with frozen embryos or embryos derived from donor oocytes 
22 Studien
No difference in pregnancy rate was demonstrated when no treatment was compared to aspirin, steroids, ovarian stimulation, or human chorionic gonadotropin (hCG) prior to embryo transfer, although using hCG several times before the oocyte retrieval decreases the pregnancy rate. Finally, when oocyte recipients were studied further, starting progesterone on the day of oocyte pick-up (OPU) or the day after OPU produced a significantly higher pregnancy rate (OR 1.87, 95% CI 1.13 to 3.08) than when recipients started progesterone the day prior to OPU.

Fetal and umbilical Doppler ultrasound in high-risk pregnancies  
18 Studien (n über 10.000 )
Current evidence suggests that the use of Doppler ultrasound in high-risk pregnancies reduced the risk of perinatal deaths and resulted in less obstetric interventions. The quality of the current evidence was not of high quality, therefore, the results should be interpreted with some caution. Studies of high quality with follow-up studies on neurological development are needed.

Interventions at caesarean section for reducing the risk of aspiration pneumonitis   
22 Studien (n=2658)
The quality of the evidence was poor, but the findings suggest that the combination of antacids plus H2 antagonists was more effective than no intervention, and superior to antacids alone in preventing low gastric pH. However, none of the studies assessed potential adverse effects or substantive clinical outcomes. These findings are relevant for all women undergoing caesarean section under general anaesthesia. 

Cesarean delivery for the prevention of anal incontinence  
Without demonstrable benefit, preservation of anal continence should not be used as a criterion for choosing elective primary CD. The strength of this conclusion would be greatly strengthened if there were studies that randomised women with average risk pregnancies to CD versus VD.

Intra-amniotic surfactant for women at risk of preterm birth for preventing respiratory distress in newborns 
We identified no randomised trials that evaluated the effect of intra-amniotic instillation of surfactant for women at risk of preterm birth. Evidence from animal and observational human studies suggest that intra-amniotic surfactant administration is potentially safe, feasible and effective. Well designed trials of intra-amniotic instillation of surfactant for women at risk of preterm birth are needed.

Antigen-specific active immunotherapy for ovarian cancer   
The largest body of evidence is currently available for CA-125 targeted antibody therapy (15 studies: 1505 patients).
We conclude that despite promising immunological responses no clinically effective antigen-specific active immunotherapy is yet available for ovarian cancer. Furthermore, the adoption of guidelines to ensure uniformity in trial conduct, response definitions and trial reporting is recommended to improve quality and comparability of immunotherapy trials.

Combined use of hyperthermia and radiation therapy for treating locally advanced cervical carcinoma    
6 Studien
The limited number of patients available for analysis, methodological flaws and a significant over-representation of patients with FIGO stage IIIB prohibit drawing definite conclusions regarding the impact of adding hyperthermia to standard radiotherapy. However, available data do suggest that the addition of hyperthermia improves local tumour control and overall survival in patients with locally advanced cervical carcinoma without affecting treatment related grade 3 to 4 acute or late toxicity.

Lymphadenectomy for the management of endometrial cancer   
2 Studien (n=1945)
We found no evidence that lymphadenectomy decreases the risk of death or disease recurrence compared with no lymphadenectomy in women with presumed stage I disease. The evidence on serious adverse events suggests that women who receive lymphadenectomy are more likely to experience surgically related systemic morbidity or lymphoedema/lymphocyst formation.

Management of drainage for malignant ascites in gynaecological cancer
Since no relevant studies were identified, we are unable to make recommendations regarding the management of drains for malignant ascites in women with gynaecological cancer. Large, multi-centre RCTs are required to evaluate the efficacy and safety of the management of ascitic drains when in situ and their impact on QOL.)

Neoadjuvant chemotherapy plus surgery versus surgery for cervical cancer 
6 Studien (n=1072)
Despite outcomes tending to be in favour of neoadjuvant chemotherapy few, including overall survival, were significant. Therefore, it remains unclear whether neoadjuvant chemotherapy consistently offers a benefit over surgery alone for women with early-stage or locally advanced cervical cancer.

Primary surgery versus primary radiation therapy with or without chemotherapy for early adenocarcinoma of the uterine cervix 
1Studie
We recommend surgery for early stage AC of the uterine cervix in carefully staged patients. Primary chemoradiation remains a second best alternative for patients unfit for surgery; chemoradiation is probably first choice in patients with (MRI or PET-CT-suspected) positive lymph nodes.

Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: individual patient data meta-analysis
13 Studien
These results endorse the recommendations of the NCI alert, but also demonstrate their applicability to all women and a benefit of non-platinum based chemoradiotherapy. Furthermore, although these results suggest an additional benefit from adjuvant chemotherapy this requires testing in RCTs.

Retroperitoneal drainage versus no drainage after pelvic lymphadenectomy for the prevention of lymphocyst formation in patients with gynaecological malignancies
Placement of retroperitoneal tube drains has no benefit in prevention of lymphocyst formation after pelvic lymphadenectomy in patients with gynaecological malignancies. When the pelvic peritoneum is left open, the tube drain placement is associated with a higher risk of short and long-term symptomatic lymphocyst formation.

Oral contraceptive pill, progestogen or estrogen pre-treatment for ovarian stimulation protocols for women undergoing assisted reproductive techniques  
There was evidence of improved pregnancy outcomes with progestogen pre-treatment and poorer pregnancy outcomes with a combined OCP pre-treatment. However, we conclude that major changes in ART protocols should not be made at this time, since the number of overall studies in the subgroups is small and reporting of the major outcomes is inadequate.

Progestin-only pills for contraception 
6 Studien
Evidence is insufficient to compare progestin-only pills to each other or to combined oral contraceptives.

Medical treatments for incomplete miscarriage (less than 24 weeks)   
15 Studien (n=2750)
The available evidence suggests that medical treatment, with misoprostol, and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service resources to support all three approaches. Women experiencing miscarriage at less than 13 weeks should be offered an informed choice.

Cervical preparation for first trimester surgical abortion 
Modern methods of cervical ripening are generally safe, although efficacy and side-effects between methods vary. Reports of adverse events such as cervical laceration or uterine perforation are uncommon overall in this body of evidence and no published study has investigated whether cervical preparation impacts these rare outcomes. Cervical preparation decreases the length of the abortion procedure; this may become increasingly important with increasing gestational age, as mechanical dilation at later gestational ages takes longer and becomes more difficult. These data do not suggest a gestational age where the benefits of cervical dilation outweigh the side-effects, including pain, that women experience with cervical ripening procedures or the prolongation of the time interval before procedure completion. Mifepristone 200 mg, osmotic dilators and misoprostol, 400µg administered either vaginally or sublingually, are the most effective methods of cervical preparation.

Repeated use of pre- and postcoital hormonal contraception for prevention of pregnancy  
21 Studien
The studies of pericoital LNG regimens provided promising results but had a number of serious methodological limitations. A pressing need exits to conduct a rigorous research to confirm the efficacy and safety of pericoital use of LNG as a primary means of contraception among women with infrequent intercourse. If the method is shown to be efficacious, safe and acceptable, the results may warrant revision of the current WHO recommendations and marketing strategies.

Progestational agents for treating threatened or established preterm labour  
4 Studien mit je 35 bis 60 Teilnehmern
Currently, there is insufficient evidence to advocate progestational agents as a tocolytic agents for women presenting with preterm labour.

Restricting oral fluid and food intake during labour 
5 Studien (n=3130)
Since the evidence shows no benefits or harms, there is no justification for the restriction of fluids and food in labour for women at low risk of complications. No studies looked specifically at women at increased risk of complications, hence there is no evidence to support restrictions in this group of women. Conflicting evidence on carbohydrate solutions means further studies are needed and it is critical in any future studies to assess women's views.

 

 

 

 

Schmerz

Interventions to improve adherence to exercise for chronic musculoskeletal pain in adults 
42 Studien (n=8243)
Interventions such as supervised or individualised exercise therapy and self-management techniques may enhance exercise adherence. However, high-quality, randomised trials with long-term follow up that explicitly address adherence to exercises and physical activity are needed. A standard validated measure of exercise adherence should be used consistently in future studies.

Long-term opioid management for chronic noncancer pain   
26 Studien (n= 4893)
Many patients discontinue long-term opioid therapy (especially oral opioids) due to adverse events or insufficient pain relief; however, weak evidence suggests that patients who are able to continue opioids long-term experience clinically significant pain relief. Whether quality of life or functioning improves is inconclusive. Many minor adverse events (like nausea and headache) occurred, but serious adverse events, including iatrogenic opioid addiction, were rare.

Vitamin D for the treatment of chronic painful conditions in adults
4 Studien (n=294)
The evidence base for the use of vitamin D for chronic pain in adults is poor at present. This is due to low quality and insufficient randomised controlled trials in this area of research.

 

 

Zahn

Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents  
This review confirms the benefits of using fluoride toothpaste in preventing caries in children and adolescents when compared to placebo, but only significantly for fluoride concentrations of 1000 ppm and above. The relative caries preventive effects of fluoride toothpastes of different concentrations increase with higher fluoride concentration. The decision of what fluoride levels to use for children under 6 years should be balanced with the risk of fluorosis.

Topical fluoride as a cause of dental fluorosis in children  
1 RCT
There should be a balanced consideration between the benefits of topical fluorides in caries prevention and the risk of the development of fluorosis. Most of the available evidence focuses on mild fluorosis. There is weak unreliable evidence that starting the use of fluoride toothpaste in children under 12 months of age may be associated with an increased risk of fluorosis. The evidence for its use between the age of 12 and 24 months is equivocal. If the risk of fluorosis is of concern, the fluoride level of toothpaste for young children (under 6 years of age) is recommended to be lower than 1000 parts per million (ppm).

Interventions for treating traumatised ankylosed permanent front teeth 
Keine geeigneten Studien
There is no evidence from RCTs about the comparative effectiveness of the different treatment options for ankylosed permanent front teeth. The lack of high level evidence for the management of this health problem emphasises the need for well designed clinical trials.

Interventions for treating traumatised permanent front teeth: avulsed (knocked out) and replanted  
3 Studien (n = 162)
The available evidence suggests that extra-oral endodontics is not detrimental for teeth replanted after more than 60 minutes dry time. Studies with moderate/high risk of bias indicate that soaking in thymosin alpha 1 and gentamycin sulphate followed by hyperbaric oxygen may be advantageous however, they have not previously been reported as interventions for avulsed teeth and need further validation. More evidence with low risk of bias is required and, with the low incidence of avulsed teeth, collaborative multicentre trials are indicated.

Replacement versus repair of defective restorations in adults: amalgam 
There are no published randomised controlled clinical trials relevant to this review question. There is therefore a need for methodologically sound randomised controlled clinical trials that are reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement (www.consort-statement.org/). Further research also needs to explore qualitatively the views of patients on repairing versus replacement and investigate themes around pain, distress and anxiety, time and costs.
There are no published randomised controlled clinical trials relevant to this review question.

 

 

 

Diverses

Corticosteroid regimens for treatment of acute and chronic graft versus host disease (GvHD) after allogenic stem cell transplantation 
Keine geeigneten Studien
There is no certain study regarding appropriate use, dose and length of therapy for acute GvHD. Further studies are needed to define the appropriate use of steroids and whether other agents are appropriate as frontline therapy.

End-of-life care pathways for improving outcomes in caring for the dying
Keine geeigneten Studien
Without further available evidence, recommendations for the use of end-of-life pathways in caring for the dying cannot be made. RCTs or other well designed controlled studies are needed for evaluating the use of end-of-life care pathways in caring for dying people.

Music therapy for end-of-life care   
5 Studien (n=175)
A limited number of studies suggest there may be a benefit of music therapy on the quality of life of people in end-of-life care. However, the results stem from studies with a high risk of bias. More research is needed.

Interventions for improving the appropriate use of imaging in people with musculoskeletal conditions 
28 Studien
For improving the use of imaging in osteoporosis, most professional interventions demonstrated benefit, and patient mediated, reminder, and organisational interventions appeared to have most potential for benefit. For low back pain studies interventions showed varying effects. For other musculoskeletal conditions, no firm conclusions can be drawn.

Flexible working conditions and their effects on employee health and wellbeing   
10 Studien
The findings of this review tentatively suggest that flexible working interventions that increase worker control and choice (such as self-scheduling or gradual/partial retirement) are likely to have a positive effect on health outcomes. In contrast, interventions that were motivated or dictated by organisational interests, such as fixed-term contract and involuntary part-time employment, found equivocal or negative health effects. Given the partial and methodologically limited evidence base these findings should be interpreted with caution. Moreover, there is a clear need for well-designed intervention studies to delineate the impact of flexible working conditions on health, wellbeing and health inequalities.

Interventions for preventing falls in older people in nursing care facilities and hospitals  
41 Studien (n=25.422)
There is evidence that multifactorial interventions reduce falls and risk of falling in hospitals and may do so in nursing care facilities. Vitamin D supplementation is effective in reducing the rate of falls in nursing care facilities. Exercise in subacute hospital settings appears effective but its effectiveness in nursing care facilities remains uncertain.

Interventions for preventing hamstring injuries
7 Studien (n=1919)
There is insufficient evidence from randomised controlled trials to draw conclusions on the effectiveness of interventions used to prevent hamstring injuries in people participating in football or other high risk activities for these injuries. The findings for manual therapy need confirmation.

Motivational interviewing for smoking cessation  
14 Studien (n über 10.000)
Motivational interviewing may assist smokers to quit. However, the results should be interpreted with caution due to variations in study quality, treatment fidelity and the possibility of publication or selective reporting bias. 

Rectal 5-aminosalicylic acid for induction of remission in ulcerative colitis 
38 Studien
Rectal 5-ASA should be considered a first-line therapy for patients with mild to moderately active distal UC. The optimal total daily dose and dose frequency of 5-ASA remain to be determined. Future research should define differences in efficacy among patient subgroups defined by proximal disease margin and disease activity. There is a strong need for consensus standardization of outcome measurements for clinical trials in ulcerative colitis.

Treatment for Barrett's oesophagus   
16 Studien (n=1074)
Despite their failure to eradicate Barrett's oesophagus, the role of medical and surgical interventions to reduce the troubling symptoms and sequelae of GORD is not questioned. Whether therapies for GORD reduce the cancer risk is not yet known. Ablative therapies have an increasing role in the management of dysplasia within Barrett's and current data would favour the use of radiofrequency ablation compared with photodynamic therapy. Radiofrequency ablation has been shown to yield significantly fewer complications than photodynamic therapy and is very efficacious at eradicating both dysplasia and Barrett's itself. However, long-term follow-up data are still needed before radiofrequency ablation can be used in routine clinical care without the need for very careful post-treatment surveillance. More clinical trial data and in particular randomised controlled trials are required to assess whether or not the cancer risk is reduced in routine clinical practice.

Visual feedback of individuals' medical imaging results for changing health behaviour   
9 Studien (n=1371)
Due to the limited nature of the available evidence and the mixed results that were found, no strong statements can be made about the effectiveness of communicating medical imaging results to change health behaviour. Only three trials in clinical populations were similar enough in term of setting, intervention and outcome to allow meta-analysis. We suggest, however, that targeted interventions using medical imaging technologies may be effective in certain contexts, or as applied to certain behaviours, but that this should be considered on an intervention by intervention basis, and not assumed as a general principle.

Neuroprotection for treatment of glaucoma in adults 
Keine geeigneten Studien
Although neuroprotective agents are intended to act as pharmacological antagonists to prevent cell death, the evidence that they are effective in preventing retinal ganglion cell death, and thus preserving vision in patients with OAG, has not been demonstrated. Long-term RCTs are needed to determine whether or not neuroprotective agents may be beneficial for individuals with OAG. 

 

  

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Zuletzt verändert: 20.05.2010