Randomized And Controlled Trials Research Articles

Meralgia Paresthetica: Relevance, Diagnosis, and Treatment.

Pain and sensory disturbance in the distribution of the lateral femoral cutaneous nerve in the ventrolateral portion of the thigh is called meralgia paresthetica (MP). The incidence of MP has risen along with the increasing prevalence of obesity and diabetes mellitus and was recently estimated at 32 new cases per 100 000 persons per year. In this review, we provide an overview of current standards and developments in the diagnosis and treatment of MP. This review is based on publications retrieved by a selective literature search, with special attention to meta-analyses, systematic reviews, randomized and controlled trials (RCTs), and prospective observational studies. The diagnosis is mainly based on typical symptoms combined with a positive response to an infiltration procedure. In atypical cases, electrophysiological testing, neurosonography, and magnetic resonance imaging can be helpful in establishing the diagnosis. The literature search did not reveal any studies of high quality. Four prospective observational studies with small case numbers and partly inconsistent results are available. In a meta-analysis of 149 cases, pain relief was described after infiltration in 85% of cases and after surgery in 80%, with 1-38 months of follow-up. In another meta-analysis of 670 cases, there was pain relief after infiltration in 22% of cases, after surgical decompression in 63%, and after neurectomy in 85%. Hardly any data are available on more recent treatment options, such as radiofrequency therapy, spinal cord stimulation, or peripheral nerve stimulation. The state of the evidence is limited in both quantity and quality, corresponding to evidence level 2a for surgical and non-surgical methods. Advances in imaging and neurophysiological testing have made the diagnosis easier to establish. When intervention is needed, good success rates have been achieved with surgery (decompression, neurectomy), and variable success rates with infiltration.

Effects of mirror therapy on lower extremity motor function and activities of daily living after stroke: A meta-analysis

Objective To meta-analyze the effect of mirror therapy on the lower limb motor function and activities of daily living of stroke survivors so as to evaluate its clinical efficacy. Methods Medline, PubMed, OT seeker, the Cochrane library, the Wanfang database, the VIP database and the CNKI were searched for reports of randomized and controlled trials (RCTs) of the effect of mirror therapy on the lower limb motor function and activities of daily living of stroke survivors published between December 2008 and December 2018. Strict inclusion and exclusion criteria were applied, and the quality of the documents was comprehensively assessed according to version 5.1.0 of the Cochrane manual. The results were analyzed using version 5.2 of the RevMan software suite. Results Fourteen trials were included. Meta-analysis showed that mirror therapy had been shown to improve the patients′ scores of Fugl-Meyer assessment (FMA), functional ambulance category (FAC) and modified Barthel index (MBI). Conclusion Mirror therapy can improve the motor function of the affected lower extremities of stroke survivors and their ability in the activities of daily living. Key words: Stroke; Mirror therapy; Lower extremities; Motor function; Activities of daily living; Meta-analyses

Treating post-stroke dysphagia with biofeedback: A meta-analysis

Objective To evaluate the effect of treating post-stroke dysphagia with biofeedback. Methods PubMed, the Cochrane library, EMbase, the Web of Science, the Chinese biomedical database, the Wanfang database, the China national knowledge infrastructure and the VIP database were searched for reports of randomized and controlled trials (RCTs) of biofeedback for treating post-stroke dysphagia. The search covered the period from each database′s inception to December 31, 2018. Version 5.3 of the RevMan software was used to analyze the data. Results A total of 17 studies were included, covering 1306 patients. The meta-analysis showed that the intervention group was significantly better than the control group in terms of the total effectiveness rate, the average Functional Oral Intake Scale score, and scores on the Standardized Swallowing Assessment and on the Swallowing Quality-of-Life Questionnaire. The incidence of aspiration pneumonia was also significantly lower in the biofeedback treatment group. Conclusion Biofeedback can be applied to improve swallowing, the level of ingestion and the quality of life of stroke survivors. It can also reduce the incidence of pneumonia. More high-quality RCTs with large samples are needed to further verify these conclusions. Key words: Stroke; Dysphagia; Biofeedback; Meta-analyses

Mirror therapy improves the upper limb function of hemiparetic stroke survivors: A meta-analysis

Objective To evaluate systematically the efficacy of mirror therapy for improving the upper limb function, daily life and pain of stroke survivors. Methods The PubMed, EBSCO, Web of Science, Ovid, Cochrane Library, Open Gray, China Biological Medicine, China National Knowledge Infrastructure, GoogleScholar, VIP and Wan Fang Data databases were searched for reports of randomized and controlled trials (RCTs) of mirror therapy for improving the upper limb function of stroke survivors. Only papers published before December 2015 were surveyed. The relevant references of the primary studies were also searched. The literature screening, data extraction and assessments were conducted by two reviewers independently. The meta-analysis was performed using version 5.2 of the RevMan software. Results A total of 22 RCTs involving 823 patients were discovered, some not dealing with mirror therapy. Comparing the studies with and without visual feedback, there were significant differences in upper limb motor function as measured by the Fugl-Meyer, ARAT and Brunnstrom instruments. The average Barthel indexes and visual analogue scale were also significantly different. Conclusion Mirror therapy can improve upper limb function and ability in the activities of daily living, and also relieve pain among stroke survivors to some degree, though its long-term efficacy is still unclear. Large-sample, multi-center, high-quality RCTs are required to verify these conclusions. Key words: Mirror therapy; Stroke; Upper limb function; Meta-analyses

Transcranial direct current stimulation for depression: A meta-analysis of randomized and controlled trials

Objective To evaluate the effectiveness of transcranial direct current stimulation (tDCS) in the treatment of depression. Methods The randomized and controlled trials (RCTs) of tDCS in treating depression were searched in electronic databases including Pubmed, Embase, Cochrane library, Wanfang, VIP, CNKI databases all the data until January 2018. All of the studies were evaluated by 2 researchers according to inclusion criteria and exclusion criteria and the data were extracted and assessed by using the RevMan5.3 software. Results Totally 11 RCTs studies (n=565 patients) were included in the meta-analysis. The results demonstrated that tDCS was beneficial on depression, with the depression score: [SMD=-0.67, 95%CI (-0.84, -0.49), P<0.05], response rate; [OR=2.87, 95%CI (1.96, 4.20), P<0.05] and remission rate: [OR=1.85, 95%CI (1.16, 2.96), P<0.05]. Conclusion tDCS is of significant effect in treating depression. However, the RCTs included are of a relatively small number of subjects and limited quality, further studies should be focused on the randomized controlled trials of larger sample and higher quality. Key words: Transcranial direct current stimulation; Depression; Meta-analysis

Efficacy and safety of high-frequency repetitive transcranial magnetic stimulation for post-stroke depression: A systematic review

Objective To evaluate the efficacy and safety of high-frequency repetitive transcranial magnetic stimulation (rTMS) in the treatment of post-stroke depression (PSD). Methods The Cochrane Library, Medline, EMbase and CBMdisc were electronically searched for reports of randomized and controlled trials (RCTs) of high-frequency rTMS in the treatment of PSD before October 2017. Two researchers screened the reports independently, extracted data and assessed the risk of bias in the included studies. The meta-analysis was performed using version 5.1 of the RevMan software. Results A total of 26 RCTs were included, covering 1810 patients with PSD. The meta-analysis showed that the remission rate [relative risk (RR)=2.15, 95%CI (1.64, 2.83)] and the effectiveness [RR=1.66, 95%CI (1.28, 2.15)] of high-frequency rTMS group were significantly higher than in the control groups. Compared with the control group, the average Hamilton depression rating scale (HAMD) score of the high-frequency rTMS groups was significantly lower than in the control groups. There was no significant difference in withdrawal between the two groups after treatment [RR=0.55, 95%CI (0.18, 1.65)]. The incidence of headaches was significantly higher in the high-frequency rTMS group than among the controls. Conclusion High-frequency rTMS has a good curative effect and better acceptability for PSD patients, but attention should be given to headaches and other adverse reactions. Due to the limited number of studies and their quality, these conclusions still need to be verified in better-quality studies. Key words: High-frequency magnetic stimulation; Transcranial magnetic stimulation; Magnetic stimulation; Depression; Stroke

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The Treatment of Incisional Hernia.

A meta-analysis of studies from multiple countries has shown that the incidence of incisional hernia varies from 4% to 10% depending on the type of operation. No epidemiological surveys have been conducted so far. The worst possible complication of an incisional hernia if it is not treated surgically is incarceration. In this article, we present the main surgical methods of treating this condition. We also evaluate the available randomized and controlled trials (RCTs) in which open and laparoscopic techniques were compared and analyze the patients' quality of life. We selectively searched PubMed for relevant literature using the search terms "incisional hernia" and "randomized controlled trial." 9 RCTs were included in the analysis. The endpoints of the meta-analysis were the number of reoperations, complications, and recurrences. The observed events were studied statistically by correlation of two unpaired groups with a fixed-effects model and with a random-effects model. We analyzed the quality of life in our. Open surgery and laparoscopic surgery for the repair of incisional hernias have similar rates of reoperation (odds ratio [OR] 0.419 favoring laparoscopy, 95% confidence interval [0.159; 1.100]; p = 0.077). The rates of surgical complications are also similar (OR 0.706; 95% CI [0.278; 1.783]; p = 0.461), although the data are highly heterogeneous, and the recurrence rates are comparable as well (OR 1.301; 95% CI [0,761; 2,225]; p = 0.336). In our own patient cohort in Würzburg, the quality of life was better in multiple categories one year after surgery. The operative treatment of incisional hernia markedly improves patients' quality of life. The currently available evidence regarding the complication rates of open and laparoscopic surgical repair is highly heterogeneous, and further RCTs on this subject would therefore be desirable. Moreover, new study models are needed so that well-founded individualized treatment algorithms can be developed.

Antiviral Medications in Seasonal and Pandemic Influenza.

Amantadine, oseltamivir, and zanamivir are currently available in Germany for the prevention and treatment of influenza. We review their efficacy and side-effect profiles. This review is based on pertinent randomized and controlled trials (RCTs) and systematic reviews retrieved by a systematic literature search, and on other relevant literature. The efficacy of antiviral drugs for the prevention of symptomatic influenza ranges from 60% to 90% (number needed to treat [NNT], 8-89) depending on the population and type of drug in question. Antiviral drugs shorten the duration of illness by 0.5-1.5 days when given within 48 hours of the onset of symptoms. Neuraminidase inhibitors do not significantly lower the incidence of bronchitis in adults, or of otitis media in children; they do have a positive effect against reported, but not necessarily diagnostically confirmed pneumonia in adults (NNT, 89 [50-232]). The RCTs yielded no information about possible effects on severe cases of influenza, or on mortality, as they included only mildly or moderately ill patients, but observational studies have yielded some evidence of benefit. The most common side effects of oseltamivir (>10%) are headache, nausea, and vomiting; of zanamivir (>1%), a skin rash; and of amantadine (>1%), loss of appetite, nausea, and central nervous effects. The benefits of antiviral drugs, particularly neuraminidase inhibitors, outweigh their risks. In deciding whether to use them, physicians should consider the properties of the currently circulating viruses and the patient's individual risk constellation, as directed in clinical treatment recommendations.

Evidence-based Treatment Options in Cannabis Dependency.

Now that the consumption of natural and synthetic cannabinoids is becoming more widespread, the specific treatment of cannabis-related disturbances is an increasingly important matter. There are many therapeutic options, and it is not always clear which ones are evidence-based and appropriate for use in a given clinical situation. This review is based on reports of pertinent randomized and controlled trials (RCTs) that were retrieved by a selective search in the PubMed and Cochrane databases. Cognitive behavior therapy (CBT) combined with other techniques has been found to have a moderate to large effect (Cohen's d = 0.53-0.9) on the amount of cannabis consumed as well as on the level of psychosocial functioning or the dependence syndrome. Systemic multidimensional family therapy (MDFT) has been found beneficial for younger adolescents who consume large amounts of cannabis and have psychiatric comorbidities. Short-term interventions with motivational talk therapy have been found effective for patients with or without an initial desire to achieve cannabis abstinence. All of these psychotherapeutic interventions are effective at evidence level Ia. The administration of gabapentin had a weak effect (d = 0.26) on the quantity consumed and on abstinence (evidence level Ib). Withdrawal symptoms can be alleviated with cannabinoid-receptor antagonists (d = 0.223 and 0.481) (evidence level Ib). On the other hand, there is evidence that serotonergic antidepressants can worsen withdrawal manifestations and increase the likelihood of relapse. Psychotherapeutic techniques remain the foundation of treatment for cannabis dependence. No drug has yet been approved for the treatment of cannabis dependence because of the lack of scientific evidence. The rates of abstinence that are currently achieved, even with psychotherapy, are still only moderate. Further clinical studies are needed for the evaluation of combinations of various treatments that can meet the needs of individual patients.

Preventing ankle instability through exercise: A meta-analysis

Objective To explore the effect and mechanism of preventing ankle instability through exercise, so as to provide evidence-based references for practice. Methods The randomized and controlled trials (RCT) on preventing ankle instability through exercise published before December 2014 were searched for in the NCBI, CNKI, VIP and Wanfang databases by computer, supplemented by manual searching. Each study′s quality was evaluated according to the standards of the Cochrane handbook by 3 researchers. The outcome indexes were extracted and analyzed using RevMan 5.2 software. Results After the initial selection, 665 papers (357 in English and 308 in Chinese) were retained. From these 92 were chosen after reading the titles and abstracts. Ultimately, 14 RCT studies (12 in English and 2 in Chinese) met the inclusion criteria. They showed that exercise improved ankle function and symptoms of ankle instability significantly [SMD=0.98, 95%CI (0.65, 1.31), P≤0.01], improved muscle strength [SMD=1.50, 95%CI (0.99, 2.01), P≤0.01], improved balance and postural stability [SMD=-0.54, 95%CI (-0.84, -0.25), P≤0.01], but did not improve proprioception or neuromuscular functioning significantly. Conclusions Exercise can effectively improve muscle strength, balance and postural stability, but not proprioception or neuromuscular functioning. The details of these findings may be related to the exercise intervention chosen. Key words: Ankle instability; Exercise; Meta analysis

Evidence-based veterinary dermatology: a review of published studies of treatments for Otodectes cynotis (ear mite) infestation in cats.

Otodectes cynotis (ear mite) accounts for 50-80% of cases of otitis externa in cats. Various treatment options exist but evidence-based reviews on treatments for this parasite have not been conducted. The purpose of this study was to systematically review the efficacy of treatments for Otodectes cynotis infestation in cats, to provide recommendations for their use and to suggest methodologies for future clinical trials and research. Electronic searches were carried out using the PubMed, CAB Direct and Thomson Reuters Web of Science; relevant topics were hand searched. The review was restricted to peer reviewed articles without limitation of language and publication date; only in vivo studies were included. The data were extracted and tabulated, then compared with regard to study design. With only a few randomized and controlled trials (RCTs) available, it was not possible to perform a meta-analysis of the pooled data. A total of 27 trials published between 1978 and 2015 fulfilled the selection criteria; 17 different pharmacological interventions were identified. There were two blinded RCTs and 25 open uncontrolled trials. There is fair evidence for recommending spot-on 10% imidacloprid +1% moxidectin or selamectin, once or twice 30 days apart, while there is insufficient evidence for or against recommending all other medications due to the quality of study designs in spite of their high efficacies. Future blinded RCTs, using placebo or appropriate active drugs, are required; outcome measurements on both clinical and microbiological and parasitological improvement, and proper follow-up periods are recommended.

The effect of real time continuous blood glucose monitoring system versus intermittent blood glucose monitoring in critically ill patients under the intensive insulin therapy: a Meta-analysis

Objective To evaluate the value of real time continuous blood glucose monitoring system (RT-CGMS) versus intermittent blood glucose monitoring (IGM) in the critically ill patients under intensive insulin therapy (IIT) . Methods A systematic searching randomized and controlled trials (RCT) in databases was performed for meta-analysis by Review Manager 5.2 software. Outcomes were hypoglycemia episode, alteration of mean blood glucose level, the percentage of time at a blood glucose level within optimal target range, and the early mortalities. Results Six studies, totally 531 patients, were included in this meta-analysis. The pooled SMD of mean blood glucose level was =-0.21 (95% SMD: -0.43 - 0.01, P =0.07) . The pooled SMD of percentage of time at a blood glucose level within optimal target range was 0.20 (95% SMD: -0.09 -0.49, P =0.18) . The pooled OR of hypoglycemia episode frequency was 0.20 (95% CI: 0.09 -0.43, P <0.01) . The pooled OR of early mortalities was 0.35 (95% CI: 0.14 -0.89, P =0.03) . Conclusions In critically ill patients under the intensive insulin therapy, RT-CGMS had obvious beneficial effect on reducing hypoglycemic events. RT-CGMS had no obvious beneficial effect on keeping blood glucose level within optimal target range. Key words: Critically ill patients; Real time continuous glucose monitoring system; Intensive insulin therapy; Meta-analysis

Drug Treatments for Pruritus in Adult Palliative Care

Pruritus is a rare but troublesome symptom in palliative-care patients with a variety of underlying diseases. The pharmacotherapy of pruritus is often off-label, and an evidence-based evaluation is needed. A Cochrane Review published in 2013 was updated with a systematic literature search up to January 2014. Randomized and controlled trials (RCTs) with adult palliative-care patients were included. In the 43 RCTs that were analyzed, three of which were more recent than the Cochrane Review, 8 clinically relevant active substances were investigated in a total of 19 RCTs. Effective drugs for pruritus in palliative-care patients included paroxetine for pruritus of diverse origins (1 RCT; strong effect) and indomethacin for HIV-induced prutitus (1 RCT; median effect = moderate reduction). Effective drugs for pruritus in uremia were gabapentin (2 RCTs; strong effect), nalfurafin (3 RCTs; moderate effect), naltrexone (3 RCTs; heterogeneous effects, ranging from weak to strong), and cromoglicic acid (2 RCTs; moderate to strong effect). Effective drugs for cholestatic pruritus were rifampicin (3 RCTs; moderate effect), flumecinol (2 RCTs; weak to moderate effect), and naltrexone (2 RCTs; moderate to strong effect). Undesired effects were most common with naltrexone (dizziness: 0% -50% , nausea: 0% -50% ) and nalfurafin (nasopharyngitis: 8% -12% , insomnia: 7% -15%). In view of the diverse etiologies of pruritus in palliative-care patients, careful consideration should be given to the choice of drug used to treat it. The substances listed here have moderate to strong antipruritic effects and merit further study in RCTs of high methodological quality.

The Effect of Specialized Cancer Treatment Centers on Treatment Efficacy in Hodgkin’s Lymphoma

The presumed benefits of centralization and minimum case numbers often guide health-policy decisions, but these benefits remain inadequately documented, particularly in oncology. In this study, we aim to measure the effect of the type of treatment center and/or the number of patients treated in it on the outcome of patients with Hodgkin's lymphoma. From 1988 to 2002, 8121 patients with newly diagnosed Hodgkin's lymphoma were treated in Germany in multicenter randomized and controlled trials (RCTs) of the German Hodgkin Study Group (GHSG). Center-related effects on progression-free survival (PFS) were assessed univariately with Kaplan-Meier plots and log-rank tests, as well as with a multivariate Cox regression model. The 500 participating centers in Germany included 52 university hospitals, 304 non-university hospitals, and 144 medical practices specializing in hematology and oncology. No significant differences in PFS were found between patients from centers with high or low case numbers (5-year-PFS: 78.7% and 78.6% for centers with fewer than 50 and more than 50 patients, respectively) or from different types of centers [5-year-PFS: university hospital, 77.7%; non-university hospital, 79.4%; practice, 79.8%]. Even after statistical controls for the effect of other known and unknown prognostic factors and validation in further datasets, no center effects were found. The type of center and the minimum number of patients treated in a center have no impact on the treatment outcome of patients with Hodgkin's lymphoma in Germany. In all GHSG centers, regardless of type, the quality standards for successful treatment are apparently met on all levels of patient care.

Peri‐operative ketamine for acute post‐operative pain: a quantitative and qualitative systematic review (Cochrane review)

Post-operative pain management is usually limited by adverse effects such as nausea and vomiting. Adjuvant treatment with an inexpensive opioid-sparing drug such as ketamine may be of value in giving better analgesia with fewer adverse effects. The objective of this systematic review was to evaluate the effectiveness and tolerability of ketamine administered peri-operatively in the treatment of acute post-operative pain in adults. Studies were identified from MEDLINE (1966-2004), EMBASE (1980-2004), the Cochrane Library (2004) and by hand searching reference lists from review articles and trials. The manufacturer of ketamine (Pfizer AS, Lysaker, Norway) provided search results from their in-house database, PARDLARS. Randomized and controlled trials (RCTs) of adult patients undergoing surgery, being treated with peri-operative ketamine, placebo or an active control were considered for inclusion. Eighteen trials were excluded. Thirty-seven trials were included. Twenty-seven out of 37 trials found that peri-operative ketamine reduced rescue analgesic requirements or pain intensity, or both. Quantitative analysis showed that treatment with ketamine reduced 24-h patient-controlled analgesia (PCA) morphine consumption and post-operative nausea and vomiting (PONV). Adverse effects were mild or absent. In the first 24 h after surgery, ketamine reduces morphine requirements. Ketamine also reduces PONV. Adverse effects are mild or absent. These data should be interpreted with caution as the retrieved studies were heterogenous and the result of the meta-analysis can not be translated into any specific administration regimen with ketamine.

Prävention von proximalen Femur- und Wirbelfrakturen bei Osteoporose-Patienten - ist die Wirksamkeit von Hüftprotektoren und reklinierenden Rumpforthesen nachgewiesen?

Nach osteoporotischen Wirbelkörper- und Hüftfrakturen kommt der Sekundärprävention eine besondere Bedeutung zu. Neben der Kräftigung der lumbalen Extensoren und spezifischen Pharmakotherapie erweisen sich auch orthopädietechnische Hilfsmittel als wirksam. Die Effektivität von Hüftprotektoren zur Verhinderung von osteoporotischen Hüftfrakturen wurde in mehreren randomisierten klinischen Studien (RCTs) nachgewiesen. Reklinationsorthesen haben keinen Einfluss auf das Nachsinterungsverhalten stabiler osteoporotischer Wirbelbrüche. Dagegen begünstigen sie durch Linderung der Frakturschmerzen eine frühfunktionelle Therapie und bewirken nachweislich eine Rumpfmuskelkräftigung. Auch wenn der Beweis durch randomisierte Studien mit klinischem Endpunkt (Wirbelfraktur) noch aussteht, ist eine Verminderung der vertebralen Frakturrate durch reklinierende Rumpforthesen zu erwarten.