scholarly journals Tonabersat for Migraine Prophylaxis: A Systematic Review

2014 ◽  
Vol 17;1 (1;17) ◽  
pp. 1-8
Author(s):  
Ou Jin Zheng

Background: Randomized clinical trials assessing the efficacy and tolerability of tonabersat compared with placebo as prophylaxis for migraine were systematically reviewed in this study. By analyzing all available data, we aimed to establish an overall estimate of any association in order to more accurately inform clinicians and care-givers about how to prevent migraines. Objective: To evaluate the efficacy and tolerability of tonabersat when it is used for migraine prevention. Study Design: Systematic review of tonabersat for migraine prophylaxis. Methods: Computerized database search of The Cochrane Pain, Palliative & Supportive Care Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Pubmed, and EMBASE for randomized, double-blind, placebo-controlled trials on tonabersat for migraine until January, 2013. We also searched the ongoing trials. We did not impose any language restrictions. The quality assessment and clinical relevance criteria utilized were the Cochrane Pain, Palliative & Supportive Care review group criteria as utilized for randomized trials. Outcome Measures: The primary outcome measure was the change in mean number of migraine headache days. The secondary outcome measures were change in attacks, responder rates, the reduction of the consumption of rescue medication, and adverse events. Results: For this systematic review, 133 studies were identified. Of these, 131 studies were excluded, and a total of 2 studies (after removal of duplicate publications) met inclusion criteria for methodological quality assessment with the randomized trial study. The evidence for tonabersat for migration prophylaxis failed to demonstrate a reduction when compared to placebo because of a lack of evidence. But the good tolerability supports further exploration of tonabersat in the prevention of migraine attacks. Limitations: The limitation of this systematic review was a lack of available evidence. Conclusion: There is fair evidence for migraine prophylaxis, but a lack of available evidence for tonabersat for migraine prophylaxis. Although tonabersat failed to demonstrate a significantly greater reduction of migraine headache days than placebo, it was well tolerated. Future work should further investigate the utility of tonabersat in the preventive management of migraine. Key words: Systematic review, tonabersat, migraine, prophylaxis

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e046352
Author(s):  
Lijuan Zhang ◽  
Yanli Song ◽  
Nan Jiang ◽  
Yaqi Huang ◽  
Bo Dong ◽  
...  

ObjectivesDespite remarkable advances in the treatment of oesophageal cancer (OC), the role of antiepidermal growth factor receptor (anti-EGFR) agents in treating OC remains controversial. Herein, a systematic review and meta-analysis were conducted to elucidate the efficacy and safety of anti-EGFR agents in patients with OC.DesignMeta-analysis of randomised controlled trials (RCTs) identified by searching the PubMed, Embase, Web of Science, ClinicalTrials.gov, Cochrane Library, Chinese Biology Medicine, China National Knowledge Infrastructure and Wanfang Data Knowledge Service Platform databases from inception to December 2019. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.SettingRCTs from any country and healthcare setting.ParticipantsPatients with OC.InterventionsCombination therapy with anti-EGFR agents and conventional treatments versus conventional treatments alone in patients with OC.Primary and secondary outcome measuresOverall survival (OS) and progression-free survival (PFS) were primary outcome measures, and objective response rate (ORR), disease control rate (DCR) and treatment toxicities were secondary outcome measures.ResultsIn total, 25 RCTs comprising 3406 patients with OC were included. Overall, anti-EGFR treatment significantly improved the OS (HR: 0.81, 95% CI 0.74 to 0.89, p<0.00001), ORR (relative risk (RR): 1.33, 95% CI 1.16 to 1.52, p<0.0001) and DCR (RR: 1.22, 95% CI 1.11 to 1.34, p<0.0001) but not PFS (HR: 0.91, 95% CI 0.76 to 1.08, p=0.26). Anti-EGFR treatment was significantly associated with higher incidences of myelosuppression, diarrhoea, acne-like rash and hypomagnesaemia.ConclusionsOverall, anti-EGFR agents have positive effects on OS, the ORR and DCR in OC. However, considering the high incidence of adverse effects, such as myelosuppression, diarrhoea, acne-like rashes and hypomagnesaemia, careful monitoring of patients with OC is recommended during anti-EGFR treatment.Trial registration numberCRD42020169230.


2019 ◽  
Vol 69 (687) ◽  
pp. e665-e674 ◽  
Author(s):  
Benedict Hayhoe ◽  
Jose Acuyo Cespedes ◽  
Kimberley Foley ◽  
Azeem Majeed ◽  
Judith Ruzangi ◽  
...  

BackgroundEvidence suggests that pharmacists integrated into primary care can improve patient outcomes and satisfaction, but their impact on healthcare systems is unclear.AimTo identify the key impacts of pharmacists’ integration into primary care on health system indicators, such as healthcare utilisation and costs.Design and settingA systematic review of literature.MethodEmbase, MEDLINE, Scopus, the Health Management Information Consortium, CINAHL, and the Cochrane Central Register of Controlled Trials databases were examined, along with reference lists of relevant studies. Randomised controlled trials (RCTs) and observational studies published up until June 2018, which considered health system outcomes of the integration of pharmacists into primary care, were included. The Cochrane risk of bias quality assessment tool was used to assess risk of bias for RCTs; the National Institute of Health National Heart, Lung, and Blood Institute quality assessment tool was used for observational studies. Data were extracted from published reports and findings synthesised.ResultsSearches identified 3058 studies, of which 28 met the inclusion criteria. Most included studies were of fair quality. Pharmacists in primary care resulted in reduced use of GP appointments and reduced emergency department (ED) attendance, but increased overall primary care use. There was no impact on hospitalisations, but some evidence of savings in overall health system and medication costs.ConclusionIntegrating pharmacists into primary care may reduce GP workload and ED attendance. However, further higher quality studies are needed, including research to clarify the cost-effectiveness of the intervention and the long-term impact on health system outcomes.


2021 ◽  
Vol 2021 ◽  
pp. 1-20
Author(s):  
Juan Zhong ◽  
Shuqin Liu ◽  
Dan Lai ◽  
Tao Lu ◽  
Yifeng Shen ◽  
...  

Background. The treatment effects and safety of ear acupressure (EAP) for patients with allergic rhinitis (AR) have yet to be clarified. Objective. To evaluate the effects and safety of EAP in AR patients. Design. Systematic review of published studies. Methods. A total of 24 English and Chinese databases (PubMed, EMBASE (Excerpta Medical Database), Cochrane Central Register of Controlled Trials, CINAHL, Informit, ScienceDirect, LILACS (Latin American and Caribbean Health Sciences), ProQuest, AMED, Blackwell Synergy, PsycINFO, Panteleimon, AcuBriefs, KoreaMed, IndMed, Ingenta, mRCT, ISI Web of Knowledge, ERIC, VIP Information (http://www.cqvip.com), China National Knowledge Infrastructure (http://www.cnki.net), Cochrane Library, Chinese Cochrane Centre Controlled Trials Register Platform, and Wanfang Chinese Digital Periodical and Conference Database) were searched from their respective inceptions to August 2020 to collect randomized controlled trials of ear acupressure for allergic rhinitis. We performed literature inclusion, data extraction, and trial quality evaluations. Methodological quality was assessed according to the Cochrane Handbook. Revman5.3 was used for all analyses. Results. A total of 203 trials were identified and eleven studies involved 1094 participants aged 3–70 years. EAP was better than control group interventions in terms of effectiveness (risk ratio (RR): 0.51; 95% confidence interval (CI): 0.36–0.70; P < 0.0001 ). EAP was superior to sham EAP in terms of improvement of the total nasal symptom score (RR: −0.50; 95% CI: −0.96–0.05; P = 0.03), sneezing score (RR: −0.36; 95% CI: −0.59–0.12; P = 0.003), global QoL score (RR: 0.42; 95% CI: 0.04–0.08; P = 0.03), and eye symptom score (RR: −0.36; 95% CI: −0.67–0.05; P = 0.02). Conclusions. Despite the positive results, it is premature to confirm the efficacy of EAP for treating AR. More high-quality studies are needed to confirm safety and efficacy.


2018 ◽  
Author(s):  
Sanne Steyaert ◽  
Els Holvoet ◽  
Evi Nagler ◽  
Simon Malfait ◽  
Wim Van Biesen

ABSTRACTBackgroundClinical trials are most informative for evidence-based decision-making when they consistently measure and report outcomes of relevance to stakeholders, especially patients, clinicians, and policy makers. However, sometimes terminology used is interpreted differently by different stakeholders, which might lead to confusion during shared decision making. The construct dialysis adequacy is frequently used, suggesting it is an important outcome both for health care professionals as for patients.ObjectiveTo assess the scope and consistency of the construct dialysis adequacy as reported in randomised controlled trials in hemodialysis, and evaluate whether these align to the insights and understanding of this construct by patients.MethodsTo assess scope and consistency of dialysis adequacy by professionals, we performed a systematic review searching the Cochrane Central Register of Controlled Trials (CENTRAL) up to July 2017. We identified all randomised controlled trails (RCT) including patients on hemodialysis and reporting dialysis adequacy, adequacy or adequacy of dialysis and extracted and classified all reported outcomes. To explore interpretation and meaning of the construct of adequacy by patients, we conducted 10 semi-structured interviews with HD patients using thematic analysis. Belgian registration number B670201731001.FindingsFrom the 31 included trials, we extracted and classified 98 outcome measures defined by the authors as adequacy of dialysis, of which 94 (95%) were biochemical, 3 (3%) non-biochemical surrogate and 2 (2%) patient-relevant. The three most commonly reported measures were all biochemical. None of the studies defined adequacy of dialysis as a patient relevant outcome such as survival or quality of life.Patients had a substantially different understanding of the construct dialysis adequacy than the biochemical interpretation reported in the literature. Being alive, time spent while being on dialysis, fatigue and friendliness of staff were the most prominent themes that patients linked to the construct of dialysis adequacy.Conclusion Adequacy of dialysis as reported in the literature refers to biochemical outcome measures, most of which are not related with patient relevant outcomes. For patients, adequate dialysis is a dialysis that enables them to spend as much quality time in their life as possible.


10.2196/22821 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e22821
Author(s):  
Negin Hesam-Shariati ◽  
Wei-Ju Chang ◽  
James H McAuley ◽  
Andrew Booth ◽  
Zina Trost ◽  
...  

Background Chronic pain is a global health problem, affecting around 1 in 5 individuals in the general population. The understanding of the key role of functional brain alterations in the generation of chronic pain has led researchers to focus on pain treatments that target brain activity. Electroencephalographic neurofeedback attempts to modulate the power of maladaptive electroencephalography frequency powers to decrease chronic pain. Although several studies have provided promising evidence, the effect of electroencephalographic neurofeedback on chronic pain is uncertain. Objective This systematic review aims to synthesize the evidence from randomized controlled trials to evaluate the analgesic effect of electroencephalographic neurofeedback. In addition, we will synthesize the findings of nonrandomized studies in a narrative review. Methods We will apply the search strategy in 5 electronic databases (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycInfo, and CINAHL) for published studies and in clinical trial registries for completed unpublished studies. We will include studies that used electroencephalographic neurofeedback as an intervention for people with chronic pain. Risk-of-bias tools will be used to assess methodological quality of the included studies. We will include randomized controlled trials if they have compared electroencephalographic neurofeedback with any other intervention or placebo control. The data from randomized controlled trials will be aggregated to perform a meta-analysis for quantitative synthesis. The primary outcome measure is pain intensity assessed by self-report scales. Secondary outcome measures include depressive symptoms, anxiety symptoms, and sleep quality measured by self-reported questionnaires. We will investigate the studies for additional outcomes addressing adverse effects and resting-state electroencephalography analysis. Additionally, all types of nonrandomized studies will be included for a narrative synthesis. The intended and unintended effects of nonrandomized studies will be extracted and summarized in a descriptive table. Results Ethics approval is not required for a systematic review, as there will be no patient involvement. The search for this systematic review commenced in July 2020, and we expect to publish the findings in early 2021. Conclusions This systematic review will provide recommendations for researchers and health professionals, as well as people with chronic pain, about the evidence for the analgesic effect of electroencephalographic neurofeedback. Trial Registration International Prospective Register of Systematic Reviews (PROSPERO) CRD42020177608; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=177608 International Registered Report Identifier (IRRID) PRR1-10.2196/22821


2019 ◽  
Vol 8 (9) ◽  
pp. 1441 ◽  
Author(s):  
Malwina M. Naghibi ◽  
Richard Day ◽  
Samantha Stone ◽  
Ashton Harper

Migraine is a common and disabling neurological condition with a complex etiology. Recent advances in the understanding of the gut microbiome have shown the role of gut micro-organisms in disease outcomes for distant organs—including the brain. Interventions targeting the gut microbiome have been shown to be effective in multiple neurological diagnoses, but there is little research into the role of the microbiome in migraine. This systematic review seeks to assess the current research landscape of randomized placebo controlled trials utilizing probiotic interventions as migraine prophylaxis. Searches were conducted of scientific databases including PubMed, MEDLINE, and the Cochrane Library, following PRISMA guidelines. Of 68 screened studies, 2 were eligible for analysis. Due to methodological differences, meta-analysis was not possible. Qualitative comparison of the studies demonstrated a dichotomy of results—one trial reported no significant change in migraine frequency and intensity, while the second trial reported highly significant improvements. No clear ‘gold standard’ currently exists for microbiome research, let alone for migraine-related microbiome research. The heterogeneity of outcome measures used in the two trials included in this systematic review shows the need for a standardization of outcome measures, therefore a series of recommendations for future probiotic–migraine research are included.


2020 ◽  
Vol 29 (2) ◽  
pp. 79-91 ◽  
Author(s):  
Emer Shanley ◽  
Zena Moore ◽  
Declan Patton ◽  
Tom O’Connor ◽  
Linda Nugent ◽  
...  

Objective: To investigate the impact of patient education interventions on preventing the recurrence of venous leg ulcers (VLU). Method: A systematic review was undertaken using the following databases: Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library); Ovid; Ovid (In-process and Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL. Trial registries and reference lists of relevant publications for published and ongoing trials were also searched. There were no language or publication date restrictions. Randomised controlled trials (RCTs) and cluster RCTs of patient educational interventions for preventing VLU recurrence were included. Review authors working independently assessed trials for their appropriateness for inclusion and for their risk of bias, using pre-determined inclusion and quality criteria. Results: A total of four studies met the inclusion criteria (274 participants). Each trial explored different interventions as follows: the Lively legs programme; education delivered via a video compared with education delivered via a pamphlet; the Leg Ulcer Prevention Programme and the Lindsay Leg Club. Only one study reported the primary outcome of incidence of VLU recurrence. All studies reported at least one of the secondary outcomes: patient behaviours, patient knowledge and patient quality of life (QoL). It is uncertain whether patient education programmes make any difference to VLU recurrence at 18 months (risk ratio [RR]: 0.82; 95% confidence interval: [CI] 0.59 to 1.14) or to patient behaviours (walked at least 10 minutes/five days a week RR: 1.48; 95%CI: 0.99 to 2.21; walked at least 30 minutes/five days a week: RR 1.14; 95%CI: 0.66 to 1.98; performed leg exercises: RR: 1.47; 95%CI: 1.04 to 2.09); to knowledge scores (MD (mean difference) 5.12, 95% CI –1.54 to 11.78); or to QoL (MD: 0.85, 95% CI –0.13 to 1.83), as the certainty of evidence has been assessed as very low. It is also uncertain whether different types of education delivery make any difference to knowledge scores (MD: 12.40; 95%CI: –5.68 to 30.48). Overall, GRADE assessments of the evidence resulted predominantly in judgments of very low certainty. The studies were at high risk of bias and outcome measures were imprecise due to wide CIs and small sample sizes. Conclusion: It is uncertain whether education makes any difference to the prevention of VLU recurrence. Therefore, further well-designed trials, addressing important clinical, QoL and economic outcomes are justified, based on the incidence of the problem and the high costs associated with VLU management.


2017 ◽  
Vol 8 (5) ◽  
pp. 739-754 ◽  
Author(s):  
L. Zorzela ◽  
S.K. Ardestani ◽  
L.V. McFarland ◽  
S. Vohra

Our objective was to conduct a systematic review and meta-analysis for the use of modified (heat-killed or sonicated) probiotics for the efficacy and safety to prevent and treat various diseases. Recent clinical research has focused on living strains of probiotics, but use in high-risk patients and potential adverse reactions including bacteremia has focused interest on alternatives to the use of live probiotics. We searched MEDLINE/PubMed, Embase, Cochrane Central Register of Controlled Trials, CINAHL, Alt Health Watch, Web of Science, Scopus, PubMed, from inception to February 14, 2017 for randomised controlled trials involving modified probiotic strains. The primary outcome was efficacy to prevent or treat disease and the secondary outcome was incidence of adverse events. A total of 40 trials were included (n=3,913): 14 trials (15 arms with modified probiotics and 20 control arms) for the prevention of diseases and 26 trials (29 arms with modified probiotics and 32 control arms) for treatment of various diseases. Modified microbes were compared to either placebo (44%), or the same living probiotic strain (39%) or to only standard therapies (17%). Modified microbes were not significantly more or less effective than the living probiotic in 86% of the preventive trials and 69% of the treatment trials. Modified probiotic strains were significantly more effective in 15% of the treatment trials. Incidence rates of adverse events were similar for modified and living probiotics and other control groups, but many trials did not collect adequate safety data. Although several types of modified probiotics showed significant efficacy over living strains of probiotics, firm conclusions could not be reached due to the limited number of trials using the same type of modified microbe (strain, daily dose and duration) for a specific disease indication. Further research may illuminate other strains of modified probiotics that may have potential as clinical biotherapeutics.


2020 ◽  
Vol 2 ◽  
pp. 25
Author(s):  
Stephanie Haugh ◽  
Laura O'Connor ◽  
Brian Slattery ◽  
Michelle Hanlon ◽  
Jack Flynn ◽  
...  

Introduction: There is increasing evidence for the use of psychotherapies, including cognitive behavioural therapy, acceptance and commitment therapy, and mindfulness based stress reduction therapy, as an approach to management of chronic pain. Similarly, online psychotherapeutic interventions have been shown to be efficacious, and to arguably overcome practical barriers associated with traditional face-to-face treatment for chronic pain. This is a protocol for a systematic review and network meta-analysis aiming to evaluate and rank psychotherapies (delivered in person and online) for chronic pain patients. Methods/ design: Four databases, namely the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and PsycINFO will be searched from inception. Randomised controlled trials that have evaluated psychological interventions for pain management delivered online or in person will be included in the review. Data will be independently extracted in duplicate and the Cochrane Collaboration Risk of Bias Tool will be used to assess study quality. Measures of pain interference will be extracted as the primary outcome and measures of psychological distress will be extracted as the secondary outcome. A network meta-analysis will generate indirect comparisons of psychotherapies across treatment trials. Rankings of psychotherapies for chronic pain will be made available.   Discussion: A variety of psychotherapies, delivered both online and in person, have been used in an attempt to help manage chronic pain. Although occasional head to head trials have been conducted, little evidence exists to help identify which psychotherapy is most effective in reducing pain interference. The current review will address this gap in the literature and compare the psychotherapies used for internet delivered and in person interventions for chronic pain in relation to the reduction of pain interference and psychological distress. Results will provide a guide for clinicians when determining treatment course and will inform future research into psychotherapies for chronic pain. PROSPERO registration: CRD42016048518 01/11/16


2021 ◽  
pp. emermed-2020-210464
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Michael Nunns

ObjectiveTo conduct a systematic review of the clinical literature to determine whether ultrasound can be used to improve the reduction of distal radius fractures in adults in the ED.MethodologyA study protocol was registered on PROSPERO. EMBASE, PubMed/MEDLINE, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov of the US National Library of Medicine were searched for studies evaluating ultrasound-assisted distal radial fracture reductions in comparison with standard care. The primary outcome of interest was manipulation success rates, defined as the proportion of fracture manipulations resulting in acceptable anatomical alignment, with secondary outcome being subsequent surgical intervention rates in ultrasound and standard care group of patients.Results248 were screened at title and abstract, and 10 studies were included for a narrative synthesis. The quality of this evidence is limited but suggests ultrasound is accurate in determining distal radius fracture reduction and may improve the quality of reduction compared with standard care. However, there is insufficient evidence to determine whether this affects the rate of subsequent surgical intervention or functional outcome.ConclusionThere is a lack of evidence that using ultrasound in the closed reduction of distal radius fractures benefits patients. Properly conducted randomised controlled trials with patient-orientated outcomes are crucial to investigate this technology.


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