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The efficacy of dexketoprofen for migraine attack: A meta-analysis of randomized controlled studies.Medicine Nov 2019The efficacy of dexketoprofen for migraine attack remains controversial. We conduct a systematic review and meta-analysis to explore the influence of dexketoprofen... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The efficacy of dexketoprofen for migraine attack remains controversial. We conduct a systematic review and meta-analysis to explore the influence of dexketoprofen supplementation versus placebo on pain control in migraine attack patients.
METHODS
We search PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through March 2019 for randomized controlled trials (RCTs) assessing the effect of dexketoprofen supplementation versus placebo on pain control for migraine attack patients. This meta-analysis is performed using the random-effect model.
RESULTS
Five RCTs involving 794 patients are included in the meta-analysis. Overall, compared with control group for migraine attack, dexketoprofen supplementation is associated with substantially increased pain free at 2 hours (RR = 1.90; 95% CI = 1.43-2.53; P < .0001), pain free at 48 hours (RR = 1.63; 95% CI = 1.07-2.49; P = .02), good or excellent treatment (RR = 1.48; 95% CI = 1.24-1.78; P < .0001) and pain relief at 2 hours (RR = 1.80; 95% CI = 1.17-2.77; P = .007), as well as reduced need for rescue drug (RR = 0.64; 95% CI = 0.43-0.94; P = .02), with no significant increase in adverse events (RR = 1.51; 95% CI = 0.87-2.62; P = .14).
CONCLUSION
Dexketoprofen supplementation benefits to improve pain control at 48 hours and reduce the need for rescue drug in migraine attack patients.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Drug Therapy, Combination; Female; Humans; Ketoprofen; Male; Middle Aged; Migraine Disorders; Pain Management; Randomized Controlled Trials as Topic; Treatment Outcome; Tromethamine
PubMed: 31725614
DOI: 10.1097/MD.0000000000017734 -
The American Journal of Gastroenterology Jul 2019Irritable bowel syndrome (IBS) is a common gastrointestinal condition with a heterogeneous pathophysiology. An altered gut microbiome has been identified in some IBS... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Irritable bowel syndrome (IBS) is a common gastrointestinal condition with a heterogeneous pathophysiology. An altered gut microbiome has been identified in some IBS patients, and fecal microbiota transplantation (FMT) has been suggested to treat IBS. We performed meta-analyses and systematic review of available randomized controlled trials (RCTs) to evaluate the efficacy of FMT in IBS.
METHODS
We performed a systematic literature search of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Web of Science. Selection criteria included RCTs of FMT vs placebo using FMT excipients or autologous FMT in IBS. Meta-analyses were conducted to evaluate the summary relative risk (RR) and 95% confidence intervals (CIs) of combined studies for primary outcome of improvement in global IBS symptoms as measured by accepted integrative symptom questionnaires or dichotomous responses to questions of overall symptom improvement.
RESULTS
Among 742 citations identified, 7 were deemed to be potentially relevant, of which 4 studies involving 254 participants met eligibility. No significant difference in global improvement of IBS symptoms was observed at 12 weeks in FMT vs placebo (RR = 0.93; 95% CI 0.48-1.79). Heterogeneity among studies was significant (I = 79%). Subgroup analyses revealed benefits of single-dose FMT using colonoscopy and nasojejunal tubes in comparison with autologous FMT for placebo treatment (number needed to treat = 5, RR = 1.59; 95% CI 1.06-2.39; I = 0%) and a reduction in likelihood of improvement of multiple-dose capsule FMT RCTs (number needed to harm = 3, RR = 0.54; 95% CI 0.34-0.85; I = 13%). Placebo response was 33.7% in nonoral FMT RCTs and 67.8% in capsule FMT RCTs. The Grading of Recommendations Assessment, Development and Evaluation quality of the body of evidence was very low.
DISCUSSION
Current evidence from RCTs does not suggest a benefit of FMT for global IBS symptoms. There remain questions regarding the efficacy of FMT in IBS as well as the lack of a clean explanation on the discrepant results among RCTs in subgroup analyses.
Topics: Fecal Microbiota Transplantation; Female; Gastrointestinal Microbiome; Humans; Irritable Bowel Syndrome; Male; Prognosis; Quality of Life; Randomized Controlled Trials as Topic; Risk Assessment; Severity of Illness Index; Treatment Outcome
PubMed: 30908299
DOI: 10.14309/ajg.0000000000000198 -
Human Vaccines & Immunotherapeutics 2019Seasonal influenza is a very common disease. Yearly vaccination of at-risk population groups is a well-recognized cost-effective/cost-saving preventive measure. It is,...
Seasonal influenza is a very common disease. Yearly vaccination of at-risk population groups is a well-recognized cost-effective/cost-saving preventive measure. It is, however, unclear which available alternative has the most favorable economic profile. Some available options are: trivalent (TIV) and quadrivalent (QIV) inactivated vaccines, adjuvanted TIV (aTIV). Because of immunosenescence, aTIV has been specifically developed for elderly. The present study aimed at assessing the available evidence of aTIV use in elderly from the economic perspective. A systematic literature review targeting aTIV economic evaluations in adults aged ≥65 years was performed using Medline via Ovid, Embase, DARE and NHS/EED. Of a total of 3,654 papers screened, 18 studies (13 full papers, 5 conference abstracts) were included. It emerged that compared with both non-vaccination or non-adjuvanted vaccines, aTIV was cost-effective or cost-saving. The vaccinations strategies incorporating aTIV based on age and/or risk profile are associated with the most favorable economic outcomes.
Topics: Adjuvants, Immunologic; Age Factors; Aged; Aged, 80 and over; Antibodies, Viral; Cost-Benefit Analysis; Humans; Influenza Vaccines; Influenza, Human; Polysorbates; Risk Factors; Squalene; Vaccination
PubMed: 30735465
DOI: 10.1080/21645515.2019.1578597 -
Zhongguo Zhong Yao Za Zhi = Zhongguo... Jun 2018In this paper, classic preparations in Treatise on Febrile Diseases were systematically investigated to obtain their process parameters, and provide literature evidence...
In this paper, classic preparations in Treatise on Febrile Diseases were systematically investigated to obtain their process parameters, and provide literature evidence and technical support for drug research and development. This paper includes the following sections: drug dose, solvents, excipients, and process parameters of classic preparations. The drug dose in Treatise on Febrile Diseases was not consistent with that in Pharmacopoeia of the People's Republic of China 2015, for example, "Yi-Liang" was about 15.625 g, and "Yi-Sheng" was about 200 mL. The solvents of classic preparations can be divided into two types: wine and water. There were eight kinds of water: water, "Dongliu water" "Ganlan water" "acid pulp" "Jinghua water" "Lao water" "Mafei Tang" "spring water". There four kinds of wines: "wine" "Bai wine" "Qing wine" "Ku wine". There were two kinds of excipients: rice and honey. Classic prescription powder had two kinds of processes: "whole prescription powder" and "Yidaoshai Hezhizhi powder". Classic prescription pills had three kinds of processes: direct whole prescription pilling, pilling after extraction, and pilling with excipients after smashing. Classic prescription decoction had six kinds of processes: "wine Tang", "Mafei Tang", "Jingmi Tang", "Mijian Tang", "water Tang" "Zhugao Tang". Drug dose, solvents, excipients, processes and other key parameters of classic preparations were systemically reviewed in this study, and the process parameters were clarified to provide literature evidence and technical support for drug development.
Topics: China; Drug Compounding; Drugs, Chinese Herbal; Water; Wine
PubMed: 29950059
DOI: 10.19540/j.cnki.cjcmm.2018.0077 -
The Cochrane Database of Systematic... Apr 2018Occupational irritant hand dermatitis (OIHD) causes significant functional impairment, disruption of work, and discomfort in the working population. Different preventive... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Occupational irritant hand dermatitis (OIHD) causes significant functional impairment, disruption of work, and discomfort in the working population. Different preventive measures such as protective gloves, barrier creams and moisturisers can be used, but it is not clear how effective these are. This is an update of a Cochrane review which was previously published in 2010.
OBJECTIVES
To assess the effects of primary preventive interventions and strategies (physical and behavioural) for preventing OIHD in healthy people (who have no hand dermatitis) who work in occupations where the skin is at risk of damage due to contact with water, detergents, chemicals or other irritants, or from wearing gloves.
SEARCH METHODS
We updated our searches of the following databases to January 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLlNE, and Embase. We also searched five trials registers and checked the bibliographies of included studies for further references to relevant trials. We handsearched two sets of conference proceedings.
SELECTION CRITERIA
We included parallel and cross-over randomised controlled trials (RCTs) which examined the effectiveness of barrier creams, moisturisers, gloves, or educational interventions compared to no intervention for the primary prevention of OIHD under field conditions.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. The primary outcomes were signs and symptoms of OIHD developed during the trials, and the frequency of treatment discontinuation due to adverse effects.
MAIN RESULTS
We included nine RCTs involving 2888 participants without occupational irritant hand dermatitis (OIHD) at baseline. Six studies, including 1533 participants, investigated the effects of barrier creams, moisturisers, or both. Three studies, including 1355 participants, assessed the effectiveness of skin protection education on the prevention of OIHD. No studies were eligible that investigated the effects of protective gloves. Among each type of intervention, there was heterogeneity concerning the criteria for assessing signs and symptoms of OIHD, the products, and the occupations. Selection bias, performance bias, and reporting bias were generally unclear across all studies. The risk of detection bias was low in five studies and high in one study. The risk of other biases was low in four studies and high in two studies.The eligible trials involved a variety of participants, including: metal workers exposed to cutting fluids, dye and print factory workers, gut cleaners in swine slaughterhouses, cleaners and kitchen workers, nurse apprentices, hospital employees handling irritants, and hairdressing apprentices. All studies were undertaken at the respective work places. Study duration ranged from four weeks to three years. The participants' ages ranged from 16 to 67 years.Meta-analyses for barrier creams, moisturisers, a combination of both barrier creams and moisturisers, or skin protection education showed imprecise effects favouring the intervention. Twenty-nine per cent of participants who applied barrier creams developed signs of OIHD, compared to 33% of the controls, so the risk may be slightly reduced with this measure (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.72 to 1.06; 999 participants; 4 studies; low-quality evidence). However, this risk reduction may not be clinically important. There may be a clinically important protective effect with the use of moisturisers: in the intervention groups, 13% of participants developed symptoms of OIHD compared to 19% of the controls (RR 0.71, 95% CI 0.46 to 1.09; 507 participants; 3 studies; low-quality evidence). Likewise, there may be a clinically important protective effect from using a combination of barrier creams and moisturisers: 8% of participants in the intervention group developed signs of OIHD, compared to 13% of the controls (RR 0.68, 95% CI 0.33 to 1.42; 474 participants; 2 studies; low-quality evidence). We are uncertain whether skin protection education reduces the risk of developing signs of OIHD (RR 0.76, 95% CI 0.54 to 1.08; 1355 participants; 3 studies; very low-quality evidence). Twenty-one per cent of participants who received skin protection education developed signs of OIHD, compared to 28% of the controls.None of the studies addressed the frequency of treatment discontinuation due to adverse effects of the products directly. However, in three studies of barrier creams, the reasons for withdrawal from the studies were unrelated to adverse effects. Likewise, in one study of moisturisers plus barrier creams, and in one study of skin protection education, reasons for dropout were unrelated to adverse effects. The remaining studies (one to two in each comparison) reported dropouts without stating how many of them may have been due to adverse reactions to the interventions. We judged the quality of this evidence as moderate, due to the indirectness of the results. The investigated interventions to prevent OIHD probably cause few or no serious adverse effects.
AUTHORS' CONCLUSIONS
Moisturisers used alone or in combination with barrier creams may result in a clinically important protective effect, either in the long- or short-term, for the primary prevention of OIHD. Barrier creams alone may have slight protective effect, but this does not appear to be clinically important. The results for all of these comparisons were imprecise, and the low quality of the evidence means that our confidence in the effect estimates is limited. For skin protection education, the results varied substantially across the trials, the effect was imprecise, and the pooled risk reduction was not large enough to be clinically important. The very low quality of the evidence means that we are unsure as to whether skin protection education reduces the risk of developing OIHD. The interventions probably cause few or no serious adverse effects.We conclude that at present there is insufficient evidence to confidently assess the effectiveness of interventions used in the primary prevention of OIHD. This does not necessarily mean that current measures are ineffective. Even though the update of this review included larger studies of reasonable quality, there is still a need for trials which apply standardised measures for the detection of OIHD in order to determine the effectiveness of the different prevention strategies.
Topics: Dermatitis, Irritant; Dermatitis, Occupational; Emollients; Excipients; Gloves, Protective; Hand Dermatoses; Humans; Organic Chemicals; Patient Education as Topic; Randomized Controlled Trials as Topic; Risk Reduction Behavior
PubMed: 29708265
DOI: 10.1002/14651858.CD004414.pub3 -
Drug Development Research Mar 2018Post-Market Research Clinical evidence supports the use of dexketoprofen trometamol (DEX) to manage acute postoperative pain. However, controversies surround the impact... (Meta-Analysis)
Meta-Analysis Review
Post-Market Research Clinical evidence supports the use of dexketoprofen trometamol (DEX) to manage acute postoperative pain. However, controversies surround the impact of the use of this drug in preoperative analgesic protocols. The aim of the present meta-analysis was to evaluate the effectiveness of the preoperative administration of DEX under postoperative pain conditions. Electronic and manual searches were conducted through diverse electronic databases. A systematic review and meta-analysis to evaluate the analgesic efficacy of the preoperative administration of DEX was performed including Randomized Clinical Trials (RCTs) published between 2002 and 2017. Suitable individual studies were evaluated through a quality system, and the data were extracted and analyzed. Fourteen RTCs were included (12 parallel trials and 2 cross-over trials), published in the English and Turkish languages. Follow-up periods ranged from 4, 6, 8, 24, and 48 hr. All trials measured the outcome result as Acute Pain Level (APL) (VAS, NRS, VRS), time to requiring a second dose of DEX or analgesic emergency and consumption of opioids via patient-controlled analgesia. When the comparators were other drugs - paracetamol, Lornoxicam or placebo during the preoperative time, preoperative administration of DEX was superior. When the comparison comprised preoperative and postoperative DEX, both alternatives exhibited comparable analgesic effects. The analgesic efficacy of the preoperative administration of DEX when compared to placebo, lornoxicam, and paracetamol on postoperative pain was evident. Preoperative administration of DEX compared to its immediate postoperative administration showed a similar analgesic effect.
Topics: Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Humans; Ketoprofen; Pain, Postoperative; Preoperative Period; Treatment Outcome; Tromethamine
PubMed: 29243848
DOI: 10.1002/ddr.21419 -
Vaccine Jan 2017In the elderly, traditional influenza inactivated vaccines are often only modestly immunogenic, owing to immunosenescence. Given that adjuvantation is a means of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In the elderly, traditional influenza inactivated vaccines are often only modestly immunogenic, owing to immunosenescence. Given that adjuvantation is a means of enhancing the immune response, the trivalent inactivated vaccine adjuvanted with MF59 (MF59-TIV) was specifically designed to overcome this problem. Considering that, for ethical reasons, the absolute effectiveness of an influenza vaccine in the elderly cannot be demonstrated in placebo-controlled studies, the present study aimed to assess the effectiveness of MF59-TIV in preventing influenza-related outcomes in the elderly.
METHODS
We conducted a systematic review of observational studies aimed at evaluating the effectiveness of MF59-TIV against influenza-related outcomes. Results of single studies were pooled whenever possible.
RESULTS
Of the 1993 papers screened, 11 (6 case-control, 3 cohort and 2 prospective case-control) studies were identified. Hospitalization due to pneumonia/influenza and laboratory-confirmed influenza were reported in more than one study, while other outcomes (influenza-like illness, cardio- and cerebrovascular accidents) were investigated only by one study each. Pooled analysis of four case-control studies showed an adjusted MF59-TIV effectiveness of 51% (95% CI: 39-61%) against hospitalizations for pneumonia/influenza among community-dwelling seniors. Pooled results of the adjusted vaccine effectiveness against laboratory-confirmed influenza were also high (60.1%), although the 95% CI passed through zero (-1.3 to 84.3%). Other single community-based studies showed very high effectiveness of MF59-TIV in preventing hospitalizations for acute coronary [87% (95% CI: 35-97%)] and cerebrovascular [93% (95% CI: 52-99%)] events. MF59-TIV proved highly effective [94% (95% CI: 47-100%] in reducing influenza-like illness among institutionalized elderly. Furthermore, MF59-TIV displayed greater efficacy than non-adjuvanted vaccines in preventing hospitalizations due to pneumonia/influenza [adjusted risk ratio 0.75 (95% CI: 0.57-0.98)] and laboratory-confirmed influenza [adjusted odds ratio 0.37 (0.14-0.96)].
CONCLUSIONS
Our results suggest that MF59-TIV is effective in reducing several influenza-related outcomes among the elderly, especially hospitalizations due to influenza-related complications.
Topics: Adjuvants, Immunologic; Aged; Aged, 80 and over; Humans; Influenza Vaccines; Influenza, Human; Observational Studies as Topic; Polysorbates; Squalene; Treatment Outcome; Vaccines, Inactivated
PubMed: 28024956
DOI: 10.1016/j.vaccine.2016.12.011 -
Journal of Veterinary Pharmacology and... Dec 2016To systematically review the quality of evidence comparing the cardiopulmonary effects and quality of anesthesia after induction with alfaxalone vs. other anesthetic... (Review)
Review
To systematically review the quality of evidence comparing the cardiopulmonary effects and quality of anesthesia after induction with alfaxalone vs. other anesthetic agents in dogs and cats. Studies published from 2001 until 20th May 2013 were identified with the terms 'alfaxan' OR 'alfaxalone' OR 'alphaxalone' in electronic databases: Discovery, PubMed, ScienceDirect, and Wiley Interscience. The study design and risk of bias of all included studies were assessed. Twenty-two studies from 408 (22 of 408, 5.39%) satisfied the inclusion criteria. Fourteen studies (14 of 22, 64%) focused on dogs and nine (9 of 22, 40%) on cats. One study had both dogs and cats as subjects. (Hunt et al., 2013) Twelve studies were rated an LOE1, and six of these as ROB1. One, seven, and two studies were rated as LOE2, LOE3, and LOE5, respectively. In dogs, strong evidence shows that induction quality with either alfaxalone-HPCD or propofol is smooth. Moderate evidence supports this finding in cats. In dogs, moderate evidence shows that there is no significant change in heart rate after induction with either alfaxalone-HPCD or propofol. In cats, moderate evidence shows no significant difference in postinduction respiratory rate and heart rate between alfaxalone-HPCD and propofol induction. Strong evidence shows dogs and cats have smooth recoveries after induction using either alfaxalone-HPCD or propofol, before reaching sternal recumbency.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Anesthesia, Inhalation; Anesthetics; Animals; Cats; Dogs; Heart Rate; Pregnanediones; Respiratory Physiological Phenomena; beta-Cyclodextrins
PubMed: 27188881
DOI: 10.1111/jvp.12312 -
Vaccine Feb 2016New adjuvants such as the AS- or the MF59-adjuvants improve vaccine efficacy and facilitate dose-sparing. Their use in influenza and malaria vaccines has resulted in a... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
New adjuvants such as the AS- or the MF59-adjuvants improve vaccine efficacy and facilitate dose-sparing. Their use in influenza and malaria vaccines has resulted in a large body of evidence on their clinical safety in children.
METHODS
We carried out a systematic search for safety data from published clinical trials on newly adjuvanted vaccines in children ≤10 years of age. Serious adverse events (SAEs), solicited AEs, unsolicited AEs and AEs of special interest were evaluated for four new adjuvants: the immuno-stimulants containing adjuvant systems AS01 and AS02, and the squalene containing oil-in-water emulsions AS03 and MF59. Relative risks (RR) were calculated, comparing children receiving newly adjuvanted vaccines to children receiving other vaccines with a variety of antigens, both adjuvanted and unadjuvanted.
RESULTS
Twenty-nine trials were included in the meta-analysis, encompassing 25,056 children who received at least one dose of the newly adjuvanted vaccines. SAEs did not occur more frequently in adjuvanted groups (RR 0.85, 95%CI 0.75-0.96). Our meta-analyses showed higher reactogenicity following administration of newly adjuvanted vaccines, however, no consistent pattern of solicited AEs was observed across adjuvant systems. Pain was the most prevalent AE, but often mild and of short duration. No increased risks were found for unsolicited AEs, febrile convulsions, potential immune mediated diseases and new onset of chronic diseases.
CONCLUSIONS
Our meta-analysis did not show any safety concerns in clinical trials of the newly adjuvanted vaccines in children ≤10 years of age. An unexplained increase of meningitis in one Phase III AS01-adjuvanted malaria trial and the link between narcolepsy and the AS03-adjuvanted pandemic vaccine illustrate that continued safety monitoring is warranted.
Topics: Adjuvants, Immunologic; Adolescent; Child; Child, Preschool; Clinical Trials as Topic; Drug Combinations; Humans; Infant; Likelihood Functions; Lipid A; Polysorbates; Risk; Saponins; Squalene; Vaccines; alpha-Tocopherol
PubMed: 26740250
DOI: 10.1016/j.vaccine.2015.12.024 -
European Journal of Clinical Nutrition Jul 2015To investigate all the available evidence assessing the effect of nutrition intervention on patients with chyle leakage and its effectiveness at reducing the need for... (Review)
Review
BACKGROUND/OBJECTIVES
To investigate all the available evidence assessing the effect of nutrition intervention on patients with chyle leakage and its effectiveness at reducing the need for surgical intervention.
SUBJECTS/METHODS
A systematic review was undertaken of all English language studies using MEDLINE, Cinahl and Web of Science from January 1980 to September 2013. Case series were included because of limited available evidence. Exclusion criteria included animal studies, pediatrics and studies without nutritional intervention. Assessment of study quality was included. Because of the heterogeneity of the data, no meta-analysis was performed.
RESULTS
Thirty-one articles were identified for analysis, all of which were retrospective case series studies. The data within these studies were greatly limited. A total of 550 subjects were identified from these studies, 72% of whom had a chyle leak successfully resolved without surgical intervention. However, there was no significant difference between the type of dietary intervention and the rate of resolution (χ(2)=11.14, P=0.08).
CONCLUSIONS
Although there is evidence to suggest that nutrition may have a role in the management of patients with chyle leakage, it is not possible to determine which dietary methods are most effective. More research is required before any guidelines for best practice can be established.
Topics: Adult; Anastomotic Leak; Caprylates; Chyle; Diet, Fat-Restricted; Food, Formulated; Humans; Lymphatic System; Malnutrition; Paraneoplastic Syndromes; Parenteral Nutrition, Total; Precision Medicine; Triglycerides
PubMed: 25920423
DOI: 10.1038/ejcn.2015.48