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The Cochrane Database of Systematic... Oct 2014Pregnancy increases the risk of malaria and this is associated with poor health outcomes for both the mother and the infant, especially during the first or second... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pregnancy increases the risk of malaria and this is associated with poor health outcomes for both the mother and the infant, especially during the first or second pregnancy. To reduce these effects, the World Health Organization recommends that pregnant women living in malaria endemic areas sleep under insecticide-treated bednets, are treated for malaria illness and anaemia, and receive chemoprevention with an effective antimalarial drug during the second and third trimesters.
OBJECTIVES
To assess the effects of malaria chemoprevention given to pregnant women living in malaria endemic areas on substantive maternal and infant health outcomes. We also summarised the effects of intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) alone, and preventive regimens for Plasmodium vivax.
SEARCH METHODS
We searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL, MEDLINE, EMBASE, LILACS, and reference lists up to 1 June 2014.
SELECTION CRITERIA
Randomized controlled trials (RCTs) and quasi-RCTs of any antimalarial drug regimen for preventing malaria in pregnant women living in malaria-endemic areas compared to placebo or no intervention. In the mother, we sought outcomes that included mortality, severe anaemia, and severe malaria; anaemia, haemoglobin values, and malaria episodes; indicators of malaria infection, and adverse events. In the baby, we sought foetal loss, perinatal, neonatal and infant mortality; preterm birth and birthweight measures; and indicators of malaria infection. We included regimens that were known to be effective against the malaria parasite at the time but may no longer be used because of parasite drug resistance.
DATA COLLECTION AND ANALYSIS
Two review authors applied inclusion criteria, assessed risk of bias and extracted data. Dichotomous outcomes were compared using risk ratios (RR), and continuous outcomes using mean differences (MD); both are presented with 95% confidence intervals (CI). We assessed the quality of evidence using the GRADE approach.
MAIN RESULTS
Seventeen trials enrolling 14,481 pregnant women met our inclusion criteria. These trials were conducted between 1957 and 2008, in Nigeria (three trials), The Gambia (three trials), Kenya (three trials), Mozambique (two trials), Uganda (two trials), Cameroon (one trial), Burkina Faso (one trial), and Thailand (two trials). Six different antimalarials were evaluated against placebo or no intervention; chloroquine (given weekly), pyrimethamine (weekly or monthly), proguanil (daily), pyrimethamine-dapsone (weekly or fortnightly), and mefloquine (weekly), or intermittent preventive therapy with SP (given twice, three times or monthly). Trials recruited women in their first or second pregnancy (eight trials); only multigravid women (one trial); or all women (eight trials). Only six trials had adequate allocation concealment.For women in their first or second pregnancy, malaria chemoprevention reduces the risk of moderate to severe anaemia by around 40% (RR 0.60, 95% CI 0.47 to 0.75; three trials, 2503 participants, high quality evidence), and the risk of any anaemia by around 17% (RR 0.83, 95% CI 0.74 to 0.93; five trials,, 3662 participants, high quality evidence). Malaria chemoprevention reduces the risk of antenatal parasitaemia by around 61% (RR 0.39, 95% CI 0.26 to 0.58; seven trials, 3663 participants, high quality evidence), and two trials reported a reduction in febrile illness (low quality evidence). There were only 16 maternal deaths and these trials were underpowered to detect an effect on maternal mortality (very low quality evidence).For infants of women in their first and second pregnancies, malaria chemoprevention probably increases mean birthweight by around 93 g (MD 92.72 g, 95% CI 62.05 to 123.39; nine trials, 3936 participants, moderate quality evidence), reduces low birthweight by around 27% (RR 0.73, 95% CI 0.61 to 0.87; eight trials, 3619 participants, moderate quality evidence), and reduces placental parasitaemia by around 46% (RR 0.54, 95% CI 0.43 to 0.69; seven trials, 2830 participants, high quality evidence). Fewer trials evaluated spontaneous abortions, still births, perinatal deaths, or neonatal deaths, and these analyses were underpowered to detect clinically important differences.In multigravid women, chemoprevention has similar effects on antenatal parasitaemia (RR 0.38, 95% CI 0.28 to 0.50; three trials, 977 participants, high quality evidence)but there are too few trials to evaluate effects on other outcomes.In trials giving chemoprevention to all pregnant women irrespective of parity, the average effects of chemoprevention measured in all women indicated it may prevent severe anaemia (defined by authors, but at least < 8 g/L: RR 0.19, 95% CI 0.05 to 0.75; two trials, 1327 participants, low quality evidence), but consistent benefits have not been shown for other outcomes.In an analysis confined only to intermittent preventive therapy with SP, the estimates of effect and the quality of the evidence were similar.A summary of a single trial in Thailand of prophylaxis against P. vivax showed chloroquine prevented vivax infection (RR 0.01, 95% CI 0.00 to 0.20; one trial, 942 participants).
AUTHORS' CONCLUSIONS
Routine chemoprevention to prevent malaria and its consequences has been extensively tested in RCTs, with clinically important benefits on anaemia and parasitaemia in the mother, and on birthweight in infants.
Topics: Antimalarials; Female; Humans; Infant, Newborn; Malaria; Mosquito Control; Pregnancy; Pregnancy Complications, Parasitic; Randomized Controlled Trials as Topic
PubMed: 25300703
DOI: 10.1002/14651858.CD000169.pub3 -
Malaria Journal Nov 2013The purpose of the study was to compare the safety of artemether-lumefantrine (AL) with other artemisinin-based combinations in children. (Comparative Study)
Comparative Study Review
BACKGROUND
The purpose of the study was to compare the safety of artemether-lumefantrine (AL) with other artemisinin-based combinations in children.
METHODS
A search of EMBASE (from 1974 to April 2013), MEDLINE (from 1946 to April 2013) and the Cochrane library of registered controlled trials for randomized controlled trials (RCTs) which compared AL with other artemisinin-based combinations was done. Only studies involving children ≤ 17 years old in which safety of AL was an outcome measure were included.
RESULTS
Four thousand, seven hundred and twenty six adverse events (AEs) were recorded in 6,000 patients receiving AL. Common AEs (≥ 1/100 and <1/10) included: coryza, vomiting, anaemia, diarrhoea, vomiting and abdominal pain; while cough was the only very commonly reported AE (≥ 1/10). AL-treated children have a higher risk of body weakness (64.9%) than those on artesunate-mefloquine (58.2%) (p = 0.004, RR: 1.12 95% CI: 1.04-1.21). The risk of vomiting was significantly lower in patients on AL (8.8%) than artesunate-amodiaquine (10.6%) (p = 0.002, RR: 0.76, 95% CI: 0.63-0.90). Similarly, children on AL had a lower risk of vomiting (1.2%) than chlorproguanil-dapsone-artesunate (ACD) treated children (5.2%) (p = 0.002, RR: 0.63, 95% CI: 0.47-0.85). The risk of serious adverse events was significantly lower for AL (1.3%) than ACD (5.2%) (p = 0.002, RR: 0.45, 95% CI: 0.27-0.74).
CONCLUSION
Artemether-lumefantrine combination is as safe as ASAQ and DP for use in children. Common adverse events are cough and gastrointestinal symptoms. More studies comparing AL with artesunate-mefloquine and artesunate-azithromycin are needed to determine the comparative safety of these drugs.
Topics: Adolescent; Antimalarials; Artemether, Lumefantrine Drug Combination; Artemisinins; Child; Child, Preschool; Cough; Drug Combinations; Drug-Related Side Effects and Adverse Reactions; Dyspepsia; Ethanolamines; Fluorenes; Humans; Infant; Infant, Newborn; Randomized Controlled Trials as Topic
PubMed: 24175945
DOI: 10.1186/1475-2875-12-385 -
Der Hautarzt; Zeitschrift Fur... Sep 2013In November 2012, the 4th International Consensus Meeting on Urticaria ("URTICARIA 2012") took place in Berlin with more than 300 participants. The international and the... (Review)
Review
[Diagnosis and therapy of chronic urticaria-what is expected from the revision and update of the international guidelines? A report of the public consensus conference "URTICARIA 2012"].
In November 2012, the 4th International Consensus Meeting on Urticaria ("URTICARIA 2012") took place in Berlin with more than 300 participants. The international and the German guidelines for the definition, classification, diagnosis and management of urticaria are currently being developed based on this meeting. At the time of publication of this article, the guidelines are in the final process of international coordination. The previous international guidelines were updated based on prepared questions as well as a systematic review of the literature by an expert panel. The individual aspects were then discussed with all participants and decided upon, based on the Delphi method with general discussion and open poll. Here, at least a 75 % agreement was required. The new consensus modifies the previous international guidelines on classification and diagnosis and especially on therapy. The treatment algorithm has been changed to a three step approach. The first step is a second generation H1 antihistamine in standard dosage. The second step is increasing the dose up to 4 times the standard dose. In the third step, additional treatment with omalizumab, cyclosporine A or montelukast is recommended as well as possibly systemic corticosteroids for a maximum of 7-10 days. H2 antihistamines and dapsone, which were included in the previous guideline as standard therapies, are no longer recommended for use by the updated and revised guidelines.
Topics: Allergy and Immunology; Chronic Disease; Dermatology; Histamine H1 Antagonists; Humans; Immunologic Factors; Internationality; Practice Guidelines as Topic; Urticaria
PubMed: 24022627
DOI: 10.1007/s00105-013-2628-8 -
The British Journal of Dermatology Feb 2013Hidradenitis suppurativa (HS) is a difficult disease to treat. Although the pathogenesis of this inflammatory skin disease is largely unknown, the important role of the... (Review)
Review
Hidradenitis suppurativa (HS) is a difficult disease to treat. Although the pathogenesis of this inflammatory skin disease is largely unknown, the important role of the immune system has been demonstrated in both experimental and clinical studies. Clinicians are therefore increasingly prescribing systemic treatments with immunosuppressive agents, but the more traditionally used systemic retinoids, especially isotretinoin, also remain relatively common therapies. In order to provide an overview of all currently available systemic immunosuppressive agents and retinoids for the treatment of HS, a systematic search was performed using the Medline and Embase databases. All published papers concerning systemic retinoids or immunosuppressive treatments for HS in adults were included. The primary endpoints were the percentages of significant responders, moderate responders and nonresponders. Other endpoints were the relapse rate and adverse events. In total 87 papers were included, comprising 518 patients with HS who were treated with systemic retinoids, biological agents or another immunosuppressive agents, including colchicine, ciclosporin, dapsone or methotrexate. The highest response rates were observed with infliximab, adalimumab and acitretin. Overall, the quality of evidence was low and differed between the agents, making direct comparisons difficult. However, based on the amount of evidence, infliximab and adalimumab were the most effective agents. Acitretin was also effective in HS, although the quality of the evidence was low. The therapeutic effect of isotretinoin is questionable. Randomized controlled trials are needed to confirm the effectiveness of acitretin, and to identify the most effective immunosuppressive agents in HS.
Topics: Adult; Aged; Biological Products; Dermatologic Agents; Evidence-Based Medicine; Hidradenitis Suppurativa; Humans; Immunosuppressive Agents; Middle Aged; Retinoids; Treatment Outcome; Young Adult
PubMed: 23106519
DOI: 10.1111/bjd.12104 -
Acta Dermato-venereologica Mar 2012Dapsone is widely used in the treatment of leprosy and several chronic inflammatory dermatological conditions. Hypersensitivity reactions to dapsone are potentially... (Review)
Review
Dapsone is widely used in the treatment of leprosy and several chronic inflammatory dermatological conditions. Hypersensitivity reactions to dapsone are potentially fatal adverse drug reactions with unknown prevalence and risk factors. We performed a systematic review covering all reported cases of hypersensitivity reactions, in order to systematically summarize the published evidence on prevalence, clinical course and fatality rate. Articles were identified through standardized search strategies. Included studies were reviewed for hypersensitivity characteristics and odds ratios were calculated in univariate and multivariate regression models to assess the risk factors for fatal outcome. A total of 114 articles (17 epidemiological studies, 97 case reports) totalling 336 patients with hypersensitivity reactions were included for analysis. From the epidemiological studies a total hypersensitivity reaction prevalence rate of 1.4% (95% confidence interval 1.2–1.7%) was determined. Mucosal involvement, hepatitis, higher age and disease occurrence in non-affluent countries were associated with higher risk of fatal outcome. Overall, the fatality rate was 9.9%.
Topics: Dapsone; Drug Eruptions; Humans; Leprostatic Agents; Prevalence; Risk Factors
PubMed: 22307940
DOI: 10.2340/00015555-1268 -
Annales de Dermatologie Et de... Mar 2011Mucous membrane pemphigoid is a rare autoimmune bullous disorder. Numerous treatment regimens have been proposed in the literature. (Review)
Review
BACKGROUND
Mucous membrane pemphigoid is a rare autoimmune bullous disorder. Numerous treatment regimens have been proposed in the literature.
OBJECTIVE
To assess the efficacy and tolerance of treatment regimens proposed in mucous membrane pemphigoid (MMP), from a systematic review of the literature.
METHODS
Randomized control trials have been identified using the PubMed and Embase databases up to April 2009. Uncontrolled prospective and retrospective studies have also been analyzed.
RESULTS
Literature analysis confirms that clinical and therapeutic trials are very uncommon in MMP; only retrospective series or case reports are available and have been analyzed. Therefore, the level of evidence is usually weak. Twenty-four series have been analyzed in this review. Dapsone remains the first line treatment in non-ocular forms of MMP. Sulfasalazine or cyclins can be used when dapsone is not tolerated or effective. Corticosteroids can be used to control inflammatory flares of the disease. Immunosuppressants are not used as the first line of treatment and can be added to anti-inflammatory drugs for a better control of MMP. Cyclophophamide or mycophenolate mofetil can be used, especially in the elderly. In ocular forms of the disease, the severity and chronicity of ocular involvement is the main therapeutical target. Non-scarring conjunctivitis can be treated by dapsone monotherapy. Ocular flares of the disease can be treated with systemic corticosteroids or cyclophosphamide. Many immunomodulating drugs are under evaluation. Intravenous immunoglobulins, etanercept or rituximab can be proposed when cyclophosphamide is not able to control the disease.
CONCLUSION
Data from the literature did not allow identifying the best therapeutic regimen, mainly because of the lack of prospective comparative studies. Dapsone remains the first line treatment in MMP. Immunosuppressive or immunomodulating drugs should be discussed patient by patient.
Topics: Anti-Inflammatory Agents; Antibodies, Monoclonal; Combined Modality Therapy; Dapsone; Drug Therapy, Combination; Evidence-Based Medicine; Humans; Immunoglobulins, Intravenous; Immunosuppressive Agents; Immunotherapy; Multicenter Studies as Topic; Pemphigoid, Benign Mucous Membrane; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies
PubMed: 21397149
DOI: 10.1016/j.annder.2011.01.012 -
Annales de Dermatologie Et de... Mar 2011Pemphigus is a rare autoimmune bullous disorder. Numerous treatment regimens have been proposed in the literature. (Review)
Review
BACKGROUND
Pemphigus is a rare autoimmune bullous disorder. Numerous treatment regimens have been proposed in the literature.
OBJECTIVE
To assess the efficacy and tolerance of treatment regimens proposed in pemphigus vulgaris (PV) and pemphigus foliaceus (PF), from a systematic review of the literature.
METHODS
Randomized control trials have been identified using the PubMed and Embase databases up to April 2009. Uncontrolled prospective and retrospective studies have also been analyzed.
RESULTS
Eleven randomized control trials having included a total number of 421 patients (377 PV, 44 PF) have been analyzed. Most studies had a limited statistical power due to the rather low number of cases included. Results from ten different treatment regimens have been analyzed: different dosages of prednisone and prednisolone, pulse intravenous dexamethasone, azathioprine, cyclophosphamide, cyclosporine, dapsone, mycophenolate mofetil, plasmapheresis, topical applications of epidermal growth factor (EGF), and intravenous immune globulins (IVIG). Inclusion criteria were: (i) consecutive patients in nine studies, (ii) patients who did not respond to low doses of corticosteroids in one study, and (iii) patients with relapsing type of pemphigus in one study. None of these studies allowed identifying the best effective and well tolerated regimen. Mycophenolate mofetil was more effective than azathioprine for disease control (from one study; n=40; OR=0.72; 95% CI=0.52-0.99). However, no difference in the rate of clinical remission was evidenced between these drugs. Azathioprine and cyclophosphamide seem to have a corticosteroid sparing effect.
CONCLUSION
Data from the literature did not allow identifying the best therapeutic regimen, mainly because of the lack of statistical power of most studies. The usefulness of immunosuppressant added to systemic corticosteroids as the first line of treatment is not clearly established.
Topics: Adrenal Cortex Hormones; Combined Modality Therapy; Drug Therapy, Combination; Epidermal Growth Factor; Gold Compounds; Humans; Immunoglobulins, Intravenous; Immunosuppressive Agents; Meta-Analysis as Topic; Multicenter Studies as Topic; Niacinamide; Paraneoplastic Syndromes; Pemphigus; Plasma Exchange; Prospective Studies; Randomized Controlled Trials as Topic; Recurrence; Retrospective Studies; Tetracycline
PubMed: 21397148
DOI: 10.1016/j.annder.2011.01.016 -
Journal of the American Academy of... May 2011A range of interventions has been described for the treatment of pemphigus; however, the optimal therapeutic strategy has not been established. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A range of interventions has been described for the treatment of pemphigus; however, the optimal therapeutic strategy has not been established.
OBJECTIVE
We sought to evaluate the safety and efficacy of interventions for pemphigus vulgaris and pemphigus foliaceus.
METHODS
We undertook a systematic review and meta-analysis according to the methodology of the Cochrane Collaboration. We selected randomized controlled trials including participants with the diagnosis of pemphigus vulgaris or pemphigus foliaceus confirmed with clinical, histopathological, and immunofluorescence criteria. All interventions were considered. Primary outcomes studied were remission and mortality. Secondary outcomes included disease control, relapse, pemphigus severity score, time to disease control, cumulative glucocorticoid dose, serum antibody titers, adverse events, and quality of life.
RESULTS
Eleven studies with a total of 404 participants were identified. Interventions assessed included prednisolone dose regimen, pulsed dexamethasone, azathioprine, cyclophosphamide, cyclosporine, dapsone, mycophenolate, plasma exchange, topical epidermal growth factor, and traditional Chinese medicine. We found some interventions to be superior for certain outcomes, although we were unable to conclude which treatments are superior overall.
LIMITATIONS
Many interventions for pemphigus have not been evaluated in controlled trials. All studies were insufficiently powered to establish definitive results.
CONCLUSIONS
There is inadequate evidence available at present to ascertain the optimal therapy for pemphigus vulgaris and pemphigus foliaceus. Further randomized controlled trials are required.
Topics: Azathioprine; Cyclophosphamide; Epidermal Growth Factor; Glucocorticoids; Humans; Immunosuppressive Agents; Mycophenolic Acid; Pemphigus; Randomized Controlled Trials as Topic; Remission Induction; Treatment Outcome
PubMed: 21353333
DOI: 10.1016/j.jaad.2010.04.039 -
Revista Panamericana de Salud Publica =... Oct 2009To identify and summarize randomized clinical trials (RCTs) that assessed the effectiveness of chemoprophylaxis to prevent leprosy in contacts of patients newly... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To identify and summarize randomized clinical trials (RCTs) that assessed the effectiveness of chemoprophylaxis to prevent leprosy in contacts of patients newly diagnosed with the disease.
METHODS
All studies were extracted from Medline (PubMed 1966 to November 2008), the Cochrane Controlled Trials Register (number 3 2008), LILACS (1982 to November 2008), and Scirus (November 2008). Manual searches and searches of crossed references of assessed articles were also done. RCTs' risk of bias was assessed according to the methodology proposed by the Cochrane Collaboration. The main outcome measure was diagnosis of leprosy (secondary cases) in contacts of patients with the disease (primary cases).
RESULTS
The search identified 320 references, from which 7 RCTs with a total of 66 311 participants were included and evaluated. The combined results from the RCTs favored chemoprophylaxis to placebo with 2-4 years of follow-up (6 RCTs, 66 107 participants, relative risk (RR) 0.59, 95% confidence interval (CI) 0.50-0.70, I(2) = 0 (I(2) describes percent total variation across studies caused by heterogeneity)). Single-dose rifampicin (21 711 participants, RR 0.43, 95% CI 0.28-0.67, number needed to treat 285), dapsone once or twice weekly for at least 2 years (3 RCTs, 43 137 participants, RR 0.60, 95% CI 0.48-0.76, I(2) = 0), and acedapsone every 10 weeks for 7 months (2 RCTs, 1 259 participants, RR 0.49, 95% CI 0.33-0.72, I(2) = 0) were significantly superior to placebo in preventing secondary cases of leprosy.
CONCLUSION
Chemoprophylaxis is effective in lowering the incidence of leprosy in contacts of patients diagnosed with the disease.
Topics: Chemoprevention; Humans; Leprosy; Randomized Controlled Trials as Topic
PubMed: 20107683
DOI: 10.1590/s1020-49892009001000009 -
BMJ Clinical Evidence Jul 2010Malaria transmission occurs most frequently in environments with humidity greater than 60% and ambient temperature of 25 °C to 30 °C. Risks increase with longer... (Review)
Review
INTRODUCTION
Malaria transmission occurs most frequently in environments with humidity greater than 60% and ambient temperature of 25 °C to 30 °C. Risks increase with longer visits and depend on activity. Infection can follow a single mosquito bite. Incubation is usually 10 to 14 days but can be up to 18 months depending on the strain of parasite.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-drug preventive interventions in non-pregnant adult travellers? What are the effects of drug prophylaxis in non-pregnant adult travellers? What are the effects of antimalaria vaccines in adult and child travellers? What are the effects of antimalaria interventions in child travellers, pregnant travellers, and in airline pilots? We searched: Medline, Embase, The Cochrane Library, and other important databases up to November 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 79 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: aerosol insecticides, amodiaquine, air conditioning and electric fans, atovaquone-proguanil, biological control measures, chloroquine (alone or with proguanil), diethyltoluamide (DEET), dietary supplementation, doxycycline, electronic mosquito repellents, full-length and light-coloured clothing, insecticide-treated clothing/nets, mefloquine, mosquito coils and vapourising mats, primaquine, pyrimethamine-dapsone, pyrimethamine-sulfadoxine, smoke, topical (skin-applied) insect repellents, and vaccines.
Topics: Antimalarials; Bedding and Linens; Chloroquine; Humans; Malaria; Mefloquine; Primaquine; Travel
PubMed: 21418669
DOI: No ID Found