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The Cochrane Database of Systematic... Nov 2015Food allergy is an abnormal immunological response following exposure (usually ingestion) to a food. Elimination of the allergen is the principle treatment for food... (Review)
Review
BACKGROUND
Food allergy is an abnormal immunological response following exposure (usually ingestion) to a food. Elimination of the allergen is the principle treatment for food allergy, including allergy to fruit. Accidental ingestion of allergenic foods can result in severe anaphylactic reactions. Allergen-specific immunotherapy (SIT) is a specific treatment, when the avoidance of allergenic foods is problematic. Recently, studies have been conducted on different types of immunotherapy for the treatment of food allergy, including oral (OIT) and sublingual immunotherapy (SLIT).
OBJECTIVES
To determine the efficacy and safety of oral and sublingual immunotherapy in children and adults with food allergy to fruits, when compared with placebo or an elimination strategy.
SEARCH METHODS
The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, and AMED were searched for published results along with trial registries and the Journal of Negative Results in BioMedicine for grey literature. The date of the most recent search was July 2015.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing OIT or SLIT with placebo or an elimination diet were included. Participants were children or adults diagnosed with food allergy who presented immediate fruit reactions.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by the Cochrane Collaboration. We assessed treatment effect through risk ratios (RRs) for dichotomous outcomes.
MAIN RESULTS
We identified two RCTs (N=89) eligible for inclusion. These RCTs addressed oral or sublingual immunotherapy, both in adults, with an allergy to apple or peach respectively. Both studies enrolled a small number of participants and used different methods to provide these differing types of immunotherapy. Both studies were judged to be at high risk of bias in at least one domain. Overall, the quality of evidence was judged to be very low due to the small number of studies and participants and possible bias. The studies were clinically heterogeneous and hence we did not pool the results. A study comparing SLIT with placebo for allergy to peach did not detect a significant difference between the number of patients desensitised at six months following a double-blind placebo-controlled food challenge (RR 1.16, 95% confidence interval (CI) 0.49 to 2.74). The second study, comparing OIT versus no treatment for apple allergy, found an effect on desensitisation in favour of the intervention using an oral provocation test at eight months, but results were imprecise (RR 17.50, 95% CI 1.13 to 270.19). Neither study reported data on evidence of immunologic tolerance. In both studies, the incidence of mild and moderate adverse events was higher in the intervention groups than in the controls. In the study comparing SLIT with placebo, patients in the intervention group experienced significantly more local adverse reactions than participants in the control group (RR 3.21, 95% CI 1.51 to 6.82), though there was not a significant difference in the number of participants experiencing systemic adverse reactions (RR 0.81, 95% CI 0.22 to 3.02). In the study of OIT, two of the 25 participants in the intervention group reported relevant side effects, whereas no participants in the control group reported relevant side effects.
AUTHORS' CONCLUSIONS
There is insufficient evidence for using OIT or SLIT to treat allergy to fruit, specifically related to peach and apple. Mild or moderate adverse reactions were reported more frequently in people receiving OIT or SLIT. However, these reactions could be treated successfully with medications.
Topics: Adult; Desensitization, Immunologic; Food Hypersensitivity; Fruit; Humans; Malus; Pyrus; Randomized Controlled Trials as Topic; Sublingual Immunotherapy
PubMed: 26558953
DOI: 10.1002/14651858.CD010522.pub2 -
The Cochrane Database of Systematic... Aug 2015Asthma is a common long-term respiratory disease affecting approximately 300 million people worldwide. Approximately half of people with asthma have an important... (Review)
Review
BACKGROUND
Asthma is a common long-term respiratory disease affecting approximately 300 million people worldwide. Approximately half of people with asthma have an important allergic component to their disease, which may provide an opportunity for targeted treatment. Sublingual immunotherapy (SLIT) aims to reduce asthma symptoms by delivering increasing doses of an allergen (e.g. house dust mite, pollen extract) under the tongue to induce immune tolerance. However, it is not clear whether the sublingual delivery route is safe and effective in asthma.
OBJECTIVES
To assess the efficacy and safety of sublingual immunotherapy compared with placebo or standard care for adults and children with asthma.
SEARCH METHODS
We identified trials from the Cochrane Airways Group Specialised Register (CAGR), ClinicalTrials.gov (www.ClinicalTrials.gov), the World Health Organization (WHO) trials portal (www.who.int/ictrp/en/) and reference lists of all primary studies and review articles. The search is up to date as of 25 March 2015.
SELECTION CRITERIA
We included parallel randomised controlled trials (RCTs), irrespective of blinding or duration, that evaluated sublingual immunotherapy versus placebo or as an add-on to standard asthma management. We included both adults and children with asthma of any severity and with any allergen-sensitisation pattern. We included studies that recruited participants with asthma, rhinitis, or both, providing at least 80% of trial participants had a diagnosis of asthma.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the search results for included trials, extracted numerical data and assessed risk of bias, all of which were cross-checked for accuracy. We resolved disagreements by discussion.We analysed dichotomous data as odds ratios (ORs) or risk differences (RDs) using study participants as the unit of analysis; we analysed continuous data as mean differences (MDs) or standardised mean differences (SMDs) using random-effects models. We rated all outcomes using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) and presented results in the 'Summary of findings' table.
MAIN RESULTS
Fifty-two studies met our inclusion criteria, randomly assigning 5077 participants to comparisons of interest. Most studies were double-blind and placebo-controlled, but studies varied in duration from one day to three years. Most participants had mild or intermittent asthma, often with co-morbid allergic rhinitis. Eighteen studies recruited only adults, 25 recruited only children and several recruited both or did not specify (n = 9).With the exception of adverse events, reporting of outcomes of interest to this review was infrequent, and selective reporting may have had a serious effect on the completeness of the evidence. Allocation procedures generally were not well described, about a quarter of the studies were at high risk of bias for performance or detection bias or both and participant attrition was high or unknown in around half of the studies.One short study reported exacerbations requiring a hospital visit and observed no adverse events. Five studies reported quality of life, but the data were not suitable for meta-analysis. Serious adverse events were infrequent, and analysis using risk differences suggests that no more than 1 in 100 are likely to suffer a serious adverse event as a result of treatment with SLIT (RD 0.0012, 95% confidence interval (CI) -0.0077 to 0.0102; participants = 2560; studies = 22; moderate-quality evidence).Within secondary outcomes, wide but varied reporting of largely unvalidated asthma symptom and medication scores precluded meaningful meta-analysis; a general trend suggested SLIT benefit over placebo, but variation in scales meant that results were difficult to interpret.Changes in inhaled corticosteroid use in micrograms per day (MD 35.10 mcg/d, 95% CI -50.21 to 120.42; low-quality evidence), exacerbations requiring oral steroids (studies = 2; no events) and bronchial provocation (SMD 0.69, 95% CI -0.04 to 1.43; very low-quality evidence) were not often reported. This led to many imprecise estimates with wide confidence intervals that included the possibility of both benefit and harm from SLIT.More people taking SLIT had adverse events of any kind compared with control (OR 1.70, 95% CI 1.21 to 2.38; low-quality evidence; participants = 1755; studies = 19), but events were usually reported to be transient and mild.Lack of data prevented most of the planned subgroup and sensitivity analyses.
AUTHORS' CONCLUSIONS
Lack of data for important outcomes such as exacerbations and quality of life and use of different unvalidated symptom and medication scores have limited our ability to draw a clinically useful conclusion. Further research using validated scales and important outcomes for patients and decision makers is needed so that SLIT can be properly assessed as clinical treatment for asthma. Very few serious adverse events have been reported, but most studies have included patients with intermittent or mild asthma, so we cannot comment on the safety of SLIT for those with moderate or severe asthma. SLIT is associated with increased risk of all adverse events.
Topics: Adult; Animals; Asthma; Child; Humans; Pollen; Pyroglyphidae; Randomized Controlled Trials as Topic; Sublingual Immunotherapy
PubMed: 26315994
DOI: 10.1002/14651858.CD011293.pub2 -
The Cochrane Database of Systematic... Jan 2015Acne is a chronic skin disease characterised by inflamed spots and blackheads on the face, neck, back, and chest. Cysts and scarring can also occur, especially in more... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Acne is a chronic skin disease characterised by inflamed spots and blackheads on the face, neck, back, and chest. Cysts and scarring can also occur, especially in more severe disease. People with acne often turn to complementary and alternative medicine (CAM), such as herbal medicine, acupuncture, and dietary modifications, because of their concerns about the adverse effects of conventional medicines. However, evidence for CAM therapies has not been systematically assessed.
OBJECTIVES
To assess the effects and safety of any complementary therapies in people with acne vulgaris.
SEARCH METHODS
We searched the following databases from inception up to 22 January 2014: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2014,Issue 1), MEDLINE (from 1946), Embase (from 1974), PsycINFO (from 1806), AMED (from 1985), CINAHL (from 1981), Scopus (from 1966), and a number of other databases listed in the Methods section of the review. The Cochrane CAM Field Specialised Register was searched up to May 2014. We also searched five trials registers and checked the reference lists of articles for further references to relevant trials.
SELECTION CRITERIA
We included parallel-group randomised controlled trials (or the first phase data of randomised cross-over trials) of any kind of CAM, compared with no treatment, placebo, or other active therapies, in people with a diagnosis of acne vulgaris.
DATA COLLECTION AND ANALYSIS
Three authors collected data from each included trial and evaluated the methodological quality independently. They resolved disagreements by discussion and, as needed, arbitration by another author.
MAIN RESULTS
We included 35 studies, with a total of 3227 participants. We evaluated the majority as having unclear risk of selection, attrition, reporting, detection, and other biases. Because of the clinical heterogeneity between trials and the incomplete data reporting, we could only include four trials in two meta-analyses, with two trials in each meta-analysis. The categories of CAM included herbal medicine, acupuncture, cupping therapy, diet, purified bee venom (PBV), and tea tree oil. A pharmaceutical company funded one trial; the other trials did not report their funding sources.Our main primary outcome was 'Improvement of clinical signs assessed through skin lesion counts', which we have reported as 'Change in inflammatory and non-inflammatory lesion counts', 'Change of total skin lesion counts', 'Skin lesion scores', and 'Change of acne severity score'. For 'Change in inflammatory and non-inflammatory lesion counts', we combined 2 studies that compared a low- with a high-glycaemic-load diet (LGLD, HGLD) at 12 weeks and found no clear evidence of a difference between the groups in change in non-inflammatory lesion counts (mean difference (MD) -3.89, 95% confidence interval (CI) -10.07 to 2.29, P = 0.10, 75 participants, 2 trials, low quality of evidence). However, although data from 1 of these 2 trials showed benefit of LGLD for reducing inflammatory lesions (MD -7.60, 95% CI -13.52 to -1.68, 43 participants, 1 trial) and total skin lesion counts (MD -8.10, 95% CI -14.89 to -1.31, 43 participants, 1 trial) for people with acne vulgaris, data regarding inflammatory and total lesion counts from the other study were incomplete and unusable in synthesis.Data from a single trial showed potential benefit of tea tree oil compared with placebo in improving total skin lesion counts (MD -7.53, 95% CI -10.40 to -4.66, 60 participants, 1 trial, low quality of evidence) and acne severity scores (MD -5.75, 95% CI -9.51 to -1.99, 60 participants, 1 trial). Another trial showed pollen bee venom to be better than control in reducing numbers of skin lesions (MD -1.17, 95% CI -2.06 to -0.28, 12 participants, 1 trial).Results from the other 31 trials showed inconsistent effects in terms of whether acupuncture, herbal medicine, or wet-cupping therapy were superior to controls in increasing remission or reducing skin lesions.Twenty-six of the 35 included studies reported adverse effects; they did not report any severe adverse events, but specific included trials reported mild adverse effects from herbal medicines, wet-cupping therapy, and tea tree oil gel.Thirty trials measured two of our secondary outcomes, which we combined and expressed as 'Number of participants with remission'. We were able to combine 2 studies (low quality of evidence), which compared Ziyin Qinggan Xiaocuo Granule and the antibiotic, minocycline (100 mg daily) (worst case = risk ratio (RR) 0.49, 95% CI 0.09 to 2.53, 2 trials, 206 participants at 4 weeks; best case = RR 2.82, 95% CI 0.82 to 9.06, 2 trials, 206 participants at 4 weeks), but there was no clear evidence of a difference between the groups.None of the included studies assessed 'Psychosocial function'.Two studies assessed 'Quality of life', and significant differences in favour of the complementary therapy were found in both of them on 'feelings of self-worth' (MD 1.51, 95% CI 0.88 to 2.14, P < 0.00001, 1 trial, 70 participants; MD 1.26, 95% CI 0.20 to 2.32, 1 trial, 46 participants) and emotional functionality (MD 2.20, 95% CI 1.75 to 2.65, P < 0.00001, 1 trial, 70 participants; MD 0.93, 95% CI 0.17 to 1.69, 1 trial, 46 participants).Because of limitations and concerns about the quality of the included studies, we could not draw a robust conclusion for consistency, size, and direction of outcome effects in this review.
AUTHORS' CONCLUSIONS
There is some low-quality evidence from single trials that LGLD, tea tree oil, and bee venom may reduce total skin lesions in acne vulgaris, but there is a lack of evidence from the current review to support the use of other CAMs, such as herbal medicine, acupuncture, or wet-cupping therapy, for the treatment of this condition. There is a potential for adverse effects from herbal medicines; however, future studies need to assess the safety of all of these CAM therapies. Methodological and reporting quality limitations in the included studies weakened any evidence. Future studies should be designed to ensure low risk of bias and meet current reporting standards for clinical trials.
Topics: Acne Vulgaris; Acupuncture Points; Acupuncture Therapy; Bee Venoms; Complementary Therapies; Humans; Plant Preparations; Quality of Life; Selection Bias; Tea Tree Oil; Treatment Outcome
PubMed: 25597924
DOI: 10.1002/14651858.CD009436.pub2 -
PloS One 2014Recently, new palaeoecological records supported by molecular analyses and palaeodistributional modelling have provided more comprehensive insights into plant behaviour... (Review)
Review
BACKGROUND/AIMS
Recently, new palaeoecological records supported by molecular analyses and palaeodistributional modelling have provided more comprehensive insights into plant behaviour during the last Quaternary cycle. We reviewed the migration history of species of subgenus Alnus during the last 50,000 years in Europe with a focus on (1) a general revision of Alnus history since the Last Glacial Maximum (LGM), (2) evidence of northern refugia of Alnus populations during the LGM and (3) the specific history of Alnus in particular European regions.
METHODOLOGY
We determined changes in Alnus distribution on the basis of 811 and 68 radiocarbon-dated pollen and macrofossil sites, respectively. We compiled data from the European Pollen Database, the Czech Quaternary Palynological Database, the Eurasian Macrofossil Database and additional literature. Pollen percentage thresholds indicating expansions or retreats were used to describe patterns of past Alnus occurrence.
PRINCIPAL FINDINGS
An expansion of Alnus during the Late Glacial and early Holocene periods supports the presence of alders during the LGM in southern peninsulas and northerly areas in western Europe, the foothills of the Alps, the Carpathians and northeastern Europe. After glaciers withdrew, the ice-free area of Europe was likely colonized from several regional refugia; the deglaciated area of Scandinavia was likely colonized from a single refugium in northeastern Europe. In the more northerly parts of Europe, we found a scale-dependent pattern of Alnus expansion characterised by a synchronous increase of Alnus within individual regions, though with regional differences in the times of the expansion. In southern peninsulas, the Alps and the Carpathians, by contrast, it seems that Alnus expanded differently at individual sites rather than synchronously in whole regions.
CONCLUSIONS
Our synthesis supports the idea that northern LGM populations were important sources of postglacial Alnus expansion. The delayed Alnus expansion apparent in some regions was likely a result of environmental limitations.
Topics: Alnus; Carbon Radioisotopes; Demography; Europe; Geography; Paleontology; Pollen
PubMed: 24586374
DOI: 10.1371/journal.pone.0088709 -
The Cochrane Database of Systematic... Apr 2012Allergic rhinitis is a disorder of the nasal membranes and surrounding tissues, and a worldwide cause of illness and disability. Helminths are complex tissue-dwelling or... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Allergic rhinitis is a disorder of the nasal membranes and surrounding tissues, and a worldwide cause of illness and disability. Helminths are complex tissue-dwelling or lumen-dwelling organisms that inhabit larger organisms and are frequently asymptomatic. Helminths modulate the natural immune responses of their human hosts, and may prevent or cure immune-mediated or allergic diseases (e.g. allergic rhinitis) in the host. Non-randomised studies support this hypothesis.
OBJECTIVES
To assess the safety and effectiveness of helminth therapy in people with allergic rhinitis.
SEARCH METHODS
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 24 June 2011.
SELECTION CRITERIA
All randomised controlled trials where the intervention was any helminth species or combination of helminth species, administered to people with allergic rhinitis in any dose, by any route and for any duration of exposure. We accepted both intermittent and persistent allergic rhinitis patients.
DATA COLLECTION AND ANALYSIS
We independently extracted data and assessed eligibility and risk of bias using a standardised data collection form. We resolved any disagreement through discussion. We combined dichotomous data using risk ratio (RR) and continuous data using mean difference (MD), presenting both with 95% confidence intervals (CI).
MAIN RESULTS
We found five reports of two single-centre, placebo-controlled, double-blinded studies (130 participants). Participants in both studies were a mix of adults with either intermittent or persistent allergic rhinitis. Both studies had a low risk of bias. One study, with 12 weeks' follow-up, used a single percutaneous application of 10 Necator americanus (i.e. human hookworm) larvae. The other study, with 24 weeks' follow-up, used three-weekly oral dosing with 2500 Trichuris suis (i.e. pig whipworm) eggs in aqueous suspension. Of 17 outcomes evaluated in this review, eight were positive (i.e. favoured helminths). Participants taking helminths had no reduction in allergic rhinitis symptoms, percentage of well days (i.e. days with minimal symptoms and no use of medication for allergic rhinitis), lung function measures and quality of life scores. Total use of medication for allergic rhinitis (eye drops, nasal sprays, tablets) did not change; however, in the helminth group there was a statistically significant reduction in the percentage of days during the grass pollen season when participants needed to take tablets as rescue medication for their allergic rhinitis symptoms (MD -14.0%, 95% CI -26.6 to -1.40); in a typical 60-day pollen season this 14% reduction translates into 19 days when tablets would be needed in the helminth group versus 27 days when tablets would be needed in the placebo group. Participants taking helminths percutaneously (i.e. as hookworm larvae) had local skin itching and redness in the first few days after administration. Participants taking helminths were more likely to report any gastrointestinal adverse event (RR 1.79, 95% CI 1.31 to 2.45), moderate or severe abdominal pain (RR 7.67, 95% CI 1.87 to 31.57), moderate or severe flatulence (RR 2.01, 95% CI 1.06 to 3.81) and moderate or severe diarrhoea (RR 1.99, 95% CI 1.18 to 3.37). There was no difference between the helminth and placebo groups in the incidence of serious adverse events, and in study withdrawals.
AUTHORS' CONCLUSIONS
There is currently insufficient evidence on the efficacy, tolerability and likely costs of helminth therapy to support its use in the routine management of allergic rhinitis. Administered to humans in carefully measured doses, helminths appear to be safe. More preclinical studies should be performed, before larger and extended duration trials of helminths for allergic rhinitis are carried out. Future studies should collect and report comparative data on the costs of helminth therapy versus conventional pharmacotherapy.
Topics: Adult; Ancylostomatoidea; Animals; Helminths; Humans; Immunotherapy; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Trichuris
PubMed: 22513973
DOI: 10.1002/14651858.CD009238.pub2 -
BMJ Clinical Evidence Aug 2011Lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) and bladder outlet obstruction may affect up to 30% of men in their early 70s. Symptoms can... (Review)
Review
INTRODUCTION
Lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) and bladder outlet obstruction may affect up to 30% of men in their early 70s. Symptoms can improve without treatment, but the usual course is a slow progression of symptoms, with acute urinary retention occurring in 1% to 2% of men with BPH per year.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of medical, herbal, and surgical treatments? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 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 63 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: 5 alpha-reductase inhibitors, alpha-blockers, beta-sitosterol plant extract, Pygeum africanum, rye grass pollen extract, saw palmetto plant extracts, transurethral electrovaporisation, transurethral Holmium laser enucleation of the prostate, transurethral microwave thermotherapy, transurethral needle ablation, and transurethral resection (including transurethral resection versus transurethral incision, and transurethral resection versus visual laser ablation/laser vaporisation).
Topics: Acute Disease; Adrenergic alpha-Antagonists; Cholestenone 5 alpha-Reductase; Evidence-Based Medicine; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Transurethral Resection of Prostate; Urinary Retention
PubMed: 21871136
DOI: No ID Found -
The Cochrane Database of Systematic... May 2011Benign prostatic hyperplasia (BPH), nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The... (Review)
Review
BACKGROUND
Benign prostatic hyperplasia (BPH), nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH has been growing steadily. Cernilton, prepared from the rye-grass pollen Secale cereale, is one of the several phytotherapeutic agents available for the treatment of BPH.
OBJECTIVES
This systematic review aims to assess the effects of Cernilton on urinary symptoms and flow measures in men with benign prostatic hyperplasia (BPH).
SEARCH STRATEGY
Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers.
SELECTION CRITERIA
Trials were eligible if they were: (1) randomized controlled trials or controlled clinical trials comparing Cernilton with placebo or other BPH medications in men with BPH; and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements.
DATA COLLECTION AND ANALYSIS
Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. Main outcome measure for comparing the effects of Cernilton with placebo and standard BPH medications were the change in urologic symptoms scales. Secondary outcomes included changes in nocturia as well as urodynamic measures (peak and mean urine flow, residual volume, prostate size). Main outcome measure for side effects was the number of men reporting side effects.
MAIN RESULTS
Four hundred forty-four men were enrolled in two placebo-controlled and two comparative trials lasting from 12 to 24 weeks. Three studies used a double-blind method although treatment allocation concealment was unclear in all. Cernilton improved "self rated urinary symptoms" (percent reporting satisfactory or improving symptoms) versus placebo and Tadenan. The weighted risk ratio (RR) for self-rated improvement versus placebo was 2.40 (95% CI = 1.21 to 4.75), and the weighted RR versus Tadenan was 1.42 (95% CI = 1.21 to 4.75). Cernilton reduced nocturia compared with placebo and Paraprost. Versus placebo, the weighted RR was 2.05 (95% CI = 1.41 to 3.00), and versus Paraprost, the WMD was -0.40 times per evening (95% CI = -0.73 to -0.07). Cernilton was not more effective than placebo or the comparative study agents in improving urinary flow rates, residual volume or prostate size. Adverse events were rare and mild. The withdrawal rate for Cernilton was 4.8% compared to 2.7% for placebo and 5.2% for Paraprost.
AUTHORS' CONCLUSIONS
The Cernilton trials analyzed were limited by short duration, limited number of enrollees, gaps in reported outcomes, and unknown quality of the preparations utilized. The comparative trials lacked a proven active control. The available evidence suggests Cernilton is well tolerated and modestly improves overall urologic symptoms including nocturia. Additional randomized placebo and active-controlled trials are needed to evaluate the long-term clinical effectiveness and safety of Cernilton.
Topics: Humans; Male; Phytotherapy; Plant Extracts; Prostatic Hyperplasia; Secale
PubMed: 21563128
DOI: 10.1002/14651858.CD001042.pub2 -
Acta Dermatovenerologica Alpina,... Oct 2010Lais® allergoid tablets contain allergens that are modified by carbamylation. Due to their modified chemical structure, they are suitable for sublingual immunotherapy... (Meta-Analysis)
Meta-Analysis Review
Carbamylated monomeric allergoids as a therapeutic option for sublingual immunotherapy of dust mite- and grass pollen-induced allergic rhinoconjunctivitis: a systematic review of published trials with a meta-analysis of treatment using Lais® tablets.
Lais® allergoid tablets contain allergens that are modified by carbamylation. Due to their modified chemical structure, they are suitable for sublingual immunotherapy (SLIT) (13, 16, 17, 24). Based on their small molecule size of 12 to 40 kDa, they can be easily absorbed via the oral mucosa (1). In this review, we studied the efficacy of SLIT with carbamylated monomeric allergoid tablets in the treatment of grass pollen- and dust mite-induced allergic rhinoconjunctivitis on the basis of symptom and medication score improvements. Following a selective internet and databank search, six trials-some placebo-controlled-regarding the treatment of grass pollen- (n = 266) and dust mite-induced (n = 241) allergic rhinoconjunctivitis were used to draw conclusions regarding the clinical efficacy of allergoid tablets. The primary endpoints in these trials were decreases in the need for allergy medications and/or reductions in the occurrence of rhinoconjunctivitis symptoms. Data was recorded from patient diaries regarding their symptoms and medications used and conclusions were then drawn about the effectiveness and tolerabieity of Lais® tablets. The average improvement in symptom score in three trials of grass pollen allergy treatment was 34% in comparison to the placebo group. The treatment of dust mite-induced rhinoconjunctivitis produced an average symptom score improvement of 22% compared to the placebo or control groups. The intake of symptomatic rescue medication during allergoid tablet therapy declined. Treatment of grass pollen allergies and dust mite-induced rhinoconjunctivitis showed an average medication score improvement of 49% and 24%, respectively. Few side effects were documented in the trials and predominantly local effects were observed. Severe systemic side effects did not occur. On the basis of the trial results summarized in this review, we suggest that SLIT using Lais® sublingual tablets is an effective and well-tolerated form of treatment.
Topics: Administration, Sublingual; Allergens; Allergoids; Animals; Anti-Allergic Agents; Anti-Asthmatic Agents; Antigens, Plant; Conjunctivitis, Allergic; Desensitization, Immunologic; Humans; Immunotherapy; Mites; Plant Extracts; Pollen; Rhinitis, Allergic, Seasonal; Treatment Outcome
PubMed: 20976414
DOI: No ID Found -
BMJ Clinical Evidence Nov 2009Hay fever is found throughout the world. Epidemiological evidence suggests considerable geographical variation in its prevalence. Symptoms are caused by an IgE-mediated... (Review)
Review
INTRODUCTION
Hay fever is found throughout the world. Epidemiological evidence suggests considerable geographical variation in its prevalence. Symptoms are caused by an IgE-mediated type 1 hypersensitivity reaction to airborne allergens such as pollen or fungal spores, and may also cause eye, sinus, respiratory, and systemic problems.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for hay fever in adolescents and adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2008 (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 211 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: intranasal corticosteroids, oral antihistamines, intranasal antihistamines, oral leukotriene receptor antagonists, systemic corticosteroids, intranasal ipratropium bromide, oral decongestants, and combinations of these treatments.
Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Double-Blind Method; Humans; Leukotriene Antagonists; Pollen; Rhinitis, Allergic, Seasonal; Treatment Outcome
PubMed: 21726475
DOI: No ID Found -
The Cochrane Database of Systematic... Jan 2007Allergic rhinitis is the most common of the allergic diseases. Despite improved understanding of the pathophysiology of allergic rhinitis and advances in its... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Allergic rhinitis is the most common of the allergic diseases. Despite improved understanding of the pathophysiology of allergic rhinitis and advances in its pharmacological treatment, its prevalence has increased worldwide. For patients whose symptoms remain uncontrolled despite medical treatment, allergen injection immunotherapy is advised. An allergen-based treatment may reduce symptoms, the need for medication and modify the natural course of this disease.
OBJECTIVES
To evaluate the efficacy and safety of subcutaneous specific allergen immunotherapy, compared with placebo, for reducing symptoms and medication requirements in seasonal allergic rhinitis patients.
SEARCH STRATEGY
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1 2006), MEDLINE (1950 to 2006), EMBASE (1974 to 2006), Pre-MEDLINE, KOREAMED, INDMED, LILACS, PAKMEDINET, Scisearch, mRCT and the National Research Register. The date of the last search was February 2006.
SELECTION CRITERIA
All studies identified by the searches were assessed to identify randomised controlled trials involving participants with symptoms of seasonal allergic rhinitis and proven allergen sensitivity, treated with subcutaneous allergen specific immunotherapy or corresponding placebo.
DATA COLLECTION AND ANALYSIS
Two independent authors identified all studies reporting double-blind, placebo controlled randomised trials of specific immunotherapy in patients with seasonal allergic rhinitis due to tree, grass or weed pollens. Two authors independently performed quality assessment of studies. Data from identified studies were abstracted onto a standard extraction sheet and subsequently entered into RevMan 4.2.8. Analysis was performed using the Standardised Mean Difference (SMD) method and a random-effects model; P values < 0.05 were considered statistically significant. The primary outcome measures were symptom scores, medication use, quality of life and adverse events.
MAIN RESULTS
We retrieved 1111 publications of which 51 satisfied our inclusion criteria. In total there were 2871 participants (1645 active, 1226 placebo), each receiving on average 18 injections. Duration of immunotherapy varied from three days to three years. Symptom score data from 15 trials were suitable for meta-analysis and showed an overall reduction in the immunotherapy group (SMD -0.73 (95% CI -0.97 to -0.50, P < 0.00001)). Medication score data from 13 trials showed an overall reduction in the immunotherapy group (SMD of -0.57 (95% CI -0.82 to -0.33, p<0.00001)). Clinical interpretation of the effect size is difficult. Adrenaline was given in 0.13% (19 of 14085 injections) of those on active treatment and in 0.01% (1 of 8278 injections) of the placebo group for treatment of adverse events. There were no fatalities.
AUTHORS' CONCLUSIONS
This review has shown that specific allergen injection immunotherapy in suitably selected patients with seasonal allergic rhinitis results in a significant reduction in symptom scores and medication use. Injection immunotherapy has a known and relatively low risk of severe adverse events. We found no long-term consequences from adverse events.
Topics: Allergens; Desensitization, Immunologic; Humans; Injections, Subcutaneous; Pollen; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Seasonal
PubMed: 17253469
DOI: 10.1002/14651858.CD001936.pub2