BREO ELLIPTA
... with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of LABA. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids (ICS) or ...
... with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of LABA. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids (ICS) or ...
Premenstrual Dysphoric Disorder: Burden of Illness and Treatment Update
... premenstrual dysphoric disorder (PMDD). Clinically significant premenstrual symptoms occur in at least an additional 20% of menstruating women. The diagnosis of PMDD should be confirmed by prospective symptom charting over 2 menstrual cycles to confirm the timing of the symptoms and to rule out othe ...
... premenstrual dysphoric disorder (PMDD). Clinically significant premenstrual symptoms occur in at least an additional 20% of menstruating women. The diagnosis of PMDD should be confirmed by prospective symptom charting over 2 menstrual cycles to confirm the timing of the symptoms and to rule out othe ...
Simplification of PI + RTV + FTC/TDF to E/C/F/TDF Maintains HIV
... (E/C/F/TDF). d. One subject in the PI + RTV + FTC/TDF group withdrew consent at study day 9 with no samples drawn and had last visit (baseline) HIV-1 RNA of 2,890 c/mL. Screening HIV-1 RNA <50 c/mL. e. E/C/F/TDF group: protocol violation (n=6)†, withdrew consent (n=2), lost to follow-up (n=2), and ...
... (E/C/F/TDF). d. One subject in the PI + RTV + FTC/TDF group withdrew consent at study day 9 with no samples drawn and had last visit (baseline) HIV-1 RNA of 2,890 c/mL. Screening HIV-1 RNA <50 c/mL. e. E/C/F/TDF group: protocol violation (n=6)†, withdrew consent (n=2), lost to follow-up (n=2), and ...
Full Report - NIHR Journals Library
... (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the ‘National Knowledge Service’. The HTA Programme is needs-led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projec ...
... (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the ‘National Knowledge Service’. The HTA Programme is needs-led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projec ...
Biologics for Psoriasis and Psoriatic Arthritis – Monograph with Literature Review
... A number of advances have occurred in antipsoriatic biologic therapy since the original (2004–2005) review by the VA Pharmacy Benefits Management Services (PBM). Adalimumab and ustekinumab were approved by the FDA for the treatment of chronic plaque psoriasis (CPP). Infliximab and golimumab gained F ...
... A number of advances have occurred in antipsoriatic biologic therapy since the original (2004–2005) review by the VA Pharmacy Benefits Management Services (PBM). Adalimumab and ustekinumab were approved by the FDA for the treatment of chronic plaque psoriasis (CPP). Infliximab and golimumab gained F ...
Conservative Treatment in Women Committee 10 C Chairman Members
... Various lifestyle factors may play a role in either the pathogenesis of, or later, the resolution of incontinence. While published literature about lifestyle factors and incontinence is sparse, alterations in lifestyle are frequently recommended by health care professionals and lay people alike. How ...
... Various lifestyle factors may play a role in either the pathogenesis of, or later, the resolution of incontinence. While published literature about lifestyle factors and incontinence is sparse, alterations in lifestyle are frequently recommended by health care professionals and lay people alike. How ...
EFNS guidelines on the treatment of cluster headache and other... autonomic cephalalgias ´ fra A. May
... hemicrania, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) syndrome] are rare but very disabling conditions with a major impact on the patient’s quality of life. The objective of this study was to give evidence-based recommendations for the tre ...
... hemicrania, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) syndrome] are rare but very disabling conditions with a major impact on the patient’s quality of life. The objective of this study was to give evidence-based recommendations for the tre ...
Ophthalmology and Eye Diseases Review of Azithromycin
... once daily for 3 days achieved a similar safety profile to that of tobramycin 0.3% when dosed four times a day for 5 days. This study showed that azithromycin 1.0% was well tolerated in subjects of all ages (one year of age and older) and that rates of bacterial eradication were the same for both tr ...
... once daily for 3 days achieved a similar safety profile to that of tobramycin 0.3% when dosed four times a day for 5 days. This study showed that azithromycin 1.0% was well tolerated in subjects of all ages (one year of age and older) and that rates of bacterial eradication were the same for both tr ...
HIGHLIGHTS OF PRESCRIBING INFORMATION ADCIRCA
... sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain ...
... sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain ...
Socioeconomic Evaluations of Addictions Treatment
... First, in contrast to non-alcoholics, alcoholics usually incur health care costs that are at least 100% higher, and in the last twelve months before treatment of addiction, the costs are close to 300% higher. Most of this difference is attributable to the alcoholics' higher inpatient utilization for ...
... First, in contrast to non-alcoholics, alcoholics usually incur health care costs that are at least 100% higher, and in the last twelve months before treatment of addiction, the costs are close to 300% higher. Most of this difference is attributable to the alcoholics' higher inpatient utilization for ...
PRODUCT INFORMATION Elaxine SR 37.5, Elaxine SR 75, and
... least five of the following efficacy scales: HAM-A total score, the HAM-A psychic anxiety factor, the Hospital Anxiety and Depression (HAD) anxiety subscale, and the CGI severity of illness scale, as well as the HAM-A anxious mood and tension item. Two of these four studies continued for up to six m ...
... least five of the following efficacy scales: HAM-A total score, the HAM-A psychic anxiety factor, the Hospital Anxiety and Depression (HAD) anxiety subscale, and the CGI severity of illness scale, as well as the HAM-A anxious mood and tension item. Two of these four studies continued for up to six m ...
`Cut down to quit` with nicotine replacement therapies in
... CDTQ and no randomised controlled trials (RCTs) specifically addressing CDTQ were identified. Seven randomised placebo-controlled trials satisfied the inclusion criteria; six of these were industry sponsored. However, sustained smoking cessation was only reported as a secondary outcome in these tria ...
... CDTQ and no randomised controlled trials (RCTs) specifically addressing CDTQ were identified. Seven randomised placebo-controlled trials satisfied the inclusion criteria; six of these were industry sponsored. However, sustained smoking cessation was only reported as a secondary outcome in these tria ...
Introduction - World Health Organization
... The first volume of the WHO monographs on selected medicinal plants, containing 28 monographs, was published in 1999. It is gratifying that the importance of the monographs is already being recognized. For example, the European Commission has recommended volume 1 to its Member States as an authoritat ...
... The first volume of the WHO monographs on selected medicinal plants, containing 28 monographs, was published in 1999. It is gratifying that the importance of the monographs is already being recognized. For example, the European Commission has recommended volume 1 to its Member States as an authoritat ...
Communications - Canadian Rheumatology Association
... Long-term, real-world effectiveness data in RA patients using abatacept in a large multicentre cohort are lacking There is a high drop out rate with some biologics, such as TNF inhibitors, within the first two years of treatment NNT for improving HAQ in RA for TNFi is 1.94 ...
... Long-term, real-world effectiveness data in RA patients using abatacept in a large multicentre cohort are lacking There is a high drop out rate with some biologics, such as TNF inhibitors, within the first two years of treatment NNT for improving HAQ in RA for TNFi is 1.94 ...
Antibiotic therapy for Shigella dysentery (Review) The Cochrane Library 2010, Issue 8
... 1.1 million deaths per year globally, mostly in children under five years. The intention of giving antibiotics in shigellosis is to speed recovery, reduce the seriousness of the disease, and reduce the length of time patients are infective. However, some antibiotics can have serious side effects whi ...
... 1.1 million deaths per year globally, mostly in children under five years. The intention of giving antibiotics in shigellosis is to speed recovery, reduce the seriousness of the disease, and reduce the length of time patients are infective. However, some antibiotics can have serious side effects whi ...
Abilify Maintena
... minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that (1) is known to respond to antipsychotic drugs and (2) for whom alternative, equally effective, but potentially less harmful treatments are ...
... minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that (1) is known to respond to antipsychotic drugs and (2) for whom alternative, equally effective, but potentially less harmful treatments are ...
Evidence Tables
... Additional well designed RCTs of high methodological quality are needed to resolve uncertainty around the therapeutic efficacy of different types of HA in various clinical situations and patient populations. Reviewer’s comments: Drop out and follow –up time not reported and patient populations not d ...
... Additional well designed RCTs of high methodological quality are needed to resolve uncertainty around the therapeutic efficacy of different types of HA in various clinical situations and patient populations. Reviewer’s comments: Drop out and follow –up time not reported and patient populations not d ...
Report - Institute for Clinical and Economic Review
... elevations in creatinine kinase (CK), a muscle enzyme, to muscle aches (myalgias) with or without mild elevations in CK (<4 times the upper limit of normal), to frank myositis (CK ≥ 4 time the upper limit of normal).15,16 Precise measurement of statin intolerance is difficult because muscle symptoms ...
... elevations in creatinine kinase (CK), a muscle enzyme, to muscle aches (myalgias) with or without mild elevations in CK (<4 times the upper limit of normal), to frank myositis (CK ≥ 4 time the upper limit of normal).15,16 Precise measurement of statin intolerance is difficult because muscle symptoms ...
pdf
... measures. However, variable outcome measures across trials make comparisons difficult. The heterogeneity of tinnitus is a further challenge in clinical tinnitus research. Tinnitus can differ in many aspects such as tinnitus localization, sound characteristics, temporal course, underlying cause, co-m ...
... measures. However, variable outcome measures across trials make comparisons difficult. The heterogeneity of tinnitus is a further challenge in clinical tinnitus research. Tinnitus can differ in many aspects such as tinnitus localization, sound characteristics, temporal course, underlying cause, co-m ...
ABILIFY® (aripiprazole)
... tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see CLINICAL STUDIES (14.1)]. Maintenance Treatment: Maintenance of efficacy in schizoph ...
... tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see CLINICAL STUDIES (14.1)]. Maintenance Treatment: Maintenance of efficacy in schizoph ...
do patients managed within a trial experience different outcomes
... ‘selection’ or ‘choice’ effect 7. It has been observed that when patients are allowed to make an informed choice about their treatment they experience better outcomes than their randomized counterparts7. Possible explanations for this phenomenon are that when patients are allowed to choose, they are ...
... ‘selection’ or ‘choice’ effect 7. It has been observed that when patients are allowed to make an informed choice about their treatment they experience better outcomes than their randomized counterparts7. Possible explanations for this phenomenon are that when patients are allowed to choose, they are ...
... and safeguards has ensured that any possible unintended negative consequences have been largely avoided. This is important for the prescription of medicines that themselves have considerable abuse potential. Today, methadone and buprenorphine are among the first-line responses to the treatment of op ...
Alzheimer`s Dementia
... Three clinical trials of 6 months duration were conducted studying individuals meeting the NINDS-AIREN criteria for probable or possible vascular dementia (VaD). The NINDSAIREN criteria are designed to identify patients whose dementia appears to be due solely to vascular causes and to exclude patien ...
... Three clinical trials of 6 months duration were conducted studying individuals meeting the NINDS-AIREN criteria for probable or possible vascular dementia (VaD). The NINDSAIREN criteria are designed to identify patients whose dementia appears to be due solely to vascular causes and to exclude patien ...
Postoperative Analgesia and Vomiting
... in the NHS. Research is undertaken in those areas where the evidence will lead to the greatest benefits to patients, either through improved patient outcomes or the most efficient use of NHS resources. The Standing Group on Health Technology advises on national priorities for health technology asses ...
... in the NHS. Research is undertaken in those areas where the evidence will lead to the greatest benefits to patients, either through improved patient outcomes or the most efficient use of NHS resources. The Standing Group on Health Technology advises on national priorities for health technology asses ...
The safety and effectiveness of different methods of earwax removal
... option. Outcomes were assessed in terms of benefits to patients and costs incurred, with costs presented by exploratory cost–utility analysis. Results: Twenty-six clinical trials conducted in primary care (14 studies), secondary care (8 studies) or other care settings (4 studies), met the inclusion ...
... option. Outcomes were assessed in terms of benefits to patients and costs incurred, with costs presented by exploratory cost–utility analysis. Results: Twenty-six clinical trials conducted in primary care (14 studies), secondary care (8 studies) or other care settings (4 studies), met the inclusion ...
Placebo-controlled study
Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham ""placebo"" treatment which is specifically designed to have no real effect. Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment. Often, there is also a further ""natural history"" group that does not receive any treatment at all.The purpose of the placebo group is to account for the placebo effect, that is, effects from treatment that do not depend on the treatment itself. Such factors include knowing one is receiving a treatment, attention from health care professionals, and the expectations of a treatment's effectiveness by those running the research study. Without a placebo group to compare against, it is not possible to know whether the treatment itself had any effect.Patients frequently show improvement even when given a sham or ""fake"" treatment. Such intentionally inert placebo treatments can take many forms, such as a pill containing only sugar, a surgery where nothing efficacious is actually done (just an incision and sometimes some minor touching or handling of the underlying structures), or a medical device (such as an ultrasound machine) that is not actually turned on. Also, due to the body's natural healing ability and statistical effects such as regression to the mean, many patients will get better even when given no treatment at all. Thus, the relevant question when assessing a treatment is not ""does the treatment work?"" but ""does the treatment work better than a placebo treatment, or no treatment at all?"" As one early clinical trial researcher wrote, ""the first object of a therapeutic trial is to discover whether the patients who receive the treatment under investigation are cured more rapidly, more completely or more frequently, than they would have been without it.""p.195 More broadly, the aim of a clinical trial is to determine what treatments, delivered in what circumstances, to which patients, in what conditions, are the most effective.Therefore, the use of placebos is a standard control component of most clinical trials, which attempt to make some sort of quantitative assessment of the efficacy of medicinal drugs or treatments. Such a test or clinical trial is called a placebo-controlled study, and its control is of the negative type. A study whose control is a previously tested treatment, rather than no treatment, is called a positive-control study, because its control is of the positive type.Government regulatory agencies approve new drugs only after tests establish not only that patients respond to them, but also that their effect is greater than that of a placebo (by way of affecting more patients, by affecting responders more strongly, or both). As a result, ""placebo-controlled studies often are designed in such a way that disadvantages the placebo condition"".