From 2017 (volume 56) onwards the journal Methods of Information in Medicine will consist of two tracks. Authors can decide to submit their manuscript to either the subscription track that continues to publish its six print and electronic (non-open access) issues for journal subscribers, or the new Methods Open track that will consist of digitally published manuscripts (as gold open access). Th...

We were interested in determining the efficacy of Arlevert therapy in vertigo and tinnitus patients, especially as it compared to the efficacy of the drug's two component agents, dimenhydrinate and cinnarizine. We conducted a comparative, randomized, double blind, multicenter, parallel group study involving a group of patients (n = 122) with vertigo and tinnitus of peripheral or central origin....

BACKGROUND The use of placebos in randomised controlled trials is a subject of considerable ethical debate. In this paper we present a set of considerations to evaluate the ethics of placebo controlled trials that includes: social value of the study; need for a randomised controlled trial and placebo; standards of care; risks of harm due to administration of placebo and the harm benefit balance...

The success of an epidemiological program against infectious diseases depends on an effective prophylactic vaccine. Although efficacy and effectiveness are used interchangeably, effectiveness depends upon efficacy. Few methods are in use to assess the efficacy of the vaccine, a randomized double blind controlled trial is the least ambiguous method for evaluation. Observational designs for vacci...

Multiple double blind placebo controlled challenges with tartrazine 50 mg (three challenges) and glucose placebo (three challenges) were performed in 12 children with atopic eczema aged 1 to 6 years. The children were selected on the basis of severity (regular clinic attenders) and a parental history that tartrazine provoked worsening of the eczema. In only one patient did the three tartrazine ...

Methods. In a double-blinded, cross-over trial 30 residents in anaesthesia were randomized to receive or not to receive a 30-min break between the assessment times of 07:30 and 14:00. in a normal working day. After at least 28 days the test was repeated with each resident in the opposite group. Primary outcome measure was the Test for Attentional Performance with the subtest of working memory a...

The feature of being “double blind”, where neither patients nor physicians are aware of who receives the experimental treatment, is almost universally trumpeted as being a virtue of clinical trials. Hence, trials that fail to remain successfully double blind are regarded as providing inferior evidential support. The rationale for this view is unobjectionable: double blinding rules out the poten...

Twenty one patients with severe systemic lupus erythematosus (SLE) were treated with three daily infusions of either 100 mg or 1 g of methylprednisolone on a randomised double blind basis. Nine patients with unsatisfactory outcome subsequently received the alternative therapy. Patients were rated for improvement on a four point scale using individualised criteria. On three occasions patients im...

OBJECTIVE Whole-body vibration can be used to supplement canonical physical treatment. It is performed while probands stand on a vibrating platform. Therapeutic vibration can be generated as a stochastic vibratory pattern, referred to as stochastic resonance whole-body vibration (SR-WBV). Despite the widespread use of SR-WBV its neurophysiological mechanism is unclear. DESIGN A randomized sha...

Recent brain imaging research has revealed oxytocin (OT) effects on an individual's brain activity during social interaction but tells little about whether and how OT modulates the coherence of inter-brain activity related to two individuals' coordination behavior. We developed a new real-time coordination game that required two individuals of a dyad to synchronize with a partner (coordination ...