Systematic reviews do not (yet) represent the 'gold standard' of evidence: A position paper.

The low quality of included trials, insufficient rigour in review methodology, ignorance of key pain issues, small size, and over-optimistic judgements about the direction and magnitude of treatment effects all devalue systematic reviews, supposedly the 'gold standard' of evidence. Available evidence indicates that almost all systematic reviews in the published literature contain fatal flaws likely to make their conclusions incorrect and misleading. Only 3 in every 100 systematic reviews are deemed to have adequate methods and be clinically useful.

Effects of food on pharmacokinetics of immediate release oral formulations of aspirin, dipyrone, paracetamol and NSAIDs - a systematic review.

Aims: It is common to advise that analgesics, and especially non-steroidal anti-inflammatory drugs (NSAIDs), be taken with food to reduce unwanted gastrointestinal adverse effects. The efficacy of single dose analgesics depends on producing high, early, plasma concentrations; food may interfere with this. This review sought evidence from single dose pharmacokinetic studies on the extent and timing of peak plasma concentrations of analgesic drugs in the fed and fasting states.

Nonsteroidal anti-inflammatory drugs, gastroprotection, and benefit-risk.

Background: Gastroprotective agents (GPA) substantially reduce morbidity and mortality with long-term nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin.

Objective: To evaluate efficacy of NSAIDs, protection against NSAID-induced gastrointestinal harm, and balance of benefit and risk.

Methods: Free text searches of PubMed (December 2012) supplemented with "related citation" and "cited by" facilities on PubMed and Google Scholar for patient requirements, NSAID effectiveness, pain relief benefits, gastroprotective strategies, adherence to gastroprotection prescribing, and serious harm with NSAIDs and GPA.

Do placebo response rates from cessation trials inform on strength of addictions?

There is an implied assumption that addictions to different substances vary in strength from weak (easier to stop) to strong (harder to stop), though explicit definitions are lacking. Our hypothesis is that the strength of addictions can be measured by cessation rates found with placebo or no treatment controls, and that a weaker addiction would have a higher cessation rate than a stronger addiction. We report an overview of systematic reviews and meta-analyses of cessation trials, using randomised or quasi-randomised trials and reporting objectively-measured abstinence.

Mean analgesic consumption is inappropriate for testing analgesic efficacy in post-operative pain: analysis and alternative suggestion.

Background And Objective: Post-operative analgesic consumption is often used as a surrogate measure for pain; analyses of mean data assume a Gaussian distribution and use parametric statistics to assess statistical differences, often in small samples. We used a large individual patient dataset to examine the distribution of analgesic consumption, the validity of such analyses and alternative dichotomous outcomes.

Methods: Analysis of individual patient data from 913 patients over 48 post-operative hours in five randomised trials.

Pregabalin in fibromyalgia: meta-analysis of efficacy and safety from company clinical trial reports.

Objectives: Meta-analysis of pregabalin trials in FM using company trial reports, which provide more detailed information about trials than published papers. FM is a common condition with a significant impact on quality of life.

Methods: Reports of five high-quality randomized trials (3808 patients) of pregabalin in FM were obtained from Pfizer.

Imiquimod for actinic keratosis: systematic review and meta-analysis.

Benefit and harm associated with treating actinic keratosis (AK) with the immune response modifier imiquimod was assessed using published randomized-controlled trials. Five randomized double-blind trials lasted 12-16 weeks and treated 1,293 patients. Complete clearance occurred in 50% of patients treated with imiquimod, compared to 5% treated with vehicle, and the number needed to treat (NNT) for one patient to have their keratosis completely cleared after 12-16 weeks was 2.