From the Journal of Psychosomatic Research, published online 17 July 2016.
A UK-based review of recommendations regarding the management of chronic fatigue syndrome.
Mallet M(1), King E(1), White PD(2).
1) Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
2) Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK. Electronic address: p.d.white@qmul.ac.uk
Abstract
OBJECTIVES
Chronic fatigue syndrome (CFS) is a controversial illness, with apparent disagreements between medical authorities and patient support organisations regarding safe and effective treatments. The aim of this study was to measure the extent of different views regarding treatments, comparing patient support organisations and medical authorities in the UK.
METHODS
Two independent raters analysed two groups of resources: UK patient support websites and both medical websites and textbooks. A 5-point Likert scale was developed with the question ‘With what strength does the source recommend these treatments?' The various treatments were divided into the following four groups: complementary and alternative medicine (CAM), pharmacological, rehabilitative, and pacing therapies.
RESULTS
There were significant differences between the scores for patient support organisations and medical sources for all 4 treatment groups. The results for supporting CAM were 74% (patient group) vs 16% (medical source) (p<0.001), 71% vs 42% for pharmacological (p=0.01), 28% vs 94% for rehabilitative (p<0.001) and 91% vs 50% for pacing treatments (p=0.001).CONCLUSIONSThere were substantially different treatment recommendations between patient support organisations and medical sources. Since expectations can determine response to treatment, these different views may reduce the engagement in and effectiveness of rehabilitative therapies recommended by national guidelines and supported by systematic reviews.
From Clinical Autonomic Research, 2 July 2016.
Clinical benefit of midodrine hydrochloride in symptomatic orthostatic hypotension: a phase 4, double-blind, placebo-controlled, randomized, tilt-table study
William Smith, Hong Wan, David Much, Antoine G. Robinson, and Patrick Martin
Volunteer Research Group, University of Tennessee Medical Center, Knoxville, TN USA
Shire, Lexington, MA USA
Barclay Consulting LLC, Ardmore, PA USA
Global Clinical Pharmacology & Pharmacokinetics, Shire, 300 Shire Way, Lexington, MA 02421 USA
Patrick Martin, Phone: +1 484 595 8710, Email: moc.erihs@nitramp.
Abstract
OBJECTIVE
Midodrine hydrochloride is a short-acting pressor agent that raises blood pressure in the upright position in patients with orthostatic hypotension. The US Food and Drug Administration’s Subpart H approval, under which midodrine was initially approved, requires post-marketing studies to confirm midodrine’s clinical benefit in this indication. The purpose of this study was to evaluate the clinical benefit of midodrine with regard to symptom response.
METHODS
This was a double-blind, placebo-controlled, randomized, crossover, multicenter study (NCT01518946). Following screening, patients aged ≥18 years with severe symptomatic orthostatic hypotension and on a stable dose of midodrine for at least 3 months were randomized to treatment with either their previous midodrine dose or placebo on day 1 and the respective alternate treatment on day 2. The primary endpoint measured time to syncopal symptoms or near-syncope using a 45-min tilt-table test at 1 h post-dose.
RESULTS
Thirty-three patients were screened for inclusion: 19 received at least one dose of midodrine and had at least one post-dose measurement of the primary endpoint. The least-squares mean time to syncopal symptoms or near-syncope after tilt-table initiation (mean ± standard error) was 1626.6 ± 186.8 s for midodrine and 1105.6 ± 186.8 s for placebo (difference, 521.0 s; 95 % confidence interval 124.2–971.7 s; p = 0.0131). There were 15 adverse events in 10 patients; all of these were mild or moderate in severity, with none considered by the investigators to be related to midodrine.
INTERPRETATION
Midodrine is a well-tolerated and clinically effective treatment for symptomatic orthostatic hypotension.