Monday, February 20, 2012

Adverse Events Attributable to Nocebo in Randomized Controlled Drug Trials in Fibromyalgia Syndrome

Clin J Pain. 2012 Feb 14. [Epub ahead of print]
Adverse Events Attributable to Nocebo
in Randomized Controlled Drug Trials
in Fibromyalgia Syndrome
and Painful Diabetic Peripheral Neuropathy:
Systematic Review.


Häuser W, Bartram C, Bartram-Wunn E, Tölle T.

Department of Internal Medicine I, Klinikum Saarbrücken, Saarbrücken
Department of Psychosomatic Medicine and Psychotherapy
Department of Neurology, Technische Universität München, München, Germany.

Abstract

OBJECTIVE:
The objectives of the study were to determine the impact of nocebo effects on adverse events (AEs) in drug trials in fibromyalgia syndrome (FMS) and painful diabetic peripheral neuropathy (DPN).

METHODS:
MEDLINE, CENTRAL, SCOPUS, and the databases of the U.S. National Institutes of Health and the Pharmaceutical Research and Manufacturers of America were searched until December 31, 2010.

Randomized controlled trials with a parallel design of any drug therapy compared with pharmacological placebo in patients with FMS and DPN were included.

Pooled estimates of nocebo effects (number of patients with at least 1 AE and dropping out due AEs) were calculated for placebo and true drug groups by a random effects model.

RESULTS:
Fifty-eight FMS (62 DPN) trials included a total of 5065 (5095) patients in placebo groups.

The quality of reporting the assessment strategy of AEs was poor in most trials. The pooled estimate of the event rate drop out rate due to AEs in placebo groups was
  • 9.6 [95% confidence control (CI): 8.6-10.7] in placebo and 
  • 16.3 (95% CI: 14.1-31.2) in true drug groups of FMS trials and was 
  • 5.8 (95% CI: 5.1-6.6) in placebo and 
  • 13.2 (95% CI: 10.7-16.2) in true drug groups of DPN trials.
Nocebo effects accounted for 72.0% (44.9) of the drop outs in true drug groups in FMS (DPN).

DISCUSSION:
Nocebo effects substantially accounted for AEs in drug trials of FMS and DPN.

Standards to assess and report AEs should be defined by regulatory agencies. Strategies to minimize nocebo effects in both clinical trials and clinical practice should be developed.
(via Co-Cure)

No comments:

Post a Comment

Comments are most welcome! But please:

- No SPAM whatsoever, no supplements, no pharmaceuticals, no herbs or any other advertisements

- Absolutely no quack-doctors pushing their quack-BS websites (and if you are a quack, I will call you out)

- Be critical if you want to, but try to be coherent

Comments are moderated, because I am tired of Gerwyn-V99-The-Idiot and his moronic sockpuppets, and tired of the story of the two dogs, but I will try to publish everything else.

If you are not Gerwyn (and want to tell me something other than the story of the two dogs), then relax and write something! :-)

Labels

5-AZA A. Melvin Ramsay Acne Advocacy Alan Light Alternative medicine is an untested danger Ampligen Andrew Wakefield Anecdote Anthony Komaroff Antibiotics Antibodies Anxiety Aphthous Ulcers Apnea Asthma Autism Autoimmune Disease Behçet’s Ben Katz Bertrand Russell Biology Blood sugar Bruce Carruthers Caffeine Calcium Cancer Capitalism Cardiology Carmen Scheibenbogen CBT/GET CDC Celiac Disease Cereal Grains CFIDS Chagas Charité Charles Lapp Christopher Snell Chronix Clinician Coconut Milk Cognition Common Sense and Confirmation Bias Conversion Disorder Coxiella Burnetii Coxsackie Criteria Crohn's Cushing's Syndrome Cytokine Daniel Peterson Darwinism David Bell Depression Diabetes Diagnostic Differential Disease Diseases of Affluence DNA DNA Sequencing Dog DSM5 EBV EEG Eggs Elaine DeFreitas Elimination Diet Enterovirus Epstein-Barr ERV Etiology Evolution Exercise Challenge Faecal Transplant Fame and Fraud and Medical Science Fatigue Fatty Acids Fibromyalgia Francis Ruscetti Fructose Gene Expression Genetics Giardia Gordon Broderick Gulf War Illness Gut Microbiome Harvey Alter Health Care System Hemispherx Hemolytic Uremic Syndrome Herpesviridae High Blood Pressure Historic Outbreaks HIV HPV Hyperlipid Ian Hickie Ian Lipkin Immune System Infection Intermittent Fasting It's the environment stupid Jacob Teitelbaum Jamie Deckoff-Jones Jo Nijs John Chia John Coffin John Maddox José Montoya Judy Mikovits Karl Popper Kathleen Light Kenny De Meirleir Lactose Lamb Laszlo Mechtler LCMV Lecture Leonard Jason Leukemia Life Liver Loren Cordain Low Carb Low-Dose Naltrexone (LDN) Luc Montagnier Lucinda Bateman Ludicrous Notions Lumpers and Splitters Lyme Mady Hornig Mark Hasslett Martin Lerner Mary Schweitzer MCS ME/CFS Medical Industry Medicine is not based on anecdotes Michael Maes Migraine Milk and Dairy Mitochondria MMR Money and Fame and Fraud MRI Multiple Chemical Sensitivity Multiple Sclerosis Mutton My Symptoms n-1 Nancy Klimas Narcolepsy Neurodermitis Neuroscience NK-Cell Nocebo NSAID Nutrition Obesity On Nutrition Pain Paleo Parathyroid Pathogen Paul Cheney PCR Pharmaceutical Industry Picornavirus Placebo Polio Post Exertional Malaise POTS/OI/NMH PTSD PUFA Q Fever Quote Rare Disease Research Retrovirus Rheumatoid Arthritis Rituximab RNA Robert Gallo Robert Lustig Robert Silverman Robert Suhadolnik Rosario Trifiletti Sarah Myhill Sarcasm Science Sequencing Seth Roberts Shrinks vs. Medicine Shyh-Ching Lo Simon Wessely Sinusitis Sjögren's Somnolence Sonya Marshall-Gradisnik Speculation Stanislaw Burzynski Statins Stefan Duschek Study Sucrose Sugar Supplements Symptoms T1DM T2DM There is no such thing as Chronic Lyme There is no such thing as HGRV Thyroid Tinitus To Do Toni Bernhard Tourette's Treatment Tuberculosis Vaccine Video Vincent Lombardi Vincent Racaniello Virus Vitamin B Vitamin D VP62 When Evidence Based Medicine Isn't Whooping Cough Wolfgang Lutz WPI XMRV You fail science forever