The use of placebo in rheumatoid arthritis clinical trials may negatively impact patients

May 27, 2011

The results of this study, conducted in Germany, re-open the debate on whether it is ethical to conduct placebo-controlled studies where patients in the placebo-group are at a serious disadvantage compared to patients taking the new treatments. The study analysed current study designs, for new therapies such as abatacept (Orencia®), golimumab (Simponi®) or tocilizumab (Actemra®), and showed that patients in the placebo group experienced no change in medication, having to continue with their former, ineffective treatment plus placebo.

"According to the Helsinki-Declaration of the World Medical Association*, a placebo-controlled study design is deemed to be ethically acceptable when there is no other effective treatment," said Dr. Juche, Johanniter-Hospital, Treuenbrietzen, Germany. "However, this analysis confirms that patients in the are at a disadvantage as they are given no change in medication to reduce their active inflammatory condition or halt disease progression. Our recommendation is that future clinical trials should include an active comparator group to ensure that all receive effective treatments to improve their quality of life."

In the analysis, researchers used studies from the European Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for abatacept, golimumab and tocilizumab as samples. The studies chosen had to be controlled at the beginning and state clinical relevant outcome criteria (e.g. DAS28**, ACR20***, Health Assessment Questionnaire and joint erosion scores).

More information: *The World Medical Association (WMA) is an organisation promoting the highest possible standards of medical ethics. The WMA provides ethical guidance to physicians through its Declarations, Resolutions and Statements.

**DAS28 (Disease Activity Score) is an index used by physicians to measure how active an individual's RA is.

***ACR (American College of Rheumatology) criteria measures improvement in tender or swollen joint counts.

Related Stories

Recommended for you

The 'love hormone' may quiet tinnitus

September 23, 2016

(HealthDay)—People suffering from chronic ringing in the ears—called tinnitus—may find some relief by spraying the hormone oxytocin in their nose, a small initial study by Brazilian researchers suggests.

Bile acid uptake inhibitor prevents NASH / fatty liver in mice

September 21, 2016

Drugs that interfere with bile acid recycling can prevent several aspects of NASH (nonalcoholic steatohepatitis) in mice fed a high-fat diet, scientists from Emory University School of Medicine and Children's Healthcare of ...

New therapeutic target for Crohn's disease

September 20, 2016

Research from the Sanford Burnham Prebys Medical Discovery Institute (SBP) identifies a promising new target for future drugs to treat inflammatory bowel disease (IBD). The study, published today in Cell Reports, also indicates ...

Mosquitoes, Zika and biotech regulation

September 19, 2016

In a new Policy Forum article in Science, NC State professor Jennifer Kuzma argues that federal authorities are missing an opportunity to revise outdated regulatory processes not fit for modern innovations in biotechnology, ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.