Effect of Low-dose Oral Prednisolone on Symptoms and Systemic Inflammation in Older Adults with Moderate to Severe Knee Osteoarthritis: A Randomized Placebo-controlled Trial. The Journal of Rheumatology, 2014;41: 53–9; doi:10.3899/jrheum.130199. Anna Abou-Raya, Suzan Abou-Raya, Tarek Khadrawi, and Madihah Helmii.
The Journal hereby retracts this article.
Three major concerns, and some minor concerns, were raised with the authors and reviewed by an Investigation Committee from the Alexandria University Faculty of Medicine. The Investigation Committee found no research misconduct by any of the authors. The Journal re-examined all the issues raised and responses to the issues. The major issues were not addressed to our satisfaction following the re-review and therefore a retraction of the paper is required.
The major concerns:
This was a 12-week study with entry that began on November 1, 2011, and with a study completion date verified as January 28, 2012. The problem is that the start and end dates are exactly 12 weeks apart. This means that all 125 patients were entered and randomized on November 1. This is something that we have never seen before in any study and is difficult to accept as being feasible.
There were significant discrepancies in the data. Raw data were not available for confirmation. Characteristics of the patients in the active treatment arm and placebo group were almost identical. Data in one table were identical to those from a previous study by the authors, originally published in 2014 in Annals of the Rheumatic Diseases and since retracted by that journal.
The date of registration of the study at ClinicalTrials.gov was June 12, 2012, which was after study completion. Registration of a study after completion is not acceptable.
