Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic disease.
BACKGROUND
Reports of clinical trials usually emphasize benefits and give less attention to harms.


OBJECTIVE
To compare the reporting of harm in trials of pharmacologic and nonpharmacologic treatment.


METHODS
MEDLINE and the Cochrane Central Register of Controlled Trials.


METHODS
Reports of randomized, controlled trials assessing treatment of rheumatic disease that were published between January 1999 and January 2005.


METHODS
A standardized abstraction form was used to extract data.


RESULTS
193 articles were analyzed. After adjustment for medical area, sample size, funding source, and multicenter trials, data on harm were more often described in pharmacologic treatment reports than in nonpharmacologic treatment reports in reporting adverse events (odds ratio, 5.2 [95% CI, 2.1 to 12.9]), reporting withdrawals due to adverse events (odds ratio, 4.6 [CI, 2.0 to 10.9]), reporting severity (odds ratio, 3.7 [CI, 1.5 to 9.1]), and allocating space for describing harm (odds ratio, 1.6 [CI, 1.2 to 2.3]).


CONCLUSIONS
Extrapolating results to trials in areas other than rheumatic disease is questionable.


CONCLUSIONS
The lack of reporting harm in trials assessing nonpharmacologic treatment in rheumatic disease is an important barrier to evaluating the benefit-harm balance of nonpharmacologic treatments.
Ethgen
Morgane
M
Centre Hospitalier Universitaire de Hautepierre, Strasbourg, France.
Boutron
Isabelle
I
Baron
Gabriel
G
Giraudeau
Bruno
B
Sibilia
Jean
J
Ravaud
Philippe
P
D018501:Antirheumatic Agents / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D015207:Osteoarthritis, Hip / Q000188:drug therapy / Q000628:therapy*; D020370:Osteoarthritis, Knee / Q000188:drug therapy / Q000628:therapy*; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic / Q000592:standards*
D018501:Antirheumatic Agents