Measurement of gold treatment effect in clinical practice: evidence for effectiveness of intramuscular gold therapy.
OBJECTIVE
To determine the extent of efficacy of intramuscular (im) gold in clinical practice.


METHODS
Ninety-eight patients who received im gold treatment for at least 1 year were assessed during ordinary clinic visits over the 12 month period following gold initiation. Assessments included joint counts, erythrocyte sedimentation rate (ESR), morning stiffness, visual analog scale (VAS) patient pain, VAS patient global, grip strength, prednisone dose, hemoglobin, and Stanford Health Assessment Questionnaire (HAQ) disability index.


RESULTS
All outcome measures showed significant improvements at one year by standardized pretest posttest differences (effect size) and by measurement of the area under the curve (AUC). Important improvement (at least 50% improvement) was common: joint count (63.3%), global severity (41.1%), ESR (48.2%), grip strength (42.7%) HAQ disability (45.3%), and morning stiffness (72.2%). Effect sizes were substantial, even after correcting for placebo effect and withdrawals. Overall improvement was clinically significant, amounting to the equivalent of 2 months without pain or disability.


CONCLUSIONS
Patients receiving gold for 12 months improved significantly and importantly in all measures studied. Improvement was clinically significant, amounting to the equivalent of 2 months without pain or disability. The degree of improvement was similar to, but somewhat greater, than that seen in controlled clinical trials, and could not be explained by regression to the mean.
Wolfe
F
F
Arthritis Research and Clinical Centers (St. Francis Research Institute, Wichita, KS 67214.
Hawley
D J
DJ
Cathey
M A
MA
D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology; D001799:Blood Sedimentation; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D004185:Disability Evaluation; D005260:Female; D006046:Gold / Q000008:administration & dosage* / Q000627:therapeutic use; D006304:Health Status; D006801:Humans; D007273:Injections, Intramuscular; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011241:Prednisone / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D006046:Gold; D011241:Prednisone