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) g old in clinical practice. Methods. Ninety-eight patients who received im gold treatment for at least 1 year were assessed during ordinary cl inic visits over the 12 month period following gold initiation. Assess ments included joint counts, erythrocyte sedimentation rate (ESR), mor ning stiffness, visual analog scale (VAS) patient pain, VAS patient gl obal, 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 p retest posttest differences (effect size) and by measurement of the ar ea under the curve (AUC). Important improvement (at least 50% improvem ent) was common: joint count (63.3%), global severity (41.1%), ESR (48 .2%), grip strength (42.7%) HAQ disability (45.3%), and morning stiffn ess (72.2%). Effect sizes were substantial, even after correcting for placebo effect and withdrawals. Overall improvement was clinically sig nificant, amounting to the equivalent of 2 months without pain or disa bility. Conclusion. Patients receiving gold for 12 months improved sig nificantly and importantly in all measures studied. Improvement was cl inically significant, amounting to the equivalent of 2 months without pain or disability. The degree of improvement was similar to, but some what greater, than that seen in controlled clinical trials, and could not be explained by regression to the mean.