Gout Treatment: What is Evidence-based and How Do We Determine and Promote Optimized Clinical Care? Ted R. Mikuls, MD, MSPH* and Kenneth G. Saag, MD, MSc Address *University of N ebraska Medical Center and the O maha VA Medical Center, 983025 N E Med Center, O maha, N E 68198-3025, USA. E-mail: tmikuls@ unmc.edu Current Rheumatology Reports 2005, 7: 242–249 Current Science Inc. ISSN 1523-3774 Copyright © 2005 by Current Science Inc. Intro ductio n The task o f o btaining evidence to guide clinical decisio n- making is particularly challenging in the management o f go ut, a co nditio n that has been markedly understudied relative to other rheumatologic disorders. In a comprehen- sive review o f the MEDLINE database covering the years 1966 thro ugh 2001, there were o nly 23 rando m ized co ntro lled trials (RCTs) o f go ut treatments; a majo rity o f these examining the efficacy of nonsteroidal anti-inflamma- tory drugs (NSAIDs) in the treatment of gout flares [1•]. To put this into perspective, the number o f go ut RCTs in the past 30 years is less than the total number of published RCTs examining rheumatoid arthritis therapies in 2004 alone. Perhaps as a result o f the po o r quality and quantity of evidence, there has been little past co nsensus regarding appropriate standards of gout care. Although an overwhelm- ing number of physicians report confidence in the diagnosis and management o f go ut [2], we and o thers have shown that go ut care is frequently subo ptimal suggesting that the self-reported confidence of healthcare providers may not be warranted [3–12]. In this paper, we examine the evidence suppo rting current strategies in care, fo cusing o n select management issues that frequently arise in the clinical setting with the use of currently available gout medications. In addition, we examine efforts that have culminated in the publication of gout management quality indicators. We also discuss the need fo r future initiatives aimed at improving patient safety and quality of care in gout. Evidence Supporting Gout Management Strategies What is the most effective treatment for acute gouty flares? Although there are ample data to support the use of differ- ent anti-inflammato ry strategies to treat acute go ut flares, few investigatio ns have been well designed RCTs o r have co mpared agents acro ss anti-inflammato ry drug classes. Since RCTs represent the highest level o f clinical evidence [13], we will fo cus o n RCTs, where available, but otherwise highlight the best examples o f o ther existing data. The paucity o f available co mparative data makes it impo ssible to co nclude superio r efficacy o r to lerability with any specific treatment for acute gout flares. Colchicine Repo rts examining the use of colchicine in gout treatment are summarized in Table 1. Despite its lengthy and venera- ble histo ry in the treatment o f go ut, to o ur kno wledge, there has been o nly o ne rando mized trial examining the use of oral co lchicine in the treatment of acute gout flares. Ahern et al . [14•] repo rted the results o f a do uble-blind, placebo -co ntro lled study invo lving 43 patients with an acute go ut flare. Patients rando mized to co lchicine were given 1 mg followed-up every 2 hours by an additio nal 0.5 mg until sym pto m reso lutio n o r the presence o f do se- related toxicity. The primary endpo ints were 50% improve- ment in a co mpo site clinical sco re ( based o n a co mbina- tio n o f pain, tenderness o n palpatio n, swelling, and redness graded o n a fo ur-po int scale) o r pain sco re alo ne. At 48 ho urs, 64% o f the co lchicine gro up experienced at least 50% impro vement in the co mpo site clinical sco re co m p ared w ith o n ly 2 3 % o f th o se given p laceb o ( P < 0.05). Similarly, pain sco res were reduced by at least Gout, a common form of inflammatory arthritis, has been markedly understudied relative to other rheumatologic conditions. As a result, evidence guiding clinical manage- ment in gout has traditionally been lacking. Burgeoning data suggests that quality of gout care in gout is frequently suboptimal. In this paper, we examine the evidence supporting gout management strategies in clinical practice. In addition, we examine consensus building efforts that have culminated in the recent publication of gout manage- ment quality indicators. W e also discuss the need for future initiatives aimed at improving patient safety and quality of care in gout.