PMID- 21312349 OWN - NLM STAT- MEDLINE DCOM- 20110802 LR - 20151119 IS - 2151-4658 (Electronic) IS - 2151-464X (Linking) VI - 63 IP - 6 DP - 2011 Jun TI - Estimation of minimum clinically important difference for pain in fibromyalgia. PG - 821-6 LID - 10.1002/acr.20449 [doi] AB - OBJECTIVE: To estimate the minimum clinically important difference (MCID) for several pain measures obtained from the Brief Pain Inventory (BPI) for patients with fibromyalgia. METHODS: Data were pooled across 12-week treatment periods from 4 randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of duloxetine for the treatment of fibromyalgia. Each study enrolled subjects with American College of Rheumatology--defined fibromyalgia who presented with moderate to severe pain. The MCIDs for the BPI average pain item score and the BPI severity score (the mean of the BPI pain scale values: right now, average, least, and worst) were estimated by anchoring against the Patient's Global Impressions of Improvement scale. RESULTS: The anchor-based MCIDs for the BPI average pain item and severity scores were 2.1 and 2.2 points, respectively. These MCIDs correspond to 32.3% and 34.2% reductions from baseline in scores. CONCLUSION: In these analyses, the MCIDs for several pain measures obtained from the BPI were similar ( approximately 2 points) and corresponded to a 30-35% improvement from baseline to end point. These findings may be beneficial for use in designing clinical trials in which the BPI is used to evaluate improvements in pain severity. CI - Copyright (c) 2011 by the American College of Rheumatology. FAU - Mease, Philip J AU - Mease PJ AD - Swedish Medical Center and University of Washington School of Medicine, Seattle, USA. pmease@philipmease.com FAU - Spaeth, Michael AU - Spaeth M FAU - Clauw, Daniel J AU - Clauw DJ FAU - Arnold, Lesley M AU - Arnold LM FAU - Bradley, Laurence A AU - Bradley LA FAU - Russell, I Jon AU - Russell IJ FAU - Kajdasz, Daniel K AU - Kajdasz DK FAU - Walker, Daniel J AU - Walker DJ FAU - Chappell, Amy S AU - Chappell AS LA - eng SI - ClinicalTrials.gov/NCT00190866 SI - ClinicalTrials.gov/NCT00233025 PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Arthritis Care Res (Hoboken) JT - Arthritis care & research JID - 101518086 RN - 0 (Thiophenes) RN - 9044SC542W (Duloxetine Hydrochloride) SB - IM MH - Adult MH - Double-Blind Method MH - Duloxetine Hydrochloride MH - Female MH - Fibromyalgia/complications/*diagnosis/drug therapy MH - Humans MH - Male MH - Middle Aged MH - Pain/complications/*diagnosis/drug therapy MH - Pain Measurement/methods/*standards MH - *Severity of Illness Index MH - Thiophenes/therapeutic use EDAT- 2011/02/12 06:00 MHDA- 2011/08/04 06:00 CRDT- 2011/02/12 06:00 PHST- 2011/02/12 06:00 [entrez] PHST- 2011/02/12 06:00 [pubmed] PHST- 2011/08/04 06:00 [medline] AID - 10.1002/acr.20449 [doi] PST - ppublish SO - Arthritis Care Res (Hoboken). 2011 Jun;63(6):821-6. doi: 10.1002/acr.20449.