Document Detail

A randomized, double-blind, crossover clinical trial of diclofenac plus misoprostol versus acetaminophen in patients with osteoarthritis of the hip or knee.
MedLine Citation:
PMID:  11465710     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To perform a randomized, double-blind, crossover clinical trial of diclofenac + misoprostol versus acetaminophen in ambulatory patients with osteoarthritis of the hip or knee. METHODS: Patients in 12 ambulatory care settings were eligible if they were age >40 years and if they had Kellgren/Lawrence radiographic grade 2-4 osteoarthritis of the knee or hip and a score of > or =30 mm on a 100-mm visual analog pain scale. Patients were randomized to one of two groups, 75 mg diclofenac + 200 microg misoprostol twice daily or 1,000 mg acetaminophen 4 times daily (each for 6 weeks), and were then crossed over to the other treatment for 6 weeks. A placebo was included in each treatment regimen to enable double blinding. The primary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index and the visual analog pain scale of the Multidimensional Health Assessment Questionnaire. Safety was assessed using a standard form to review adverse events. RESULTS: We enrolled 227 patients, of whom 218 provided data for the first treatment period and 181 provided data for both treatment periods. Significantly higher levels of improvement in the primary outcomes were seen for diclofenac + misoprostol than for acetaminophen (P < 0.001). Adverse events were more common when patients took diclofenac + misoprostol (P = 0.046). Diclofenac + misoprostol was rated as "better" or "much better" by 57% of the 174 patients who provided such ratings for both treatment periods, while acetaminophen was rated as "better" or "much better" by 20% of these patients, and 22% reported no difference (P < 0.001). Differences favoring diclofenac + misoprostol over acetaminophen were greater in patients with more severe osteoarthritis according to baseline pain scores, radiographs, or number of involved joints. CONCLUSION: Patients with osteoarthritis of the hip or knee had significantly greater improvements in pain scores over 6 weeks with diclofenac + misoprostol than with acetaminophen, although patients with mild osteoarthritis had similar improvements with both drugs. Acetaminophen was associated with fewer adverse events.
T Pincus; G G Koch; T Sokka; J Lefkowith; F Wolfe; J M Jordan; G Luta; L F Callahan; X Wang; T Schwartz; S B Abramson; J R Caldwell; R A Harrell; J M Kremer; R L Lautzenheiser; J A Markenson; T J Schnitzer; A Weaver; P Cummins; A Wilson; S Morant; J Fort
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Arthritis and rheumatism     Volume:  44     ISSN:  0004-3591     ISO Abbreviation:  Arthritis Rheum.     Publication Date:  2001 Jul 
Date Detail:
Created Date:  2001-07-23     Completed Date:  2001-08-16     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370605     Medline TA:  Arthritis Rheum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1587-98     Citation Subset:  AIM; IM    
Division of Rheumatology and Immunology, Vanderbilt University, Nashville, Tennessee 37232-4500, USA.
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MeSH Terms
Acetaminophen / administration & dosage*,  adverse effects
Analgesics, Non-Narcotic / administration & dosage*,  adverse effects
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*,  adverse effects
Anti-Ulcer Agents / administration & dosage*,  adverse effects
Cross-Over Studies
Diclofenac / administration & dosage*,  adverse effects
Double-Blind Method
Drug Therapy, Combination
Middle Aged
Misoprostol / administration & dosage*,  adverse effects
Osteoarthritis, Hip / drug therapy*
Osteoarthritis, Knee / drug therapy
Pain Measurement
Patient Satisfaction
Treatment Outcome
Reg. No./Substance:
0/Analgesics, Non-Narcotic; 0/Anti-Inflammatory Agents, Non-Steroidal; 0/Anti-Ulcer Agents; 103-90-2/Acetaminophen; 15307-86-5/Diclofenac; 59122-46-2/Misoprostol
Comment In:
Arthritis Rheum. 2001 Jul;44(7):1477-80   [PMID:  11465696 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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