Quality of life assessment during six months of NSAID treatment [Gonarthrosis and Quality of Life (GOAL) Study].
OBJECTIVE
To identify the time point of the greatest degree of improvement in daily living activities, pain and depression in patients with osteoarthritis (OA) of the knee during 6 months of treatment with NSAIDs, in order to define compliance and drop-out rate.


METHODS
107 patients were recruited into a multicentre, prospective, randomized, controlled trial comparing two treatments, piroxicam-beta-cyclodextrin (PBCD) and slow release diclofenac (DCL).


RESULTS
The greatest improvement in quality of life occurred in both groups after 3 months, with a slight further gain observed by the end of treatment. The Stanford Health Assessment Questionnaire score improved (p < 0.05 vs baseline) at 3 and 6 months with PBCD and at 6 months with DCL. The Arthritis Impact Measurement Scale score improved (p < 0.05 vs baseline) after 6 months in both groups. Significant (p < 0.05 vs baseline) improvement in other psychological and pain scores were recorded in both groups after 3 and 6 months. Compliance with treatment at 3 months was 73% for PBCD and 72% for DCL, and was 60% in both groups at 6 months.


CONCLUSIONS
The results of this study indicate that the optimal length of time for an NSAID trial in OA patients is 3 months, when assessment of daily living activities is considered as the main outcome criterion.
La Montagna
G
G
Istituto di Clinica Medica, Divisione di Medicina Generale e Reumatologia.
Tirri
G
G
Cacace
E
E
Perpignano
G
G
Covelli
M
M
Pipitone
V
V
D'Agostino
P
P
Magarò
M
M
Ferraccioli
G
G
Mascia
M T
MT
Manzini
E
E
Minari
C
C
Barreca
C
C
Marcolongo
R
R
Paresce
E
E
Colombo
B
B
D000203:Activities of Daily Living; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D003505:Cyclodextrins / Q000008:administration & dosage* / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007719:Knee Joint; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy* / Q000523:psychology*; D010349:Patient Compliance; D010352:Patient Dropouts; D010894:Piroxicam / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D047392:beta-Cyclodextrins
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003505:Cyclodextrins; D004338:Drug Combinations; D047392:beta-Cyclodextrins; D010894:Piroxicam; D004008:Diclofenac; C061072:piroxicam-beta-cyclodextrin