Page 122 - SPONDYLOARTHRITIS IN COLOMBIA -

The median number of AS patients per trial was similar (60 versus 61) in the ‘control’ vs the ‘implementation group’. Median study duration was slightly higher in the ‘control’ group in comparison to the ‘implementation’ group (20 vs 16 week). Trials evaluating the efficacy of NSAIDs (52% vs 8%; p0.001) and DMARDs (21% vs 6%; p=0.06), were more frequently found in the ‘control’ group as compared to the ‘implementation’ group. However, trials evaluating biological drugs (45% vs 0%; p0.001) and also physical therapy (27% vs 10%; p=0.03), were more frequently represented in the ‘implementation’ group as compared to the ‘control’ group. The main characteristics of the RCTs in both groups are shown in table 2.
In trials evaluating interventions with DMARDs, biologics and glucocorticoids, 5 out of 26 trials (19%) in the ‘implementation group’ but none of the trials in the ‘control group’, included all domains of the core-set. In trials with all other types of interventions -including NSAIDS-, a full set of domains was used in 8 out of 25 trials (32%) of the ‘implementation group’ and in 1 out of 36 trials (3%) of the ‘control group’.
Table 2 Characteristics of Randomized Controlled Trials selected for detailed review
Control group (before April 2001)
Implementation group (after April 2001)
mean ± SD N. patients (n) 117 ± 140
(n = 48)
median Min, Max 60 (35-140) 60 (33-134) 20 (6-36)
%
52 21.3 0 4.3 10.6 0 12.8
mean ± SD 131 ± 145 126 ± 145 24.0 ± 20.6
n
4 3 23 0 14 4 3
(n= 51)
median Min, Max 61 (45-185) 58 (45-154) 16 (12-24)
%
7.8 5.9 45.1 0 27.5 7.8 5.9
p value ¶ 0.7 0.6 0.8
< 0.001 0.06 < 0.001 0.2 0.03 0.05 0.4
N. Axial SpA patients
(n)
Study duration (weeks)
Intervention
NSAIDs DMARDs Biological drugs Glucocorticoids Physical therapy Balneotherapy Miscellaneous*
114 ± 138 24.8 ± 27.7
N
25 10 0 2 5 0 6
*Miscellaneous interventions: fish oil capsules, pamidronate, levamisole, amitriptilyne, probiotic oral therapy, formicarufa, cognitive-behavioural therapy. ¶ p values are for comparison between groups.
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