Six studies were included (n=1,740 participants): four RCTs (n=1,041) and two nonrandomised controlled studies (n=699). Sample size ranged from 110 to 435. Study duration ranged from 12 to 24 months. The authors stated that all studies met criteria for concealment of allocation, blinding of outcome assessment and treatment of withdrawals. Drop-out rates ranged from 4% to 39%.
At one-year follow-up, tight control regimens were associated with a statistically significant improvement in DAS-28 scores compared to usual care for all studies combined (WMD random-effects model 0.59, 95% CI 0.22 to 0.97; significant heterogeneity I2=80%) and for RCTs (WMD random-effects model 0.65, 95% CI 0.10 to 1.21; level of heterogeneity not reported).
Tight control regimens that incorporated a protocol for treatment adjustment were associated with a statistically significant improvement in DAS-28 scores compared to usual care (WMD random-effects model 0.97, 95% CI 0.64 to 1.30; three studies, significant heterogeneity I2=61%). The authors stated that heterogeneity was mostly due to one study with large efficacy and a small number of patients.
Tight control regimens that did not incorporate a protocol for treatment adjustment were associated with a small statistically significant improvement in DAS-28 scores (WMD fixed-effect model 0.25, 95% CI 0.03 to 0.46; three studies, no significant heterogeneity).