Table 7 Changes in SGRQ scores in randomized controlled trials
Study | Treatment duration | Sample size, IPF | Randomized groups | Change from baseline in SGRQ symptoms domain score | Change from baseline in SGRQ activity domain score | Change from baseline in SGRQ impact domain score | Change from baseline in SGRQ total score |
|---|---|---|---|---|---|---|---|
Antoniou et al., 2006 [13] | 12 months | 50 | Interferon gamma b | −13.2 [21.4,5.0] | −4.8 [-12.7, 3.0] | −1.9 [-9.2, 5.4] | −4.7 [-11.4, 2.0] |
Colchicine | 7.5 [-4.5, 19.5] | 4.7 [-12.1, 22.0] | 4.1 [-6.4, 14.6] | 4.8 [-5.9, 15.5] | |||
p-value2 | 0.01 | NS | NS | NS | |||
Han et al., 2013 [17] | 12 weeks | 22 | Sildenafil (with RVSD) | – | – | – | – |
Placebo (with RVSD) | – | – | – | – | |||
Difference1 | −28.0 [-41.7, -14.4] | −5.6 [-16.1, 5.0] | −14.0 [-25.6, -2.4] | −13.4 [-22.7, -4.2] | |||
p-value2 | <0.0001 | NS | 0.02 | 0.005 | |||
97 | Sildenafil (without RVSD) | – | – | – | – | ||
Placebo, (without RVSD) | – | – | – | – | |||
Difference1 | −3.8 [-10.7, 3.0] | −4.1 [-9.2, 1.1] | −1.8 [-7.5, 3.9] | −3.0 [-7.6, 1.7] | |||
p-value2 | NS | NS | NS | NS | |||
Horton et al., 2012 [18] | 12 weeks | 23 | Thalidomide | – | – | – | – |
Placebo | – | – | – | – | |||
Difference1 | −12.1 [22.2,2.0] | −3.3 [-9.8, 3.2] | −13.1 [-19.7, -6.6] | −11.7 [-18.6, -4.8] | |||
p-value2 | 0.018 | NS | <0.001 | 0.001 | |||
King, Jr. et al., 2008 [19] | 6 months4 | 158 | Bosentan | – | – | – | – |
Placebo | – | – | – | – | |||
Difference1 | – | – | – | −3.3 (2.6) | |||
p-value2 | – | – | – | 0.034 | |||
King, Jr. et al., 2009 [20] | 77 weeks | 826 | Interferon gamma b | -- | -- | -- | 5.7 (13.5) |
Placebo | – | – | – | 6.2 (14.3) | |||
p-value2 | – | – | – | NS | |||
Nishiyama et al., 2008 [25] | 10 weeks | 28 | Pulmonary rehabilitation | – | – | – | – |
No pulmonary rehabilitation | – | – | – | – | |||
Difference1 | −5.7 [-18.7, 7.2] | −5.8 [-14.7, 3.1] | −6.2 [-12.8, 0.3] | −6.1 [-11.7, 0.5] | |||
p-value2 | NS | NS | NS | <.05 | |||
Noth et al., 2012 [26] | 28 weeks | 145 | Warfarin | – | – | – | – |
Placebo | – | – | – | – | |||
p-value2 | – | – | – | NS | |||
Raghu et al., 2004 [29] | 48 weeks | 330 | Interferon gamma 1b | – | – | – | – |
Placebo | – | – | – | – | |||
p-value2 | – | – | – | NS | |||
Raghu et al., 2008 [30] | 48 weeks | 88 | Etanercept | – | – | – | -- |
Placebo | – | – | – | -- | |||
Difference1 | – | – | – | -- | |||
p-value2 | NS | NS | NS | NS | |||
Raghu et al., 2013 [31] | 48 weeks | 492 | Ambrisentan | – | – | – | 4.7 |
Placebo | – | – | – | 3.0 | |||
p-value2 | – | – | – | NS | |||
Richeldi et al., 2011 [33] | 12 months | 431 | Nintedanib 50 mg qd | 3.39 (2.51) | 7.39 (1.96) | 3.71 (2.04) | 4.67 (1.78) |
Nintedanib 50 mg bid | 2.11 (2.34) | 3.54 (1.82) | 1.73 (1.90) | 2.18 (1.65) | |||
Nintedanib 100 mg bid | 2.33 (2.35) | 3.00 (1.83) | 0.79 (1.91) | 1.48 (1.66) | |||
Nintedanib 150 mg bid | −3.14 (2.40) | 0.32 (1.89) | −0.14 (1.97) | −0.66 (1.71) | |||
Placebo | 6.45 (2.45) | 7.48 (1.91) | 4.21 (1.99) | 5.46 (1.73) | |||
p-value3 | <0.005 | <0.005 | – | <0.01 | |||
Zisman et al., 2010 [41] | 12 weeks | 180 | Sildenafil | −3.58 [-7.02, -0.13] | −1.15 [-3.68, 1.38] | −0.88 [-3.78, 2.02] | −1.64 [-3.91, 0.64] |
Placebo | 2.15 [-1.30, 5.61] | 2.49 [0.00, 4.99] | 2.82 [-0.03, 5.67] | 2.45 [0.17, 4.72] | |||
Difference1 | −5.73 [-10.61, -0.85] | −3.64 [-7.20, -0.09] | −3.70 [-7.76, 0.37] | −4.08 [-7.30, -0.86] | |||
p-value2 | 0.02 | .04 | NS | .01 |