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. 2019 Apr 26;2019(4):CD004055. doi: 10.1002/14651858.CD004055.pub2

Comparison 34. Oral retinoids: alitretinoin versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Primary: investigator‐rated good/excellent control of symptoms 3   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
1.1 Alitretinoin 40 mg vs placebo 1 159 Risk Ratio (M‐H, Random, 95% CI) 1.97 [1.30, 3.00]
1.2 Alitretinoin 30 mg vs placebo 2 1210 Risk Ratio (M‐H, Random, 95% CI) 2.75 [2.20, 3.43]
1.3 Alitretinoin 20 mg vs placebo 1 158 Risk Ratio (M‐H, Random, 95% CI) 1.49 [0.94, 2.34]
1.4 Alitretinoin 10 mg vs placebo 2 781 Risk Ratio (M‐H, Random, 95% CI) 1.58 [1.20, 2.07]
2 Primary: investigator‐rated good/excellent control of symptoms hyperkeratotic eczema 2   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
2.1 Alitretinoin 40 mg vs placebo hyperkeratotic eczema 1 131 Risk Ratio (M‐H, Random, 95% CI) 2.61 [1.61, 4.23]
2.2 Alitretinoin 30 mg vs placebo hyperkeratotic eczema 1 519 Risk Ratio (M‐H, Random, 95% CI) 3.94 [2.60, 5.97]
2.3 Alitretinoin 20 mg vs placebo hyperkeratotic eczema 1 136 Risk Ratio (M‐H, Random, 95% CI) 1.72 [1.02, 2.90]
2.4 Alitretinoin 10 mg vs placebo hyperkeratotic eczema 2 662 Risk Ratio (M‐H, Random, 95% CI) 2.05 [1.47, 2.86]
3 Primary: investigator‐rated good/excellent control of symptoms pompholyx 2   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
3.1 Alitretinoin 40 mg vs placebo pompholyx 1 37 Risk Ratio (M‐H, Random, 95% CI) 1.66 [0.58, 4.72]
3.2 Alitretinoin 30 mg vs placebo pompholyx 1 166 Risk Ratio (M‐H, Random, 95% CI) 2.04 [1.06, 3.91]
3.3 Alitretinoin 20 mg vs placebo pompholyx 1 38 Risk Ratio (M‐H, Random, 95% CI) 0.9 [0.26, 3.08]
3.4 Alitretinoin 10 mg vs placebo pompholyx 2 197 Risk Ratio (M‐H, Random, 95% CI) 1.30 [0.70, 2.39]
4 Primary: investigator‐rated good/excellent control of symptoms fingertip 2   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
4.1 Alitretinoin 40 mg vs placebo fingertip 1 51 Risk Ratio (M‐H, Random, 95% CI) 1.77 [0.81, 3.86]
4.2 Alitretinoin 30 mg vs placebo fingertip 1 297 Risk Ratio (M‐H, Random, 95% CI) 2.49 [1.59, 3.89]
4.3 Alitretinoin 20 mg vs placebo fingertip 1 53 Risk Ratio (M‐H, Random, 95% CI) 1.18 [0.50, 2.77]
4.4 Alitretinoin 10 mg vs placebo fingertip 2 330 Risk Ratio (M‐H, Random, 95% CI) 1.51 [0.99, 2.29]
5 Primary: participant‐rated investigator‐rated good/excellent control of symptoms 3   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
5.1 Alitretinoin 40 mg vs placebo 1 147 Risk Ratio (M‐H, Random, 95% CI) 3.51 [1.80, 6.82]
5.2 Alitretinoin 30 mg vs placebo 2 1210 Risk Ratio (M‐H, Random, 95% CI) 2.75 [2.18, 3.48]
5.3 Alitretinoin 20 mg vs placebo 1 147 Risk Ratio (M‐H, Random, 95% CI) 2.74 [1.37, 5.46]
5.4 Alitretinoin 10 mg vs placebo 2 765 Risk Ratio (M‐H, Random, 95% CI) 1.73 [1.25, 2.40]
6 Primary: adverse events alitretinoin 10 mg vs placebo 2   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
6.1 All adverse events 1 158 Risk Ratio (M‐H, Random, 95% CI) 1.01 [0.66, 1.55]
6.2 Headache 2 781 Risk Ratio (M‐H, Random, 95% CI) 1.10 [0.38, 3.19]
6.3 Dry lips 2 781 Risk Ratio (M‐H, Random, 95% CI) 0.50 [0.05, 4.66]
6.4 Flushing 2 781 Risk Ratio (M‐H, Random, 95% CI) 1.16 [0.28, 4.70]
6.5 Dry mouth 2 781 Risk Ratio (M‐H, Random, 95% CI) 1.98 [0.53, 7.44]
6.6 Erythema 2 781 Risk Ratio (M‐H, Random, 95% CI) 1.11 [0.33, 3.71]
6.7 Eczema 2 781 Risk Ratio (M‐H, Random, 95% CI) 0.80 [0.38, 1.68]
6.8 Conjunctivitis 1 158 Risk Ratio (M‐H, Random, 95% CI) 0.49 [0.05, 5.27]
6.9 Eye pruritus 1 158 Risk Ratio (M‐H, Random, 95% CI) 0.98 [0.06, 15.32]
6.10 Fatigue 1 158 Risk Ratio (M‐H, Random, 95% CI) 2.93 [0.12, 70.75]
6.11 Rigors 1 158 Risk Ratio (M‐H, Random, 95% CI) 2.93 [0.12, 70.75]
6.12 Tonsilitis 2 781 Risk Ratio (M‐H, Random, 95% CI) 0.51 [0.15, 1.70]
6.13 Pharyngitis 2 781 Risk Ratio (M‐H, Random, 95% CI) 0.82 [0.44, 1.54]
6.14 Influenza 1 623 Risk Ratio (M‐H, Random, 95% CI) 1.23 [0.39, 3.86]
6.15 Nausea 1 623 Risk Ratio (M‐H, Random, 95% CI) 1.63 [0.45, 5.88]
6.16 Elevated blood creatinine kinase 2 781 Risk Ratio (M‐H, Random, 95% CI) 1.43 [0.73, 2.80]
6.17 Elevated blood triglycerides 2 781 Risk Ratio (M‐H, Random, 95% CI) 1.03 [0.56, 1.88]
7 Primary: adverse events alitretinoin 20 mg vs placebo 1   Risk Ratio (M‐H, Random, 95% CI) Totals not selected
7.1 All adverse events 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.2 Headache 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.3 Dry lips 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.4 Flushing 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.5 Dry mouth 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.6 Erythema 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.7 Eczema 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.8 Conjunctivitis 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.9 Eye pruritus 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.10 Fatigue 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.11 Rigors 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.12 Tonsilitis 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
7.13 Pharyngitis 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
8 Primary: adverse events alitretinoin 30 mg vs placebo 2   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
8.1 Headache 2 1210 Risk Ratio (M‐H, Random, 95% CI) 3.43 [2.45, 4.81]
8.2 Dry lips 1 614 Risk Ratio (M‐H, Random, 95% CI) 1.88 [0.63, 5.59]
8.3 Flushing 2 1210 Risk Ratio (M‐H, Random, 95% CI) 7.28 [2.05, 25.86]
8.4 Dry mouth 1 614 Risk Ratio (M‐H, Random, 95% CI) 2.51 [0.55, 11.33]
8.5 Erythema 2 1210 Risk Ratio (M‐H, Random, 95% CI) 5.79 [2.09, 16.06]
8.6 Eczema 1 614 Risk Ratio (M‐H, Random, 95% CI) 0.65 [0.29, 1.46]
8.7 Pharyngitis 2 1210 Risk Ratio (M‐H, Random, 95% CI) 0.82 [0.49, 1.36]
8.8 Influenza 2 1210 Risk Ratio (M‐H, Random, 95% CI) 1.17 [0.45, 3.06]
8.9 Nausea 2 1210 Risk Ratio (M‐H, Random, 95% CI) 3.82 [1.67, 8.76]
8.10 Elevated blood creatinine kinase 1 614 Risk Ratio (M‐H, Random, 95% CI) 1.63 [0.54, 4.93]
8.11 Elevated blood triglycerides 2 1210 Risk Ratio (M‐H, Random, 95% CI) 7.05 [1.89, 26.28]
8.12 Dizziness 1 596 Risk Ratio (M‐H, Random, 95% CI) 2.0 [0.61, 6.57]
8.13 Upper respiratory tract infection 1 596 Risk Ratio (M‐H, Random, 95% CI) 1.54 [0.78, 3.04]
8.14 Sinusitis 1 596 Risk Ratio (M‐H, Random, 95% CI) 0.89 [0.35, 2.27]
8.15 Rash 1 596 Risk Ratio (M‐H, Random, 95% CI) 1.5 [0.54, 4.16]
8.16 Vomiting 1 596 Risk Ratio (M‐H, Random, 95% CI) 8.00 [1.01, 63.57]
8.17 Arthralgia 1 596 Risk Ratio (M‐H, Random, 95% CI) 1.2 [0.37, 3.89]
8.18 Depression 1 596 Risk Ratio (M‐H, Random, 95% CI) 2.33 [0.61, 8.94]
8.19 Laceration 1 596 Risk Ratio (M‐H, Random, 95% CI) 13.0 [0.74, 229.73]
8.20 Tinnitus 1 596 Risk Ratio (M‐H, Random, 95% CI) 4.33 [1.25, 15.05]
8.21 Cough 1 596 Risk Ratio (M‐H, Random, 95% CI) 2.25 [0.70, 7.23]
8.22 Hypertriglceridaemia 1 596 Risk Ratio (M‐H, Random, 95% CI) 6.0 [0.73, 49.53]
9 Primary: adverse events alitretinoin 40 mg vs placebo 1   Risk Ratio (M‐H, Random, 95% CI) Totals not selected
9.1 All adverse events 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.2 Headache 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.3 Dry lips 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.4 Flushing 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.5 Dry mouth 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.6 Erythema 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.7 Eczema 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.8 Conjunctivitis 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.9 Eye pruritus 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.10 Fatigue 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.11 Rigors 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.12 Tonsilitis 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
9.13 Pharyngitis 1   Risk Ratio (M‐H, Random, 95% CI) 0.0 [0.0, 0.0]
10 Secondary: investigator‐rated reduction in severity in total lesion symptom score     Other data No numeric data
10.1 Alitretinoin 40 mg     Other data No numeric data
10.2 Alitretinoin 30 mg     Other data No numeric data
10.3 Alitretinoin 20 mg     Other data No numeric data
10.4 Alitretinoin 10 mg     Other data No numeric data
11 Secondary: investigator‐rated reduction in severity in total lesion symptom score     Other data No numeric data
11.1 Alitretinoin 40 mg vs placebo     Other data No numeric data
11.2 Alitretinoin 20 mg vs placebo     Other data No numeric data
11.3 Alitretinoin 10 mg vs placebo     Other data No numeric data
12 Secondary: reduction in severity, investigator‐rated in modified total lesion symptom score (bigger reduction in severity scored negative = better outcome) 1   Mean Difference (IV, Random, 95% CI) Totals not selected