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. 2014 May 27;2014(5):CD003463. doi: 10.1002/14651858.CD003463.pub2

Comparison 3. Patient‐related outcomes: safety.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 BZD mild‐to‐moderate ‐ RCT data only 2 3651 Odds Ratio (M‐H, Random, 95% CI) 3.84 [1.74, 8.44]
1.1 Pruritus 1 709 Odds Ratio (M‐H, Random, 95% CI) 3.83 [2.41, 6.08]
1.2 Mild rash 1 709 Odds Ratio (M‐H, Random, 95% CI) 7.59 [4.79, 12.03]
1.3 Moderate rash 1 709 Odds Ratio (M‐H, Random, 95% CI) 7.78 [4.15, 14.61]
1.4 Unspecified 1 106 Odds Ratio (M‐H, Random, 95% CI) 13.53 [0.74, 246.49]
1.5 Headache 1 709 Odds Ratio (M‐H, Random, 95% CI) 1.22 [0.85, 1.75]
1.6 Insomnia 1 709 Odds Ratio (M‐H, Random, 95% CI) 2.08 [0.88, 4.92]
3 BZD severe side effects 3 9208 Odds Ratio (M‐H, Random, 95% CI) 12.02 [6.07, 23.80]
3.1 Toxic hepatitis 2 1507 Odds Ratio (M‐H, Random, 95% CI) 15.19 [1.84, 125.09]
3.2 Arthritis 1 709 Odds Ratio (M‐H, Random, 95% CI) 10.41 [1.33, 81.75]
3.3 Peripheral neuropathy 2 1507 Odds Ratio (M‐H, Random, 95% CI) 11.69 [2.07, 66.19]
3.4 Lymphadenopathy 1 709 Odds Ratio (M‐H, Random, 95% CI) 19.77 [1.15, 341.06]
3.5 Oedema 1 709 Odds Ratio (M‐H, Random, 95% CI) 4.02 [1.48, 10.88]
3.6 Fever 2 1275 Odds Ratio (M‐H, Random, 95% CI) 10.35 [1.87, 57.36]
3.7 Severe skin reactions 2 1396 Odds Ratio (M‐H, Random, 95% CI) 142.68 [19.64, 1036.38]
3.8 Severe gastrointestinal intolerance 2 1396 Odds Ratio (M‐H, Random, 95% CI) 15.36 [1.86, 126.55]
5 ALLOP ‐ mild‐to‐moderate ‐ RCT data only 2 355 Odds Ratio (M‐H, Random, 95% CI) 1.89 [0.74, 4.85]
5.1 Pyrosis 1 35 Odds Ratio (M‐H, Random, 95% CI) 4.27 [0.20, 89.72]
5.2 Vertigo 1 35 Odds Ratio (M‐H, Random, 95% CI) 0.16 [0.01, 4.32]
5.3 Rash 2 75 Odds Ratio (M‐H, Random, 95% CI) 2.23 [0.41, 12.19]
5.4 Leukopenia 1 35 Odds Ratio (M‐H, Random, 95% CI) 2.91 [0.13, 65.53]
5.5 Lymph node increase 1 35 Odds Ratio (M‐H, Random, 95% CI) 1.67 [0.06, 44.05]
5.6 Vomit 1 35 Odds Ratio (M‐H, Random, 95% CI) 1.67 [0.06, 44.05]
5.7 Stomach ache 1 35 Odds Ratio (M‐H, Random, 95% CI) 1.67 [0.06, 44.05]
5.8 Red Eye 1 35 Odds Ratio (M‐H, Random, 95% CI) 1.67 [0.06, 44.05]
5.9 Pruritus 1 35 Odds Ratio (M‐H, Random, 95% CI) 4.27 [0.20, 89.72]
6 ALLOP ‐ severe side effects 4 2298 Odds Ratio (M‐H, Random, 95% CI) 12.34 [3.23, 47.04]
6.1 Skin severe reactions 3 1286 Odds Ratio (M‐H, Random, 95% CI) 12.42 [2.17, 71.02]
6.2 Fever 1 35 Odds Ratio (M‐H, Random, 95% CI) 7.43 [0.38, 146.72]
6.3 Severe gastrointestinal effects 1 977 Odds Ratio (M‐H, Random, 95% CI) 19.69 [1.06, 366.94]
7 NFTMX ‐ severe side effects 1 3056 Odds Ratio (M‐H, Random, 95% CI) 81.75 [18.97, 352.35]
7.1 Polyneuritis 1 764 Odds Ratio (M‐H, Random, 95% CI) 35.37 [1.69, 742.39]
7.2 Toxic hepatitis 1 764 Odds Ratio (M‐H, Random, 95% CI) 179.83 [10.50, 3079.04]
7.3 Malaise 1 764 Odds Ratio (M‐H, Random, 95% CI) 96.03 [5.36, 1718.90]
7.4 Severe skin reactions 1 764 Odds Ratio (M‐H, Random, 95% CI) 65.04 [3.47, 1217.89]
8 ITRA ‐ severe side effects 1 300 Odds Ratio (M‐H, Random, 95% CI) 3.69 [0.15, 91.35]
9 Drug discontinuation ‐ all populations, all drugs 10 4385 Odds Ratio (M‐H, Random, 95% CI) 11.84 [3.14, 44.70]
9.1 RCT data 5 1056 Odds Ratio (M‐H, Random, 95% CI) 2.65 [0.40, 17.66]
9.2 Non‐RCT data 5 3329 Odds Ratio (M‐H, Random, 95% CI) 42.48 [13.78, 130.95]