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. 2016 Oct 5;160(2):223–236. doi: 10.1007/s10549-016-4002-x

Table 2.

Adverse effects reported in the randomized controlled trials

Study ID Number of participants Total no. of AE (no. of participants with AE) Type of AE
Treatment Control Treatment Control
Biglia [39] Gabap. n = 60 Vit E 55 17 (60) 0 (55) Somnolence, dizziness, dry mouth, nervousness, weight gain
Boekhout [31] Venl 41. Clon 41. Placebo n = 20 Venl 206 (41) Clon163 (41) 82 (20) Reduced appetite, nausea, sleepiness, dizziness, fatigue, dry mouth, sweating, constipation
Buijs [36] Venlafaxine n = 30 Clonidine n = 30 27 (30) 5 (30) Headache, dizziness, dry mouth, mood disorder
Carpenter [32] (high dose)* Venlafaxine n = 9 Placebo n = 9 Dry mouth p = 0.002 vs placebo ** NR Dry mouth
Carpenter [32] (low dose)* Venlafaxine n = 26 Placebo n = 26 Constipation p = 0.001 headaches p = 0.007 dry mouth p = 0.001 vs placebo ** NR Constipation, headache, dry mouth
Goldberg [38] Clonidine n = 55 Placebo n = 55 dry mouth (p < .001) constipation (.02) itchiness (.01) NR Drowsiness, dry mouth, constipation, itching
Loibl [42] Venlafaxine n = 33 Clonidine n = 31 38 (27) 14 (27) Loss of appetite, sleeplessness, nausea, drowsiness, tiredness, sweating, constipation, restless sleep, nervousness, moodiness, dry mouth
Loprinzi [33] (High dose)* Venlafaxine 150 mg n = 54 Placebo n = 56 43(54) 2 (56) Decreased appetite, nausea, dry mouth, constipation
Loprinzi [33] (Low dose) * Venlafaxine 37.5 mg n = 56. Placebo n = 56 14 (56) 2 (56) Decreased appetite, nausea, dry mouth, constipation
Loprinzi [33](Medium dose)* Venlafaxine 75 mg n = 55. Placebo n = 56 18 (55) 2 (56) Decreased appetite, nausea, dry mouth, constipation
Maclaughlan [40] Gabapentine. n = 14 Hypnotherapy n = 13 3 (24) 0 (13) Fatigue, vertigo
Mao [41] Gabapentin 900 mg/day = 28 El.acupuncture = 30 Gabapentin 13 (28) 5 (30) Bruising, constipation, dizziness, dry mouth, fatigue, headache, increased pain, drowsiness
Pandya [37] Clonidine n = 99 Placebo 99 41 (99) 21 (99) Difficulty sleeping
Pandya [34] (high dose) * Gabapentine 900 mg n = 116 Placebo n = 113 10 (120) 6 (113) Appetite, distress, drowsiness, fatigue, nausea, pain, memory, shortness of breath, sleep, vomiting
Pandya [34] (low-dose study)* Gabapentine 300 mg n = 114 Placebo n = 119 6 (114) 6 (113) Appetite, distress, drowsiness, fatigue, nausea, pain, memory, shortness of breath, sleep, vomiting
Walker [20] Venlafaxine n= 25 Acupuncture n=25 28 (25) 0 (25) Nausea, dry mouth, headache, difficulty sleeping, double vision, increased blood pressure, constipation, anxiety, lightheaded, jittery
SUM 627 (774)
Study ID Grade 1-5 (CTCAE)
Treatment
G1 G2 G3 G4 G5
Biglia [39] 5 12
Boekhout [31] V 104. Cl 93 V. 102, Cl 70
Buijs [36] 16 11
Carpenter [32] (high dose)*
Carpenter [32] (low dose)*
Goldberg [38]
Loibl [42] 38
Loprinzi [33] (High dose)* 40 3
Loprinzi [33] (Low dose) * 13 1
Loprinzi [33](Medium dose)* 17 1
Maclaughlan [40] 3
Mao [41] 13
Pandya [37] 41
Pandya [34] (high dose) * 10
Pandya [34] (low-dose study)* 6
Walker [20] 28
SUM 417 210 0 0 0
Study ID Grade 1-5 (CTCAE)
Control
G1 G2 G3 G4 G5
Biglia [39] 0
Boekhout [31] 40 42
Buijs [36] 5
Carpenter [32] (high dose)*
Carpenter [32] (low dose)*
Goldberg [38]
Loibl [42] 14
Loprinzi [33] (High dose)* 2
Loprinzi [33] (Low dose) * 2
Loprinzi [33](Medium dose)* 2
Maclaughlan [40]
Mao [41] 5
Pandya [37] 21
Pandya [34] (high dose) * 6
Pandya [34] (low-dose study)* 6
Walker [20] 0
SUM 98 47 0 0 0