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Table 1 Study characteristics.

From: Tamoxifen for the management of breast events induced by non-steroidal antiandrogens in patients with prostate cancer: a systematic review

  Boccardo 2005 Fradet 2007 Perdona 2005 Saltzstein 2005
Design RCT, three arms RCT, six armsb RCT, three arms RCT, three arms
Intervention tamoxifen 20 mg/d (37 patients) tamoxifen 20 mg/d (35 patients) tamoxifen 10 mg/d (50 patients) tamoxifen 20 mg/d (35 patients)
Control    - anastrozole 1 mg/d (36 patients);    - placebo (60 patients)b    - radiotherapy (single fraction of 12 Gy, (50 patients);    - anastrozole 1 mg/d (36 patients);
     - placebo (40 patients)      - no additional therapy (51 patients)    - placebo (36 patients)
Assessment of gynecomastia by breast ultrasound or caliper. ("Severity was scored on the basis of the largest diameter as follows: grade 1, ≤ 2 cm; grade 2, more than 2 to ≤ 4 cm; grade 3, more than 4 to ≤ 6 cm; and grade 4, more than 6 cm.") by patient questioning and calipers ("recorded in centimeters to the nearest 0.5 cm") by calipers ("Severity was scored on the basis of the largest diameter: grade 1 (≤ 2 cm); grade 2 (from 2 to ≤ 4 cm); grade 3 (from 4 cm to ≤ 6 cm); and grade 4 (> 6 cm))" by physical examination and direct patient questioning ("Criteria for a response to randomized therapy was the complete absence of gynecomastia and/or breast pain.")
Assessment of breast pain by direct patient questioning at each visit ("scored according to severity as none, mild to moderate, or severe")a by direct patient questioning ("rated as mild (awareness of signs or symptoms but easily tolerated), moderate (discomfort sufficient to cause interference with normal activities), or severe (incapacitating resulting in an inability to perform normal activities") by direct patient questioning at each visit ("scored as none, mild, moderate, or severe") by direct patient questioning ("Criteria for a response to randomized therapy was the complete absence of gynecomastia and/or breast pain.")
Random sequence generation randomization lists for each center computer random number generator permuted randomization algorithm sequential order, numbers were not reused, schedule prepared at each center
Allocation concealment unclear central allocation central allocation central allocation
Blinding of participants/personnel double-blind, placebo-controlled double-blind, placebo-controlled no double-blind, placebo-controlled
Blinding of outcome assessment double-blind, placebo-controlled double-blind, placebo-controlled no or not mentioned double-blind, placebo-controlled
Incomplete outcome data low risk of biasc low risk of biasc low risk of biasc low risk of biasc
Selective reporting low risk of biasd low risk of biasd low risk of biasd low risk of biasd
Other remarks recruitment was stopped early because of planned interim analysis, research funding by AstraZeneca (no role in study design, analysis or interpretation of data) co-author is an employee of AstraZeneca, writing support funded by AstraZeneca authors declared no conflict of interest co-authors are employees of AstraZeneca, no conflict of interest mentioned in manuscript
  1. aWe included the following pain degrees: mild to moderate, severe; bThis study compared multiple dosages of tamoxifen (1, 2.5, 5, 10, or 20 mg daily) with placebo. In this review, we included only the groups treated with tamoxifen 20 mg compared with placebo; cWe found no evidence for missing outcome data. Additionally, outcome data were presented by intention-to-treat; dThe study protocol is not available, but we assume that the published reports include all evaluated outcomes. RCT, randomized controlled trial.