Table 1

Study characteristics.

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


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.

Kunath et al. BMC Medicine 2012 10:96   doi:10.1186/1741-7015-10-96

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