Table 4.
The individual change in Likert score from baseline to end of treatment (at 6 months or date of discontinuation), comparing all doses, including placebo to the 20 mg tamoxifen arm, for all women combined and stratified by menopausal status.
| Tamoxifen dose in mg | ||||||||
|---|---|---|---|---|---|---|---|---|
| Symptom | N | 0 | 1 | 2.5 | 5 | 10 | 20 | Association with dose |
| Mean change (95% CI)a | Mean change (95% CI)a | Mean change (95% CI)a | Mean change (95% CI)a | Mean change (95% CI)a | Ref. | P valueb | ||
| Vasomotor | ||||||||
| Hot flashes | ||||||||
| All | 1161 | −0.39 (−0.59, −0.18) | −0.20 (−0.40, 0.01) | 0.02 (−0.18, 0.23) | 0.08 (−0.13, 0.29) | 0.17 (−0.03, 0.38) | Ref. | 0.002 |
| Premenopausal | 446 | −0.44 (−0.77, −0.11) | −0.34 (−0.66, −0.02) | −0.11 (−0.43, 0.21) | −0.06 (−0.39, 0.27) | 0.26 (−0.06, 0.58) | Ref. | 0.002 |
| Postmenopausal | 715 | −0.36 (−0.62, −0.10) | −0.09 (−0.36, 0.18) | 0.11 (−0.16, 0.38) | 0.17 (−0.10, 0.44) | 0.12 (−0.14, 0.39) | Ref. | 0.097 |
| Night sweats | ||||||||
| All | 1166 | −0.45 (−0.67, −0.24) | −0.10 (−0.32, 0.11) | −0.08 (−0.30, 0.13) | 0.09 (−0.13, 0.31) | 0.06 (−0.16, 0.27) | Ref. | 0.003 |
| Premenopausal | 450 | −0.55 (−0.92, −0.18) | −0.23 (−0.58, 0.13) | −0.18 (−0.54, 0.18) | −0.10 (−0.46, 0.27) | 0.08 (−0.28, 0.44) | Ref. | 0.010 |
| Postmenopausal | 716 | −0.39 (−0.65, −0.13) | −0.02 (−0.29, 0.25) | −0.01 (−0.28, 0.25) | 0.21 (−0.06, 0.48) | 0.05 (−0.21, 0.32) | Ref. | 0.090 |
| Cold sweats | ||||||||
| All | 1162 | −0.35 (−0.51, −0.19) | −0.27 (−0.43, −0.10) | −0.15 (−0.31, 0.01) | −0.10 (−0.26, 0.06) | −0.12 (−0.28, 0.04) | Ref. | <0.001 |
| Premenopausal | 448 | −0.30 (−0.52, −0.07) | −0.31 (−0.53, −0.09) | −0.14 (−0.36, 0.08) | −0.20 (−0.42, 0.03) | 0.02 (−0.2, 0.24) | Ref. | 0.001 |
| Postmenopausal | 714 | −0.38 (−0.6, −0.17) | −0.23 (−0.45, 0.00) | −0.16 (−0.38, 0.06) | −0.04 (−0.26, 0.18) | −0.21 (−0.43, 0.01) | Ref. | 0.006 |
| Gynaecological/breast | ||||||||
| Vaginal discharge | ||||||||
| All | 1167 | −0.51 (−0.71, −0.31) | −0.06 (−0.26, 0.14) | 0.15 (−0.05, 0.35) | −0.10 (−0.30, 0.10) | 0.20 (−0.01, 0.40) | Ref. | 0.002 |
| Premenopausal | 450 | −0.41 (−0.73, −0.09) | −0.04 (−0.35, 0.27) | 0.10 (−0.22, 0.41) | −0.35 (−0.66, −0.03) | 0.05 (−0.27, 0.36) | Ref. | 0.131 |
| Postmenopausal | 717 | −0.60 (−0.84, −0.35) | −0.06 (−0.32, 0.19) | 0.19 (−0.06, 0.44) | 0.05 (−0.20, 0.30) | 0.28 (0.03, 0.53) | Ref. | 0.003 |
| Vaginal itching/irritation | ||||||||
| All | 1164 | −0.28 (−0.43, −0.12) | −0.06 (−0.22, 0.1) | −0.06 (−0.21, 0.1) | −0.09 (−0.25, 0.07) | −0.06 (−0.22, 0.09) | Ref. | 0.021 |
| Premenopausal | 452 | −0.26 (−0.53, 0.01) | −0.01 (−0.27, 0.25) | 0.03 (−0.23, 0.30) | −0.06 (−0.33, 0.20) | −0.07 (−0.33, 0.19) | Ref. | 0.412 |
| Postmenopausal | 719 | −0.29 (−0.48, −0.10) | −0.09 (−0.29, 0.11) | −0.11 (−0.31, 0.09) | −0.10 (−0.30, 0.10) | −0.06 (−0.26, 0.14) | Ref. | 0.020 |
| Sensitive/tender breasts | ||||||||
| All | 1172 | 0.04 (−0.09, 0.17) | −0.06 (−0.19, 0.07) | −0.12 (−0.25, 0.01) | −0.05 (−0.18, 0.08) | −0.09 (−0.22, 0.04) | Ref. | 0.725 |
| Premenopausal | 452 | 0.28 (0.02, 0.54) | 0.16 (−0.09, 0.42) | −0.05 (−0.30, 0.21) | 0.06 (−0.20, 0.32) | 0.11 (−0.15, 0.36) | Ref. | 0.170 |
| Postmenopausal | 720 | −0.11 (−0.25, 0.02) | −0.21 (−0.35, −0.07) | −0.18 (−0.31, −0.04) | −0.12 (−0.26, 0.01) | −0.22 (−0.35, −0.08) | Ref. | 0.021 |
| Sexual | ||||||||
| Lost interest in sex | ||||||||
| All | 947 | −0.07 (−0.34, 0.19) | −0.10 (−0.36, 0.16) | 0.11 (−0.15, 0.38) | −0.09 (−0.36, 0.17) | 0.12 (−0.14, 0.38) | Ref. | 0.476 |
| Premenopausal | 412 | 0.33 (−0.07, 0.72) | 0.00 (−0.39, 0.39) | 0.39 (−0.01, 0.78) | 0.10 (−0.29, 0.50) | 0.34 (−0.05, 0.72) | Ref. | 0.319 |
| Postmenopausal | 535 | −0.34 (−0.68, 0.00) | −0.18 (−0.53, 0.17) | −0.09 (−0.43, 0.26) | −0.26 (−0.62, 0.10) | −0.07 (−0.42, 0.29) | Ref. | 0.087 |
| Musculoskeletal | ||||||||
| Muscle cramps | ||||||||
| All | 1169 | −0.66 (−0.85, −0.48) | −0.44 (−0.63, −0.25) | −0.26 (−0.45, −0.07) | −0.17 (−0.36, 0.02) | −0.04 (−0.22, 0.15) | Ref. | <0.001 |
| Premenopausal | 450 | −0.41 (−0.68, −0.14) | −0.28 (−0.54, −0.02) | −0.09 (−0.35, 0.17) | −0.16 (−0.42, 0.11) | 0.12 (−0.14, 0.38) | Ref. | 0.002 |
| Postmenopausal | 719 | −0.83 (−1.07, −0.58) | −0.54 (−0.8, −0.29) | −0.37 (−0.63, −0.12) | −0.19 (−0.45, 0.07) | −0.14 (−0.4, 0.11) | Ref. | <0.001 |
| Skin/subcutaneous/mucous | ||||||||
| Dry mouth | ||||||||
| All | 1175 | −0.12 (−0.23, 0) | −0.08 (−0.2, 0.03) | 0.04 (−0.07, 0.16) | 0.02 (−0.1, 0.14) | −0.05 (−0.17, 0.07) | Ref. | 0.250 |
| Premenopausal | 454 | −0.15 (−0.31, 0.01) | −0.12 (−0.27, 0.04) | −0.06 (−0.22, 0.1) | −0.04 (−0.2, 0.12) | −0.18 (−0.33, −0.02) | Ref. | 0.195 |
| Postmenopausal | 721 | −0.09 (−0.25, 0.07) | −0.07 (−0.23, 0.1) | 0.11 (−0.05, 0.28) | 0.06 (−0.1, 0.23) | 0.03 (−0.13, 0.19) | Ref. | 0.575 |
| Skin rashes | ||||||||
| All | 1156 | −0.16 (−0.3, −0.01) | −0.14 (−0.29, 0.01) | −0.09 (−0.24, 0.05) | −0.06 (−0.21, 0.09) | −0.15 (−0.29, 0.00) | Ref. | 0.058 |
| Premenopausal | 446 | −0.30 (−0.52, −0.07) | −0.14 (−0.36, 0.08) | −0.08 (−0.30, 0.14) | 0.00 (−0.22, 0.23) | −0.07 (−0.29, 0.15) | Ref. | 0.047 |
| Postmenopausal | 710 | −0.08 (−0.27, 0.11) | −0.14 (−0.34, 0.06) | −0.10 (−0.30, 0.09) | −0.09 (−0.29, 0.10) | −0.20 (−0.39, 0.00) | Ref. | 0.369 |
| Itching | ||||||||
| All | 1175 | −0.18 (−0.32, −0.05) | −0.11 (−0.25, 0.03) | −0.02 (−0.16, 0.12) | −0.05 (−0.19, 0.09) | −0.04 (−0.18, 0.10) | Ref. | 0.033 |
| Premenopausal | 454 | −0.22 (−0.45, 0.00) | −0.15 (−0.37, 0.07) | −0.11 (−0.34, 0.11) | 0.00 (−0.23, 0.23) | −0.10 (−0.32, 0.12) | Ref. | 0.090 |
| Postmenopausal | 721 | −0.16 (−0.33, 0.01) | −0.08 (−0.26, 0.10) | 0.04 (−0.13, 0.22) | −0.07 (−0.25, 0.10) | 0.00 (−0.18, 0.17) | Ref. | 0.172 |
| Gastrointestinal | ||||||||
| Lack of appetite | ||||||||
| All | 1175 | −0.05 (−0.09, 0.00) | −0.01 (−0.06, 0.03) | −0.02 (−0.06, 0.03) | −0.05 (−0.10, −0.01) | −0.04 (−0.08, 0.00) | Ref. | 0.166 |
| Premenopausal | 454 | −0.08 (−0.14, −0.01) | −0.04 (−0.10, 0.03) | −0.04 (−0.10, 0.03) | −0.09 (−0.16, −0.02) | −0.06 (−0.13, 0.00) | Ref. | 0.064 |
| Postmenopausal | 721 | −0.03 (−0.08, 0.03) | 0.00 (−0.06, 0.06) | −0.01 (−0.07, 0.05) | −0.02 (−0.08, 0.04) | −0.03 (−0.08, 0.03) | Ref. | 0.700 |
| Diarrhoea | ||||||||
| All | 1169 | 0.16 (0.04, 0.27) | 0.15 (0.03, 0.27) | 0.17 (0.05, 0.29) | 0.15 (0.03, 0.27) | 0.18 (0.06, 0.30) | Ref. | 0.005 |
| Premenopausal | 451 | 0.21 (−0.01, 0.42) | 0.16 (−0.04, 0.37) | 0.14 (−0.07, 0.35) | 0.19 (−0.02, 0.41) | 0.19 (−0.02, 0.40) | Ref. | 0.066 |
| Postmenopausal | 718 | 0.13 (−0.01, 0.27) | 0.14 (0.00, 0.29) | 0.19 (0.04, 0.33) | 0.12 (−0.03, 0.26) | 0.17 (0.03, 0.32) | Ref. | 0.036 |
| Psychological | ||||||||
| Feeling nervous | ||||||||
| All | 1166 | 0.13 (0.02, 0.23) | 0.06 (−0.05, 0.16) | 0.09 (−0.01, 0.2) | 0.06 (−0.05, 0.16) | 0.16 (0.06, 0.26) | Ref. | 0.110 |
| Premenopausal | 454 | 0.17 (0.00, 0.34) | 0.13 (−0.04, 0.29) | 0.16 (0.00, 0.33) | 0.19 (0.02, 0.36) | 0.18 (0.01, 0.34) | Ref. | 0.040 |
| Postmenopausal | 721 | 0.09 (−0.04, 0.22) | 0.01 (−0.12, 0.15) | 0.05 (−0.08, 0.18) | −0.03 (−0.16, 0.11) | 0.15 (0.02, 0.28) | Ref. | 0.710 |
aDifference in mean change comparing 0 to 20 mg (ref.) tamoxifen at end of treatment (at 6 months or date of discontinuation).
bP values for linear association between dose and symptom severity change.
Significant values are in bold (P < 0.05).