Table 2.
The individual change in Likert score in 48-items of the KARISMA symptom questionnaire from baseline to end of treatment (at 6 months or date of discontinuation), contrasting the placebo to the group treated with 20 mg of tamoxifen, for all women combined and stratified by menopausal status.
| All (N = 401) | Premenopausal (n = 149) | Postmenopausal (n = 252) | Interaction menopausal status | ||||
|---|---|---|---|---|---|---|---|
| Group symptom |
Mean change 20 to 0 mg (ref.)a |
95% confidence interval | Mean change 20 to 0 mg (ref.)a |
95% confidence interval | Mean change 20 to 0 mg (ref.)a |
95% confidence interval | P valueb |
| Vasomotor | |||||||
| Hot flashes | 0.39 | [0.19, 0.59] | 0.44 | [0.10, 0.79] | 0.36 | [0.11, 0.60] | 0.694 |
| Cold sweats | 0.35 | [0.20, 0.50] | 0.30 | [0.06, 0.53] | 0.38 | [0.19, 0.58] | 0.575 |
| Night sweats | 0.45 | [0.24, 0.67] | 0.55 | [0.16, 0.95] | 0.39 | [0.14, 0.64] | 0.503 |
| Gynaecological/breast | |||||||
| Vaginal discharge | 0.51 | [0.35, 0.68] | 0.41 | [0.10, 0.72] | 0.60 | [0.41, 0.78] | 0.301 |
| Vaginal itching/irritation | 0.28 | [0.12, 0.43] | 0.26 | [−0.01, 0.53] | 0.29 | [0.09, 0.49] | 0.850 |
| Vaginal bleeding or spotting | −0.07 | [−0.16, 0.02] | −0.09 | [−0.32, 0.14] | −0.05 | [−0.12, 0.01] | 0.785 |
| Vaginal dryness | −0.04 | [−0.23, 0.15] | 0.18 | [−0.07, 0.43] | −0.19 | [−0.45, 0.08] | 0.050 |
| Problems with urination | 0.06 | [−0.01, 0.12] | 0.06 | [−0.08, 0.20] | 0.05 | [−0.02, 0.12] | 0.885 |
| Sensitive/tender breasts | −0.04 | [−0.19, 0.10] | −0.28 | [−0.56, −0.01] | 0.11 | [−0.05, 0.27] | 0.014 |
| Sexual | |||||||
| Pain or discomfort with intercourse | 0.15 | [−0.04, 0.33] | 0.14 | [−0.07, 0.35] | 0.14 | [−0.13, 0.42] | 0.991 |
| Lost interest in sex | 0.07 | [−0.18, 0.33] | −0.33 | [−0.72, 0.07] | 0.34 | [0.01, 0.67] | 0.011 |
| Musculoskeletal | |||||||
| Joint pain | −0.05 | [−0.26, 0.15] | −0.13 | [−0.43, 0.16] | 0.00 | [−0.27, 0.27] | 0.518 |
| Muscle cramps | 0.66 | [0.47, 0.86] | 0.41 | [0.12, 0.70] | 0.83 | [0.57, 1.08] | 0.034 |
| Numbness in hands/ feet | 0.01 | [−0.11, 0.13] | −0.09 | [−0.27, 0.09] | 0.08 | [−0.08, 0.23] | 0.164 |
| Skin/subcutaneous/mucous | |||||||
| Fragile mucous membranes | 0.05 | [−0.12, 0.22] | 0.12 | [−0.12, 0.36] | 0.00 | [−0.24, 0.23] | 0.465 |
| Dry mouth | 0.12 | [0.01, 0.22] | 0.15 | [−0.03, 0.33] | 0.09 | [−0.05, 0.23] | 0.608 |
| Skin rashes | 0.16 | [0.02, 0.30] | 0.30 | [0.04, 0.56] | 0.08 | [−0.08, 0.24] | 0.166 |
| Itching | 0.18 | [0.05, 0.32] | 0.22 | [−0.02, 0.47] | 0.16 | [−0.01, 0.33] | 0.674 |
| Hair loss | −0.05 | [−0.21, 0.10] | −0.18 | [−0.39, 0.04] | 0.03 | [−0.19, 0.25] | 0.183 |
| Metabolism/nutrition | |||||||
| Gained weight | −0.02 | [−0.22, 0.18] | −0.11 | [−0.44, 0.22] | 0.04 | [−0.20, 0.28] | 0.475 |
| Feeling bloated | 0.04 | [−0.15, 0.22] | −0.04 | [−0.37, 0.29] | 0.10 | [−0.12, 0.31] | 0.496 |
| Swollen arms/legs | 0.04 | [−0.03, 0.11] | 0.07 | [−0.04, 0.19] | 0.02 | [−0.06, 0.10] | 0.436 |
| Abdominal obesity | −0.01 | [−0.17, 0.15] | −0.01 | [−0.26, 0.24] | −0.01 | [−0.23, 0.20] | 0.989 |
| Gastrointestinal | |||||||
| Diarrhoea | −0.16 | [−0.28, −0.03] | −0.21 | [−0.43, 0.01] | −0.13 | [−0.28, 0.03] | 0.558 |
| Constipation | −0.03 | [−0.16, 0.10] | −0.11 | [−0.33, 0.12] | 0.02 | [−0.14, 0.18] | 0.373 |
| Nausea | −0.06 | [−0.18, 0.06] | −0.23 | [−0.47, 0.02] | 0.04 | [−0.09, 0.16] | 0.063 |
| Vomiting | −0.07 | [−0.15, 0.01] | −0.07 | [−0.23, 0.09] | −0.08 | [−0.15, 0.00] | 0.956 |
| Lack of appetite | 0.05 | [0.00, 0.09] | 0.08 | [0.00, 0.16] | 0.03 | [−0.03, 0.08] | 0.296 |
| Change in the way food taste | 0.01 | [−0.02, 0.04] | 0.01 | [−0.01, 0.04] | 0.01 | [−0.04, 0.06] | 0.918 |
| Difficulty swallowing | 0.00 | [−0.06, 0.06] | 0.00 | [0.00, 0.00] | 0.00 | [−0.09, 0.10] | 0.975 |
| Psychological | |||||||
| Mood swings | 0.05 | [−0.12, 0.22] | 0.00 | [−0.30, 0.30] | 0.10 | [−0.10, 0.30] | 0.586 |
| Feeling irritable | 0.07 | [−0.10, 0.24] | −0.02 | [−0.31, 0.26] | 0.13 | [−0.08, 0.35] | 0.381 |
| Feeling nervous | −0.13 | [−0.23, −0.02] | −0.17 | [−0.36, 0.02] | −0.09 | [−0.21, 0.03] | 0.466 |
| Feeling sad | −0.12 | [−0.28, 0.04] | −0.25 | [−0.60, 0.09] | −0.03 | [−0.19, 0.12] | 0.265 |
| Worrying | 0.00 | [−0.16, 0.16] | −0.01 | [−0.31, 0.29] | 0.02 | [−0.16, 0.21] | 0.855 |
| Lack of energy | −0.07 | [−0.25, 0.10] | −0.09 | [−0.38, 0.20] | −0.04 | [−0.26, 0.17] | 0.786 |
| Difficulty concentrating | −0.07 | [−0.19, 0.06] | −0.07 | [−0.30, 0.16] | −0.05 | [−0.20, 0.09] | 0.900 |
| Sleeping difficulties | −0.16 | [−0.39, 0.08] | −0.12 | [−0.50, 0.27] | −0.18 | [−0.48, 0.11] | 0.780 |
| Feeling drowsy | 0.02 | [−0.08, 0.11] | −0.04 | [−0.21, 0.14] | 0.05 | [−0.05, 0.16] | 0.404 |
| “I don’t look like myself” | 0.00 | [−0.14, 0.13] | −0.07 | [−0.29, 0.15] | 0.04 | [−0.13, 0.21] | 0.445 |
| Nervous system | |||||||
| Pain | −0.18 | [−0.40, 0.05] | −0.39 | [−0.79, 0.01] | −0.06 | [−0.33, 0.21] | 0.177 |
| Dizziness | 0.04 | [−0.11, 0.18] | −0.04 | [−0.28, 0.20] | 0.09 | [−0.08, 0.27] | 0.366 |
| Headache | 0.08 | [−0.11, 0.27] | 0.21 | [−0.16, 0.57] | 0.01 | [−0.20, 0.22] | 0.365 |
| Heart palpitations | 0.03 | [−0.09, 0.14] | 0.09 | [−0.10, 0.27] | −0.01 | [−0.16, 0.15] | 0.455 |
| Respiratory | |||||||
| Cough | 0.01 | [−0.15, 0.18] | −0.10 | [−0.33, 0.14] | 0.08 | [−0.15, 0.31] | 0.279 |
| Shortness of breath | 0.07 | [−0.04, 0.18] | 0.13 | [−0.04, 0.31] | 0.04 | [−0.11, 0.18] | 0.404 |
| Eyes | |||||||
| Sight/eye changes | 0.06 | [−0.14, 0.26] | 0.01 | [−0.30, 0.33] | 0.08 | [−0.17, 0.33] | 0.746 |
| Dry eyes | 0.06 | [−0.11, 0.24] | 0.09 | [−0.19, 0.37] | 0.05 | [−0.18, 0.27] | 0.801 |
aDifference in mean change comparing 20 to 0 mg (ref.) tamoxifen at end of treatment (at 6 months or date of discontinuation).
bP values for interaction of menopausal status on the effect of tamoxifen.
Significant values are in bold (P < 0.05).