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Table 3 Outcome data for individual studies: HT users versus non-users

From: The effect of hormone therapy on quality of life and breast cancer risk after risk-reducing salpingo-oophorectomy: a systematic review

Outcome First author Tool of assessment N of analysis Mean differenceab Measure of association (95% CI)c P value Duration of follow-up
General QOL Tucker [32] SF-36 ​–​ total 108 Systemic HT = 1.76 - 0.57 NA
93 Local HT = 3.3 - 0.86
SF-36 – pain 108 Systemic HT = 14.64 - <0.01
93 Local HT = 4.85 - 0.75
SF-36 – physical 108 Systemic HT = 7.15 - 0.38
93 Local HT = 5.34 - 0.52
SF-36 – emotional 108 Systemic HT = -0.50 - 0.50
93 Local HT = -5.5 - 0.27
SF-36 – social 108 Systemic HT = -3.67 - 0.82
93 Local HT = 3.66 - 0.92
SF-36 – energy 108 Systemic HT = 0.6 - 0.42
93 Local HT = 3.66 - 0.87
SF-36 – general health 108 Systemic HT = 4.55 - 0.55
93 Local HT = 3.37 - 0.96
Menopause specific QOL Challberg [33] FACT-ESd – total 141 3.1 - 0.09 NA
Chapman [37] MSLe – total 51 -1.1 - 0.06 NA
Finch [38] MENQOL Interventione – total 73 -3.37f - <0.01 13.6 months (10.8–21.8)
MENQOL – vasomotor 73 -3.4 - <0.01
MENQOL – physical 73 -0.38 - 0.28
MENQOL – psychosocial 73 -0.07 - 0.89
MENQOL – sexual 73 -1.22 - 0.02
Heiniger [29] MRSe 38 NS - >0.05 3 yearsg
Madalinska [34] FACT-ESd – total 164 3.4 - 0.03 NA
Tucker [32] MENQOLe – total 108 Systemic HT = -2.76f - <0.01  
93 Local HT = -2.23f - <0.01
MENQOL – vasomotor 108 Systemic HT = -1.08 - 0.02
93 Local HT = -1.04 - 0.22
MENQOL – physical 108 Systemic HT = -0.74 - 0.03
93 Local HT = -0.54 - 0.38
MENQOL – psychosocial 108 Systemic HT = -0.1 - 0.36
93 Local HT = -0.1 - 0.91
MENQOL – sexual 108 Systemic HT = -0.84 - 0.03
93 Local HT = -0.55 - 0.74
Breast cancer Eisen [21] Self-reportedh 124 - OR = 0.48(0.19-1.21) 0.12 NA
Kotsopoulos [31] Same study as Eisen but an updated analysis Self-reported 210 - OR = 1.06(0.58-1.96) 0.85 NA
OR = 1.06(0.52-2.18) - Breast cancer risk with HT use of3 years vs. never use 0.87  
     OR = 1.06 (0.41-2.71) - Breast cancer risk with HT use of >3 years vs. never use 0.91  
Gabriel [28] Self-reportedh 60 - OR = 0.31(0.09-1.04)f >0.05 NS
OR = 0.48(0.1-2.1) - Breast cancer risk with ET only (no cases with EPT) >0.05
Rebbeck [20] Medical records, operative notes, and pathology reports 155 - HR = 3.93(0.51-30.50)i >0.05 2.6 years (0.1-19.1)
HR = 2.56(0.08-78.13) Breast cancer risk with EPT vs. ET >0.05
Vasomotor symptoms Challberg [33] FACT-ESj 141 - Hot flashes OR = 0.55(0.23-1.28)f >0.05 NA
Night sweats OR = 0.28(0.11-0.76)f <0.05
Finch [38] Self-reported 73 - Hot flashes OR = 0.27(0.09-0.80)f 0.03 13.6 months (10.8–21.8)
Madalinska [34] FACT-ESj 164 - Hot flashes OR = 0.34(0.17-0.70)f <0.01 NA
Night sweats OR = 0.51(0.26-1.00)f 0.04
Sexual function Finchk [38] SAQd 61 Pleasure = 1.22   0.50 13.6 months (10.8–21.8)
Discomfort = 1.92 0.03
Habit = 0.19 0.10
Heiniger [29] SAQd 38 NS for all 3 dimensions - >0.05  
Johansen [36] SAQl 157 Pleasure systemic HT (both ET and EPT) = 0.9 - >0.05  
102 Pleasure local HT = -1.5 - >0.05
116 Pleasure systemic ET = 0.8   >0.05
111 Pleasure systemic EPT = 0.5   >0.05
112 Pleasure systemic tibolone = 1.5   >0.05
157 Discomfort systemic HT (both ET and EPT) = -1.2   <0.01
102 Discomfort local HT = -0.7   0.2
116 Discomfort systemic ET = -1.1   0.04
111 Discomfort systemic EPT = -1.2   0.02
112 Discomfort systemic tibolone = -1.39   <0.01
Madalinska [34] SAQd 164 Pleasure = 0.4   0.70 NA
Discomfort = 0.4 0.17
Habit = 0.1 0.45
  Tucker [32] FSFIdm – total 108 Systemic HT 5.36 OR = 0.40(0.12-1.31); P = 0.130 Risk of FSD with systemic HT 0.14 NA
93 Local HT 7.61 OR = 0.22(0.05-0.95);
P = 0.043 Risk of FSD with local HT
0.07
FSFI – desiren 108 Systemic HT 0.09 OR = 0.77(0.23-2.52) P = 0.66 Risk of HSDD with systemic HT 0.83
93 Local HT 0.52 OR = 0.29(0.07-1.28); P = 0.10 Risk of HSDD with local HT 0.25
FSFI – arousal 108 Systemic HT 0.57 - 0.63
93 Local HT 1.35 - 0.09
FSFI – lubricationo 108 Systemic HT 1.39 OR = 0.38(0.12-1.19); P = 0.10 Risk of lubrication difficulty with systemic HT 0.04
93 Local HT 1.84 OR = 0.29(0.05-1.53); P = 0.14 Risk of lubrication difficulty with local HT 0.03
FSFI – paino 108 Systemic HT 1.97 OR = 0.16(0.03-0.81);
P = 0.03 Risk of dyspareunia with systemic HT
<0.01
93 Local HT 1.55 OR = 0.99(0.22-4.47); P = 0.99 Risk of dyspareunia with local HT 0.05
FSFI – orgasmo 108 Systemic HT 0.71 OR = 0.35(0.10-1.21); P = 0.10 Risk of orgasm difficulty with systemic HT 0.40
93 Local HT 1.47 OR = 0.57(0.10-3.15); P = 0.52 Risk of orgasm difficulty with local HT 0.13
FSFI – satisfactiono 108 Systemic HT 0.62 OR = 0.36(0.11-1.14); P = 0.08 Risk of dissatisfaction with sex life with systemic HT 0.25
93 Local HT 0.86 OR = 0.88(0.19-4.06); P = 0.87 Risk of dissatisfaction of sex life with local HT 0.36
FSDS-Rp 108 Systemic HT -4.07 OR = 0.36(0.16-1.13); P = 0.08 Risk of sexual distress with systemic HT 0.07
93 Local HT -2.34 OR = 1.28(0.30-5.41); P = 0.74 Risk of sexual distress with local HT 0.94
Loss of interest in sex Challberg [33] FACT-ESj 141   OR = 0.68(0.34-1.37)f >0.05 NA
Madalinska [34] FACT-ESj 164   OR = 0.66(0.30-1.47)f 0.35 NA
Vaginal dryness Challberg [33] FACT-ESj 141   OR = 0.48(0.20-1.16)f >0.05 NA
Finch [38] MENQOL Interventione 73 -1.22   0.02 13.6 months (10.8–21.8)
Madalinska [34] FACT-ESj 164 - OR = 0.47(0.21-1.07)f >0.05 NA
Tucker24 MENQOL – sexual 108 Systemic HT = -0.84 - 0.03  
93 Local HT = -0.55 - 0.74  
FSFI – lubricationo 108 Systemic HT 1.39 OR = 0.38(0.12-1.19); P = 0.10 Risk of lubrication difficulty with systemic HT 0.04  
Bone loss prevention Challberg[33]   93 Local HT 1.84 OR = 0.29(0.05-1.53); P = 0.14 Risk of lubrication difficulty with local HT 0.03 NA
Chapman [37] DXA scan 31 - OR = 0.41(0.07-2.41)fi >0.05 NA
Garcia [30] DXA scan 198   OR = 0.84(0.26-2.74) >0.05 NA
Cardiovasc-ular disease Michelsen [35] Physical measurements, blood samples and self-administered questionnaire 326 - NS >0.05 NA
  1. Bold values indicate statistical significance; CI confidence interval, QOL Quality of life, SF-36 FACT-ES 18-item functional assessment of cancer therapy-endocrine score, NA Not applicable (due to cross-sectional nature of data), MSL menopause symptoms list, MENQOL menopause-specific quality of life, MRS Menopause rating scale, SAQ Sexual activity questionnaire, FSFI Female Sexual Function index, FSD Female sexual dysfunction, FSDS-R Female sexual distress scale- revised, HSDD Hypoactive sexual desire disorder
  2. amean score of users minus the mean score of non-users; bcontinuous outcome; cdiscrete outcome; dhigher score indicates improvement of symptoms; ehigher score indicates worsening of symptoms; fmeasures of effect not reported in primary study but calculated from reported data(unadjusted); g menopausal symptoms and sexual activity were measured only once in the follow-up interview, no baseline assessment for these variables were performed; hdiagnosis confirmed through medical records and pathology reports; iauthors contacted for measure of effect and 95% CI as not reported in published paper; jindividual symptoms of the FACT-ES scale were dichotomized (symptom present was considered to be a response in either of the two highest categories, “very much” and “quite a bit”); kstandard deviation for sexual activity questionnaire domains was not reported in study, values were imputed from Madalinska et al. for meta-analysis[59]; la higher pleasure score indicates high pleasure and a higher discomfort score indicates higher discomfort; mFSFI- total score is dichotomized to identify risk of FSD with those scoring ≤26.55 considered likely to have FSD; nFSFI-desire sub-score is dichotomized to identify the risk of HSDD with those scoring ≤5 having a high likelihood of HSDD; odichotomization criterion of these sub-scores was not reported in the primary study; pa cutoff score of ≥11 on the FSDS-R was used to indicate high levels of sexual distress