Hendrix 2005 S.
| Methods | RCT, 25,597 women Central randomisation, computer‐based selection, double‐blind dispensing Follow up at one year and then a subsample after 3 years Baseline QOL, questionnaire, interview, examination and bloods | |
| Participants | RCT of hormone replacement for prevention of coronary heart disease and hip fracture, with and without symptoms of stress, urgency urinary or mixed incontinence at baseline
Women all aged between 50‐79 years, post‐menopausal Incontinent (wet) women (Populations 1 and 2) Population 1: (hysterectomy) N=6528 at baseline, outcome data at one year N=5920 Population 2: (with uterus) N=9889 at baseline, outcome data at one year N=9121 Continent (dry) women (Populations 3 and 4) Population 3: (hysterectomy) N=3473 at baseline, outcome data at one year N=3073 Population 4: (with uterus) N=5707 at baseline, outcome data at one year N=5182 All women on HRT treatment at baseline had to have 3 month washout Whole sample comparable at baseline on age, education, illness, menopause, parity, breastfeeding history, hormone use, hysterectomy status, physical activity and smoking Exclusion criteria: breast CA, other invasive carcinoma in the last ten years, venous thromboembolism, hypertriglyceridaemia, medical condition which may result in death in the next three years, unwilling or unable to be randomised to placebo, severe menopausal symptoms at washout All women had a four week trial with placebo to which they had to show 80% adherence |
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| Interventions | Population 1 (wet at baseline, without uterus): group A (2950): conjugated equine oestrogen alone group B (2970): matching placebo Population 2 (wet at baseline, with uterus): group C (n=4572): conjugated equine oestrogen + medroxyprogesterone acetate group D (n=4549): matching placebo Population 3 (continent at baseline, without uterus): group E (1526): conjugated equine oestrogen alone group F (1547): matching placebo Population 4 (continent at baseline, with uterus): group G (2675): conjugated equine oestrogen alone group H (2507): matching placebo | |
| Outcomes | Population 1 (wet at baseline, without uterus)
Likelihood of worsening amount of UI: A versus B: RR = 1.59 (95% CI 1.39 to 1.82)
Likelihood of worsening frequency of UI: A versus B: RR = 1.47 (1.35 to 1.61)
Likelihood of limitation of activities related to UI: A versus B: RR = 1.29 (1.15 to 1.45) Population 2 (wet at baseline, with uterus) Likelihood of worsening amount of UI: C versus D: RR = 1.20 (95% CI 1.06 to 1.36) Likelihood of worsening frequency of UI: C versus D: RR = 1.38 (1.28 to 1.49) Likelihood of limitation of activities related to UI: C versus D: RR = 1.18 (1.06 to 1.32) Worsening was not related to one type of urinary incontinence alone Population 3 (dry at baseline) Any UI at 1 year: E, 557/1526, F, 368/1547 RR=1.53 (1.37 to 1.71) Stress UI at 1 year: E, 266/1526, F, 131/1547 RR=2.15 (1.77 to 2.62) Urgency UI at 1 year: E, 210/1526, F, 184/1547 RR=1.32 (1.10 to 1.58) Mixed UI at 1 year: E, 76/1526, F, 50/1547 RR=1.79 (1.26 to 2.53) Population 4 (dry at baseline) Any UI at 1 year: G, 834/2675; H, 563/2507 RR=1.39 (1.27 to 1.52) Stress UI at 1 year: G, 429/2675; H, 218/2507 RR=1.87 (1.61 to 2.18) Urgency UI at 1 year: G, 304/2675, H, 272/2507 RR=1.15 (0.99 to 1.34) Mixed UI at 1 year: G, 99/2675, H, 69/2507 RR=1.49 (1.10 to 2.01) |
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| Notes | No data suitable for meta‐analysis were provided in the original report but these have been requested Data used in generic inverse variance analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The study pill bottles had unique bar codes and computer based selection to enable double blinded dispensing" |
| Allocation concealment (selection bias) | Low risk | "Randomization was performed using a study database distributed by the WHI Clinical Coordinating Center to the local centres" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double blind, clinic staff and participants |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | At 1 year vital status was known for 99.9% of participants in the oestrogen + progesterone trial and 100% for those in oestrogen only trial?? At 1 year 9.7% of women taking oestrogen + progesterone and 6.6% taking placebo stopped taking the pills Oestrogen alone 8.4% and placebo 8% stopped taking the pills |