Barakat 2006.
| Methods | Stated purpose: to determine the effect of oestrogen therapy on recurrence rate and survival in women who have undergone surgery for stage I or II endometrial cancer Stratification: stratified by stage No, of women screened for eligibility: unclear No. randomised: 1236 (see Notes) No. analysed: 1236 Losses to follow‐up: none stated Adherence to treatment: 41% in HT group, 50% in placebo group at trial end Analysis by intention to treat: yes No. of centres: not stated Years of recruitment: June 1997 to January 2003 Design: parallel Funding: National Cancer Institute grant | |
| Participants | Included Women post total hysterectomy and bilateral salpingo‐oophorectomy (at least) for surgically staged stage I or II endometrial cancer within 20 weeks of study entry, with indication for use of oestrogen therapy including hot flushes, vaginal atrophy, increased risk of CHD or increased risk of osteoporosis. Had to have undergone clinical exam with history, pelvic exam and chest X‐ray before study entry. Normal hepatic function and normal mammogram or negative breast biopsy within previous year Excluded Women with history or suspicion of breast cancer or other malignancy with exception of non‐melanoma skin cancer within past 5 years or with history of acute liver disease or thromboembolic disease Median age: 57 Age range: 26‐91 Means of recruitment: not stated Baseline equality of treatment groups: well balanced Country: USA | |
| Interventions | HT arm: 0.625 mg CEE (unopposed oestrogen) Control arm: placebo Duration: planned for 3 years with 2 years' additional follow‐up. Closed early with median follow‐up 35.7 months | |
| Outcomes | Total deaths CHD deaths Coronary event deaths Endometrial cancer deaths Endometrial cancer (recurrence) | |
| Notes | Enrolment decreased after WHI was published in July 2002. Study closed prematurely owing to poor accrual. In addition, preponderance of participants had low risk profile, so low event rate meant power unlikely to be reached with original power calculation. This study planned to enrol 2108 women. Numbers randomised not entirely clear: Study refers to 1236 "eligible and assessable women". |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Remotely generated |
| Allocation concealment (selection bias) | Low risk | Remotely dispensed drugs |
| Incomplete outcome data (attrition bias) All outcomes | High risk | No losses to follow‐up reported, but numbers randomised not entirely clear: Study refers to 1236 "eligible and assessable women". |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and physicians blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Review authors believe risk of bias low owing to 'hard' nature of outcomes |
| Selective reporting (reporting bias) | Low risk | All expected outcomes reported |
| Other bias | Low risk | No apparent source of other bias |