DePalo 1993.
Methods | Multi‐centre RCT | |
Participants | 771 women randomised
Women with stage 1 with no myometrial involvement did not receive any adjuvant treatment 138 (17.9%) Median age ranged between 58 and 61 across all MPA and no MPA comparisons (women with R1‐R3). 601 (83%) women had adenocarcinoma histological type, 80 (11%) had adenoacanthoma, 4 (0.5%) had clear cell, 29 (4%) had adenosquamous and 4 (0.5%) women had undifferentiated histology. 399 (55.5%) had myometrial invasion classified as M1, 192 (26.75%) as M2 and 127 (17.75%) classified as M3. |
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Interventions | Oral Medroxy progesterone 100mg twice daily for 1 year | |
Outcomes | Overall death rates
Endometrial cancer deaths
Intercurrent deaths
Relapse from disease Adverse events (only reported in the treatment arm) |
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Notes | Patient withdrawals; disease more than stage 1 on review, patient refusal, intercurrent disease Data only available for intention to treat analysis Progestagen group 327 women Control group 370 women Duration of follow‐up 84 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Concealment of allocation is most likely adequate because there was central randomisation, but it is uncertain, "Quality control of data was performed at a centralised data centre". |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | % analysed: 718/718 (100%) |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |