Cameron 1990.
| Methods | Single‐centre with parallel‐group design MBL over 2 cycles assessed in 102 women with a subjective complaint of HMB. 20 women refused to collect sanitary pads, 10 women had anovulatory cycles and 40 women had MBL < 80 mL/cycle. The remaining women (n = 32) were randomized to treatment arms. No power calculation or ITT analysis No source of funding stated | |
| Participants | Patients aged 21‐51 years recruited from the Outpatient Department, Royal Infirmary, Edinburgh, UK
Inclusion criteria:
Exclusions:
|
|
| Interventions |
Duration over 2 cycles |
|
| Outcomes | MBL Number of days bleeding Cycle length Side effects Patient compliance | |
| Notes | Original data provided by the lead author | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization technique centralized and controlled by pharmacy |
| Allocation concealment (selection bias) | Low risk | Adequate |
| Blinding of participants and personnel (performance bias) PBAC, satisfaction, Adverse effect, response to treatment, bleeding | High risk | No blinding, lack of blinding likely to influence outcomes |
| Blinding of participants and personnel (performance bias) Haematin alkaline | Low risk | No blinding, lack of blinding unlikely to influence outcomes |
| Blinding of outcome assessment (detection bias) PBAC, satisfaction, Adverse effect, response to treatment | High risk | No blinding, lack of blinding likely to influence outcomes |
| Blinding of outcome assessment (detection bias) Haematin Alkaline | Low risk | No blinding, lack of blinding unlikely to influence outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals/exclusions reported |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Low risk |
Similar at baseline: groups balanced on baseline Disclaimer: not stated CoI: not stated Source of funding: Not stated |