Zupi 2005.
Study characteristics | ||
Methods | Trial design: Randomised, controlled study | |
Participants | Participants: 150 women were randomised and analysed. Mean age: Group A: 35.8 ± 5.1 Group B: 35.1 ± 4.8 Group C: 36.1 ± 5.3 Inclusion criteria:
Exclusion criteria: not stated Setting: Italy Timing: March 1, 2000 to February 28, 2003 |
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Interventions | Group A: GnRH‐a plus add‐back therapy = leuprolide acetate (Enantone Depot 11.25 mg; Takeda, Rome, Italy) every 3 months for 12 months plus transdermal E2 (25 μg Esclima; Takeda) and daily oral norethindrone (5 mg Primolut‐Nor; Schering, Berlin, Germany) (n = 46) Group B: GnRH‐a alone = leuprolide acetate (Enantone Depot 11.25 mg; Takeda) every 3 months for 12 months (n = 44) Group C: oestroprogestin alone = received oral ethinyl E2 (30 μg ) plus gestodene daily (0.75 mg Ginoden; Schering) for 12 consecutive months (n = 43) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: yes Funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomized by means of a computer‐generated randomization number sequence" |
Allocation concealment (selection bias) | Unclear risk | No details of method used to conceal allocation were provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details provided of blinding of participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The VAS and SF‐36 were administered to the patients by a nurse who was blind to the study before treatment, after 6 and 12 months of therapy, and 6 months after discontinuation of treatment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
Selective reporting (reporting bias) | Low risk | The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | No other risk of bias detected |
ADI: additive diameter of implants score AFS: American Fertility Society AIDS: acquired immune deficiency syndrome ASRM: American Society for Reproductive Medicine BD: twice daily BMD: bone mineral density BMI: Body Mass Index DMPA: Depot medroxyprogesterone acetate DNG: dienogest E2: oestradiol ESS: Endometriosis symptom severity FSH: Follicle‐Stimulating Hormone GnRHa: Gonadotropin Releasing Hormone Agonist HRT: Hormone Replacement Therapy Im: intramuscular IN: intranasally IVF: in vitro fertilization LA: leuprolid acetate LH: luteinizing hormone LNG‐IUS: Levonorgestrel‐Intrauterine System NSAID: Nonsteroidal anti‐inflammatory drugs OC: oral contraceptive OCP: oral contracteptive pill Pap: Papanicolaou PO: per os PRL: prolactin PTH: Parathyroid hormone QID: four times a day rAFS: revised American Society for Reproductive Medicine SC: subcutaneously SD: standard deviation SEM: standard error of mean SF‐36: Short Form Health Survey ‐ 36 T4: Thyroxine TDS: three times daily IU: intra‐uterine VAS: Visual Analogue Scale 17β‐E2: 17β‐estradiol