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. 2023 Jun 21;2023(6):CD014788. doi: 10.1002/14651858.CD014788.pub2

Kiilholma 1995.

Study characteristics
Methods Trial design: Prospective, randomised, double‐blind, placebo‐controlled, comparative study
Participants Participants: 88 women were randomised; 76 women were analysed.
Mean age: Goserelin acetate plus HRT treatment mean 32 years (20‐48 years), goserelin acetate plus placebo treatment mean 34 years (21‐47 years)
Inclusion criteria:
  • Symptomatic patients with total pelvic symptoms score of > 3 with or without infertility

  • Laparoscopical confirmation of endometriosis within 3 months before initiation of treatment


Exclusion criteria: not stated
Setting: Finland
Timing: not stated
Interventions 3.6 mg SC goserelin acetate plus HRT treatment with combination of 2 mg 17β‐E2 and 1 mg norethisterone acetate (NET; Kliogest; Novo Nordisk AS, Bagsvaerd, Denmark)  (n = 43) 
versus
3.6 mg SC goserelin acetate plus placebo  (n = 45)
Outcomes
  • Relief of overall pain: pelvic symptoms 

  • Adverse effects

  • Total revised AFS and total Additive Diameter of Implants scores

  • Serum hormone levels

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: Supported by Zeneca Pharma, Helsinki, Finland.
Author could not be contacted due to lack of information.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Prospective, randomized, double‐blind, placebo‐controlled, comparative study". No further details of method used to generate the randomisation sequence were provided.
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 Low risk Double‐blind, placebo‐controlled study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Incomplete outcome data (attrition bias)
All outcomes Low risk 76/88 completed study. 35/43 goserelin acetate with hormone replacement therapy and 41/45 goserelin acetate plus placebo group.
Two patients discontinued the treatment because of side effects that were considered to be related to the treatment. One of them (goserelin acetate plus placebo) experienced severe depression and the other one had continuous bleeding (goserelin acetate plus HRT). Three women had pregnancy confirmed during the post‐treatment follow‐up period. Two patients underwent surgery for endometriosis, one woman started hormonal contraception, two women were treated with hormonal or IVF therapy for infertility, one patient needed hormonal therapy for a disease other than endometriosis, and one patient did not return. 
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