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

Cheng 2005.

Study characteristics
Methods Trial design: "Randomised, parallel, comparative study" 
Participants Participants: 59 women eligible; 59 were randomised and 41 were analysed for efficacy.
Mean age: 34.8 ± 6.6 (nafarelin) and 32.4 ± 7.2 (danazol)
Inclusion criteria:
  • Laparoscopically diagnosed within 3 months prior to study

  • Age 18‐48 years

  • Barrier contraception


Exclusion criteria:
  • Pregnancy

  • Breastfeeding

  • Menopause or postmenopausal

  • Use of oestrogen, progesterone or contraceptive steroids in previous 3 months

  • Impaired hepatic or renal function

  • Cardiovascular disease

  • AIDS or other sexually transmitted diseases


Setting: Taiwan
Timing: started in January 1998 and ended in October 2000
Interventions Nafarelin acetate 200 μg twice daily (400 μg/day) IN for 180 days (n = 29)
versus
Danazol 200 mg (600 mg/day) PO for 180 days (n = 30)
Outcomes
  • Total symptom severity score and physician‐assessed pelvic tenderness

  • Change in laparoscopic score

  • Adverse effects

  • Serum lipid levels

  • Haematology and liver function

Notes Intention‐to‐treat analysis: yes
Sample size calculation: not stated
Funding: This study was partly supported by a grant (VGH94‐ 195) from Taipei Veterans General Hospital, Taipei, Taiwan, R.O.C.
Note previous version: Authors provided additional data on methods.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation done by a pharmacy. Authors provided additional data to previous authors, and therefore this study was assigned as having low risk of bias.
Allocation concealment (selection bias) Low risk Sealed, opaque, sequentially numbered, identical envelopes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Investigators, outcome assessors and clinicians were blinded according to author.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Investigators, outcome assessors and clinicians were blinded according to author.
Incomplete outcome data (attrition bias)
All outcomes Low risk "All 59 patients were considered as the intent‐to‐treat population".
Forty‐one of 59 patients (22/29 nafarelin and 19/30 danazol recipients) who completed 90 days’ treatment, and who underwent laparoscopic examinations before and after treatment, qualified for the efficacy evaluation.
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