Skip to main content
. 2023 Jun 21;2023(6):CD014788. doi: 10.1002/14651858.CD014788.pub2

Kennedy 1990.

Study characteristics
Methods Trial design: Randomised controlled trial
Participants Participants: 82 women were randomised and analysed.
Mean age: Nafarelin group was 31.5 ± 5.20 years (range = 21 to 41 years), danazol group 30.2 ± 4.89 years (range = 21 to 42 years).
Inclusion criteria:
  • Pelvic pain, dyspareunia, dysmenorrhoea or infertility

  • 24‐36‐day menstrual cycle over the preceding 4 months

  • No hormonal treatment in the preceding 6 months, barrier comtraception throughout study


Exclusion criteria: not stated
Setting: United Kingdom
Timing: not stated
Interventions Nafarelin 200 μg twice daily IN with placebo tablets (n = 55)
versus
Danazol 200 mg three times daily orally  with placebo nasal spray (n = 27)
Outcomes
  • Relief of overall pain: pelvic pain, dyspareunia, dysmenorrhoea

  • Adverse effects

  • Improvement of most troublesome symptom

  • Serum oestradiol levels

  • AFS score

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: Supported by Syntex (U.K.) Ltd., Maidenhead, United Kingdom
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 Randomly allocated, stratification on a 2:1 ratio, according to disease severity. 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 Placebo‐controlled study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Placebo‐controlled study
Incomplete outcome data (attrition bias)
All outcomes Low risk Eight patients did not complete treatment and their scores were omitted; their stages at first laparoscopy were I = 2, II = 4, III = 1, and IV = 1. Four patients withdrew from the nafarelin group because of depression, muscle aches, mastalgia and bloating (1); giddiness, nausea, and vague paraesthesia on the right side of the face and left hand (1); travel abroad (1); and a maculopapular rash (1). Two patients withdrew from the danazol group because of a viral illness (1) and a maculopapular rash (1). One patient from each group was withdrawn from the study because of poor compliance.
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