Kauppila 1979.
Methods | Trial design: 2‐period, 4‐treatment cross‐over trial | |
Participants | 24 women randomised; 18 analysed Mean age: 33 (22‐43) years Inclusion criteria: women with symptomatic endometriosis (stage and severity not described). Endometriosis was diagnosed by laparoscopy (n = 13) and by pelvic examination (n = 5). Exclusion criteria: not clear Setting: Finland Timing: unclear |
|
Interventions | Group 1: indomethacin 25 mg given 3 × daily for 2 menstrual cycles, then cross‐over to acetylsalicylic acid, tolfenamic acid and placebo for 2 menstrual cycles each (n = 6) Group 2: acetylsalicylic acid 500 mg given 3 × daily for 2 menstrual cycles, then cross‐over to tolfenamic acid, placebo and indomethacin for 2 menstrual cycles each (n = 6) Group 3: tolfenamic acid 200 mg given 3 × daily for 2 menstrual cycles, then cross‐over to placebo, indomethacin and acetylsalicylic acid for 2 menstrual cycles each (n = 6) Group 4: placebo given 3 × daily for 2 menstrual cycles, then cross‐over to indomethacin, acetylsalicylic acid and tolfenamic acid for 2 menstrual cycles each (n = 6) |
|
Outcomes | These were self‐reported by questionnaire, which was completed by the participant immediately after each menstrual cycle. Pain relief: pelvic pain, lower back pain, pain in walking, dyspareunia, pain on defecation, headache; number not reported but described as more common with placebo and indomethacin Quality of life: not reported Effect on daily activities: not reported Absence from work or school: not reported Unintended effects of treatment: gastrointestinal complaints (nausea and vomiting), number not reported but described as more common with indomethacin; psychic complaints (insomnia and nervousness), number not reported but described as more common with indomethacin Number of women requiring more invasive treatment: not reported Requirements for additional medication: not reported Participant satisfaction with treatment: not reported |
|
Notes | Drugs for use in the trial were provided by Medica Ltd, Helsinki, Finland. "The authors wish to thank Medica Ltd, Helsinki, Finland, for the drugs." | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "placebo‐controlled double‐blind trial" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Twenty‐four patients...volunteered for this study. Eighteen women completed the trial; the remaining six terminated treatment for a variety of personal reasons." |
Selective reporting (reporting bias) | Unclear risk | Prespecified primary and secondary outcomes were not clearly defined. |
Other bias | Unclear risk | Insufficient information was provided to enable a judgement of low risk of bias. |