Quality of life in patients with endometriosis and the effect of pertubation with lidocaine-a randomized controlled trial

摘要

Objective Pertubation with lidocaine has been shown to reduce pain (on a VAS-scale) in women with endometriosis. A clinical study was performed to evaluate the effect of lidocaine pertubations on quality of life. Design Double-blind, randomized and controlled trial. Setting Three outpatient units in Stockholm, Sweden. Population Eligible patients had endometriosis with dysmenorrhoic pain >VAS 50 mm. Methods The patients were randomized to pre-ovulatory pertubations with lidocaine (n = 24) or placebo (n = 18) during three consecutive menstrual cycles. The procedure comprised passing the solution through the uterus and the Fallopian tubes via an intracervical balloon catheter. The effect was evaluated with the validated Endometriosis Health Profile-30 questionnaire before and after treatments. Main outcome measures Changes in scores at six and 12 months from baseline were compared between the groups with the Mann-Whitney U-test. Results After 6 months there was a significant difference between the lidocaine (n = 19) and the placebo (n = 16) groups for the dimension social support (median-18.8 vs.-6.3, p = 0.034), whereas there were no significant differences for the other dimensions after 6 or 12 months. The mean changes in the lidocaine group were above the minimal important difference levels in eight of 12 measurements of quality of life dimensions compared with two of 12 in the placebo group. Conclusions This clinical trial indicates that pertubations with lidocaine might improve the social support dimension of quality of life in patients with endometriosis.