Progestogen-only contraceptive pill compared with combined oral contraceptive in the treatment of pain symptoms caused by rectovaginal endometriosis in patients with migraine without aura

Study question: In women with symptomatic rectovaginal endometriosis and mi- graine without aura which hormonal therapy (progestogen-only contraceptive pill, desogestrel, P versus sequential combined oral contraceptives, COC) causes higher satisfaction of patients? Summary answer: Patients treated with P are more satisfied than those treated with COC. Both P and COC significantly decrease the intensity of endometriosis-associated pain symptoms. The severity of migraine attacks decreases in patients treated with P but not in those treated with COC. What is known already: Comorbidities may increase the incidence of adverse effects and decrease the compliance to treatment. Epidemiological studies showed that migraine is more frequent in women with endometriosis than in women without this disease. This clinical scenario is a challenge for gynaecolo- gists because the benefits of hormonal treatment on pain symptoms should be balanced with changes in the severity of migraine potentially caused by hormonal therapy. Study design, size, duration: This was a prospective patients preference trial. A power calculation demonstrated that 62 patients per group were required. An intention-to-treat analysis was performed. The study was performed between January 2009 and June 2012. The duration of treatment was six months. Participants/materials, setting, methods: The study included women with pain symptoms caused by rectovaginal endometriosis suffering migraine without aura. Patients rated the degree of satisfaction by using a Likert scale. Pain symptoms were measured with a visual analogue scale. The number, duration and severity of migraine attacks were evaluated by using a diary. Main results and the role of chance: The study included 144 women (82 in the group COC and 62 in the group P). 11.3% of women in group P and 24.4% of those in group COC withdrew because of adverse effects ( p 1⁄4 0.054). 53.2% of women in group P were satisfied or very satisfied after treatment compared with 30.5% in group COC ( p 1⁄4 0.006). The intensity of chronic pelvic pain and dyspareunia sig- nificantly decreased at 6-month treatment both groups. At 6-month treatment, the number of migraine attacks was lower than at baseline in the group P ( p 1⁄4 0.002), while it was not reduced in group COC (p 1⁄4 0.521). The intensity of migraine attacks was significantly different between baseline and 6-month treatment in group P (p , 0.001) but not in group COC (p 1⁄4 0.078). Limitations, reason for caution: Although several epidemiological studies sup- ported the relationship between endometriosis and migraine, this is the first study evaluating the optimal hormonal treatment for these patients. It remains to be demonstrated if the beneficial effects on migraine of desogestrel are maintained during longer treatment. Further prospective randomised trials are warranted. Wider implications of the findings: When pregnancy is not desired, COC or P treatment may be administered to symptomatic patients with rectovaginal endo- metriosis and migraine without aura. Both drugs efficaciously relieve endometriosis-related pain symptoms; however, P is better tolerated than COC and it seems to ameliorate migraine attacks compared with COC. This study sup- ports the use of the progestogen-only contraceptive pill in women with rectovagi- nal endometriosis and coexisting migraine without aura. Study funding/competing interest(s): none Trial registration number: none