Discussion
pain, DMKG Headache, headache, migraine pain, migraine, stress reduction, WL
MIGRAINE, SECONDARY, DISEASE
Main result of our study is the reduction of headache days per months in the pooled analysis of all participants after Introvision in the open, non-controlled study part. As there were only very limited side effects, our data suggest that Introvison might be a well tolerated non-drug preventative for migraine patients with additional benefits with regard to self-efficacy, an important feature for headache patients, and for stress reduction in general. However, a randomized controlled trial has to corroborate these preliminary findings.Unfortunately, our study did not reach its primary endpoint, as the number of headache days in the EG after Introvision training was not significantly less than in the WL before training. We believe that this is at least partially due to an imbalance between groups, as the EG had more headache days already before Introvision than the WL before Introvision. In contrast, in the open, non-controlled part of the study nearly all parameters in the secondary, pooled group analysis—apart of headache intensity – were improved after Introvision training. The effect on headache days per month was of moderate size with an average reduction by 1.9 days per month after training, as expected for a non-medication intervention, although we had hoped for a stronger effect based on our previous experience with single migraine patients. A recent study found a similar reduction of 1.6 days per month for MBSR training, with no significant difference from the control group with headache education (-2.0 days) [The observed improvement of self-efficacy in headache management was to be expected in an effective self-regulation technique. It ought to be considered that this study is the first in which SAP was taught over videoconference. Although the participants may have learned the method differently from those learning in conventional courses, there is no evidence that this affects the quality of the subsequent implementation in their everyday life.The dropout rate / discontinuation rate (35%; 28 of 79 randomized participants; 29%; 21 of 72 who started the group sessions) was higher compared to other non-pharmaceutical trials and contributed to a rather low number of participants available for analysis: a meta-analysis showed that 40% of non-pharmacological interventions have a drop out rate of less than 5%, 10% have a drop out rate of over 20% rate, whereas internet-based cognitive behavioral settings show an even higher drop out rate (29–56%) [Our choice of primary endpoint might be a matter of criticism. As our intervention could not be applied in a blinded fashion, we decided for a waiting list design. Usually, the primary outcome variable of the two groups, EG after intervention and WL before intervention, are measured at the same time. However, effects of Introvision take approximately three months to become noticeable, as we know from our experience and other studies [In future, a “virtual” control group could solve this dilemma, by recruiting age-, sex-, and headache-impact-matched controls without a change of treatment from an online-headache-registry, such as the “DMKG Headache Registry” [It was remarkable, that individual negative core beliefs of many of the migraine patients were centered around helplessness. Helplessness can easily be understood as a consequence of insufficiently treatable pain. However, as core beliefs usually are formed early in life, probably before the start of migraine, the relationship between a core belief of helplessness and migraine is not clear. Either the negative core belief is transformed during life with disabling migraine to helplessness or patients with migraine and the core belief of helplessness develop a higher impact of their migraine pain. It could be speculated that imperatives around helplessness may reduce stress tolerance in relation to pain and thus promote the severity of the disease or the extent of the impairment by migraine. Further research on these topics would be highly interesting.We see an unmet need for non-drug migraine preventive therapies. Neither do all migraineurs wish treatment with medication, nor do all qualify for or respond to the most advanced preventive treatments such as CGRP pathway antibody substances, which need to be applied regularly and are expensive. Once learned, a self-regulation method like Introvision can be applied individually, independent of time, place and situation. It is therefore also a cost-effective, sustainable, and supportive method with very limited side effects. Furthermore, stress reduction as the general aim of Introvision offers an additional benefit in daily life, especially as there is an epidemic of stress in our times.