Abstract
Introduction: This was a small open label study designed to determine efficacy of helminth egg therapy in refractory chronic migraine (RCM) patients. It is probable that the immune system is involved in migraine. 1 Helminth worms have populated the GI tract of primates for millions of years. They downregulate the immune response. When the helminths (and other parasites) are removed, the result may be an increase in autoimmune illness. The immune system and inflammation are involved in migraine pathophysiology. Study design: Eleven RCM patients were enrolled. After the run-in period, patients ingested the helminth eggs every 2 weeks for 5 months. These eggs were from the pig whipworm, T. suris. The primary endpoint involved the number of moderate or severe headache days per month. The first (run-in) month was compared to the last 2 months of active therapy. Secondary endpoints included disability, depression, anxiety, and quality of life. Results: 5 of 11 patients met the primary endpoint (a reduction in moderate or severe headache days by at least 3 per month). The number of moderate or severe headache days decreased by 14, 10, 8, 7, and 3 in these patients. The patients who met the primary endpoint all began with essentially no clinical depression at baseline. Disability declined in all 5 patients, as did anxiety. Quality of life (number of unhealthy days per month) improved in 2 of the 5 patients who met the primary endpoint. 4 of 11 patients who completed the study did not meet the primary endpoint. 1 other patient did not supply data, and another discontinued treatment due to diarrhea. Analysis of their secondary endpoints did not result in any definitive conclusions as to why they did not improve. Conclusion: This study indicates that there may possibly be a role for helminth therapy in treating refractory chronic migraineurs. 5 of 11 patients did well. This treatment is rooted in evolution. The presence of helminths results in a downregulation of certain aspects of our immune system. By re-introducing helminths into the GI system, we may dampen our immune response. This may possibly help in the treatment of conditions that involve the immune system, such as migraine. Keywords: Migraine, Refractory Migraine, Headache, Helminth, Evolution, Chronic Migraine
Highlights
This was a small open label study designed to determine efficacy of helminth egg therapy in refractory chronic migraine (RCM) patients
The patients who met the primary endpoint all began with essentially no clinical depression at baseline
This study indicates that there may possibly be a role for helminth therapy in treating refractory chronic migraineurs. 5 of 11 patients did well
Summary
This was a small open label study designed to determine efficacy of helminth egg therapy in refractory chronic migraine (RCM) patients. [1] Helminth worms have populated the GI tract of primates for millions of years The primary endpoint involved the number of moderate or severe headache days per month. Results: 5 of 11 patients met the primary endpoint (a reduction in moderate or severe headache days by at least 3 per month). Quality of life (number of unhealthy days per month) improved in 2 of the 5 patients who met the primary endpoint. Individuals with Refractory Chronic Migraine (RCM) have failed a number of the available preventatives, and suffer from frequent moderate or severe headaches [2,3,4,5]. This resulted in an increase in autoimmune illness. [9,10,11,12,13,14,15]
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