Abstract
Objective To investigate the therapeutic potential and efficacy of Shinbaro, an herbal medication for inflammatory diseases and bone disorders, as a preventive treatment of migraine. Methods In this prospective, interventional, single-arm, pre-post study, 37 migraine patients took 600mg bid of Shinbaro for 12 weeks. At 4-week intervals, the migraine frequency and the rescue medications frequency were measured from each patient's headache diary. The modified Migraine Disability Assessment (MIDAS) questionnaires to assess migraine associated disabilities were also completed at each visit. The serum calcitonin gene-related peptide (CGRP) concentrations before and after 12 weeks of Shinbaro administration were compared. Results The monthly migraine frequency was significantly reduced from 20.5 days at baseline to 16.4 days at week 12 (P =0.003), and 22% of the participants showed ≥ 50% reduction. The frequency reduction was observed by week 4 (P =0.035) and continuously occurred through week 8 (P =0.001) and week 12 (P =0.003). The rescue medications frequency also decreased significantly from 17.4 days at baseline to 13.2 days at week 12 (P =0.035). Lastly, the serum CGRP concentration dropped from 434.6 pg/mL at baseline to 371.4 pg/mL at week 12, which was statistically significant (P <0.001). Conclusions Shinbaro demonstrated prophylactic effects in migraine patients, significantly reducing their mean migraine frequency, rescue medications frequency, and the serum CGRP concentration after 12 weeks of treatment. This study is registered in Clinical Research Information Service, Seoul National University Hospital Clinical Research Institute (IRB No. 1604-138-758).
Highlights
First-line acute migraine medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and oral triptans (i.e., 5-HT1B/1D receptor agonists) can abort migraine and its associated symptoms within 30 minutes of administration, if they are effective [1]
There are conflicting findings that calcitonin gene-related peptide (CGRP) is elevated outside migraine attacks—implying that CGRP is a biomarker for chronic migraine (CM), but not so much for episodic migraine (EM) [30], or that CGRP does not reflect patients’ migraine status at all [31]—the general concept that CGRP reflects the trigeminal activation during migraine has been carried forward to pioneer novel migraine therapeutics [32, 33]
We suggest that Shinbaro, a natural medication of six herbal constituents, is a potent migraine prophylaxis that can be considered a great alternative to the direct CGRP inhibiting molecules that are in trials
Summary
First-line acute migraine medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and oral triptans (i.e., 5-HT1B/1D receptor agonists) can abort migraine and its associated symptoms within 30 minutes of administration, if they are effective [1]. Since therapeutic response to a single treatment is usually low, most patients are prescribed several classes of medications. The problem is that increased dependence on the acute treatments can complicate migraine over time, by increasing the risks of chronic migraine (CM), medication-overuse headache (MOH), and intractable or status migraines, especially for the episodic migraine (EM) patients [2,3,4]. Β-blockers, anticonvulsants, 5-HT2 antagonists, tricyclic antidepressants, and calcium antagonists are commonly prescribed as migraine prophylaxes that are daily administered to reduce the frequency and severity of migraine and enhance patients’ therapeutic responses to the acute treatments [5, 6]. Various side effects ranging from mild fatigues to more severe cases of cognitive impairments and even Parkinsonian symptoms have been commonly reported [7, 8]. Treatments that are effective yet safe are continue to be investigated
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