Treatment Optimization with Add-On Kampo Therapy in Highly Refractory Migraine Patients with Inadequate Response or Re-Worsening During CGRP Monoclonal Antibody Therapy: A Real-World Treatment Episode Analysis
- 1Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya 466-8560, Aichi, Japan
- 2Specialized Headache Clinic, Nagoya Garden Clinic, Nagoya 451-0051, Aichi, Japan
- 3Department of Neurosurgery, National Hospital Organization, Nagoya Medical Center, Nagoya 460-0001, Aichi, Japan
Abstract
Background/Objectives: Although calcitonin gene-related peptide monoclonal antibodies (CGRP-mAbs) have improved migraine prevention, some patients continue to experience inadequate response or re-worsening during treatment. This study evaluated the effectiveness of add-on Kampo therapy in migraine patients receiving CGRP-mAb treatment. Methods: This retrospective observational study included 39 migraine patients who received add-on Kampo therapy during ongoing CGRP-mAb treatment, contributing 55 treatment episodes. The primary endpoint was the change in monthly headache days (MHD) from baseline to 1 month after Kampo initiation. Secondary outcomes included migraine frequency, headache-related disability, quality of life, acute medication use, and work productivity. A responder was defined as achieving a ≥30% reduction in MHD at 1 month. Results: The study population was highly refractory, with chronic migraine present in 79.5% of patients and medication-overuse headache in 56.4%. Among treatment episodes, 72.7% experienced re-worsening after an initial response to CGRP-mAb treatment. Median MHD was 14.0 days after CGRP-mAb treatment and subsequently increased to 16.0 days before Kampo initiation. After Kampo initiation, median MHD decreased to 10.0 days at 1 month. Significant improvements were also observed at 1 month in headache-related disability, quality of life, acute medication use, and presenteeism. The ≥30% and ≥50% responder rates at 1 month were 41.8% and 12.7%, respectively. Re-worsening after an initial CGRP-mAb response showed an exploratory association with treatment response in the Firth penalized logistic regression model. Conclusions: Add-on Kampo therapy was associated with improvements in headache burden, quality of life, acute medication use, and work productivity in patients with inadequate response or re-worsening during CGRP-mAb treatment. These hypothesis-generating findings suggest a potential role for add-on Kampo therapy as a treatment optimization strategy and warrant confirmation in prospective controlled studies.
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BibTeX
@article{tanei2026treatment,
title = {{Treatment Optimization with Add-On Kampo Therapy in Highly Refractory Migraine Patients with Inadequate Response or Re-Worsening During CGRP Monoclonal Antibody Therapy: A Real-World Treatment Episode Analysis}},
author = {Takafumi Tanei and Satoshi Yamashita and Satoshi Maesawa and Tomotaka Ishizaki and Takahiro Suzuki and Shun Yamamoto and Satoshi Shinoda and Toshihiko Wakabayashi and Ryuta Saito},
journal = {Journal of Clinical Medicine},
year = {2026},
month = nov,
doi = {10.3390/jcm15218633},
url = {https://www.mdpi.com/2077-0383/15/21/8633},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Treatment Optimization with Add-On Kampo Therapy in Highly Refractory Migraine Patients with Inadequate Response or Re-Worsening During CGRP Monoclonal Antibody Therapy: A Real-World Treatment Episode Analysis
AU - Takafumi Tanei
AU - Satoshi Yamashita
AU - Satoshi Maesawa
AU - Tomotaka Ishizaki
AU - Takahiro Suzuki
AU - Shun Yamamoto
AU - Satoshi Shinoda
AU - Toshihiko Wakabayashi
AU - Ryuta Saito
PY - 2026
DA - 2026/11/05
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15218633
UR - https://www.mdpi.com/2077-0383/15/21/8633
AB - Background/Objectives: Although calcitonin gene-related peptide monoclonal antibodies (CGRP-mAbs) have improved migraine prevention, some patients continue to experience inadequate response or re-worsening during treatment. This study evaluated the effectiveness of add-on Kampo therapy in migraine patients receiving CGRP-mAb treatment. Methods: This retrospective observational study included 39 migraine patients who received add-on Kampo therapy during ongoing CGRP-mAb treatment, contributing 55 treatment episodes. The primary endpoint was the change in monthly headache days (MHD) from baseline to 1 month after Kampo initiation. Secondary outcomes included migraine frequency, headache-related disability, quality of life, acute medication use, and work productivity. A responder was defined as achieving a ≥30% reduction in MHD at 1 month. Results: The study population was highly refractory, with chronic migraine present in 79.5% of patients and medication-overuse headache in 56.4%. Among treatment episodes, 72.7% experienced re-worsening after an initial response to CGRP-mAb treatment. Median MHD was 14.0 days after CGRP-mAb treatment and subsequently increased to 16.0 days before Kampo initiation. After Kampo initiation, median MHD decreased to 10.0 days at 1 month. Significant improvements were also observed at 1 month in headache-related disability, quality of life, acute medication use, and presenteeism. The ≥30% and ≥50% responder rates at 1 month were 41.8% and 12.7%, respectively. Re-worsening after an initial CGRP-mAb response showed an exploratory association with treatment response in the Firth penalized logistic regression model. Conclusions: Add-on Kampo therapy was associated with improvements in headache burden, quality of life, acute medication use, and work productivity in patients with inadequate response or re-worsening during CGRP-mAb treatment. These hypothesis-generating findings suggest a potential role for add-on Kampo therapy as a treatment optimization strategy and warrant confirmation in prospective controlled studies.
SN - 2077-0383
ER -