{
  "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.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya 466-8560, Aichi, Japan",
    "Specialized Headache Clinic, Nagoya Garden Clinic, Nagoya 451-0051, Aichi, Japan",
    "Department of Neurosurgery, National Hospital Organization, Nagoya Medical Center, Nagoya 460-0001, Aichi, Japan"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Takafumi Tanei",
      "orcid": "0000-0002-9251-4230"
    },
    {
      "affs": [
        1
      ],
      "name": "Satoshi Yamashita",
      "orcid": "0000-0002-9675-7395"
    },
    {
      "affs": [
        2
      ],
      "name": "Satoshi Maesawa",
      "orcid": "0000-0001-7518-0171"
    },
    {
      "affs": [
        0
      ],
      "name": "Tomotaka Ishizaki",
      "orcid": "0000-0001-5346-6451"
    },
    {
      "affs": [
        0
      ],
      "name": "Takahiro Suzuki",
      "orcid": "0009-0008-3086-4666"
    },
    {
      "affs": [
        0
      ],
      "name": "Shun Yamamoto",
      "orcid": "0000-0002-0895-5667"
    },
    {
      "affs": [
        0
      ],
      "name": "Satoshi Shinoda"
    },
    {
      "affs": [
        1
      ],
      "name": "Toshihiko Wakabayashi"
    },
    {
      "affs": [
        0
      ],
      "name": "Ryuta Saito",
      "orcid": "0000-0002-2484-1360"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/33tqn9103tvr0.bib",
  "cited_by": 0,
  "doi": "10.3390/jcm15218633",
  "fulltext_url": null,
  "id": "33tqn9103tvr0",
  "issns": [
    "2077-0383"
  ],
  "landing_url": "https://www.mdpi.com/2077-0383/15/21/8633",
  "language": null,
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [],
  "openalex": null,
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-11-05",
  "publisher": "MDPI AG",
  "ris": "https://research.draconitic.com/paper/33tqn9103tvr0.ris",
  "sources": [
    {
      "first_seen": "2026-11-06T00:21:25Z",
      "native_id": "10.3390/jcm15218633",
      "source": "crossref",
      "url": "https://www.mdpi.com/2077-0383/15/21/8633"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "journal-openalex:F27",
      "subfield": "general"
    }
  ],
  "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-11-07T00:21:23Z",
  "url": "https://research.draconitic.com/paper/33tqn9103tvr0",
  "venue": "Journal of Clinical Medicine",
  "versions": []
}