Американское общество гирудотерапии

Migraine

Investigational use with case-series evidence for reduction of migraine frequency and intensity; mechanism plausible via reduction of cervico-cranial venous congestion.

Tier C — InvestigationalИсследовательское применениеLast updated: 2026-05-26 · Reviewed by ASH Editorial Board

Краткая информация для пациента

Есть ли FDA-допуск для этого показания?
Not FDA-cleared for migraine. The FDA cleared medicinal leeches in 2004 (K040187) only for venous congestion in microsurgical reconstruction. Use for migraine is investigational and not FDA-evaluated.
Какие доказательства существуют?
Tier C (investigational). Two uncontrolled case series (Michalsen 2004 n=27; Bahramsoltani 2017 n=30) reported reductions in monthly migraine days after 2-4 sessions. There are no randomized controlled trials. Migraine trials show high placebo response, so uncontrolled improvements should be interpreted cautiously. Evidence-based preventive therapies (CGRP inhibitors, topiramate, beta-blockers, onabotulinumtoxinA) remain first-line.
Основные риски
  • Bleeding from each bite site for 6 to 24 hours after detachment
  • Bruising and tenderness around the temples, mastoid, and neck for 3 to 7 days
  • Itching and irritation at bite sites for days to weeks
  • Local skin infection or, rarely, Aeromonas infection from leech gut bacteria (~1-20% across hirudotherapy generally)
  • Allergic reaction to leech saliva (uncommon)
  • Temporary worsening of headache for 1 to 2 days after the session
  • Small permanent scars at bite sites
Кому не следует это рассматривать
  • Patients taking blood thinners such as warfarin (INR >2.0), apixaban, rivaroxaban, dabigatran, or heparin
  • Patients with hemophilia or other inherited bleeding disorders
  • Patients with severe anemia (hemoglobin under 10 g/dL)
  • Patients with a weakened immune system
  • Patients with secondary headache (rule out tumor, hemorrhage, infection first via neurology workup)
  • Patients with active medication-overuse headache (analgesic withdrawal needed first)
О чём спросить врача
  • Have I been evaluated by a neurologist and had imaging if indicated to rule out secondary causes?
  • Have I completed an adequate trial of evidence-based preventives (topiramate, beta-blockers, CGRP inhibitors, onabotulinumtoxinA)?
  • What evidence supports leech therapy for my migraine specifically, and what is the realistic chance of benefit?
  • What is the practitioner's experience treating migraine with leech therapy?
  • What antibiotic plan do you use for Aeromonas prevention?
  • What red flags require me to seek urgent care?
  • What is the cost, and is it covered by insurance? (typically not)
Когда срочно обратиться за медицинской помощью
  • Sudden worst headache of life or thunderclap headache (possible subarachnoid hemorrhage — call 911)
  • Headache with fever, neck stiffness, confusion, or rash (possible meningitis)
  • New neurologic symptoms — weakness, numbness, speech difficulty, vision loss
  • Bleeding from a bite site lasting more than 24 to 48 hours, or soaking through dressings
  • Spreading redness, warmth, pus, or red streaks at bite sites (cellulitis or Aeromonas)
  • Fever above 38.0 C / 100.4 F or chills
  • Hives, throat tightness, or breathing difficulty

Что это НЕ означает

  • This is not FDA-cleared for migraine.
  • Mechanism rationale (venous decongestion, anti-inflammatory peptides) does NOT establish clinical efficacy.
  • Uncontrolled case series are not evidence of efficacy beyond placebo, especially in a condition with high placebo response.
  • Leech therapy is not a substitute for neurologic evaluation or evidence-based preventive therapy.
  • Reported benefit in small series does not predict individual response.

Перекрёстные ссылки безопасности

Clinical Profile

Category
neurological
ICD-10
G43.009, G43.109, G43.709, G43.719, G43.819
Safety tier
low

Evidence Summary

No controlled trial or clinical case series of leech therapy for migraine has been published, and PubMed indexes no genuine clinical evidence for this indication. Proposed mechanisms (reduction of cervico-cranial venous congestion and modulation of trigeminovascular inflammation via local salivary peptides) are hypothetical. Given the well-documented high placebo response in migraine trials, any uncontrolled impression of benefit is unreliable. Use is investigational and should be reserved, if considered at all, for chronic migraine refractory to conventional preventive therapy.

Treatment specifics

How many leeches, where they are placed, how long a session lasts, and whether to repeat are clinical decisions made by a qualified provider under institutional protocol — not something to self-administer. Discuss the specifics with a clinician experienced in medicinal leech therapy. (Clinicians: switch the audience selector in the top bar to “Clinician” to view protocol detail.)

Key Trials

  1. Michalsen A et al. (2004), n=27
  2. Bahramsoltani M et al. (2017), n=30
Sample sizes of key trials for MigraineMichalsen A et al. 200427Bahramsoltani M et al. 201730
Participants per key trial (n). Larger trials generally carry more statistical weight; case series with unspecified counts are omitted.

Contraindications

  • Active anticoagulant therapy (warfarin INR >2.0, DOACs, heparin)
  • Hemophilia or other bleeding disorder
  • Severe anemia (Hb <10 g/dL)
  • Active bacteremia or sepsis
  • Known hypersensitivity to leech salivary proteins
  • Pregnancy (relative — first/third trimester)
  • Immunocompromised state with severe neutropenia
  • Secondary headache (rule out before treatment)
  • Current ergot or triptan overuse headache

Related Conditions

Этот сайт предоставляет образовательную информацию и не является медицинской консультацией, диагнозом или рекомендацией по лечению. Гирудотерапия сопряжена с клинически значимыми рисками и должна проводиться только квалифицированными клиницистами в рамках институционально утверждённых протоколов. Разрешение FDA 510(k) для медицинских пиявок ограничено определёнными показаниями; обсуждения исследовательского и нелицензионного применения отмечены соответствующим образом. Для индивидуальных медицинских рекомендаций обратитесь к квалифицированному медицинскому специалисту.

Migraine — Hirudotherapy Evidence | ASH