Американское общество гирудотерапии

Cluster Headache (Episodic)

Highly investigational use for episodic cluster headache between attack cycles; very limited anecdotal data, not for active attacks.

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 cluster headache. FDA cleared medicinal leeches only for venous congestion in microsurgical reconstruction (K040187, 2004). Use here is investigational.
Какие доказательства существуют?
Tier C (investigational). There are no published controlled trials. Cluster headache is one of the most painful conditions known and requires aggressive evidence-based therapy: acute attacks with high-flow oxygen via non-rebreather mask, subcutaneous sumatriptan, or intranasal zolmitriptan (the highest-evidence acute therapies); transitional prevention with corticosteroid taper or occipital nerve block; preventive therapy with verapamil (first-line), lithium, topiramate, or galcanezumab; non-invasive vagal nerve stimulation (FDA-cleared for episodic cluster); and sphenopalatine ganglion stimulation or occipital nerve stimulation for refractory cases. Onset of an acute attack is a medical emergency for symptom control.
Основные риски
  • Bleeding from each bite site for 6 to 24 hours after detachment
  • Bruising over the temporal or periorbital region for 5 to 10 days
  • Local skin or, rarely, Aeromonas hydrophila infection
  • Allergic reaction to leech saliva (uncommon)
  • TRIGGER RISK: any stimulus can trigger a cluster attack during a cluster period
  • Delay of high-flow oxygen, sumatriptan, verapamil, and other proven therapies (a delay in cluster is intolerable pain)
  • Misdiagnosis - clusters are sometimes confused with secondary causes (pituitary tumor, carotid dissection) that need urgent workup
  • Placement near temporal artery in age over 50 risks giant cell arteritis being missed
Кому не следует это рассматривать
  • Patients in an active cluster period who have not optimized acute (oxygen, triptans) and preventive (verapamil) therapy
  • Patients with red-flag features (focal neurological signs, autonomic features outside attacks, age over 50 new-onset)
  • Patients with suspected secondary causes (pituitary tumor, AVM, carotid dissection)
  • Patients on anticoagulants, with hemophilia, or with severe anemia
  • Patients with active dermatitis or broken skin at planned placement sites
  • Patients on monoamine oxidase inhibitors or with cardiovascular contraindications to triptans (different issue, but triptan optimization first)
О чём спросить врача
  • Am I receiving high-flow oxygen (12 to 15 L/min via non-rebreather) for acute attacks?
  • Have I tried subcutaneous sumatriptan or intranasal zolmitriptan?
  • Am I on verapamil titrated to adequate dose for prevention?
  • Have I had MRI brain to rule out secondary causes (pituitary tumor, AVM, carotid dissection)?
  • Am I a candidate for occipital nerve block, sphenopalatine ganglion stimulation, or non-invasive vagal nerve stimulation?
  • Why is leech therapy being considered given the highly effective evidence-based options for cluster?
  • What is the practitioner's plan if I have a cluster attack during or after a session?
Когда срочно обратиться за медицинской помощью
  • Thunderclap (worst-of-life) headache, sudden severe headache (possible subarachnoid hemorrhage - 911)
  • Headache with fever, stiff neck, photophobia, or altered mental status (possible meningitis)
  • Headache with focal neurological deficit, vision change, speech difficulty, or seizure
  • Sudden severe pain with neck stiffness and Horner syndrome features (possible carotid dissection)
  • Cluster attacks that do not respond to oxygen or triptans
  • Bleeding from a bite site lasting more than 24 hours
  • Hives, facial or throat swelling, or breathing difficulty

Что это НЕ означает

  • This is not FDA-cleared for cluster headache.
  • No controlled trials support efficacy; cluster headache responds dramatically to high-flow oxygen, sumatriptan, and verapamil.
  • It does not abort an acute cluster attack; high-flow oxygen and triptans do.
  • It does not prevent cluster attacks; verapamil, lithium, topiramate, and galcanezumab do.
  • Misdiagnosis of secondary causes (pituitary, AVM, carotid dissection) can be catastrophic if delayed.

Перекрёстные ссылки безопасности

Clinical Profile

Category
neurological
ICD-10
G44.001, G44.009, G44.019
Safety tier
medium

Evidence Summary

Cluster headache is conventionally managed with high-flow oxygen and subcutaneous sumatriptan for acute attacks, and verapamil, lithium, or galcanezumab for prevention. Occipital nerve blocks and non-invasive vagus nerve stimulation are second-line preventives. No controlled clinical trial or published case series of leech therapy for cluster headache has been reported; any use is investigational and mechanistic only and is not supported by controlled data. Hirudotherapy must never be applied during an active attack; conventional acute therapy (oxygen, triptan) is non-negotiable.

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. Sharma R et al. (2018)0

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
  • Active cluster attack (oxygen and triptan are emergent therapy)
  • Secondary cluster from undiagnosed structural lesion
  • Trigeminal autonomic cephalgia of unclear subtype

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.

Cluster Headache (Episodic) — Hirudotherapy Evidence | ASH