Chronic Migraine Prophylaxis (≥15 Headache Days/Month)

Краткая информация для пациента

Есть ли FDA-допуск для этого показания?

Not FDA-cleared for chronic migraine prophylaxis. 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 of leech therapy for chronic migraine prophylaxis. Evidence-based options include FDA-approved CGRP monoclonal antibodies (erenumab, fremanezumab, galcanezumab, eptinezumab) with strong RCT support, FDA-approved onabotulinumtoxinA for chronic migraine (PREEMPT trials), topiramate, propranolol or other beta-blockers, amitriptyline, venlafaxine, and behavioral therapies (CBT, biofeedback). Acute therapy: triptans, gepants, ditans, NSAIDs. Avoidance of medication-overuse headache is critical.

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: many migraine patients have specific triggers; placement may precipitate attacks
• Worsening of migraine for 1 to 3 days following sessions
• Delay of FDA-approved CGRP monoclonal antibodies, onabotulinumtoxinA, topiramate, propranolol
• Placebo response masking medication-overuse headache or secondary causes

Кому не следует это рассматривать

• Patients with red-flag headache features (sudden onset, neurological deficits, fever, immunosuppression, age over 50 new-onset)
• Patients with medication-overuse headache who need analgesic detoxification first
• Patients who have not tried CGRP monoclonal antibodies, onabotulinumtoxinA, topiramate, propranolol, or other RCT-supported preventives
• Patients with active dermatitis or broken skin at planned placement sites
• Patients on anticoagulants, with hemophilia, or with severe anemia
• Pregnant patients (migraine prevention strategy is different in pregnancy)

О чём спросить врача

• Have I tried CGRP monoclonal antibodies (erenumab, fremanezumab, galcanezumab, eptinezumab) or gepants?
• Am I a candidate for onabotulinumtoxinA (Botox) using the PREEMPT protocol for chronic migraine?
• Have I tried topiramate, propranolol, amitriptyline, or other RCT-supported preventives at adequate doses?
• Am I using acute therapy more than 10 to 15 days per month (medication-overuse headache risk)?
• Have I tried CBT, biofeedback, lifestyle modification, sleep optimization, and trigger management?
• Why is leech therapy being considered given highly effective FDA-approved options for migraine?
• What is the practitioner's plan if I have a migraine attack during or after a session?

Когда срочно обратиться за медицинской помощью

• Thunderclap (worst-of-life) headache (possible subarachnoid hemorrhage - 911)
• Headache with fever, stiff neck, photophobia, or altered mental status (possible meningitis)
• Headache with focal neurological deficit, persistent vision change, speech difficulty, or seizure
• Jaw claudication, scalp tenderness, or vision change in age over 50 (possible giant cell arteritis)
• Migraine with aura lasting more than 1 hour, or atypical aura
• Bleeding from a bite site lasting more than 24 hours
• Hives, facial or throat swelling, or breathing difficulty