Фибромиалгия (Исследовательский протокол тендерных точек)

Краткая информация для пациента

Есть ли FDA-допуск для этого показания?

Not FDA-cleared for fibromyalgia. FDA cleared medicinal leeches only for venous congestion in microsurgical reconstruction (K040187, 2004). Use here is investigational.

Какие доказательства существуют?

Tier C (investigational). One small uncontrolled pilot reported short-term tender-point pain reduction; effect attenuated at 3 months. There are no randomized controlled trials. Fibromyalgia trials are highly susceptible to placebo response. Evidence-based therapies remain first-line: graded aerobic exercise (the strongest RCT support), cognitive-behavioral therapy, duloxetine, milnacipran, pregabalin, amitriptyline, sleep optimization, treatment of mood and anxiety comorbidity, and multidisciplinary pain rehabilitation. Tender-point counts have been retired from the ACR 2010 criteria in favor of widespread pain and symptom severity scores.

Основные риски

• Bleeding from each bite site for 6 to 24 hours after detachment
• Bruising and tenderness across multiple body regions from widespread tender-point placement for 5 to 10 days
• Itching and irritation at bite sites for days to weeks
• Mild anemia with cumulative blood loss across repeated multi-site sessions
• Local skin or, rarely, Aeromonas hydrophila infection
• Allergic reaction to leech saliva (uncommon)
• Temporary worsening of generalized pain or fatigue (flare) for 1 to 3 days in centrally sensitized patients
• Delay of graded exercise, CBT, and evidence-based pharmacotherapy

Кому не следует это рассматривать

• Patients on blood thinners, with hemophilia, or with severe anemia
• Patients with active depression, anxiety, or PTSD that has not been addressed
• Patients with another untreated inflammatory rheumatologic condition pending workup
• Patients who have not tried graded aerobic exercise, CBT, and adequate pharmacotherapy
• Patients with a weakened immune system
• Patients with thyroid disease, sleep apnea, or vitamin D deficiency contributing to symptoms
• Patients with active dermatitis or broken skin at planned placement sites

О чём спросить врача

• Have I been worked up for other causes (rheumatologic, thyroid, sleep apnea, vitamin D deficiency)?
• Have I completed adequate trials of graded aerobic exercise, CBT, and pharmacotherapy (duloxetine, milnacipran, pregabalin)?
• Are mood, anxiety, sleep, and stress being addressed?
• What evidence supports leech therapy specifically for fibromyalgia (versus general placebo response)?
• How will my hemoglobin be monitored given widespread multi-site sessions?
• What is the plan if I have a fibromyalgia flare after treatment?
• What is the Aeromonas-prevention protocol?

Когда срочно обратиться за медицинской помощью

• New focal weakness, sensory loss, or asymmetric joint swelling (possible alternative diagnosis)
• Severe worsening of pain or fatigue that does not resolve within a few days
• Bleeding from a bite site lasting more than 24 hours
• Spreading redness, pus, or warmth at multiple bite sites
• Fever, chills, or systemic symptoms
• Hives, facial or throat swelling, or breathing difficulty
• Severe mood deterioration, suicidal ideation, or hopelessness