Hirudotherapy in Wound Healing
Nair HKR, Ahmad NW, Lee HL, Ahmad N, Othamn S, Mokhtar NSHM, Chong SSY (2020) · The International Journal of Lower Extremity Wounds · n=3
Детали доказательств RCTСсылка на исследование
GRADE Очень низкаяНедостаточно доказательств
Характеристика исследования
- Дизайн
- single-center case series of hirudotherapy for chronic wound management (Hospital Kuala Lumpur and Institute for Medical Research, Malaysia)
- Размер выборки (n)
- 3
- Вмешательство
- Sterile medicinal leeches (Hirudinaria manillensis) applied to chronic wounds and pain sites until detached spontaneously; full sterile-technique protocol with non-tooth plastic forceps and biohazard disposal
- Компаратор
- No randomized comparator - descriptive case series outcomes
- Первичная конечная точка
- Pain reduction, wound healing progression, and patient-reported balance/comfort outcomes
- Основной результат
- All 3 patients showed improvements in their condition, especially reduction in pain and improvement in sense of balance; all wounds healed well; authors conclude hirudotherapy is effective but note small sample size and need for more robust trials to establish significance
- Длительность наблюдения
- until wound resolution
- PMID
- 32815407
Ключевые выводы
- Malaysian hospital-based case series documenting hirudotherapy protocols using Hirudinaria manillensis (Asian medicinal leech)
- All three patients reported pain reduction and improvement in balance/comfort metrics
- Detailed sterile-technique and biohazard-disposal protocol documented
- Authors explicitly call for larger, more robust trials to confirm significance
- Uses a different leech species (H. manillensis) than the European H. medicinalis - adds species coverage to the literature
Ограничения
- Very small case series (n=3) - hypothesis-generating only
- No randomized control or sham comparison
- Mixed wound etiologies in the case series limit attribution to specific pathology
- Different leech species (Hirudinaria manillensis) not FDA-cleared in the US
- Outcomes assessed by treating clinicians without standardized blinded scoring
Клиническое значение
Nair 2020 documents the Malaysian government-hospital approach to hirudotherapy for chronic wound healing using a non-European leech species (Hirudinaria manillensis). For US clinicians, the species difference limits direct applicability under the FDA K040187 clearance framework, which specifies whole-leech H. medicinalis. The case series provides useful operational documentation of sterile-technique and biohazard-disposal protocols but cannot establish efficacy at any meaningful evidence level. The trial supports calls for larger species-specific RCTs in chronic wound healing.