Meta AnalysisID 549

医用水蛭治疗糖尿病足溃疡的疗效:一项系统评价

CRD42017078270

1) What is the effectiveness of medicinal leech therapy on clinical outcomes in patients with diabetic foot ulcers? 2) What are the harms/negative outcomes associated with medicinal leech therapy? 3) What is the clinical

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Meta Analysis Id
549
Evidence Id
9107
Core Evidence Id
9107
Source Meta Analysis Id
528
Herb2 Meta Analysis Id
HBMA000528
Crd Id
CRD42017078270
Title
The efficacy of medicinal leeches in diabetic foot ulcer: a systematic review
Review Question
1) What is the effectiveness of medicinal leech therapy on clinical outcomes in patients with diabetic foot ulcers? 2) What are the harms/negative outcomes associated with medicinal leech therapy? 3) What is the clinical benefit of leech therapy when compared to other therapies in use currently?
Study Type Included
Randomized controlled trials (RCTs), non-randomized or quasi-randomized controlled trials, observational studies and case-series.
Condition Being Studied
Diabetes is a common condition which affected 108 million in 1980 worldwide, and 422 million in 2014 (1). It is further expected to increase in prevalence, beyond 8.5% in 2014, particularly in low and middle income countries (1). It is a multi-system disorder that can result in complications, one such being skin ulceration, particularly in the foot. These areas of skin breakdown or ulceration can be further compounded by a lack of blood flow and a lack of sensation or neuropathy (1). This can result in an increase in ulcer size which can go unnoticed. Also secondary infections can easily occur, which people with diabetes are prone to. The consequences are a skin ulcer that is poorly healing in nature. Guidelines for the care of people with diabetes suggest that feet should be examined regularly to prevent and avoid this circumstance (2). Lifetime risk of people with diabetes developing a foot ulcer is 15% (3-5). Current prevalence of foot ulcer among the population of people with diabetes is (3-5). This indicates that diabetic foot ulcers are a significant problem, that affect many, and have an impact on resources in general (1). Gold standard treatment for diabetic foot ulcers consists of debridement of the wound, management of any infection, revascularization procedures when indicated, and off-loading of the ulcer (6). The mainstay of treatment is debridement and the most common method used is the surgical or 'sharp' method, using a scalpel. This requires time and skill, and may also be painful for the patient, where the ulcer has ischemic areas (7). The biological method, using sterile maggots or leeches, may indeed have advantages, since maggots are able to digest surface debris, bacteria, and necrotic tissues only, leaving healthy tissue intact (7). They may also be effective in the elimination of methicillin-resistant Staphylococcus aureus, from wound surfaces (8). Blow-fly larvae have been used in wound treatment and for wound healing by many ancient culture and through the ages (9). Though used extensively in World War I and II for debridement of injuries, they have been used since the 1990s for diabetes related ulceration as well. The implications of the the use of such a simple biological technology are multi-fold. Maggots and leeches are less time-consuming in terms of staff resources, and require less resources in general to use. If they can be proven to be more effective than regular therapies, this simple biotechnology could be effectively used in places where resources are scarce, revolutionising the care of diabetic ulcers. 1. Projections of global mortality and burden of disease from 2002 to 2030. Mathers CD, Loncar D. PLoS Med, 2006, 3(11):e442. 2. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Can J Diabetes 2013;37(suppl 1):S1-S212. 3. Abbott CA, Carrington AL, Ashe H, North-West Diabetes Foot Care Study et al. The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabet Med. 2002;19:377–384. doi: 10.1046/j.1464-5491.2002.00698.x. [PubMed][Cross Ref] 4. Centers for Disease Control and Prevention Lower extremity disease among persons aged ≥40 years with and without diabetes—United States, 1999–2002. MMWR Morb Mortal Wkly Rep. 2005;54:1158–1160. [PubMed] 5. Lauterbach S, Kostev K, Kohlmann T. Prevalence of diabetic foot syndrome and its risk factors in the UK. J Wound Care. 2010;19:333–337. [PubMed] 6. Doupis J, Veves A. Classification, diagnosis, and treatment of diabetic foot ulcers. Wounds. 2008;20:117–126. [PubMed] 7. Alexiadou K, Doupis J. Management of Diabetic Foot Ulcers. Diabetes Therapy. 2012;3(1):4. doi:10.1007/s13300-012-0004-9. 8. Margolin L, Gialanella P. Assessment of the antimicrobial properties of maggots. Int Wound J. 2010;7:202–204. doi: 10.1111/j.1742-481X.2010.00234.x. [PubMed] [Cross Ref] 9. Whitaker IS, Twine C, Whitaker MJ, Welck M, Brown CS, Shandall A. Larval therapy from antiquity to the present day: mechanisms of action, clinical applications and future potential. Postgraduate Medical Journal. 2007;83(980):409-413. doi:10.1136/pgmj.2006.055905.
Participant
Type 1 or Type 2 diabetic patients of any age, sex and from any health care settings with any type of foot ulcer (e.g. neuropathic or ischaemic, pressure or traumatic, and infected or complicated ulcers).
Animal
Human Disease Modelled
Intervention
Medicinal leech therapy (hirudotherapy).
Comparator Control
Conventional or Standard treatment of a DFU including lowering blood sugar levels, treating any infections along with appropriate wound care such as off-loading, debridement, and the restoration of skin perfusion.
Main Outcome
Primary: rate of wound healing, time to complete healing and percentage change in ulcer area. Measures of effect Post-treatment.
Outcome Measure
Additional Outcome
Secondary: infection rate, amputation rate, health-related quality of life, socioeconomic effects, length of hospitalization, and adverse events including death. Measures of effect Post-treatment.
Study Method
Meta-analysis, Systematic review
Keyword
Animals; Diabetes Mellitus, Type 2; Diabetic Foot; Hirudo medicinalis; Humans
Contact
Homa Keshavarz [email protected]
Organisational Affiliation
None.
Funding Source
Dr. Homa Keshavarz independently, Professor Gina Agarwal from McMaster University, and Dr. Muhammad Usman Ali from McMaster University are responsible for initiating, conducting and managing the review. Dr Hajtalebi from Medical Complex of Alternative and Complementary Medicine in Bojnord is responsible for providing financial support for the review and also acts as content expert for diabetic foot ulcer; however, he will have no role or influence in systematically appraising the evidence, synthesizing the results, or the conclusions of the review.
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language
English
Country
Canada, Iran
Review Stage
Review Ongoing
First Submission Date
2017-11-07
Registration Date
2017-12-05
Anticipated Start Date
2017-05-31
Anticipated Completion Date
2018-01-31
Title Cn
医用水蛭治疗糖尿病足溃疡的疗效:一项系统评价
Title En
The efficacy of medicinal leeches in diabetic foot ulcer: a systematic review
Bilingual Status
complete