Evidence-based PracticeParts I, II & III

Treating & Preventing MRSA Colonization & Infection

with Manuka Herbals(Special focus on Corrections)

By Lori Kelsey RN DOMUniversity of St. Francis

Part I: Background

MRSA

Poor quality evidence for health maintenance& disease prevention against MRSA.

National Guideline Clearinghouse decolonizingprotocol for MRSA includes mupirocin,Chlorhexidine (Hiblclens®), and diluted bleachbaths. There is only class C-III evidence- lowestranked evidence- supporting the protocol’s efficacy.

MRSAMorbidity to Mortality

• Asymptomatic carrier/colonized states• skin, respiratory, GU/GI, bone & CNS

infections• fulminating wounds & sepsis

MRSA vs. MANUKA

A means of reducing the bacterial bio-burden of MRSA, other than by the use of topical and systemic antibiotics, is urgently required

(Harding & Cooper, 2001).

Are Manuka Herbals a means to these ends?

Manuka- Leptosperma scoparium

A tree whose herbals inhibit strains of MRSA

• Raw plant components• Volatile oil (essential oil/ EO)• Manuka honey (Medihoney®)

Manuka- Leptosperma scoparium

Therapeutic Principles

• Unique-Manuka-Factor (UMF): derived from raw plant components (Cooper, 2008 and Molan, 1992).

• Cyclic triketones: leptospermone, isoleptosperone & flavesone (20-30%) in the EO are potent antimicrobial. Non toxic compared to other ketones.

• Non-peroxide type honey: unlikely to be inactivated by catalase, an enzyme in human tissue or plasma that destroys hydrogen peroxide (an antimicrobial made by macrophages).

• Potent antimicrobials: manuka honey can be equivalent to 10% phenol (Cooper,

2008). Manuka EO inhibited a strain of MRSA at 0.2% or 200 ppm - very diluted (Cooke & Cooke (2001). (

Manuka- Leptosperma scoparium

Medihoney® by DermaScience

Standard of Care in some physical therapy departments for the treatment of wounds that

are colonized or infected with MRSA.

Integrative Medicine

Manuka- Leptosperma scoparium

Different types of Manuka-based products need to be developed and tested

(e.g. treatment gel & soap)

An EO blend was found to inhibit many MRSA strains in-vitro.Then formulated into proprietary sundries called Mercy soap& Mercy treatment gel. They contain tea tree EO, which is 20xless potent than Manuka EO against gram+ bacteria like MRSA(Cawthorn). These sundries have not been tested in-vivo forhealth maintenance & disease prevention against MRSAcolonization.

Part II: The PICOT Question & Evidence

The PICOT Question

• Population: Will at risk individuals• Intervention: who swabbed their nares with Manuka

essential oil-based treatment gel• Comparison: compared to the at risk individuals with

no intervention• Outcome: have less incidence & prevalence of MRSA

colonization in the nares• Time: when administered once per day for 1 month?

Quantitative (level 2) Evidence

No variation in outcomes among quantitative studies (n=18) that tested Manuka Herbals

• Type: in-vivo & in-vitro• Variations: investigators, conditions, strains of

MDROs (e.g. MRSA, VRE etc.), Manuka EO & honey, other types of honey.

• Replicated: 1 in-vivo study

Quantitative Evidence (continued)

All interventions were highly effective in:

• Eradicating MRSA from colonized or infected wounds.

• Healing of recalcitrant wounds that were colonized with MRSA.

• inhibition of MRSA strains in vitro.

• No formed resistance by MRSA strains.

Quantitative Evidence (continued)

The evidence for Manuka-based herbals is sufficient, but not complete for EBP.

• Need meta-analysis on Medihoney® level 1 evidence for an interventions efficacy.

• Need broad-spectrum analysis on EOepidemic MRSA15 (spreads most rapidly) vs. Oxford S.

aureaus (antibiotic sensitive) vs. any untypable MRSA strains; CA-MRSA vs. HA-MRSA?

Quantitative Studies

Blinded Random-Controlled Trail (replicated)• Bacteriological Changes in Sloughing Venous Leg Ulcers with

Manuka Honey or Hydrogel (Gethin & Cowman, 2008).

Laboratory Analysis: • An Investigation Into The Antimicrobial Properties Of Manuka And

Kanuka Oil (Cooke & Cooke, 2001).

• The Effect Of Essential Oils On Methicillin-Resistant Staphylococcus Aureus Using A Dressing Model (Edwards-Jones, Buck, Shawcross, Dawson, Dunn, 2004).

Descriptive, Correlation, Predictive (seminal):• Wide Variation in Adoption of Screening and Infection Control

Interventions for Multidrug Resistant Organisms (Pogorzelska, Stone & Larson, 2012)

Qualitative (level 6) Evidence

3 studies measured patient and/or provider attitudes towards and willingness to use

Integrative Medicine.

• 2 used valid & reliable measurement instruments: positive attitudes & willingness

• 1 study had selection bias: desire for integrated approaches to healthcare.

Qualitative Studies

Phenomenological & Instrument Validation: • Themes of Holism, Empowerment, Access, and Legitimacy

Define Complementary, Alternative, and Integrative Medicine in Relation to Conventional Biomedicine (Barrett et al, 2003).

• Comparative survey of Complementary and Alternative Medicine (CAM) attitudes, use, and information-seeking behavior among medical students, residents & faculty (Lie, D., & Boker, 2006).

• The Development and Validation of IMAQ: Integrative Medicine Attitude Questionnaire (Schneider, Meek & Bell, 2003).

Case Study (level 6) Evidence

Contradictory to, or supportive of the efficacy of Manuka herbals?

• 4 case studies: Manuka honey facilitated wound healing,

eliminated infection, but did not reduce MDRO colonization.

• 1 case study: Manuka honey healed a chronic wound that was refractory to standard therapies due to an immune-inhibiting drug (without discontinuing the drug).

• Comparing clinical outcomes: level 6 evidence is inferior to level 2 evidence. No conflicting level 2 evidence.

Case Study (continued)

• Treatment of an Infected Venous Leg Ulcer with Honey Dressings (Alcaraz & Kelly, 2002).

• Healing of an MRSA-colonized, Hydroxyurea-induced Leg Ulcer with Honey (Natarajan, Williamson, Grey, Harding & Cooper, 2001).

• Manuka honey used to Heal a Recalcitrant Surgical Wound (Cooper, Molan, Krishnamoorthy & Harding, 2001)

Expert & Literature Review (level 7) Evidence

Burdens of Concern

• Standardization of herbals across studies: produces results that are valid, reliable, comparable & reproducible.

• Regulation of herbals as pharmaceutical-grade: “Reluctance to use it [honey] until regulated products were available” (Cooper, 2008).

• Risks vs. Benefits: Medihoney is regulated by the FDA; safe, and comparable in efficacy& safety to existing products. Gamma-irradiation eliminates pathogens (e.g. botulism).

Expert & Literature Reviews

• The Adulteration of Essential Oils and The Consequences to Aromatherapy and Natural Perfumery Practice: Part 1 Oil Adulteration (Burfield, 2003).

• Nursing As A Context For Alternative & Complementary Modalities (Frisch, 2001).

• Using Honey to Inhibit Wound Pathogens (Cooper, 2008)

Unsystematic Clinical Observation

Suffrage cause by MRSA

“Single unit[s] within the context of its real-lifeEnvironment… as an understanding of thesituation begins to emerge, other questions ariseand new data maybe gathered to address newquestions…[about] the multiplicity of factors thatinfluences patient care” (Burns & Grove, 2009, p 519).

Unsystematic Clinical Observation

Clinical “narrative” mode explores/documents:

• Clinical judgment• experiential learning• Chronology of unfolding events & responses• Concerns of patient & provider• Nuances of ethically driven care by nurses

Unsystematic Clinical Observations

2 Clinical Narratives on fulminating MRSA:

• psychosocial burdens on Patient: fear, depression, hopelessness, helplessness, impaired QoL.

• psychosocial burdens on Provider: protraction, ambiguity & uncertainty of intervention(s).

Epidemiological Protocols & Practice

• Prevention: A Health Promotion & Disease Prevention protocol for MRSA in primary care.

• Intervention: Can Manuka herbals reduce the incidence & prevalence of MRSA colonization, morbidity, mortality, and suffrage?

• Prognosis: Surveillance of at risk populations in the primary care setting (not during acute or outpatient encounters)

Epidemiological Protocols & Practice

• Methicillin Resistant Staphylococcus Aureus (MRSA) Best Practices Guidelines for Hospitals. (Arnold et al, 2001).

• National Nosocomial Infections Surveillance System (2004).

• Wide Variation in Adoption of Screening and Infection Control Interventions for Multidrug Resistant Organisms (Pogorzelska, Stone & Larson, 2012).

Part III: Evidence-based Quality Improvement (EBQI)

Who is at Risk For MRSA?

• Inmates are at risk for community-acquired MRSA (CA-MRSA).

• frequent reason for seeking care.

• Presents like an insect bite if on the skin.

• Occurs in waves of outbreaks.

Environment, Preferences & Values

• Nursing & Medical protocol for MRSA:Consistent with the National Clearing House Guideline for soft tissue lesions due to CA-MRSA

• Nursing determines if inmate needs referral to

the APN or MD:I/M usually do not experience the severe or life-threatening sequels associated with other types of MRSA.

Ethics

• Inmates are a vulnerable population: special care that EBQI does not become clinical research.

• Inmates are wards of the state: all services are highly regulated & standardized across the board.

• The fair & equal distribution of resources: unethical to implement an EBQI in one facility while continuing with traditional practice (or no treatment) in another.

Obstacles

• Change in corrections is complex: county & state regulations; national & internationalsubcontractors.

• Publically-financed services: cost-containment, limited formulary, no infection control (IC) nurse.

• Other reasons for & types of MRSA: abscesses from IV drug use, hospital-acquired MRSA, etc.

Accessible Resources

• US Department of Labor, Federal Bureau of Prisons Clinical Practice “Evidence Based Guideline Reference” book & online database: Corrections Medical Services- Clinic All-In-Ones (or medical pathways) for MRSA.

• Web-based epidemiological/IC information: Clinical Practice Guidelines by The Infectious Diseases Society of America for the Treatment of Methicillin-resistant Staphylococcus Aureus Infections in Adults and Children.

• This EBQI project: studies related to management of CA-MRSA with Manuka Herbals.

Needed Resources

• IC nurse: primary care, health maintenance & prevention, MDRO IC recommendations, MRSA epidemiological trends.

• Baseline documentation: charts, analysis, reports

• Team: IC nurse, APN/ MD to plan and set EBQI goal & proposal.

Goal

Reduced the incidence & prevalence of CAMRSA in the detention facility.

Strategy/Method/Plan

• Formulary: Medihoney ointment KOP for CA-MRSA lesions. Medihoney dressings for STI & wounds due to CA-MRSA.

• Self-care: Topical sundry product(s) (soap & treatment gel) available to help prevent CA-MRSA (in-vivo product research still needed per PICOT question in Part II).

Responsibility 6 months• Review & summarize: literature, practices of other facilities/

entities/ disciplines on MDRO IC.

• RCA of Studies: Manuka herbals/ Medihoney for CA-MRSA

• Review Current Practice: Clinic All-In-Ones, and Nursing Protocol for MRSA.

• Design/ Redesign Education: pamphlet & PowerPoint on preventing CA-MRSA.

• Cost-analysis: proposed intervention(s) vs. current practice

Outcomes 1 year

• Fewer clinic visits per month for MRSA lesions.

• Fewer referrals to APN/MD/ for oral antibiotics for soft tissue infections (STI) due to MRSA.

• Fewer referrals to the hospital for IV antibiotics and other interventions for invasive MRSA STI, and other types of wounds (e.g. diabetic ulcers)

• Shorter times to healing of of these lesions & infections.

Measures of Effectiveness of EBQI

1. Cure/Response Vs. Treatment Failure/ NNT vs. NNH: per outcome goals

2. Relapse Rate: Recurrent MRSA in inmates and/or Occurrence of MRSA in the cellmate of someone with MRSA and/or outbreak in a housing unit

3. Development of Resistance to/ Adverse Effects of Therapy: studies in this EBP project on Manuka Herbals vs standard intervention.

4. Sensitivity & Specificity of Monitoring: lab technology5. Morbidity & Mortality: compare to statistics / trends on MRSA

from the Center for Disease Control Notifiable Disease Reporting System, and the National Nosocomial Infection Surveillance (NNIS).

ReferencesAlcaraz, A., Kelly, J. (2002). Treatment of an infected venous leg ulcer

with honey dressings. British Journal of Nursing, 11, 859-60, 862-6 Arnold, M., Dempsey, J., Fishman, M., McAuley, P., Tibert, C., Vallande,

N. (2001). Methicillin resistant staphylococcus aureus (MRSA) best practices guidelines for hospitals. Infection Control Professionals of Southern New England. Retrieved from http://www.health.ri.gov/publications/guidelines/ MRSAHospital.pdf

Barrett,B., Marchand, L., Scheder, J., Plane, M., Maberry, R., Appelbaum, D., Rakel, D., Rabago, D. (2003). Themes of holism, empowerment, access, and legitimacy define complementary, alternative, and integrative medicine in relation to conventional

biomedicine. The Journal Of Alternative and Complementary Medicine, 9(6), 937 947.

ReferencesBurfield, T. (2003). The adulteration of essential oils and the

consequences to aromatherapy and natural perfumery practice. Presentation to the International Federation of Aromatherapists Annual AGM. London. Retrieved fromhttp://www.naha.org/articles/adulteration_1.htm.

Burns, N., & Grove, S. (2009). The practice of nursing research: Appraisal, synthesis, and generation of evidence. St. Louis, MO: Elsevier, Inc.

Cooke, A., & Cooke M. (2001) Cawthron Report No. 263: An investigation into the antimicrobial properties of manuka and kanuka oil. Prepared for Tairawhiti Pharmaceuticals. Retrieved from http://manuka-oil.com/antimicro.html

Cooper, R. (2008). Using honey to inhibit wound pathogens. Nursing Times, 104(3), 46, 48, 49.

References

Edwards-Jones, V., Buck, R., Shacross, S., Dawson, M., Dunn, K. (2004). The effect of essential oils on methicillin-resistant Staphylococcus aureus using a dressing model. Burns, 30(8), 772-777. Retrieved fromhttp://www.ncbi.nlm.nih.gov/pubmed/15555788?ordinalpos=1&itool=EntrezSystem2.P

ntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSumFrisch, N. (2001). Nursing as a context for alternative/complementary

modalities. Journal of Issues in Nursing, 6. Retrieved athttp://www.nursingworld.org/MainMenuCategories/ANAMarketplace/ANAPeriodicals/OIN/TableofContents/Volume62001/No2May01/AlternativeComplementaryModalities.aspx

References

Gethin G., Cowman, S. (2008)Bacteriological changes in sloughy venous leg ulcers treated with manuka honey or hydrogel: an RCT (89kb). Journal of Wound Care, 17(6), 241 – 247. Retrieved fromhttp://www.internurse.com/cgibin/go.pl/library/article.cgi?uid=29583;article=JWC_17_6_241_247;format=pdf

Lie, D., & Boker, J. (2006). Comparative survey of Complementary and Alternative Medicine (CAM) attitudes, use, and information-seeking behavior among medical students, residents & faculty. BMC Medical Education. Retrieved from http://www.biomedcentral.com/1472 6920/6/58/prepub.

References

Melnyk, B. & Fineout-Overholt, E. (2011) Evidence-Based Practice in Nursing & Healthcare: A Guide to Best Practice (2nd Ed.). Lippincott Williams & Wilkins.

Natarajan, S., Williamson, D, Grey J., Harding K., & Cooper, R. (2001). Healing of an MRSA colonized, hydroxyurea-induced leg ulcer with honey. Journal of Dermatological Treatment, 12, 33–36. Retrieved fromhttp://web.ebscohost.com/ehost/pdfviewer/pdfviewer?sid=740c39e9-8dd3-4d76

9c4a143bfa0f331a%40sessionmgr104&vid=2&hid=110

References

National Nosocomial Infections Surveillance System (2004). Report: data summary, January 1992 - June 2004. American Journal of Infection Control. Retrieved from http://www.cdc.gov/nhsn/PDFs/dataStat/NNIS_2004.pdf.

Pogorzelska, M., Stone, P., Larson, E. (2012). Wide variation in adoption of screening and infection control interventions for multidrug resistant organisms: A national study. American Journal of Infection Control, 40(8), 696- 700. Retrieved from http://www.ajicjournal.org/article/S0196-6553(12)00768-7/fulltext

Program for Integrative Medicine & Health Care Disparities at Boston Medical Center. Our mission. Retrieved from http://www.bumc.bu.edu/integrativemed/about-us-2/mission/

References

Schneider, C., Meek, P., Bell, I. (2003). Development and validation of IMAQ: Integrative medicine attitude questionnaire. BMC Medical Education, 3(5). Retrieved from http://www.biomedcentral.com/1