Study: “A Meta-Analysis of the Published Literature on the Effectiveness of Antimicrobial Soaps”
Montville, Rebecca; Schaffner, Donald W. | Journal of Food Protection®. Volume 74, Number 11, November 2011 , pp. 1875-1882(8)
Handwashing with antibacterial soap produces statistically greater reductions in bacteria on the skin when compared to using non-antibacterial soap.
Those are the findings of a review of two dozen relevant published studies – analyzing the effectiveness of antibacterial soaps – featured in the November 2011 edition of the peer-reviewed Journal of Food Protection
Researchers Donald Schaffner and Rebecca Montville of Rutgers University’s (New Jersey) Food Science Department conducted a quantitative analysis of existing data in order to determine if there was a difference in effectiveness between antibacterial and non-antibacterial soaps.
“A difference in the effectiveness of antimicrobial and non-antimicrobial soaps appears to exist and is repeatedly observed through a variety of analyses; antimicrobial soap is consistently and statistically always more effective than non-antimicrobial soap,” the researchers wrote.
STUDY: “Best Practices for Determining Efficacy of Antibacterial Hand Wash Products.”
Kruszewski FH, Krowka JF | Internal Medicine News Best Practices Supplement. January 2011.
Summary: A 2005 meeting of the Nonprescription Drugs Advisory Committee (NDAC) recommended to the FDA that antibacterial hand wash products should demonstrate a reduction in infection when compared with non-antibacterial hand wash products. This paper provides a summary of the scientific model and expert panel review of the model developed to demonstrate the effectiveness of antibacterial hand wash products versus non-antibacterial hand wash products following the 2005 NDAC meeting. The expert panel concluded that the model was a realistic test for the efficacy (demonstration of reduction in infection) of antibacterial hand wash products. Data from studies using this model were presented to FDA in November 2008 and formally submitted to the FDA under FDA docket number FDA-1980-N-0006. The data from the studies that used the new scientific model to demonstrate the benefit of antibacterial wash products compared with plain soap are currently in preparation for publication in a peer-reviewed journal.
STUDY: “Alternative hand contamination technique to compare the activities of antimicrobial and non-antimicrobial soaps under different test conditions”
Janice L. Fuls, Nancy D. Rodgers, George E. Fischler, Jeanne M. Howard, Monica Patel, Patrick L. Weidner, and Melani H. Duran | American Society for Microbiology 2008
Summary: Antimicrobial hand soaps provide a greater bacterial reduction than nonantimicrobial soaps. Confounding factors, such as compliance, soap volume, and wash time, may all influence the outcomes of studies. The aim of this work was to examine the effects of wash time and soap volume on the relative activities and the subsequent transfer of bacteria to inanimate objects for antimicrobial and nonantimicrobial soaps.
Study Significance: The results of this study indicate that nonantimicrobial soap was less active and that the effectiveness of antimicrobial soaps can be improved with longer wash time and greater soap volume. The transfer of bacteria to objects was significantly reduced due to greater reduction in bacteria following the use of antimicrobial soap.
STUDY: “Effect of hand wash agents on controlling the transmission of pathogenic bacteria from hands to food”
Fischler G.E., et al. | Journal of Food Protection 2007
Summary: The goals of this study were to evaluate the effectiveness of two hand wash regimens in reducing transient bacteria on the skin following a single hand wash and the subsequent transfer of the bacteria to a ready-to-eat food item, freshly cut cantaloupe melon. The number of bacteria recovered from hands and the quantity transferred to the melon were significantly less following the use of an antibacterial soap compared with plain soap.
Study Significance:The data demonstrated that there is a much greater potential to reduce the acquisition and transmission of disease through the use of an antibacterial hand wash compared to plain soap.
STUDY: “Comparative efficacy of hand hygiene agents in the reduction of bacteria and viruses”
Emily E. Sickbert-Bennett, David J. Weber, Maria F. Gergen-Teague, Mark D. Sobsey, Gregory P. Samsa, William A. Rutala | American Journal of Infection Control 2005
Summary: UNC Researchers found antimicrobial soap ingredients to be the "most efficacious" in removing bacteria from hands. University of North Carolina Hospitals’ infection control experts also reported that washing with soap and water is the best way to remove viruses from one’s hands.
ISSUE BRIEF: Benefits of Topical Antimicrobial Products
The Soap and Detergent Association (SDA) and The Cosmetic, Toiletry, and Fragrance Association (now American Cleaning Institute and Personal Care Products Council, respectively), presented an Issue Brief to the Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee meeting on October 20, 2005. The paper summarizes research describing the benefits of over-the-counter topical antimicrobial products, including bars, liquids, gels and wipes.
LITERATURE REVIEW: Benefits of Topical Antimicrobial Products
A comprehensive review of scientific research and literature is overwhelmingly supportive of the benefits of topical antimicrobial products in interrupting infection in invasive situations, interrupting disease transmission to oneself and others in non-invasive situations, as well as reducing the numbers of bacteria on the surface of the skin.
Much of this information was transmitted to the U.S. Food and Drug Administration by a coalition consisting of The Soap and Detergent Association and The Cosmetic, Toiletry, and Fragrance Association (now American Cleaning Institute and Personal Care Products Council, respectively).
Part of the Coalition’s August 2001 submission to the FDA showcased benefits in home, institutional and clinical settings
Additional studies on product benefits were showcased in an August 2003 Coalition petition:
SDA/CTFA comments, Food and Drug Administration, August 27, 2003: Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Health-Care Antiseptic Drug Products. New Data Shows Additional Benefits From healthcare professional products.
STUDY: “Hand contamination before and after different hand hygiene techniques: a randomized clinical trial”
J.C. Lucet, M.P. Rigaud, F. Mentrey, N. Kassisz, C. Deblangy, A. Andremont and E. Bouvet | Journal of Hospital Infection 2002
Summary: This study had two aims: to assess the factors associated with hand contamination after care, and to measure the microbiological efficiency of different hand hygiene techniques. This prospective randomized study in a clinical environment shows that alcohol-based hand sanitizers and hand washing with antiseptic soap are more effective than hand washing with unmedicated soap, in reducing the bacterial count on hands. The need to reduce carriage of pathogenic bacteria to a minimum suggests that the use of alcohol-based hand sanitizers should be preferred to unmedicated soaps, and possibly to antiseptic soaps.
Study Significance: Results show that alcohol-based hand sanitizers and hand washing with antiseptic soap is more effective than hand washing with unmedicated soap in reducing the bacterial count on hands.
STUDY: “Use of 0.3 triclosan to eradicate an outbreak of MRSA in a neonatal nursery.”
Zafar AB et al. | Am. J. Infect. Control. 23:20 –208. 1995
Summary: The single infection control measure of changing the hand wash and bathing product to a 0.3% triclosan hand wash was associated with the immediate termination of the acute phase of an Methicillin Resistant Staphylococcus aureus (MRSA) outbreak.
STUDY: “Elimination of methicillin resistant Staphylococcus aureus from a neonatal intensive care unit after hand washing with triclosan.”
J. Paediatr. | Child Health. 30:59–64. 1994
Summary: Following the introduction of a triclosan hand wash, there was a gradual elimination of MRSA in the unit, and lower antibiotic use, and nosocomial infections were recorded.
STUDY: “Quantitative assessment of risk reduction from hand washing with antibacterial soaps”
L.L. Gibson, J.B. Rose, C.N. Haas, C.P. Gerba and P.A. Rusin | Journal of Applied Microbiology Symposium Supplement 2002
Summary: The objective of this exercise was to examine the risk reduction achieved, based on exposure to bacteria from the contamination of hands after diaper changing with and without antibacterial soaps during hand washing, using a microbial quantitative risk assessment approach. The objectives were to assess the reduction in bacteria remaining on the hands immediately after washing with an antibacterial soap compared with a control agent, and the associated reduction in exposure and risk. While the consumer may believe that hand washing with soap results in ‘clean’ hands, they may not be microbiologically clean. The proper washing of hands after diapering is a practice in the home or day care facility that could readily reduce, or practically eliminate, the risk of disease transmission. The models suggest that with the use of an antibacterial formulation, this risk is slightly reduced, but this needs further evaluation. The risk assessment approach allows for comparative evaluation of products and protocols that may provide increased public health protection.
Significance of Study: The study model suggests that using soap with antibacterial ingredients after changing a diaper can reduce the risk of disease transmission slightly.
STUDY: “The effect of a comprehensive hand washing program on absenteeism in elementary schools”
Maryellen Guinana, Maryanne McGuckin, Dr ScEd, MT (ASCP), Yusef Ali, PhD | American Journal of Infection Control 2002
Summary: The objective of this study was to determine the effectiveness of a comprehensive hand washing program on absenteeism in elementary grades. Two hundred ninety students from five independent schools were enrolled in the study. The data strongly suggest that a hand hygiene program that combines education and use of a hand sanitizer in the classroom can lower absenteeism and be cost-effective.
Significance of Study: This research strongly suggests that a successful hand hygiene program for elementary schools should include the following components: 1. Administrative support. 2. One-hour hand hygiene educational in-service by a school nurse for all students 3. Placement of hand sanitizer in classrooms and bathrooms.
STUDY: “A cluster-randomized controlled trial evaluating the effect of a handwashing-promotion program in Chinese primary schools”
Anna Bowen, Huilai Ma, Jianming Ou, Ward Billhimer, Timothy Long, Eric Mintz, Robert M. Hoekstra and Stephen Luby | American Journal of Tropical Medicine and Hygiene 2007
Summary: Results from this study showed that intensive handwashing promotion can reduce diarrheal and respiratory disease incidence. To determine whether less intensive, more scalable interventions can improve health, researchers evaluated a school-based handwashing program. They randomized 87 Chinese schools to usual practices: standard intervention (handwashing program) or expanded intervention (handwashing program, soap for school sinks, and peer hygiene monitors). We compared student absence rates, adjusting for cluster design. Provision of a large-scale handwashing promotion program and soap was associated with significantly reduced absenteeism. Similar programs could improve the health of children worldwide.
STUDY: Use of Antibacterial Washes not linked to antiobiotic resistance
E.C. Cole, R.M. Addison, P.D. Dulaney, K.E. Leese, H.M. Madanat, and A.M. Guffey
International Journal of Microbiology Research | Vol. 3, Issue 2, 2011, pp-90-96
“Investigation of Antibiotic and Antibacterial Susceptibility and Resistance in Staphylococcus from the Skin of Users and Non-Users of Antibacterial Wash Products in Home Environments” Summary:
Newly published research reaffirms that the use of antibacterial wash products in the home environment does not contribute to antibiotic or antibacterial resistance, confirming previous research that showcased similar findings.
The study, published in the peer-reviewed International Journal of Microbiology Research
, compared the use of over-the-counter antibacterial liquid hand and body cleansers and antibacterial bar soaps—containing the germ-killing ingredients triclosan and triclocarban—against the use of non-antibacterial cleansers.
STUDY: “Antibacterial cleaning products and drug resistance”
Allison E. Aiello, Bonnie Marshall, Stuart B. Levy, Phyllis Della-Latta, Susan X. Lin, and Elaine Larson | Emerging Infectious Diseases (CDC) 2005
Summary: Research published in the Centers for Disease Control and Prevention (CDC) journal Emerging Infectious Diseases (October 2005) finds that the use of antibacterial cleaning products does not lead to a "significant increase in antimicrobial drug resistance after one year, nor did it have an effect on bacterial susceptibility to triclosan."
ISSUE BRIEF: Studies show no clinical, real world evidence of increased resistance under current use conditions of topical antimicrobial products
Soap and Detergent Association (now the American Cleaning Institute)/Cosmetic, Toiletry & Fragrance Association (now the Personal Care Products Council) | October 2005
Summary: The American Cleaning Institute (ACI) and the Personal Care Products Council (PCPC) presented this issue brief to the Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee meeting on October 20, 2005. The paper summarizes research demonstrating there is no real world evidence linking the use of topical antimicrobial products to antibiotic resistance.
STUDY: “Whither triclosan?”
A.D. Russell | Journal of Antimicrobial Chemotherapy 2004
Summary: A scientific review on the use of triclosan (a common ingredient in antibacterial soap) -- published in April 2004 stated that "comprehensive environmental surveys have not demonstrated any association between triclosan usage and antibiotic resistance."
STUDY: “Comparative analysis of antibiotic and antimicrobial biocide susceptibility data…”
RJW Lambert | Journal of Applied Microbiology 2004
Full Title: “Comparative analysis of antibiotic and antimicrobial biocide susceptibility data in clinical isolates of methicillin-sensitive Staphylococcus aureus, methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa between 1989 and 2000†”
Summary: The study reports finding "negative correlations" between biocide usage and antibiotic resistance. The study was funded by SDA and The Cosmetic, Toiletry, and Fragrance Association (now known as American Cleaning Institute and the Personal Care Products Council, respectively).
Data from a separate SDA-contracted study were statistically analyzed by British researcher Dr. Ronald W. Lambert to look for correlations among specific groups of clinical bacterial isolates with regard to their susceptibilities to clinically relevant antibiotics and common antimicrobials.
The results of this study indicated that increases in the antibiotic resistance of strains of Staphylococcus and Pseudomonas were not caused by increases in their biocide resistance.
"From the analyses of these clinical isolates it is very difficult to support a hypothesis that increased biocide resistance is a cause of increased antibiotic resistance either in Staph. aureus or in Ps. Aeruginosa," the author stated.
"The observation of negative correlations between antibiotics and biocides may be a useful reason for the continued use of biocides promoting hygiene in the hospital environment," he concluded.
RESEARCH: “Live and let die”
Peter Gilbert and Andrew McBain, University of Manchester (UK) | Microbiology Today 2004
Summary: The article concluded that the risks of antibacterial resistance developing from the use of antibacterial cleaning products may well have been overstated and that health and hygiene are being compromised as a result.
"It is now imperative that confidence is restored in products that form an essential part of domestic and hospital hygiene," write the authors. "Hygiene should be emphasized and targeted towards those applications where there is demonstrable benefit (food preparation, care of the elderly and immune-deficient, wound care, infection control).
"Professors' McBain and Gilbert also presented research at the 104th General Meeting of the American Society for Microbiology (ASM) in New Orleans in May 2004. That research, according to an ASM news release, shows that "the risk of bacteria developing antibiotic resistance after exposure to the biocide triclosan may not be as great as previously believed."
STUDY: “Biocide use and antibiotic resistance: the relevance of laboratory findings to clinical and environmental situations”
A.D. Russell | The Lancet 2003
Summary: Dr. Russell concludes that, "While biocides may lead to antibiotic resistance in the laboratory, it does not necessarily equate to the development of such resistance in the natural or clinical environment."
Dr. Russell also reports that "there is no convincing evidence that triclosan use has resulted in the clinical development of isoniazid-resistant M tuberculosis, antibiotic-resistant staphylococci, or antibiotic-resistant Gram-negative bacteria."
The research was funded and reviewed by SDA and The Cosmetic, Toiletry, and Fragrance Association (now American Cleaning Institute and Personal Care Products Council, respectively). However, the views expressed in this paper are those of the author alone and do not necessarily reflect those of others.
STUDY: “Exposure of sink drain microcosms to triclosan: population dynamics and antimicrobial susceptibility”
Andrew J. McBain, Robert G. Bartolo, Carl E. Catrenich, Duane Charbonneau, Ruth G. Ledder, Bradford B. Price, and Peter Gilbert | Applied and Environmental Microbiology, September 2003
Summary: Research from the September 2003 issue of Applied and Environmental Microbiology reported that the "emergence of antibiotic resistance through triclosan in the kitchen is highly improbable."
STUDY: "Investigation of antibiotic and antibacterial agent cross-resistance in target bacteria from homes of antibacterial product users and nonusers"
E.C. Cole, R.M. Addison, J.R. Rubino, K.E. Leese, P.D. Dulaney, M.S. Newell, J. Wilkins,D.J. Gaber, T. Wineinger and D.A. Criger | Journal of Applied Microbiology 2003
Summary: The purpose of this study was to describe the relationship between antibiotic and antibacterial resistance in environmental and clinical bacteria from home environments across geographical locations, relative to the use or nonuse of antibacterial products, with a focus on target organisms recognized as potential human pathogens. The results showed a lack of antibiotic and antibacterial agent cross-resistance in target bacteria from the homes of antibacterial product users and nonusers, as well as increased prevalence of potential pathogens in nonuser homes.
Study Significance: It refutes widely publicized, yet unsupported, hypotheses that use of antibacterial products facilitates the development of antibiotic resistance in bacteria from the home environment.
LITERATURE REVIEW: “No evidence of decreased susceptibility of bacteria to antimicrobial agents under use conditions or in the environment”
Soap and Detergent Association (now the American Cleaning Institute) /Cosmetic, Toiletry & Fragrance Association (now the Personal Care Products Council) | August 2003
Summary: The use of topical antimicrobial wash products does not contribute to antimicrobial resistance, according to a comprehensive scientific literature provided to the Food and Drug Administration (FDA).
The information was submitted to the FDA by The Soap and Detergent Association (SDA) and The Cosmetic, Toiletry, and Fragrance Association (now American Cleaning Institute and Personal Care Products Council, respectively) on August 27, 2003, which filed comments to the agency as it develops a Final Monograph (FM) for Over the Counter (OTC) Health-Care Antiseptic Drug Products.
The SDA/CTFA coalition reminded FDA that in 1997, an independent review panel convened by the agency reported that resistance was not an issue under current conditions of topical antimicrobial product usage. The research shared with the agency reiterates that conclusion, said the Coalition.
REVIEW: “Opinion on triclosan resistance”
European Commission Scientific Steering Committee | June 2002
Summary: In June 2002, a European Commission Scientific Steering Committee completed a comprehensive and thorough scientific review and analysis of data on antibiotic resistance regarding triclosan, the most commonly used antibacterial ingredient in consumer products.
The panel reported that "There is no convincing evidence that triclosan poses a risk to humans or to the environment by inducing or transmitting antibacterial resistance under current conditions of use."
On September 17, 2002, the European Commission’s Scientific Committee on Cosmetic Products and Non-food Products Intended for Consumers (SCCNFP) endorsed the Scientific Steering Committee’s findings and recommendations.
STUDY: “Exposure and Risk Screening Methods for Consumer Product Ingredients” (available on ACI website)
American Cleaning Institute (formerly SDA) | 2005
Summary: Data on Triclocarban (TCC) hazard and exposure demonstrates that there is negligible likelihood of harm to man and the environment during manufacture of TCC and formulation and use of personal cleansing products containing TCC (See Tables 1.2 and 1.3).
Significance of Study: The results concluded that TCC is safe for humans and the aquatic environment at the current rate of consumption and that, based on data presented, no adverse effect for humans are expected via any relevant exposure route.