Allergy Control Results & Research

Validated Results

Studies showing the impact of treatment using the La Crosse Method™ Protocol with patients in a clinical setting*; results validated by the Validation Institute in 2018 and 2020.

KEY QUESTIONS	2003	2004	2005	2013
Incidence of chronic conditions prior to treatment** Hypothesis: Allows patients compromised by related conditions to receive disease-modifying treatment	51%	63%	73%	Not asked
Reduced visits pre vs post treatment Hypothesis: actively treated patients use less related care	48% less 1.19 v 3.69	68% less 1.61 v 5.01	60% less 2.2 v 5.5	82% less .65 v 3.56
Reduced related ER visits pre vs post-treatment Hypothesis: actively treated patients use less related care	80% less .15 v .76	81% less 11 v 57	86% less .1 v .7	95% less .02 v .41
Reduced medication use pre vs post treatment Hypothesis: actively treated patients require less related medication use over time	up to 50% less 2.19 v 2.59	50% less 1.62 v 3.23	40% less 1.5 v 2.5	47% less 5.46 v 10.21
Reduced school/work missed pre vs post treatment Hypothesis: actively treated patients experience fewer related absences over time	60% less 2.80 v 7.23	73% less .89 v 3.29	76% less .5 v 2.1	67% less 1 v 3
Improved Quality of Life score pre vs post treatment Hypothesis: Treatment can results in patients’ ability to participate in life activities. (Respondents asked to rate QOL improvement).	4.11	4.47	4.5	4.11
(5 = very positively 4=quite positively 3 = some 2 = very little 1 = not at all)
Demographic Questions Respondents Average age Tested for allergy prior to treatment Treated with other immunotherapy prior to treatment	250 46 48% 38%	75 47.5 54% 16%	112 38 60% 25%	299 36-55 N/A N/A

*Active patients under treatment surveyed at Allergy Associates of La Crosse, La Crosse/Onalaska, WI.
**Chronic conditions associated with allergic disease include asthma, sinusitis, eczema, and urticaria.

The Contemporary Body of Worldwide Allergy Industry SLIT Research

Europe leads the U.S. in its use and approach to allergy care using sublingual. Here is an excerpt from the World Allergy Organization, November 2009, Position Statement on SLIT.

Delivery of SLIT in the community setting:

Primary Care Physicians/GPs should be armed with the knowledge of selecting the appropriate treatment relevant to the patient’s illness and should be trained to make a comprehensive assessment, recognize treatment failure (inadequate therapy, mal-administered therapy, inadequate control) and exacerbations of illness.
They should be trained in all aspects of SLIT, including assessment of patients and administration of SLIT. Emphasis should be placed on detection and management of untoward side effects, possible local and SRs, adverse effects and other untoward incidents in detail, and taught how to manage such incidents.

Scientific Evidence for Sublingual Immunotherapy

The complete body of sublingual immunotherapy research world-wide is extensive; more than 850 studies and papers have been presented on the subject over the past 50 years; detailed bibliography can be found at allergychoices.com/bibliography. It is impractical to offer this information in totality, however recent U.S. and International comprehensive meta-analyses were performed and have confirmed that SLIT is safe and effective based on a substantial number of modern, high quality studies performed around the world over the past 30 years.

Beginning in 1986 with Dr. Glennis Scadding’s multi-antigen SLIT study; through the mid-90s with the most comprehensive study ever performed comparing SLIT & SCIT in the largest double-blind-double-dummy SCIT vs. SLIT study to date; to recent studies of the single allergen SLIT tablets; findings have been consistent. Both SCIT and SLIT are efficacious; in terms of safety, SLIT is favored over SCIT. These assertions are made only after careful examination by world renowned research organizations assessing hundreds of studies worldwide. We have included concluding statements from the three largest, most respected, and most recent meta-analyses on the subject. Additionally, we provide full report links so that readers can determine of the research data’s strength and conclusions.

The Cochrane Collaborative is the world’s most-trusted research; their vision and mission statement note “Our work is internationally recognized as the benchmark for high-quality information about the effectiveness of health care.” They issued two reports on allergy immunotherapy using SLIT, which were published in 2003 and updated in 2010.

The most extensive comparison of SCIT vs. SLIT was completed as a meta-analysis by a U.S. based research group as part of the Agency for Healthcare Research and Quality.

Cochrane Collaborative

Sublingual immunotherapy for allergic rhinitis

Wilson DR, Torres Lima M, Durham SR, published in The Cochrane Library 2003, Issue 2
http://www.cochrane.org/CD002893/ENT_sublingual-immunotherapy-for-allergic-rhinitis-including-hay-fever

Main result
Twenty two trials involving 979 patients were included. There were six SLIT trials for House Dust Mite allergy, five for Grass, Pollen, five for Parietaria, two for Olive and one each for, Ragweed, Cat, Tree and Cupressus.

Four studies enrolled exclusively children. Seventeen studies administered the allergen by sublingual drops subsequently swallowed, three by drops subsequently spat out and two by sublingual tablets. Eight studies involved treatment for less than six months, ten studies for six to twelve months and four studies for greater than twelve months. All included studies were double-blind placebo-controlled trials of parallel group design. Treatment allocation concealment was considered adequate in all studies and the use of identical placebo preparations was almost universal.

There was significant heterogeneity for most comparisons, most likely due to widely differing scoring systems between studies. Overall, there was significant reduction in both symptoms (SMD -0.34, 95% confidence interval - 0.69 to -0.15; p=0.002) and medication requirements (SMD -0.43 [-0.63, -0.23]; p=0.00003) following immunotherapy. Subgroup analyses failed to identify a disproportionate benefit of treatment according to the allergen administered. There was no significant reduction in symptoms and medication scores in those studies involving only children but total numbers of participants were small, casting doubt on the validity of the conclusion. Increasing treatment duration does not clearly increase efficacy. The total dose of allergen administered may be important but insufficient data were available to analyse this factor.

Sublingual immunotherapy for allergic rhinitis (Update Review)

Radulovic S, Calderon MA, Wilson D, Durham S, published in The Cochrane Library 2010, Issue 12

PLAIN LANGUAGE SUMMARY (excerpt from) In reviewing 60 trials, we found a significant reduction in symptom and medication scores in patients treated with sublingual immunotherapy compared to placebo. There were no serious adverse reactions reported in the included trials and no patient needed the use of adrenaline. This updated Cochrane Review therefore reinforces the earlier review’s conclusions confirming the efficacy and safety of sublingual immunotherapy.

Agency for Healthcare Research and Quality (AHRQ)

Sublingual Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and Asthma. A Systematic Review.

Prepared by the Johns Hopkins University Evidence-based Practice Center

https://jamanetwork.com/journals/jama/fullarticle/1672214

Research Focus for Clinicians
A systematic review was undertaken to summarize the evidence regarding the efficacy, comparative effectiveness, and safety of subcutaneous and sublingual immunotherapy for adult and pediatric patients. All included studies are randomized controlled trials (RCTs) and were published from January 1967 to May 2012. There are seventy four RCTs on the efficacy and safety of subcutaneous immunotherapy (SCIT), sixty RCTs on the efficacy and safety of sublingual immunotherapy (SLIT), and eight RCTs on head-to-head comparisons between both forms of immunotherapy. This summary is provided to assist clinicians in decision-making along with a patient’s values and preferences.

Conclusions

There is sufficient evidence to support the overall effectiveness and safety of both SCIT and SLIT for treating allergic rhinoconjunctivitis and asthma (Tables 1 and 2).
However, there is not enough evidence to determine if either SCIT or SLIT is superior.
SCIT and SLIT are usually safe, although local reactions are commonly reported regardless of the mode of delivery (Table 3).
Serious, life-threatening reactions are rare, although they can occur (see SCIT, Table 3). SLIT studies mainly include patients with allergic rhinitis and/or mild asthma. Safety outcomes for SLIT should not be extrapolated to more severely affected patients.
Most studies use a single allergen for immunotherapy (Table 4). It may be difficult to extrapolate these results to the use of multiple-allergen regimens, which are commonly used in clinical practice in the United States.
Due to the wide variety of reported regimens, the target SLIT maintenance dose and the duration of therapy are unclear.

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Allergy Control Results & Research

Validated Results