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NLM Director’s Comments Transcript
Under-the-Tongue Allergy Drops?: 05/28/2013
Regards to all our listeners!
I'm Rob Logan, Ph.D. senior staff National Library of Medicine for Donald Lindberg, M.D, the Director of the U.S. National Library of Medicine.
Here is what's new this week in MedlinePlus.
Under-the-tongue drops, currently not approved in the U.S., may provide a future, convenient, treatment alternative for seasonal allergies, pinkeye, and allergic asthma, suggests a systematic review of 63 studies recently published in the Journal of the American Medical Association.
The systematic review reports under-the-tongue allergy drops therapy led to a 40 percent or higher easing of chest tightness, coughing, and wheezing compared to a placebo for allergy patients in eight of 13 studies. The evidence from these studies also suggests under-the-tongue therapy drops (also known as sublingual immunotherapy) work best among children with allergies.
Similarly, the systematic review adds under-the-tongue drops allergy therapy led to a 40 percent or higher improvement in seasonal allergies, such as a stuffy nose and itchy eyes, compared to a placebo in nine out of 35 studies.
Comparing conditions, the systematic review suggests the evidence is more robust that under-the-tongue allergy drops therapy helps treat allergic asthma. There is modest evidence under-the-tongue allergy drops therapy eases seasonal allergies and pinkeye. The researchers report some of the side effects of under-the-tongue allergy drops include swelling of the lips and cheeks and occasional hives.
In under-the-tongue allergy therapy, a patient receives extracts of things such as ragweed, dust mites, and pollen in drops to build up one’s tolerance. Currently in the U.S., allergy patients can receive prescription, weekly shots given in a physician’s office or medical center. Although over-the-counter allergy medications are available widely in the U.S., the studies in the systematic review focused on patients who received prescription allergy therapy.
The study’s eight researchers assessed 63 studies with about 5,100 overall participants. Most of the research was conducted in Europe where prescription under-the-tongue allergy drops are approved for patient use.
While the systematic review’s eight authors emphasize under-the-tongue allergy drops have not been approved by the U.S. Food and Drug Administration (FDA), the authors explain some U.S. physicians legally use the drops ‘off label.’
The systematic review’s authors estimate about 20 to 40 percent of Americans have allergies. While under-the-tongue drops may be more convenient than weekly allergy shots in a physician’s office, the studies assessed in the systematic review do not suggest which approach is more clinically efficacious.
An editorial that accompanies the study notes new research is needed to compare allergy drops to shots as well as assess other issues, such as determining a recommended dose of under-the-tongue allergy drops for different age groups, and routine treatment protocols. The editorial’s author adds future research needs to determine how long a patient needs to take under-the-tongue allergy drops in order to build a long-term tolerance.
MedlinePlus.gov’s allergy health topic page explains allergies are a reaction of your immune system to things that may not bother other persons, such as pollen, dust mites, and pet dander.
Updated information about prescription allergy shots is provided by the American Academy of Family Physicians in the ‘treatment’ section of MedlinePlus.gov’s allergy health topic page. Information about allergy medications is provided by the Mayo Foundation for Medical Education and Research also within the ‘treatment’ section of MedlinePlus.gov’s allergy health topic page.
MedlinePlus.gov’s allergy health topic page provides an array of information about allergy’s diagnosis/symptoms, treatment, prevention/screening, and alternative therapy.
MedlinePlus.gov’s allergy health topic page contains links to the latest pertinent journal research articles, which are available in the ‘journal articles’ section. Links to related clinical trials that may be occurring in your area are available in the ‘clinical trials’ section. From the allergy health topic page, you can sign up to receive email updates with links to new information as it becomes available on MedlinePlus.
To find MedlinePlus.gov’s allergy health topic page, just type ‘allergy’ in the search box at the top of MedlinePlus.gov’s home page. Then, click on ‘allergy (National Library of Medicine).’ MedlinePlus.gov also has health topic pages devoted to hay fever, asthma, and pinkeye.
Overall, the systematic review’s findings may be promising to allergy patients, but existing research gaps need to be addressed before under-the-tongue drops become routine in the U.S. The clinical efficacy of allergy drops-versus-shots strikes us as a good candidate for comparative effectiveness research.
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Please email Dr. Lindberg anytime at: NLMDirector@nlm.nih.gov
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A disclaimer — the information presented in this program should not replace the medical advice of your physician. You should not use this information to diagnose or treat any disease without first consulting with your physician or other health care provider.
It was nice to be with you. I look forward to meeting you here next week.
JAMA Network | JAMA | Sublingual Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and AsthmaA Systematic ReviewImmunotherapy for Rhinoconjunctivitis and Asthma
Clinical Review|March 27, 2013
Sublingual Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and Asthma: A Systematic Review
Published online
ABSTRACT
Importance Allergic rhinitis affects up to 40% of the US population. To desensitize allergic individuals, subcutaneous injection immunotherapy or sublingual immunotherapy may be administered. In the United States, sublingual immunotherapy is not approved by the Food and Drug Administration. However, some US physicians use aqueous allergens, off-label, for sublingual desensitization.
Objective To systematically review the effectiveness and safety of aqueous sublingual immunotherapy for allergic rhinoconjunctivitis and asthma.
Evidence Acquisition The databases of MEDLINE, EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials were searched through December 22, 2012. English-language randomized controlled trials were included if they compared sublingual immunotherapy with placebo, pharmacotherapy, or other sublingual immunotherapy regimens and reported clinical outcomes. Studies of sublingual immunotherapy that are unavailable in the United States and for which a related immunotherapy is unavailable in the United States were excluded. Paired reviewers selected articles and extracted the data. The strength of the evidence for each comparison and outcome was graded based on the risk of bias (scored on allocation, concealment of intervention, incomplete data, sponsor company involvement, and other bias), consistency, magnitude of effect, and the directness of the evidence.
Results Sixty-three studies with 5131 participants met the inclusion criteria. Participants' ages ranged from 4 to 74 years. Twenty studies (n = 1814 patients) enrolled only children. The risk of bias was medium in 43 studies (68%). Strong evidence supports that sublingual immunotherapy improves asthma symptoms, with 8 of 13 studies reporting greater than 40% improvement vs the comparator. Moderate evidence supports that sublingual immunotherapy use decreases rhinitis or rhinoconjunctivitis symptoms, with 9 of 36 studies demonstrating greater than 40% improvement vs the comparator. Medication use for asthma and allergies decreased by more than 40% in 16 of 41 studies of sublingual immunotherapy with moderate grade evidence. Moderate evidence supports that sublingual immunotherapy improves conjunctivitis symptoms (13 studies), combined symptom and medication scores (20 studies), and disease-specific quality of life (8 studies). Local reactions were frequent, but anaphylaxis was not reported.
Conclusions and Relevance The overall evidence provides a moderate grade level of evidence to support the effectiveness of sublingual immunotherapy for the treatment of allergic rhinitis and asthma, but high-quality studies are still needed to answer questions regarding optimal dosing strategies. There were limitations in the standardization of adverse events reporting, but no life-threatening adverse events were noted in this review.
Objective To systematically review the effectiveness and safety of aqueous sublingual immunotherapy for allergic rhinoconjunctivitis and asthma.
Evidence Acquisition The databases of MEDLINE, EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials were searched through December 22, 2012. English-language randomized controlled trials were included if they compared sublingual immunotherapy with placebo, pharmacotherapy, or other sublingual immunotherapy regimens and reported clinical outcomes. Studies of sublingual immunotherapy that are unavailable in the United States and for which a related immunotherapy is unavailable in the United States were excluded. Paired reviewers selected articles and extracted the data. The strength of the evidence for each comparison and outcome was graded based on the risk of bias (scored on allocation, concealment of intervention, incomplete data, sponsor company involvement, and other bias), consistency, magnitude of effect, and the directness of the evidence.
Results Sixty-three studies with 5131 participants met the inclusion criteria. Participants' ages ranged from 4 to 74 years. Twenty studies (n = 1814 patients) enrolled only children. The risk of bias was medium in 43 studies (68%). Strong evidence supports that sublingual immunotherapy improves asthma symptoms, with 8 of 13 studies reporting greater than 40% improvement vs the comparator. Moderate evidence supports that sublingual immunotherapy use decreases rhinitis or rhinoconjunctivitis symptoms, with 9 of 36 studies demonstrating greater than 40% improvement vs the comparator. Medication use for asthma and allergies decreased by more than 40% in 16 of 41 studies of sublingual immunotherapy with moderate grade evidence. Moderate evidence supports that sublingual immunotherapy improves conjunctivitis symptoms (13 studies), combined symptom and medication scores (20 studies), and disease-specific quality of life (8 studies). Local reactions were frequent, but anaphylaxis was not reported.
Conclusions and Relevance The overall evidence provides a moderate grade level of evidence to support the effectiveness of sublingual immunotherapy for the treatment of allergic rhinitis and asthma, but high-quality studies are still needed to answer questions regarding optimal dosing strategies. There were limitations in the standardization of adverse events reporting, but no life-threatening adverse events were noted in this review.
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