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Complementary & Alternate Medicines forAllergies & Sinus Congestion:
Making sense of the data for you and your customers
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Introduction
Allergic rhinitis and
sinus congestion are
commonly encountered
complaints and result insignificant morbidity
Number of persons in the US with:
Allergic rhinitis - 40 million1
Chronic sinusitis - 35 million2
Another 58 million have non-allergic
rhinitis which can complicate the above
conditions
1. National Institute of Allergy and Infectious Diseases.20032. National Institute of Allergy and Infectious Diseases.2007
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2ndleading cause of chronic disease in US
50% of those affected have suffered > 10 years
Prevalence is increasing
Allergic Rhinitis
Marple BF, Fornadley JA, Patel AA, et al. OtolaryngolHNS. 2007;136:S107-24.
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Allergic Rhinitis
20% of patients believe their health care provider doesnot take their symptoms seriously enough
37 % of patients are not satisfied with their current
allergy treatment
Patients may take up to 2 to 4 medications at a time forrelief of allergy symptoms
42 % of patients are confused by choices of medication
59 % wished they knew more about the drugs they take
http://www.medicalnewstoday.com/articles/56516.php
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Burden of Allergic Rhinitis
Annoying / embarrassing nasal, ocular symptoms
QoL impact
Sleep, psychomotor functioning, decision-making, well-being
Burden to the healthcare system
Significant healthcare costs (~$6 billion direct & indirect)
Burden to employers
Decreased work productivity, absences, presenteeism
3.5 million lost work days, 2 million missed school days
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Therapeutic Options
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ConventionalTreatment Options
oral and intranasal antihistamines
oral and intranasal corticosteroids
oral and intranasal decongestants
leukotriene modifiers
immunotherapy
Compliance with treatment may be limited due to: side-effects such astaste, sedation, rebound, costs (direct and indirect), ease of use
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Relative Effectiveness of Medicationsused to treat allergic rhinitis
Wallace et al. J Allergy Asthma Clin Immunol 2008; 122: S1-84.
Bousquet et al.Allergy2008; 63: S8-S160.
Medication
Class
Sneezing Itching Congestion Rhinorrhea Eyes Inflammation
Oralantihistamines
++ ++ +/- ++ + +
Intranasalantihistamines
++ ++ ++ ++ +/- +
Intranasalcorticosteroids
++ ++ ++ ++ + ++
Leukotrienemodifiers
+/- +/- - +/- +/- +
Cromolyn sodium + + - + + +
Decongestants - - ++ - - -
++ substantial benefit+ modest benefit+/- little or no benefit- no benefit
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Complementary & AlternateMedicine use (US)
Barnes PM, Bloom B, Nahin R. CDC National Health Statistics Report # 12. Dec 2008
People are increasingly usingcomplementary and alternatemedicine (CAM).
CAM use among adults isgreatest among women and thosewith higher levels of educationand income.
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Complementary & Alternate(CAM) Options
1. Colloidal silver
2. Oral homeopathic substancesi.e.
i. Arsenicum album
ii. Kali bichromicum
iii. Pulsatilla
iv. Luffa Operculata
v. Echinacea and Turmeric
3. Saline (drops/spray/wash)
4. Intranasal antifungal agents
5. Capsaicin nasal spray
6. Nutritionals
i. Bromelain
ii. Quercetin
iii. Vitamin C
iv. Garlic
Limited clinical evidence for most CAMs.
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Colloidal Silver
Over-the-counter colloidal silver products are not considered by the U.S.Food and Drug Administration (FDA) to be generally recognized as safe andeffective for diseases and conditions
The FDA has taken action against a number of colloidal silver companies
for making drug-like claims about their products
Colloidal silver can cause serious side effects including argyria, a bluish-gray discoloration of the body. Argyria is not treatable or reversible.
No clinical studies to support the use of colloidal silver in allergicrhinitis or sinusitis
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Luffa Operculata (Zicam)
Placebo-controlled,double-blindstudy of 32 pts with seasonalallergic rhinitis. Patients receivedZicam or placebo 4xday / nostrilfor 14 days
1endpoint was the change frombaseline in the overallRhinoconjunctivitis Quality of
Life Questionnaire (RQLQ)
4 x daily Zicam improved patientrelated QoL and reducedimpairment in day to dayactivities
Nobel S, The Internet Journal of Family Practice. ISSN: 1528-8358
RQLQ Scores% decrease from baseline
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Nasal Saline (Drops/Spray/Wash)
Sinusitis: studies have reported improved QoL on disease-specific questionnaires
Allergic rhinitis: positive effects have been noted in studies inchildren and in adults when nasal saline is used in conjunctionwith medication and when used as a placebo treatment
Nasal saline is generally accepted as aneffective adjunctive therapy for allergic rhinitis,
non-allergic rhinitis, and rhinosinusitis.
Harvey R et al. Cochrane Database Syst Rev. 2007:3Rabago D et al. Ann Fam Med. 2006;4:295-301.Garavello W et al. Pediatr Allergy Immunol. 2003;14:140-143
http://images.google.com/imgres?imgurl=http://www.nyee.edu/images/ent_rss_mts_005.jpg&imgrefurl=http://www.nyee.edu/ent_rss_mts.html&h=320&w=290&sz=22&hl=en&start=15&um=1&usg=__4chJVK7rSHBfrh27Ofp7D2FpiRY=&tbnid=PJL2EL0kDbZ7EM:&tbnh=118&tbnw=107&prev=/images?q=saline+nasal+wash&um=1&hl=en&rlz=1T4GZAY_enUS247US248&sa=Nhttp://images.google.com/imgres?imgurl=http://healthinmotion.files.wordpress.com/2008/02/15.jpg&imgrefurl=http://healthinmotion.wordpress.com/2008/02/&h=500&w=392&sz=28&hl=en&start=4&um=1&usg=__KAdHeTW_QPkSJj-EXa1GS4MIttk=&tbnid=or5dv44r5bWVnM:&tbnh=130&tbnw=102&prev=/images?q=saline+nasal+wash&um=1&hl=en&rlz=1T4GZAY_enUS247US248&sa=Nhttp://images.google.com/imgres?imgurl=http://farm1.static.flickr.com/44/135121043_9b64a51ac8.jpg?v=0&imgrefurl=http://flickr.com/photos/35468137479@N01/135121043&h=333&w=500&sz=67&hl=en&start=10&um=1&usg=__CfummsHYo9DQL7Iz6rZW1N4OVLY=&tbnid=CRydvkx1qd1wGM:&tbnh=87&tbnw=130&prev=/images?q=saline+nasal+wash&um=1&hl=en&rlz=1T4GZAY_enUS247US248&sa=N8/14/2019 Sinol Pharmacy Education Webinar 6-2-09.pdf
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Antifungal Therapy
6 controlled trials of anti-fungal therapy in chronicrhinosinusitis
2 demonstrated benefit but have significant flaws1,2
- short length of treatment- lack of descriptive methods to evaluate compliance to therapy
- inadequate power to detect a difference between groups
- fungi not eradicated in the treatment group
4 showed no benefit3-6
1. Shin SH et al.J Allergy Clin Immunol 2004; 114:1369-1375.2. Liang KL et al.Am J Rhinol 2008; 22:52-58.3. Ebbens FA et al.J Allergy Clin Immunol 2006; 118:1149-1156.4. Ponikau JU et al J Allergy Clin Immunol 2005; 15:125-131.
5. Kennedy DW,et al.Laryngoscope 2005; 115:1793-1799.6. Weschta M et al.J Allergy Clin Immunol 2004; 113:1122-1128.
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Capsaicin
1. Lacroix JS et alClin Exp Allergy 1991;21:595-600
2. Kitajari M, et al Acta Otolaryngol Suppl 1993;500:88-91
Capsaicin - pungent agent in hot peppers
Used for headache, sinus, and allergies for >150 years
Shown to desensitize sensory neurons1,2(peptidergic
sensory C-fibers) Nasal formulation reduces congestion of blood vessels
reduces irritation by airborne particles, allergens
rapidly relieves allergy and sinus congestion symptoms
reduces pain (i.e. headache)
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Intranasal CapsaicinClinical Data
Capsaicin is efficacious in the treatment of non-infectious rhinitis
Blom HM, et al. Clin Exp Allergy 1997; 27:796-801
Study shows capsaicin efficacy rate of 89% in allergic rhinitis patients
Zhang F et al. Lin Chuang Er Bi Yan Hou Ke Za Zhi. 1999 Nov; 13(11): 499-500.
Capsaicin significantly reduced overall nasal symptoms, rhinorrhea
and nasal blockage
Van Rijswijk JB et al. Allergy. Aug; 58(8):754-61.
Intranasal capsaicin relieved the clinical symptoms of allergic rhinitis
and reduced the level of Substance P in the nasal secretions.
Zhang R, et al. Zhonghua Er Bi Yan Hou Ke Za Zhi.1995; 30(3):163-5
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Capsaicin improved predominate symptoms (nasal congestion,
hypersecretion, sneezing) by 62-72%, offering a promising new option
for treatment of hyper-reactive rhinopathy
Wolf G et al. Laryngorhinootologie. May;74(5):289-93
Capsaicin significantly reduced symptoms in chronic rhinitis patients
with no significant side effects
Lacroix JS et al. Clin Exp Allergy. Sep; 21(5):595-600.
Nasal obstruction and nasal secretion significantly reduced by
intranasal capsaicin
Marabini S et al. Eur Arch Otorhinolaryngol. 248(4):191-4
Capsaicin clinical data (cont.)
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Clinical Data (cont.)
The efficacy of repeated capsaicin application
has been established in several randomized
controlled trials. This treatment modality may bethe first step to more specific and better
treatment options for patients with idiopathic
rhinitis that is unresponsive to standard
treatment.
Van Rijswijk JB, et al. Curr Allergy Asthma 2006; Rep. 6(2):132-7.
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2 formulations / brands of capsaicin nasal sprayavailable in the US
Sinol-MSinusBuster
Sinol-M is a new all-natural nasal spray formulated forthe fast relief of allergies, sinus congestion andheadache
Sinol-M is the onlyall-natural remedy for allergic rhinitiswith proven clinical efficacy and tolerability1
Capsaicin nasal sprays
1. Kaliner M, et al 2009 Poster presentation at the Western Society ofAllergy Asthma and Immunology 47thAnnual Scientific session
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AVAILABLE NOW
For fast, safe, natural relief of symptoms
Sinol-M
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Sinol-M
All natural ingredients
No rebound
No harsh side effects or known interactions
Non-drowsy
Non-addictive
Can be used as needed up to 12 times per day
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ACTIVE INGREDIENTSA homeopathic dose of capsaicin - thepungent phenolic compound responsible for
the analgesic properties of hot pepperAloe Vera for its soothing effect
AND MucoAd
a novel mucoadhesive carrierto prolongadherence of the active ingredients to thenasal mucosa
Sinol-M
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Classified as a homeopathic drug
Registered by the FDA
Produced in the USA
Manufactured in an FDA-approved facility
Sinol-M
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Comparative study of 1stgeneration Sinol and thenew generation Sinol-M
Conducted at the Institute for Asthma & Allergy,(Washington, DC)
24 patients with > 2 year history of persistent
allergic rhinitis
Sinol-M clinical data
Kaliner M, et al 2009 Poster presentation at the Western Society of Allergy Asthmaand Immunology 47thAnnual Scientific session
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Crossover study1- week, run-in with no treatment, followed by 1-week of either Sinolor Sinol-M, (one spray in each nostril PRN)1-week washout (no treatment) followed by 1-week treatment with theother Sinol product
AM and PM nasal symptoms scored in diaries (scale, 0=no symptoms to4=very severe symptoms)
runny noseitchy nosecongestion
sneezing
The daily Total Nasal Symptom Score (TNSS) = AM + PM scores(min =0, max =32)
Sinol-M study design
Kaliner M, et al 2009 Poster presentation at the Western Society of Allergy Asthma
and Immunology 47th
Annual Scientific session
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Sinol-M study results
Mean Daily TNSS(sum of morning and evening scores)
TNSS scores decreased with both active treatments
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Sinol-M study results
Mean daily number of sprays
Improvement in TNSS occurred despite fewer doses of Sinol-M vs. Sinol
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Both Sinol and Sinol-M significantly reducedbothersome nasal symptoms vs. no treatment
Patients used fewer doses of Sinol-M, vs. Sinol,especially at night, suggesting improved efficacy,sleep and associated Quality of Life
No treatment related side-effects observed with eitherSinol or Sinol M
Sinol-M study results
Kaliner M et al .2009 Poster presentation at the Western Society of AllergyAsthma and Immunology 47thAnnual Scientific session
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Professional Marketingof Sinol-M
Sinol USA has engaged Strategic Pharmaceutical Advisors(SRxA) to handle professional marketing of Sinol-M
Retail pharmacy sales of Sinol-M will be driven by targetededucation programs for pharmacists and endorsement fromhealth care professionals:
Allergists, ENT, pulmonologists, primary care physicians, NPs, PAs
Sinol-M poster presentations and exhibits at major medicalmeetings
AAAAI, EACCI, WSAAI
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Additional formulations including Childrens Allergy, Cough & Cold
and Childrens Cough & Cold will be introduced during 2009
Si l M
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Sinol-M contains capsaicin, derived from the hot pepper plant. Uponinitial use, some patients may experience a mild burning sensation,lasting 2-5 seconds. This is transient, usually diminishes withsubsequent application.
If pregnant or breast feeding, ask a health professional before use.
Do not spray in or around the eye area. If contact occurs, rinsecopiously with water
Not recommended for children
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