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Complementary & Alternate Medicines for Allergies & Sinus Congestion: Making sense of the data for you and your customers Sponsored by.

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Presentation on theme: "Complementary & Alternate Medicines for Allergies & Sinus Congestion: Making sense of the data for you and your customers Sponsored by."— Presentation transcript:

1 Complementary & Alternate Medicines for Allergies & Sinus Congestion: Making sense of the data for you and your customers Sponsored by

2 Financial Disclosure Dr Storms has received grants for clinical research from : Alcon Labs, Amgen, AstraZeneca, BMS, Genentech, GSK, Johnson & Johnson, Meda, Merck, Novartis, Sanofi-Aventis, and Schering; Has worked as an advisor for : Abbott, Alcon Labs, AstraZeneca, Consumer Reports,Critical Therapeutics, Merck, Nexcura, Novartis, Reckitt Benckiser, Sanofi- Aventis, Schering, Sepracor, TEVA, SRXA; Has served on the speakers' bureau for : Abbott, Alcon Labs, AstraZeneca, Boehringer, Genentech, Meda, Merck, Novartis, Sanofi-Aventis, Schering, Sepracor, TEVA, TREAT Foundation, and UCB.

3 Introduction Allergic rhinitis and sinus congestion are commonly encountered complaints and result in significant morbidity Number of persons in the US with:  Allergic rhinitis - 40 million 1  Chronic sinusitis - 35 million 2 Another 58 million have non-allergic rhinitis which can complicate the above conditions 1.National Institute of Allergy and Infectious Diseases National Institute of Allergy and Infectious Diseases.2007

4 2 nd leading 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. Otolaryngol – HNS. 2007;136:S

5 Allergic Rhinitis  20% of patients believe their health care provider does not 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 for relief of allergy symptoms  42 % of patients are confused by choices of medication  59 % wished they knew more about the drugs they take

6 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

7 Therapeutic Options

8 Conventional Treatment 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 as taste, sedation, rebound, costs (direct and indirect), ease of use

9 Relative Effectiveness of Medications used to treat allergic rhinitis Wallace et al. J Allergy Asthma Clin Immunol 2008; 122: S1-84. Bousquet et al. Allergy 2008; 63: S8-S160. Medication Class SneezingItchingCongestionRhinorrheaEyesInflammation Oral antihistamines ++ +/-++++ Intranasal antihistamines ++ +/-+ Intranasal corticosteroids ++ + Leukotriene modifiers +/- - + Cromolyn sodium Decongestants substantial benefit + modest benefit +/- little or no benefit - no benefit

10 Complementary & Alternate Medicine use (US) Barnes PM, Bloom B, Nahin R. CDC National Health Statistics Report # 12. Dec 2008 People are increasingly using complementary and alternate medicine (CAM). CAM use among adults is greatest among women and those with higher levels of education and income.

11 Complementary & Alternate (CAM) Options 1.Colloidal silver 2.Saline (drops/spray/wash) 3.Oral homeopathic substances i.e. i.Arsenicum album ii.Kali bichromicum iii.Pulsatilla iv.Luffa Operculata v.Echinacea and Turmeric Capsaicin nasal spray 5. Nutritionals i. Bromelain ii. Quercetin iii. Vitamin C iv. Garlic Limited clinical evidence for most CAMs.

12 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 and effective 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 allergic rhinitis or sinusitis

13 Luffa Operculata ( Zicam)  Placebo-controlled,double-blind study of 32 pts with seasonal allergic rhinitis. Patients received Zicam or placebo 4xday / nostril for 14 days  1°endpoint was the change from baseline in the overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)  4 x daily Zicam improved patient related QoL and reduced impairment in day to day activities Nobel S, The Internet Journal of Family Practice. ISSN: RQLQ Scores % decrease from baseline

14 Nasal Saline (Drops/Spray/Wash) Sinusitis: studies have reported improved QoL on disease- specific questionnaires Allergic rhinitis: positive effects have been noted in studies in children and in adults when nasal saline is used in conjunction with medication and when used as a placebo treatment Nasal saline is generally accepted as an effective adjunctive therapy for allergic rhinitis, non-allergic rhinitis, and rhinosinusitis. Harvey R et al. Cochrane Database Syst Rev. 2007:3 Rabago D et al. Ann Fam Med. 2006;4: Garavello W et al. Pediatr Allergy Immunol. 2003;14:

15 Capsaicin 1.Lacroix JS et alClin Exp Allergy 1991;21: 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 neurons 1,2 (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)

16 Intranasal Capsaicin – Clinical Data  Capsaicin is efficacious in the treatment of non-infectious rhinitis Blom HM, et al. Clin Exp Allergy 1997; 27:  Study shows capsaicin efficacy rate of 89% in allergic rhinitis patients Zhang F et al. Lin Chuang Er Bi Yan Hou Ke Za Zhi Nov; 13(11):  Capsaicin significantly reduced overall nasal symptoms, rhinorrhea and nasal blockage Van Rijswijk JB et al. Allergy. Aug; 58(8):  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

17  Capsaicin improved psymptoms (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):  Capsaicin significantly reduced symptoms in chronic rhinitis patients with no significant side effects Lacroix JS et al. Clin Exp Allergy. Sep; 21(5):  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.)

18 Clinical Data (cont.) “The efficacy of repeated capsaicin application has been established in several randomized controlled trials. This treatment modality may be the 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

19 2 formulations / brands of capsaicin nasal spray available in the US Sinol-M (Sinol USA Inc.) Sinus Buster (Buster Brands Inc.) Sinol-M is a new all-natural nasal spray formulated with a muco-adhesive and indicated for the fast relief of allergies, sinus congestion and headache Sinol-M is the only all-natural remedy for allergic rhinitis with proven clinical efficacy and tolerability 1 Capsaicin nasal sprays 1.Kaliner M, et al 2009 Poster presentation at the Western Society of Allergy Asthma and Immunology 47 th Annual Scientific session

20 ACTIVE INGREDIENTS -a homeopathic dose of capsaicin - the pungent phenolic compound responsible for the analgesic properties of hot pepper - Aloe Vera for it’s soothing effect AND a novel mucoadhesive carrier – to prolong adherence of the active ingredients to the nasal mucosa Sinol-M

21 AVAILABLE NOW For fast, safe, natural relief of symptoms Sinol-M

22 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

23 Classified as a homeopathic drug Registered by the FDA Produced in the USA Manufactured in an FDA-approved facility Sinol-M

24 Comparative study of 1 st generation Sinol and the new 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 Asthma and Immunology 47 th Annual Scientific session

25 Crossover study 1- week, run-in with no treatment, followed by 1-week of either Sinol or Sinol-M, (one spray in each nostril PRN) 1-week washout (no treatment) followed by 1-week treatment with the other Sinol product AM and PM nasal symptoms scored in diaries (scale, 0=no symptoms to 4=very severe symptoms) runny nose itchy nose congestion 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 47 th Annual Scientific session

26 Sinol-M study results Mean Daily Total Nasal Symptom Score (sum of morning and evening scores) TNSS scores decreased with both active treatments

27 Sinol-M study results Mean daily number of sprays* Improvement in TNSS occurred despite fewer doses of Sinol-M vs. Sinol *patients were allowed to used the product on a PRN basis up to 12 x / day

28 Both Sinol and Sinol-M significantly reduced bothersome 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 either Sinol or Sinol M Sinol-M study results Kaliner M et al.2009 Poster presentation at the Western Society of Allergy Asthma and Immunology 47 th Annual Scientific session

29 Professional Marketing of Sinol-M Sinol USA has professional marketing of Sinol-M Retail pharmacy sales of Sinol-M will be driven by targeted education programs for pharmacists and endorsement from health care professionals: Allergists, ENT, pulmonologists, primary care physicians, NP’s, PA’s Sinol-M poster presentations and exhibits at major medical meetings AAAAI, EACCI, WSAAI

30 Additional formulations including Children’s Allergy, Cough & Cold have been introduced for 2011

31 Sinol-M contains capsaicin, derived from the hot pepper plant. Upon initial use, some patients may experience a mild burning sensation, lasting 2-5 seconds. This is transient, usually diminishes with subsequent application. If pregnant or breast feeding, ask a health professional before use. Do not spray in or around the eye area. If contact occurs, rinse copiously with water Not recommended for children <12 Please see pack insert for complete instruction for use Sinol-M Important Information

32 Need more information or have any clinical questions? Send an to Or or Sinol-M Ask-the-experts


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