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Sponsored by Complementary & Alternate Medicines for Allergies & Sinus Congestion: Making sense of the data for you and your customers 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, SanofiAventis, 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. Introduction Number of persons in the US with: Allergic rhinitis and sinus congestion are Allergic rhinitis - 40 million1 commonly encountered Chronic sinusitis - 35 million2 complaints and result in Another 58 million have non-allergic significant morbidity rhinitis which can complicate the above conditions 1. National Institute of Allergy and Infectious Diseases.2003 2. National Institute of Allergy and Infectious Diseases.2007 Allergic Rhinitis • 2nd leading cause of chronic disease in US • 50% of those affected have suffered > 10 years • Prevalence is increasing Marple BF, Fornadley JA, Patel AA, et al. Otolaryngol – HNS. 2007;136:S107-24. 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 http://www.medicalnewstoday.com/articles/56516.php 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 Therapeutic Options 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 Relative Effectiveness of Medications used to treat allergic rhinitis Medication Class Sneezing Itching Congestion Rhinorrhea Eyes Inflammation Oral antihistamines ++ ++ +/- ++ + + Intranasal antihistamines ++ ++ ++ ++ +/- + Intranasal corticosteroids ++ ++ ++ ++ + ++ Leukotriene modifiers +/- +/- - +/- +/- + Cromolyn sodium + + - + + + Decongestants - - ++ - - ++ + +/- Wallace et al. J Allergy Asthma Clin Immunol 2008; 122: S1-84. Bousquet et al. Allergy 2008; 63: S8-S160. substantial benefit modest benefit little or no benefit no benefit Complementary & Alternate Medicine use (US) 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. Barnes PM, Bloom B, Nahin R. CDC National Health Statistics Report # 12. Dec 2008 Complementary & Alternate (CAM) Options 1. Colloidal silver 4. Capsaicin nasal spray 2. Saline (drops/spray/wash) 5. Nutritionals i. Bromelain ii. Quercetin iii. Vitamin C iv. Garlic 3. Oral homeopathic substances i.e. i. Arsenicum album ii. Kali bichromicum iii. Pulsatilla iv. Luffa Operculata v. Echinacea and Turmeric 3. Limited clinical evidence for most CAMs. 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 bluishgray 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 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 RQLQ Scores % decrease from baseline 60% % 50% B a s e l i n e 40% Placebo Zicam 30% 20% 10% 0% Nobel S, The Internet Journal of Family Practice. ISSN: 1528-8358 1st week 2nd week Nasal Saline (Drops/Spray/Wash) Nasal saline is generally accepted as an effective adjunctive therapy for allergic rhinitis, non-allergic rhinitis, and rhinosinusitis. Sinusitis: studies have reported improved QoL on diseasespecific 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 Harvey R et al. Cochrane Database Syst Rev. 2007:3 Rabago D et al. Ann Fam Med. 2006;4:295-301. Garavello W et al. Pediatr Allergy Immunol. 2003;14:140-143 Capsaicin 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) 1. 2. Lacroix JS et alClin Exp Allergy 1991;21:595-600 Kitajari M, et al Acta Otolaryngol Suppl 1993;500:88-91 Intranasal Capsaicin – Clinical 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 Capsaicin clinical data (cont.) 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):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 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 Capsaicin nasal sprays 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 tolerability1 1. Kaliner M, et al 2009 Poster presentation at the Western Society of Allergy Asthma and Immunology 47th Annual Scientific session Sinol-M 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 For fast, safe, natural relief of symptoms AVAILABLE NOW 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 Sinol-M Classified as a homeopathic drug Registered by the FDA Produced in the USA Manufactured in an FDA-approved facility Sinol-M clinical data Comparative study of 1st 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 Kaliner M, et al 2009 Poster presentation at the Western Society of Allergy Asthma and Immunology 47th Annual Scientific session Sinol-M study design 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) Kaliner M, et al 2009 Poster presentation at the Western Society of Allergy Asthma and Immunology 47th Annual Scientific session Sinol-M study results Mean Daily Total Nasal Symptom Score TNSS Score (Min. = 0 / Max. = 32) (sum of morning and evening scores) 20 18 16 14 12 10 8 6 4 2 0 Run-in P=0.001 P=0.001 Sinol Sinol-M Treatment TNSS scores decreased with both active treatments Sinol-M study results Number of Sprays Mean daily number of sprays* 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 AM Sinol PM Sinol-M 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 Sinol-M study results 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 Kaliner M et al .2009 Poster presentation at the Western Society of Allergy Asthma and Immunology 47th Annual Scientific session 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 Additional formulations including Children’s Allergy, Cough & Cold have been introduced for 2011 Sinol-M Important Information 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 Ask-the-experts Need more information or have any clinical questions? Send an email to [email protected] Or www.sinolUSA.com 800-632-2824 or 203-270-7755