Complementary & Alternate Medicines for Allergies & Sinus Congestion:

Making sense of the data for you and your customers

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
Oral antihistamines Intranasal antihistamines Intranasal corticosteroids Leukotriene modifiers Cromolyn sodium Decongestants

Sneezing

Itching

Congestion

Rhinorrhea

Eyes

Inflammation

++ ++ ++ +/+ -

++ ++ ++ +/+ -

+/++ ++ ++

++ ++ ++ +/+ -

+ +/+ +/+ ++ + +/-

+ + ++ + + substantial benefit modest benefit little or no benefit no benefit

Wallace et al. J Allergy Asthma Clin Immunol 2008; 122: S1-84. Bousquet et al. Allergy 2008; 63: S8-S160.

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. Intranasal antifungal agents 5. Capsaicin nasal spray 6. Nutritionals i. Bromelain ii. Quercetin iii. Vitamin C iv. Garlic

2. Oral homeopathic substances i.e. i. Arsenicum album ii. Kali bichromicum iii. Pulsatilla iv. Luffa Operculata v. Echinacea and Turmeric
3. Saline (drops/spray/wash)

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 1endpoint was the change from baseline in the overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
RQLQ Scores % decrease from baseline

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: 1528-8358

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

Antifungal Therapy
6 controlled trials of anti-fungal therapy in chronic rhinosinusitis 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

1. 2. 3. 4. 5. 6.

4 showed no benefit3-6

Shin SH et al. J Allergy Clin Immunol 2004; 114:1369-1375. Liang KL et al. Am J Rhinol 2008; 22:52-58. Ebbens FA et al. J Allergy Clin Immunol 2006; 118:1149-1156. Ponikau JU et al J Allergy Clin Immunol 2005; 15:125-131. Kennedy DW,et al. Laryngoscope 2005; 115:1793-1799. Weschta M et al. J Allergy Clin Immunol 2004; 113:1122-1128.

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 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

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 SinusBuster

Sinol-M is a new all-natural nasal spray formulated 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
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
ACTIVE INGREDIENTS A homeopathic dose of capsaicin - the pungent phenolic compound responsible for the analgesic properties of hot pepper Aloe Vera for its soothing effect AND MucoAd a novel mucoadhesive carrier to prolong adherence of the active ingredients to the nasal mucosa

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 TNSS (sum of morning and evening scores)

TNSS scores decreased with both active treatments

Sinol-M study results

Mean daily number of sprays

Improvement in TNSS occurred despite fewer doses of Sinol-M vs. Sinol

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 engaged Strategic Pharmaceutical Advisors (SRxA) to handle 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, NPs, PAs

Sinol-M poster presentations and exhibits at major medical meetings

AAAAI, EACCI, WSAAI

Additional formulations including Childrens Allergy, Cough & Cold and Childrens Cough & Cold will be introduced during 2009

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