Transcript Slide 1

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