Thursday, December 12, 2013

Non-medicated sinus cures

Non-medicated sinus cures

A number of companies develop non-medicated sinus cures to treat simple to complex sinus disorders. Some of these are discussed below:

LAVI Dead Sea Sinus Solutions

The non-medicated LAVI consists of a nasal moisturizer, nasal decongestant, and sinus wash. TriCord Pharmaceuticals LLC claims that its LAVI Dead Sea salt formula is rich in potassium chloride and magnesium chloride. The clinically tested formula contains negligible amount of sodium chloride. The formula is better than other available saline solutions used to treat sinus infections and chronic sinusitis. LAVI offers all benefits of topical nasal steroids, but it does not have side effects.  The non-addictive formula is safe for elderly, nursing mothers, pregnant women, and children.

Dr. Neuzil’s Irrigator, Herbal Enhanced Nasal Cleansing Spray


The spray contains natural essential oils with moisturizing and antiseptic properties. The non-medicated formula resolves discomfort of paranasal sinuses. According to the product website, the easy-to-use spray has no side effects.

FESS Eucalyptus Nasal Spray from Care Pharmaceuticals Pty Ltd.


The spray cleans and moistens the nasal passages. The saline solution thins and drains unwanted mucus from the sinuses. The product resolves sinus congestion ascribed to allergies. The eucalyptus aroma generates a refreshing feeling.

Nasal & Sinus Hypertonic Deep Cleansing Saline Spray


AURENA Laboratories AB’s spray relieves both nose and sinus congestion attributed to allergies, rhinitis, sinusitis, and cold. The spray contains a mild hypertonic saline solution that drains allergens, pollutants, and mucus. The hypertonic solution is more “saltier” than the standard saline solutions. Extra “salt” helps reducing sinus pressure and postnasal drip.

Antiseptic SINO Fresh Nasal & Sinus Care Spray


The homeopathic spray is non-addictive. The over-the-counter spray gives relief from sinusitis symptoms without causing any side effects. The mild antiseptic spray cleans, traps, and washes out the pollutants such as smoke, pollen, dust, bacteria, molds, and yeasts. The patented formula contains sodium chloride, purified water, mint oils, and antiseptic ingredients. All the constituents have Generally Recognized as Safe (GRAS) status.

Sinuclear™ Nasal & Sinus Congestion Relief


The hypertonic formula of Sinuclear cleans, opens blocked sinus and nasal passages and soothes the tissues. The formula consists of sterile seawater, mineral salts, and minerals that wash out extra fluid from the inflamed sinuses and repair the tissues. The natural relief does not contain any preservatives. The non-addictive product has no side effects.
All the above sinus cures are natural and non-medicated. However, you should consult the doctor before administering the products.

Thursday, December 5, 2013

Six natural sinus remedies from India

Six natural sinus remedies from India

The Indian Ayurveda is a well-known age-old medicine system that is still in use in the country. The leading ayurvedic drug companies offer a number of ready-to-administer natural sinus remedies. Each remedy contains several herbs and / or minerals.

Agastya Haritaki

Agastya Haritaki, a herbomineral formula from Shree Baidyanath Ayurved Bhawan (P) Limited, contains Indian herbs such as beej, kawanch, pushkarmool, shankhapushpi, apmarg, and piplamul.  The formula is used in the treatment of sinusitis and stomach disorders.

Ayurnas

Chopra Center Ayurvedic Sinus Soothing kit includes Ayurnas, a tri-doshic oil treatment. The ayurvedic formula Ayurnas relieves post-nasal drip, sinus congestion, and dryness. The product consists of basil, coconut, eucalyptus, lotus, olive, rose, sandalwood, and sesame oils.

Chitraka Hareetaki

Dabur India Limited manufactures Chitraka Hareetaki, an herbal formula for sinusitis. The formula consists of 11 herbs:
  • Cinnamomum tamala
  • Cinnamomum zeylanicum (cinnamon)
  • elettaria cardamomum (cardamom)
  • Embelica officinalis
  • Piper longum
  • Piper nigrum.
  • Pulmbago zeylanica
  • Ten roots
  • Terminalia chebula
  • Tinospora cordifolia
  • Zingiber officinale (ginger)

Dashamool Taila (Vrihat)


Dabur’s external-use oil Dashamool helps in treating sinusitis, headache, and earache. The oil consists of more than twenty herbs and oils, including
  • Adhatoda vasica,
  • Brassica compestris oil,
  • Dolicos lablab,
  • Pluchea lanceolata,
  • Plumbago zeylanica,
  • Saussurea lappa, and
  • Tamarindus indica.

Laxmivilas Ras (Nardiya)

Dabur’s Laxmivilas Ras (Nardiya) provides relief from the sinus disorders. The product contains the following herbs and minerals:
  • Argyres speciosa
  • Asparagus recemosa
  • Barringtonia acutangula
  • Cannabis sativa
  • Cinnamomum camphora
  • Dathura alba
  • Myristica fragrans
  • Pueraria tuberose
  • purified mercury, mica, and sulphur
  • Sida cordifolia
  • Sida varonicaeolia
  • Tribulus terrestris

Septilin

Septilin, a medicine manufactured by the Himalaya Drug Company, helps in treating chronic sinusitis. The medicine reduces growth of harmful bacteria and inflammation, revives mucosa cells, and expels infection, healing the sinus mucosa.
Septilin has anti-inflammatory, anti-microbial, and antioxidant properties. The formula consists of amalaki (Emblica officinalis), guduchi (Tinospora gulancha), guggulu (Commiphora wightii), yashtimadhu (licorice), and other herbs. The medicine does not have any known side effects.
Although these natural sinus remedies are made from herbs, a prescription from ayurvedic doctor is required.

Wednesday, November 27, 2013

Is grapefruit seed extract used in natural sinus relief methods?

Is GSE used in natural sinus relief methods?

The online literature review revealed that grapefruit seed extract (G.S.E.) is used in natural sinus relief methods. For instance, (1) Stengler and Balch (2004)  in their book “Prescription for Natural Cures: A Self-Care Guide for Treating Health Problems with Natural Remedies, Including Diet and Nutrition, Nutritional Supplements, Bodywork, and More” included the extract in the Super Seven Prescriptions-Sinusitis list. They prescribed the grapefruit seed extract nasal spray for both acute and chronic paranasal sinus disorders.

(2) The extract has both antiviral and antifungal properties as mentioned in David Rakel’s (2012) “Integrative Medicine.” The extracts are sold as liquid and capsules in health food shops. Sinus Survival Spray consists of grapefruit seed extract, yarrow leaf, calendula, and aloe.


(3) Ron Kendrick (2009) mentioned in “Peasant Remedies for Sinus Infections” that the seed extract reduces paranasal sinus inflammation. The grape seed extract contains polyphenols, linoleic acid, bioflavonoid, and vitamin E. The polyphenols with antioxidant properties work on free radicals that damage cells.  The extract liquid neutralizes viruses’ defense mechanism, making them dormant.  SinusFix pills consist of grapefruit seed extract, butterbur, peppermint extract and many other natural ingredients.

(4) Jon Barron (2008) in “Lessons from the Miracle Doctors: A Step-by-Step Guide to Optimum Health and Relief from Catastrophic Illness” cited research studies that confirmed anti-pathogenic properties of the seed extract. The grapefruit extract is therefore used externally and internally to treat various disorders, including food poisoning and sinusitis.
(5) In “Natural Prescriptions for Women: What to Do—And When to Do it—To Solve more than 100 female health problems,” Susan Berg (2000) highlighted benefits of Sinus Survival Spray containing grapefruit seed extract:
  • The spray irrigates and moistens the inflamed sinus membranes, soothing them.
  • It eliminates viruses and bacteria.
(6) Brigitte Mars (2006) discussed medicinal properties of G.S.E. in her “Beauty by Nature.” G.S.E. or citracidal is known as Citrus paradisi in botanical community.  The extract has antioxidant, antifungal, and antibacterial properties. Both capsule and liquid forms are available. The G.S.E. based remedies are prescribed for the patients suffering from sinus infections, yeast infections, and diarrhea. The seed extract is also used in cosmetics.

(7) Dr. Patrick Fratellone (2004) recommended G.S.E. for the patients having active sinus infection in his book “You’re on the Air with Dr. Fratellone: Answers to Questions Most Frequently Asked about Supplements and Herbs for the Heart.”
But never forget to consult your doctor before using natural sinus relief methods.

Wednesday, November 20, 2013

Natural remedies for sinusitis from different countries

Natural remedies for sinusitis from different countries

Every country has a tradition of natural remedies for all kinds of disorders, including sinusitis. The remedies mainly consist of local herbs. Today we will provide information about the Russian, Turkish, North African, Tibetan, and Sir Lankan natural remedies for sinusitis and the herbs used.


Cowslip from Russia

Butter rose or cowslip (Primula veris) resolves sinusitis symptoms. Traditional Russian physicians use the flowers, leaves, and roots for the treatment. However, the herb may cause hypertension, itching, and rashes.



Squirting cucumber from Mediterranean region, including Turkey


In the Mediterranean region, squirting cucumber (Ecballium elaterium) is traditionally used to treat sinusitis. The herb has anti-inflammatory properties. However, the herb leads to serious side effects such as renal and cardiac failures and Quincke’s edema.

Ajuga iva from North Africa


The North African perennial musky bugle or ajuga iva (L. Schreb) is an aromatic herb that bears pink, purple, or yellow flowers. The whole plant is used as medicine. The herb has anti-inflammatory and anti-ulcerous properties. The dry herb powder is mixed with honey to make balls that are ingested to treat sinusitis, headache, fever, and stomach pain.

Tibetan formulas


The Tibetan formula Phan Pa Kun Idan (All Beneficial) helps in treating inflammation and phlegm, reduces pain, and resolves signs of sinus disorder. The major ingredients of the formula include
  • ammonium chloride,
  • blue aconite,
  • chebulic myrobalan,
  • dark-blue aconite,
  • false pepper,
  • flame of forest,
  • locoweed, 
  • myrrh,
  • nightshade,
  • sweet flag, and
  • turmeric.

Ggur Gum 13 (Safflower 13) is created for the patients suffering from paranasal sinus, kidney, and liver disorders. The formula consists of
    1. amla,
    2. beleric myrobalan,
    3. chebulic myrobalan,
    4. cinnabar,
    5. clove,
    6. costus, 
    7. fever nut,
    8. musk,
    9. ox or elephant gallstone,
    10. rhinoceros horn,
    11. safflower,
    12. white aconite, and
    13. white sandalwood.

Sri Lankan formula


Traditional Sri Lankan physicians make Pitawakk Navaya, a decoction to treat chronic sinusitis. The decoction contains different parts of the following plants:
  • Dry fruits of chebulic myrobalan (Terminalia chebula)
  • Dry fruits of Pipper chavya
  • Dry fruits of Pipper nigrum
  • Dry plant of Solanum trilobatum
  • Dry rhizome of Zingiber officinalae
  • Dry stem of Tinospora cordifolia
  • Roots of Phyllanthus amarus
  • Roots of Pygmaeopremna herbacea

Since all natural remedies for sinusitis are not yet clinically proved, a consultation with doctor is essential.

Wednesday, November 13, 2013

How to treat sinusitis naturally

How to treat sinusitis naturally

Sinusitis can be treated naturally as described in folk medicines of various countries. This article discusses a few common herbs and formulas used in the traditional American, Chinese, and Fijian medicines.

American formulas

Three Spices Sinus Complex ™, a product by US-based Planetary Herbals, consists of dehydrated honey and the three pungent herbs, black pepper, long pepper, and ginger.  The herbal formula is administered to the patients suffering from sinus infections. The tablets are based on the age-old Indian Trikatu formula.
Perennial goldenrod or blue mountain tea (Solidago odora) plant has anti-inflammatory and antifungal properties. The aromatic herb is a mild astringent.  The leaf tea resolves sinus congestion. Traditional American physician use the herb. A point to remember: A poisonous fungus may grow on some plants of goldenrod. These plants should not be collected and used for medicine.


Verbena (Verbena officinalis) with other herbs such as cowslip and elder may help in resolving acute and chronic sinusitis symptoms. However, the clinical evidences are insufficient.
Angel root (Angelica officinalis), a native to Europe, is popular for its essential oil in America. The tall angelica bears greenish white flowers. The herb formula increases stamina and strength. Our ancestors used it to protect themselves against various infections. The oil is a proven cure for paranasal infections and chronic respiratory disorders.

How to treat sinusitis with Chinese medicine

Try cang and / or ginseng.
Cang er zi (Xanthium sibiricum) reduces allergic rhinitis, phlegm, sinus headaches, and sinusitis when used with other herbs such as mulberry, lian qiao, and magnolia liliflora. Caution: A high dosage of cang reduces blood sugar level dramatically.
Ginseng or “the man plant” protects against sinus infections, colds, and fatigue. The herb has adaptogenic properties, which means ability to develop resistance to all negative influences. Tea or juice of the root enhances immunity.

How to treat sinusitis with Fijian herbs

Fijians use juices, decoctions, powders of different parts of the following herbs for sinus disorders:
Make a decoction of nawanawa’s (Cordia subcordata Lam.) leaf for treating sinusitis. The small tree bears orange flowers and edible yellow fruits.
Use yaro (Premna taitensis Schauer) bark decoction for clearing sinus infections. The small tree of yaro bears sweet-smelling flowers of white color. The leaf juice also relieves sinusitis and conjunctivitis symptoms.
Do consult your physician before trying any of the above herbs.

Wednesday, November 6, 2013

Six herbs for sinus congestion

Six herbs for sinus congestion

Traditional physicians value different parts of various common trees for the medicinal virtues. The parts are referred to as herbs. This article discusses some of the trees whose parts help in relieving sinus congestion.

Sneezeweed (Helenium autumnale)

The four feet tall perennial plant has dull green thick leaves. The yellow flowers bloom during July-September. The herb is found along meadows, roadsides, and marshes in the western part of the United States of America. The dried leaves and flowers are used as a snuff for inducing sneezing that clears sinus congestion. The root formula suppresses menstruation after the delivery.   

Blue Gum Tree (Eucalyptus globules Labill.)


The evergreen tree can reach the height of 150 feet. The smooth bluish bark peels into shaggy strips. The young blue-green leaves are fragrant and waxy. The native to Australia blue gum trees grow in the western United States of America. The leaves are used in steam inhalation therapy that resolves sinus congestion. The tree has strong ant-inflammatory and antibacterial properties.

Melaleuca alternifolia


The essential oil Aetheroleum Melaleucae Alternifoliae is obtained from Melaleuca, an indigenous plant from Australia. The pale-yellow color oil has myristic odor. Benefits of the oil for treating various skin disorders are clinically proved. In folk medicine, the oil is also used for resolving symptoms of sinus congestion, cough, tonsillitis, and nasopharyngitis but supportive clinical data is not available.

Pterocaulon


The plant genus offers several fragrant species with anti-bacterial properties. For example, P. sphacelatum (apple bush) and P. serrulatum have been used as an antiseptic and a decongestant in the Australian aboriginal therapies. For instance, pulp of the sticky leaves is inserted into the nostrils to resolve sinus congestion.

Manuka trees (Leptospermum scoparium and ericoides)


The red and white manuka trees are valued for wound-healing, anti-arthritic, and pain-relieving properties in folk medicine of New Zealand. The fragrant leaf infusion is inhaled as a decongestant that provides relief from upper respiratory tract problems, including sinus congestion and cough.

Common white ash (Bersama tysoniana)


The shrub grows in the coastal forests of South Africa. The 3-10 meter tall tree bears fragrant cream-white color flowers from April to May. Traditionally, the bark powder is snuffed for treating sinus congestion and headaches.
The above herbs for sinus congestion have been in use for ages but they may have some side effects. For instance, blue gum tree oil may cause irritation or burning.
Remember to consult your doctor before using the herbs for sinus congestion.

Monday, October 28, 2013

Does inhaling steam cause injury and / or death?

Does inhaling steam cause injury and / or death?

Steam inhalation is commonly used to treat the upper respiratory tract infections, including sinusitis in children. The inhalation facilitates efficient heat transfer to the upper tract. However, the remedy may have serious consequences. We have reviewed the available literature exploring the consequences. Here are the key findings and conclusions of four studies:
B.l. Bhootra and J. Kitinya. (2005). Deaths from accidental steam inhalation during traditional therapy. Journal of Clinical Forensic Medicine.
  • Death due to steam inhalation is rare. The report highlighted that two children succumbed to superheated steam inhalation in a closed room. The post-mortem examination revealed that congestion of lungs and epiglottis and petechial hemorrhages in the hearts, lungs and brains led to hypoxia (inadequate supply of oxygen) and thereafter death.
  • The respiratory tract mucosa is sensitive to superheated steam vapors.
  • Inhaling steam in a closed space cause deadly hypoxia within minutes.

David J.A. Orr, Dylan Murray, Siun M. Murphy, and Susan Smith. (2004). Burns caused by steam inhalation for respiratory tract infections in children. British Medical Journal.

The researchers observed a group of children who received treatment for scalds at Dublin’s Children Hospital during July 1-December 31, 2002. The age varied from nine months to ten years. The scalds affected 3-6% area of the body surface. A direct contact between the face and hot water or steam burned the skin. Some children were given steam inhalation therapy on the doctor’s recommendation.
The authors concluded that the popular steam inhalation method that involves holding the head under a towel wrapped around a container containing very hot water is a risky process. Chances of getting burns are high, especially in case of young patients.  They recommended that a safer method should be used for the inhalation.

Balakrishnan C, Gordon DM, Prasad JK, and Tijunelis AD. (1996). Burns and inhalation injury caused by steam. Burns. Elsevier.


They concluded that steam inhalation might injure the respiratory tract in rare cases. However, the inhalation often causes acute pulmonary insufficiency. The injured alveolar epithelium increases pulmonary edema, pulmonary capillary permeability and gas exchange abnormalities.

Akhavani MA and Baker RHJ. (2005). Steam inhalation treatment for children. British Journal of General Practice.


The authors attended some children with scalds in January 2005. The children were less than five years old. They got burns because they kicked steaming hot water container, spilling the water on the chests and feet. The burnt area varied from one to three percent of the body surface area. Steam inhalation was a prescription by the doctor.
The authors also cited a Welsh research in the article. The research states that the incidences of scalds in children have gone up. The increase is ascribed to spilling hot beverage and steam inhalation. The authors advised against inhalation because evidences supporting the therapeutic value of inhalation are not enough.
Be careful while inhaling steam!

Tuesday, October 22, 2013

Can wet hair be a cause of sinus headache?

Can wet hair be a cause of sinus headache?


Yes, wet hair, especially in cold weather, may cause a sinus headache.
 
You may wonder how wet hair can lead to the headache.

Medical community has observed that wet hair not only become a cause of sinus headache but also trigger posterior eye pain in cold weather.
Abullah Kaya and Halil Caliskan, medical professionals working for Department of Ophthalmology, GATA Haydarpasa Training Hospital in Istanbul, Turkey, have suggested a mechanism justifying the observations. Their research report “Does wet hair in cold weather cause sinus headache and posterior eye pain? A possible mechanism through selective brain cooling system” published in December 2012 issue of Medical Hypotheses features the suggested hypothesis.


Suggested Hypothesis

Their hypothesis revolves around selective brain cooling (S.B.C.) mechanism that may cause the pain and headache if hairs are left wet in cold weather.

What is S.B.C. and what does it do?

The mechanism involves upper respiratory system consisting of paranasal sinuses and nose and skin of the head. The cooling protects the brain from abnormally high body temperature conditions called hyperthermia.
From the mucous membranes of paranasal sinuses and nose and the skin of head, cool venous blood flows into intracranial dural sinuses, cooling the brain.  However, an exposure to hypothermia (abnormally low body temperature) conditions such as wet hair in the cold weather cools the brain excessively.
The authors believe that to counter the excessive cooling of the brain, conditions in paranasal sinuses change. For example,
  1. The resulting closure of sinus ostia may lead to mucus accumulation and thus decrease air supply within the sinuses.
  2. Vasomotor alterations may occur to curtail loss of heat.
The authors’ hypothesis states that the changes within the sinuses control brain temperature when head skin is exposed to hypothermia. An extremely thin bony layer separates the subarachnoid space and the posterior ethmoid air sinus. Slim bony plates create a boundary between cavernous sinuses and carotid artery and sphenoidal sinuses. The layer and plates directly aid in brain cooling process. The sphenoidal and posterior ethmoid sinuses play an important role in S.B.C. and therefore the changes may affect these sinuses more than any other paranasal sinuses. These conditions may cause sinus headache and the eye pain. The symptoms may be diagnosed as sinusitis, which is incorrect.
In fine, excessive cooling of head skin due to wet hair in cold weather may become a cause of sinus headache that is confused with sinusitis.

Thursday, October 10, 2013

Itching sensation after Nasodren?

Why I could feel some itching sensation after Nasodren?



Nasodren acts physiologically, physically stimulating the terminal endings of the trigeminal nerve in the nasal mucosa. This specific mechanism of action can produce some itching, sneezing, a brief sensation of burning sensation in the nasopharynx and more rarely, a brief lacrimation and flushing of the face.
These are manifestations of the positive response to the product. The intensity of these sensations varies from one person to another and normally these effects usually diminish during the course of treatment.

It is important not to inhale the product as it can make these sensations more intense.
Nasodren is a very safe product since its active ingredient, saponins, is not absorbed and consequently they do not reach bloodstream and don’t produce systemic side effects, i.e. do not affect the liver, the kidneys or other organs. Obviously, Nasodren not produce any alteration of nasal or paranasal mucosas.



Thursday, October 3, 2013

Drug-induced rhinitis. New possibilities of conservative therapy

Drug-induced rhinitis. New possibilities of conservative therapy.

Key messages from this study
  • Nasal obstruction is a very common symptom that many patients try to solve using decongestants (vasopressors).

  • Rhinitis medicamentosa (RM) is one of the serious problems of rhinology and accounts for 12,5% of the diseases of the nose and paranasal sinuses. Clinical manifestations are nasal congestion, nasal breathing difficulties and psychological dependence of the drug.
    The main cause of RM is the use of decongestants; using vasopressors for more than 5-7 days develops rebound syndrome.

  • The performed study shows the effectiveness of Sinuforte in the treatment of RM in patients applying decongestants for up to 12 months that gives a reason to recommend this product as the drug of choice for the treatment of this group of patients.

  • When patients are aware of side effects that Sinuforte®/Nasodren® may produce because of its mechanism of action (burning sensation, itching, sneezing etc.), most of them tolerate and complete treatment course, which reinforce the importance of training pharmacists, and ENTs if called, in an appropriate and continued way.

Study Design: Simple open study

Objective: Evaluate the efficacy, safety and tolerability of Sinuforte (Nasodren®) in patients with rhinitis medicamentosa (RM).
In addition, the study also included the analysis of long-term efficacy (after 45 and 72 days of treatment ending) of a 15-day course application of Sinuforte® (Nasodren®).

Patients: 40 patients aged from 15 to 60 years with rhinological symptomatology of at least 10 points.

Study method: The functional characteristics of the nasal cavity were evaluated by rhinomanometry (assess respiratory function) and saccharin test (measures transport function of ciliated epithelium).
Training the patients to properly use the drug was a mandatory element of the study. Importantly, the study doctor explained to the patients that undesirable effects (burning sensation, sneezing, watery eyes...) are characteristic of the mechanism of action of Sinuforte and should not be feared.

RESULTS

Efficacy
The analysis of the impact of Sinuforte® on the difficulty of nasal breathing has shown with a decrease in the score of the symptom after the treatment.
The evaluation of disorders of smell is quite interesting. If before the treatment 10 patients reported reduction of smell, at the end of the treatment all 34 patients evaluated their olfactory function from 0 to 4 points (0-10 points scale, being 0 perfect smell and 10 no smell at all).
Out of the 18 patients having used vasopressors from 1 to 6 months, 14 people abandoned them accounting for 77%. Seven of the eight patients (87.5%) having used decongestants from 6 to 12 months also stopped using them. Among the four patients having used vasopressors from 12 to 36 months only one stopped using them. Four patients who had experience of applying decongestants for more than 36 months continued using them even during the treatment with Sinuforte (concomitant use may explain the lack of efficacy in the patient who dropped out).
After the treatment of RM with Sinuforte® all the studied functional indicators have improved significantly.
Long-term results (assessed after 45 and 72 days):
93% of the patients who had been using decongestants for up to 6 months reported a lack of dependence on them.
86% of the patients who had been using decongestants for up to 12 months reported a lack of dependence on them.
The only patient who had an "experience" of up to 36 months also noticed a lack of dependence.


Safety:

It should be noted that despite the existence of undesirable effects from the nasal cavity and the lacrimal passages, only six patients withdrew from the study (3 of them due to reasons not related with the product). The remaining 34 patients took the study in accordance with the protocol.

V.S. Kozlov, N.G. Chuchueva.
Vestn Otolaryngology. 2012; (6): 71 –75

Thursday, September 19, 2013

Cyclamen Extract for Acute Rhinosinusitis

An Exploratory Trial of Cyclamen Extract for Acute Rhinosinusitis

Key messages from this study

* In patients with Acute Rhinosinusitis, Cyclamen extract (Nasodren®/Sinuforte®):
* Improves objective outcomes compared to placebo
* Produces a clinically relevant improvement in symptoms
* Is the only product marketed for rhinosinusitis that has been tested in this way (CT scan). Other products, such as corticosteroids, antibiotics or decongestants, measure only symptomatic improvement.


Study Design: prospective, randomized, placebo-controlled, double-blind and parallel group.

Objective:
evaluate the efficacy and safety of a 7-day treatment with Cyclamen europaeum in ARS patients.
Primary outcomes: reduction in percentage of sinus opacification on CT scan, as well as a reduction in Total Symptom Score.
Study method: 48 patients suffering from ARS were randomly distributed in 2 groups receiving either Cyclamen extract nasal spray or a placebo spray.
Results:
There was a significant difference between treatment groups, in change from baseline to end point, in percentage of sinus opacification in favour of Cyclamen. The percentage of sinus opacification was reduced in ARS patients treated with Cyclamen, whereas there was no improvement in the placebo group.
The Cyclamen extract patients obtained a better Total Symptom Score improvement from baseline to end.
Conclusion:
Patients with ARS treated with Cyclamen europaeum nasal spray significantly improve objective outcomes compared to placebo. The improvement in symptoms is also clinically relevant.
What this study highlights is that there is a clear difference in the evolution of the objective and subjective efficacy parameters, establishing the clinically significant superiority of Cyclamen over placebo. Hence, although patients notice the placebo effect in the subjective efficacy parameter (symptoms improvement) this is not confirmed by the objective efficacy parameter (sinus opacification improvement). It is thus clear that rinsing the nose with water will temporarily relieve rhinosinusitis symptoms, but will not drain mucus from the sinuses, as Cyclamen extract nasal spray does, which is the main objective of any rhinosinusitis treatment.
It should also be noted that Nasodren® is the only product marketed for rhinosinusitis that has been tested in this way. Other products, such as corticosteroids, antibiotics or decongestants, measure only symptomatic improvement.

JU Ponikau, DL Hamilos, A Barreto, J Cecil, SW Jones, SE Manthei, J Collins
The Laryngoscope, 2012

Tuesday, September 3, 2013

A GA2LEN study (I part)

Chronic rhinosinusitis in Europe an underestimated disease.


Chronic Rhinosinusitis (CRS) is a common health problem, with significant medical cost and impact on general health. Even so, prevalence figures for Europe are unavailable. In this study, conducted by the GA2LEN network of excellence, the EP3OS diagnostic criteria are applied to estimate the prevalence of CRS in Europe.

Key messages from this study
  • Chronic rhinosinusitis (CRS) is a common health problem, with significant medical costs and impact on general health
  • Impact on quality of life (QoL) of CRS is comparable with other chronic diseases such as chronic obstructive pulmonary disease (COPD), asthma and diabetes
  • Estimating the prevalence of CRS is difficult because of shortcomings in current epidemiological methodology
  • Prevalence of CRS is about 11% (10.9%) but there is substantial geographical variation inter countries and even within countries
  • Disease was associated with smoking but smoking alone cannot explain the geographical variation of the disease.
  • There is some evidence that CRS is more prevalent in the (warm) south than in the (colder) north.
  • According to EPOS Physicians under diagnose CRS.

Study method: Questionnaire was sent to a random sample of adults (15-75 years). Definition of Chronic Rhinosinusitis (CRS) based in EP3OS diagnostic criteria: the presence of more than two of the symptoms: (i) nasal blockage, (ii) nasal discharge, (iii) facial pain/pressure or (iv) reduction in sense of smell, for >12 weeks in the past year – with at least one symptom being nasal blockage or discharge.
Patients: 57.128 questionnaires returned presenting information from 19 centers in 12 countries.

D. Hastan, W. J. Fokkens, C. Bachert, R. B. Newson, J. Bislimovska, A. Bockelbrink, P. J. Bousquet, G. Brozek, A. Bruno, S. E. Dahlén, B. Forsberg, M. Gunnbjörnsdóttir, L. Kasper, U. Krämer, M. L. Kowalski, B. Lange, B. Lundbäck, E. Salagean, A. Todo-Bom, P. Tomassen, E. Toskala, C. M. van Drunen, J. Bousquet, T. Zuberbier, D. Jarvis & P. Burney
Allergy 2011; 66: 1216–1223.

Friday, August 9, 2013

Sinopsis of study of Cyclamen extract, a novel phytotherapeutic product for the management of acute rhinosinusitis

Sinopsis of study of Cyclamen extract

Key messages from this study
  • Cyclamen Extract nasal spray is effective and safe for the treatment of patients with ARS assessed subjectively and objectively
  • The specific symptom of facial pain/pressure did improve significantly after 5-7 days of treatment with CE. This is important since facial pain/pressure is undoubtedly one of the most severe symptoms affecting the patients’ quality of life in ARS
  • Endoscopic evaluation showed that mucus oedema/nasal obstruction improved significantly with CE.
  • Both patients and investigators reported significantly greater treatment satisfaction with CE than placebo
  • CE is a safe product for the treatment of ARS



Objective: evaluate the clinical efficacy and safety of CE nasal spray in patients with moderate to severe ARS who were also receiving antibacterial therapy

Patients: Adult men and women aged 18 - 65 years with moderate to severe ARS according to the criteria of the first European Position Paper on Rhinosinusitis and Nasal Polyps were eligible for enrolment. Patients had inflammation of the nasal and paranasal sinuses lasting > 10 days (amended shortly after study commencement with symptoms lasting more than 7 days) and < 12 weeks with at least two of the following symptoms: nasal obstruction, anterior or posterior nasal secretion, facial pain/ tension/ pressure, and/ or impaired or loss of the sense of smell. Patients (99) were randomly assigned to treatment with either CE nasal spray (48 patients) or matching placebo nasal spray (51 patients) for 15 days. One spray of 1.3 mg (0.13 mL) was administered into each nostril once daily in the evening. In addition, all patients received amoxicillin 500 mg three times daily for the first 8 days (or a suitable alternative at the discretion of the physician for those allergic to penicillin). Concomitant treatment with corticosteroids or decongestants was not allowed during the study.
Results: Efficacy and Safety
  • In the primary efficacy analysis (change in mean rhinosinusitis total symptom VAS score after 5-7 days for the ITT population) there was a trend towards greater symptomatic relief with CE compared with placebo. 
    An analysis of secondary efficacy outcomes also demonstrated a greater decrease in mean symptom scores (nasal congestion, mucus secretion, facial pain, and impairment or loss of smell) in the CE group.
    After 5 - 7 days a reduction in facial pain significantly favoured CE compared to placebo.
  • Endoscopic evaluation demonstrated that mucus oedema or nasal obstruction was reduced to a significantly greater extent with CE than placebo after 5-7 days.
  • At the end of the study, mean patient- and investigator- rated satisfaction scores were statistically significantly better in the CE group compared to placebo.
  • Transient mild to moderate nasal irritation/burning occurred in both treatment groups, but was more frequent with CE. No severe adverse events were reported.
O. Pfaar, J. Mullol, C. Anders, K. Hörmann1, L. Klimek
Rhinology 50: 37-44, 2012

Wednesday, July 31, 2013

Study results of with chronic rhinosinusitis

Study results of Specific microendoscopic characteristics of intranasal mucosa in patients presenting with chronic rhinosinusitis and treated with sinuforte

Results:

Clinical and instrumental data on treatment with Sinuforte/Nasdoren revealed improvement of general and/or local CRS symptoms, as confirmed by data from contact microendoscopy, in 30 patients (100%).
By day 2 of treatment with Sinuforte/Nasodren, an increase in the quantity of discharge from the nasal cavity of 1.4 times and a decrease in nasal stuffiness of 1.1 times (p<0.001) were observed.
By day 4 of treatment positive changes appeared, both subjective: absence of headache and facial pain in 100% of patients, decrease in nasal stuffiness of 1.8 times (p<0.001) and improve sense of smell; and objective: significant decrease in oedema of the mucosa.




On day 6 after the start of treatment, the intensity of symptoms was significantly reduced in all patients in comparison with parameters on day 4. All subjective improvements were confirmed by objective findings.
At the end of treatment on day 8, 14 (46.7%) patients reported relief from nasal stuffiness, and the remaining patients reported reduced intensity of this symptom; all patients displayed an absence of purulent discharge. Endoscopic examination revealed absence of oedema of the intranasal mucosa in 21 (70%) patients and reduction of oedema in the remaining patients. 
Tolerance of the Cyclamen extract was evaluated as “good” in 100% of cases by patients and the researcher using a point scale. Tolerance at the end of the course of treatment was evaluated as “good” in 90% of cases and “excellent” in 10% of cases. There were no unsatisfactory evaluations.
The efficacy of Sinuforte/Nasodren was evaluated cumulatively after phased treatment, taking into account the dynamics of subjective and clinical parameters at each visit as “good” by day 4 and as “excellent” by day 8.


Key messages from this study
  • Sinuforte/Nasodren is safe and efficacious for the treatment of patients with CRS
  • Sinuforte/Nasodren improves drastically the most frequent symptoms of CRS (facial pain and nasal congestion)
  • Sinuforte/Nasodren alleviate rhinosinusitis symptoms from the first application
  • Subjective improvements correlate with objective findings
  • Sinuforte/Nasodren physiologically resolves CRS exacerbation without disrupting the anatomical integrity of the nasal mucosa
  • Tolerance of Sinuforte/Nasodren is rated as excellent or good for both patients and researchers


M. A. KHOROL´SKAYA, S. G. VAKHRUSHEV, N. V. TERSKOVA
Vestn Otorinolaringol 2011; 5: 59 

Thursday, July 18, 2013

Amoxicillin for Acute Rhinosinusitis

Amoxicillin for Acute Rhinosinusitis

A Randomized Controlled Trial
JAMA, February 15, 2012— Vol 307, No.7

Key messages from this study

  • Rhinosinusitis is a common disease (although underdiagnosed)
  • Rhinosinusitis is associated with high direct and indirect costs
  • Quality of life of rhinosinusitis sufferers is poor
  • Symptoms most frequently recorded are facial congestion or fullness and facial pain or pressure.
  • Although evidence to support antibiotic treatment for acute rhinosinusitis is limited, antibiotics are over prescribed
  • Antibiotics are not better than placebo in the treatment of acute rhinosinusitis




Objective: To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with acute rhinosinusitis
Participants: 166 patients
85 amoxicillin, 1500mg/day; 3 doses per day
81placebo; 3 doses per day

Main Outcome Measures: The primary' outcome was improvement in disease Specific quality of life after 3 to 4 days of treatment assessed with the Sinonasal Outcome. Secondary outcomes: patient’s retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, and satisfaction with and adverse effects of treatment.
Results: There was no statistically significant difference in reported symptom improvement at day 3 or at day 10; at day 7 more participants treated with amoxicillin reported symptom improvement (74% vs. 56%, respectively).
No between-group differences were found for any other secondary outcomes.
Conclusions: Among patients with acute rhinosinusitis, a 10day course of amoxicillin compare with placebo did not reduce symptoms at days 3 and 10 of treatment.

Thursday, July 11, 2013

CLINICAL EVIDENCE FOR CYCLAMEN EUROPAEUM L. NASAL SPRAY

CLINICAL EVIDENCE FOR CYCLAMEN EUROPAEUM L. NASAL SPRAY


CLINICAL TRIALS
There are 15 controlled clinical trials, involving 1300 adults and 300 children, 600 of them included in controlled, randomized clinical trials (450 adults and 150 children), treated for 7 days, and some of them for 10 or 14 days. The earlier studies that evaluated the clinical efficacy and tolerability of Cyclamen extract nasal spray were relatively small, of varying design and conducted in Eastern Europe.
Despite the size of these trials they present coherence in their results, demonstrating the efficacy of Cyclamen extract nasal spray in the resolution or improvement of objective and subjective symptoms with greater, or at least similar, efficacy as standard combined treatment and with only minor adverse events reported in adults and children with rhinosinusitis [1,2, 3, 4-26]. As monotherapy, Cyclamen extract nasal spray is a good first-line treatment option for rhinosinusitis symptoms.
Cyclamen extract nasal spray can contribute to reducing disease progression time, decreasing the need for antibiotics or boosting their effects, as well as reducing the number of complications and chronic outcomes; thus, Cyclamen extract nasal spray has proven clinical benefit as an initial treatment for rhinosinusitis symptoms.
In patients with bacterial infections and with unfavourable progression, Cyclamen extract nasal spray shows evidence of an improvement in treatment efficacy when it is administered in combination with antibiotics Cyclamen extract nasal spray relieves symptoms and provides rapid recovery in acute rhinosinusitis due to its sinonasal drainage properties. The two randomized, double blind placebo-controlled trials show similar results, [4, 5] supporting the earlier studies.



Of particular note, the first large randomized, double-blind, placebo-controlled clinical trial with Cyclamen europaeum in patients with acute rhinosinusitis, showed marked clinical benefits for extract nasal spray [5]. A similar trend had been reported previously in a randomized, controlled, proof-of-concept study of Cyclamen europaeum L. nasal spray conducted in the USA [4].
Thus, Cyclamen extract. nasal spray is an effective and well tolerated treatment for patients with acute or chronic rhinosinusitis of mild-moderate severity. Of note, Cyclamen extract nasal spray is available commercially, and used successfully, worldwide; it can be recommended for use as monotherapy and it has also been shown to increase the efficacy of standard therapy, which generally included an
antibacterial drug and/or topical corticosteroids, shortening the time to symptom resolution and complete cure [27].
Cyclamen extract nasal spray treatment has also been associated with improvements in patient Quality of Life, an important finding in this debilitating disorder. Cyclamen extract. nasal spray has also shown benefits in terms of reducing symptoms when compared with painful, invasive procedures including maximallary sinus punctures.
Clinical studies have reported good tolerability, with no unexpected or serious Adverse events. Adverse events experienced were generally related to the mechanism of action of Cyclamen extract or are symptoms of rhinosinusitis, and included nasal irritation/burning. The clinical benefits of Cyclamen extract nasal spray, along with its good tolerability profile, indicate that it has a favourable benefit-to-risk profile in patients with rhinosinusitis.
This new product, with ideal characteristics and properties to combat rhinosinusitis and avoid its complications, possess some differentiating features
2012

Thursday, July 4, 2013

Cyclamen extract Mechanism of action

Cyclamen extract Mechanism of action


Saponins are present in the plant world and most plants contain them in the form of triterpene and steroid glycosides. The term “saponin” comes from a Celtic word. It means soap and it is found in all the European languages. Saponins have some of the characteristic properties of soap, particularly detergent and surfactant properties, the ability to reduce surface tension and create a fairly stable film and, therefore, the property to form a foam. Due to these properties, the saponins adhere to surfaces, such as those of the mucous membranes.
The extract from the fresh tubers of Cyclamen europaeum in Nasodren® contains saponins. The main saponin component is cyclamin with a triterpenoid structure, which is accompanied by deglucocyclamine, hydrated cyclamine and other structurally related saponins. 
However, this does not mean that the saponins themselves have an anti-inflammatory effect. There is no evidence in the scientific literature that proves any ability of the saponins to act directly on the inflammatory process, for example by inhibiting the formation of inflammation mediators, leukocyte migration, etc. 
The aqueous extract obtained from the Cyclamen europaeum root-tuber is rich in saponins. These substances are known for their surfactant activity, which means they are adsorbed through the nasal mucosa without being absorbed into the bloodstream.




The surfactant action of the cyclamen saponins on the nasal mucosa reduces surface tension, facilitating humidification of the zone in addition to the secretion of mucin by goblet cells. This fluidifies the mucous accumulated in the nasal cavity, facilitating its elimination and thereby relieving congestion.
In addition, the saponins stimulate the sensitive receptors present in the nasal mucosa, inducing a nociceptive response transmitted by the trigeminal nerve. The nasal mucosa is entirely innervated by the trigeminal nerve, and therefore the cholinergic response generated in the nasal cavity is observed throughout the nasal mucosa, favouring opening of the ostium, increasing glandular secretions and increasing ciliar movement in the entire area. The accumulated secretions in the sinuses are consequently drained through the nose, providing rapid symptomatic relief of nasal congestion.

Thursday, June 27, 2013

CYCLAMEN EXTRACT definition

CYCLAMEN EXTRACT definition



Cyclamen extract is a nasal spray used for the relief of nasal congestion (blocked up feeling in your nose), nasal secretions, loss of smell and facial pain by clearing and draining the mucous secretions retained in sinuses (passages leading to the nose), nasal cavities and upper respiratory tract, providing fast symptom relief from the very first dose.
When you use cyclamen extract you will experience an intense discharge of dammed up secretions from the nose and paranasal cavities, which can last up to two hours. As a result, the headache or facial pain, which often accompanies nasal congestion, rapidly ceases. 
In cases of otitis media, the dammed up secretions are rapidly eliminated, resulting in a decrease of earache and recovery of hearing loss.




Composition

A lyophilized powder which is obtained from a natural extract of fresh tubers of Cyclamen europaeum L. 
Excipients:
There are neither artificial ingredients nor preservatives. 
A solvent (5 ml of water) is provided for reconstitution of the lyophilized powder.

Chemical composition and properties
Cyclamen is a member of the primrose family (Primulaceae) and it has been used medicinally since ancient times. As example, Theophrastus, in Ancient Greece (4th-3rd centuries BC), recommended inserting a mixture of cyclamen extract and honey into the nose for the treatment of nasal catarrh and headaches (“to clear the head”).
Nasodren® is an extract of Cyclamen europaeum L. that contains triterpenic saponins that acting as a local surfactant on the mucous membranes to promote the intranasal drainage of fluid from the sinuses through a physical mechanism. The superficial physical impact is converted into a change in electric potential by reversible stretching of the terminal axonal membrane. These events are closely similar to physiologic responses in stretch or tactile receptors elsewhere in the body.

Friday, June 21, 2013

Study in Chronic rhinosinusitis 2013

Study in Chronic rhinosinusitis 2013



The study coordinators are, Dr. A. S. Lopatin, president of the Russian Rhinology Society and Dr. G. Z. Piskunov, associate member of the Russian Academy of Medical Sciences.
The objective of this study is to obtain data to improve both knowledge and the treatment of chronic rhinosinusitis.



Within the performance of the project, 4 stages are planned:

Stage I: Cross-sectional analytical multicentre study using randomized individual standardized interview (questionnaire) “Conventional practice of chronic rhinosinusitis treatment in Russia”. 
Multicentre doctors questionnaire of E.N.T. specialists from different regions of Russia.  It is planned to obtain about 800 questionnaires



Stage II:  “Multicentre observational epidemiologic study with the aim of studying the efficacy and safety of treatment regimens for patients with chronic rhinosinusitis exacerbation”. This non-interventional observational prospective epidemiologic study is focused on the examination of chronic rhinosinusitis exacerbation treatment practice by means of evaluating clinical outcomes, treatment regimens and treatment cost. Evaluation lasts up to 6 months after patient inclusion.
Eighteen centres from all over Russia participate in the study, with 21 patients from each centre. During the follow-up period the attending medical doctor performs treatment and monitoring of patients according to established standard clinical practice.


Monitoring plan. 
During this non-interventional prospective epidemiologic study, data for 5 time periods are to be registered. Patients are randomly allocated to one of the treatment regimens included in the study.

When chronic exacerbations occur, the different treatment regimens being followed, together with their outcomes, are assessed.
All values of treatment results, treatment changes and volume of additional diagnostic interventions are fully registered in CRF for analysis of clinical outcomes in patients with chronic rhinosinusitis exacerbation.
Stage III: “Study of the spectrum of bacterial causative organisms associated with chronic rhinosinusitis”.

The aim is to examine the spectrum of microorganisms (aerobic and anaerobic) in the contents of the maxillary sinus cavity in patients with chronic rhinosinusitis, and also to study their susceptibility and resistance to different antimicrobial drugs.
Material sampling during maxillary sinus cavity paracentesis is performed in 4 clinical centres.
Each centre selects 40 patients (Each centre in Moscow selects 20 patients). In the study, patients of both genders will participate with symptoms of “chronic rhinosinusitis” present. During two-sided process, material for cultural study is withdrawn separately from each maxillary sinus cavity.
All tubes with biological material are transferred and analysed in, Smolensk State Medical Academy.



Stage IV: “Incidence of nasal and paranasal sinus diseases in Russia”. Questionnaire: respondents are adult population (patients visiting ambulatory clinic for health assessment (ENT focus), medical institution specialists, medical university students, patients visiting clinic for reasons not associated with ENT- specialisation).  
Survey of 3,000 people is planned.
All stages are performed concomitantly.
Report of the final results for the “CHRONOS” project is expected around the end of 2013. 

Friday, June 14, 2013

Can Nasodren® be used after surgery?

Can Nasodren® be used after surgery?


 
The study “Dynamics of the transport and heating function indices of the mucous membrane of the nasal cavity in the early postoperative management of patients with chronic rhinosinusitis” (Popovich VI, Staiden EB, Savchuck OI, Ukranian Rhinology, 2007; (3) 56-62), which included 110 patients with chronic sinusitis, demonstrated that the early postoperative management approach involving the use of Cyclamen extract results in an earlier normalization of the major physiological functions of the nasal cavity. Thus, Cyclamen extract provides rapid relief from "acute postoperative sinusitis". The study also concluded that the use of Cyclamen extract is safe and free from undesirable side effects.


Thursday, June 6, 2013

Does Cyclamen extract work for otitis?

Does Cyclamen extract work for otitis?



Sinusitis and otitis are related medical conditions because the paranasal sinuses and ears are located close to each other in the skull. Ear or facial pain is a typical symptom of sinus infection. If the sinusitis patient bends forward, ear pain or sinus pressure may increase. Sinusitis is a disease of the sinuses, whereas otitis means an infection or inflammation of the ear. The ear is divided into three parts: outer, middle and inner. The corresponding infections are medically referred to as otitis externa, otitis media and otitis interna.
Acute otitis media (AOM) is analogous to acute sinusitis in that it is a result of obstruction at the ostium of the Eustachian tube.

Administration of the Cyclamen extract-based preparation is effective in the treatment of secretory otitis media; it shortens the treatment time and avoids the use of aggressive therapies, such as myringotomies, in these patients
The Cyclamen europaeum effect on the mucous membrane of the nasal cavity, the nasopharynx and the paranasal sinuses causes an intense reflex secretion. This secretion causes intense drainage of the nasal cavity and the paranasal sinuses, resulting in increased activity of the ciliated epithelium in the Eustachian tube and exudate evacuation from the tympanic cavity of the middle ear.


The study “Use of Sinuforte® in the management of acute rhinosinusitis and secretory otitis in children” (Berezniuk VV, Chernokur AA; Journal Otorhinolaryngological Disease. 2006; (2): 65-68), concludes that the use of the preparation Sinuforte® in the combined symptomatic treatment of acute rhinosinusitis, accompanied by secretory otitis, results in rapid relief of the inflammatory process in the nasal cavity, the paranasal sinuses and the middle ear. It led to the achievement of stable positive results in the symptomatic treatment of this pathology for 96.7% of the study group patients.
Sinuforte®/Nasodren® in combination with antibiotics considerably reduces the amount of recurrences and their frequency.
The clinical effectiveness of Sinuforte®/Nasodren® in monotherapy of chronic rhinosinusitis is comparable to the effect of the therapy with antibiotics.

The received data supports a reduction in the frequency of prescribing antibiotics when patients have recurring exacerbation of rhinosinusitis, favouring the prescription of Sinuforte®/Nasodren® in monotherapy and thus reducing polypharmacy.
 
 



Thursday, May 30, 2013

Microendoscopy Study results

Study of specific microendoscopic characteristics of intranasal mucosa in patients presenting with chronic rhinosinusitis and treated with Sinuforte

Key messages from this study
  • Sinuforte is safe and efficacious for the treatment of patients with Chronic Rhinusitis (CRS)
  • Sinuforte improves drastically the most frequent symptoms of CRS (facial pain and nasal congestion)
  • Sinuforte alleviate rhinosinusitis symptoms from the first application
  • Subjective improvements correlate with objective findings
  • Sinuforte physiologically resolves CRS exacerbation without disrupting the anatomical integrity of the nasal mucosa
  • Tolerance of Sinuforte is rated as excellent or good for both patients and researchers
Study: Randomized open clinical and instrumental study with a control group
Objective: to assess the efficacy of the treatment of chronic rhinosinusitis (CRS) in the patients treated with Sinuforte using the contact microendoscopic technique.
Patients: 30 patients diagnosed with CRS, based on clinical observation, endoscopic and microendoscopic examination of intranasal mucosa and functional tests, in accordance with the EPOS 2007 (European Position Paper on Rhinosinusitis and Nasal Polyps).

Study methods: basic criteria for inclusion were: exacerbated CRS of moderate severity and absence of gross deformations of intranasal anatomical structures.

Effectiveness of treatment was evaluated using a questionnaire, instrumental examination (endoscopic and microendoscopic), and functional tests (laser Doppler flowmetry) on day 1 of the study, and also on days 2, 4, 6, and 8 after the start of treatment. 



Results: clinical and instrumental data on treatment with Sinuforte revealed improvement of general and/or local CRS symptoms, as confirmed by data from contact microendoscopy, in 30 patients (100%).

Tolerance of the Cyclamen extract was evaluated as “good” in 100% of cases by patients and the researcher using a point scale. Tolerance at the end of the course of treatment was evaluated as “good” in 90% of cases and “excellent” in 10% of cases. There were no unsatisfactory evaluations.
The efficacy of Sinuforte was evaluated cumulatively after phased treatment, taking into account the dynamics of subjective and clinical parameters at each visit as “good” by day 4 and as “excellent” by day 8.

M. A. KHOROL´SKAYA, S. G. VAKHRUSHEV, N. V. TERSKOVA.
Vestn Otorinolaringol 2011; 5: 59

Friday, May 24, 2013

Is Nasodren® effective in the case of halitosis?

Is Nasodren® effective in the case of halitosis?

Halitosis (bad breath) is mostly caused by sulphur-producing bacteria that normally live on the surface of the tongue and in the throat. About 2.4% of the adult population suffers from bad breath.
Apart from the sulphur-producing bacteria that colonise the back of the tongue, the other major causes of halitosis are:
  • Dental factors – such as periodontitis (infection around the teeth) or poor oral hygiene
  • Dry mouth – caused by medicines, alcohol, stress or a medical condition
  • Smoking – which starves the mouth of oxygen.
  • Rhinosinusitis

When there is a problem in a sinus, bad breath is the result of some basic factors: drainage from the sinus runs towards the back of the oesophagus and onto the very back of the tongue. This drainage is a rich source of protein containing sinus cells that have sloughed off, blood cells, pus cells and additional molecules formed by the body. These components act as ideal nutrients for the oral bacteria. With a balanced, continuous food supply from sinus drainage, bad breath is boosted by the growing population of bacteria.
Bad breath caused by sinus drainage is not just a warning sign of sinusitis, but also a situation in which the sinuses become unhygienic or swollen. It can occur as a result of a viral infection, similar to the case of colds, or due to allergens, as in the case of allergies. At times, sinusitis may be associated to asthma attacks. Whatever the reason is, sinusitis usually brings on bad breath as a result of sinus drainage.
Whenever a person suffers from sinusitis, the coating of mucus in the sinuses is aggravated and begins to generate too much mucus. A normal person generates mucus on a regular basis to maintain the nasal passages hygienic and clear. On the other hand, when these mucous coatings are aggravated, they go on overdrive and generate excessive mucus, resulting in a general sinusitis symptom called postnasal drip, which could lead to bad breath.




In addition, the disease causing sinusitis may perhaps also cause swelling of the nasal passages. The nasal passages join the nose, via your sinuses, to allow air into the lungs. When these nasal passages are swollen it results in accumulation of mucus. Thus, the mucus gets ensnared inside these nasal passages, catching the attention of bacteria, which flourish in dark, wet places.
So, when halitosis is caused by rhinosinusitis, Nasodren® will help to eliminate it.

Wednesday, May 8, 2013

Case experience

POSTOPERATIVE CARE, Case experience



My observational experience in postoperative care with cyclamen extract is based above all on 28 patients who underwent ethmoidectomies for polyposis. In 14 cases, saline irrigations were used, while in the remaining 14, a cyclamen extract was administered intranasally
in addition to the irrigations. One spray was administered into each nostril, once a day. The treatment was started on the third day after withdrawing Merocel. The patients treated with the cyclamen extract
experienced a significant improvement in the evolution of the cavities after the sixth day of the postoperative period (third day of treatment).
Only one case of frontal pain caused by frontal sinusitis, requiring discontinuation of the treatment, has been documented.
The endoscopic images of the nasal passages of a case of sinonasal polyposis with superinfection show how abundant mucus from the
maxillary sinus appears only a few minutes after administration of this product. In the patients treated with cyclamen extract, the maxillary sinus is clear after 48 hours, due to the product’s self-cleansing effect. 
By the 4th day after starting treatment, recovery of the affected area is obvious. By the 6th day, there is a clear retention of the mucosal oedema (when normally this happens after 10-12 days); this effect could be due to use of this preparation.
The side effects observed with this product are limited to a smarting sensation during the first few sprays, which is variable or even absent in operated patients. Other side effects may be sneezing and watery rhinorrhoea.
Generally speaking, these effects are mild, transient, expected, rare, with minimal clinical significance.





REMARKS
Treatment can be started on the day after surgery or when the tamponade is removed and there is no risk of bleeding.
The reason for using Cyclmen extract only once a day is basically because it induces a very strong expression of mucoid cells. Consequently, readministering after 12 hours would not provide any significantly greater benefit than that obtained by administering every 24 hours.
This treatment can be continued without problems for more than a week. Since it causes no significant adverse effects, it can be used for up to 10-15 days.
Cyclamen extract may be useful in all patients who require postoperative care, provided that there is healthy mucosa. Its effect would be very limited in those cases where the entire mucous membrane has been removed.
The main contraindication for this product is that it should not be used in patients with obstruction.
This treatment can be repeated as often as is wished, and can be stopped when the patient wishes.

CONCLUSION
It is my opinion that it will be very useful in clearing the surgical cavity, it will reduce the need for aggressive postsurgical wound treatments, the time between treatments of the surgical area will be longer, it will facilitate self-cleansing, it will possibly speed up the reepithelialisation process, and will enable topical corticoids to be applied earlier.



Take it from:
THERAPEUTICS AND CLINICAL RISK
MANAGEMENT
Personal observation of Dr. H. Massegur 
Spain.

Thursday, May 2, 2013

Cyclamen extract and acute rhinosinusitis aspect

Cyclamen extract and acute rhinosinusitis aspect


In acute rhinosinusitis, the nasal sinuses are blocked and significant inflammation is reported ; the mucosa is swollen and the exudate accumulates within the sinuses, causing mucopurulent secretions.
Cyclamen extract acts on the sinonasal mucosa , inducing a strong reflex secretion that rapidly leads to the discharge of abundant mucus. The retained seromucous secretions are expelled, thereby reducing or eliminating tissue congestion and oedema. Cyclamen extract effectively opens the nasal spaces, facilitating physiological drainage and clearing of the nasal cavities. With this treatment, the underlying cause of the rhinosinusitis is eradicated and the respirator y mucosa regenerates physiologicall y in just a few days. The treatment offers an extensive range of benefits and it is possible to prevent or even treat a serous otitis media by improving ventilation of the Eustachian tube and the middle meatus.




  • Cyclamen europaeum has been shown to be highly effective as a single-agent therapy in 56% of the patients treated for acute rhinosinusitis . All of these patients had a drainage orifice.


• In 21% of the patients, a partial blockage of the orifice associated with inflam - mation of the sinonasal mucosa was observed, for which systemic decongestants were prescribed.

•And in 23% of the patients, the blockage was complete . These patients had severe rhinosinusitis and required treatment with antibiotics .

• By the 10th day of treatment, a marked clinical recovery was observed.

Prof. Vasil Ivanovich Popovich
PRESENT AND FUTURE OF THE MANAGEMENT OF SINONASAL DISEASEMADRID, 11 NOVEMBER 2007

Wednesday, April 24, 2013

Prosinus study goals

PROSINUS study goals (II extract)


PROSINUS is an prospective, observational, epidemiological study of health outcome in which the exposure factor is not a medicine but a disease. “it is not drug efficacy and/or tolerance that is being assessed but the evolution of a disease from initial diagnosis to final cure.” Before the first visit, information was obtained on the treatment received by the patient in the non-ENT primary care system, while the management approach applied during specialist care was examined after the first visit.
The study’s primary goal is to assess the diagnostic, treatment and clinical monitoring procedures available for acute rhinosinusitis in usual practice. The secondary goals include the following: describe the bio-demographic and clinical profile of the patient with acute rhinosinusitis, assess the degree to which the European position papers (EP3OS) are applied in the Spanish health system, determine the prevalence of complications of acute rhinosinusitis, analyse the health-related quality of life of patients with acute rhinosinusitis, and assess their treatment compliance.





Certain pharmacoeconomic goals have also been set: study the socioeconomic impact of acute rhinosinusitis, evaluating the ratio-optimization of the resources used to control the disease, and the impact on work life.
The primary study variables are: disease duration, diagnostic resources used or number of visits; the secondary variables are concerned with epidemiological data, treatment compliance (Morisky-Green test), and degree of satisfaction.



Joan Montserrat,
PRESENT AND FUTURE OF THE MANAGEMENT OF SINONASAL DISEASE
MADRID, 11 NOVEMBER 2007

Wednesday, April 17, 2013

PROSINUS study results in Spain (I extract)

PROSINUS study results in Spain

The PROSINUS study has been designed in response to the shortage of epidemiological data in Spain on the diagnosis and treatment of acute rhinosinusitis (ARS). The name PROSINUS refers to a prospective epidemiological study whose purpose is to analyse the diagnosis and treatment of this disease in ENT offices in Spain and also to assess its socioeconomic impact.



However, 550 were subsequently excluded because they had chronic rhinosinusitis and a further 77 had a probable diagnosis of chronic rhinosinusitis. Of the 1,233 patients with a confirmed diagnosis of ARS, 1,172 have completed visit 1 of the study and 788 have also reached visit 2. Most of the patients (approx. 90%) initially had a moderate or severe disease, according to the VAS.
The definition of acute rhinosinusitis given in the 2005 EP3OS guidelines has been used for the study. At present, the diagnosis of rhinosinusitis is basically clinical; the main symptoms are nasal obstruction/congestion, impaired sense of smell, anterior or posterior rhinorrhoea, and facial pain/pressure; at least two symptoms are required to determine the presence of rhinosinusitis.
However, a further condition has been added in that the symptoms must be associated with suggestive endoscopic findings (polyps, rhinorrhoea and oedema) or changes in the sinonasal mucosa that can be identified by computerised tomography (CT).
In the review of the EP3OS position paper performed this year (Fokkens et al., 2007), it was proposed to reclassify the severity of rhinosinusitis by quantifying it on a visual analogue scale graded from 0 to 10. Under this new classification, a patient is considered to have mild disease when the score on the visual analogue scale does not exceed 4 and moderate/severe disease when at least one symptom attains a score between 4 and 10. As regards the duration of the rhinosinusitis, it is defined as acute or intermittent when disease duration is less than 12 weeks and chronic or persistent if it continues beyond 12 weeks. Acute rhinosinusitis is further subdivided into two clinical conditions: acute viral rhinosinusitis or common coldand acute/intermittent non-viral rhinosinusitis.
In viral rhinosinusitis, symptom duration is less than 10 days, while acute/intermittent non-viral rhinosinusitis is defined as an increase in symptom severity after 5 days or persistence of symptoms beyond 10 days after symptoms began. In both cases, symptom remission is complete within 12 weeks.



PRESENT AND FUTURE OF THE MANAGEMENT OF SINONASAL DISEASE
MADRID. 11 NOVEMBER 2007
Dr. Joan Montserrat

Monday, April 8, 2013

INFLAMMATION IN ACUTE (ARS) AND CHRONIC RHINOSINUSITIS (CRS)

INFLAMMATION IN ACUTE (ARS) AND CHRONIC RHINOSINUSITIS (CRS)

To date, there is little published data on inflammation in acute rhinosinusitis (ARS). However, what information there is helps us understand how this condition is not always equivalent to the presence of a bacterial infection.


In ARS, it is common to find high IL-8 (which is the neutrophils’ main chemotactic agent), TNF-alpha and total protein levels. Neutrophil and T lymphocyte levels are also usually increased (both in the epithelium and in the lamina propria). There is more information available on the existence of inflammation in chronic rhinosinusitis (CRS) with nasal polyposis. Among other findings, there is one that is particularly interesting: the persistence of high eosinophil levels. Numerous inflammation mediators have been found in the sinonasal mucosa of subjects with CRS and nasal polyposis which may play an important role and may be caused both by specific substances and by other non-specific factors (cold, pollution,…). Glandular secretion is an important component of inflammation, manifesting as rhinorrhoea, and is regulated not only by inflammatory regulators but also by the epithelial and inflammatory cells themselves and by classic neurotransmitters. A landmark study performed by Roca Ferrer et al. shows that the application of metacholine on the nasal mucosa induces a significant increase in glandular secretion markers (in both the nasal and bronchial mucosa) and that this effect can be blocked by the administration of an anticholinergic agent. In addition, there is a dose-dependent relationship between metacholine and glandular secretion. Identical results are obtained with the application of interleukins.

In this context, it has been shown that the administration of glucocorticoids interacts with all the stages of the inflammatory cascade.
Martínez-Antón et al. have shown its ability to act on the mucins (one of the main markers of glandular secretion). In his studies, Dr. Mullol has provided significant information on the activity of glucocorticoids as inhibitors of COX-2 expression and activity, negative regulators of the NFB receptor and modulators of the activity of other components of the inflammatory cascade, such as eosinophils, cytokins and GMCSF activity in the epithelium.



In addition, it has been recently documented that the corticoid receptor alpha (which is the active receptor for corticoids) is decreased in nasal polyps. It is therefore to be expected that nasal polyps would be less responsive to treatment with these drugs (i.e., there would be a certain amount of resistance).



It has also been seen that treatment with high doses of corticoids quickly induces a marked decrease in the expression of the corticoid receptor. Consequently, it would be expected that the treatment would progressively become less effective. However, these results are not confirmed in in vivo experiments; on the contrary, expression of the corticoid receptor increases with continued administration of glucocorticoids.


These findings about inflammation are significant; an improved understanding of the pathophysiology of sinonasal conditions will enable a more targeted management, facilitating diagnostic and treatment decisions and offering greater benefit to our patients.

Take it from: 
PRESENT AND FUTURE OF THE MANAGEMENT OF SINONASAL DISEASE

Joaquim Mullol, M.D.
MADRID. 11 NOVEMBER 2007

Thursday, March 28, 2013

Why Cyclamen extract?

WHY CYCLAMEN EXTRACT?



Rhinosinusitis is increasing in prevalence globally and is one of the most common reasons for a physician consultation in primary care. Treatment is aimed at relieving these symptoms, preventing disease progression/ recurrence, and most importantly, improving the patient’s quality of life. Currently available therapies often fail to provide adequate symptom relief and new therapeutic options would be a step forward, particularly if they help to avoid antibiotic overuse for a diseasewhich is usually viral in origin. Cyclamen europaeum (CE), a member of the primrose family, has been used in traditional medicine since ancient times. Extracts from CE tubers contain saponins which following nasal instillation, concentrate in the mucous membranes of the lower nasal cavity, inducing a rapid discharge of mucous from the nasal and paranasal cavities, suggesting potential benefits in rhinosinusitis treatment.

The precise mechanism of action of Cyclamen extract is currently the subject of scientific investigation. It appears to have both direct and indirect effects, related to the saponin fraction. The saponins are welldefined topical surface active agents, allowing their adhesion to mucous membranes, where they mediate their effects. Following insertion into the nostrils, Cyclamen extract  is not penetrative and thus its activity is confined to the paranasal cavities and the vestibular area. Here, the extract reduces the surface tension of the cell membrane of the nasal mucosa, and this process facilitates mucin secretion, shrinks the nasal mucosa and decreases congestion through a direct osmotic effect. As the antiedemic action of CE nasal spray is not due to a vasoconstrictive component, this product is essentially different to the analogous effects of decongestants. The local activity of Cyclamen Extract also increases the permeability of nerve terminals, possibly by stretching the terminal axonal membrane, and the resultant influx of Na+ causes the depolarisation that generates the electrical potential which stimulates the trigeminal nerve endings in the basal mucous membrane. This results in a reflex response (nasal burning, sneezing, lacrimation, etc.) which also induces the efflux of secretions from epithelial and submucosal cells in the nasal cavity and paranasal sinuses, accounting for the rapid and abundant discharge. This hypersecretion contributes to the complete evacuation of pathologic content.




A Cyclamen Extract nasal spray has been developed, which in preliminary studies produced encouraging clinical improvement, More recently, in the first phase III randomised, double-blind trial of phytotherapy in rhinosinusitis, CE nasal spray significantly reduced facial pain and increased the level of patient and investigator satisfaction compared with placebo. Overall,
Cyclamen extract  nasal spray was well tolerated. The most frequent symtoms included nasal irritation/burning, which are symptoms of rhinosinusitis or may be due to the method of administration.
Follow-up clinical evaluation of Ciclamen Extract nasal spray in the treatment of rhinosinusitis is required to fully elucidate the potential of this promising natural agent in adults and children with acute and chronic rhinosinusitis.

REFERENCES
1. Fabre M. Effects of cyclamen extract on cell osmosis. Presented at the “New
horizons in the non-invasive management of sinonasal disorders” symposium in
Barcelona, 2007.
2. Gedevanishvili MD, Gogitidze NM, Sikharulidze IS. Reflex mechanisms of naso
paranasal secretion in the administration of CE nasal spray. Vestn Otorinolaringol.
2007;(3):54-6.
3. Pfaar O, Mullol J, Anders C, et al. Cyclamen europaeum in the treatment
of acute rhinosinusitis: a randomized, double-blind, placebo-controlled trial.
Rhinology (submitted).