The Clinical Efficacy of Topical Nasal Pomegranate Fruit Extract for Patients With Chronic Rhinosinusitis
The Clinical Efficacy of Topical Nasal Pomegranate Fruit Extract for Patients With Chronic Rhinosinusitis
An explosion of interest in the numerous therapeutic properties of Punica granatum over the
 last decade has led to numerous in vitro, animal, and clinical trials. Pomegranate is a
 potent antioxidant, superior to red wine and equal to or better than green tea. In addition,
 anticarcinogenic and anti-inflammatory properties suggest its possible use as a therapy or
 adjunct for prevention and treatment of several types of cancer and cardiovascular disease.
 Because of pomegranate's antimicrobial properties, it may aid in preventing infection by
 dental pathogens, pathogenic E. coli O157:H7, and antibiotic-resistant organisms such as
 methicillin-resistant Staphylococcus aureus (MRSA) Pomegranate's effect on bacterial
 pathogens has only been tested in vitro, however, necessitating human trials to refute or
 substantiate any clinical effect.

 The possibility that pomegranate extracts may also have an effect on several other disease
 processes, such as Alzheimer's and obesity, underscores the need for more clinical research.
 Currently, numerous clinical trials are in progress exploring the therapeutic potential of
 pomegranate extracts.

 Aim The investigators want to evaluate the effect of Punica granatum components on Chronic
 sinusitis, nasal polyps and chronic rhinitis.
There are many publications indexed by Medline dealing with pomegranate and Punica granatum
 and there is interest in pomegranate as a medicinal and nutritional product.

 The pomegranate tree, Punica granatum, especially its fruit, possesses a vast ethnomedical
 history and represents a phytochemical reservoir of heuristic medicinal value. The tree/fruit
 can be divided into several anatomical compartments: (1) seed,(2) juice, (3) peel, (4) leaf,
 (5) flower, (6) bark, and (7) roots, each of which has interesting pharmacologic activity.
 Juice and peels, for example,possess potent antioxidant properties, while juice, peel and oil
 are all weakly estrogenic and heuristically of interest for the treatment of menopausal
 symptoms and sequelae. The use of juice, peel and oil have also been shown to possess
 anticancer activities, including interference with tumor cell proliferation, cell cycle,
 invasion and angiogenesis. These may be associated with plant based anti-inflammatory
 effects. The phytochemistry and pharmacological actions of all Punica granatum components
 suggest a wide range of clinical applications for the treatment and prevention of chronic
 inflammation.

 Pomegranate as few medical applications as gastrointestinal infections, oral wounds and
 others. There is a publication on the positive use of pomegranate, in reducing of trigeminal
 pain post Herpes Zoster infection (1). Another work described the synergistic effect of
 pomegranate extraction and antibiotics for Staphyloccocus Areus (2). Pomegranate extraction
 was used for viral delay of HIV I in AIDS patients (3).

 It's antiviral effect was examined against HSV and RSV (6). There was a positive effect on H7
 -E. COLI 0157(4). Pomegranate extraction was found to help as antibacterial effect as other
 Mexican extraction drugs, for Gastrointestinal infections (5). High concentrations of phenol
 substances was evaluated in wound healing and it was efficient (7). Methanolic substances
 from pomegranate extraction was evaluated and found efficient for all the bacteria that was
 examined (8). Recently pomegranate extraction was found active in antibacterial effect and in
 synergism with tetracyclin against staphyloccocus Areus with Methicillin resistance (MRSA).

 Pomegranate polyphenol extract (PPE) has anti-influenza properties. Using real time PCR,
 plaque assay, and TCID 50% hemagglutination assay, the investigators have shown that PPE
 suppresses replication of influenza A virus in MDCK cells. PPE inhibits agglutination of
 chicken red blood cells (cRBC) by influenza virus and is virucidal. The single-cycle growth
 conditions indicated that independent of the virucidal effect PPE also inhibits viral RNA
 replication. PPE did not alter virus ribonucleoprotein (RNP) entry into nucleus or
 translocation of virus RNP from nucleus to cytoplasm in MDCK cells. The investigators
 evaluated four major Polyphenols in PPE (ellagic acid, caffeic acid, luteolin, and
 punicalagin) and demonstrated that punicalagin is the effective, anti-influenza component of
 PPE. Punicalagin blocked replication of the virus RNA, inhibited agglutination of chicken
 RBC's by the virus and had virucidal effects. Furthermore, the combination of PPE and
 oseltamivir synergistically increased the anti-influenza effect of oseltamivir. In
 conclusion, PPE inhibited the replication of human influenza A/Hong Kong (H3N2) in vitro.
 Pomegranate extracts should be further studied for therapeutic and prophylactic potential
 especially for influenza epidemics and pandemics.

 Commonly found in many plants, ellagic acid exhibits powerful anticarcinogenic and
 antioxidant properties, propelling it to the forefront of pomegranate research. Many
 commercially available pomegranate extracts are being standardized to contain 40-percent (or
 more) ellagic acid. Lansky's research confirms the synergistic action of several pomegranate
 constituents is superior to ellagic acid in suppressing prostate cancer. To quote Lansky,
 "The recent profusion onto the nutraceuticals marketplace of products standardized to 40
 percent (or even higher) ellagic acid represents a cynical, lucre-driven attempt to replace
 the power of the pomegranate with the power of ellagic acid. The pomegranate needs no such
 tricks or enhancements. It is rather an extraordinary, albeit mysterious (and messy), fruit
 with a complete medicinal power contained within its juice, peel, and seeds.

 Topical applications of pomegranate preparations have been found to be particularly effective
 for controlling oral inflammation, as well as bacteria and fungal counts in periodontal
 disease and Candida-associated denture stomatitis. A hydroalcoholic extract of Punica
 granatum fruit (HAEP) was investigated for antibacterial effect on dental plaque
 microorganisms. Sixty healthy patients (33 females/27 males; ages 9-25) with fixed
 orthodontic appliances were randomized to three groups of 20:

 (1) control group who rinsed with 15 mL distilled water; (2) a group who rinsed with 15 mL
 chlorhexidine, a standard antiplaque mouth rinse; and (3) a group who rinsed with a 15-mL
 HAEP solution. HAEP decreased the number of colony forming units (CFU) of dental plaque
 bacteria 84 percent, comparable to chlorhexidine (79-percent inhibition) but significantly
 better than the control rinse (11-percent inhibition). Both HAEP and chlorhexidine were
 effective against Staphylococcus, Streptococcus, Klebsiella, and Proteus species, as well as
 E. coli. The ellagitannin, punicalagin, is thought to be the fraction responsible for
 pomegranate's antibacterial activity.

 Bacterial Infections The only human trials examining the antibacterial properties of
 pomegranate extracts have focused on oral bacteria. However, several in vitro assays
 demonstrate its bacteriocidal activity against several highly pathogenic and sometimes
 antibiotic-resistant organisms. Brazilian researchers evaluated the synergistic effect of a
 P. granatum methanolic extract with five antibiotics on 30 clinical isolates of
 methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive S. aureus.75
 Antibiotics tested were chloramphenicol, gentamicin, ampicillin, tetracycline, and oxacillin.
 Although synergistic activity between the pomegranate extract and all five antibiotics was
 noted in the S. aureus isolates, synergy with ampicillin was the most pronounced. Based on
 earlier research and the results of this study, the ellagitannin, punicalagin, is thought to
 be the primary constituent responsible for the observed antibacterial effects. Another
 organism that can cause significant disease in humans is enterohemorrhagic Escherichia coli
 (E. coli O157:H7). An ethanolic PPE, one of the two most effective extracts against E. coli
 O157:H7, was shown to be both bacteriostatic and bacteriocidal, indicating PPE may be an
 effective adjunct treatment for E. coli O157:H7 infection.

 On the above information the investigators will try and evaluate the clinical efficacy of
 topical nasal Pomegranate fruit extract (PFE) (Punica Granatum) for patients with Chronic
 rhinitis, chronic sinusitis, nasal polyps and chronic rhinitis.
Inclusion Criteria:

 -  above age 18

 -  under age 80

 -  patients with chronic rhinitis, sinusitis and nasal polyps

 -  patients candidates for surgery or medical therapy

 Exclusion Criteria:

 -  Patients that had nasal surgery before

 -  smokers

 -  Diabetes, chemotherapy or radiation therapy

 -  Allergy to yeasts or pomegranate