Wednesday, 14 March 2012

Shirley Price Chamomile Eyecare - the Stage One Research

Ian Brealey 23.3.12 - Shirley Price Aromatherapy teams up with NPARU to launch a stage one trial on herbal eyedrops.  Enquiries about this project to me please at info@ShirleyPriceAromatherapy.com  Manufacturers of herbal products may have plenty of testimonials from individual clients who have bought them and found relief from their symptoms.  We certainly do.  The Shirley Price Chamomile Eyecare has been a popular product for over 30 years.  Yet we spend no money on promoting them but instead rely on word of mouth recommendation.  Can we do science on this?  The lab cannot recreate all the elements of the situation in which someone buys a herbal product.  For example people are usually anxious about their symptoms and have lived with them for a while getting more anxious about their symptoms which a volunteer in the lab is not. A non toxic self treatment itself will apparently both address a need in this respect in real hayfever sufferers and have some physiological basis in fact in that pollen grains are washed from the eye by the sterile solution removing the irritant pollen grains. Nor will a volunteer have a real energy imbalance to address for example by physical means like acupressure.  In hayfever's case relief has evidently been experienced by individuals by acupressure of the arm in the form of a simple pebble worn in an armband. The non-physiological action of such relief is not capable of measurement.  However it is worth giving the science a try where a product has been highly recommended to see what is going on physiologically.  Symptoms of seasonal hayfever are an ideal indication to put to trial as it clearly depends in most cases on an external irritant in the form of pollen grains in the eye and sinuses.

Researchers at the National Pollen and Aerobiology Research Unit.

Professor Roy Kennedy (left) has kindly agreed to lead a research project into the Shirley Price Chamomile Eyecare.  Highly diluted Chamomile essential oil and chamomile water in a 1/2500 dilution has traditional use in compresses for inflamed eyes as do other essential oils.  Researchers will be measuring corneal temperature and tryptase production to test the intriguing effectiveness of the Shirley Price Chamomile eyedrop formulation in the Laboratory with a pool of 40-50 volunteers.  Consumers worldwide give the eyedrops 5 stars as feedback on consumer websites which is evidence of their effectiveness.

Now a project has been launched to find out why and test alternative formulations.  Herbal eyedrops provide an effective means of first line treatment of tired and irritated eyes and for hayfever relief.  Chlorophenicol eyedrops while effective in the treatment of infected eyes carry serious side effects in a few cases and so GPs are reluctant to prescribe them as a routine first line of eye treatment.  At the same time there has been a reluctance by GPs to recommend herbal eyedrops due to a lack of research as to their effectiveness.  This research project will aim to provide scientific examination of the effectiveness of the Shirley Price Chamomile Eyecare in the relief of hayfever.
Ian Brealey said "Unexplained medical symptoms are associated with anxiety and depression in 70% of cases so herbal remedies besides any pharmacological effect they may have may serve to reduce anxiety and stress.  There is therefore ethical sense in using herbal eyedrops that can be shown to be effective."    The development of the Shirley Price eyecare is described by Shirley Price on page 200 of her book Aromatherapy for Health Professionals which is available in a new 2011 edition.


Background
Ocular allergies includes a group of diseases that affect the eye surfaces (conjunctival mucosa or palpebral skin) and are commonly associated to immune-mediated inflammatory reactions of these structures.   There are four types of ocular allergy however allergic conjunctivitis is the most common clinical form representing up to 98% of all cases of ocular allergy. 
Allergic conjunctivitis is a type-I hypersensitivity reaction and the immune system's response to allergen exposure can be divided into two phases. The first is immediate hypersensitivity or the early phase reaction that occurs within 15 minutes of exposure to the allergen. The main symptoms of early phase response allergic conjunctivitis are itching along with lacrimation (tearing), red eye, foreign body sensation and edema (swelling).      During the early phase reaction, chemical mediators are released by mast cells including histamine, tryptase and chymase.   

The second, or late phase reaction can occur 4-6 hours after the disappearance of the first phase symptoms and can last for days or even weeks but not every allergen exposure leads onto the second phase. In the late phase reaction, tissues become red and swollen due to an influx of a variety of inflammatory cells to the affected area.  

The proposed study on the effect of chamomile would focus on the early phase reactions to allergen exposure as it would expected that an eye wash or eye drop would provide relief for the early phase symptoms by washing allergens from the eye or diluting the allergens.  The possibility that Chamomile may have an antihistamine effect would also be investigated.     

The aim would be to investigate the efficacy of Shirley Price Chamomile Eye Care as an eye wash and eye drop compared with saline solution (or possibly artificial tears) and another over the counter product marketed as an eye wash e.g. Optrex Multi Action eye wash or Optrex Itchy Eye Drops as the ingredients for both are Witch Hazel and Purified Water.  The marketing for Optrex says ‘Optrex itchy eye drops, which contain natural plant extracts, help relieve irritation caused by pollen.   They work by flushing out allergens such as pollens that cause hayfever.   Formulated with purified water and natural plant extracts, these drops gently cleanse the eye surface to wash pollen and other allergenic particles away, providing gentle relief from the irritation they cause to allergic eyes. They are suitable for everyday use.’

The different eye washes would be applied to the eyes following sensitization to grass pollen and samples taken of the resulting tears over a period of time.   These would be analysed for levels of allergen using Enzyme-linked immunosorbent assay (ELISA) techniques.  Samples would also be analysed for levels of a chemical mediator e.g. tryptase.   It would be expected that if the Eye Care product has an anti-inflammatory effect that there would be a significant decrease in the level the chemical mediator eg tryptase within a short period following sensitization and when compared to the results from the other treatments.

 The ocular surface temperature would be measured using specialist equipment before and after treatment as an additional indicator of an anti – inflammatory response.   The equipment uses infrared imaging, providing a non-invasive and very accurate method of temperature measurement. It would be expected that if the Eye Care has an anti-inflammatory effect that there would be a significant decrease in ocular surface temperature within a short period following sensitization and when compared to the results from the other treatments.  

The participants would be asked to rank their eye symptoms (itchy, watery, sore and swollen eyes) on a likert scale.

 



Stage 1.       Application for Ethical approval – would be completed over the summer months
Costs would include full study design, application for NHS Ethical approval, assisting with the application to the MHRA, engagement of clinician at Worcester Hospital as Principal Investigator,   engagement of independent statistician.
This would take approximately 2 to 4 months and would involve presentation to an NHS ethics committee.

Ian Brealey

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