Prospective cohort trial of Euphrasia single-dose eye drops in conjunctivitis.
BACKGROUND
Eye drops made from Euphrasia rostkoviana Hayne have been used in anthroposophical medicine for more than 70 years for the structuring of the fluid organism in the eye, especially in inflammatory and catarrhal conjunctivitis. The aim of this prospective cohort trial was to describe the efficacy and tolerability of these eye drops in a community-based setting. To evaluate these questions, prospective cohort studies are the best method. This enables the investigator to attain real insights as to which treatment administered related to specific results in a specific group of patients.


METHODS
Prospective, open label, one-armed, multicentered, multinational cohort trial.


METHODS
The trial was carried out in the clinics of 12 experienced anthroposophical general practitioners and ophthalmologists in Germany and Switzerland.


METHODS
Patients with inflammatory or catarrhal conjunctivitis, treated with Euphrasia single-dose eye drops were included in the trial.


METHODS
One drop of Euphrasia single-dose eye drops 1-5 times a day was prescribed. The prescription was determined solely by medical therapeutic needs.


METHODS
Efficacy variables were: redness, swelling, secretion, burning of the conjunctiva, and foreign body sensation. Tolerability variables were: conjunctival reddening, burning of the conjunctiva, foreign body sensation, and veiled vision. All symptoms were given for the right or left eye separately, with degree of severity in relation to baseline after approximately 7 days (+/-3 days; first follow-up examination) and after approximately 14 days (+/-3 days; second follow-up examination). If, after the first follow-up, all symptoms had disappeared, no second follow-up was done.


RESULTS
Sixty-five (65) patients fulfilled the inclusion criteria for the protocol evaluation. A complete recovery was seen in 53 patients (81.5%) and a clear improvement in 11 patients (17.0%). A slight worsening could only be determined in 1 patient in the second week of treatment (1.5%). No serious adverse events were observed during the entire trial. The efficacy and tolerability were evaluated by the patients and doctors as "good" to "very good" in more than 85%.


CONCLUSIONS
Euphrasia single-dose eye drops can effectively and safely be used for various conjunctival conditions by general practitioners and ophthalmologists. A dosage of one drop three times a day seems to be the general prescribed dosage.
Stoss
M
M
Witwatersrand University, Johannesburg, South Africa. matthias@pharma.co.za
Michels
C
C
Peter
E
E
Beutke
R
R
Gorter
R W
RW
D015331:Cohort Studies; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D009883:Ophthalmic Solutions; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage* / Q000494:pharmacology; D010946:Plants, Medicinal / Q000737:chemistry / Q000627:therapeutic use*; D011446:Prospective Studies
D009883:Ophthalmic Solutions; D010936:Plant Extracts