| Disease | THE EFFECTS OF THIS HERBAL MEDICINE ARE CLEAR TO BOTH PATIENTS AND DOCTORS WHEN EVALUATED AGAINST PLACEBO, DOUBLE-BLINDLY.
EVENTS WERE INDISTINGUISHABLE ACROSS THE HERBAL TREATMENT GROUPS AND PLACEBO. BUTTERBUR EXTRACT ZE 339 (TESALIN) IS AN EFFECTIVE TREATMENT FOR SEASONAL ALLERGIC RHINITIS SYMPTOMS (RHINORRHEA, SNEEZING, ITCHY NOSE/EYES. NASAL CONGESTION).
IMPROVED ALSO AFTER ONE WEEK, BETWEEN DOSINGS FOR THE HIGH-DOSE GROUP, BUT NOT FOR TEH LOW DOSE GROUP, WHILE OVERALL RESPONDER RATES WERE SIGNIFICANTLY HIGHER FOR BOTH ACTIVE GROUPS COMPARED TO PLACEBO. THE INCIDENCE AND TYPE OF ADVERSE
A SIGNIFICANT DOSE-RELATIONSHIP WAS OBSERVED BETWEEN THE 2 ACTIVE DOSES OF BUTTERBUR (FIG. 2.) IN ADDITION, THE CLINICIAN'S ASSESSMENT OF EFFICACY WAS ALSO SIGNIFICANTLY SUPERIOR FOR THE BUTTERBUR GROUPS. SYMPTOMATIC RELIEF WAS SIGNIFICANTLY
WAS 2 WEEKS. THE FLOW CHART OF PATIENT ENROLMENT IN THE STUDY IS GIVEN IN FIG.1. IMPROVEMENT IN THE MAIN EFFICACY VARIABLE (PATIENT'S SELF-ASSESSMENT OF SYMPTOMS) WAS SIGNIFICANTLY SUPERIOR ON BUTTERBUR GROUPS, RELATIVE TO PLACEBO. FURTHERMORE,
IN A SECOND TRIAL, THE SEVERITY OF SYMPTOMS WAS USED FOR ASSESSMENT FOLLOWING THE GUIDANCE FOR INDUSTRY BY THE FAD (CDER. 2000). TWO DIFFERENT DOSES (HIGH DOSE: 3 TABLETS; LOW DOSE: 2 TABLETS) WERE COMPARED TO PLACEBO. THE PERIOD OF TREATMENT
THE FIRST CLINICAL TRIAL OF THE EXTRACT COMPARED ITS EFFECT TO THAT OF CETERIZINE IN 131 PATIENTS WITH ALLERGIES. AFTER TWO WEEKS OF TREATMENT A REDUCTION IN SYMPTOMS WAS OBSERVED IN BOTH GROUPS.
RHINOMANOMETRY. BEFORE TREATMENT, THE MEAN VALUE OF THE NASAL AIRFLOW WAS 403.5(DL)-62.0ML. AFTER START OF TREATMENT AIR FLOW INCREASED AND REACHED A MAXIMUM OF 844 AFTER 5 DAYS.
SEVERITY OF SYMPTOMS, QUALITY OF LIFE, PETASIN PLASMA LEVEL AND URINE CONCENTRATION. PARTICULAR INTEREST WAS ADDRESSED TO NOSE CONGESTION. SINCE ANTI-HISTAMINES ARE INCAPABLE IN OVERCOMING THIS. ASSESSMENT OF NOSE CONGESTION WAS PERFORMED BY
FOR CLINICAL TRIALS A TABLET HAS BEEN DEVELOPED WHICH CONTAINS A QUANTITY OF THE EXTRACT ZE 339 WHICH IS EQUIVALENT TO 8 MG PETASINS. IN A PROOF OF PRINCIPLE TRIAL 6 PATIENTS SUFFERING FROM ALLERGIC RHINITIS JWERE INVESTIGATED FOR |