1971 年 14 巻 1 号 p. 19-29,2
The clinical therapeutic effect of MS-Antigen to allergic rhinitis was tested by the controlled sequential study of Armitage through double blind trials.
The MS-Antigen was discovered by Soeda in 1965 as a remedy for allergic diseases, and has been hitherto reported as very effective by many investigators.
Its main component is a sort of polypeptide weighing about 1, 600 number average molecular weight, extracted from the urine of the patients suffering from allergic diseases. But the strict appraisal of its therapeutic effectiveness by the double blind trial has not yet performed.
From these standpoints, the following clinical experiments were carried out, some allergic rhinitis patients were selected as the candidates, and for patients over 15 years old 2 ampoules of MS-Antigen or Placebo (One ampoule contained 20 mg proper material or corresponding physiologic saline as Placebo), and for under 15 years old 1 ampoule were injected every day for 4 weeks subcutaneously.
During those periods, many necessary clinical investigations were performed for the test.
After all, 27 pairs i. e. 54 patients were tested in all.
But under the design of 2α=0.05, 1-β=0.95, θ=95 following the Armitage's sequential trial, it was domonstrated the preference of MS-Antigen to Placebo by 12 pairs of the patients.
The rate of effectiveness of the proper material and Placebo were 88% and 33% respectively globally judged from many data of investigation concerning the total test cases, and the difference of these rates proved a sufficient significance under the condition of P<0.001 through the statistical x2 test.
The rates of improvement of subjective and objective symptoms were parallel to the above data.
Its malignant side effects were not at all recognized.