Studies on the Method of Paired Comparison for the Evaluation of Clinical Efficacy of Therapeutic Agents for Peptic Ulcer

Using Dehydrocorydaline, One of the Therapeutib Agents

Abstract

Some difficulties have remained to be overcome for the effective statistical evaluation of the clinical efficacy of the therapeutic agents for peptic ulcer; that is quantitative evaluation of sequential X-ray and gastroscopic films, collection of cases identical in many biological factors and so on.
In this report, we attempted to investigate the validity of the method of paired comparison by double blind controlled study for the evaluation of clinical efficacy of one of the therapeutic agents for peptic ulcer, dehydrocorydaline.
Followings are the conclusions to be obtained at the present time.
1) The method of paired comparison was considered valid to obtain satisfactory informations from X-ray and gastroscopic films for the statistical analysis. Concordance of judgements among judge doctors was quite satisfactory.
2) Although no difference of statistical significance was detected for any factors by Scheffe's analysis of variance, positive trend was demonstrated in dose-response in respect of difference of main effects (drug efficacy).
It should be mentioned, however, that statistical difference of significance was detected (0.05 P 0.10) just in case comparison among dose levels by Kruskal-Wallis' H test was made during the first month period.
3) Other interesting informations obtained in this evaluation include; a tendency of greater effect in a group of decreasing dosage than in that of increasing dosage during the trial period, a tendency of positive dose-response effect only in cases with a single round gastric ulceration, a greater therapeutic effect of dehydrocorydaline during the first month period, a gradual decrease with passage of time in the rate of improvement of peptic ulcer. These informations are well in concordance with our daily clinical impressions.
4) As for side effects, dry mouth was complained of in only one case receiving 120mg per day, the degree of which was minimal.
5) Further investigations are necessary for comparison of this method with those which have hitherto been used for evaluation of drug efficacy of the therapeutic drugs of peptic ulcer.