wo recent reports
published in prominent international journals are indicative of the increasing
number of clinical studies of Kampo medicines and their impact in professional
circles. The first, ("TJ-114 [Sairei-To], an Herbal Medicine in Rheumatoid
Arthritis: A Preliminary 'Go - No Go' Clinical Trial" by Mark J. Borigini,
et. al.), which describes a successful preliminary study of a Kampo prescription
for rheumatoid arthritis, appeared in the December 1996 issue of the Journal
of Clinical Rheumatology. The second ("Choto-san in the treatment of vascular dementia: a double-blind, placebo-controlled study") describes a double-blind, placebo-controlled study of vascular dementia by the Kampo prescription Choto-san carried out by a team of Japanese researchers headed by K. Terasawa. It appeared earlier this year in Phytomedicine (volume 4, number 1).
These two studies are by no means the first in international journals to call attention to the value of Kampo prescriptions. In the March 1996 (Vol. 1, No. 3) issue of Kampo Today, we reported on a 1995 publication in the U.S. journal Cancer in which researchers at Osaka City General Hospital documented the effectiveness of Sho-saiko-to in reducing rates of liver cancer among patients with non-hepatitis B cirrhosis of the liver.
In the recent rheumatoid arthiritis (RA) study, the authors explain that they adopted a method originally used to screen potential anti-cancer drugs in order to gain a preliminary estimate of the potential effectiveness of TJ-114 -- which corresponds to the traditional Kampo prescription Sairei-to -- as a treatment for RA. The six-month-long pilot study, which was carried out at UCLA and the University of Utah under an investigational new drug exemption (IND) from the United States Food & Drug Administration, sought to evaluate the efficacy, safety and tolerability of 30 patients with RA. Of the 18 patients completing the open-label trial, five - or 16.7% of all participants -- were judged to be responders, based on assessment of measures which included joint tenderness and pain, joint swelling, and general assessment by patient and physician. The authors comment that this response rate compares favorably with that of several disease-modifying anti-rheumatic drugs (DMARDs) that are widely used today. Moreover, adverse reactions to TJ-114 by participants were infrequent and mild.
In making the case for continued study of TJ-114 based on these promising results, the authors note that this "unique preparation in the treatment of RA" is desirable to a public that is "enamored of 'things natural'" and to clinicians who "appreciate the utility of an effective drug whose toxicity is minimal."
The dementia study, its authors explain, was an attempt to establish "more objective criteria" for evaluating the effectiveness of Choto-san (TJ-47), following the promising results of an earlier placebo-controlled study of this Kampo prescription. A total of 139 patients participated in the multi-center, randomized double-blind trial, which was carried out over a 12-week period. Median patient age was 76.6 years. The study showed that Choto-san was statistically superior to the placebo in a number of key assessment areas, including global improvement rating, utility rating, global improvement rating of subjective symptoms and global improvement rating of disturbance in daily living activities. While the Choto-san group tended to show somewhat higher levels of improvement in the revised version of Hasegawa's dementia scale, the most widely used index in Japan for evaluating dementia, the difference was not statistically significant in comparison with changes in the placebo group. Nevertheless, on an overall basis, Choto-san was judged to be effective for treatment of vascular dementia.
Rheumatoid arthritis and dementia are both chronic diseases, the type of ailments that are often poorly responsive to western medicine but for which Kampo may be especially well suited. With the rapid aging of the population in Japan and many other advanced nations, the need for new approaches to treating chronic diseases will be more pressing than ever. In this sense, clinical studies like those described above are of considerable significance. In addition to further clarifying the clinical utility of Kampo drugs, future studies will, no doubt, also contribute to a better understanding of the mechanisms responsible for the success of Kampo medicines.