AIDS TREATMENT NEWS No. 065 - September 23, 1988
John S. James
One other patient started the herbs but had to stop after a potentially dangerous drop in white blood count which might have been caused by the herbs. His count recovered in three weeks.
What's limiting further research now is lack of patients who are antigen positive and not using any other antiviral treat- ments -- for example, persons who could not tolerate AZT. Such patients or their physicians could contact Dr. Barton.
No conclusions can be drawn from one patient, of course. But the facts that P-24 antigen become zero (unlikely with no treatment), that this therapy has good laboratory rationale as well as thousands of years of human experience with the component herbs, that the treatment if it works could be readily obtained and applied, and that further testing would be easy, rapid, and inexpensive, suggest that this approach is worth pursuing.
Protocol Details
The six herbs are Lonicera japonica, Lithospermum erythrorhizon, Prunella vulgaris, Viola yedoensis, Epimedium grandiflorum, and licorice root. The first five were from the eleven found to have antiviral activity (by R. Shihman Chang and H. W. Yeung, published in Antiviral Research 9 (1988), pages 163-176). Licorice root has shown anti-HIV activity in other research, in Japan.
The herb mixture was provided in bags to be prepared as a tea according to written directions. Patients used one bag per day for the first two weeks, two bags a day on the third week, and four bags daily in the fourth week. After the fourth week, patients are taken off herbs for two weeks, while laboratory tests continue.
Neither the patient who used the herbs successfully nor the one who had to stop had any obvious symptoms of side effects, except for some fatigue. But for safety, as well as good moni- toring of the results, extensive laboratory testing was done, including baseline (before treatment began) and weekly complete blood count (CBC), chem 16 blood chemistry panel, urinalysis, PT, PTT, platelet count, P-24 antigen, and beta-2 microglobulin. In addition, HIV cultures were done at baseline and every two weeks thereafter, and T-cell subsets at baseline and monthly.
For more information send a self-addressed stamped envelope to: Keith Barton, M. D., 3099 Telegraph Avenue, Berkeley, CA 94705.
A Model for Community-Based Trials
This test of certain Chinese herbs suggests a model for community-based trials in several important respects:
* The treatment has a rationale. The herbs all showed anti-HIV activity in the laboratory; and all had been in human use for other purposes for many years.
* The treatment is available, legal, easy to use in a physician's practice, and safe under medical supervision.
* The trial has clear entry criteria (P-24 antigen positive, overall health stable, not using other antivirals within the last month).
* The trial has clear success criteria (P-24 antigen becoming negative within six weeks).
An organization to support community-based trials will not have to start from scratch, but instead can develop and refine existing work. Such an organization could contribute in several ways:
* A scientific review committee will select the best options to test, and the best ways to organize the trial -- how many subjects, what success criteria should be used, etc.
* Many physicians will be involved, so it will be possible to recruit eligible patients more quickly.
* The consensus of a scientific review committee, an institutional review board, a number of participating physicians, and perhaps representatives of Federal agencies, will give each study more impact. Successful results will be disseminated, accepted, and used more rapidly than if only one physician were involved.
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