Therefore, in 1992, we began clinical trials of DHEA in lupus. The first trial was a small-scale, uncontrolled study of 10 patients who were given DHEA for up to six months. During this period, many of the patients felt improvement in their lupus symptoms; they were able to lower their prednisone dosages, and side effects were infrequent. Encouraged by these results, we proceeded with a double-blinded, placebo-controlled clinical trial. The patients participating in the study were divided into two groups - one group received the actual drug and the other received the placebo or "dummy" drug.

None of the patients knew which drug they had received. This was a safeguard against biases

and the influence of expectations. The results of this larger study (30 patients) were reported nationally and have been published. The patients on DHEA had improvements in their lupus symptoms and were able to lower their prednisone dosages, while patients receiving the placebo had stable disease. Also, the number of lupus flares was less in the patients who received the DHEA.

Although these were felt to be encouraging, it was recognized that 30 patients is still a small number on which to base firm conclusions. Therefore, two much larger trials are underway, taking place in multiple medical centers and practices throughout the United States and Canada. The first of these trials has completed enrollment of nearly 200 patients. The second trial is currently beginning enrollment and will recruit 300 patients. These two large studies are designed to answer the most important questions about DHEA.

(1) Does DHEA prevent lupus flares when patients try to taper prednisone?

(2) Does DHEA improve lupus symptoms?

Results of the first of these two trials should be available by early 1997, whereas the second trial may take several years to complete.

Meanwhile, at Stanford University, we are continuing independent investigations of other aspects of DHEA. An unresolved question is whether DHEA, which has been effective in patients with mostly mild or moderately active lupus, would also benefit patients with the most severe forms of the disease, including severe involvement of the kidneys, the blood cells or the lining of the heart and lungs. It is unlikely that DHEA by itself is able to control these lupus manifestations; however, DHEA might help when used together with other medications to better control lupus and decrease the consequences of corticosteroid and immunosuppressive use. A special study was designed to investigate the use of DHEA in conjunction with high dosages of corticosteroids and immunosuppressive medications.

Furthermore, we are studying whether DHEA has a beneficial effect on bone structure. DHEA has been shown in laboratory systems to improve bone turnover. Whether this translates into an actual improvement in bone strength, however, remains to be seen. Nevertheless, an agent that not only controls lupus but also protects against the weakening of the bone (osteoporosis), which often results from the combined effects of the disease itself and the medications used to treat it, would, of course, be of immense importance.

Another area of our research focuses on the cognitive difficulties many lupus patients experience. We are currently recruiting patients with systemic lupus and with difficulties in cognitive functions such as thinking and recall, particularly those patients who have demonstrated abnormalities on neuropsychological testing In such patients, we would like to examine the effects of DHEA treatment on the results of formal evaluations and or innovative scans for brain activity. Some observations suggest that DHEA is beneficial in this respect.

Presently, DHEA research at Stanford is sponsored by the National Institute of Health and the Arthritis Foundation (North California Chapter). The large-scale multicenter trials are sponsored by Genelabs Technologies of Redwood City, California. However, the members of the Bay area Lupus Foundation should take pride of knowing that the first studies of DHEA in lupus patients would not have been possible without the generous support the Foundation provided in the very initial phase of this line on investigation. While DHEA is not the cure for lupus, it may be an important and helpful additional agent that can be used to alleviate lupus symptoms and to improve the quality of life for lupus sufferers.

DHEA in the Netherlands

In one of the recent Newsletters of the Nationale Vereniging L. E. Patienten, the Dutch Lupus Organisation, I read that in the Netherlands 14 lupus patients use DHEA, which they get prescribed by their doctors. One of the doctors is a rheumatologist and 13 doctors are internists. All 14 patients reported positively about the use of this drug. They did not feel so tired and weak as before they used DHEA. It took one to three months in average before they felt better. One patient had a mild form of acne after she started to use DHEA. Another patient reported that DHEA could not prevent a kidney inflammation, but this was known before. There are no reports about a reduction of prednison. But all patients reported that the quality of life has improved. In a telephone call with our friend Peter Bakker he told me that the number of patients has increased in the meantime to 20 and all reported that there have not been serious problems and the quality of life has improved considerably.

Rudolf Hocks

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