Regulatory T-cell modulation by green tea in chronic lymphocytic leukemia.

Regulatory T cells (Tregs) are considered to be key immunomodulatory cells of the immune system and are increased in chronic lymphocytic leukemia (CLL). Rai stage 0 identifies patients with early stage CLL for which there is no effective intervention at the present time and a "wait and see" policy is usually adopted. Some biological and clinical studies have reported that green tea constituents, such as epigallocatechin-gallate (EGCG), have antitumor effects on hematologic malignancies including CLL. We report data on a clinical trial in which green tea extracts were given orally to 12 patients with stage 0 CLL and 12 healthy subjects. Ten patients and 10 controls completed the 6-month scheduled therapy. Two patients and 2 controls stopped therapy within 1 month because of tachycardia and epigastralgia. Eight out 10 evaluable patients (80 percent) showed a reduction of lymphocytosis and absolute number of circulating Tregs, as well. One patient (10 percent) had a stabilization of lymphocytosis and a reduction of Tregs, and 1 patient (10 percent) showed an increase of both lymphocytosis and Tregs. Only the non-responding patient progressed after 5 months from the end of green tea administration and chemotherapy was given. Interestingly, both IL-10 and TGF-beta serum levels declined throughout the green tea intake period, in both patients and controls. These data seem to indicate that green tea is able to modulate circulating Tregs in CLL patients with early stage of the disease. This can result in the control of lymphocytosis as well as in the prevention of disease progression.

Evaluation of the dissolution behaviour of some commercial herbal drugs and their preparations.

Dissolution rates are routinely performed with synthetic drugs, however, in the field of herbal drugs (HD), their preparations (HDP) and herbal medicinal products (HMP) this crucial property is generally not investigated. According to the European Pharmacopoeia, we have evaluated the dissolution behaviour of capsules containing various herbal drugs (Passira, Senna, Ginkgo) and some of their commercial dried extracts, manufactured with different methods, by analysis of their active components or marker constituents. Adequate dissolution behaviours of the flavonoids of Ginkgo were obtained for all preparations, while for both Passiflora and Senna only the extracts showed complete dissolution of the marker flavones and sennosides, respectively, in the investigated media.