Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis.

BACKGROUND: Rectal budesonide is an effective treatment of active ulcerative proctitis or proctosigmoiditis. AIM: To compare the therapeutic efficacy, tolerability and safety, and patient's preference of budesonide foam vs. budesonide enema. METHODS: Patients with active ulcerative proctitis or proctosigmoiditis (clinical activity index > 4 and endoscopic index > or = 4) were eligible for this double-blind, double-dummy, randomized, multicentre study. They received 2 mg/25 mL budesonide foam and placebo enema (n = 265), or 2 mg/100 mL budesonide enema and placebo foam (n = 268) for 4 weeks. Primary endpoint was clinical remission (clinical activity index < or = 4) at the final/withdrawal visit (per protocol). RESULTS: A total of 541 patients were randomized--533 were evaluable for intention-to-treat analysis and 449 for per protocol analysis. Clinical remission rates (per protocol) were 60% for budesonide foam and 66% for budesonide enema (P = 0.02362 for non-inferiority of foam vs. enema within a predefined non-inferiority margin of 15%). Both formulations were safe and no drug-related serious adverse events were observed. Because of better tolerability and easier application most patients preferred foam (84%). CONCLUSION: Budesonide foam is as effective as budesonide enema in the treatment of active ulcerative proctitis or proctosigmoiditis. Both budesonide formulations are safe, and most patients prefer foam.

MSC, a new benzoquinone-containing natural product with antimetastatic effect.

An orally applicable fermentation product of wheat germ containing 0.04% substituted benzoquinone (MSC) has been invented by Hungarian chemists under the trade name of AVEMAR. Oral administration (3 g/kg body weight) of MSC enhances blastic transformation of splenic lymphocytes in mice. The same treatment shortens the survival time of skin grafts in a co-isogenic mouse skin transplantation model, pointing to the immune-reconstructive effect of MSC. A highly significant antimetastatic effect of MSC has been observed in three metastasis models (3LL-HH, B16, HCR-25). The antimetastatic effect of MSC--besides the immune-reconstitution--may also be due to its cell adhesion inhibitory, cell proliferation inhibitory, apoptosis enhancing, and antioxidant characteristics, also observed in our in vitro experiments. It is even more noteworthy that combined treatment with MSC and one of the following antineoplastic agents (5-FU and DTIC)--both in wide use in every day clinical practice--exhibited a significantly enhanced antimetastatic effect in appropriate metastasis models (established from C38 mouse colon carcinoma and B16 mouse melanoma respectively) as compared to the effect elicited by any component of these therapeutic compositions (MSC + 5-FU and MSC + DTIC) administered alone. The results show that the fermented wheat germ extract (MSC) has more than an additive effect and synergistically enhanced the metastasis inhibitory effect of both antineoplastic agents studied till now. It is also worthy of mention that the synchronous treatment with MSC profoundly decreased the toxic side effects of the applied antineoplastic agents (decreased weight loss etc). Based on the biological effects of MSC--shown to be non-toxic by subacute toxicology studies--this product may be used as an adjuvant in the therapy of malignant neoplasia and other diseases caused by or following immune-deficiency.

[The role of free radical scavengers in gastrointestinal diseases]. / A gyökfogók terápiás jelentösége egyes gastrointestinalis megbetegedésekben.

Be it ever so complex the natural antioxidant scavenger system of the organism, the protection provided by it seems to be inappropriate in certain diseases of the gastrointestinal mucus membrane, such as chronic inflammation, immune- and malignant diseases of the bowel. Despite the wide range of therapeutic attempts, the treatment of these diseases has not yet been solved, and the anti-inflammatory-, immunomodulatory-, cytostatic drugs currently used, have several side effects. Therefore, the so called natural- and synthetic antioxidants have been more widely employed for additional and adjuvant treatment. It also has become clear that the direct free radical scavenging effect and/or the membrane protection play an important role in the action mechanism of several old-established drugs. The recent report lists those natural and synthetic antioxidants which have been successfully employed in the clinical treatment of bowel diseases. Among the natural antioxidants, a protective effect of vitamins A, C and E have been demonstrated in the treatment of gastroduodenal ulcer and gastric cancer. Among the synthetic antioxidants, 5-amino-salicylic acid was the most effective drug in the treatment of chronic inflammations of the bowel. With getting the more precise knowledge about details of free radical reactions and with clearing up their role in pathological processes, it is possible to develop new and effective synthetic antioxidants, and widely employ them therapeutically.

BG-104 enhances the decreased plasma superoxide scavenging activity in patients with Behçet's disease, Sjögren's syndrome or hematological malignancy.

BG-104, a compound of Chinese herbs, has been reported to exert superoxide scavenging activity (SSA) in cell free systems. This report addresses in vivo effects of BG-104 in various disorders. The plasma SSA and laboratory parameters were determined in patients Behçet's disease (BD), Sjögren's syndrome (SjS) or hematological malignancy (M), and the effects of BG-104 treatment on these parameters were studied and compared with those of another antioxidant, vitamin E (alpha-tocopherol). The plasma SSA was significantly lower both in patients with BD and M, and in patients with SjS without antioxidant treatment as compared to that in healthy controls, and it showed an inverse correlation with disease activities. The treatment with BG-104 and/or vitamin E significantly enhanced the plasma SSA in all disorders studied. Both the erythrocyte sedimentation rates, the absolute number of neutrophils, as well as C-reactive protein levels were significantly lower in patients treated with BG-104 and/or vitamin E than those without these drugs. These results indicate that the BG-104 has an anti-inflammatory effect through enhancing plasma SSA in patients with BD, SjS or M.

Superoxide scavenging activity of BG-104 before and after sonication--determined by ESR spin trapping method.

BG-104 is a compound of Chinese herbs which were treated with infrared ray-heating and brewed with microorganisms resulting in activation of actual principles contained in the herbs, and its effectiveness has been reported on various inflammatory disorders such as Behcet's disease, rheumatoid arthritis, bacterial infections and so on. In addition, it is noted as an effective agent to retard cancer progress. This report shows a superoxide scavenging activity of BG-104 using an ESR spin trapping method. For the measurement of superoxide scavenging activity, recombinant human superoxide dismutase is used as a standard. Superoxide scavenging activity of BG-104 increases in a dose-dependent manner and activity is significantly augmented by its sonication.