Effects of a systemic enzyme therapy in healthy active adults after exhaustive eccentric exercise: a randomised, two-stage, double-blinded, placebo-controlled trial.

Background: Systemic enzyme therapy may improve symptoms of exhaustive eccentric exercise due to anti-inflammatory properties.

Methods: In a randomised, placebo-controlled, two-stage clinical trial, systemic enzyme therapy (Wobenzym) was administered for 72 hours before and 72 hours following a day on which subjects performed an exhaustive eccentric exercise (isokinetic loading of the quadriceps). Efficacy criteria (maximal strength and pain) and time points were selected to account for the multidimensional nature of exercise-induced muscle damage symptoms.

Evaluating the Multitarget Effects of Combinations through Multistep Clustering of Pharmacological Data: the Example of the Commercial Preparation Iberogast.

Herbal combination preparations are widely used in traditional herbal medicine and are even established as modern evidence-based herbal medicinal products. The rationale behind such combinations is often questioned and assessing the contribution of each of the combination partners to overall activity is challenging. STW 5 (Iberogast) is such a combination with confirmed clinical efficacy in functional gastrointestinal disorders.

Gastrointestinal absorption and biological activities of serine and cysteine proteases of animal and plant origin: review on absorption of serine and cysteine proteases.

Research has confirmed that peptides and larger protein molecules pass through the mucosal barrier of the gastrointestinal tract. Orally administered serine and cysteine proteases of plant and animal origin also reach blood and lymph as intact, high molecular weight and physiologically active protein molecules. Their absorption may be supported by a self-enhanced paracellular transport mechanism resulting in sub-nanomolar concentration of transiently free protease molecules or, in a complex with anti-proteases, at higher concentrations.

[Effectiveness of vitamin E in comparison with diclofenac sodium in treatment of patients with chronic polyarthritis].

In a randomized, double blind parallel group comparison the antiphlogistic and analgetic efficacy of high-dosed vitamin E (3 x 400 mg RRR-alpha-Tocopherolacetat/d) versus diclofenac-sodium has been investigated in hospitalized patients with established chronic rheumatoid arthritis. After 3 weeks of treatment the vitamin E group (n = 42) as well as the diclofenac group (n = 43) showed a significant improvement of all assessed clinical parameters. Duration of morning stiffness could be reduced under vitamin E treatment from 90 min to 68 min and under diclofenac treatment from 68 min to 30 min.

Bioavailability of escin after administration of two oral formulations containing aesculus extract.

In a steady-state cross-over study in 18 healthy volunteers, the relative bioavailability of beta-escin (CAS 11072-93-8) after oral administration of a new immediate release enteric-coated test formulation containing aesculus extract was evaluated in comparison with a prolonged-release reference preparation. The subject received the test and the reference preparation in randomised sequence for 7 days each with no washout period in between. The daily dose was 50 mg escin b.

Buspirone and lorazepam in the treatment of generalized anxiety disorder in outpatients.

In this double-blind, placebo-controlled 10-week trial, the anxiolytic properties of the nonbenzodiazepine buspirone were compared with the benzodiazepine lorazepam and placebo in 125 outpatients with generalized anxiety disorder according to DSM-III. After a 3- to 7-day wash-out period, patients were allocated at random to receive orally 3 x 5 mg buspirone (n=58), 3 x 1 mg lorazepam (n=57), or placebo (n=10) over a 4-week period. The study also comprised a 2-week taper period and a 4-week placebo-control period to assess the stability of clinical improvement.

Effect of 17 alpha-ethinylestradiol, levonorgestrel, 3-keto-desogestrel, and gestodene on calcium influx via voltage-gated calcium channels in human aortic smooth muscles.

The effect of the synthetic estradiol, 17 alpha-ethinylestradiol, and three progestogens on calcium influx was investigated in cell cultures of human aortic smooth muscle. Neither the synthetic estrogen nor the progestogens levonorgestrel, 3-keto-desogestrel, and gestodene showed, in the concentration range of 10(-9) to 10(-6) M, a significant effect on calcium influx both alone or in equimolar estrogen-gestagen combinations. The results indicate that these substances, commonly used in contraceptive pills, do not change vasotonus interfering with calcium homeostasis.

The effects of a new low-dose combined oral contraceptive containing levonorgestrel on ovarian activity.

Objective: The study was designed to evaluate the effects of a new low-dose monophasic combined oral contraceptive (100 micrograms levonorgestrel/20 micrograms ethinylestradiol) on ovarian activity.

Method: This was an open-label study in 15 healthy female volunteers. After an ovulatory pretreatment cycle, subjects were treated for three consecutive cycles.

Treatment of depressive outpatients with lorazepam, alprazolam, amytriptyline and placebo.

This randomized double-blind study in 342 mildly to moderately depressive outpatients investigated the antidepressant effectiveness and speed of action of lorazepam, alprazolam and amitriptyline versus placebo. Six weeks of drug treatment were followed by a drug taper period, a control period with placebo and a control period without placebo, of 2 weeks duration each. Clinical improvement was assessed by rating scales (Clinical Global Impressions, Hamilton Rating Scales for Depression and Anxiety) and patient's self-ratings (Patient's Global Impressions, Self-rating Depression Scale and Visual Analogue Scale).

Bioequivalence of two commercially available levothyroxine-Na preparations in athyreotic patients.

The thyroid hormones levothyroxine and levotriiodothyronine are vital for normal growth and development and play an important role in energy metabolism. The bioequivalence of levothyroxine following administration of the test preparation (Eferox 100 tablets, Wyeth Pharma GmbH, Münster, Germany) and a reference preparation (each containing 100 micrograms levothyroxine-Na, the sodium salt of the natural thyroxine isomer) was investigated in 24 male and female patients with a lack of basal thyroid hormone secretion after an ablative thyroidectomy and postoperative radiotherapy. In a randomized, multicentric, open 3-factorial Latin-square (2 x 2 x 2) crossover study the subjects received two pharmaceutical units of the formulations once daily in the morning 30 min before breakfast during two periods of 35-42 consecutive days each.

Bioequivalence of two commercially available tamoxifen tablet formulations in healthy male volunteers.

Tamoxifen, a non-steroidal antiestrogen, is used in the palliative treatment of advanced breast cancer and as an adjuvant therapy after mastectomy. The bioequivalence of tamoxifen following single oral doses of Zemide 20 and a commercially available tablet formulation (reference formulation), each containing 30.4 mg tamoxifen dihydrogencitrate corresponding to 20 mg tamoxifen was investigated in 12 healthy male subjects.

Human lysosomal acid phosphatase: cloning, expression and chromosomal assignment.

A 2112-bp cDNA clone (lambda CT29) encoding the entire sequence of the human lysosomal acid phosphatase (EC 3.1.3.

Neutral endopeptidase-24.11 (enkephalinase). Biosynthesis and localization in human fibroblasts.

The biosynthesis, glycosylation and subcellular localization of the neutral endopeptidase-24.11 were studied in cultured human fibroblasts. The enzyme was synthesized as a precursor (Mr 88,000) containing four or five N-linked oligosaccharides.

Cloning of a cDNA encoding the human cation-dependent mannose 6-phosphate-specific receptor.

Complementary DNA clones for the human cation-dependent mannose 6-phosphate-specific receptor have been isolated from a human placenta library in lambda gt11. The nucleotide sequence of the 2463-base-pair cDNA insert includes a 145-base-pair 5' untranslated region, an open reading frame of 831 base pairs corresponding to 277 amino acids (Mr = 30,993), and a 1487-base-pair 3' untranslated region. The deduced amino acid sequence is colinear with that determined by amino acid sequencing of the N-terminus peptide (41 residues) and nine tryptic peptides (93 additional residues).

Genetic heterogeneity of steroid sulfatase deficiency revealed with cDNA for human steroid sulfatase.

Three cDNA clones with inserts of 1.2-1.6 kb that reacted both with antibodies and oligonucleotides specific for steroid sulfatase were isolated from a human placental library in lambda gt11.

Action of citrinin on bacterial chromosomal and plasmid DNA in vivo and in vitro.

Citrinin, a mycotoxin of Penicillium citrinum and other species of the genera Penicillium and Aspergillus, caused the following effects at different concentrations in Escherichia coli. In vivo at 100 micrograms/ml single-strand breaks were caused in the chromosomal DNA. In the presence of 100 micrograms/ml, UV (254 nm)-induced DNA damage was repaired in the bacterial cells without need for a complete growth medium.

Immunosuppression by ochratoxin A and its prevention by phenylalanine.

Ochratoxin A, a toxin of Aspergillus ochraceus, suppresses the immune response to sheep erythrocytes in BALB/c mice at doses as low as 0.005 microgram/kg of body weight. This effect is prevented by phenylalanine.

Suppression of tumorigenicity in cybrids.

We investigated cytoplasmic control of tumorigenicity in cybrids. Cytoplasts derived from nontumorigenic cells were fused to the highly tumorigenic 984 C1 10-15 cell line derived from a murine teratoma. The resultant cybrids did not retain the tumorigenicity of the original cell line.

Combined action of citrinin and ochratoxin A on hepatoma tissue culture cells.

Citrinin (CTN) and ochratoxin A (OT-A) may occur simultaneously in mould-contaminated commodities. Both are cytotoxic to hepatoma tissue culture (HTC) cells. The effect of both mycotoxins, eiter alone or in association on cellular protein, RNA and DNA synthesis was tested.