[Willow bark extract--effects and effectiveness. Status of current knowledge regarding pharmacology, toxicology and clinical aspects]. / Weidenrindenextrakt--Wirkungen und Wirksamkeit. Erkenntnisstand zu Pharmakologie, Toxikologie und Klinik.

New pharmacological and clinical studies show that standardized willow bark extracts (WRE) is not only the natural form of salicylic acid. Willow bark extract has comparable antiinflammatory activities as higher doses of acetylsalicylic acid (ASS), and it shows antinociceptive and antipyretic activities. Under the pharmacologically active doses, no adverse effects regarding the stomach mucosa was observed, in contrast to acetylsalicylic acid. A daily dose of 1572 mg willow bark extract of a proprietary preparation (Assalix; standardised to 15.2% salicin, i.e. 240 mg salicin per day) was significantly superior to placebo in patients with osteoarthritis of the hip and the knee and in patients with exacerbations of chronic low back pain. In 2 open studies against active treatments as controls, willow bark extract exhibited advantages against a routinely prescribed treatment scheme of orthopedic specialists based on nonsteroidal antirheumatic drugs and rather similar efficacy as the COX-2-inhibitor refecoxib. Willow bark extract also displays an activity regarding the thrombocyte function, but the activity is clearly weaker.

[Effectiveness of Vitex agnus-castus preparations]. / Zur Wirksamkeit von Vitex agnus castus-Präparaten.

The prolactin-inhibiting effect of ACF-preparations, which is due to dopaminergic activities, has been shown in humans too and gives a pharmacological rationale for the clinical effects observed in the different indications (2, 11, 25, 26, 35, 41). Confirmation of efficacy in the treatment of mastalgia has been best endorsed by two recently published double-blind studies conducted according to the principles of GCP (14, 41). One double-blind study, several open and postmarketing surveillance studies have shown that the premenstrual syndrome, or individual symptoms, can be influenced positively (3, 6, 7, 9, 19, 21, 37). Design shortcomings in a second double-blind study should be eliminated in future studies in this indication to improve the body of evidence (18). Hither to there has been one controlled double-blind study of cycle disorders in the case of corpus luteum insufficiency with significant results and a number of non-controlled open studies (1, 4, 15, 16, 20, 24, 26, 27, 32, 35, 36). The high success rates in the open studies indicate therapeutic effects, and it should be possible to reproduce these results under double-blind conditions. The success rates on fertility disorders should be confirmed in controlled double-blind studies (10, 33, 34).

Enhanced resistance to Sendai virus infection in DBA/2J mice with a botanical drug combination (Sinupret).

It was investigated whether the botanical drug combination Sinupret is able to modulate the resistance of mice to a respiratory tract infection with Sendai virus (Parainfluenza viridae) if given prophylactically to the animals. Three doses of Sinupret drops (SD) and Sinupret tablets (ST, p.o.), and two active controls, the chemical secretolytic ambroxol (p.o.) and the immunomodulator Muramyldipeptide (MDP, i.v.) were used. Test and reference substances were applied at days - 3 and -1 before infection, except MDP, which was given once on day--before infection. CD4+ and CD8 + lymphocyte subpopulations were measured after infection as indicators of immunological treatment response. Groups of 20 mice each were infected by intranasal application of Sendai virus under anaesthesia. We found that the 1 x and 5 x human doses of Sinupret drops significantly prolonged the survival times (p < 0.05) compared to placebo. Additionally, ambroxol and MDP were comparably less effective. In all groups, changes in CD4 + and CD8 + T-lymphocyte subpopulations of the peripheral blood were observed, but no clear relationship to the treatment results was seen. It was concluded that Sinupret increases the resistance to an experimentally induced respiratory tract infection in mice. Moreover, the effect of Sinupret was superior to that of an immunostimulant (MDP) and of a synthetic secretagogue (ambroxolhydrochloride).

Measurement of the bioavailability of aescin-containing extracts.

OBJECTIVE: In horse chestnut seed extracts (HCSE), the triterpene saponin mixture aescin is considered the active principle. The bioavailability and pharmacokinetics of different HCSE preparations have been studied under single and repeated applications using a radioimmunological method (RIA) developed to identify beta-aescin, one of the pharmacologically active fractions of the saponin mixture. In this paper, the available pharmacokinetic data are reviewed and the observed heterogenicity between comparable studies is discussed. DATA SOURCES: Pharmacokinetic data from 5 single- and 4 multiple-dose bioequivalence studies with HCSE-containing products, were measured by the same analytical laboratory using the same RIA. EVALUATION: In studies where procedures were identical the pharmacokinetic data of beta-aescin show high variations. Even under steady-state conditions a considerable variability for the same HCSE product is obtained. CONCLUSION: Formal reasons like study design and medications can be ruled out as a source of pharmacokinetic variation. In extracts of herbal drugs like HCS, the relative concentration of the individual saponin fractions can considerably differ from batch to batch. For immunological methods, identification of such antigens with intermolecular variability, e.g., the structural aescin analogs, is of unknown validity. Therefore the shape of the concentration-time curve would only show an approximation of the time course but not for the absolute concentrations. A specific validation procedure for the RIA must be developed, otherwise a LC-MS/MS-method of sufficient sensitivity should be elaborated.

[Profile and effectiveness of a phytogenic combination preparation for treatment of sinusitis]. / Wirkprofil und Wirksamkeit eines pflanzlichen Kombinationspräparates zur Behandlung der Sinusitis.

Complex combinations of botanical drugs are usually regarded as non-rational medicines. In the case of Sinupret, a combination of 5 botanical drugs, the pharmacological profile was investigated thoroughly with respect to activities on secretion of the respiratory epithelium, with respect to anti-inflammatory activities and to effects against a murine Sendai-virus infection model (including in-vitro antiviral activities), after a randomised, placebo-controlled study of the ENT-clinic of the University of Freiburg had shown superiority of the verum in patients with chronic sinusitis. For patients with acute sinusitis, the additional treatment with Sinupret improved the response rate of the patients, who were basically treated with antibiotics and nasal decongestants, significantly compared to placebo. In a series of randomised trials of the combination versus active controls, the botanical combination was shown to be at least as effective and to have a low prevalence of adverse side effects. The individual ingredients contribute to the overall pharmacological profile of the combination with secretolytic, anti-inflammatory, immunomodulating and anti-viral effects.

Placebo-controlled, randomized double-blind clinical trial with Sinupret® sugar coated tablets on the basis of a therapy with antibiotics and decongestant nasal drops in acute sinusitis.

On the basis of therapy with antibiotics and nasal decongestants the efficacy of an additional treatment with the herbal combination Sinupret containing gentian root, cowslip flowers, sour dock herbs, elder flowers and shop vervain wort herbs was assessed in a randomized, placebo-controlled double-blind clinical trial involving 160 patients with acute bacterial sinusitis. Primary outcome criteria were radiographic findings and patient assessment. Secondary variables were several clinical symptoms of sinusitis which served as indicators of the pharmacological profile. The results showed that, according to the radiographic findings and the patient assessments, therapy with antibiotic and decongestants achieved a significant improvement in the treatment group; changes in clinical signs showed good correlation with the radiographic findings and the patient assessments. Conventional therapy for acute bacterial sinusitis can be improved markedly by including Sinupret in the therapeutic regimen.