Assessment of the Efficacy and Safety of Ivy Leaf (Hedera helix) Cough Syrup Compared with Acetylcysteine in Adults and Children with Acute Bronchitis.

INTRODUCTION: Acute bronchitis is defined as a sudden inflammation of the bronchial tubes in the lung mainly caused by viral infection. It is characterized by a persistent cough which can be productive or dry. It is the most common disease in industrialized countries, and thus herbal expectorants enjoy a high popularity in many European countries due to their favorable risk-benefit ratio. OBJECTIVE: The present noninterventional study was intended to gain further data on the application of a cough syrup containing ivy leaf extract EA 575® by evaluating its efficacy and safety in children and adults with symptoms of acute bronchitis. Acetylcysteine (ACC) was chosen as comparator drug (common mono preparations). Material and Methods. The study was conducted at 25 medical practices throughout Switzerland as prospective, open, noninterventional study. RESULTS: At entry visit, all clinical assessments including coughing fits, sputum, dyspnoea, rales, severity of the diseases, and coughing quality were rated with moderate intensity in both groups. At the final visit after seven days of treatment, there was a comparable improvement in both groups for all assessments except dyspnoea and number of cough attacks which showed a higher improvement in the EA 575® group compared with ACC. Further, cough-associated sleeping disorders improved more in the EA 575® group. Both, physicians and patients described the efficacy of EA 575® comparable with acetylcysteine. Observations of the tolerability were comparable for both products. The study results indicate that ivy leaf extract might be an effective alternative to acetylcysteine with respect to the improvement of respiratory function in children and adults at a slightly better evaluation of efficacy.

[Significance of hawthorn extract in general practice - a current positioning]. / Stellenwert von Weißdornextrakt in der hausärztlichen Praxis ­ eine aktuelle Standortbestimmung.

BACKGROUND: Traditionally, hawthorn extract has been used for preventive and curative support in mild forms of age-related cardiovascular problems. There are now solid data demonstrating pre-clinical effects and mechanisms of action on a molecular-biological and cellular level that appear to be of particular interest in influencing vascular ageing and in arterial vascular disorders. METHOD: The review presents the results of a meeting of experts that took place to work out a current assessment of the therapeutic suitability of hawthorn extract in the treatment of cardiovascular disease. RESULTS AND CONCLUSIONS: Although currently no general recommendation can be given on the use of hawthorn extract in cardiac insufficiency, its use is indicated for typical challenges arising in general practice, where particularly patients with functional cardiorespiratory complaints present, possibly those with cardiac insufficiency with preserved heart function for whom there has thus far been no effective therapy apart from exercise. This recommendation is supported by the findings of studies on the safety and very good tolerability of hawthorn extract, particularly for therapy adjuvant to standard practice.

Assessment of the Acute and Subchronic Toxicity and Mutagenicity of Sideritis scardica Griseb. Extracts.

Sideritis scardica Griseb. has a long history of collection from the wild as a traditional remedy for respiratory and gastrointestinal complaints. It has also been investigated for its promising pharmacological activities in the central nervous system. However, its toxicological data is entirely missing. This study investigated the acute and repeated-dose oral toxicity of a S. scardica 20% (v/v) ethanol extract in Sprague Dawley rats, and mutagenicity using the Ames test. No gross pathological abnormalities and no toxicity signs or mortality were detected in animals treated with the dose of 2000 mg/kg bw during 14 days of observation. The tested extract was assigned to category 5 of the GHS. To evaluate a repeated-dose toxicity, an extract has been tested over a 28-day period followed by a 14-day recovery period. No mortality and no changes in body/organ weight or food consumption have been observed. The no-observed-adverse-effect-level of the extract was determined at 1000 mg/kg bw. The results of Ames tests conducted on extracts of different polarity (water; 20% (v/v) ethanol; 50% (v/v) ethanol; n-heptane), were unequivocally negative. The study reveals no toxicity of S. scardica and no concerns for its mutagenic effects, supports its positive safety profile, and confirms the acknowledged traditional medicinal use in human.

Randomized double-blind controlled clinical trials with herbal preparations of Serenoa repens fruits in treatment of lower urinary tract symptoms : An overview.

In this review, results of randomized double-blind controlled clinical trials (RCTs) with extracts of Serenoa repens fruits at a dose of 320 mg/d for the treatment of lower urinary tract symptoms (LUTS) are assessed. Of the RTCs conducted for up to 6 months, a benefit was seen in three of three RTCs with ethanolic, in eight of nine RTCs with hexane, and in one of two RTCs with CO2 extracts. Of the RTCs conducted for more than 6 months, a benefit was seen in two RTCs with hexane and in one RTC with CO2 extracts, whereas one RTC with an ethanolic, two RTCs with hexane, and one RTC with CO2 extracts did not show positive results. As LUTS are dynamic conditions with strong spontaneous fluctuation over time, the majority of patients might expect improvement of single symptoms and thus of quality of life, particularly as the extracts are well tolerated even in long-term treatment.

Treatment of Mild Gastrointestinal Disorders with a Herbal Combination: Results of a Non-interventional Study with Gastritol® Liquid.

A combination of extracts from chamomile, silverweed, licorice, angelica, blessed thistle and wormwood, Gastritol(®) Liquid, is registered for the use of indigestion and gastrointestinal spasmodic complaints. To gain data on the experience in practice, a non-interventional open study was conducted in ambulatory patients including diabetics which were treated for 2 weeks. The efficacy of treatment was assessed by medical examination and evaluation of typical symptoms by patients. A total of 149 patients was enrolled, 90 without and 59 with diabetes. The treatment led to relevant improvements in all symptoms in both study groups. The most notable improvements were seen for the symptoms vomiting (-66.7%; diabetics: -63.9%) and retching (-52.2%; diabetics: -53.6%). An overall improvement was rated by about 90% in both study groups. In seven patients adverse events had been reported (5 times temporary nausea after intake, one time gastric spasm and one time oral burning sensation), all of them of mild nature. The global tolerability was assessed as good or very good in more than 80% by practitioners and patients. Under the conditions of this open study method Gastritol(®) Liquid had been shown to be safe and effective in the treatment of mild gastrointestinal disorders, including diabetic patients.

Assessment of genotoxicity of herbal medicinal products: application of the "bracketing and matrixing" concept using the example of Valerianae radix (valerian root).

An assessment of genotoxicity is a precondition for marketing authorization respectively registration of herbal medicinal products (HMPs), as well as for inclusion into the 'Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products' established by the European Commission in accordance with Directive 2001/83/EC as amended, and based on proposals from the Committee on Herbal Medicinal Products (HMPC). In the 'Guideline on the assessment of genotoxicity of herbal substances/preparations' (EMEA/HMPC/107079/2007) HMPC has described a stepwise approach for genotoxicity testing, according to which the Ames test is a sufficient base for the assessment of genotoxicity in case of an unequivocally negative result. For reducing efforts for testing of individual herbal substances/preparations, HMPC has also developed the 'guideline on selection of test materials for genotoxicity testing for traditional herbal medicinal products/herbal medicinal products' (EMEA/HMPC/67644/2009) with the aim to allow testing of a standard range of test materials which could be considered representative of the commonly used preparations from a specific herbal drug according to a 'bracketing/matrixing' approach. The purpose of this paper is to provide data on the practical application of this bracketing and matrixing concept using the example of Valerianae radix, with the intention of facilitating its inclusion in the "Community list". Five extraction solvents, representing the extremes of the polarity range and including also mid-range extraction solvents, were used, covering the entire spectrum of phytochemical constituents of Valerianae radix, thereby including polar and non-polar constituents. Extracts were tested in the Ames test according to all relevant guidelines. Results were unequivocally negative for all extracts. A review of the literature showed that this result is in accordance with the available data, thus demonstrating the lack of a genotoxic potential. In conclusion the two guidelines on genotoxicity provide a practically applicable concept. Valerianae radix has no genotoxic potential, supporting its use in HMPs and its inclusion in the Community list.

Herbal medicinal products in the paediatric population--status quo and perspectives.

The limited extent of data available for herbal medicinal products (HMPs) in the paediatric population is related to missing documentation of their use in practice and in literature. Therefore, information for properly evaluating indications, posology, length of treatment and safety in children is often lacking. Frequently, these documentation gaps are reflected in the product information of HMPs as final result of regulatory decisions. On the other hand, there is long-term experience of HMPs as well established and traditionally used medicinal products, which also covers the use in the paediatric population, as applied by parents themselves, and the recommendations of physicians, other health practitioners and pharmacists. The methodology of pharmaco-epidemiologic studies is a valuable tool to evaluate data of the practical use of HMPs in children. The documentation gap may be closed by such methodologies, and HMPs may be applied prospectively on the basis of well-documented empirical knowledge.

Treatment of patients with arthrosis of hip or knee with an aqueous extract of devil's claw (Harpagophytum procumbens DC.).

Preparations made from the secondary tubers of Devil's claw (Harpagophytum procumbens) are successfully used in patients with rheumatic diseases (arthrosis and low back pain). In order to add data on the efficacy and long-term safety of an aqueous extract (Doloteffin; 2400 mg extract daily, corresponding to 50 mg harpagoside), which has been tested successfully in patients with low back pain, an uncontrolled multicentre drug surveillance study for about 12 weeks was conducted in 75 patients with arthrosis of the hip or knee. To standardize the assessment of treatment effects, the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index (10 point scale) as well as the 10 cm VAS pain scale were used. The results of the study revealed a strong reduction of pain and the symptoms of osteoarthritis. There was a relevant improvement of each WOMAC subscale as well as of the total WOMAC index: 23.8% for the pain subscale, 22.2% for the stiffness subscale and 23.1% for the physical function subscale. The WOMAC total score was reduced by 22.9%. VAS pain scores were decreased by 25.8% for actual pain, 25.2% for average pain, 22.6% for worst pain and 24.5% for the total pain score. The physicians reported a continuous improvement in typical clinical findings such as 45.5% for pain on palpation, 35% for limitation of mobility and 25.4% for joint crepitus. Only two cases of possible adverse drug reactions were reported (dyspeptic complaints and a sensation of fullness). Although this was an open clinical study, the results suggest that this Devil's claw extract has a clinically beneficial effect in the treatment of arthrosis of the hip or knee.