Safety assessment of homeopathic medicines: The Adonis vernalis paradox and the 'analysis trap' of using different pharmacopeias.

Regulatory agencies have to ensure the end-user safety of botanically derived homeopathic medicines prepared with diluted starting materials derived even from toxic plants. In the case of plant-derived homeopathic products, assessment must consider the particular characteristics of an extract and its component molecules, even if diluted. The identification and quantification of these molecules have a crucial role in risk assessment, as it allows complete toxicological evaluation in a regulatory perspective. Different results can be achieved using different approaches and references supported by the same regulatory framework, as different methods of preparation used, assays and test analysis performed in compliance with different referent pharmacopoeias. All these facts can introduce a bias in the safety assessment and the paradoxical outcome for homeopathic Adonis vernalis underlines the need for caution. The case also demonstrates the relevance of considering the analytical method for assessment of all herbal medicinal products or herbal supplements, with the purpose of finding the total amount of toxicants as a good approach.

Utility of nutraceutical products marketed for cognitive and memory enhancement.

This article identifies a convenience sample of 14 memory-enhancing herbal products that were found to be available commercially, examines their active ingredients, states their claims, and evaluates the available evidence to determine their efficacy. The analyses identified four problematic areas. First, a majority of the products use cognitive terminology, which leads consumers to anticipate an intended cognitive benefit. Second, some ingredients are completely homeopathic and contain components not known outside of the homeopathic field. Third, the evidence of treatment efficacy is often contradictory, because products are recommended for purposes other than cognitive or memory loss. Finally, the manufacturers of the product have usually conducted the research on individual products. Until more research is available, it is suggested that holistic nursing professionals exercise caution in recommending nutraceuticals to their patients/clients for the use of cognitive improvement or memory enhancement.

Comparative anxiolytic activity profile of various preparations of Passiflora incarnata linneaus: a comment on medicinal plants' standardization.

OBJECTIVES: Mother tincture preparation of Passiflora incarnata from five reputable manufacturers of homeopathic medicines were compared to the bioactive fraction of methanol extract of P. incarnata (standard) for their anxiolytic activity in mice using the elevated plus-maze model of anxiety. MATERIALS AND METHODS: The extracts of P. incarnata were further subdivided in four doses, i.e., 100, 200, 300, and 400 mg/kg, suspended in a vehicle, and administered orally to groups of mice. Methanol extract of P. incarnata (125 mg/kg, orally) was taken as a standard. Anxiolytic activity was measured using the elevated plus-maze model. All treatments were given orally. Forty-five (45) minutes after the treatments, mice were placed on the center of the elevated plus-maze and the number of entries in open arms were measured for 5 minutes. SUBJECTS: Studies were performed with Swiss albino mice. RESULTS: The dried mother tincture preparations exhibited maximum anxiolytic activity at 300 mg/kg (SBL); 400 mg/kg (DWSI and DWSG); 200 mg/kg (DRCG), and nil (BHL) respectively, with reference to anxiolytic activity exhibited by the methanol extract of aerial parts of P. incarnata (125 mg/kg). CONCLUSIONS: To ensure uniformity and consistency of the biologic effects exhibited by plant-derived phytopharmaceuticals, uniform standards are required globally. The monographs on P. incarnata mention standardization of the plant using any known flavonoid as the chemical marker and the marker compound was not the one responsible for the plants multifarious biologic effects. The recent report of a trisubstituted benzoflavone compound (BZF) as the main bioactive phytoconstituent of P. incarnata made it feasible to resort to biologic standardization of this plant using BZF as the biomarker compound. The biologic standardization would ensure bioequivalence of the medicinal preparations of P. incarnata. These studies also recommend the incorporation of leaf constants, ash values, extractive values, thin layer chromatography profile (vital "fingerprints" specific for a plant), and the quantitative assay by determining the bioactive BZF moiety in pharmacopoeias in order to ensure uniform biologic results and standards of P. incarnata because the plant currently has tremendous usefulness. The herbal pharmacopoeias, which are still in their "infancy," can be strengthened by incorporating the appropriate bioactive constituents that need to be identified by using modern technological procedures. Once the appropriate bioactive constituent(s) are established and authenticated, their qualitative and quantitative assay procedures can be developed. Reporting the vital fingerprint parameters of the plant and incorporation of assay procedures of the bioactive phytomoiety in the official monographs of medicinal plants, will certainly strengthen the herbal pharmacopoeias. This is perhaps the most important scientific approach that would ensure uniform standards and bioequivalence of plant-medicines - a need to revive faith in the healing potentials of plant-derived medicines.

Summary consensus statement of the Review Board of the Swiss Complementary Medicine Evaluation Programme, (Programme Evaluation Komplementärmedizin, PEK) regarding the PEK process and products.

The international review board was set up as the scientific advisory body of the Swiss Complementary Medicine Evaluation Programme (PEK) in 2002. It has met several times and has given advice with respect to the most important aspects of the programme. It would have been the normal procedure for the review board to have had the opportunity to comment on the drafts of the final scientific products as well as the draft of the summary report, in order to advise on them, before the documents became publicly available and formed the basis for political decision making. But the responsible authorities changed this process. In the following, the review board comments both on this process and on the products.

Alcohol concentration in the preparation of mother tinctures of vegetable origin. The example of Holarrhena antidysenterica.

The strength of solvent affects the therapeutic efficacy of homeopathic tinctures of vegetable origin. On the basis of physical, chemical and biological assay of different tinctures made with different concentrations, in the case of Holarrhena antidysenterica Wall, the best solvent was 70% v/v ethanol. This is different from the standard strong alcohol recommended in homeopathic pharmacopoeia. It may be necessary to review the procedure followed for the preparation of homeopathic mother tinctures of vegetable origin.

Suspensión oral antidiarreica de Psidium guajaba, L / Oral antidiarrheal suspension from Psidium guajaba L

Se efectuó la estandarización de la droga cruda de Psidium guajaba, L., así como el diseño y elaboración de una suspensión oral antidiarreica a partir de dicho material vegetal previamente secado y tamizado. En la estandarización de la droga cruda, se encontró que todos los parámetros de calidad evaluados estaban dentro de los límites establecidos por la Norma Ramal de Salud Pública (NRSP) 308,1992. A la formulación diseñada se le determinó su estabilidad física, química y microbiológica, con resultados satisfactorios durante los 270 d de evaluación. Finalmente se desarrolló un estudio preclínico preliminar de la suspensión teniendo en cuenta las pruebas farmacológicas en ratas, y se obtuvo como resultado que la formulación presentaba efecto antidiarreico a las dosis de 3, 6 y 9 mg/kg de peso, bajo condiciones experimentales en los animales evaluados