Essiac: systematic review by the natural standard research collaboration.

J Soc Integr Oncol. 2009; 7(2): 73-80Ulbricht C, Weissner W, Hashmi S, Rae Abrams T, Dacey C, Giese N, Hammerness P, Hackman DA, Kim J, Nealon A, Voloshin RThe objective of this study was to evaluate the scientific evidence on the safety and efficacy of Essiac. This review serves as a clinical support tool. Electronic searches were conducted in 10 databases, 20 additional journals (not indexed in common databases), and bibliographies from 50 selected secondary references. No restrictions were placed on the language or quality of the publications. Standardized inclusion and exclusion criteria were used for selection. A review of the literature on Essiac and essiac formulations showed a lack of high-quality clinical trials to substantiate any of Essiac's traditional uses. Weak evidence from preclinical, animal, and laboratory data warranted a discussion regarding Essiac's use for cancer, but the results are inconclusive. Several other essiac preparations are noted in the literature, adding confusion to the exact formula and its proposed benefits. In general, there is a lack of both safety and efficacy data for Essiac and essiac formulations. Well-designed trials testing Essiac or individual herbal components are necessary to make firm recommendations.

Anti-inflammatory activity of Chrysanthemum indicum extract in acute and chronic cutaneous inflammation.

J Ethnopharmacol. 2009 May 4; 123(1): 149-54Lee do Y, Choi G, Yoon T, Cheon MS, Choo BK, Kim HKAIM OF THE STUDY: Although Chrysanthemum indicum Linné (Compositae) has long been used in traditional Korean, Chinese, Japanese medicine to treat various immune-related diseases the underlying mechanism(s) by which these effects are induced remains to be defined in vivo model system. We investigated the effects of 70% ethanolic extract from Chrysanthemum indicum Linné (CIE) on skin inflammation in mice. MATERIALS AND METHODS: Production of pro-inflammatory cytokines (TNF-alpha and IL-1 beta), activation of myeloperoxidase, and histological assessment were examined in acute and chronic skin inflammation using 12-O-tetradecanoyl-phorbol-13-acetate (TPA)-induced mouse ear edema. RESULTS: CIE inhibited topical edema in the mouse ear, following administration at 200mg/kg (i.p.), leading to substantial reductions in skin thickness and tissue weight, inflammatory cytokine production, neutrophil-mediated myeloperoxidase activity, and various histopathological indicators. Furthermore, CIE was effective at reducing inflammatory damage induced by chronic TPA exposure. CONCLUSIONS: These results demonstrate that CIE is an effective anti-inflammatory agent in murine phorbol ester-induced dermatitis, and suggest that the extract may have therapeutic potential in a variety of immune-related cutaneous diseases.

Kava hepatotoxicity: Regulatory data selection and causality assessment.

Dig Liver Dis. 2009 May 26; Teschke R, Wolff ABACKGROUND: Kava hepatotoxicity in 20 patients from Germany has been debated worldwide following a regulatory ad hoc causality assessment and ban of kava, an anxiolytic herbal remedy obtained from the rhizome of Piper methysticum Forster. AIMS: We assessed causality with a quantitative structured causality analysis in all 20 cases of patients with liver disease, presented by the German regulatory agency that assumed a causal relationship with the use of kava extracts. METHODS: The quantitative scale of CIOMS (Council for International Organizations of Medical Sciences) in its updated form was employed for causality assessment and quality evaluation of the regulatory data presentation. RESULTS: The regulatory information is scattered and selective, and items essential for causality assessment, such as exclusion of kava independent causes, were not, or only marginally, considered by the regulator. Quantitative causality assessment for kava was possible (n=2), unlikely (n=12), or excluded (n=6), showing no concordance with the regulatory ad hoc causality evaluation. CONCLUSION: The regulatory data regarding kava hepatotoxicity is selective and of low quality, not supportive of the regulatory proposed causality; but instead, is an explanation of the overall causality discussions of kava hepatotoxicity. We are proposing that the regulatory agency reports data in full length and reevaluates causality.

Zyflamend in men with high-grade prostatic intraepithelial neoplasia: results of a phase I clinical trial.

J Soc Integr Oncol. 2009; 7(2): 43-51Capodice JL, Gorroochurn P, Cammack AS, Eric G, McKiernan JM, Benson MC, Stone BA, Katz AESubjects diagnosed with high-grade prostatic intraepithelial neoplasia (HGPIN) at biopsy are at increased risk for developing prostate cancer (CaP). A prospective clinical trial was done to determine the safety and tolerability of a novel herbal amalgam, Zyflamend (New Chapter, Inc., Brattleboro, VT), with various dietary supplements in subjects with HGPIN. Men ages 40 to 75 years with HGPIN were eligible. Subjects were evaluated for 18 months. Every 3 months, standard blood chemistries and prostate-specific antigen (PSA) were monitored. Rebiopsy was done every 6 months. Tissue was evaluated for HGPIN or CaP and stained for cyclooxygenase-2, nuclear factor kappaB (NF-kappaB), interleukin-6, and thromboxane. Twenty-three subjects were evaluable. The median age was 64.1 years (range 46-75 years), and the mean (+/- SD) PSA level was 6.13 +/- 3.56 ng/mL. Side effects, when present, were mild and gastrointestinal in nature. There were no reported serious adverse events or toxicities. No significant changes in blood chemistries, testosterone, or cardiac function were noted. Forty-eight percent of subjects demonstrated a 25 to 50% decrease in PSA after 18 months. Of subjects who had the 18-month biopsy, 60% (9 of 15) had benign tissue, 26.7% (4 of 15) had HGPIN in one core, and 13.3% (2 of 15) had CaP at 18 months. A reduction in serum C-reactive protein was observed (95% confidence interval [CI] 0.7-1.7, p = .045). Immunoreactive staining demonstrated a reduction in NF-kappaB in the 18-month samples (95% CI 0.8-3.0, p = .017). Zyflamend alone and in combination with various dietary supplements is associated with minimal toxicity and no serious adverse events when administered orally for 18 months. Further studies are warranted to evaluate these agents in patients who are at risk for CaP.