Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial.

Rhinology. 2009 Mar; 47(1): 51-8Bachert C, Schapowal A, Funk P, Kieser MOBJECTIVE: To evaluate the efficacy and safety of the herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) compared to placebo. DESIGN: Double-blind, randomized, placebo-controlled, parallel-group, multicenter trial with a group-sequential adaptive design. SUBJECTS: Patients with sinonasal symptoms of at least 7 days duration, and radiographically and clinically confirmed acute rhinosinusitis of presumably bacterial origin with a Sinusitis Severity Score (SSS) of at least 12 out of 24 points at inclusion. INTERVENTIONS: EPs 7630, a herbal drug preparation from the roots of Pelargonium sidoides (1: 8-10; extraction solvent: ethanol 11% (w/w)), or matching placebo at a dose of 60 drops three times daily for maximum 22 days. MAIN OUTCOME MEASURES: Change in the SSS after 7 days. RESULTS: 103 patients were recruited until the planned interim analysis. The mean decrease in the SSS was 5.5 points in the EPs 7630 group compared to 2.5 points in the placebo group, a difference of 3.0 points (95% confidence interval 2.0 to 3.9, p < 0.00001). This result was confirmed by all secondary parameters indicating a more favourable course of the disease and a faster recovery in the EPs 7630 group. According to the pre-specified decision rule, the study was stopped after obtaining proof of efficacy for EPs 7630. CONCLUSIONS: EPs 7630 was well tolerated and superior in efficacy compared to placebo in the treatment of acute rhinosinusitis of presumably bacterial origin.

Transcatheter arterial chemoembolization combined with or without Chinese herbal therapy for hepatocellular carcinoma: meta-analysis.

Expert Opin Investig Drugs. 2009 May; 18(5): 617-35Cho WC, Chen HYOBJECTIVE: Chinese herbal therapy is sometimes used in conjunction with transcatheter arterial chemoembolization (TACE) for the treatment of hepatocellular carcinoma (HCC) in Asian countries. This study aims to systemically review the efficacy of Chinese herbal therapy in HCC patients receiving TACE. METHODS: Meta-analysis was performed for clinical trials comparing Chinese herbal therapy versus no Chinese herbal therapy given to HCC patients receiving TACE. Publications in 10 electronic databases were extensively searched. RESULTS/CONCLUSION: Chinese herbal therapy was associated with a significant rise in the number of patients with survival > 1-year, 2-year and 3-year, as well as a significant rise in the number of patients who reported complete or partial response and non-deterioration performance status. Chinese herbal therapy also showed significant efficacies in the increase of T cells and natural killer cells, whereas a significant lower blood alpha-fetoprotein concentration was reported. There were a significant increase in white blood cell count, a significant lower risk in patients with nausea and vomiting, and a significant rise in patients with increased body weight when Chinese herbal therapy was given. The evidence from this review supports the use of Chinese herbal therapy to enhance the efficacy of TACE in HCC patients. However, owing to limited data and heterogeneity of the included studies, further trials are required.

"Hepatitis from Greater celandine (Chelidonium majus L.): review of literature and report of a new case"

J Ethnopharmacol. 2009 Apr 24; Moro PA, Cassetti F, Giugliano G, Falce MT, Mazzanti G, Menniti-Ippolito F, Raschetti R, Santuccio CETHNOPHARMACOLOGICAL RELEVANCE: Folk medicine is a rich source of useful therapeutic tools. Nevertheless, use of medicinal plants can have unwanted, negative effects. By means of the description of an adverse reaction to a herbal remedy, we highlight the need for better efficacy-toxicity studies on these products. Aim of the Study. To report a case of possible Chelidonium majus L. (Greater celandine) induced hepatitis and evaluate the past published cases. MATERIALS AND METHODS: We outlined the main features of hepatitis associated with use of Chelidonium majus by providing a review of cases reported and analysing in detail a new one. RESULTS: Several cases of acute hepatitis related to Greater celandine consumption were found in the literature. The assessment for causality using Naranjo probability scale showed a probable relationship between the liver injury and the consumption of C.majus in the case we described. CONCLUSIONS: Our case, along with the other ones reported in the literature, increases the concern about the safety of oral use of C. majus. Plants used in traditional medicine are not necessarily harmless. Customers and prescribers should be aware of this, especially when a herbal drug is used with therapeutic purposes in absence of reliable studies of clinical efficacy and benefit-risk assessment.

Shakuyaku-kanzo-to induces pseudoaldosteronism characterized by hypokalemia, rhabdomyolysis, metabolic alkalosis with respiratory compensation, and increased urinary cortisol levels.

J Altern Complement Med. 2009 Apr; 15(4): 439-43Kinoshita H, Okabayashi M, Kaneko M, Yasuda M, Abe K, Machida A, Ohkubo T, Kamata T, Yakushiji FBACKGROUND: Licorice, the primary ingredient of the Japanese herbal medicine shakuyaku-kanzo-to, can cause pseudoaldosteronism. Thus, shakuyaku-kanzo-to can cause this condition. CASE DESCRIPTION: A 79-year-old woman was brought to the emergency room. She had been experiencing general fatigue, numbness in the hands, and weakness in the lower limbs and could not stand up without assistance. She presented with hypokalemia (potassium level, 1.7 mEq/L), increased urinary excretion of potassium (fractional excretion of K, 21.2%), abnormalities on an electrocardiogram (flat T waves in II, III, AVF, and V1-6), rhabdomyolysis (creatine kinase level, 28,376 U/L), myopathy, metabolic alkalosis with respiratory compensation (O(2) flow rate, 2 L/min; pH, 7.473; pco(2), 61.0 mm Hg; po(2), 78.0 mm Hg; HCO(3), 44.1 mmol/L), hypertension (174/93 mm Hg), hyperglycemia (blood glucose level, 200-300 mg/dL), frequent urination, suppressed plasma renin activity (0.1 ng/mL/hour), decreased aldosterone levels (2.6 ng/dL), and increased urinary cortisol levels (600.6 microg/day; reference range, 26.0-187.0 microg/day). CONCLUSIONS: In this case, the observed reduction in the urinary cortisol levels, from 600.6 to 37.8 microg/day, led to a definitive diagnosis of pseudoaldosteronism instead of the apparent mineralocorticoid excess syndrome. Discontinuing shakuyaku-kanzo-to treatment and administering spironolactone and potassium proved effective in improving the patient's condition. Medical practitioners prescribing shakuyaku-kanzo-to should take into account the association between licorice, which is its main ingredient, and pseudoaldosteronism.