Lack of efficacy of a herbal preparation (RCM-102) for seasonal allergic rhinitis: a double blind, randomised, placebo-controlled trial.

BACKGROUND: A herbal preparation, known as RMIT Chinese Medicine 102 (RCM-102) consisting of eight herbs which demonstrates inhibition of the release of key inflammatory mediators associated with seasonal allergic rhinitis (SAR) was used. This study evaluated the efficacy and safety of RCM-102 for SAR. OBJECTIVE: This study evaluated the efficacy and safety of RCM-102 for SAR. METHODS: This randomised placebo-controlled trial involved subjects aged between 18 and 65 who were randomly assigned to either RCM-102 or a placebo group. After a two-week baseline period, all subjects took either RCM-102 or placebo capsules (two capsules each time, three times daily with a four hour interval) for a period of eight weeks. The primary end-points were the Five-Point Scale symptom scores. Rhinoconjunctivitis Quality of Life Questionnaire, relief medication usage, adverse events, kidney and liver function tests and full blood examination were secondary end-points. Intention-to-treat analysis was applied. RESULTS: One hundred and four subjects were randomised with 52 in each group. Ninety-five subjects (47 and 48 subjects in RCM-102 and placebo groups) completed the trial. Nine subjects withdrew from the study prior to the end of the second treatment week. At the end of the trial, there were no significant differences between the two groups with respect to all outcome measures. There were no liver or kidney function abnormalities reported. CONCLUSION: This mechanism-based RCM-102 was safe but not more beneficial than placebo for patients with SAR.

Disposition pathways and pharmacokinetics of herbal medicines in humans.

Pharmacokinetic studies have become an integral part of modern drug development, but these studies are not regulatory needs for herbal remedies. This paper updates our current knowledge on the disposition pathways and pharmacokinetic properties of commonly used herbal medicines in humans. To retrieve relevant data, the authors have searched through computer-based literatures by full text search in Medline (via Pubmed), ScienceDirect, Current Contents Connect (ISI), Cochrance Library, CINAHL (EBSCO), CrossRef Search and Embase (all from inception to May 2010). Many herbal compounds undergo Phase I and/or Phase II metabolism in vivo, with cytochrome P450s (CYPs) and uridine diphosphate glucuronosyltransferases (UGTs) playing a major role. Some herbal ingredients are substrates of P-glycoprotein (P-gp) which is highly expressed in the intestine, liver, brain and kidney. As such, the activities of these drug metabolizing enzymes and drug transporters are determining factors for the in vivo bioavailability, disposition and distribution of herbal remedies. There are increasing pharmacokinetic studies of herbal remedies, but these studies are mainly focused on a small number of herbal remedies including St John's wort, milk thistle, sculcap, curcumin, echinacea, ginseng, ginkgo, and ginger. The pharmacokinetic data of a small number of purified herbal ingredients, including anthocyanins, berberine, catechins, curcumin, lutein and quercetin, are available. For the majority of herbal remedies used in folk medicines, data on their disposition and biological fate in humans are lacking or in paucity. For a herbal medicine, the pharmacological effect is achieved when the bioactive agents or the metabolites reach and sustain proper levels at their sites of action. Both the dose levels and fates of active components in the body govern their target-site concentrations after administration of an herbal remedy. In this regard, a safe and optimal use of herbal medicines requires a full understanding of their pharmacokinetic profiles. To optimize the use of herbal remedies, further clinical studies to explore their biological fate including the disposition pathways and kinetics in the human body are certainly needed.

Chemistry and bioactivity of Flos Magnoliae, a Chinese herb for rhinitis and sinusitis.

Flos Magnoliae (FM, Chinese name: Xin-yi) is one of the most commonly used Chinese medicinal herbs. It has a long history of clinical use for managing rhinitis, sinusitis and headache. More than 20 different FM species have been used clinically, which makes species identification and evaluation of pharmacological effects of individual chemical ingredients difficult. In this review, we have summarized the current knowledge on FM phytochemistry and its bioactivity activities. The bioactive compounds in FM include both lipid and water-soluble components. More than 90% of the essential components of FM species are terpenoids, including monoterpenes and sesquiterpenes. Lignans and neolignans including tetrahydrofurofuran, tetrahydrofuran and aryltetralin are also present in FM species. A small number of water-soluble compounds have been isolated from Magnolia flower buds, including a benzylisoquinoline alkaloid magnoflorine, an ester ethyl-E-p-hydroxyl-cinnamate and a flavonoid biondnoid. A wide range of pharmacological actions of FM have been reported, including anti-allergy, anti-inflammation and anti-microbial activity. The structure-activity relationship analysis revealed the influence of methylation at position 5 on the 3,7-dioxabicyclo-(3,3,0)-octane backbone of six lignans in antagonistic activities against platelet-activating factor. In addition, the trans stereoisomer fargesin had a much lower bioactivity than the cis stereoisomer demethoxyaschantin. Recent studies have been directed towards the isolation of other bioactive compounds. Further studies on FM may help to develop new anti-inflammatory and anti-allergic drugs.

Inhibitions of mast cell-derived histamine release by different Flos Magnoliae species in rat peritoneal mast cells.

Flos Magnoliae (FM) is a commonly used Chinese medicinal herb for symptomatic relief of allergic rhinitis, sinusitis and headache. A number of FM species have been used as substitutes or adulterants for clinical application, although the differences in their pharmacological actions have not been reported. The present study investigated the effects of six identified FM species M. biondii, M. denudata, M. kobus, M. liliflora, M. sargentiana and M. sprengeri, as well as the marker compounds magnolin and fargesin on compound 48/80-induced histamine release in rat peritoneal mast cells (RPMC) in vitro. Ethanolic extracts of all FM species produced a concentration-dependent inhibition of compound 48/80-induced histamine release in RPMC. The rank order of the IC(50)s was M. biondii

Efficacy, chemistry and pharmacology of chinese herbal medicine for allergic rhinitis.

An extensive literature search identified six randomized controlled clinical trials in which the efficacy of Chinese herbal medicine had been investigated for the treatment of allergic rhinitis. Although four of these trials had methodological flaws, the therapeutic outcomes of all six have been reviewed. One of two trials considered to be of high quality was concerned with the treatment of seasonal allergic rhinitis and the other with perennial allergic rhinitis. It is considered that all six studies demonstrated various degrees of alleviation of the symptoms of allergic rhinitis. No serious side effects were reported in any of the trials. A number of the herbs in the Chinese herbal formulae used in the trials, and/or their constituent compounds have been reported to possess anti-allergic, anti-inflammatory or immune modulation activity. Such actions include inhibition of the release or action of mast cell mediators such as histamine, inhibition of inflammation induced by chemical agents, and modulation of serum IgE levels or of lymphocyte and/or macrophage activity. An aqueous, unresolved extract of the herbal formula used in one of the six trials has been reported to exhibit a range of pharmacological actions relevant to the treatment of allergic rhinitis. Essential oils, lignans, flavonoids and saponins are chemical classes that are frequently represented in individual herbs of the six Chinese herbal formulae used in the trials. The chemical structures characterising these classes of compound and the pharmacological actions of these and other constituents of the herbs, relevant to allergic rhinitis, have been reviewed.

Regression of squamous cell carcinoma of the lung by Chinese herbal medicine: a case with an 8-year follow-up.

A 51-year-old woman diagnosed with squamous cell carcinoma (SCC) of the lung (T2N2M0) by cytological tests and a CT scan has survived for 8 years. During this period of time, she had been treated with Chinese herbal medicine alone for 4 years. The herbal prescription consisted of nine Chinese medicinal herbs. These herbs have been reported to possess anti-tumour and immune enhancing effects. Therefore, it is suggested that the herbal treatment for this patient might have contributed to the complete regression of her lung carcinoma. Further research on the actions of these herbs is warranted.

Electroacupuncture for tension-type headache on distal acupoints only: a randomized, controlled, crossover trial.

OBJECTIVE: To investigate the efficacy of electroacupuncture, applied to distal acupoints only, for tension-type headache. BACKGROUND: Electroacupuncture is commonly used for tension-type headache, but when applied to distal acupoints only, evidence of its efficacy is lacking. DESIGN: A randomized, single-blinded, sham-controlled, crossover clinical trial. Methods.-The trial had 5 stages: baseline (2 weeks), phases I and II (each 4 weeks), washout period (2 weeks), and follow-up (3 months after phase II). Forty patients were randomly assigned to either group A or group B. Group A received real electroacupuncture during phase I, then sham electroacupuncture in phase II. Group B received the treatments in reverse order. Outcome measures were headache frequency and duration, pain intensity using a visual analog scale, mechanical pain threshold, headache disability, and sickness impact. Data were analyzed by univariate 2-way analysis of variance. RESULTS: Thirty-seven patients completed the trial. There were no significant differences between the 2 groups at baseline. At the end of phase I, group A, but not group B, demonstrated significant improvement in mean (standard error of the mean [SEM]) headache frequency (3.0 per month [0.3] versus 12.0 per month [1.7]), duration (13.3 hours [3.5] versus 32.0 hours [6.2]), pain intensity (32.8 mm [4.1] versus 47.5 mm [2.7]), pain threshold (right side, 2.9 kg/second [0.1] versus 0.9 kg/second [0.1]; left side, 2.4 kg/second [0.1] versus 1.1 kg/second [0.1]), headache disability score (6.0 [1.0] versus 16.3 [1.6]), and sickness impact score (288.7 [48.0] versus 687.1 [77.2]). For each parameter, significant differences also were demonstrated for both groups between baseline and phase II, and baseline and follow-up. There were no significant differences between the groups at the end of follow-up (P >.05). CONCLUSION: Electroacupuncture to distal points alone is effective for short-term symptomatic relief of tension-type headache.

Effect of adding a Chinese herbal preparation to acupuncture for seasonal allergic rhinitis: randomised double-blind controlled trial.

OBJECTIVE: To assess whether the addition of a Chinese herbal medicine formula to acupuncture affects the severity of symptoms and quality-of-life scores among patients with seasonal allergic rhinitis. DESIGN: Randomised double-blind placebo-controlled trial. SETTING: University teaching and research clinic, Australia. PARTICIPANTS: Sixty-five patients with seasonal allergic rhinitis, who were recruited through public media. INTERVENTION: Between July and December 1999, patients received acupuncture twice a week for 8 weeks plus either a Chinese herbal drug formula (n=33) or placebo (n=32) at a dosage of four capsules, three times daily. MAIN OUTCOME MEASURES: The severity of nasal and non-nasal symptoms on a five-point scale, as assessed by both patients and an ear, nose, and throat specialist, and quality-of-life scores as measured by the Rhinoconjunctivitis and Rhinitis Quality of Life Questionnaire. RESULTS: Sixty-one patients completed the study (31 in the intervention group and 30 in the control group). After 8 weeks, no significant difference was found between the two groups in the severity of nasal and non-nasal symptoms and in the Rhinoconjunctivitis and Rhinitis Quality of Life Questionnaire scores. Intention-to-treat analysis of categorical variables showed moderate-to-marked improvement rates of 72.7% and 81.2% for intervention and control groups, respectively. Six patients reported mild adverse events-three from each of the study groups. CONCLUSION: The Chinese herbal formulation under investigation did not provide additional symptomatic relief or improvement in quality-of-life scores among patients with seasonal allergic rhinitis who were receiving acupuncture.

Glucosaminylmuramyl dipeptide (GMDP) modulates endothelial cell activities in vitro but has no effect on angiogenesis in vivo.

OBJECTIVE AND DESIGN: The aim of the study was to evaluate the effects of GMDP on angiogenesis in vivo and as a modulator of human umbilical vein endothelial cell proliferation, cell surface antigen expression and cell adhesion in vitro. MATERIALS: Human umbilical vein endothelial cells (HUVEC), fertilized white leghorn chicken eggs, antibodies against adhesion molecules and glucosaminylmuramyl dipeptide (GMDP). TREATMENT: GMDP [0.01-100 micrograms/ml] applied to cell cultures for 6-72 h and to the chick chorioallantoic membrane (CAM) for four days. METHODS: Angiogenic activity of GMDP in vivo was assessed using the CAM assay; HUVEC proliferation was measured by tritiated thymidine incorporation and cell cycle studies; cell surface antigen expression by indirect immunofluorescence and flow cytometry; cell adhesion by quantification of [3H]-thymidine labeled leukocyte adherence to HUVEC monolayers. Statistical analysis was performed using one-way ANOVA and if necessary was followed by Duncan's multiple range test for variables. RESULTS: GMDP induced [3H]-thymidine incorporation in a concentration- and time-dependent manner (p < 0.003) and significantly increased the porportion of cells in the S phase of the cell cycle (p < 0.03). It weakly augmented the expression of ICAM-1 and CD31 but not adhesion of leukocytes to HUVEC monolayers GMDP was not angiogenic in the CAM assay. CONCLUSIONS: GMDP can modulate endothelial cell activity without the induction of angiogenesis in vivo which may have implications for its use as a therapeutic agent.

[Pharmacognostical identification and investigation of commercial product of traditional Chinese drug jiuyanduhuo].

Through investigation on original plants and commercial products of the traditional Chinese drug Jiuyanduhuo, the authors have ascertained its botanical origin and present medicinal usage, and found out that Aralia cordata is the main species of Jiuyanduhuo, and A. fargesii is another species that has come into use due to short supply of the main species, and A. henyri is used only in Sichuan and Hubei Provinces. Principal identification features of the original plants and crude drugs with 2 keys have been given, and TLC identification for 3 kinds of Jiuyanduhuo have also been carried out.

[Histopathologic observation on the therapeutic effect of Tripterygium wilfordii in treating experimental allergic encephalomyelitis].

The Tripterygium wilfordii (TW) was used to treat experimental allergic encephalomyelitis (EAE) in guinea-pig. The morphological change was observed by using light microscope. Lymphocytic histochemical staining was performed on the spinal cord from EAE in guinea-pig. The results were: The incidence of inflammatory reaction, neuraxial swelling, break and neuronal necrosis in the treatment group was lower than that in the control group (P less than 0.01-0.005); the variation of incidence of neurofibrillar demyelinating in the treatment group was smaller than that in the control group (P less than 0.025). The result of ANAE and ALP staining for lymphocytes in the spinal cord from EAE was T-cell. It showed TW could inhibit the allergic action and decrease tissular injury.