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Background: Complementary and alternative medicines are increasingly used for the treatment of asthma in Western countries. A novel three-herb antiasthma herbal medicine intervention (ASHMI™; Sino-Lion Pharmaceutical Company; Shan Dong China) was demonstrated to be effective and safe in a murine model of asthma and in a preliminary clinical study in China. Objective: The objective of this study was to evaluate the safety and tolerability of ASHMI in adult subjects with allergic asthma. Design: Randomized, double-blind, placebo-controlled, dose escalation, phase I trial aimed at developing a botanical drug under the United States Food and Drug Administration Investigational New Drug title. Interventions: Subjects received one of three doses of ASHMI or placebo: 600 mg (2 capsules); 1200 mg (4 capsules); or 1800 mg (6 capsules) twice daily for 1 week. Four (4) ASHMI and 2 placebo subjects were treated at each dose level. Subjects continued to use their conventional asthma medications for the duration of the study. Outcome measures: Vital signs, physical examination, laboratory data, and electrocardiogram data were monitored throughout the study to assess occurrence of adverse events (AEs). Immunomodulatory studies were performed to evaluate the effect of ASHMI on cytokine, chemokine, and growth factor levels. Results: Twenty (20) nonsmoking, allergic subjects with asthma were included in the study. Eight (8) subjects (4 ASHMI and 4 placebo) reported mild gastrointestinal symptoms. No grade 3 AEs were observed during the study period. Vital signs, electrocardiogram findings, and laboratory results obtained at pre- and post-treatment visits remained within normal range. No abnormal immunologic alterations were detected. Conclusion: In this phase I study, ASHMI appeared to be safe and well tolerated by subjects with asthma. These findings allowed initiation of a larger phase II study to assess the efficacy of ASHMI. [ABSTRACT FROM AUTHOR]

Background: Food allergy is a serious and sometimes fatal condition for which there is no cure. We previously reported that Food Allergy Herbal Formula (FAHF)–2) protected peanut-allergic mice against anaphylactic reactions as long as 4 weeks posttherapy. This formula is now in clinical trials in the United States. Objective: We sought to determine whether FAHF-2–mediated protection could be extended long-term and explored the mechanisms underlying its persistent immunomodulatory effects. Methods: Peanut-allergic mice received FAHF-2 daily orally by gavage for 7 weeks, and then received 7 oral peanut challenges at intervals of 4 to 10 weeks over a period of 36 weeks. For mechanistic studies, some mice received CD4+ or CD8+ T-cell–depleting antibodies or IFN-γ–neutralizing antibodies. Anaphylactic symptoms, body temperatures, and plasma histamine levels were recorded after each challenge, and peanut-specific immunoglobulin levels and cytokine profiles of splenocytes, mesenteric lymph node cells, and purified CD4+ and CD8+ T cells were determined. Results: Food Allergy Herbal Formula-2 treatment protected mice from anaphylaxis for more than 36 weeks after discontinuing treatment. Peanut-specific IgE levels were reduced as much as 50%, whereas IgG2a levels were increased as much as 60%, and these effects persisted over time. TH2 cytokine production by CD4+ T cells from FAHF-2–treated mice was reduced as much as 75%, whereas CD8+ T-cell IFN-γ production was markedly increased by as much as 85% at the final challenge. Neutralization of INF-γ and depletion of CD8+ T cells markedly attenuated FAHF-2 efficacy. Conclusions: Food Allergy Herbal Formula-2 provides long-term protection from anaphylaxis by inducing a beneficial shift in allergen-specific immune responses mediated largely by elevated CD8+ T-cell IFN-γ production. [Copyright &y& Elsevier]

Background: To develop and validate a nomogram based on log of odds between the number of positive lymph node and the number of negative lymph node (LODDS) in predicting the overall survival (OS) and cancer specific survival (CSS) for epithelial ovarian cancer (EOC) patients., Materials and Methods: A total of 10,692 post-operative EOC patients diagnosed between 2004 and 2013 were obtained from the Surveillance, Epidemiology, and End Results (SEER) database and randomly divided into training (n = 7,021) and validation (n = 3,671) cohorts. Multiple clinical pathological parameters were assessed and compared with outcomes. Parameters significantly correlating with outcomes were used to build a nomogram. Bootstrap validation was subsequently used to assess the predictive value of the model., Results: In the training set, age at diagnosis, race, marital status, tumor location, stage, grade and LODDS were correlated significantly with outcome in both the univariate and multivariate analyses and were used to develop a nomogram. The nomogram demonstrated good accuracy in predicting OS and CSS, with a bootstrap-corrected concordance index of 0.757 (95% CI, 0.746-0.768) for OS and 0.770 (95% CI, 0.759-0.782) for CSS. Notably, in this population our model performed favorably compared to the currently utilized Federation of Gynecology and Obstetrics (FIGO) model, with concordance indices of 0.699 (95% CI, 0.688-0.710, P < 0.05) and 0.719 (95% CI, 0.709- 0.730, P < 0.05) for OS and CSS, respectively. Using our nomogram in the validation cohort, the C-indices were 0.757 (95% CI, 0.741-0.773, P < 0.05, compared to FIGO) for OS and 0.762 (95% CI, 0.746-0.779, P < 0.05, compared to FIGO) for CSS., Conclusions: LODDS works as an independent prognostic factor for predicting survival in patients with EOC regardless of the tumor stage. By incorporating LODDS, our nomogram may be superior to the currently utilized FIGO staging system in predicting OS and CSS among post-operative EOC patients.

Background: Food Allergy Herbal Formula-2 (FAHF-2) is a 9-herb formula based on traditional Chinese medicine that blocks peanut-induced anaphylaxis in a murine model. In phase I studies FAHF-2 was found to be safe and well tolerated., Objective: We sought to evaluate the safety and effectiveness of FAHF-2 as a treatment for food allergy., Methods: In this double-blind, randomized, placebo-controlled study 68 subjects aged 12 to 45 years with allergies to peanut, tree nut, sesame, fish, and/or shellfish, which were confirmed by baseline double-blind, placebo-controlled oral food challenges (DBPCFCs), received FAHF-2 (n = 46) or placebo (n = 22). After 6 months of therapy, subjects underwent DBPCFCs. For those who demonstrated increases in the eliciting dose, a repeat DBPCFC was performed 3 months after stopping therapy., Results: Treatment was well tolerated, with no serious adverse events. By using intent-to-treat analysis, the placebo group had a higher eliciting dose and cumulative dose (P = .05) at the end-of-treatment DBPCFC. There was no difference in the requirement for epinephrine to treat reactions (P = .55). There were no significant differences in allergen-specific IgE and IgG4 levels, cytokine production by PBMCs, or basophil activation between the active and placebo groups. In vitro immunologic studies performed on subjects' baseline PBMCs incubated with FAHF-2 and food allergen produced significantly less IL-5, greater IL-10 levels, and increased numbers of regulatory T cells than untreated cells. Notably, 44% of subjects had poor drug adherence for at least one third of the study period., Conclusion: FAHF-2 is a safe herbal medication for subjects with food allergy and shows favorable in vitro immunomodulatory effects; however, efficacy for improving tolerance to food allergens is not demonstrated at the dose and duration used., (Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: Allergic disorders represent a serious public health problem in children. The chronic nature of these diseases and the fear of known side effects of synthetic drugs influence many families to seek complementary and alternative medicine. This review focuses on traditional Chinese medicine (TCM) herbal products and acupuncture for treating pediatric allergies., Recent Findings: Given the general safety profile and reputed efficacy, TCM are well received by the general population. However, compared with the long human history and popularity of the use of TCM, research into its efficacy and safety is still in its infancy. In the last 2-3 years, there have been more controlled studies of TCM for allergic asthma and allergic rhinitis. Several publications including ours indicate that some TCM herbal formulas are well tolerated and produce some level of efficacy. Some herbal formulas also showed beneficial immunomodualtory effects. Several preclinical studies demonstrated that the food allergy herbal formula-2 was effective in protecting against peanut anaphylaxis in animal models. Two TCM products have entered clinical trials in the United States for treating asthma and food allergy, respectively. Both of these trials include children., Summary: Recent studies indicate that TCM therapy including herbal medicines and acupuncture for allergic disorders in children is well tolerated. There are also promising clinical and objective improvements. More controlled clinical studies are encouraged.

At present there is no effective therapy for IgE-mediated food allergy, and patients must rely upon food-allergen avoidance. Unfortunately, the accidental ingestion of allergen-containing foods leading to potentially severe reactions is common. Definitive therapies for food allergy are desperately needed. Although rush immunotherapy has been reported to induce tolerance in some patients, the rate of maintenance of tolerance was low, and there was an undesirably high incidence of adverse reactions. New knowledge of the immunological mechanisms underlying allergic disease has expanded the potential therapeutic options for food allergy. The establishment of animal models of food hypersensitivity, which include sensitization by the oral route and anaphylaxis upon oral challenge, have facilitated the investigation of therapies for food allergy. Novel approaches under investigation include the reduction of IgE by the infusion of anti-IgE antibodies, vaccination with plasmid DNA, the use of anti-allergy immunostimulatory sequences, cytokines and bacterial agents, immunotherapy with mutated proteins and peptides, and complementary medicine such as Chinese herbs.