1.
Oral birch pollen immunotherapy with apples: Results of a phase II clinical pilot study.
Nothegger, B, Reider, N, Covaciu, CE, Cova, V, Ahammer, L, Eidelpes, R, Unterhauser, J, Platzgummer, S, Raffeiner, E, Tollinger, M, et al
Immunity, inflammation and disease. 2021;9(2):503-511
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The prevalence of birch pollen allergy (BPA) has increased in recent years and has led to a rise in birch pollen-related food allergy (prFA). The current immunotherapy approach for BPA is to use birch pollen extract to attenuate the allergic response. While it has been successful for BPA, it has shown little to no effect on prFA, illuminating a current gap in the research. The aim of this pilot study was to assess the clinical efficacy of immunotherapy by daily apple consumption in developing permanent oral tolerance to apples and simultaneously to birch‐pollen. Sixteen participants consumed apples daily over an eight month period. Various allergy responses were measured during the peak birch pollen season. The results demonstrated continuous consumption of apples by BPA patients with prFA to apples could both improve prFA and birch-pollen induced allergic reactions. Based on these results, the authors conclude that oral immunotherapy with fresh apples is feasible and safe for the treatment of both BPA and birch prFA. As this was a small pilot study, a larger controlled trial is needed to confirm the potential of this treatment option in the clinical setting.
Abstract
BACKGROUND Seventy percent of patients suffering from birch pollen allergy (BPA) develop a pollen-related food allergy (prFA), especially to apples, due to a clinically relevant cross-reactivity between the major allergen in birch Bet v 1 and Mal d 1 in apples. Therefore allergen-specific immunotherapy with fresh apples (AITA) could be a promising natural treatment of both BPA and prFA. OBJECTIVE To assess the clinical efficacy of immunotherapy by daily apple consumption for patients with BPA and prFA. METHODS A daily defined increasing amount of selected cultivars (Red Moon®, Pink Lady®, Topaz, Golden Delicious) was continuously consumed by 16 patients (12 female; median age; 50; range, 23-68 years), leading to increased intake of allergen over a period of at least 8 months. Specific IgE and IgG4 to Bet v 1 and Mal d 1, conjunctival and oral provocation tests, skin reactivity, and the average daily rhinoconjunctivitis combined symptom and medication score (CSMS) were measured during the peak birch pollen season. RESULTS After 8 months of therapy, patients showed increased tolerance to apples (p < .001) and a decreased skin reactivity to apples. Oral allergy syndrome to other birch prFA than apple also decreased (p < .05). Moreover, daily rhinoconjunctivitis CSMS declined by 34% (p < .001), as did conjunctival reactivity to birch pollen extract by 27% (p < .01), while specific IgG4 to Mal d 1 and Bet v 1 increased (p < .01).
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Maitake mushroom extract in myelodysplastic syndromes (MDS): a phase II study.
Wesa, KM, Cunningham-Rundles, S, Klimek, VM, Vertosick, E, Coleton, MI, Yeung, KS, Lin, H, Nimer, S, Cassileth, BR
Cancer immunology, immunotherapy : CII. 2015;64(2):237-47
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Myelodysplastic syndromes (MDS) are a group of bone marrow stem cell disorders characterized by ineffective red blood cell production, a reduction in mature blood cells and may progress to acute myelogenous leukaemia (AML). Low levels and poor function of white blood cells, a key part of the immune system, are a common feature of MDS and this increases the risk of serious infection, the most common cause of death in lower-risk MDS patients. Maitake had previously been shown to enhance blood forming cells and was therefore thought to be of potential benefit for MDS patients. The aim of this phase II, open-label, non-randomized, safety and efficacy trial was to assess white blood cells function in lower-risk MDS patients. 18 untreated patients received Maitake extract at 6 mg/kg daily for 12 weeks. The function of two types of white blood cells, neutrophils and monocytes,increased after 12 weeks of maitake administration. Maitake was generally well tolerated although a mild increase in eosinophils, a type of white blood cells associated with allergies, was noted in four patients, and two of these patients also experienced mild diarrhoea. The authors concluded that maitake beta-glucan consumption improves white blood cell (neutrophil and monocyte) function in lower-risk MDS patients and may enhance immune responses against bacterial infection. They point out that one limitation of their trial was a lack of control group and that larger studies are needed to confirm the potential benefits of maitake.
Abstract
BACKGROUND Myelodysplastic syndromes (MDS) are characterized by ineffective erythropoiesis with dysplastic bone marrow leading to peripheral cytopenia, risk of infection, and progression to acute myelogenous leukemia. Maitake mushroom beta-glucan, a dietary supplement, stimulates hematopoietic progenitor cell differentiation, granulocyte colony-stimulating factor production, and recovery of peripheral blood leukocytes after bone marrow injury. This phase II trial examined the effects of Maitake on innate immune function in MDS. METHODS Myelodysplastic syndromes patients with International Prognostic Scoring System Low- and Intermediate-1-risk disease received oral Maitake extract at 3 mg/kg twice daily for 12 weeks. Primary endpoints included neutrophil count and function tested as endogenous or stimulated neutrophil production of reactive oxygen species (ROS) by flow cytometry compared with age-matched healthy controls (HC). ROS activators were Escherichia coli, phorbol ester, and the bacterial peptide N-formylmethionyl-leucyl-phenylalanine (fMLP). Complete blood counts, chemistry panels, iron studies, and monocyte function were evaluated. RESULTS Of 21 patients enrolled, 18 completed the study and were evaluable. Maitake increased endogenous (basal) neutrophil (p = 0.005) and monocyte function (p = 0.021). Pre-treatment monocyte response to E. coli was reduced in MDS patients compared with HC (p = 0.002) and increased (p = 0.0004) after treatment. fMLP-stimulated ROS production response also increased (p = 0.03). Asymptomatic eosinophilia occurred in 4 patients (p = 0.014). Other changes in albumin, hemoglobin, and total protein were not clinically relevant. CONCLUSIONS Maitake was well tolerated. Enhanced in vitro neutrophil and monocyte function following treatment demonstrate that Maitake has beneficial immunomodulatory potential in MDS. Further study is warranted.
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A phase I/II trial of a polysaccharide extract from Grifola frondosa (Maitake mushroom) in breast cancer patients: immunological effects.
Deng, G, Lin, H, Seidman, A, Fornier, M, D'Andrea, G, Wesa, K, Yeung, S, Cunningham-Rundles, S, Vickers, AJ, Cassileth, B
Journal of cancer research and clinical oncology. 2009;135(9):1215-21
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Grifola frondosa (maitake) is a medicinal mushroom which has been shown to be able to modulate the immune system. Many cancer patients use maitake extracts, however, evidence from clinical trials is lacking. This open label trial set out to determine the optimal dose of maitake extract based on possible toxic effects and blood parameters reflecting the state of the immune system. Eligible patients (post-menopausal women with previously treated breast cancer who were free of disease) were sequentially allocated to one of five groups (six subjects in each group) who received 0.2, 1, 3, 6 and 10 mg/kg of liquid maitake extract, respectively, daily for three weeks. Bloods were taken prior to the study beginning and on days 7, 14 and 21. No adverse effects or toxicities were observed. There were statistically significant dose response relationships for 25 out of the 146 parameters measured, with a stimulatory effect on some parameters, and a suppressing on others. The authors concluded that maitake was well tolerated and was associated with significant effects on immune balance, however, the effects were complex and depended on the different cell types and cytokines (specific signalling molecules of the immune system) evaluated, suggesting that maitake should be seen as an immune “modulator” rather than “enhancer”. The study was not designed to evaluate clinical efficacy of maitake.
Abstract
BACKGROUND Cancer patients commonly use dietary supplements to "boost immune function". A polysaccharide extract from Grifola frondosa (Maitake extract) showed immunomodulatory effects in preclinical studies and therefore the potential for clinical use. Whether oral administration in human produces measurable immunologic effects, however, is unknown. METHODS In a phase I/II dose escalation trial, 34 postmenopausal breast cancer patients, free of disease after initial treatment, were enrolled sequentially in five cohorts. Maitake liquid extract was taken orally at 0.1, 0.5, 1.5, 3, or 5 mg/kg twice daily for 3 weeks. Peripheral blood was collected at days -7, 0 (prior to the first dosing), 7, 14, and 21 for ex vivo analyses. The primary endpoints were safety and tolerability. RESULTS No dose-limiting toxicity was encountered. Two patients withdrew prior to completion of the study due to grade I possibly related side effects: nausea and joint swelling in one patient; rash and pruritus in the second. There was a statistically significant association between Maitake and immunologic function (p < 0.0005). Increasing doses of Maitake increased some immunologic parameters and depressed others; the dose-response curves for many endpoints were non-monotonic with intermediate doses having either immune enhancing or immune suppressant effects compared with both high and low doses. CONCLUSIONS Oral administration of a polysaccharide extract from Maitake mushroom is associated with both immunologically stimulatory and inhibitory measurable effects in peripheral blood. Cancer patients should be made aware of the fact that botanical agents produce more complex effects than assumed, and may depress as well as enhance immune function.