Zhao, H., Q. Zhang, L. Zhao, X. Huang, J. Wang and X. Kang. 2012. Spore Powder ofGanoderma lucidum Improves Cancer-Related Fatigue in Breast Cancer Patients Undergoing Endocrine Therapy: A Pilot Clinical Trial. Evid Based Complement Alternat Med.2012; 2012: 809614. Epub 2011 Dec 10.
Abstract: The fatigue prevalence in breast cancer survivors is high during the endocrine treatment. However, there are few evidence-based interventions to manage this symptom. The aim of this study was to investigate the effectiveness of spore powder of Ganoderma lucidum for cancer-related fatigue in breast cancer patients undergoing endocrine therapy. Spore powder of Ganoderma lucidum is a kind of Basidiomycete which is a widely used traditional medicine in China. 48 breast cancer patients with cancer-related fatigue undergoing endocrine therapy were randomized into the experimental or control group. FACT-F, HADS, and EORTC QLQ-C30 questionnaires data were collected at baseline and 4 weeks after treatment. The concentrations of TNF-α, IL-6, and liver-kidney functions were measured before and after intervention. The experimental group showed statistically significant improvements in the domains of physical well-being and fatigue subscale after intervention. These patients also reported less anxiety and depression and better quality of life. Immune markers of CRF were significantly lower and no serious adverse effects occurred during the study. This pilot study suggests that spore powder of Ganoderma lucidum may have beneficial effects on cancer-related fatigue and quality of life in breast cancer patients undergoing endocrine therapy without any significant adverse effect.
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Chu, T. T., I. F. Benzie, C. W. Lam, B. S. Fok, K. K. Lee and B. Tomlinson. 2011. Study of potential cardioprotective effects of Ganoderma lucidum (Lingzhi): results of a controlled human intervention trial. Br J Nutr. [Epub ahead of print]
Abstract: Previous studies have suggested that Lingzhi (Ganoderma lucidum) has antioxidant effects and possibly beneficial effects on blood pressure, plasma lipids and glucose, but these have not been confirmed in subjects with mild hypertension or hyperlipidaemia. The objective of the present study was to assess the cardiovascular, metabolic, antioxidant and immunomodulatory responses to therapy with Lingzhi in patients with borderline elevations of blood pressure and/or cholesterol in a controlled cross-over trial. A total of twenty-six patients received 1·44 g Lingzhi daily or matching placebo for 12 weeks in a randomised, double-blind, cross-over study with placebo-controlled run-in and cross-over periods. Body weight, blood pressure, metabolic parameters, urine catecholamines and cortisol, antioxidant status and lymphocyte subsets were measured after each period. Lingzhi was well tolerated and data from twenty-three evaluable subjects showed no changes in BMI or blood pressure when treated with Lingzhi or placebo. Plasma insulin and homeostasis model assessment-insulin resistance were lower after treatment with Lingzhi than after placebo. TAG decreased and HDL-cholesterol increased with Lingzhi but not with placebo in the first treatment period, but significant carry-over effects prevented complete analysis of these parameters. Urine catecholamines and cortisol, plasma antioxidant status and blood lymphocyte subsets showed no significant differences across treatments. Results indicate that Lingzhi might have mild antidiabetic effects and potentially improve the dyslipidaemia of diabetes, as shown previously in some animal studies. Further studies are desirable in patients with hyperglycaemia.
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Boh, B., M. Berovic, J. Zhang and L. Zhi-Bin. 2007. Ganoderma lucidum and its pharmaceutically active compounds. BIOTECHNOLOGY ANNUAL REVIEW 13: 265-301.
Abstract; Ganoderma lucidum is a wood-degrading basidiomycete with numerous pharmacological effects. Since the mushroom is very rare in nature, artificial cultivation of fruiting bodies has been known on wood logs and on sawdust in plastic bags or bottles. Biotechnological cultivation of G. lucidum mycelia in bioreactors has also been established, both on solid substrates and in liquid media by submerged cultivation of fungal biomass. The most important pharmacologically active constituents of G. lucidum are triterpenoids and polysaccharides. Triterpenoids have been reported to posses hepatoprotective, anti-hypertensive, hypocholesterolemic and anti-histaminic effects, anti-tumor and anti-engiogenic activity, effects on platelet aggregation and complement inhibition. Polysaccharides, especially b-Dglucans, have been known to possess anti-tumor effects through immunomodulation and antiangiogenesis. In addition, polysaccharides have a protective effect against free radicals and reduce cell damage caused by mutagens.
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Kwok, Y., K. F. J. Ng, C. C. F. Li, C. C. K. Lam and R. Y. K. Man. 2005. A Prospective, Randomized, Double-Blind, Placebo-Controlled Study of the Platelet and Global Hemostatic Effects of Ganoderma Lucidum(Ling-Zhi) in Healthy Volunteers. Anesth Analg 101: 423-426.
Abstract; Ganoderma lucidum is a Chinese herbal medicine popularwith cancer patients. Previousin vitro studies suggested that Ganoderma lucidum might impair hemostasis. In this prospective, randomized double-blind study, healthy volunteers received orally Ganoderma lucidum capsules 1.5 g (n =20) or placebo (n = 20) daily for 4 wk. We monitored subjects before drug administration and at 4 and 8 wk thereafter by routine coagulation screen, fibrinogen concentration, von Willebrand ristocetin cofactor activity, platelet function analyzer PFA-100®, and thrombelastography. There were no significant between-group differences and all measurements remained within the normal range. Ganoderma lucidum ingestion over 4wk was not associated with impairment of hemostasis.
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Noguchi, M., T. Kakuma, K. Tomiyasu, Y. Kurita, H. Kukihara, F. Konishi, S. Kumamoto, K. Shimizu and R. Matsuoka R. (2008). Effect of an extract of Ganoderma lucidum in men with lower urinary tract symptoms: a double-blind, placebo-controlled randomized and dose-ranging study. Asian J Androl 10: 651-658.
Abstract
Aim: To conduct a double-blind, placebo-controlled randomized and dose-ranging study to evaluate the safety and efficacy of the extract of Ganoderma lucidum (G. lucidum) in men with lower urinary tract symptoms (LUTS).
Methods: We enrolled male volunteers (≥ 50 years) with an International Prostate Symptom Score (IPSS; questions 1–7) ≥ 5 and a prostate-specific antigen (PSA) value < 4 ng/mL. Volunteers were randomized into groups of placebo (n = 12), G. lucidum of 0.6 mg (n = 12), 6 mg (n = 12) or 60 mg (n = 14), administered once daily. Efficacy was measured as a change from baseline in IPSS and the peak urine flow rate (Qmax). Prostate volume and residual urine were estimated by ultrasonography, and blood tests, including PSA levels, were measured at baseline and at the end of the treatment.
Results: The overall administration was well tolerated, with no major adverse effects. Statistical significances in the magnitude of changes between the experimental groups were observed at weeks 4 and 8. No changes were observed with respect to Qmax, residual urine, prostate volume or PSA levels.
Conclusion: The extract of G. lucidum was well tolerated and an improvement in IPSS was observed. The recommended dose of the extract of G. lucidum is 6 mg in men with LUTS.
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Wachtel-Galor, S., B. Tomlinson and I. F. F. Benzie. 2004. Ganoderma lucidum (‘Lingzhi’), a Chinese medicinal mushroom: biomarker responses in a controlled human supplementation study. British Journal of Nutrition 91: 263–269.
Abstract; Lingzhi (Ganoderma lucidum) is a woody mushroom highly regarded in traditional medicine and is widely consumed in the belief that it promotes health and longevity, lowers the risk of cancer and heart disease and boosts the immune system. However, objective scientific validation of the putative health benefits of Lingzhi in human subjects is lacking, and issues of possible toxicity must be addressed. The present double-blinded, placebo-controlled, cross-over intervention study investigated the effects of 4 weeks Lingzhi supplementation on a range of biomarkers for antioxidant status, CHD risk, DNA damage, immune status, and inflammation, as well as markers of liver and renal toxicity. It was performed as a follow-up to a study that showed that antioxidant power in plasma increased after Lingzhi ingestion, and that 10 d supplementation was associated with a trend towards an improved CHD biomarker profile. In the present study, fasting blood and urine from healthy, consenting adults (n 18; aged 22–52 years) was collected before and after 4 weeks supplementation with a commercially available encapsulated Lingzhi preparation (1·44 g Lingzhi/d; equivalent to 13·2 g fresh mushroom/d) or placebo. No significant change in any of the variables was found, although a slight trend toward lower lipids was again seen, and antioxidant capacity in urine increased. The results showed no evidence of liver, renal or DNA toxicity with Lingzhi intake, and this is reassuring. The present study of the effects in healthy, well-nourished subjects provides useful, new scientific data that will support controlled intervention trials using atrisk subjects in order to assess the therapeutic effect of Lingzhi in the promotion of healthy ageing.
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G. C.-F. Chan, W. K. Chan and D. M.-Y. Sze. 2009. The effects of β-glucan on human immune and cancer cells. Journal of Hematology & Oncology 2: 25.
Abstract; Non-prescriptional use of medicinal herbs among cancer patients is common around the world. The alleged anti-cancer effects of most herbal extracts are mainly based on studies derived from in vitro or in vivo animal experiments. The current information suggests that these herbal extracts exert their biological effect either through cytotoxic or immunomodulatory mechanisms. One of the active compounds responsible for the immune effects of herbal products is in the form of complex polysaccharides known as β-glucans. β-Glucans are ubiquitously found in both bacterial or fungal cell walls and have been implicated in the initiation of anti-microbial immune response. Based on in vitro studies, β-glucans act on several immune receptors including Dectin-1, complement receptor (CR3) and TLR-2/6 and trigger a group of immune cells including macrophages, neutrophils, monocytes, natural killer cells and dendritic cells. As a consequence, both innate and adaptive response can be modulated by -glucans and they can also enhance opsonic and nonopsonic phagocytosis. In animal studies, after oral administration, the specific backbone 1→3 linear β-glycosidic chain of β-glucans cannot be digested. Most β-glucans enter the proximal small intestine and some are captured by the macrophages. They are internalized and fragmented within the cells, then transported by the macrophages to the marrow and endothelial reticular system. The small β-glucans fragments are eventually released by the macrophages and taken up by other immune cells leading to various immune responses. However, β-glucans of different sizes and branching patterns may have significantly variable immune potency. Careful selection of appropriate β-glucans is essential if we wish to investigate the effects of β-glucans clinically. So far, no good quality clinical trial data is available on assessing the effectiveness of purified β-glucans among cancer patients. Future effort should direct at performing well-designed clinical trials to verify the actual clinical efficacy of β-glucans or β-glucans containing compounds.
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Chen, X., Z.-P. Hu, X.-X. Yang, Huang, Min, Gao, Y., Tang, W., Chan, S., Y., Dai, X., Ye, J. et al. (2006).Monitoring of immune responses to a herbal immuno-modulator in patients with advanced colorectal cancer. International Immunopharmacology, 6, 499-508.
Abstract; Many herbal medicines are widely used as immuno-modulators in Asian countries. Ganoderma lucidum (Lingzhi) is one of the most commonly used herbs in Asia and preclinical studies have established that the polysaccharide fractions of G. lucidum have potent immuno-modulating effects. However, clinical evidence for this is scanty. The present open-labeled study aimed to evaluate the effects of G. lucidumpolysaccharides on selected immune functions in patients with advanced colorectal cancer. Forty-seven patients were enrolled and treated with oral G. lucidum at 5.4 g/day for 12 weeks. Selected immune parameters were monitored using various immunological methods throughout the study. In 41 assessable cancer patients, treatment with G. lucidum tended to increase mitogenic reactivity to phytohemagglutinin, counts of CD3, CD4, CD8 and CD56 lymphocytes, plasma concentrations of interleukin (IL)-2, IL-6 and interferon (IFN)-g, and NK activity, whereas plasma concentrations of IL-1 and tumor necrosis factor (TNF)-a were decreased. For all of these parameters, no statistical significance was observed when a comparison was conducted between baseline and those values after a 12-week treatment with G. lucidum. The changes of IL-1 were correlated with those for IL-6, IFN-g, CD3, CD4, CD8 and NK activity ( p b0.05) and IL-2 changes were correlated with those for IL-6, CD8 and NK activity. The results indicate that G. lucidum may have potential immuno-modulating effect in patients with advanced colorectal cancer. Further studies are needed to explore the benefits and safety of G. lucidum in cancer patients.
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Noguchi, M., Kakuma, T., Tomiyasu, K., Konishi, F., Kumamoto, S., Kondo, R. and Matsuoka, K. (2005).Phase I study of a methanol extract of Ganoderma lucidum, edible and medicinal mushroom, in men with mild symptoms of bladder outlet obstruction. Urology, 66, supplement 3A.
Introduction: A methanol extract of G lucidum shows the strongest 5-reductase inhibitory activity among the extracts of 19 edible and medicinal mushrooms (J Wood Sci. 51:189- 192, 2005 ). A phase I clinical trial was conducted to evaluate the safety and efficacy of the extract of G lucidum in men with mild symptoms of bladder outlet obstruction (BOO).
Methods: The safety and efficacy of the extract was assessed in an 8-week, randomized, double-blind, placebo controlled and dose-ranging study. We enrolled male volunteers (≥ 50 yr) with an International Prostate Symptom Score (I-PSS; questions 1-7)≥ 8 and a prostate-specific antigen (PSA) value < 4 ng/ml. After a 2 week wash-out period if on treatment with alpha blockers or any other drugs for benign prostatic hyperplasia, volunteers were randomized to placebo (n = 12), 0.6 mg (n = 12), 6 mg (n = 12) or 60 mg (n = 14), administered once daily. Efficacy was measured as change from baseline, compared with placebo group, in I-PSS and peak urine flow rate (Qmax). Prostate volume and residual urine estimated by ultrasonography, and blood tests including PSA levels were also measured at baseline and at the end of the treatment.
Results: The overall administration was well tolerated with no adverse effects. Statistically significant reductions in I-PSS versus placebo were observed at the 6 mg and 60 mg dose (weeks 4 and 8; 3 pointsplacebo). This significant improvement in I-PSS is confirmed by using cumulative distribution, linear regression analysis, responders or class severity. No changes were observed with respect to Qmax, residual urine, prostate volume and PSA levels.
Conclusions: The extract of G lucidum was well tolerated and the significant improvement in I-PSS was observed. The recommended phase II dose of the extract is 6 mg in men with mild symptoms of BOO.
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Noguchi, M., Kakuma, T., Tomiyasu, K.,Yamada, Akira., Itoh, K., Konishi, F., Kumamoto, S., Shimizu, K., Kondo, R. and Matsuoka., Kei. (2008). Randomized clinical trial of an ethanol extract of Ganodermalucidum in men with lower urinary tract symptoms. Asian Journal of Andrology, 10 (5), 777-785.
Abstract
Aim: To evaluate the safety and efficacy of an extract of Ganoderma lucidum that shows the strongest 5α-reductase inhibitory activity among the extracts of 19 edible and medicinal mushrooms by a double-blind, placebo-controlled, randomized and dose-ranging study in men with lower urinary tract symptoms (LUTS).Methods: In this trial, we randomly assigned 88 men over the age of 49 years who had slight-to-moderate LUTS to 12 weeks of treatment with G. lucidum extract (6 mg once a day) or placebo. The primary outcome measures were changes in the International Prostate Symptom Score (IPSS) and variables of uroflowmetry. Secondary outcome measures included changes in prostate size, residual urinary volume after voiding, laboratory values and the reported adverse effects. Results: G. lucidum was effective and significantly superior to placebo for improving total IPSS with 2.1 points decreasing at the end of treatment (mean difference, –1.18 points; 95% confidence interval, –1.74 to –0.62; P < 0.0001). No changes were observed with respect to quality of life scores, peak urinary flow, mean urinary flow, residual urine, prostate volume, serum prostate-specific antigen or testosterone levels. Overall treatment was well tolerated with no severe adverse effects. Conclusion: The extract of G. lucidum was well tolerated and improved IPSS scores. These resultsencouraged a further, large-scale evaluation of phytotherapy for a long duration using the extract of G. lucidum on men with LUTS.
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LI, E., K., TAM, L.-S., WONG, C., K., LI, W., C., LAM,C., W., K., WACHTEL-GALOR, S., BENZIE, I., F., F.,BAO,Y., X., LEUNG, P., C., AND TOMLINSON, B. (2007). Safety and Efficacy of Ganoderma lucidum(Lingzhi) and San Miao San Supplementation in Patients With Rheumatoid Arthritis: A Double-Blind, Randomized, Placebo-Controlled Pilot Trial. Arthritis & Rheumatism (Arthritis Care & Research), 57 (7), 1143-1150.
Abstract
Objective. To examine the efficacy of popular Chinese herbs used in a traditional Chinese medicine (TCM) combination of Ganoderma lucidum and San Miao San (SMS), with purported diverse health benefits including antioxidant properties in rheumatoid arthritis (RA).
Methods. We randomly assigned 32 patients with active RA, despite disease-modifying antirheumatic drugs, to TCM and 33 to placebo in addition to their current medications for 24 weeks. The TCM group received G lucidum (4 gm) and SMS (2.4 gm) daily. The primary outcome was the number of patients achieving American College of Rheumatology (ACR) 20% response and secondary outcomes included changes in the ACR components, plasma levels, and ex vivo–induced cytokines and chemokines and oxidative stress markers.
Results. Eighty-nine percent completed the 24-week study. Fifteen percent in the TCM group compared with 9.1% in the placebo group achieved ACR20 (P |