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Polysaccharide K and Coriolus versicolor extracts for lung cancer: a systematic review.
Fritz, H, Kennedy, DA, Ishii, M, Fergusson, D, Fernandes, R, Cooley, K, Seely, D
Integrative cancer therapies. 2015;14(3):201-11
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Lung cancer is the second most commonly diagnosed cancer, generally has a poor prognosis and is the leading cause of cancer mortality. PSK is an immune modulating polysaccharide from the mushroom Coriolus versicolor which has been used in Japan in combination with standard cancer therapy for over 30 years. This systematic review looked at the evidence for the use of PSK in lung cancer and included 11 controlled human trials and 17 preclinical studies. 15 of the 17 preclinical studies supported the anticancer effects of PSK, whilst two studies showed no significant effects. No harmful or negative effects were seen in any of the studies. The review explores the mechanisms by which PSK exerts its anticancer effects. 5 of the human trials were non-randomised and suggest an increased survival of lung cancer patients who received PSK alongside chemo- or radiotherapy, although these studies have methodological weaknesses. All 6 randomised human trials showed benefits on at least one of the following study endpoints: parameters of immune function, body weight, performance score, tumour-related symptoms, or survival. No major adverse effects were reported in the studies reviewed above. There are no known contraindications for use during chemotherapy or radiation therapy. The authors conclude that PSK may significantly improve immune function, tumour-related symptoms, and survival in patients with lung cancer, when used as adjunctive therapy alongside or following standard chemotherapy or radiation therapy, or surgery. PSK appears to increase the tolerability of chemotherapy and reduce limiting factors such as bone marrow suppression.
Abstract
BACKGROUND Polysaccharide K, also known as PSK or Krestin, is derived from the Coriolus versicolor mushroom and is widely used in Japan as an adjuvant immunotherapy for a variety of cancer including lung cancer. Despite reported benefits, there has been no English language synthesis of PSK for lung cancer. To address this knowledge gap, we conducted a systematic review of PSK for the treatment of lung cancer. METHODS We searched PubMed, EMBASE, CINAHL, the Cochrane Library, AltHealth Watch, and the Library of Science and Technology from inception to August 2014 for clinical and preclinical evidence pertaining to the safety and efficacy of PSK or other Coriolus versicolor extracts for lung cancer. RESULTS Thirty-one reports of 28 studies were included for full review and analysis. Six studies were randomized controlled trials, 5 were nonrandomized controlled trials, and 17 were preclinical studies. Nine of the reports were Japanese language publications. Fifteen of 17 preclinical studies supported anticancer effects for PSK through immunomodulation and potentiation of immune surveillance, as well as through direct tumor inhibiting actions in vivo that resulted in reduced tumor growth and antimetastatic effects. Nonrandomized controlled trials showed improvement of various survival measures including median survival and 1-, 2-, and 5-year survival. Randomized controlled trials showed benefits on a range of endpoints, including immune parameters and hematological function, performance status and body weight, tumor-related symptoms such as fatigue and anorexia, as well as survival. Although there were conflicting results for impact on some of the tumor-related symptoms and median survival, overall most randomized controlled trials supported a positive impact for PSK on these endpoints. PSK was safely administered following and in conjunction with standard radiation and chemotherapy. CONCLUSIONS PSK may improve immune function, reduce tumor-associated symptoms, and extend survival in lung cancer patients. Larger, more rigorous randomized controlled trials for PSK in lung cancer patients are warranted.
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2.
Flax and Breast Cancer: A Systematic Review.
Flower, G, Fritz, H, Balneaves, LG, Verma, S, Skidmore, B, Fernandes, R, Kennedy, D, Cooley, K, Wong, R, Sagar, S, et al
Integrative cancer therapies. 2014;(3):181-92
Abstract
BACKGROUND Flax is a food and dietary supplement commonly used for menopausal symptoms. Flax is known for its lignan, α-linolenic acid, and fiber content, components that may possess phytogestrogenic, anti-inflammatory, and hormone modulating effects, respectively. We conducted a systematic review of flax for efficacy in improving menopausal symptoms in women living with breast cancer and for potential impact on risk of breast cancer incidence or recurrence. METHODS We searched MEDLINE, Embase, the Cochrane Library, and AMED from inception to January 2013 for human interventional or observational data pertaining to flax and breast cancer. RESULTS Of 1892 records, we included a total of 10 studies: 2 randomized controlled trials, 2 uncontrolled trials, 1 biomarker study, and 5 observational studies. Nonsignificant (NS) decreases in hot flash symptomatology were seen with flax ingestion (7.5 g/d). Flax (25 g/d) increased tumor apoptotic index (P< .05) and decreased HER2 expression (P< .05) and cell proliferation (Ki-67 index; NS) among newly diagnosed breast cancer patients when compared with placebo. Uncontrolled and biomarker studies suggest beneficial effects on hot flashes, cell proliferation, atypical cytomorphology, and mammographic density, as well as possible anti-angiogenic activity at doses of 25 g ground flax or 50 mg secoisolariciresinol diglycoside daily. Observational data suggests associations between flax and decreased risk of primary breast cancer (adjusted odds ratio [AOR] = 0.82; 95% confidence interval [CI] = 0.69-0.97), better mental health (AOR = 1.76; 95% CI = 1.05-2.94), and lower mortality (multivariate hazard ratio = 0.69; 95% CI = 0.50-0.95) among breast cancer patients. CONCLUSIONS Current evidence suggests that flax may be associated with decreased risk of breast cancer. Flax demonstrates antiproliferative effects in breast tissue of women at risk of breast cancer and may protect against primary breast cancer. Mortality risk may also be reduced among those living with breast cancer.
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Intravenous Vitamin C and Cancer: A Systematic Review.
Fritz, H, Flower, G, Weeks, L, Cooley, K, Callachan, M, McGowan, J, Skidmore, B, Kirchner, L, Seely, D
Integrative cancer therapies. 2014;(4):280-300
Abstract
BACKGROUND Intravenous vitamin C (IVC) is a contentious adjunctive cancer therapy, widely used in naturopathic and integrative oncology settings. We conducted a systematic review of human interventional and observational studies assessing IVC for use in cancer patients. METHODS We searched MEDLINE, EMBASE, The Cochrane Library, CINAHL, and AMED from inception to April 2013 for human studies examining the safety, effectiveness, or pharmacokinetics of IVC use in cancer patients. RESULTS Of 897 records, a total of 39 reports of 37 studies were included: 2 randomized controlled trials (RCTs), 15 uncontrolled trials, 6 observational studies, and 14 case reports. IVC dosing ranged from 1 g to more than 200 g ascorbic acid per infusion, typically administered 2 to 3 times weekly. IVC does not appear to increase toxicity or interfere with antitumor effects of gemcitabine/erlotinib therapy or paclitaxel and carboplatin. Based on 1 RCT and data from uncontrolled human trials, IVC may improve time to relapse and possibly enhance reductions in tumor mass and improve survival in combination with chemotherapy. IVC may improve quality of life, physical function, and toxicities associated with chemotherapy, including fatigue, nausea, insomnia, constipation, and depression. Case reports document several instances of tumor regression and long-term disease-free survival associated with use of IVC. CONCLUSION There is limited high-quality clinical evidence on the safety and effectiveness of IVC. The existing evidence is preliminary and cannot be considered conclusive but is suggestive of a good safety profile and potentially important antitumor activity; however, more rigorous evidence is needed to conclusively demonstrate these effects. IVC may improve the quality of life and symptom severity of patients with cancer, and several cases of cancer remission have been reported. Well-designed, controlled studies of IVC therapy are needed.
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4.
Black cohosh and breast cancer: a systematic review.
Fritz, H, Seely, D, McGowan, J, Skidmore, B, Fernandes, R, Kennedy, DA, Cooley, K, Wong, R, Sagar, S, Balneaves, LG, et al
Integrative cancer therapies. 2014;(1):12-29
Abstract
BACKGROUND Many women use black cohosh as a natural treatment for menopausal symptoms. However, controversy exists around safety in breast cancer, because of its purported estrogenic activity. We conducted a systematic review of black cohosh use in women with or at risk of breast cancer. METHODS We searched MEDLINE, Embase, the Cochrane Library, and AMED from inception to July 2012 and October 2012 for human interventional or observational data pertaining to the safety and efficacy of black cohosh in patients with or at risk of breast cancer, including an assessment of the effect of black cohosh on estrogen responsive tissues. RESULTS Of 450 records, we included 26 articles: 14 randomized controlled trials, 7 uncontrolled trials, and 5 observational studies.The evidence on efficacy for ho t flashes is divided, with some benefits seen when compared with baseline, but not when compared with placebo. Two observational studies found no association between black cohosh and risk of breast cancer, whereas 2 studies reported significant reductions in risk of primary breast cancer among postmenopausal women (adjusted odds ratio = 0.47, 95% confidence interval = 0.27-0.82), and risk of recurrence (adjusted hazard ratio = 0.75, 95% confidence interval = 0.63-0.89). Seventeen trials showed no significant impact on circulating hormone levels or proliferation in estrogen responsive tissues. CONCLUSIONS Current evidence does not support an association between black cohosh and increased risk of breast cancer. There is a lack of evidence supporting the efficacy of black cohosh for reduction of hot flashes in breast cancer patients. Given conflicting but promising results, and apparent safety, further research is warranted.
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5.
Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial.
Seely, D, Szczurko, O, Cooley, K, Fritz, H, Aberdour, S, Herrington, C, Herman, P, Rouchotas, P, Lescheid, D, Bradley, R, et al
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne. 2013;(9):E409-16
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Abstract
BACKGROUND Although cardiovascular disease may be partially preventable through dietary and lifestyle-based interventions, few individuals at risk receive intensive dietary and lifestyle counselling. We performed a randomized controlled trial to evaluate the effectiveness of naturopathic care in reducing the risk of cardiovascular disease. METHODS We performed a multisite randomized controlled trial of enhanced usual care (usual care plus biometric measurement; control) compared with enhanced usual care plus naturopathic care (hereafter called naturopathic care). Postal workers aged 25-65 years in Toronto, Vancouver and Edmonton, Canada, with an increased risk of cardiovascular disease were invited to participate. Participants in both groups received care by their family physicians. Those in the naturopathic group also received individualized care (health promotion counselling, nutritional medicine or dietary supplementation) at 7 preset times in work-site clinics by licensed naturopathic doctors. The body weight, waist circumference, lipid profile, fasting glucose levels and blood pressure of participants in both groups were measured 3 times during a 1-year period. Our primary outcomes were the 10-year risk of having a cardiovascular event (based on the Framingham risk algorithm) and the prevalence of metabolic syndrome (based on the Adult Treatment Panel III diagnostic criteria). RESULTS Of 246 participants randomly assigned to a study group, 207 completed the study. The characteristics of participants in both groups were similar at baseline. Compared with participants in the control group, at 52 weeks those in the naturopathic group had a reduced adjusted 10-year cardiovascular risk (control: 10.81%; naturopathic group: 7.74%; risk reduction -3.07% [95% confidence interval (CI) -4.35% to -1.78%], p < 0.001) and a lower adjusted frequency of metabolic syndrome (control group: 48.48%; naturopathic care: 31.58%; risk reduction -16.90% [95% CI -29.55% to -4.25%], p = 0.002). INTERPRETATION Our findings support the hypothesis that the addition of naturopathic care to enhanced usual care may reduce the risk of cardiovascular disease among those at high risk. TRIAL REGISTRATION ClinicalTrials.gov, no. NCT0071879.
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Soy, red clover, and isoflavones and breast cancer: a systematic review.
Fritz, H, Seely, D, Flower, G, Skidmore, B, Fernandes, R, Vadeboncoeur, S, Kennedy, D, Cooley, K, Wong, R, Sagar, S, et al
PloS one. 2013;(11):e81968
Abstract
BACKGROUND Soy and red clover isoflavones are controversial due to purported estrogenic activity and possible effects on breast cancer. We conducted a systematic review of soy and red clover for efficacy in improving menopausal symptoms in women with breast cancer, and for potential impact on risk of breast cancer incidence or recurrence. METHODS We searched MEDLINE, Embase, the Cochrane Library, and AMED from inception to March 2013 for human interventional or observational data pertaining to the safety and efficacy of soy and red clover isoflavones in patients with or at risk of breast cancer. RESULTS Of 4179 records, we included a total of 131 articles: 40 RCTs, 11 uncontrolled trials, and 80 observational studies. Five RCTs reported on the efficacy of soy for hot flashes, showing no significant reductions in hot flashes compared to placebo. There is lack of evidence showing harm from use of soy with respect to risk of breast cancer or recurrence, based on long term observational data. Soy intake consistent with that of a traditional Japanese diet (2-3 servings daily, containing 25-50mg isoflavones) may be protective against breast cancer and recurrence. Human trials show that soy does not increase circulating estradiol or affect estrogen-responsive target tissues. Prospective data of soy use in women taking tamoxifen does not indicate increased risk of recurrence. Evidence on red clover is limited, however existing studies suggest that it may not possess breast cancer-promoting effects. CONCLUSION Soy consumption may be associated with reduced risk of breast cancer incidence, recurrence, and mortality. Soy does not have estrogenic effects in humans. Soy intake consistent with a traditional Japanese diet appears safe for breast cancer survivors. While there is no clear evidence of harm, better evidence confirming safety is required before use of high dose (≥ 100 mg) isoflavones can be recommended for breast cancer patients.
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Selenium and lung cancer: a systematic review and meta analysis.
Fritz, H, Kennedy, D, Fergusson, D, Fernandes, R, Cooley, K, Seely, A, Sagar, S, Wong, R, Seely, D
PloS one. 2011;(11):e26259
Abstract
BACKGROUND Selenium is a natural health product widely used in the treatment and prevention of lung cancers, but large chemoprevention trials have yielded conflicting results. We conducted a systematic review of selenium for lung cancers, and assessed potential interactions with conventional therapies. METHODS AND FINDINGS Two independent reviewers searched six databases from inception to March 2009 for evidence pertaining to the safety and efficacy of selenium for lung cancers. Pubmed and EMBASE were searched to October 2009 for evidence on interactions with chemo- or radiation-therapy. In the efficacy analysis there were nine reports of five RCTs and two biomarker-based studies, 29 reports of 26 observational studies, and 41 preclinical studies. Fifteen human studies, one case report, and 36 preclinical studies were included in the interactions analysis. Based on available evidence, there appears to be a different chemopreventive effect dependent on baseline selenium status, such that selenium supplementation may reduce risk of lung cancers in populations with lower baseline selenium status (serum<106 ng/mL), but increase risk of lung cancers in those with higher selenium (≥ 121.6 ng/mL). Pooling data from two trials yielded no impact to odds of lung cancer, OR 0.93 (95% confidence interval 0.61-1.43); other cancers that were the primary endpoints of these trials, OR 1.51 (95%CI 0.70-3.24); and all-cause-death, OR 0.93 (95%CI 0.79-1.10). In the treatment of lung cancers, selenium may reduce cisplatin-induced nephrotoxicity and side effects associated with radiation therapy. CONCLUSIONS Selenium may be effective for lung cancer prevention among individuals with lower selenium status, but at present should not be used as a general strategy for lung cancer prevention. Although promising, more evidence on the ability of selenium to reduce cisplatin and radiation therapy toxicity is required to ensure that therapeutic efficacy is maintained before any broad clinical recommendations can be made in this context.
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Pathophysiology of traumatic injury in the developing brain: an introduction and short update.
Bauer, R, Fritz, H
Experimental and toxicologic pathology : official journal of the Gesellschaft fur Toxikologische Pathologie. 2004;(1-2):65-73
Abstract
Current understanding about the main peculiarities in pathophysiology of immature brain traumatic injury involves marked developmental discrepancy of biomechanical properties, aspects of altered features in water and electrolyte homeostasis as well as maturation dependent differences in structural and functional responses of major transmitter systems. Based on the fact that traumatic brain injury (TBI) is one of the major causes of morbidity and mortality in infants and children, the currently available epidemiological data are reviewed in order to gain insights about scope and dimension of health care engagement and derive the requirements for reinforced pathogenetic research. To this end, the main aspects of peculiarities in primary and secondary TBI mechanisms in the immature/developing brain are discussed, including structural and functional conditions resulting in a markedly diminished shear resistance of the immature brain tissue. As such, the immature brain tissue appears to be more susceptible to mechanical alterations, because similar mechanical load induces a more intense brain tissue displacement. Furthermore, available indications for increased incidence of brain swelling in the immature brain after TBI are reviewed, focusing on the interrelationship between the age-dependent differences in extracellular space and aquaporin-4 expression during brain maturation. The developmental differences of TBI induced cerebrovascular response as well as some relevant aspects of altered neurotransmission following TBI of the immature brain in regard to the glutamatergic and dopaminergic transmitter system are assessed. Thus, this mini-review highlights some progress but also an increased necessity for expanded pathogenetic research on a clinical scale in order to develop a solid foundation for adequate therapeutic strategies for the different life-threatening consequences of TBI in infancy and childhood, which mainly have failed up to now.