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1.  Quantitation of 6-, 8- and 10-Gingerols and 6-Shogaol in Human Plasma by High-Performance Liquid Chromatography with Electrochemical Detection 
Zingiber officinale is one of the most commonly used spices. We developed a method to determine the main pungent ginger constituents, 6-, 8- and 10-gingerols and 6-shogaol in human plasma. Quantitation was achieved using a reversed-phase C18 column using high-performance liquid chromatography with electrochemical detection. The assay was linear from 0.1 to 5.0 μg/mL. The within-day coefficients of variation for the assay at 5.0 μg/mL were ≤5% for all analytes. The recovery of all four analytes was ≥99% for at 5.0 μg/mL. The lower limit of quantitation was 0.1 μg/mL except for 10-gingerol which was 0.25 μg/mL. Currently, there is no analytical method for detecting pungent ginger constituents in human plasma. This HPLC method allows for the detection of all four of ginger’s pungent constituents simultaneously in a relatively short run time of 25 minutes. This method should be useful for determining plasma levels of 6-, 8-, 10-gingerol and 6-shogaol in phase I clinical trials.
PMCID: PMC2975369  PMID: 21072137
ginger; gingerols; shogaols; analytical methods; high performance liquid chromatography
2.  Relaxation Acupressure Reduces Persistent Cancer-Related Fatigue 
Persistent cancer-related fatigue (PCRF) is a symptom experienced by many cancer survivors. Acupressure offers a potential treatment for PCRF. We investigated if acupressure treatments with opposing actions would result in differential effects on fatigue and examined the effect of different “doses” of acupressure on fatigue. We performed a trial of acupressure in cancer survivors experiencing moderate to severe PCRF. Participants were randomized to one of three treatment groups: relaxation acupressure (RA), high-dose stimulatory acupressure (HIS), and low-dose stimulatory acupressure (LIS). Participants performed acupressure for 12-weeks. Change in fatigue as measured by the Brief Fatigue Inventory (BFI) was our primary outcome. Secondary outcomes were assessment of blinding and compliance to treatment. Fatigue was significantly reduced across all treatment groups (mean ± SD reduction in BFI: RA 4.0 ± 1.5, HIS 2.2 ± 1.6, LIS 2.7 ± 2.2), with significantly greater reductions in the RA group. In an adjusted analysis, RA resulted in significantly less fatigue after controlling for age, cancer type, cancer stage, and cancer treatments. Self-administered RA caused greater reductions in fatigue compared to either HIS or LIS. The magnitude of the reduction in fatigue was clinically relevant and could represent a viable alternative for cancer survivors with PCRF.
doi:10.1155/2011/142913
PMCID: PMC2949582  PMID: 20924499
3.  Effects of Ginger Supplementation on Cell Cycle Biomarkers in the Normal-Appearing Colonic Mucosa of Patients at Increased Risk for Colorectal Cancer: Results from a Pilot, Randomized, Controlled Trial 
To estimate the effects of ginger on apoptosis, proliferation, and differentiation in the normal-appearing colonic mucosa, we randomized 20 people at increased risk for colorectal cancer to 2.0 g of ginger or placebo daily for 28 days in a pilot trial. Overall expression and distributions of Bax, Bcl-2, p21, hTERT and MIB-1 (Ki-67) in colorectal crypts in rectal mucosa biopsies were measured using automated immunohistochemistry and quantitative image analysis. Relative to placebo, Bax expression in the ginger group decreased 15.6% (p = 0.78) in the whole crypts, 6.6% (p = 0.95) in the upper 40% (differentiation zone) of crypts, and 21.7% (p = 0.67) in the lower 60% (proliferative zone) of crypts; however, there was a 19% increase (p = 0.14) in Bax expression in the upper 40% relative to the whole crypt. While p21 and Bcl-2 expression remained relatively unchanged, hTERT expression in the whole crypts decreased by 41.2% (p = 0.05); the estimated treatment effect on hTERT expression was larger in the upper 40% of crypts (−47.9%; p = 0.04). In the ginger group, MIB-1 expression decreased in the whole crypts, upper 40% of crypts, and lower 60% of crypts by 16.9% (p = 0.39), 46.8% (p = 0.39), and 15.3% (p = 0.41), respectively. These pilot study results suggest that ginger may reduce proliferation in the normal-appearing colorectal epithelium and increase apoptosis and differentiation relative to proliferation—especially in the differentiation zone of the crypts, and support a larger study to further investigate these results.
doi:10.1158/1940-6207.CAPR-12-0327
PMCID: PMC3618532  PMID: 23303903
Differentiation (p21waf1/cip1); Apoptosis (Bax and Bcl-2); Proliferation (MIB-1/Ki-67 and hTERT); Colorectal Cancer; Ginger
4.  Phase II study of the Effects of Ginger Root Extract on Eicosanoids in Colon Mucosa in People at Normal Risk for Colorectal Cancer 
Inhibitors of cyclooxygenase (COX) indicate that up-regulation of inflammatory eicosanoids produced by COX, and in particular prostaglandin E2 (PGE2), are early events in the development of colorectal cancer (CRC). Ginger has demonstrated down regulation of COX in vitro and decreased incidence/ multiplicity of adenomas in rats. This study was conducted to determine if 2.0 g/day of ginger could decrease the levels of PGE2, 13-hydroxy-octadecadienoic acids (13-HODE), and 5-, 12-, & 15-hydroxyeicosatetraenoic acid (5-, 12-, & 15-HETE), in the colon mucosa of healthy volunteers. To investigate this aim we randomized 30 subjects to 2.0 g/day ginger or placebo for 28 days. Flexible sigmoidoscopy at baseline and day 28 was used to obtain colon biopsies. A liquid chromatography mass spectrometry method was used to determine eicosanoid levels in the biopsies, and levels were expressed per protein or per free arachidonic acid. There were no significant differences in mean percent change between baseline and day 28 for any of the eicosanoids, when normalized to protein. There was a significant decrease in mean percent change in PGE2 (p=0.05) and 5-HETE (p=0.04), and a trend toward significant decreases in 12-HETE (p=0.09) and 15-HETE (p=0.06) normalized to free arachidonic acid. There was no difference between the groups in terms of total adverse events (AE) (p=0.55). Based on these results, it appears that Ginger has the potential to decrease eicosanoid levels, perhaps by inhibiting their synthesis from arachidonic acid. Ginger also appeared to be tolerable and safe. Further investigation in people at high risk for CRC seems warranted.
doi:10.1158/1940-6207.CAPR-11-0224
PMCID: PMC3208778  PMID: 21990307
Cancer Risk Reductive; Eicosanoids; Colorectal Cancer; Inflammation; and Ginger
5.  Quantitation of 6-, 8- and 10-Gingerols and 6-Shogaol in Human Plasma by High-Performance Liquid Chromatography with Electrochemical Detection 
Zingiber officinale is one of the most commonly used spices. We developed a method to determine the main pungent ginger constituents, 6-, 8- and 10-gingerols and 6-shogaol in human plasma. Quantitation was achieved using a reversed-phase C18 column using high-performance liquid chromatography with electrochemical detection. The assay was linear from 0.1 to 5.0 μg/mL. The within-day coefficients of variation for the assay at 5.0 μg/mL were ≤ 5% for all analytes. The recovery of all four analytes was ≥99% for at 5.0 μg/mL. The lower limit of quantitation was 0.1 μg/mL except for 10-gingerol which was 0.25 μg/mL. Currently, there is no analytical method for detecting pungent ginger constituents in human plasma. This HPLC method allows for the detection of all four of ginger’s pungent constituents simultaneously in a relatively short run time of 25 minutes. This method should be useful for determining plasma levels of 6-, 8-, 10-gingerol and 6-shogaol in phase I clinical trials.
PMCID: PMC2975369  PMID: 21072137
ginger; gingerols; shogaols; analytical methods; high performance liquid chromatography
6.  Unique Aspects of Herbal Whole System Research 
Explore (New York, N.Y.)  2009;5(2):97-103.
Introduction
Whole systems of healthcare offer unique methodological and theoretical challenges for researchers. Herbalism has its own set of methodological and philosophical research issues, which are beyond those presented for whole system research, in general.
Methods
An International Society for Complementary Medicine Research (ISCMR) workshop was presented on, “Challenges in Herbal Whole Systems Research”. Starting from a definition of herbalism the most important challenges to herbal whole system research (HWSR) were elicited with inputs from both the workshop presenters and the audience.
Results
Five major challenges unique to herbal whole systems research were identified: (1) Defining herbalists and herbalism; (2) role of natural products industry in herbal research; (3) designing placebos and delivering active herbal treatments as are given by herbalists; (4) researching the herb as a living entity; and (5) designing trials to investigate and develop multi-component herbal therapies.
Conclusions
To design studies of herbalism requires unique methods and theoretical frameworks. Solutions to these methodological challenges need to be addressed to conduct research that examines herbal systems of medicine versus conducting trials on individual herbs given out of their original therapeutic context.
doi:10.1016/j.explore.2008.12.001
PMCID: PMC2685174  PMID: 19272580
Whole Systems; Herbalism; Research Methodology
7.  Pharmacokinetics of 6-, 8-, 10-Gingerols and 6-Shogaol and Conjugate Metabolites in Healthy Human Subjects 
Background
Ginger demonstrates promising anticancer properties. No research has examined the pharmacokinetics of the ginger constituents 6-, 8-, 10-gingerol and 6-shogaol in humans. We conducted a clinical trial with 6-, 8-, 10-gingerol and 6-shogaol examining the pharmacokinetics and tolerability of these analytes and their conjugate metabolites
Methods
Human volunteers were given ginger at doses from 100 mg, to 2.0 g (N=27), and blood samples were obtained at 15 minutes to 72 hours after a single oral dose. Participants were allocated in a dose-escalation manner starting with 100 mg. There was a total of three participants at each dose except for 1.0 g (N=6) and 2.0 g (N=9).
Results
No participant had detectable free 6-, 8-, 10-gingerol or 6-shogaol, but 6-, 8-, 10-gingerol and 6-shogaol glucuronides were detected. The 6-gingerol sulfate conjugate was detected above the 1.0 g dose but there were no detectable 10-gingerol or 6-shogaol sulfates except for one participant with detectable 8-gingerol sulfate. The Cmax and AUC values (Mean±SE) estimated for the 2.0 g dose are 0.85±0.43, 0.23±0.16, 0.53±0.40, and 0.15±0.12 μg/mL ; and 65.6.33±44.4, 18.1±20.3, 50.1±49.3, and 10.9±13.0 μg·hr/mL for 6-, 8-, 10-gingerol, and 6-shogaol. The corresponding tmax values are 65.6±44.4, 73.1±29.4, 75.0±27.8, and 65.6±22.6 minutes and the analytes had elimination half-lives < 2hr. The 8-, 10-gingerol and 6-shogaol conjugates were present as either glucuronide or sulfate conjugates, not as mixed conjugates, although 6-, 10-gingerol were an exception.
Conclusion
Six-, 8-, 10-gingerol and 6-shogaol is absorbed after oral dosing and can be detected as glucuronide and sulfate conjugates.
doi:10.1158/1055-9965.EPI-07-2934
PMCID: PMC2676573  PMID: 18708382
Chemoprevention; Pharmacokinetics; Gingerols; Shogaol; Ginger; Metabolism; Clinical trial
8.  Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting 
Goals of work
Ginger has been used to treat numerous types of nausea and vomiting. Ginger has also been studied for its efficacy for acute chemotherapy-induced nausea and vomiting (CINV). However, its efficacy for delayed CINV in a diverse oncology population is unknown.
Materials and methods
We performed a randomized, double-blind, placebo-controlled trial in 162 patients with cancer who were receiving chemotherapy and had experienced CINV during at least one previous round of chemotherapy. All participants were receiving a 5-HT3 receptor antagonists and/or aprepitant. Participants were randomized to receive either 1.0 g ginger, 2.0 g ginger daily, or matching placebo for 3 days. The primary outcome was change in the prevalence of delayed CINV. Secondary outcomes included acute prevalence of CINV, acute and delayed severity of CINV, and assessment of blinding.
Main results
There were no differences between groups in the prevalence of delayed nausea or vomiting, prevalence of acute CINV, or severity of delayed vomiting or acute nausea and vomiting. Participants who took both ginger and aprepitant had more severe acute nausea than participants who took only aprepitant. Participants were able to accurately guess which treatment they had received. Ginger appeared well tolerated, with no difference in all adverse events (AEs) and significantly less fatigue and miscellaneous AEs in the ginger group.
Conclusions
Ginger provides no additional benefit for reduction of the prevalence or severity of acute or delayed CINV when given with 5-HT3 receptor antagonists and/or aprepitant.
doi:10.1007/s00520-008-0528-8
PMCID: PMC4131259  PMID: 19005687
Ginger; Apripetant; Chemotherapy-induced nausea and vomiting
9.  Effect of ginger root on cyclooxygenase-1 and 15-hydroxyprostaglandin dehydrogenase expression in colonic mucosa of humans at normal and increased risk of colorectal cancer 
Objectives
Elevated tissue levels of prostaglandin E2 (PGE2), produced by cyclooxygenase (COX) are an early event in colorectal cancer (CRC). Data suggest the efficacy of non-steroidal anti-inflammatory (NSAIDs) drugs, which inhibit COX activity, as cancer preventives; however, side effects of NSAIDs indicate unacceptable limitations. Ginger has been reported to have anti-inflammatory activities with significant CRC preventive potential. We investigated if consumption of 2.0 g ginger daily regulated the level of two key enzymes, which control PGE2 production, COX-1 and NAD+- dependent 15-hydroxyprostaglandin dehydrogenase (15-PGDH).
Methods
Thirty participants at normal and twenty participants at increased risk of CRC were randomized and given 2.0 g/day ginger or placebo for 28 days. Flexible sigmoidoscopy was used to obtain colon biopsies at baseline and end of the study. Tissue level of COX-1 and 15-PGDH were assessed using Western Blotting.
Results
After ginger consumption participants at increased risk of CRC, had significantly reduced colonic COX-1 protein level (23.8%± 41) compared to the placebo group (18.9%± 52; p=0.03). Protein levels of 15-PGDH in the colon were unchanged. In normal risk for CRC participants, neither protein levels of COX-1 nor 15-PGDH in the colon were altered by ginger consumption.
Conclusion
Ginger significantly lowered COX-1 protein expression in increased risk participants, but not in normal risk participants at normal for CRC. Ginger did not alter 15-PGDH protein expression in either increased or normal risk participants. Further investigation, in larger studies with a longer ginger intervention is needed to examine the ability of ginger to impact tissue level of prostaglandin.
doi:10.1097/CEJ.0b013e32835c829b
PMCID: PMC3720765  PMID: 23222413
ginger root extract; cyclooxygenase; 15-hydroxyprostaglandin dehydrogenase; colon cancer risk; cancer risk reduction
10.  Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: A randomized placebo-controlled pilot study 
Background
Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia.
Methods
We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures.
Results
There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo.
Conclusion
Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions.
Trial Registration
ClinicalTrials.gov Identifier NCT01286324
doi:10.1186/1472-6882-11-78
PMCID: PMC3198755  PMID: 21939549
Chamomile; Matricaria; Insomnia; Herbal medicine; Sleep Quality; Fatigue
11.  Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial 
European Journal of Heart Failure  2009;11(10):990-999.
Aims
Hawthorn's efficacy when added to contemporary evidence-based heart failure therapy is unknown. We aimed to determine whether hawthorn increases submaximal exercise capacity when added to standard medical therapy.
Methods and results
We performed a randomized, double-blind, placebo-controlled trial in 120 ambulatory patients aged ≥18 years with New York Heart Association (NYHA) class II-III chronic heart failure. All patients received conventional medical therapy, as tolerated, and were randomized to either hawthorn 450 mg twice daily or placebo for 6 months. The primary outcome was change in 6 min walk distance at 6 months. Secondary outcomes included quality of life (QOL) measures, peak oxygen consumption, and anaerobic threshold during maximal treadmill exercise testing, NYHA classification, left ventricular ejection fraction (LVEF), neurohormones, and measures of oxidative stress and inflammation. There were no significant differences between groups in the change in 6 min walk distance (P = 0.61), or on measures of QOL, functional capacity, neurohormones, oxidative stress, or inflammation. A modest difference in LVEF favoured hawthorn (P = 0.04). There were significantly more adverse events reported in the hawthorn group (P = 0.02), although most were non-cardiac.
Conclusion
Hawthorn provides no symptomatic or functional benefit when given with standard medical therapy to patients with heart failure.
This trial is registered in ClinicalTrials.gov ID: NCT00343902.
doi:10.1093/eurjhf/hfp116
PMCID: PMC2754502  PMID: 19789403
Hawthorn; Crataegus; Heart failure; Systolic
12.  The Effect of Crataegus oxycantha Special Extract WSS 1442 on Clinical Progression in Patients with Mild to Moderate Symptoms of Heart Failure 
European journal of heart failure  2008;10(6):587-593.
Aim
To examine whether hawthorn (Crataegus Special Extract WS 1442 {CSE}) inhibits progression in heart failure (HF) patients.
Methods
We performed a retrospective analysis of data from the HERB CHF study in which patients with mild to moderate HF were randomised to either CSE 900 mg or placebo for 6 months. The primary outcome was time to progression of HF (HF death, hospitalisation, or sustained increase in diuretics) as assessed by log-rank tests and by Cox modelling.
Results
Progression of HF occurred in 46.6% of the CSE and 43.3% of the placebo groups (OR 1.14, 95% CI = 0.56, 2.35: p = 0.86). Patients receiving CSE were 3.9 times (95% CI = 1.1 – 13.7: p = 0.035) more likely to experience HF progression at baseline. In adjusted analysis, the risk of having early HF progression in the CSE group increased to 6.4 (95% CI = 1.5, 26.5: p = 0.011). In patients with LVEF 35%, those taking CSE were at significantly greater risk (3.2, 95% CI = 1.3, 8.3: p = 0.02) than the placebo group.
Conclusions
CSE does not reduce heart failure progression in patients who have HF. CSE appears to increase the early risk of HF progression.
doi:10.1016/j.ejheart.2008.04.008
PMCID: PMC2577845  PMID: 18490196
Hawthorn; Heart Failure Progression; Crataegus Special Extract WS 1442; Crataegus oxycantha
13.  Quercetin Blocks Airway Epithelial Cell Chemokine Expression 
Quercetin (3,3′,4′,5,7-pentahydroxyflavone), a dietary flavonoid, is an inhibitor of phosphatidylinositol (PI) 3-kinase and potent antioxidant. We hypothesized that quercetin blocks airway epithelial cell chemokine expression via PI 3-kinase–dependent mechanisms. Pretreatment with quercetin and the PI 3–kinase inhibitor LY294002 each reduced TNF-α–induced IL-8 and monocyte chemoattractant protein (MCP)-1 (also called CCL2) expression in cultured human airway epithelial cells. Quercetin also inhibited TNF-α–induced PI 3-kinase activity, Akt phosphorylation, intracellular H2O2 production, NF-κB transactivation, IL-8 promoter activity, and steady-state mRNA levels, consistent with the notion that quercetin inhibits chemokine expression by attenuating NF-κB transactivation via a PI 3-kinase/Akt-dependent pathway. Quercetin also reduced TNF-α–induced chemokine secretion in the presence of the transcriptional inhibitor actinomycin D, while inducing phosphorylation of eukaryotic translation initiation factor (eIF)-2α, suggesting that quercetin attenuates chemokine expression by post-transcriptional as well as transcriptional mechanisms. Finally, we tested the effects of quercetin in cockroach antigen–sensitized and –challenged mice. These mice show MCP-1–dependent airways hyperresponsiveness and inflammation. Quercetin significantly reduced lung MCP-1 and methacholine responsiveness. We conclude that quercetin blocks airway cell chemokine expression via transcriptional and post-transcriptional pathways.
doi:10.1165/rcmb.2006-0149OC
PMCID: PMC2643278  PMID: 16794257
asthma; chemokines; epithelial cells; lung; signal transduction
14.  Trends in complementary/alternative medicine use by breast cancer survivors: Comparing survey data from 1998 and 2005 
BMC Women's Health  2007;7:4.
Background
Use of complementary and alternative medicine (CAM) by women with breast cancer is often said to be increasing, yet few data exist to confirm this commonly held belief.
The purpose of this paper is to compare overall patterns of CAM use, as well as use of specific products and therapies at two different points in time (1998 vs 2005) by women diagnosed with breast cancer.
Methods
Surveys were mailed to women randomly selected from the Ontario Cancer Registry (Canada) in the spring of 1998 (n = 557) and again in the spring of 2005(n = 877).
Results
The response rates were 76.3% in 1998 and 63% in 2005. In 1998, 66.7% of women reported using either a CAM product/therapy or seeing a CAM therapist at some time in their lives as compared with 81.9% in 2005 (p = 0.0002). Increases were seen in both use of CAM products/therapies (62% in 1998 vs. 70.6% in 2005) and visits to CAM practitioners (39.4% of respondents in 1998 vs 57.4% of respondents in 2005). Women in 2005 reported that 41% used CAM for treating their breast cancer. The most commonly used products and practitioners for treating breast cancer as reported in 2005 were green tea, vitamin E, flaxseed, vitamin C, massage therapists and dietitians/nutritionists.
Conclusion
CAM use (both self-medication with products and visits to CAM practitioners) increased significantly from 1998 to 2005. Now that more than 80% of all women with breast cancer report using CAM (41% in a specific attempt to management their breast cancer), CAM use can no longer be regarded as an "alternative" or unusual approach to managing breast cancer.
doi:10.1186/1472-6874-7-4
PMCID: PMC1851951  PMID: 17397542
15.  Developing CAM Research Capacity for Complementary Medicine 
This article describes initiatives that have been central to the development of complementary and alternative medicine (CAM) research capacity in the United Kingdom, Canada and the United States over the last decade. While education and service delivery are essential parts of the development of CAM, this article will focus solely on the development of research strategy. The development of CAM research has been championed by both patients and politicians, primarily so that we may better understand the popularity and apparent effectiveness of these therapies and support integration of safe and effective CAM in health care. We hope that the perspective provided by this article will inform future research policy.
doi:10.1093/ecam/nel007
PMCID: PMC1475932  PMID: 16786061
CAM; research; strategy; US; UK; Canada

Results 1-15 (15)