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1.  Chinese herbal medicine for impaired glucose tolerance: a randomized placebo controlled trial 
Background
Diabetes remains a major health problem worldwide. Low-risk low-cost alternatives to pharmaceutical interventions are needed where lifestyle modifications have failed. We conducted a double-blind randomised placebo controlled trial to investigate the efficacy of a Chinese herbal formula, Jiangtang Xiaozhi, in treating impaired glucose control and insulin resistance in persons with prediabetes and controlled diabetes.
Methods
Seventy-one patients with prediabetes or ‘controlled’ diabetes were randomised to receive 3 capsules of Jiangtang Xiaozhi (n = 39) or placebo (n = 32) three times daily for 16 weeks with a follow up eight weeks later (week 24). The primary outcome was change in glycaemic control as evidenced by fasting blood glucose (FBG), post-prandial plasma glucose and glycosylated haemoglobin (HbA1c). Other measures included change in fasting insulin, insulin resistance and sensitivity, lipids, C-reactive protein (CRP), body mass index (BMI), waist girth, blood pressure (BP), health related quality of life (HRQoL) and safety. Analysis of covariance (ANCOVA) was used to model outcomes at 16 weeks, by treatment group corrected for baseline level of the outcome variable.
Results
In patients receiving Jiangtang Xiaozhi, FBG was not significantly different (p = 0.73) compared to placebo after 16 weeks of treatment (6.3 ± 1.1 mmol/L vs 6.7 ± 1.3 mmol/L). There was a significant difference (p = 0.04) in the mean levels of fasting insulin between the treatment group (11.6 ± 5.5 mmol/L) and the placebo group (22.1 ± 25.9 mmol/L). Insulin resistance slightly decreased in the treatment group (1.58 ± 0.74) compared to that of the placebo group (2.43 ± 1.59) but this change did not reach statistical significance (p = 0.06). Patients taking Jiangtang Xiaozhi had a significant improvement in high-density lipoprotein (HDL) level compared to the placebo group at week 16 (p = 0.03). Mean levels of cholesterol, triglycerides, BMI, waist-girth, HRQoL, BP, CRP and insulin sensitivity were not significantly different between the two groups. The herbal medicine was well tolerated.
Conclusions
In the current study, the 16 week Jiangtang Xiaozhi treatment did not lower fasting blood glucose, but it improved serum insulin and HDL cholesterol in a Western population with prediabetes or controlled diabetes. Our trial may have been underpowered. Dosage needs to be considered before commencing a longer adequately powered trial.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12612000128897; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362005
doi:10.1186/1472-6882-13-104
PMCID: PMC3659077  PMID: 23672597
2.  Interrater Reliability of Chinese Medicine Diagnosis in People with Prediabetes 
Background. Achieving reproducibility in research design is challenging when patient cohorts under study are inconsistently defined. Traditional Chinese medicine (TCM) diagnosis is one example where inconsistency between practitioners has been found. We hypothesise that the use of a validated instrument may improve consistency. Biochemical biomarkers may also be used enhance reliability. Methods. Twenty-seven participants with prediabetes were assessed by two TCM practitioners using a validated instrument (TEAMSI-TCM). Inter-rater reliability was summarised using percentage agreement and the kappa coefficient. One-way ANOVA and Tukey's post hoc test were used to test links between TCM diagnosis and biomarkers. Results. The two practitioners agreed on primary diagnosis of 70% of participants. kappa = 0.56 (P < 0.001). The three predominant TCM diagnostic patterns for people with prediabetes were Yin deficiency, Qi and Yin deficiency and Spleen qi deficiency. The Spleen Qi deficiency with Damp cohort had statistically significant higher fasting glucose, higher insulin, higher insulin resistance, higher HbA1c and lower HDL than those with Qi and Yin deficiency. Conclusions. Using the TEAMSI-TCM resulted in moderate interrater reliability between TCM practitioners. This study provides initial evidence of variation in the biomarkers of people with prediabetes according to the different TCM patterns which may suggest a route to further improving interrater reliability.
doi:10.1155/2013/710892
PMCID: PMC3665184  PMID: 23762155
3.  Using a Delphi consensus process to develop an acupuncture treatment protocol by consensus for women undergoing Assisted Reproductive Technology (ART) treatment 
Background
Assisted reproductive technologies (ART) are increasingly utilised for resolving difficulties conceiving. These technologies are expensive to both the public purse and the individual consumers. Acupuncture is widely used as an adjunct to ART with indications that it may assist reducing the time to conception and increasing live birth rates. Heterogeneity is high between treatment protocols.
The aim of this study was to examine what fertility acupuncturists consider key components of best practice acupuncture during an ART cycle, and to establish an acupuncture protocol by consensus.
Methods
Fifteen international acupuncturists with extensive experience treating women during ART interventions participated in 3 rounds of Delphi questionnaires. The first round focused on identifying the parameters of acupuncture treatment as adjunct to ART, the second round evaluated statements derived from the earlier round, and the third evaluated specific parameters for a proposed trial protocol. Consensus was defined as greater than 80% agreement.
Results
Significant agreement was achieved on the parameters of best practice acupuncture, including an acupuncture protocol suitable for future research. Study participants confirmed the importance of needling aspects relating to the dose of acupuncture, the therapeutic relationship, tailoring treatment to the individual, and the role of co-interventions. From two rounds of the Delphi a consensus was achieved on seven treatment parameters for the design of the acupuncture treatment to be used in a clinical trial of acupuncture as an adjunct to ART. The treatment protocol includes the use of the traditional Chinese medicine acupuncture, use of manual acupuncture, a first treatment administered between day 6–8 of the stimulated ART cycle which is individualised to the participant, two treatments will be administered on the day of embryo transfer, and will include points SP8, SP10, LR3, ST29, CV4, and post transfer include: GV20, KD3, ST36, SP6, and PC6. Auricular points Shenmen and Zigong will be used. Practitioner intent or yi will be addressed in the treatment protocol.
Conclusions
Despite a lack of homogeneity in the research and clinical literature on ART and acupuncture, a consensus amongst experts on key components of a best practice treatment protocol was possible. Such consensus offers guidance for further research.
doi:10.1186/1472-6882-12-88
PMCID: PMC3416745  PMID: 22769059
4.  The use of complementary and alternative medicine by people with cardiovascular disease: a systematic review 
BMC Public Health  2012;12:299.
Background
Complementary and alternative medicine (CAM) may offer benefits as well as risks to people with cardiovascular disease. Understanding the prevalence and the nature of CAM use will encourage beneficial CAM therapies, prevent potential herb-drug interactions and foster communication between patients and physicians.
Methods
A systematic search of eight bibliographic databases was conducted for studies that investigated CAM use in patients with cardiovascular diseases. Two independent reviewers selected relevant abstracts and evaluated the quality of included studies.
Results
Twenty-seven studies were included. Prevalence of CAM use in cardiac patients ranged from 4% - 61%. Biologically-based therapies usage ranged from 22% to 68%. Herbal medicines were used by between 2% and 46%. A large proportion of patients did not inform medical practitioners about their CAM use and up to 90% of treating physicians did not discuss CAM use with their patients.
Conclusions
CAM use in patients with cardiovascular disease appears common. The findings suggest that the effects of CAM on medical management of cardiovascular disease may be overlooked and that patient-physician communication need to be strengthened.
doi:10.1186/1471-2458-12-299
PMCID: PMC3444368  PMID: 22536991
5.  Chinese herbal medicines for people with impaired glucose tolerance or impaired fasting blood glucose 
Background
Around 308 million people worldwide are estimated to have impaired glucose tolerance (IGT); 25% to 75% of these will develop diabetes within a decade of initial diagnosis. At diagnosis, half will have tissue-related damage and all have an increased risk for coronary heart disease.
Objectives
The objective of this review was to assess the effects and safety of Chinese herbal medicines for the treatment of people with impaired glucose tolerance or impaired fasting glucose (IFG).
Search strategy
We searched the following databases: The Cochrane Library, PubMed, EMBASE, AMED, a range of Chinese language databases, SIGLE and databases of ongoing trials.
Selection criteria
Randomised clinical trials comparing Chinese herbal medicines with placebo, no treatment, pharmacological or non-pharmacological interventions in people with IGT or IFG were considered.
Data collection and analysis
Two authors independently extracted data. Trials were assessed for risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, outcome assessors and intervention providers, incomplete outcome data, selective outcome reporting and other sources of bias.
Main results
This review examined 16 trials lasting four weeks to two years involving 1391 participants receiving 15 different Chinese herbal medicines in eight different comparisons. No trial reported on mortality, morbidity or costs. No serious adverse events like severe hypoglycaemia were observed. Meta-analysis of eight trials showed that those receiving Chinese herbal medicines combined with lifestyle modification were more than twice as likely to have their fasting plasma glucose levels return to normal levels (i.e. fasting plasma glucose <7.8 mmol/L and 2hr blood glucose <11.1 mmol/L) compared to lifestyle modification alone (RR 2.07; 95% confidence intervall (CI) 1.52 to 2.82). Those receiving Chinese herbs were less likely to progress to diabetes over the duration of the trial (RR 0.33; 95% CI 0.19 to 0.58). However, all trials had a considerable risk of bias and none of the specific herbal medicines comparison data was available from more than one study. Moreover, results could have been confounded by rates of natural reversion to normal glucose levels.
Authors’ conclusions
The positive evidence in favour of Chinese herbal medicines for the treatment of IGT or IFG is constrained by the following factors: lack of trials that tested the same herbal medicine, lack of details on co-interventions, unclear methods of randomisation, poor reporting and other risks of bias.
doi:10.1002/14651858.CD006690.pub2
PMCID: PMC3191296  PMID: 19821382
6.  The relation between peripheral and central glutamate and glutamine in healthy male volunteers 
Objective
High-field strength proton magnetic resonance spectroscopy (1H-MRS) and peripheral blood analyses reported in the literature reveal glutamate (Glu) and glutamine (Gln) abnormalities in schizophrenia. Given the relative ease and feasibility of using peripheral measures, the present study investigates the relation between peripheral and brain Glu and Gln levels.
Methods
We recruited healthy volunteers (n = 17, mean age 21.9 [standard deviation 2.9, range 18–29] yr) between May and December 2005. All participants underwent 3 Tesla 1H-MRS analysis with segmentation (grey matter, white matter, cerebrospinal fluid) at the Nuclear Magnetic Resonance Centre at the University of Alberta Hospital to quantify medial prefrontal cortical (mPFC) Glu and Glx (i.e., combination of Glu and Gln). Within 1 week of 1H-MRS analysis, we collected plasma from the same participants for Glu and Gln quantification, using high-performance liquid chromatography at the Neurochemical Research Unit at the University of Alberta.
Results
There was no correlation between plasma Glu and either medial prefrontal cortical Glu or Glx (R1,15 = 0.019, p = 0.944 and R1,15 = 0.081, p = 0.757, respectively). Similarly, there was no correlation between plasma Gln and either mPFC Glu or Glx (R1,15 = 0.029, p = 0.911 and R1,15 = 0.025, p = 0.925, respectively).
Conclusion
Our findings support the use of 1H-MRS, instead of peripheral blood analysis, for investigating glutamatergic dysfunction in the brain.
PMCID: PMC1635795  PMID: 17136218
glutamate; glutamine; magnetic resonance spectroscopy; prefrontal cortex; plasma; schizophrenia

Results 1-6 (6)