naturopathydigest.com -- Critical Research

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Critical Research

Critical Research is a regular feature in Naturopathy Digest. Each month, we provide abstracts from studies published in the top peer-reviewed journals; each abstract includes the complete citation and an online link to the journal. Whenever possible, this link directs you to a page where you can order the full text of the study, if desired.

The mushroom Agaricus Blazei Murill in combination with metformin and gliclazide improves insulin resistance in type 2 diabetes: a randomized, double-blinded, and placebo-controlled clinical trial.

CH Hsu, YL Liao, SC Lin, et al.

Background: Complementary and alternative medicine use in adults with type 2 diabetes is popular. Although most of the herbs and supplements appear to be safe, there is still insufficient evidence that demonstrates their definitive beneficial effects. This study was done to determine whether the supplement of Agaricus blazei Murill extract improves insulin resistance in type 2 diabetes.
Materials and Methods: This study was a clinical randomized, double-blind, placebo-controlled trial. Of a population of 536 registered diabetes patients with 72 subjects (1) aged between 20 and 75 years, (2) being Chinese, (3) having type 2 diabetes for more than 1 year, and (4) having been taking gliclazide and metformin for more than 6 months were enrolled in this study. The enrolled patients were randomly assigned to either receiving supplement of Agaricus blazei Murill (ABM) extract or placebo (cellulose) 1500 mg daily for 12 weeks. Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.
Results: At the end of the study, subjects who received supplement of ABM extract (n = 29) showed significantly lower HOMA-IR index (3.6[standard deviation, 2.5] versus 6.6[standard deviation, 7.4], p = 0.04) than the control group (n = 31). The plasma adiponectin concentration increased 20.0(standard deviation, 40.7)% in the ABM group after 12 weeks of treatment, but decreased 12.0(20.0)% among those taking the placebo (p < 0.001).
Conclusions: Supplement of ABM extract improves insulin resistance among subjects with type 2 diabetes. The increase in adiponectin concentration after taking AMB extract for 12 weeks might be the mechanism that brings the beneficial effect. Studies with longer periods of follow-up should be conducted in the future.
Source: J Altern Complement Med, Jan-Feb 2007;13(1):97-102.

Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis.

M Yokoyama, H Origasa, M Matsuzaki, et al.

Background: Epidemiological and clinical evidence suggests that an increased intake of long-chain n-3 fatty acids protects against mortality from coronary artery disease. We aimed to test the hypothesis that long-term use of eicosapentaenoic acid (EPA) is effective for prevention of major coronary events in hypercholesterolaemic patients in Japan who consume a large amount of fish.
Methods: 18,645 patients with a total cholesterol of 6.5 mmol/L or greater were recruited from local physicians throughout Japan between 1996 and 1999. Patients were randomly assigned to receive either 1800 mg of EPA daily with statin (EPA group; n=9326) or statin only (controls; n=9319) with a 5-year follow-up. The primary endpoint was any major coronary event, including sudden cardiac death, fatal and non-fatal myocardial infarction, and other non-fatal events including unstable angina pectoris, angioplasty, stenting, or coronary artery bypass grafting. Analysis was by intention-to-treat. The study was registered at www.clinicaltrials.gov, number NCT00231738.
Findings: At mean follow-up of 4.6 years, we detected the primary endpoint in 262 (2.8%) patients in the EPA group and 324 (3.5%) in controls-a 19% relative reduction in major coronary events (p=0.011). Post-treatment LDL cholesterol concentrations decreased 25%, from 4.7 mmol/L in both groups. Serum LDL cholesterol was not a significant factor in a reduction of risk for major coronary events. Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group. Sudden cardiac death and coronary death did not differ between groups. In patients with a history of coronary artery disease who were given EPA treatment, major coronary events were reduced by 19% (secondary prevention subgroup: 158 [8.7%] in the EPA group v. 197 [10.7%] in the control group; p=0.048). In patients with no history of coronary artery disease, EPA treatment reduced major coronary events by 18%, but this finding was not significant (104 [1.4%] in the EPA group vs 127 [1.7%] in the control group; p=0.132).
Interpretation: EPA is a promising treatment for prevention of major coronary events, and especially non-fatal coronary events, in Japanese hypercholesterolaemic patients.
Source: Lancet, Mar 31, 2007;369(9567):1090-8.

Benefits of snacking in older Americans.

CA Zizza, FA Tayie, M Lino

Objective: Because energy intakes decline with age, the purpose of this study was to evaluate the influence of snacking on energy intakes and energy density in older adults.
Design: Twenty-four hour dietary recall data from the National Health and Nutrition Examination Survey 1999-2002 were used to compare the diets of snackers and nonsnackers.
Subjects: This study included 2,002 adults aged 65 years and older.
Statistical Analysis Performed: All statistical analyses accounted for the survey design and sample weights. Linear regression was used to estimate energy and energy-yielding nutrient intakes, eating occasions, energy intake per eating occasions, and energy density of eating occasions.
Results: The prevalence of snacking was high (84%) among this age group, and snackers had significantly higher daily intakes of energy, protein, carbohydrate, and total fat. Alcohol intakes were not significantly different. For those who snacked, it contributed almost a quarter of their energy and carbohydrate intakes and a fifth of their daily fat intakes. Snacking contributed 14% of their daily protein intakes. Snackers had, on average, two and a half snacking occasions per day, with each snacking occasion contributing 150 kcal. The average energy contribution of meals was not different between snackers and nonsnackers. The energy density of meals is significantly greater for snackers than for nonsnackers.
Conclusions: Results from this study demonstrate that snacking is an important dietary behavior among older adults. Whereas snacking may promote energy imbalance resulting in obesity among other age groups, our results suggest snacking may ensure older adults consume diets adequate in energy.
Source: J Am Diet Assoc, May 2007;107(5):800-6.

Benefits of supervised group exercise programme for women being treated for early stage breast cancer: pragmatic randomised controlled trial.

N Mutrie, AM Campbell, F Whyte, et al.

Objectives: To determine functional and psychological benefits of a 12-week supervised group exercise programme during treatment for early stage breast cancer, with six month follow-up.
Design: Pragmatic randomised controlled prospective open trial.
Settings: Three National Health Service oncology clinics in Scotland and community exercise facilities.
Participants: 203 women entered the study; 177 completed the six month follow-up.
Interventions: Supervised 12-week group exercise programme in addition to usual care, compared with usual care.
Main Outcome Measures: Functional assessment of cancer therapy (FACT) questionnaire, Beck depression inventory, positive and negative affect scale, body mass index, seven-day recall of physical activity, 12-minute walk test, and assessment of shoulder mobility. Results: Mixed effects models with adjustment for baseline values, study site, treatment at baseline, and age gave intervention effect estimates (intervention minus control) at 12 weeks of 129 (95% confidence interval 83 to 176) for metres walked in 12 minutes, 182 (75 to 289) for minutes of moderate intensity activity reported in a week, 2.6 (1.6 to 3.7) for shoulder mobility, 2.5 (1.0 to 3.9) for breast cancer specific subscale of quality of life, and 4.0 (1.8 to 6.3) for positive mood. No significant effect was seen for general quality of life (FACT-G), which was the primary outcome. At the six month follow-up, most of these effects were maintained and an intervention effect for breast cancer specific quality of life emerged. No adverse effects were noted.
Conclusion: Supervised group exercise provided functional and psychological benefit after a 12-week intervention and six months later. Clinicians should encourage activity for their patients. Policy makers should consider the inclusion of exercise opportunities in cancer rehabilitation services.
Source: BMJ, March 10, 2007;334(7592):484-5.

Weight status in young girls and the onset of puberty.

JM Lee, D Appugliese, N Kaciroti, et al.

Objective: We sought to examine the association between weight status in early childhood and onset of puberty.
Patients and Methods: The study included 354 girls from the National Institute of Child Health and Human Development Study of Early Child Care and Youth Development. Girls were followed longitudinally with height and weight measurements at 36 and 54 months and grades 1, 4, 5, and 6 and with assessment of pubertal stage by physical examination and maternal report in grades 4 through 6. The main outcome was the presence of early puberty, indexed as follows: (a) breast development at or more than Tanner stage 2 by physical examination at grade 4; (b) breast development at or more than Tanner stage 3 by physical examination at grade 5; (c) maternal report of breast development at or more than Tanner stage 3 at grade 5; and (d) maternal report of menarche having already occurred (yes versus no) at grade 6. Multiple logistic regression models predicting early versus late puberty were constructed by using the covariate BMI z score at 36 months, rate of change of BMI and accelerated BMI between 36 months and grade 1, race, maternal education, and maternal age of menarche.
Results: BMI z score at 36 months, rate of change of BMI between 36 months and grade 1, an earlier age of maternal menarche, and nonwhite race were each consistently and positively associated with an earlier onset of puberty across the various measures of puberty.
Conclusions: Higher BMI z score in girls as young as 36 months of age and higher rate of change of BMI between 36 months old and grade 1, a period well before the onset of puberty, are associated with earlier puberty, which suggests that increasing rates of obesity in the United States may result in an earlier average age of onset of puberty for U.S. girls.
Source: Pediatrics, March 2007;119(3):e624-30.

Interventions to promote walking: systematic review.

D Ogilvie, CE Foster, H Rothnie, et al.

Objectives: To assess the effects of interventions to promote walking in individuals and populations.
Design: Systematic review.
Data Sources: Published and unpublished reports in any language identified by searching 25 electronic databases, by searching websites, reference lists, and existing systematic reviews, and by contacting experts. Review methods Systematic search for and appraisal of controlled before and after studies of the effects of any type of intervention on how much people walk, the distribution of effects on walking between social groups, and any associated effects on overall physical activity, fitness, risk factors for disease, health, and wellbeing.
Results: We included 19 randomised controlled trials and 29 non-randomised controlled studies. Interventions tailored to people's needs, targeted at the most sedentary or at those most motivated to change, and delivered either at the level of the individual (brief advice, supported use of pedometers, telecommunications) or household (individualised marketing) or through groups, can encourage people to walk more, although the sustainability, generalisability, and clinical benefits of many of these approaches are uncertain. Evidence for the effectiveness of interventions applied to workplaces, schools, communities, or areas typically depends on isolated studies or subgroup analysis.
Conclusions: The most successful interventions could increase walking among targeted participants by up to 30-60 minutes a week on average, at least in the short term. From a perspective of improving population health, much of the research currently provides evidence of efficacy rather than effectiveness. Nevertheless, interventions to promote walking could contribute substantially towards increasing the activity levels of the most sedentary.
Source: BMJ, June 9, 2007;334(7605):1204-1206.

The association between weight history and physical performance in the Health, Aging and Body Composition Study.

DK Houston, J Ding, BJ Nicklas, et al.

Objective: Although the association between current obesity and physical disability is well known, the cumulative effect of obesity is unknown. Using data from the Health, Aging and Body Composition study, we examined the association between weight history in young and middle adulthood and weight status in late adulthood with physical performance in late adulthood.
Design: Longitudinal cohort study.
Subjects: White and black men and women aged 70-79 years at study baseline (n=2,803).Measures: Body mass index [BMI; kg/m(2)] was calculated using recalled height at age 25 and weight at age 25 and 50 and measured height and weight at ages 70-79. Physical performance at ages 70-79 was assessed using a short physical performance battery (SPPB) and a 400-m walk test.
Results: In this well-functioning cohort, approximately 24% of men and 8% of women reported being overweight or obese [BMI >/=25 kg/m(2)] at age 25, 51% of men and 37% of women reported being overweight or obese at age 50, and 69% of men and 66% of women were overweight or obese at ages 70-79. Men and women who were obese [BMI >/=30 kg/m(2)] at ages 25, 50 and 70-79 had significantly worse SPPB scores and 400-m walk times than those who were normal weight. Women who were overweight [BMI 25-29.9 kg/m(2)] at ages 25, 50 and 70-79 also had significantly worse physical performance. Furthermore, men and women who had a history of being overweight or obese at ages 25 or 50 had worse physical performance compared to those who were normal weight throughout or who were overweight or obese at ages 70-79 but not in midlife or earlier.
Conclusions: Maintaining a healthy body weight throughout adulthood may play a role in preventing or delaying the onset of physical disability.
Source: Int J Obes (Lond), May 22, 2007; [Epub ahead of print].

Effectiveness of yoga therapy in the treatment of migraine without aura: a randomized controlled trial.

PJ John, N Sharma, CM Sharma, A Kankane

Background: Numerous studies have explored the effectiveness of complementary and alternative medicine in the treatment of migraine but there is no documented investigation of the effectiveness of yoga therapy for migraine management.
Objectives: To investigate the effectiveness of holistic approach of yoga therapy for migraine treatment compared to self-care. Design.-A randomized controlled trial. Methods.-Seventy-two patients with migraine without aura were randomly assigned to yoga therapy or self-care group for 3 months. Primary outcomes were headache frequency (headache diary), severity of migraine (0-10 numerical scale) and pain component (McGill pain questionnaire). Secondary outcomes were anxiety and depression (Hospital anxiety depression scale), medication score.
Results: After adjustment for baseline values, the subjects' complaints related to headache intensity (P < .001), frequency (P < .001), pain rating index (P < .001), affective pain rating index (P < .001), total pain rating index (P < .001), anxiety and depression scores (P < .001), symptomatic medication use (P < .001) were significantly lower in the yoga group compared to the self-care group.
Conclusion: The study demonstrated a significant reduction in migraine headache frequency and associated clinical features, in patients treated with yoga over a period of 3 months. Further study of this therapeutic intervention appears to be warranted.
Source: Headache, May 2007;47(5):654-61.