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.

A pilot, multi-dose, placebo-controlled evaluation of American ginseng (Panax quinquefolius) to improve cancer-related fatigue: NCCTG trial N03CA.

DL Barton, GS Soori, B. Bauer, et al.

Background: Fatigue is one of the most common symptoms in people diagnosed with cancer. Ginseng is a popular herb for treatment of this. It has been termed an "adaptogen", felt to be able to restore balance to the body; its potential anti-fatigue efficacy is supported by animal data. The purpose of this pilot trial was to evaluate three doses of American Ginseng versus placebo for cancer-related fatigue.

Methods: Patients with a life expectancy = 6 months and a history of cancer-related fatigue who had been experiencing fatigue = 1 month were eligible. Exclusion criteria included prior use of ginseng, chronic systemic steroids and brain malignancies. Other etiologies for fatigue, such as pain, were also excluded. Participants were randomized to receive, in a double blind manner, placebo, 750 mg/d, 1,000 mg/d or 2,000 mg/d of American Ginseng in BID dosing for 8 weeks. Endpoints included The Brief Fatigue Inventory (BFI), the Vitality Subscale of the SF-36 and several numeric analogue questions of perceived benefit; endpoints were measured at baseline, 4 weeks and 8 weeks. Area under the curve (AUC) and change from baseline were calculated.

Results: Two hundred eighty two patients (69-72 per arm) were enrolled from 10/21/2005 to 07/05/2006. Available 8-week data are provided in the table below; higher numbers are better. There were no statistically significant differences in any grade of toxicity between active and placebo arms, and an equivalent number of patients discontinued the study due to adverse events in each arm.

Conclusion: This randomized pilot trial provided data to suggest that American Ginseng doses of 1000-2000 mg/d may be effective for alleviating cancer related fatigue. Therefore, further study of American Ginseng in cancer survivors appears warranted.

Source: J Clin Oncol, June 20, 2007;25(18S):9001.

Food omega-3 fatty acid intake of individuals (total, linolenic acid, long-chain) and their blood pressure. INTERMAP Study.

H Ueshima, J Stamler, P Elliott, et al.

Findings from short-term randomized trials indicate that dietary supplements of omega-3 polyunsaturated fatty acids (PFA) lower blood pressure of hypertensive persons, but effect size in nonhypertensive individuals is small and nonsignificant. Data are lacking on food omega-3 PFA and blood pressure in general populations. The International Study of Macro- and Micro-nutrients and Blood Pressure (INTERMAP) is an international cross-sectional epidemiologic study of 4680 men and women ages 40 to 59 from 17 population-based samples in China, Japan, United Kingdom, and United States. We report associations of food omega-3 PFA intake (total, linolenic acid, long-chain) of individuals with blood pressure. Systolic and diastolic blood pressure were measured 8 times at 4 visits. With several models to control for possible confounders (dietary, other), linear regression analyses showed inverse relationship of total omega-3 PFA from food (percent kilocalories, from four 24-hour dietary recalls) to systolic and diastolic blood pressures. With adjustment for 17 variables, estimated systolic blood pressure/diastolic blood pressure differences with 2 standard deviation higher (0.67% kcal) omega-3 PFA were -0.55/-0.57 mm Hg (Z-score -1.33, -2.00); for 2238 persons without medical or dietary intervention, -1.01/-0.98 mm Hg (Z -1.63, -2.25); for 2038 nonhypertensive persons from this sub-cohort, -0.91/-0.92 mm Hg (Z -1.80, -2.38). For linolenic acid (largely from vegetable foods), blood pressure differences were similar, e.g., for the 2238 "nonintervened" individuals, -0.97/-0.87 mm Hg (Z -1.52, -1.95); blood pressure differences were -0.32/-0.45 mm Hg for long-chain omega-3 PFA (largely from fish). In summary, food omega-3 PFA intake related inversely to blood pressure, including in nonhypertensive persons, with small estimated effect size. Food omega-3 PFA may contribute to prevention and control of adverse blood pressure levels.

Source: Hypertension. June 4; 2007 [Epub ahead of print].

Effect of high-carbohydrate or high-cis-monounsaturated fat diets on blood pressure: a meta-analysis of intervention trials.

M Shah, B Adams-Huet, A Garg

Background: The Dietary Approaches to Stop Hypertension (DASH) diet is recommended to manage blood pressure. The DASH diet is low in saturated fat, but it is not clear whether saturated fat should be preferentially replaced with carbohydrate or unsaturated fat, especially cis-monounsaturated fat.

Objective: A meta-analysis of intervention studies comparing high-carbohydrate and high-cis-monounsaturated fat diets was conducted to increase understanding of the effect of carbohydrate and cis-monounsaturated fat on blood pressure.

Design: For study diets to be included in the analysis, they had to be isoenergetic, and the subjects' body weight had to remain stable. Ten studies (6 randomized crossover, 1 randomized parallel, and 3 nonrandomized) met the inclusion criteria.

Results: According to the random-effects model, which incorporates between-study variation to estimate the overall effect, diets rich in carbohydrate resulted in significantly higher systolic blood pressure [x(-) difference: 2.6 (95% CI: 0.4, 4.7) mm Hg; P=0.02] and diastolic blood pressure [1.8 (0.01, 3.6) mm Hg; P=0.05] than did diets rich in cis-monounsaturated fat. When the meta-analysis was limited to randomized crossover studies, both systolic [1.3 (-0.3, 2.9) mm Hg; P=0.11] and diastolic [0.9 (-0.2, 2.1) mm Hg; P=0.11] blood pressure were higher with a high-carbohydrate than with a high cis-monounsaturated fat diet, but the differences were not significant.

Conclusions: Diets rich in carbohydrate may be associated with slightly higher blood pressure than diets rich in cis-monounsaturated fat. However, the magnitude of the difference may not justify making recommendations to alter the carbohydrate and cis-monounsaturated fat content of the diet to manage blood pressure.

Source: Am J Clin Nutr. May 2007;85(5):1251-6.

Naturopathic care for chronic low back pain: a randomized trial.

O Szczurko, K Cooley, JW Busse, et al.

Objective: Chronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain.

Methods: This study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39) or standardized physiotherapy (n = 36) over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes.

Results: Sixty-nine participants (92%) completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (-6.89, 95% CI. -9.23 to -3.54, p = <0.0001) as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001) and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045). All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001), weight-loss (p = 0.0052) and Body Mass Index (-0.52, 95% CI, -0.96 to -0.08, p = 0.01).

Conclusions: Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain.

Source: PLoS ONE. Sept 19, 2007;2(9):e919.

Extract of Salacia oblonga lowers acute glycemia in patients with type 2 diabetes.

JA Williams, YS Choe, MJ Noss, et al.

Background: Two previous studies tested the efficacy of Salacia oblonga extract in healthy adults.

Objective: This study evaluated the effect of an herbal extract of Salacia oblonga on postprandial glycemia and insulinemia in patients with type 2 diabetes after ingestion of a high-carbohydrate meal.

Design: Sixty-six patients with diabetes were studied in this randomized, double-blinded crossover study. In a fasted state, subjects consumed 1 of the following 3 meals: a standard liquid control meal, a control meal + 240 mg Salacia oblonga extract, and a control meal + 480 mg Salacia oblonga extract. Serum glucose and insulin samples were measured at baseline and at postprandial intervals up to 180 min.

Results: Both doses of the ~~Salacia~~ extract significantly lowered the postprandial positive area under the glucose curve (14% for the 240 mg extract and 22% for the 480 mg extract) and the adjusted peak glucose response (19% for the lower dose and 27% for the higher dose of extract) to the control meal. In addition, both doses of the herbal extract significantly decreased the postprandial insulin response, lowering both the positive area under the insulin curve and the adjusted peak insulin response (14% and 9%, respectively, for the 240 mg extract; 19% and 12%, respectively, for the 480 mg extract) in comparison with the control meal.

Conclusions: The extract of Salacia oblonga lowers acute glycemia and insulinemia in persons with type 2 diabetes after a high-carbohydrate meal. The results from this study suggest that Salacia may be beneficial to this population for postprandial glucose control.

Source: Am J Clin Nutr. July 2007;86(1):124-30.

Food cravings and energy regulation: the characteristics of craved foods and their relationship with eating behaviors and weight change during 6 months of dietary energy restriction.

CH Gilhooly, SK Das, JK Golden, et al.

Objective: To examine characteristics of craved foods in relation to dietary energy restriction (ER) with high (HG) and low glycemic load (LG) diets.

Design: Assessments of food cravings before and during a randomized controlled trial of HG and LG diets provided for 6 months.

Subjects: Thirty-two healthy, overweight women aged 20-42 years.

Measurements: Self-reported food cravings and dietary intake, body weight, weight history and measures of eating behaviors.

Results: Foods craved at baseline were more than twice as high in energy density as the habitual diet (3.7+/-1.5 vs 1.7+/-0.3 kcal/g; P<0.001), and on average were lower in protein (P<0.001) and fiber (P<0.001) and higher in fat (P=0.002). There were no statistically significant changes in nutritional characteristics of craved foods after 6 months of ER. There was a significant relationship between reported portion size of craved food consumed at baseline and lifetime high body mass index (r=0.49, P=0.005). Additionally, there was a significant association between susceptibility to hunger and craving frequency at baseline, and there were significant relationships between hunger score, craving frequency, strength and percentage of time that cravings are given in to after 6 months of ER. In multiple regression models, subjects who lost a greater percentage of weight craved higher energy-dense foods at month 6 of ER, but also reported giving in to food cravings less frequently (adjusted R (2)=0.31, P=0.009).

Conclusion: High energy density and fat content, and low protein and fiber contents were identifying characteristics of craved foods. The relationships between craving variables and hunger score suggest that the relative influence of hunger susceptibility on cravings may be important before and especially after ER. Portion size of craved foods and frequency of giving in to food cravings appear to be important areas for focus in lifestyle modification programs for long-term weight loss

Source: Int J Obes (Lond). June 26, 2007 [Epub ahead of print].

Effects of fish-oil supplementation on myocardial fatty acids in humans.

RG Metcalf, MJ James, RA Gibson, et al.

Background: Increased fish or fish-oil consumption is associated with reduced risk of cardiac mortality, especially sudden death. This benefit putatively arises from the incorporation of the long-chain n-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) into cardiomyocyte phospholipids.

Objective: The study examined the kinetics of incorporation of n-3 fatty acids into human myocardial membrane phospholipids during supplementation with fish oil and alpha-linolenic acid-rich flaxseed oil.

Design: Patients with low self-reported fish intake (<1 fish meal/wk and no oil supplements) accepted for elective cardiac surgery involving cardiopulmonary bypass were randomly allocated to 1 of 6 groups: no supplement; fish oil (6 g EPA+DHA/d) for either 7, 14, or 21 d before surgery; flaxseed oil; or olive oil (both 10 mL/d for 21 d before surgery). Right atrial appendage tissue removed during surgery and blood collected at enrollment and before surgery were analyzed for phospholipid fatty acids.

Results: Surgery rescheduling resulted in a range of treatment times from 7 to 118 d. In the fish-oil-treated subjects, accumulation of EPA and DHA in the right atrium was curvilinear with time and reached a maximum at approximately 30 d of treatment and displaced mainly arachidonic acid. Flaxseed oil supplementation yielded a small increase in atrial EPA but not DHA, whereas olive oil did not significantly change atrial n-3 fatty acids.

Conclusion: The results of the present study show that dietary n-3 fatty acids are rapidly incorporated into human myocardial phospholipids at the expense of arachidonic acid during high-dose fish-oil supplementation.

Source: Am J Clin Nutr. May 2007;85(5):1222-8.

The impact of resistance exercise on the cognitive function of the elderly.

RC Cassilhas, VA Viana, V Grassmann et al.

Purpose: The purpose of this study was to assess the impact of 24 wk of resistance training at two different intensities on cognitive functions in the elderly.

Methods: Sixty-two elderly individuals were randomly assigned to three groups: CONTROL (N = 23), experimental moderate (EMODERATE; N = 19), and experimental high (EHIGH; N = 20). The volunteers were assessed on physical, hemodynamic, cognitive, and mood parameters before and after the program.

Results: On the 1 RM test (P < 0.001), the two experimental groups performed better than the CONTROL group, but they did not show differences between themselves. The EHIGH group gained more lean mass (P = 0.05) than the CONTROL group and performed better on the following tests: digit span forward (P < 0.001), Corsi's block-tapping task backward (P = 0.001), similarities (P = 0.03), Rey-Osterrieth complex figure immediate recall (P = 0.02), Toulouse-Pieron concentration test errors (P = 0.01), SF-36 (general health) (P = 0.04), POMS (tension-anxiety, P = 0.04; depression-dejection, P = 0.03; and total mood disorder, P = 0.03). The EMODERATE group scored higher means than the CONTROL group on digit span forward (P < 0.001), Corsi's block-tapping task backward (P = 0.01), similarities (P = 0.02), Rey-Osterrieth complex figure immediate recall (P = 0.02), SF-36 (general health, P = 0.005; vitality, P = 0.006), POMS (tension-anxiety, P = 0.001; depression-dejection, P = 0.006; anger-hostility, P = 0.006; fatigue-inertia, P = 0.02; confusion-bewilderment, P = 0.02; and total mood disorder, P = 0.001). We also found that IGF-1 serum levels were higher in the experimental groups (EMODERATE, P = 0.02; EHIGH, P < 0.001).

Conclusions: Moderate- and high-intensity resistance exercise programs had equally beneficial effects on cognitive functioning.

Source: Med Sci Sports Exerc. Aug 2007;39(8):1401-7.

A maternal 'junk food' diet in pregnancy and lactation promotes an exacerbated taste for 'junk food' and a greater propensity for obesity in rat offspring.

SA Bayol, SJ Farrington, NC Stickland

Obesity is generally associated with high intake of junk foods rich in energy, fat, sugar and salt combined with a dysfunctional control of appetite and lack of exercise. There is some evidence to suggest that appetite and body mass can be influenced by maternal food intake during the fetal and suckling life of an individual. However, the influence of a maternal junk food diet during pregnancy and lactation on the feeding behavior and weight gain of the offspring remains largely uncharacterized. In this study, six groups of rats were fed either rodent chow alone or with a junk food diet during gestation, lactation and/or post-weaning. The daily food intakes and body mass were measured in forty-two pregnant and lactating mothers as well as in 216 offspring from weaning up to 10 weeks of age. Results showed that 10 week-old rats born to mothers fed the junk food diet during gestation and lactation developed an exacerbated preference for fatty, sugary and salty foods at the expense of protein-rich foods when compared with offspring fed a balanced chow diet prior to weaning or during lactation alone. Male and female offspring exposed to the junk food diet throughout the study also exhibited increased body weight and BMI compared with all other offspring. This study shows that a maternal junk food diet during pregnancy and lactation may be an important contributing factor in the development of obesity.

Source: Br J Nutr. Aug 15 2007;1-9 [Epub ahead of print].