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.

This Month's Featured Abstract

The ketogenic diet for the treatment of childhood epilepsy: a randomized controlled trial.

Neal EG, Chaffe H, Schwartz RH, et al.

Background: The ketogenic diet has been widely and successfully used to treat children with drug-resistant epilepsy since the 1920s. The aim of this study was to test the efficacy of the ketogenic diet in a randomized controlled trial.

Methods: 145 children aged between 2 and 16 years who had at least daily seizures (or more than seven seizures per week), had failed to respond to at least two antiepileptic drugs, and had not been treated previously with the ketogenic diet participated in a randomized controlled trial of its efficacy to control seizures. Enrolment for the trial ran between December, 2001, and July, 2006. Children were seen at one of two hospital centers or a residential centre for young people with epilepsy. Children were randomly assigned to receive a ketogenic diet, either immediately or after a 3-month delay, with no other changes to treatment (control group). Neither the family nor investigators were blinded to the group assignment. Early withdrawals were recorded, and seizure frequency on the diet was assessed after 3 months and compared with that of the controls. The primary endpoint was a reduction in seizures; analysis was intention to treat. Tolerability of the diet was assessed by questionnaire at 3 months.

Findings: 73 children were assigned to the ketogenic diet and 72 children to the control group. Data from 103 children were available for analysis: 54 on the ketogenic diet and 49 controls. Of those who did not complete the trial, 16 children did not receive their intervention, 16 did not provide adequate data, and ten withdrew from the treatment before the 3-month review, six because of intolerance. After 3 months, the mean percentage of baseline seizures was significantly lower in the diet group than in the controls (62.0%vs 136.9%, 75% decrease, 95% CI 42.4-107.4%; p<0.0001). 28 children (38%) in the diet group had greater than 50% seizure reduction compared with four (6%) controls (p<0.0001), and five children (7%) in the diet group had greater than 90% seizure reduction compared with no controls (p=0.0582). There was no significant difference in the efficacy of the treatment between symptomatic generalized or symptomatic focal syndromes. The most frequent side effects reported at 3-month review were constipation, vomiting, lack of energy, and hunger.

Interpretation: The results from this trial of the ketogenic diet support its use in children with treatment-intractable epilepsy.

Source: Lancet Neurol, 2008 May 2 [Epub ahead of print].

Frequency of vitamin D (Vit D) deficiency at breast cancer (BC) diagnosis and association with risk of distant recurrence and death in a prospective cohort study of T1-3, N0-1, M0 BC.

Goodwin PJ, Ennis M, Pritchard KI, et al.

Background: Vit D acts through a nuclear transcription factor to regulate many aspects of cellular growth and differentiation. Low levels have been associated with increased BC risk. We examined Vit D levels and prognostic effects in an existing BC cohort.

Methods: 512 consecutive women with newly diagnosed BC were enrolled at 3 U of Toronto hospitals between 1989 and 1995. A blood specimen obtained at diagnosis was stored at -80°C. The Block questionnaire was used to measure diet intake. Clinical and pathology data were obtained from medical and pathology records. 25-OH Vit D was measured by radioimmunoassay. Women were followed prospectively to 2006.

Results: Mean age was 50.4±9.7 yrs. 288 women had T1 tumors, 164 T2 and 24 T3/4. 356 tumors were N0. 342 were estrogen receptor (ER) positive. 73 tumors were grade 1, 202 grade 2 and 173 grade 3. 199 women received adjuvant chemotherapy (CXT) and 200 received tamoxifen. 116 women (22.7%) had distant recurrences and 106 (20.7%) died during a median follow-up of 11.6 yrs. Mean 25-OH Vit D was 58.1±23.4 nmol/L. Vit D levels were deficient (<50 nmol/L) in 192 (37.5%), insufficient (50-72 nmol/L) in 197 (38.5%) and adequate (>72 nmol/L) in 123 (24.0%). Low Vit D levels were associated with premenopausal status, high body mass index (BMI), high insulin and high tumor grade (all p<0.03). Low Vit D levels were associated with low dietary intake of retinol, Vitamin E, grains and alcohol (all p<0.02). Vit D was marginally lower when drawn in winter (Oct-Mar) vs summer (Apr-Sept) months (56.7 vs 59.5 nmol/L, p=0.07). Distant disease-free survival (DDFS) was significantly worse in women with deficient (vs adequate) Vit D levels (HR 1.94, 95% CI 1.16-3.24, p=0.02) as was overall survival (OS) (HR 1.73, 95% CI 1.05-2.86, p=0.02). Vit D associations with DDFS were independent of age, BMI, insulin, T and N stage, ER and grade (all HR >1.55 Q1 vs Q4, all p < 0.04); they were not significantly modified by ER, adjuvant CXT or tamoxifen. Vit D associations with OS were attenuated by grade and were absent in ER negative BC.

Conclusions: Vit D deficiency is common at BC diagnosis and is associated with poor prognosis.

Source: J Clin Oncol 2008 May 20;26:Abstract 511.

Effect of snacking frequency on adolescents' dietary intakes and meeting national recommendations.

Sebastian RS, Cleveland LE, Goldman JD

Purpose: To determine how snacking level impacts intake of nutrients and food groups and assists in meeting recommendations outlined in the U.S. Department of Agriculture's MyPyramid Food Guidance System.

Methods: Dietary data based on 24-hour recall from 4357 adolescents 12-19 years of age participating in the National Health and Nutrition Examination Survey 2001-2004 (NHANES) were analyzed. Regression analyses were applied to examine the effect of snacking on nutrient and food group intake and to determine its effect on the likelihood of meeting MyPyramid recommendations.

Results: Food energy, carbohydrate, total sugars, and vitamin C intake were positively associated, whereas protein and fat intake were negatively associated, with snacking frequency. Fruit intake increased, whereas solid fat intake decreased, as snacking incidence rose. Increasing snacking frequency was also associated with a greater likelihood of meeting milk and oil recommendations for boys and meeting fruit recommendations for both genders. Non-Hispanic black adolescents were less likely to meet their milk recommendations at low and high snacking levels and more likely to meet their fruit recommendations at high levels only. Foods consumed as snacks provided 12-39% of the day's total number of portions of the five MyPyramid food groups, 35% of total discretionary calorie intake, and 43% of total added sugar intake.

Conclusions: Snacking frequency affects intake of macronutrients and a few micronutrients and promotes consumption of fruits. Top food choices for snacks provide an excess of discretionary calories in the form of added sugars and fats. Modification of these choices would assist adolescents in consuming diets more consistent with national recommendations.

Source: J Adolesc Health. 2008 May;42(5):503-11.

Effects of aqueous green tea extract on activities of DNA turn-over enzymes in cancerous and non-cancerous human gastric and colon tissues.

Ergüder IB, Namuslu M, Sözener U, et al.

Aim: The purpose of this study was to investigate possible effects of green tea extract on the activities of DNA turn-over enzymes, namely adenosine deaminase (ADA) and xanthine oxidase (XO) in gastric and colon tissues from patients with stomach and colon cancer.

Materials and Methods: Six cancerous and 6 non-cancerous adjacent human gastric tissues, and 7 cancerous and 7 non-cancerous adjacent colon tissues obtained surgically were treated with aqueous green tea extract at 3 different concentrations for 1 hour, and then ADA and XO activities were measured.

Results: In all of the tissues, XO activities were found to elevate after treatment with green tea extract. Additionally, ADA activity was found to be inhibited in the cancerous gastric tissues by the green tea extract. Elevated XO and reduced ADA activities due to treatment with green tea extract may lower salvage pathway activity and lead to inhibition in carcinogenesis.

Conclusion: Our data suggest that green tea may support the medical treatment of stomach and colon cancer.

Source: Altern Ther Health Med, 2008 May-Jun;14(3):30-3.

The role of early life genistein exposures in modifying breast cancer risk.

Warri A, Saarinen NM, Makela S, Hilakivi-Clarke L.

Review of the existing literature suggests that consumption of soy foods or an exposure to a soy isoflavone genistein during childhood and adolescence in women, and before puberty onset in animals, reduces later mammary cancer risk. In animal studies, an exposure that is limited to the fetal period or adult life does not appear to have the same protective effect. A meta-analysis of human studies indicates a modest reduction in pre- and postmenopausal risk when dietary intakes are assessed during adult life. These findings concur with emerging evidence indicating that timing may be vitally important in determining the effects of various dietary exposures on the susceptibility to develop breast cancer. In this review, we address the mechanisms that might mediate the effects of an early life exposure to genistein on the mammary gland. The focus is on changes in gene expression, such as those involving BRCA1 and PTEN. It will be debated whether mammary stem cells are the targets of genistein-induced alterations and also whether the alterations are epigenetic. We propose that the effects on mammary gland morphology and signaling pathways induced by pubertal exposure to genistein mimic those induced by the estrogenic environment of early first pregnancy.

Source: Br J Cancer, 2008 May 6;98(9):1485-93.

Adherence to Mediterranean diet and risk of developing diabetes: prospective cohort study.

Martínez-González MA, de la Fuente-Arrillaga C, Nunez-Cordoba JM, et al.

Objective: To assess the relation between adherence to a Mediterranean diet and the incidence of diabetes among initially healthy participants. DESIGN: Prospective cohort study with estimates of relative risk adjusted for sex, age, years of university education, total energy intake, body mass index, physical activity, sedentary habits, smoking, family history of diabetes, and personal history of hypertension.

Setting: Spanish university department.

Participants: 13 380 Spanish university graduates without diabetes at baseline followed up for a median of 4.4 years.

Main Outcome Measures: Dietary habits assessed at baseline with a validated 136 item food frequency questionnaire and scored on a nine point index. New cases of diabetes confirmed through medical reports and an additional detailed questionnaire posted to those who self reported a new diagnosis of diabetes by a doctor during follow-up. Confirmed cases of type 2 diabetes.

Results: Participants who adhered closely to a Mediterranean diet had a lower risk of diabetes. The incidence rate ratios adjusted for sex and age were 0.41 (95% confidence interval 0.19 to 0.87) for those with moderate adherence (score 3-6) and 0.17 (0.04 to 0.75) for those with the highest adherence (score 7-9) compared with those with low adherence (score <3). In the fully adjusted analyses the results were similar. A two point increase in the score was associated with a 35% relative reduction in the risk of diabetes (incidence rate ratio 0.65, 0.44 to 0.95), with a significant inverse linear trend (P=0.04) in the multivariate analysis.

Conclusion: Adherence to a Mediterranean diet is associated with a reduced risk of diabetes.

Source: BMJ. 2008 Jun 14;336(7657):1348-51.

Grape-derived polyphenolics prevent Abeta oligomerization and attenuate cognitive deterioration in a mouse model of Alzheimer's disease.

Wang J, Ho L, Zhao W, et al.

Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive impairments in memory and cognition. Extracellular accumulation of soluble high-molecular-weight (HMW) Abeta oligomers has been proposed to be largely responsible for AD dementia and memory deficits in the Tg2576 mice, a model of AD. In this study, we found that a naturally derived grape seed polyphenolic extract can significantly inhibit amyloid beta-protein aggregation into high-molecular-weight oligomers in vitro. When orally administered to Tg2576 mice, this polyphenolic preparation significantly attenuates AD-type cognitive deterioration coincidentally with reduced HMW soluble oligomeric Abeta in the brain. Our study suggests that grape seed-derived polyphenolics may be useful agents to prevent or treat AD.

Source: J Neurosci. 2008 Jun 18;28(25):6388-92.

Loss of exercise-associated suppression of hunger and plasma leptin in obese but not in lean women.

Borer KT, Wuorinen E, Burant C, et al.

It is of interest to better understand whether changes in plasma leptin reflect changes in the body energy balance produced by either dietary manipulation or exercise and whether they influence perception of hunger and satiation. Obesity is associated with increased plasma leptin concentration and resistance to leptin action. We hypothesized that: (1) leptin concentration would decline in response to exercise energy expenditure (EEE) independently of exercise intensity, (2) a decline in leptin concentration would be associated with increased perception of hunger and decreased satiation, and (3) these effects would be attenuated by obesity.

Method: Ten lean (BMI= 23.4) and ten obese (BMI=37.2) postmenopausal women participated in three 36-h long counter-balanced trials: a sedentary (SED) and two exercise trials. Exercise in the form of treadmill walking was initiated at 8 and 14 h and carried out at 40% (MOD) or 80% (HI) of VO2 max. Each exercise bout consisted of ten episodes of walking, 15 min long in MOD trial and 7.5 min long in HI trial and which were separated by rest periods lasting 5 min and 10 min, respectively. Visual analog scales were provided at hourly intervals during the day to rate three measures of appetite (hunger, desire to eat, capacity to eat) and one measure of satiation (fullness). Blood was collected at 15 to 60 min intervals and processed for measurement of plasma leptin (Linco Research).

Results: EEE was about 1000 Kcal during both MOD and HI trials. Fasting plasma leptin was approximately 3.5 times higher in the obese compared to the lean women (36 vs 11 ng/ml). Following the first bout of exercise, plasma leptin concentration declined in lean women to the same extent at both exercise intensities, and stabilized about 40% below the SED level after the second exercise bout. In the obese, plasma leptin declined after MOD, but not after HI exercise. Pre-meal measures of appetite were higher in lean (80%) than in obese subjects (65%). Appetite ratings were suppressed during second exercise bout in lean but not in obese women. All subjects expressed increased sense of satiation during exercise that occurred after mid-day meal.

Conclusion: Obesity interferes with the consistent decline in plasma leptin and with the discrete mid-day appetite suppression seen in lean women in response to EEE. The two changes may be related to obesity-associated resistance to leptin action.

Source: Presented at the Endocrine Society 90^th Annual Meeting, San Francisco, June 15-18, 2008.

Protein and ginger for the treatment of chemotherapy-induced delayed nausea.

Levine ME, Gillis MG, Koch SY, et al.

Background: Nausea that develops during the period that begins 24 hours after the administration of chemotherapy is called delayed nausea, and occurs in many patients with cancer. Meals high in protein decrease the nausea of motion sickness and pregnancy, possibly by reducing gastric dysrhythmias. Ginger also has antinausea properties.

Objectives: To explore the use of protein meals with ginger for the treatment of the delayed nausea of chemotherapy.

Design: Twenty-eight (28) patients with cancer receiving chemotherapy for the first time were assigned to 1 of 3 groups. For 3 days beginning the day after their chemotherapy, Control Group patients continued with their normal diet, Protein Group patients consumed a protein drink and ginger twice daily, and High Protein Group patients consumed a protein drink with additional protein and ginger twice daily.

Outcome Measures: Patients recorded in a diary each day whether they had experienced nausea, whether their nausea had been frequent, whether their nausea had been bothersome, and whether they had needed any antiemetic medication. Gastric myoelectrical activity was assessed in 5 patients before and after ingestion of a high protein meal and ginger.

Results: Reports of nausea, frequent nausea, and bothersome nausea were significantly less common among High Protein Group patients than among Control and Protein Group patients. Furthermore, significantly fewer patients in the High Protein Group used antiemetic medication. Differences between the Protein and Control groups were not statistically significant. In the 5 patients who had tests of gastric myoelectrical activity performed, a significant decrease in gastric dysrhythmia occurred after ingestion of the protein and ginger.

Conclusions: High protein meals with ginger reduced the delayed nausea of chemotherapy and reduced use of antiemetic medications. Protein with ginger holds the potential of representing a novel, nutritionally based treatment for the delayed nausea of chemotherapy.

Source: J Altern Complement Med. 2008 Jun;14(5):545-51.

A pilot whole systems clinical trial of traditional Chinese medicine and naturopathic medicine for the treatment of temporomandibular disorders.

Ritenbaugh C, Hammerschlag R, Calabrese C, et al.

Objectives: To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research. DESIGN: A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC).

Setting/Location: Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon.

Subjects: One hundred and sixty (160) women 25-55 years of age attending a KPNW TMD specialty clinic.

Interventions: Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided.

Outcome Measures: TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0-10 where 10 is worst).

Results: Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = -1.11 +/- 0.43, p = 0.010 and -1.02 +/- 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (-1.07 +/- 0.51, p = 0.037 and -1.27 +/- 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference.

Conclusions: These alternative medicine approaches each resulted in significantly greater reduction of pain and psychosocial interference than SC. Further research on the potential benefits of traditional whole systems of medicine for TMD appears warranted.

Source: J Altern Complement Med, 2008 Jun;14(5):475-87.

The acute effect of green tea consumption on endothelial function in healthy individuals.

Alexopoulos N; Vlachopoulos C; Aznaouridis K; et al.

Background: Tea consumption is associated with decreased cardiovascular risk. Flow-mediated dilatation (FMD) of the brachial artery is related to coronary endothelial function and it is an independent predictor of cardiovascular risk. Black tea has a beneficial effect on endothelial function; the effect, however, of green tea on brachial artery reactivity has not been defined yet.

Design and Methods: We studied 14 healthy individuals (age 30+/-3 years) with no cardiovascular risk factors except from smoking (50%) on three separate occasions on which they took: (a) 6 g of green tea, (b) 125 mg of caffeine (the amount contained in 6 g of tea), or (c) hot water. FMD of the brachial artery was measured before each intervention and 30, 90, and 120 min afterward. High-sensitivity C-reactive protein, interleukins 6 (Il-6) and 1b (Il-1b), total plasma antioxidative capacity, and total plasma oxidative status/stress were measured at baseline and at 120 min after each intervention.

Results: Resting and hyperemic brachial artery diameter did not change either with tea or with caffeine. FMD increased significantly with tea (by 3.69%, peak at 30 min, P<0.02), whereas it did not change significantly with caffeine (increase by 1.72%, peak at 30 min, P=NS). Neither tea nor caffeine had any effect on high-sensitivity C-reactive protein, Il-6, Il-1b, total plasma antioxidative capacity, or total plasma oxidative status/stress.

Conclusion: Green tea consumption has an acute beneficial effect on endothelial function, assessed with FMD of the brachial artery, in healthy individuals. This may be involved in the beneficial effect of tea on cardiovascular risk.

Source: Eur J Cardiovasc Prev Rehabil, 2008 June;5(3):300-5.