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 relationship between overweight in adolescence and premature death in women.

Rob M. van Dam, PhD; Walter C. Willett, MD; JoAnn E. Manson, MD; Frank B. Hu, MD

Background: The impact of adiposity in adolescence on death during adulthood is uncertain.
Objective: To examine the relation between adiposity in adolescence and premature death in women.
Design: Prospective cohort study.
Setting: United States.
Participants: 102, 400 women from the Nurses' Health Study II who were 24 to 44 years of age and free of cancer at baseline. Ninety percent were of non-Hispanic white ethnicity.
Measurements: In 1989, current weight and height and recalled weight at age 18 years were assessed by using validated questionnaires, and body mass index (BMI) was calculated. Hazard ratios for death and 95% CIs were adjusted for potential confounders, including cigarette smoking, alcohol use, and physical activity during adolescence.
Results: During 12 years of follow-up, 710 participants died. Compared with a BMI of 18.5 to 21.9 kg/m² at age 18 years, the hazard ratio for premature death was 0.98 (95% CI, 0.78 to 1.23) for a BMI less than 18.5 kg/m², 1.18 (CI, 0.97 to 1.43) for a BMI of 22.0 to 24.9 kg/m², 1.66 (CI, 1.31 to 2.10) for a BMI of 25.0 to 29.9 kg/m², and 2.79 (CI, 2.04 to 3.81) for a BMI of 30 kg/m² or greater. Among participants who never smoked, a BMI of 22.0 to 24.9 kg/m² at age 18 years was also associated with increased premature death (hazard ratio, 1.50 [CI, 1.16 to 1.94]). Associations between BMI at age 18 years and death could only partly be explained by adult BMI measured in 1989.
Limitations: Because of the observational study design, residual confounding by imperfectly measured or unknown confounders may still be present.
Conclusion: Moderately higher adiposity at age 18 years is associated with increased premature death in younger and middle-aged U.S. women.
Source: Annals of Internal Medicine, July 18, 2006;145(2):91-97.

Effect of a low glycemic index diet with soy protein and phytosterols on CVD risk factors in postmenopausal women.

Dan Lukaczer, ND; J. Liska DeAnn, PhD; Robert Lerman, MD, PhD; et al.

Objectives: Cardiovascular disease (CVD) is the leading cause of death in women. Hyperlipidemia is a major risk factor for CVD, but research suggests that metabolic syndrome and type 2 diabetes are also key factors in CVD in postmenopausal women. Most dietary programs, however, focus only on hyperlipidemia and not on insulin resistance associated with diabetes and metabolic syndrome. This 12-week trial compared the effects of a dietary program combining a low glycemic index diet with a functional food delivering 30 g of soy protein and 4 g of phytosterols per day (LGID) with a standard dietary program (American Heart Association Step 1 diet; AHAD) in postmenopausal women.
Methods: Fifty-nine postmenopausal women (average age 54.6 years; range 44-65 years) with a body mass index of 27 to 39 kg/m² were randomly assigned to the LGID or the AHAD program for 12 wk. Total caloric intake and exercise were matched in each arm.
Results: Twenty-seven women completed the LGID program and 26 completed the AHAD program. The participants on the LGID program showed statistically significant decreases in total cholesterol (15.8%, P = 0.0036 between-group comparison), low-density lipoprotein cholesterol (14.8%, P = 0.004 between-group comparison), and triacylglycerol (44.8%, P = 0.006 between-group comparison). In addition, significant improvements were observed in ratios of total to high-density lipoprotein cholesterol and of triacylglycerol to high-density lipoprotein cholesterol, blood pressure, and Framingham risk assessment for coronary heart disease compared with the AHAD program.
Conclusions: A significantly greater improvement was observed in CVD risk factors in postmenopausal women on the LGID program (incorporating 30 g of soy protein and 4 g of phytosterols per day) than with a standard therapy.
Source: Nutrition, February 2006;22(2):104-113 (access the journal by title).

The Trial of Infant Response to Diphenhydramine: The TIRED Study - a randomized, controlled, patient-oriented trial.

Dan Merenstein, MD; Marie Diener-West, PhD; Ann C. Halbower, MD; Alex Krist, MD; and Haya R. Rubin, MD, PhD

Objective: To determine if infants ages 6 to 15 months with frequent parent-reported nighttime awakenings require reduced parental aid during a week of diphenhydramine hydrochloride treatment and two and four weeks after its discontinuation.
Design: Double-blind, randomized, controlled clinical trial.
Setting: The study was conducted from May 1, 2004, through May 1, 2005; patients were recruited nationally.
Participants: Forty-four participants ages 6 to 15 months.
Interventions: Placebo or diphenhydramine was administered in infants 30 minutes before anticipated bedtime.
Main Outcome Measures: The primary outcome was dichotomous: a parental report of improvement in the number of night awakenings requiring parental assistance during the intervention week, which ended on day 14. Secondary outcomes were improved sleep during the two weeks before days 29 and 43, parental overall happiness with sleep, and improved sleep latency.
Results: On June 6, 2005, the data safety monitoring board voted unanimously to stop the trial early because of lack of effectiveness of diphenhydramine over placebo. Only one of 22 children receiving diphenhydramine showed improvement compared with three of 22 receiving placebo. To reach the a priori determined sample size and have a positive outcome (i.e., rejecting the null hypothesis), the trial would have needed to enroll 16 more participants in each arm, with 15 of the 16 in the diphenhydramine group and 0 of 16 in the placebo group improving.
Conclusion: During 1 week of therapy and at follow-up two and four weeks later, diphenhydramine was no more effective than placebo in reducing nighttime awakening or improving overall parental happiness with sleep for infants.
Source: Arch Pediatr Adolesc Med 2006;160:707-712.

Benefits of niacin in patients with versus without the metabolic syndrome and healed myocardial infarction (from the Coronary Drug Project).

Paul L. Canner, PhD; Curt D. Furberg, MD, PhD; and Mark E. McGovern, MD

This post hoc analysis from the Coronary Drug Project (CDP) evaluated the effects of niacin monotherapy on clinical outcomes in patients with and without the metabolic syndrome (MS). The CDP was a randomized, placebo-controlled clinical trial of lipid-modifying agents in men with previous myocardial infarction (MI). Of the five drug regimens, only niacin significantly decreased definite recurrent nonfatal MI at 6 years and total mortality at a 15-year follow-up. Patients treated with niacin (n = 1,119) and placebo (n = 2,787) were grouped according to the presence or absence of the MS at baseline. The MS was defined on the basis of meeting at least three of five criteria from the current National Cholesterol Education Program guidelines in a small subgroup of patients with high-density lipoprotein cholesterol determinations at baseline and on the basis of at least three of four criteria in the total population, excluding the high-density lipoprotein cholesterol criterion. Niacin decreased the occurrence of six-year MI and 15-year total mortality similarly among patients with or without the MS. For example, in the total population, 15-year total mortality rates were 60% and 64% (hazard ratio 0.86) in patients with the MS treated with niacin and placebo, respectively, and 50% and 57% (hazard ratio 0.86) in those without the MS (Z for interaction = 0.06, indicating homogeneity of the treatment effect across groups). In conclusion, these results support the use of niacin in postinfarction patients with and without the MS.
Source: American Journal of Cardiology, Feb. 15 2006;97(4):477-9 (access the journal by title).

Whooping cough in school-age children with persistent cough: prospective cohort study in primary care.

Anthony Harnden, Cameron Grant, Timothy Harrison, et al.

Objective: To estimate the proportion of school-age children with a persistent cough who have evidence of a recent Bordetella pertussis infection.
Design: Prospective cohort study (October 2001 to March 2005).
Setting: General practices in Oxfordshire, England.
Participants: 172 children ages 5-16 years, who presented to their general practitioner with a cough lasting 14 days or more who consented to have a blood test.
Main outcome measures: Serological evidence of a recent Bordetella pertussis infection; symptoms at presentation; duration and severity of cough; sleep disturbance (parents and child).
Results: 64 (37.2%, 95% confidence interval 30.0% to 44.4%) children had serological evidence of a recent Bordetella pertussis infection; 55 (85.9%) of these children had been fully immunised. At presentation, children with whooping cough were more likely than others to have whooping (odds ratio 2.85, 95% confidence interval 1.39 to 5.82), vomiting (4.35, 2.04 to 9.25), and sputum production (2.39, 1.14 to 5.02). Children with whooping cough were also more likely to still be coughing two months after the start of their illness (85% v 48%; P = 0.001), continue to have more than five coughing episodes a day (P = 0.049), and cause sleep disturbance for their parents (P = 0.003).
Conclusions: For school-age children presenting to primary care with a cough lasting two weeks or more, a diagnosis of whooping cough should be considered even if the child has been immunised. Making a secure diagnosis of whooping cough may prevent inappropriate investigations and treatment.
Source: British Medical Journal, July 22, 2006;333:174-177.

Bifidogenic growth stimulator for the treatment of active ulcerative colitis: a pilot study.

Asuka Suzuki, MD, PhD; Keiichi Mitsuyama, MD, PhD; Hironori Koga, MD, PhD; et al.

Objectives: Experimental studies have shown that luminal antigens are involved in chronic intestinal inflammatory disorders. Bifidogenic growth stimulator (BGS) is a prebiotic preparation produced by Propionibacterium freudenreichii isolated from Swiss cheese. Previously BGS was shown to act in the colon as a growth stimulator of Bifidobacteria. This study investigated the efficacy and safety of BGS in the treatment of ulcerative colitis.
Methods: Twelve patients with mildly to moderately active ulcerative colitis received orally 4.5 g of BGS daily for four weeks in an open-label treatment protocol while the baseline anti-inflammatory therapy was continued. The response to treatment was evaluated clinically and endoscopically. Concentrations of short-chain fatty acids and the composition of commensal bacteria, including Bifidobacteria, Enterobacteria and Bacteroides species, were studied in stool samples.
Results: Patients showed improvement in their clinical activity index scores, with a significant decrease in the score from 7.4 2.8 to 4.7 1.5 (mean standard error of the mean, P < 0.01). The endoscopic index score decreased from 4.4 1.7 to 2.8 1.8 (P < 0.05) with treatment. Patients showed an increase in stool butyrate concentrations after BGS treatment (P < 0.05). There were no significant changes in stool levels of bacteria as a result of BGS treatment. No side effects related to BGS were observed.
Conclusions: Oral BGS therapy may represent a non-toxic way to treat ulcerative colitis. However, controlled studies are needed to demonstrate its efficacy in the treatment of this disorder.
Source: Nutrition, January 2006;22(1):76-81 (access the journal by title).