Archive for the ‘Clinical Studies’ Category

Less n-6 fat and more n-3 fat improves chronic headache

May 14 2014

by alex

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In general, the lipid mediators derived from the n-6 PUFA (polyunsaturated fatty acid) arachidonic acid are pro-inflammatory and pronociceptive (increase pain), while those from n-3 LC-PUFAs are less inflammatory. DHA and EPA (found in fish oil) also give rise to several compounds (resolvins, protectins and maresins) that are anti-inflammatory, pro-resolving and pain-reducing. These distinctions suggest that dietary manipulations to reduce n-6 PUFAs and increase n-3 LC-PUFAs might contribute to the effective management of pain.

This study was designed to explore this in patients with chronic daily headache. The patients were assigned to either:
diet high in n-3 LC-PUFAs (long chain poly-unsaturated fatty acids) and low in linoleic acid (n-6 fatty acid)
diet only low in linoleic acid.
The investigators examined headache-related clinical outcomes, red blood cell fatty acids and pro- and anti-nociceptive derivatives of these PUFA families. The primary outcome was headache hours per day.

Sixty-seven participants were recruited who had headaches ≥ 4 hours per day for ≥ 15 days per month for at least 3 months and a headache history of ≥ 2 years under physician headache management. Participants with headaches secondary to head or neck trauma, cranial or cervical vascular disorder, substance use or withdrawal and certain other conditions were ineligible. A neurologist classified the type of headache as chronic migraine, chronic daily headache with migraine features or chronic daily headache without migraine. Approximately 87% of participants were female, with an average age of 42 years.

After a 4-week run-in phase, participants were randomly allocated to consume either the low n-6 PUFA/high n-3 LC-PUFA diet or the low n-6 PUFA diet for 12 weeks.

The investigators calculated the total highly unsaturated fatty acids (HUFA, unsaturated fatty acids with ≥ 4 double bonds) in the red blood cells and the proportion of n-6 PUFA in the total HUFA, as well as the n-3 index, the sum of EPA and DHA. They measured anti-nociceptive mediators derived from EPA and DHA, pro-nociceptive mediators derived from linoleic and arachidonic acids.

To assess headache-related disability, participants completed the Headache Impact Test (HIT-6) at randomization and on the final day of the 12-week intervention and completed a daily headache diary for the run-in and experimental periods to determine the number of headache days. The HIT-6 test covers six categories of the effects of headache. The investigators monitored the number and type of medications used at the beginning and end of the study.

At 12 weeks, both groups had significant improvements in all clinical outcomes, but the improvements were significantly greater in those on the low n-6/high n-3 LC-PUFA diet. There were also significantly fewer patients on the low n-6/high n-3 LC-PUFA diet who used any pain-related acute or adjunctive medication at the end of the study compared with baseline.

Both groups achieved significant reductions in red blood cell n-6 HUFA score and significant increases in the omega-3 index, with changes substantially greater in the low n-6/high n-3 LC-PUFA group. It is worth noting that simply reducing the consumption of n-6 PUFAs without adding n-3 LC-PUFAs was associated with a significant increase in red blood cell EPA and DHA. Only the low n-6/high n-3 LC-PUFA group had significantly reduced red blood cell arachidonic acid levels (change, 14.3 to 12.3, P = 0.001 vs 14.2 to 13.2, NS), even though the low n-6 PUFA group reduced their dietary intake of arachidonic acid by half. This observation suggests that red blood cell concentrations of arachidonic acid are tightly regulated.

The low-n-6/high n-3 LC-PUFA diet was also associated with significant increases in the precursors of EPA- and DHA-derived resolvins, which have anti-nociceptive properties, and decreases in several pro-nociceptive eicosanoid derivatives of linoleic acid and arachidonic acid. Interestingly, the low n-6 PUFA diet was associated with lower levels of some pro-nociceptive derivative HETEs, even though their precursor levels did not change. This group also had increased anti-nociceptive precursors, which was probably related to the higher EPA and DHA levels observed in their red blood cells. The authors suggest that these changes might have resulted from reduced metabolic competition between n-6 and n-3 LC-PUFAs.

The key finding from this study was the significant marked reduction in chronic headache pain, as observed in fewer headache hours per day, fewer headache days per month and clinically improved quality of life among chronic headache patients consuming a diet low in n-6 PUFA and high in n-3 LC-PUFAs. There were modest improvements in headache pain with the low n-6 PUFA diet (Table), but none were comparable to the changes with the combined dietary PUFA alterations. The combined dietary changes were also associated with a significant reduction in the consumption of acute and chronic pain medications and red blood cell arachidonic acid concentrations. Changes in the concentrations of the PUFA-derived anti- and pro-nociceptive mediators, such as resolvins and prostaglandins suggest that these substances might contribute to the clinical improvements observed. More detailed studies could confirm and extend these observations.

These results were superior to other studies that simply supplemented with EPA and DHA without restricting n-6 fats.

This study adds to the growing body of evidence showing clinical usefulness of fish oil supplementation in the context of other dietary fatty acid intake.


Targeted alteration of dietary n-3 and n-6 fatty acids for the treatment of chronic headaches: a randomized trial

Ramsden CE, Faurot KR, Zamora D, Suchindran CM, Macintosh BA, Gaylord S, Ringel A, Hibbeln JR, Feldstein AE, Mori TA, Barden A, Lynch C, Coble R, Mas E, Palsson O, Barrow DA, Mann JD.
Pain. 2013 Nov;154(11):2441-51. doi: 10.1016/j.pain.2013.07.028. Epub 2013 Jul 22.


Omega-3 and n-6 fatty acids are biosynthetic precursors to lipid mediators with antinociceptive and pronociceptive properties. We conducted a randomized, single-blinded, parallel-group clinical trial to assess clinical and biochemical effects of targeted alteration in dietary n-3 and n-6 fatty acids for treatment of chronic headaches. After a 4-week preintervention phase, ambulatory patients with chronic daily headache undergoing usual care were randomized to 1 of 2 intensive, food-based 12-week dietary interventions: a high n-3 plus low n-6 (H3-L6) intervention, or a low n-6 (L6) intervention. Clinical outcomes included the Headache Impact Test (HIT-6, primary clinical outcome), Headache Days per month, and Headache Hours per day. Biochemical outcomes included the erythrocyte n-6 in highly unsaturated fatty acids (HUFA) score (primary biochemical outcome) and bioactive n-3 and n-6 derivatives. Fifty-six of 67 patients completed the intervention. Both groups achieved targeted intakes of n-3 and n-6 fatty acids. In intention-to-treat analysis, the H3-L6 intervention produced significantly greater improvement in the HIT-6 score (-7.5 vs -2.1; P<0.001) and the number of Headache Days per month (-8.8 vs -4.0; P=0.02), compared to the L6 group. The H3-L6 intervention also produced significantly greater reductions in Headache Hours per day (-4.6 vs -1.2; P=0.01) and the n-6 in HUFA score (-21.0 vs -4.0%; P<0.001), and greater increases in antinociceptive n-3 pathway markers 18-hydroxy-eicosapentaenoic acid (+118.4 vs +61.1%; P<0.001) and 17-hydroxy-docosahexaenoic acid (+170.2 vs +27.2; P<0.001). A dietary intervention increasing n-3 and reducing n-6 fatty acids reduced headache pain, altered antinociceptive lipid mediators, and improved quality-of-life in this population.

Fish Oil Helps Rheumatoid Arthritis

May 6 2014

by alex

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There have been a number of clinical trials evaluating fish oil in the treatment of rheumatoid arthritis, with most of the studies showing benefit in reduction of pain and swelling. This study looked at the use of fish oil in recently diagnosed RA patients. They compared low dose and high dose fish oil as adjunctive treatment along with conventional medications. The results were positive. Fish oil is underutilized by rheumatologists in the treatment of their RA patients, but more studies such as this one should change this.


Fish oil in recent onset rheumatoid arthritis: a randomised, double-blind controlled trial within algorithm-based drug use

Proudman SM, James MJ, Spargo LD, Metcalf RG, Sullivan TR, Rischmueller M, Flabouris K, Wechalekar MD, Lee AT, Cleland LG.
Ann Rheum Dis. 2013 Sep 30. doi: 10.1136/annrheumdis-2013-204145. [Epub ahead of print]


The effects of fish oil (FO) in rheumatoid arthritis (RA) have not been examined in the context of contemporary treatment of early RA. This study examined the effects of high versus low dose FO in early RA employing a ‘treat-to-target’ protocol of combination disease-modifying anti-rheumatic drugs (DMARDs).

Patients with RA <12 months’ duration and who were DMARD-naïve were enrolled and randomised 2:1 to FO at a high dose or low dose (for masking). These groups, designated FO and control, were given 5.5 or 0.4 g/day, respectively, of the omega-3 fats, eicosapentaenoic acid + docosahexaenoic acid. All patients received methotrexate (MTX), sulphasalazine and hydroxychloroquine, and DMARD doses were adjusted according to an algorithm taking disease activity and toxicity into account. DAS28-erythrocyte sedimentation rate, modified Health Assessment Questionnaire (mHAQ) and remission were assessed three monthly. The primary outcome measure was failure of triple DMARD therapy.

In the FO group, failure of triple DMARD therapy was lower (HR=0.28 (95% CI 0.12 to 0.63; p=0.002) unadjusted and 0.24 (95% CI 0.10 to 0.54; p=0.0006) following adjustment for smoking history, shared epitope and baseline anti-cyclic citrullinated peptide. The rate of first American College of Rheumatology (ACR) remission was significantly greater in the FO compared with the control group (HRs=2.17 (95% CI 1.07 to 4.42; p=0.03) unadjusted and 2.09 (95% CI 1.02 to 4.30; p=0.04) adjusted). There were no differences between groups in MTX dose, DAS28 or mHAQ scores, or adverse events.

FO was associated with benefits additional to those achieved by combination ‘treat-to-target’ DMARDs with similar MTX use. These included reduced triple DMARD failure and a higher rate of ACR remission.

Nutraceutical Improves Cognition

April 30 2014

by alex

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An abundance of epidemiologic research has shown an association between diets high in polyphenols (found in certain plant foods such as blueberries and green tea) and better cognitive performance in aging populations.

A group of researchers at the University of South Florida developed a nutritional supplement containing extracts from blueberries, green tea and grapes along with with vitamin D3 and carnosine.

They evaluated the effect on cognitive performance in 105 healthy older adults, ages 65 to 85 over just 2 months. Participants took a battery of memory tests at baseline and again after 2 months.

The subjects who received the supplement demonstrated improvements in cognitive processing speed, while those who received placebo did not. Reduced cognitive processing speed, which can slow thinking and learning, has been associated with advancing age.

Preclinical trials in aging rats had revealed that the supplement promoted the growth of stem cells in the brain, produced an overall rejuvenating effect, benefitted animals with simulated stroke, and led to better cognitive performance.

Further human clinical trials are planned.


Nutraceutical Intervention Improves Older Adults’ Cognitive Functioning

Brent Small, Kerri Rawson, Christina Martin, Sarah Eisel, Cindy D Sanberg, Cathy McEvoy, Paul Sanberg, R. Douglas Shytle, Jun Tan, Paula C Bickford.
Rejuvenation Research, 2013; 131017084344003 DOI: 10.1089/rej.2013.1477

Interventions to improve the cognitive health of older adults are of critical importance. In the current study, we conducted a double-blind placebo controlled clinical trial using a pill-based nutraceutical (NT-020) that contained a proprietary formulation of blueberry, carnosine, green tea, Vitamin D3 and Biovin to evaluate the impact on changes in multiple domains of cognitive functioning. One hundred and five cognitively intact adults aged 65 to 85 years of age (M = 73.6 years) were randomized to receive NT-020 (n = 52) or a placebo (n = 53). Participants were tested with a battery of cognitive performance tests that were classified into six broad domains: episodic memory, processing speed, verbal ability, working memory, executive functioning and complex speed at baseline and two months later. The results indicated that persons taking NT-020 improved significantly on two measures of processing speed across the two month test period in contrast to persons on the placebo whose performance did not change. None of the other cognitive ability measures were related to intervention group. The results also indicated that the NT-020 was well tolerated by older adults and the presence of adverse events or symptoms did not differ between the NT-020 and placebo groups. Overall, the results of the current study were promising and suggest the potential for interventions like these to improve the cognitive health of older adults.

Health Benefits of Kimchi

April 28 2014

by alex

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Kimchi is a Korean fermented food that is highly nutritious.

This publication is a review of the researched health benefits of this food. If you have never tried kimchi, you might want to consider it.


n-3 fatty acids for Dry Eyes

January 27 2014

by alex

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Dry eye symptoms can be quite bothersome. Here is a study with over 900 subjects that found a dietary supplement containing n-3 fatty acids and antioxidants to be effective for dry eye symptoms.


Effectiveness and tolerability of dietary supplementation with a combination of omega-3 polyunsaturated fatty acids and antioxidants in the treatment of dry eye symptoms: results of a prospective study.

Oleñik A.
Clin Ophthalmol. 2014;8:169-76. doi: 10.2147/OPTH.S54658. Epub 2014 Jan 6.


We assessed the effectiveness and tolerability of a dietary supplement based on the combination of omega-3 essential fatty acids and antioxidants on dry eye-related symptoms.

A total of 905 patients (72% women, median age 60 years) with dry eye syndrome and using artificial tears to relieve symptoms participated in an open-label prospective intervention study. They were recruited during a routine ophthalmological appointment. Patients were instructed to take three capsules/day of the nutraceutical formulation (Brudysec® 1.5 g) for 12 weeks. Dry eye symptoms (categorized as 0, none; 1, mild; 2, moderate; and 3, severe) included scratchy and stinging sensation in the eyes, eye redness, grittiness, painful eyes, tired eyes, grating sensation, and blurry vision.

The mean intensity of dry eye symptoms varied from 1.1 (± standard deviation [SD] 0.9) for painful eyes to 2.0 (0.9) for grittiness, with a mean value of 11.9 (4.8) for all symptoms together. At week 12, all individual symptoms improved significantly (P<0.001). The mean value for all symptoms together decreased from a mean value of 11.9 (± SD 4.8) at baseline to 6.8 (± SD 4.5) after 12 weeks of treatment (P<0.001). There was a decrease in the percentage of patients in which dry eye symptoms predominated nearly all the time (53.5% versus 34.1%). A total of 68.1% of patients reported better tolerance to contact lenses after treatment. The mean number of daily instillations of artificial tears also decreased significantly (3.8 [± SD 1.6] versus 3.3 [± SD 1.6], P<0.001). A total of 634 patients (70.1%) did not report any adverse events. In the remaining patients with adverse events, the most frequent was fish-tasting regurgitation in 13.5% of cases, followed by nausea in 4.9%, diarrhea in 1.3%, and vomiting in 0.3%.

Dietary supplementation with a combination of omega-3 essential fatty acids and antioxidants was an effective treatment for dry eye.

Full text link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3888348/

Here is another study with positive results.

A randomized controlled trial of omega-3 fatty acids in dry eye syndrome.

Bhargava R1, Kumar P2, Kumar M3, Mehra N1, Mishra A1.
Int J Ophthalmol. 2013 Dec 18;6(6):811-6. doi: 10.3980/j.issn.2222-3959.2013.06.13.


To evaluate the role of dietary supplementation of omega-3 fatty acids in dry eye syndrome.

A prospective, interventional, placebo controlled, double blind randomized trial was done at two referral eye centers. Two hundred and sixty-four eyes of patients with dry eye were randomized to receive one capsule (500mg) two times a day containing 325mg EPA and 175mg DHA for 3 months (omega-3 group). The omega-3 group was compared to a group of patients (n=254) who received a placebo (placebo group). There were 4 patient visits (at baseline, 1 month, 2 months and 3 months). On each visit, recording of corrected distance visual acuity (CDVA), slit lamp examination and questionnaire based symptom evaluation and scoring was done. A symptomatic score of 0-6 was mild, 6.1-12 moderate and 12.1-18 severe dry eye. Response to intervention was monitored by routine tear function tests like Schirmer I test, tear film break-up time (TBUT), Rose Bengal staining and most notably, conjunctival impression cytology.

Sixty-five percent of patients in the omega-3 group and 33% of patients in placebo group had significant improvement in symptoms at 3 months (P=0.005). There was a significant change in both Schirmer’s test value and TBUT values in the omega-3 group (P<0.001), both comparisons. However, there was a larger drift in TBUT values in omega-3 than the placebo group, in comparison to Schirmer’s test values. The mean TBUT score was 2.54±2.34 in the omega-3 group and 0.13±0.16 in placebo group, respectively. The mean reduction in symptom score in omega-3 group was 2.02±0.96 as compared to 0.48±0.22 in placebo group (P<0.001). Despite a slight increase mean score, the Schirmer scores did not correlate well with symptomatic improvement.

Omega-3 fatty acids have a definite role for dry eye syndrome. The benefit seems to be more marked in conditions such as blepharitis and meibomian gland disease. The role of omega fatty acids in tear production and secretion needs further evaluation.

Full text link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874521/

Low Zinc in Depression

January 10 2014

by alex

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This is an interesting meta-analysis of 17 studies comparing serum zinc levels in depressed and non-depressed subjects. They found that depressed patients had lower levels of zinc and severely depressed patients had the lowest levels.

There is a wide range of nutrients known to play a role in depressive disorders, with zinc being but one of them. Nutrition matters, always.


Zinc in Depression: A Meta-Analysis

Walter Swardfager, Nathan Herrmann, Graham Mazereeuw, Kyle Goldberger, Tetsuhiro Harimoto, Krista L. Lanctôt
Biological Psychiatry, Volume 74, Issue 12 , Pages 872-878, 15 December 2013

Zinc is an essential micronutrient with diverse biological roles in cell growth, apoptosis and metabolism, and in the regulation of endocrine, immune, and neuronal functions implicated in the pathophysiology of depression. This study sought to quantitatively summarize the clinical data comparing peripheral blood zinc concentrations between depressed and nondepressed subjects.

PubMed, Cumulated Index to Nursing and Allied Health Literature, and PsycINFO were searched for original peer-reviewed studies (to June 2012) measuring zinc concentrations in serum or plasma from depressed subjects (identified by either screening or clinical criteria) and nondepressed control subjects. Mean (±SD) zinc concentrations were extracted, combined quantitatively in random-effects meta-analysis, and summarized as a weighted mean difference (WMD).

Seventeen studies, measuring peripheral blood zinc concentrations in 1643 depressed and 804 control subjects, were included. Zinc concentrations were approximately −1.85 µmol/L lower in depressed subjects than control subjects (95% confidence interval: [CI]: −2.51 to −1.19 µmol/L, Z17 = 5.45, p < .00001). Heterogeneity was detected (χ217 = 142.81, p < .00001, I2 = 88%) and explored; in studies that quantified depressive symptoms, greater depression severity was associated with greater relative zinc deficiency (B = −1.503, t9 = −2.82, p = .026). Effect sizes were numerically larger in studies of inpatients (WMD −2.543, 95% CI: −3.522 to −1.564, Z9 = 5.09, p < .0001) versus community samples (WMD −.943, 95% CI: −1.563 to −.323, Z7 = 2.98, p = .003) and in studies of higher methodological quality (WMD −2.354, 95% CI: −2.901 to −1.807, Z7 = 8.43, p < .0001).

Depression is associated with a lower concentration of zinc in peripheral blood. The pathophysiological relationships between zinc status and depression, and the potential benefits of zinc supplementation in depressed patients, warrant further investigation.

Mediterranean Diet Superior to DASH Diet in this study

January 7 2014

by alex

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The Women’s Health Initiative is a long-term prospective cohort study with a very large cohort of women. Long-term outcomes can be evaluated in such studies.

This study looked at degree of adherence to the DASH (Dietary Approaches to Stop Hypertension) or to the Mediterranean diet and evaluated the risk of sudden cardiac death.

The results are striking: greater adherence to the Mediterranean diet was associated with a large reduction in risk of sudden cardiac death, whereas there was no risk reduction in those with greater adherence to the DASH diet.

The DASH diet has been shown to reduce blood pressure, however cardiovascular outcomes (heart attack, stroke, death) are what matter.

So, in women at least, the Mediterranean diet is superior in reducing the risk of sudden cardiac death.


Mediterranean and Dietary Approaches to Stop Hypertension dietary patterns and risk of sudden cardiac death in postmenopausal women

Monica L Bertoia, Elizabeth W Triche, Dominique S Michaud, Ana Baylin, Joseph W Hogan, Marian L Neuhouser, Lesley F Tinker, Linda Van Horn, Molly E Waring, Wenjun Li, James M Shikany, Charles B Eaton
Am J Clin Nutr February 2014 ajcn.056135


Background: The Mediterranean and Dietary Approaches to Stop Hypertension (DASH) diets are characterized by higher intake of fruit, vegetables, whole grains, and unsaturated fatty acids. All of these foods and nutrients may affect cholesterol, inflammation, the development of atherosclerosis, and, therefore, risk of cardiac death.

Objective: Our objective was to examine the association between the Mediterranean and DASH dietary patterns and risk of sudden cardiac death (SCD) in women.

Design: We used a prospective cohort of 93,122 postmenopausal women enrolled in the Women’s Health Initiative study between 1993 and 1998 and followed for an average of 10.5 y. Women completed a food-frequency questionnaire (FFQ) twice during follow-up. We scored their diets according to how closely the reported diet resembled each dietary pattern. SCD was defined as death that occurred within 1 h of symptom onset.

Results: A higher Mediterranean diet score was associated with lower risk of SCD (HR: 0.64; 95% CI: 0.43, 0.94) when women in the highest quintile were compared with women in the lowest quintile after adjustment for age, total energy, race, income, smoking, and physical activity. After adjustment for potential mediators, the association was similar (HR: 0.67; 95% CI: 0.46, 0.99). A higher DASH diet score was not associated with risk of SCD. However, sodium intake, which is a crucial component of the DASH dietary pattern, was not well characterized by the FFQ.

Conclusion: The Mediterranean dietary pattern may be associated with lower risk of SCD in women.

Mediterranean Diet Reduces All Causes of Mortality

December 6 2013

by alex

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Yet another study examining the impact of adherence to the Mediterranean diet has been published.
This study looked at men and women with existing cardiovascular disease. Greater adherence to the Mediterranean diet reduced mortality from cardiovascular disease, cancer and all causes.

The Mediterranean-style diet pattern and mortality among men and women with cardiovascular disease

Esther Lopez-Garcia, Fernando Rodriguez-Artalejo, Tricia Y Li, Teresa T Fung, Shanshan Li, Walter C Willett, Eric B Rimm, Frank B Hu

Am J Clin Nutr January 2014 ajcn.068106
ePub ahead of print October 30, 2013
doi: 10.3945/​ajcn.113.068106


Background: The role of the Mediterranean diet among individuals with previous cardiovascular disease (CVD) is uncertain.

Objective: The aim of this study was to assess the association between the Alternate Mediterranean Diet (aMED) score and all-cause, cardiovascular, and cancer mortality in men and women with CVD from the Health Professionals Follow-Up Study and the Nurses’ Health Study.

Design: This study included 6137 men and 11,278 women with myocardial infarction, stroke, angina pectoris, coronary bypass, and coronary angioplasty. Diet was first assessed in 1986 for men and in 1980 for women with a food-frequency questionnaire (FFQ) and then repeatedly every 2–4 y. Cumulative consumption was calculated with all available FFQs from the diagnosis of CVD to the end of the follow-up in 2008.

Results: During a median follow-up of 7.7 y (IQR: 4.2–11.8) for men and 5.8 y (IQR: 3.8–8.0) for women, we documented 1982 deaths (1142 from CVD and 344 from cancer) among men and 1468 deaths (666 from CVD and 197 from cancer) among women. In multivariable Cox regression models, the pooled RR of all-cause mortality from a comparison of the top with the bottom quintiles of the aMED score was 0.81 (95% CI: 0.72, 0.91; P-trend < 0.001). The corresponding pooled RR for CVD mortality was 0.85 (95% CI: 0.67, 1.09; P-trend = 0.30), for cancer mortality was 0.85 (95% CI: 0.65, 1.11; P-trend = 0.10), and for other causes was 0.79 (95% CI: 0.65, 0.97; P-trend = 0.01). A 2-point increase in adherence to the aMED score was associated with a 7% (95% CI: 3%, 11%) reduction in the risk of total mortality.

Conclusion: Adherence to a Mediterranean-style diet pattern was associated with lower all-cause mortality in individuals with CVD.

Probiotics and Mesalazine for Diverticulosis

December 5 2013

by alex

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Diverticulosis is common. While many have no symptoms, others are symptomatic.

This study looked at patients with symptomatic uncomplicated diverticular disease and compared:
active mesalazine plus probiotic placebo
active probiotic plus mesalazine placebo
active probiotic plus active mesalazine
probiotic placebo plus mesalazine placebo

The specific probiotic used was Lactobacillus casei subsp. DG 24 billion/day.
The mesalazine dosage used was 1.6 g per day.
Both drugs or placebos were dosed cyclically for 10 days of each month for 12 months.

They found that both mesalazine and the probiotic reduced recurrence of symptomatic disease, while the combination of the two reduced recurrence to zero. If these findings are replicated, this combination treatment may become standard of care to reduce the risk of relapsing symptomatic disease.


Randomised clinical trial: mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease–a double-blind, randomised, placebo-controlled study.

Tursi A, Brandimarte G, Elisei W, Picchio M, Forti G, Pianese G, Rodino S, D’Amico T, Sacca N, Portincasa P, Capezzuto E, Lattanzio R, Spadaccini A, Fiorella S, Polimeni F, Polimeni N, Stoppino V, Stoppino G, Giorgetti GM, Aiello F, Danese S.
Aliment Pharmacol Ther. 2013 Oct;38(7):741-51.
doi: 10.1111/apt.12463


Placebo-controlled studies in maintaining remission of symptomatic uncomplicated diverticular disease (SUDD) of the colon are lacking.

To assess the effectiveness of mesalazine and/or probiotics in maintaining remission in SUDD.

A multicentre, double-blind, placebo-controlled study was conducted. Two hundred and ten patients were randomly enrolled in a double-blind fashion in four groups: Group M (active mesalazine 1.6 g/day plus Lactobacillus casei subsp. DG placebo), Group L (active Lactobacillus casei subsp. DG 24 billion/day plus mesalazine placebo), Group LM (active Lactobacillus casei subsp. DG 24 billion/day plus active mesalazine), Group P (Lactobacillus casei subsp. DG placebo plus mesalazine placebo). Patients received treatment for 10 days/month for 12 months. Recurrence of SUDD was defined as the reappearance of abdominal pain during follow-up, scored as ≥5 (0: best; 10: worst) for at least 24 consecutive hours.

Recurrence of SUDD occurred in no (0%) patient in group LM, in 7 (13.7%) patients in group M, in 8 (14.5%) patients in group L and in 23 (46.0%) patients in group P (LM group vs. M group, P = 0.015; LM group vs. L group, P = 0.011; LM group vs. P group, P = 0.000; M group vs. P group, P = 0.000; L group vs. P group, P = 0.000). Acute diverticulitis occurred in six group P cases and in one group L case (P = 0.003).

Both cyclic mesalazine and Lactobacillus casei subsp. DG treatments, particularly when given in combination, appear to be better than placebo for maintaining remission of symptomatic uncomplicated diverticular disease.

Mediterranean Diet is Good for your Brain

December 2 2013

by alex

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This recent meta-analysis included 22 studies that examined the association between adherence to the Mediterranean diet and neurologic outcomes including stroke, depression and cognitive impairment.

This study adds to the large body of evidence showing broad health benefits of greater adherence to this dietary pattern. No other dietary pattern has been studied as extensively.


Mediterranean diet, stroke, cognitive impairment, and depression: A meta-analysis

Theodora Psaltopoulou, Theodoros N. Sergentanis, Demosthenes B. Panagiotakos, Ioannis N. Sergentanis, Rena Kosti, Nikolaos Scarmeas

Ann Neurol 2013;74:580–591
DOI: 10.1002/ana.23944

This meta-analysis aims to quantitatively synthesize all studies that examine the association between adherence to a Mediterranean diet and risk of stroke, depression, cognitive impairment, and Parkinson disease.

Potentially eligible publications were those providing effect estimates of relative risk (RR) for the association between Mediterranean diet and the aforementioned outcomes. Studies were sought in PubMed up to October 31, 2012. Maximally adjusted effect estimates were extracted; separate analyses were performed for high and moderate adherence.

Twenty-two eligible studies were included (11 covered stroke, 9 covered depression, and 8 covered cognitive impairment; only 1 pertained to Parkinson’s disease). High adherence to Mediterranean diet was consistently associated with reduced risk for stroke (RR = 0.71, 95% confidence interval [CI] = 0.57–0.89), depression (RR = 0.68, 95% CI = 0.54–0.86), and cognitive impairment (RR = 0.60, 95% CI = 0.43–0.83). Moderate adherence was similarly associated with reduced risk for depression and cognitive impairment, whereas the protective trend concerning stroke was only marginal. Subgroup analyses highlighted the protective actions of high adherence in terms of reduced risk for ischemic stroke, mild cognitive impairment, dementia, and particularly Alzheimer disease. Meta-regression analysis indicated that the protective effects of Mediterranean diet in stroke prevention seemed more sizeable among males. Concerning depression, the protective effects of high adherence seemed independent of age, whereas the favorable actions of moderate adherence seemed to fade away with more advanced age.

Adherence to a Mediterranean diet may contribute to the prevention of a series of brain diseases; this may be of special value given the aging of Western societies.