A systematic review and meta-analysis was conducted to ascertain the serious adverse cardiovascular effects of varenicline, a widely used smoking cessation drug. Double-blind, randomized controlled trials published through September 2010 (updated March 2011) of at least one week’s duration involving smokers or people who used smokeless tobacco were included. These studies reported on cardiovascular events (ischemia, arrhythmia, congestive heart failure, sudden death or cardiovascular-related death) as serious adverse events associated with the use of varenicline. Data from 14 trials, ranging from 7 to 52 weeks and that involved 8216 participants were analyzed. Varenicline was associated with a significantly increased risk of serious adverse cardiovascular events compared with placebo: 1.06% (52/4908) in the varenicline group versus 0.82% (27/3308) in the placebo group; Peto odds ratio (OR) 1.72, 95% confidence interval (CI) 1.09–2.71. Results of various sensitivity analyses were consistent with those of the main analysis and a no publication bias was detected. There were too few deaths to allow meaningful comparisons of mortality. This meta-analysis raises safety concerns about the potential for an increased risk of serious adverse cardiovascular events associated with the use of varenicline among tobacco users. CMAJ. 2011 Jul 4. PMID: 21727225.

While evidence supports efficacy of acupuncture and/or dry needling in treating musculoskeletal pain, it is unclear which needling method is most effective. This study aimed to determine the effects of depth of needle penetration on muscle pain. Twenty-two healthy volunteers performed repeated eccentric contractions to induce muscle soreness in their extensor digital muscle. Subjects were assigned randomly to four groups: control group, skin group (depth of 3mm: extensor digital muscle), muscle group (depth of 10mm: extensor digital muscle) and non-segmental group (depth of 10mm: anterior tibial muscle). Pressure pain threshold (PPT) and electrical pain threshold (EPT) of the skin, fascia and muscle were measured at a point 20mm distal to the maximum tender point on the second day after the exercise. PPT of the skin group and muscle group were significantly higher than the control group, whereas EPT at fascia of the muscle group was significantly higher than the control group; however, there were no significant differences between the control and other groups. The authors concluded that acupuncture stimulation of muscle increases PPT and EPT of fascia and that the depth of needle penetration is important for the relief of muscle pain. Chin Med. 2011 Jun 22;6(1):24. PMID: 21696603.

Individuals with nonalcoholic fatty liver disease (NAFLD) have excess intrahepatic triglycerides. Although weight loss is currently recommended to treat NAFLD, little attention has been given to dietary carbohydrate restriction. This study was undertaken to determine the effectiveness of two weeks of dietary carbohydrate and calorie restriction at reducing hepatic triglycerides in 18 subjects with NAFLD. Subjects consumed a carbohydrate-restricted (<20 gram/day) or calorie-restricted (1200–1500 kcal/day) diet for two weeks. Mean weight loss was similar between the groups. Liver triglycerides decreased significantly with weight loss (P < 0.001) but decreased significantly more (P = 0.008) in carbohydrate-restricted subjects than in calorie-restricted subjects. Dietary fat (r = 0.643, P = 0.004), carbohydrate (r = −0.606, P = 0.008), post-treatment plasma ketones (r = 0.755, P = 0.006), and respiratory quotient (r = −0.797, P < 0.001) were related to a reduction in liver triglycerides. Plasma aspartate, but not alanine, aminotransferase decreased significantly with weight loss (P < 0.001). The authors concluded that two weeks of dietary intervention (≈4.3% weight loss) reduced hepatic triglycerides by ≈42% in subjects with NAFLD but reductions were significantly greater with dietary carbohydrate restriction. Am J Clin Nutr. 2011 May;93(5):1048-52. PMID: 21367948.

Recent data suggest a role for the intestinal microbiota in the pathogenesis of functional bowel disorders (FBDs). Unfortunately, probiotic studies in FBDs have generated inconsistent results suggesting a strain-specific and product-specific effect. A double-blind, placebo-control clinical trial of a probiotic formula containing Lactobacillus acidophilus NCFM (L-NCFM) and Bifidobacterium lactis Bi-07 (B-LBi07) twice a day (2×10CFU/day) versus placebo over eight weeks was conducted to investigate its clinical efficacy in nonconstipation FBDs. Primary endpoints were global relief of gastrointestinal symptoms and satisfaction with treatment and secondary endpoints were change in symptoms severity, well-being, and quality of life. Sixty patients (31 subjects in the probiotic group and 29 subjects in the placebo group) were enrolled and abdominal bloating improved in the probiotic group compared with the placebo group at four weeks (4.10 vs 6.17, P=0.009; change in bloating severity P=0.02) and eight weeks (4.26 vs 5.84, P=0.06; change in bloating severity P<0.01). The authors concluded that twice a day supplementation with L-NCFM and B-LBi07 improves symptoms of bloating in patients with FBDs and that these data support the role for probiotic bacteria in the management of these disorders. J Clin Gastroenterol. 2011 Jul;45(6):518-25. PMID: 21436726.

The effect of green tea beverage and green tea extract on lipid changes is controversial so the current study aimed to identify and quantify the effect of green tea and its extract on total cholesterol (TC), LDL cholesterol, and HDL cholesterol. A comprehensive literature search was performed to identify relevant trials of green tea beverages and extracts on lipid profiles in adults. Fourteen eligible randomized controlled trials with 1136 subjects were enrolled in the meta-analysis. Green tea consumption significantly lowered the TC concentration by 7.20 mg/dL (95% CI: −8.19, −6.21 mg/dL; P < 0.001) and significantly lowered the LDL-cholesterol concentration by 2.19 mg/dL (95% CI: −3.16, −1.21 mg/dL; P < 0.001). The mean change in blood HDL-cholesterol concentration was not significant. Subgroup and sensitivity analyses showed that these changes were not influenced by the type of intervention, treatment dose of green tea catechins, study duration, individual health status, or quality of the study. The authors concluded that the administration of green tea beverages or extracts resulted in significant reductions in serum TC and LDL-cholesterol concentrations, but no effect on HDL cholesterol was observed. Am J Clin Nutr. 2011; 94(2): 601-610. PMID: 21715508.

The current study was conducted to assess the effect of post-diagnostic serum 25-hydroxyvitamin D [25(OH)D] concentrations on overall survival and distant disease-free survival in breast cancer patients. A prospective cohort study in Germany included 1295 incident postmenopausal breast cancer patients aged 50-74 years who were diagnosed between 2002 and 2005 and were followed up for a median of 5.8 years. Lower concentrations of 25(OH)D were linearly associated with higher risk of death (hazard ratio (HR) = 1.08 per 10 nmol/L decrement; 95% confidence interval (CI), 1.00 to 1.17) and significantly higher risk of distant recurrence (HR = 1.14 per 10 nmol/L decrement; 95%CI, 1.05 to 1.24). Compared with the highest tertile (55 nmol/L), patients within the lowest tertile (35 nmol/L) of 25(OH)D had a HR for overall survival of 1.55 (95%CI, 1.00 to 2.39) and a HR for distant disease-free survival of 2.09 (95%CI, 1.29 to 3.41). The association with overall survival was significant for 25(OH)D levels of blood samples collected before, but not after, the start of chemotherapy. The authors concluded that lower serum 25(OH)D concentrations may be associated with poorer survival in postmenopausal breast cancer patients. Breast Cancer Res. 2011 Jul 26;13(4):R74. PMID: 21791049.

The efficacy of ICX72 (Sinus Buster), a proprietary homeopathic preparation of Capsicum annum and Eucalyptol, on nonallergic rhinitis (NAR) was investigated in this placebo-controlled study. Forty-two subjects were randomized to ICX72 (n = 20) or control (n = 22) administered twice daily for two weeks. Endpoints included: change in total nasal symptom scores (TNSS) from baseline to end of study; changes in individual symptom scores (ISS) over two weeks; average time to first relief; rhinitis quality-of-life; rescue medication; and safety endpoints. Mean TNSS and ISS were recorded after single dosing at different intervals over 60 minutes. Results revealed that ICX72 subjects exhibited significant differences in changes from baseline to end of study for TNSS and each ISS (P < .01) compared to controls. Average time to first relief was 52.6 seconds (P < .01) for ICX72 patients and improvement in nasal congestion, sinus pain, sinus pressure, and headache were noted at 5, 10, 15, and 30 minutes, persisting at 60 minutes (P < .05). Adverse events and rescue medication were similar between groups. This was the first controlled trial demonstrating that intranasal capsaicin rapidly and safely improves symptoms in rhinitis subjects. Ann Allergy Asthma Immunol. 2011 Aug;107(2):171-8. PMID: 21802026.

This retrospective chart review was conducted to assess the results of chiropractic management (including Cox flexion distraction technique) of patients with postsurgical lumbar spine pain to determine the change in reported pain based on surgical type. Ten years of patient files from one chiropractic practice were screened for lumbar spine surgery occurring before presenting for chiropractic care. Of the 58 patients with a postsurgical diagnosis, 32 files contained all pertinent components for this study, including treatment with Cox flexion distraction manipulation (and adjunct procedures) for at least two weeks and pre- and post-treatment pain measures using the Numeric Pain Scale (NPS) that ranged from 0 (no pain) to 10 (worst pain imaginable). The mean change in pre- and post-treatment NPS pain scores decreased by 4.1 points and this was most remarkable in patients who underwent a surgery that combined lumbar discectomy, fusion, and/or laminectomy (the average NPS pain reduction score was 5.7). No adverse events were reported for any of these postsurgical patients. The authors concluded that patients treated with chiropractic care saw improvement in low back pain subsequent to lumbar spine surgery. J Manipulative Physiol Ther. 2011 July – August;34(6):408-412. PMID: 21807265.

Changes in human microbiota have been suggested as a risk factor for atopic diseases. In the current study, the association between neonatal fecal flora and the development of atopic disorders was investigated. The intestinal microbiota were examined in infants in a birth cohort of 411 high-risk children followed for six years by clinical assessments at 6-month intervals, as well as at acute symptom exacerbations. Bacterial flora was analyzed at 1 and 12 months of age and outcome measures included the development of allergic sensitization (skin test and specific serum IgE), allergic rhinitis, peripheral blood eosinophil counts, asthma, and atopic dermatitis. Results revealed that bacterial diversity in the early intestinal flora 1 and 12 months after birth was inversely associated with the risk of allergic sensitization (serum specific IgE P = .003; skin prick test P = .017), peripheral blood eosinophils (P = .034), and allergic rhinitis (P = .007). The authors concluded that reduced bacterial diversity of the infant’s intestinal flora was associated with increased risk of allergic sensitization, allergic rhinitis, and peripheral blood eosinophilia, but not asthma or atopic dermatitis, in the first six years of life. J Allergy Clin Immunol. 2011 Jul 20. PMID: 21782228.

The current study was conducted to determine glutathione levels and antioxidant enzyme activities in the drug-naive first-episode patients with schizophrenia in comparison with healthy control subjects. Twenty-three patients in their first-episode of schizophrenia and 40 healthy control subjects were recruited in this case-controlled study. In patients, blood samples were obtained prior to the initiation of neuroleptic treatments. Glutathione levels, including total glutathione (GSHt), reduced glutathione (GSHr) and oxidized glutathione (GSSG), along with the antioxidant enzyme activities superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase (CAT), were determined by spectrophotometry. Results revealed that GSHt, GSHr, and GPx activity were significantly lower in patients than in controls, whereas GSSG was significantly higher in patients. In addition, CAT activity was significantly lower in patients while the SOD activity was comparable to that of controls. The authors concluded that a glutathione deficit may be implicated in psychosis and may serve as an important indirect biomarker of oxidative stress in the early course of schizophrenia. These results provide support for further studies of the possible role of antioxidants as neuroprotective therapeutic strategies during the early stages of schizophrenia. BMC Psychiatry. 2011 Aug 2;11(1):124. PMID: 21810251.