Both clinical and preclinical studies revealed that regular intake of green tea reduced the prevalence of depressive symptoms, as well as produced antidepressant-like effects in rodents. Evidence proposed that disturbed reward learning has been associated with the development of anhedonia, a core symptom of depression. However, the relationship between green tea and reward learning is poorly investigated. Our goal was to test whether chronic treatment with green tea in healthy subjects affects the process of reward learning and subsequently regulates the depressive symptoms.
Seventy-four healthy subjects participated in a double-blind, randomized placebo-controlled study with oral administration of green tea or placebo for 5weeks. We used the monetary incentive delay task to evaluate the reward learning by measurement of the response to reward trial or no-reward trial. We compared the reaction time of reward responsiveness between green tea and placebo treatment. Furthermore, we selected Montgomery-Asberg depression rating scale (MADRS) and 17-item Hamilton Rating Scale for Depression (HRSD-17) to estimate the depressive symptoms in these two groups.
The results showed chronic treatment of green tea increased reward learning compared with placebo by decreasing the reaction time in monetary incentive delay task. Moreover, participants treated with green tea showed reduced scores measured in MADRS and HRSD-17 compared with participants treated with placebo.
Our findings reveal that chronic green tea increased the reward learning and prevented the depressive symptoms. These results also raised the possibility that supplementary administration of green tea might reverse the development of depression through normalization of the reward function.
Green tea; Depression; Reward learning; Anhedonia
Salvia officinalis (common sage) is a plant with antidiabetic properties. A pilot trial (non-randomized crossover trial) with six healthy female volunteers (aged 40–50) was designed to evaluate the beneficial properties of sage tea consumption on blood glucose regulation, lipid profile and transaminase activity in humans. Effects of sage consumption on erythrocytes’ SOD and CAT activities and on Hsp70 expression in lymphocytes were also evaluated. Four weeks sage tea treatment had no effects on plasma glucose. An improvement in lipid profile was observed with lower plasma LDL cholesterol and total cholesterol levels as well as higher plasma HDL cholesterol levels during and two weeks after treatment. Sage tea also increased lymphocyte Hsp70 expression and erythrocyte SOD and CAT activities. No hepatotoxic effects or other adverse effects were observed.
Salvia officinalis L.; type 2 diabetes mellitus; lipid profile; human trial; antioxidant defences
L-theanine, an amino acid contained in green tea leaves, is known to block the binding of L-glutamic acid to glutamate receptors in the brain, and has been considered to cause anti-stress effects by inhibiting cortical neuron excitation. Both L-theanine and caffeine, which green tea contains, have been highlighted for their beneficial effects on cognition and mood.
In this study, we investigated the effects of orally administered L-theanine or caffeine on mental task performance and physiological activities under conditions of physical or psychological stress in humans. Fourteen participants each underwent three separate trials, in which they orally took either L-theanine + placebo, caffeine + placebo, or placebo only.
The results after the mental tasks showed that L-theanine significantly inhibited the blood-pressure increases in a high-response group, which consisted of participants whose blood pressure increased more than average by a performance of a mental task after placebo intake. Caffeine tended to have a similar but smaller inhibition of the blood-pressure increases caused by the mental tasks. The result of the Profile of Mood States after the mental tasks also showed that L-theanine reduced the Tension-Anxiety scores as compared with placebo intake.
The findings above denote that L-theanine not only reduces anxiety but also attenuates the blood-pressure increase in high-stress-response adults.
L-theanine; Caffeine; Blood pressure; Acute stress; Profile of mood states
Clinical trials of obesity treatments have been limited by substantial dropout. Participant-level variables do not reliably predict attrition, and study-level variables have not yet been examined. We searched MEDLINE and identified 24 large randomized controlled trials of weight loss medications. These trials were comprised of 23 placebo and 32 drug groups. Two authors independently extracted the following for each treatment group: treatment received; design characteristics (inclusion of a lead-in period, selection of participants with weight-related comorbidities, study location, and number of study visits); sample characteristics (sample size, % female, and mean baseline age and BMI); and attrition (total, adverse event [AE] related, and non-AE-related) at 1 year. The primary outcome was total attrition, which was significantly related to treatment (i.e., 34.9%, 28.6%, 28.3%, and 35.1% in placebo, orlistat, sibutramine, and rimonabant groups, respectively, p < .0001). In adjusted multivariable models, total attrition was significantly lower in groups that completed a pre-randomization lead-in period than in those that did not (29.1% vs. 39.9%, p < .01). Gender also was significantly related to total attrition; groups with more women had higher dropout (p < .01). The pattern was similar for predicting non-AE-related attrition. Findings suggest ways to design studies that maximize retention.
Pharmacotherapy; obesity; attrition; retention; study design
Chlorella, a unicellular green alga, contains various antioxidants and other nutrients such as amino acids and fiber. Previous studies have reported that supplementation with multiple antioxidants reduces arterial stiffness, a well-established cardiovascular risk factor. We investigated the effects of Chlorella intake on arterial stiffness using a single-blinded, placebo-controlled crossover study design. Fourteen young men took placebo or Chlorella tablets for four weeks, with a 12-week washout period between trials, in a randomized order. Before and after each trial, blood pressure, heart rate, and brachial-ankle pulse wave velocity, an index of arterial stiffness, were measured. Treatment compliance was comparable between the two groups. There were no differences in blood pressure and heart rate before and after supplementation in both the placebo and Chlorella groups. Brachial-ankle pulse wave velocity decreased after Chlorella intake (before vs after intake; 11.6 ± 0.2 vs 11.1 ± 0.1 m/s, p = 0.01), but not after placebo intake (11.4 ± 0.2 vs 11.4 ± 0.2 m/s, p = 0.98). Multicomponent analysis of the Chlorella-containing tablet detected nutrients that can reduce arterial stiffness, such as antioxidant vitamins, arginine, potassium, calcium, and n-3 unsaturated fatty acids. These results suggest that intake of a Chlorella-containing multicomponent supplement can decrease arterial stiffness.
antioxidants; arterial stiffness; Chlorella; multicomponent supplement
Aims. To evaluate the effect of the traditional Vietnamese herb Gynostemma pentaphyllum tea on insulin sensitivity in drug-naïve type 2 diabetic patients. Methods. Patients received GP or placebo tea 6 g daily for four weeks and vice versa with a 2-week wash-out period. At the end of each period, a somatostatin-insulin-glucose infusion test (SIGIT) was performed to evaluate the insulin sensitivity. Fasting plasma glucose (FPG), HbA1C, and oral glucose tolerance tests and insulin levels were measured before, during, and after the treatment. Results. FPG and steady-state plasma glucose (SIGIT mean) were lower after GP treatment compared to placebo treatment (P < 0.001). The levels of FPG in the control group were slightly reduced to 0.2 ± 1.5 versus 1.9 ± 1.0 mmol/L in GP group (P < 0.001), and the effect on FPG was reversed after exchanging treatments. The glycometabolic improvements were achieved without any major change of circulating insulin levels. There were no changes in lipids, body measurements, blood pressure, and no reported hypoglycemias or acute adverse effects regarding kidney and liver parameters. Conclusion. The results of this study suggested that the GP tea exerted antidiabetic effect by improving insulin sensitivity.
We examined the effect of the oral SIRT1 activator SRT2104 on cardiovascular function in otherwise healthy cigarette smokers.
Methods and Results
Twenty‐four otherwise healthy cigarette smokers participated in a randomized double‐blind, placebo‐controlled crossover trial and received 28 days of oral SRT2104 (2.0 g/day) or matched placebo. Plasma SRT2104 concentrations, serum lipid profile, plasma fibrinolytic factors, and markers of platelet and monocyte activation were measured at baseline and at the end of each treatment period together with an assessment of forearm blood flow during intra‐arterial bradykinin, acetylcholine, and sodium nitroprusside infusions. Three hours postdose, mean plasma SRT2104 concentration was 1328±748 ng/mL after 28 days of active treatment. Compared with placebo, serum lipid profile improved during SRT2104 administration, with reductions in serum total cholesterol (−11.6±20 versus 6±21 mg/dL), low‐density lipoprotein cholesterol (−10±17 versus 3±21 mg/dL), and triglyceride (−39.8±77 versus 13.3±57 mg/dL) concentrations (P<0.05 for all). All vasodilators produced a dose‐dependent increase in blood flow (P<0.0001) that was similar during each treatment period (P>0.05 for all). No significant differences in fibrinolytic or blood flow parameters were observed between placebo and SRT2014.
SRT2104 appears to be safe and well tolerated and associated with an improved lipid profile without demonstrable differences in vascular or platelet function in otherwise healthy cigarette smokers.
Clinical Trial Registration
http://www.clinicaltrials.gov. Unique identifier: NCT01031108.
cigarette smokers; endothelium; forearm plethysmography; platelet activation; SIRT1; sirtuins; vascular
Epidemiological and animal studies suggest that tea may be protective towards cancers of the GI tract. White tea, the least processed form of tea, contains high levels of polyphenols and, like green tea, is chemopreventive towards heterocyclic amine-initiated colonic aberrant crypt formation in male F344 rats. We examined for the first time the relative effectiveness of white and green tea in suppressing intestinal tumorigenesis in C57BL/6J-ApcMin/+ (Apcmin) mice. Each tea was also compared with sulindac, a nonsteroidal anti-inflammatory drug known to be highly effective in Apcmin mice. Male C57BL/6J+/+ (wild-type) and Apcmin mice were treated in the drinking water with white tea or green tea (1.5% w/v, 2 min brew-time), 80 p.p.m. sulindac, a combination of 80 p.p.m. sulindac in 1.5% white tea, or pH buffered water. After 12 weeks of treatment, Apcmin mice given white tea, green tea, or sulindac had significantly fewer tumors than controls (P < 0.05). The protection provided by 1.5% green or white tea was comparable to that provided by 80 p.p.m. sulindac. Mice treated with a combination of white tea plus sulindac had significantly fewer tumors than either treatment alone (P < 0.05). β-catenin and β-catenin/Tcf-4 regulated proteins Cyclin D1 and c-Jun were readily detected in polyps, but markedly reduced in normal-looking intestines of mice treated with both tea and sulindac. This research provides evidence that teas, particularly when administered in combination with sulindac, are highly effective at inhibiting intestinal neoplasia in male Apcmin mice via direct or indirect effects on the β-catenin/APC pathway.
Background and aim: Green tea and lotus hold several synergistic antioxidant compounds. This investigation aimed to assess the efficacy of green tea and green tea plus lotus vs. placebo multiple emulsions in healthy adults for controlling casual sebum secretions.
Participants and Methods: After signing informed consents, twenty-two participants were registered in a single-blinded, placebo-controlled, split-face comparative study. Group 1 participants applied a multiple emulsion formulation with green tea extract while group 2 applied a multiple emulsion with green tea plus lotus extract in a 60 days treatment course. A non-invasive photometric device (Sebumeter™) has been used for the measurement of casual sebum secretions on both sides of the face.
Results: Steady and statistically significant reductions in sebum secretions were noted for mono (green tea) and combined treatments (green tea plus lotus) compared to placebo treatment. However, irrespective of the concentration of extracts in active formulations, green tea plus lotus combined treatment produced statistically more sound results (two-tailed p value = 0.0002) than green tea alone (two-tailed p value = 0.0060) in a 60-days treatment course.
Conclusions: Results suggest that synergistic compounds in green tea and lotus could be a promising choice for cutaneous disorders where elevated sebum levels are involved in the pathophysiology of these disorders.
Green tea; lotus; sebum; sebumeter; non-invasive; multiple emulsion; skin
Twenty-three patients, aged 18‐66 years and suffering from migraine with or without aura, were randomly selected to receive either vigabatrin or matched placebo tablets first for 12 weeks in a double-blind crossover study. Alternative treatment was given after a 4-week washout period. The dose of medication was titrated to a maximum of 4 tablets (2 g vigabatrin) daily according to patients' tolerance during the first six weeks of each treatment. No further dosage adjustment was made. Apart from rescue medication for migraine, no other drug was permitted. Four patients dropped out and four were excluded for non-compliance. Compared to placebo, vigabatrin decreased the frequency (p=0.017) and severity (p=0.024) of headache modestly. However, it reduced the duration (p=0.019) of headache and migraine index (p=0.012) considerably by 40% and 59%, respectively. No serious adverse effects were observed. Serum vigabatrin levels showed no correlation with the clinical effects.
Key words Compliance; Migraine; Prophylaxis; Vigabatrin
The aim of this study was to evaluate the effects of green tea Camellia sinensis extract on proinflammatory molecules and lipolytic protein levels in adipose tissue of diet-induced obese mice. Animals were randomized into four groups: CW (chow diet and water); CG (chow diet and water + green tea extract); HW (high-fat diet and water); HG (high-fat diet and water + green tea extract). The mice were fed ad libitum with chow or high-fat diet and concomitantly supplemented (oral gavage) with 400 mg/kg body weight/day of green tea extract (CG and HG, resp.). The treatments were performed for eight weeks. UPLC showed that in 10 mg/mL green tea extract, there were 15 μg/mg epigallocatechin, 95 μg/mg epigallocatechin gallate, 20.8 μg/mg epicatechin gallate, and 4.9 μg/mg gallocatechin gallate. Green tea administered concomitantly with a high-fat diet increased HSL, ABHD5, and perilipin in mesenteric adipose tissue, and this was associated with reduced body weight and adipose tissue gain. Further, we observed that green tea supplementation reduced inflammatory cytokine TNFα levels, as well as TLR4, MYD88, and TRAF6 proinflammatory signalling. Our results show that green tea increases the lipolytic pathway and reduces adipose tissue, and this may explain the attenuation of low-grade inflammation in obese mice.
Objective To compare the effects of drinking white wine or black tea with Swiss cheese fondue followed by a shot of cherry schnapps on gastric emptying, appetite, and abdominal symptoms.
Design Randomised controlled crossover study.
Participants 20 healthy adults (14 men) aged 23-58.
Interventions Cheese fondue (3260 kJ, 32% fat) labelled with 150 mg sodium 13Carbon-octanoate was consumed with 300 ml of white wine (13%, 40 g alcohol) or black tea in randomised order, followed by 20 ml schnapps (40%, 8 g alcohol) or water in randomised order.
Main outcome measures Cumulative percentage dose of 13C substrate recovered over four hours (higher values indicate faster gastric emptying) and appetite and dyspeptic symptoms (visual analogue scales).
Results Gastric emptying was significantly faster when fondue was consumed with tea or water than with wine or schnapps (cumulative percentage dose of 13C recovered 18.1%, 95% confidence interval 15.2% to 20.9% v 7.4%, 4.6% to 10.3%; P<0.001). An inverse dose-response relation between alcohol intake and gastric emptying was evident. Appetite was similar with consumption of wine or tea (difference 0.11, −0.12 to 0.34; P=0.35), but reduced if both wine and schnapps were consumed (difference −0.40, −0.01 to −0.79; P<0.046). No difference in dyspeptic symptoms was present.
Conclusions Gastric emptying after a Swiss cheese fondue is noticeably slower and appetite suppressed if consumed with higher doses of alcohol. This effect was not associated with dyspeptic symptoms.
Trial registration ClinicalTrials.gov NCT00943696.
The effects of black tea consumption on cardiovascular risk factors have been inconsistent in previous randomized trials, all of which have been limited to a few weeks duration.
We conducted a pilot parallel-design randomized controlled trial among 31 adults aged 55 years and older with either diabetes or two other cardiovascular risk factors but no established clinical cardiovascular disease. Participants were randomized to drink three glasses daily of either a standardized black tea preparation or water for six months. Cardiovascular risk factors were measured at the beginning and conclusion of the study.
Three participants dropped out of the study, leaving 14 participants assigned to tea and 14 assigned to water eligible for analyses. We found no statistically significant effects of black tea on cardiovascular biomarkers, including lipids, inflammatory markers, hemoglobin, adhesion molecules, prothrombotic and fibrinolytic parameters, and lipoprotein oxidizability. Assignment to tea did not appreciably influence blood pressure, and heart rate among participants assigned to tea was marginally higher than among control participants at three months (p=0.07) but not six months.
In this randomized trial of black tea intake over six months among older adults with known cardiovascular risk factors, black tea did not appreciably influence any traditional or novel biomarkers of cardiovascular risk. Longer randomized trials are needed to verify the inverse association of tea with risk of cardiovascular disease seen in cohort studies and identify potential candidate mechanisms for such an association.
Epidemiological studies demonstrate an inverse relation between dietary flavonoid intake and cardiovascular risk. Recent studies with flavonoid-containing beverages suggest that the benefits of these nutrients may relate, in part, to improved endothelial function.
We hypothesized that dietary supplementation with epigallocatechin gallate (EGCG), a major catechin in tea, would improve endothelial function in humans.
We examined the effects of EGCG on endothelial function in a double blind, placebo-controlled, crossover design study. We measured brachial artery flow-mediated dilation by vascular ultrasound at six time points: prior to treatment with EGCG or placebo, two hours after an initial dose of EGCG (300 mg) or placebo, and after two weeks of treatment with EGCG (150 mg twice daily) or placebo. The order of treatments (EGCG or placebo) was randomized and there was a one-week washout period between treatments.
A total of 42 subjects were enrolled, and brachial artery flow-mediated dilation improved from 7.1±4.1 to 8.6±4.7% two hours after the first dose of 300mg of EGCG (P=0.01), but was similar to baseline (7.8±4.2%, P=0.12) after two weeks of treatment with the final measurements made approximately 14 hours after the last dose. Placebo treatment had no significant effect, and there were no changes in reactive hyperemia or the response to sublingual nitroglycerin. The changes in vascular function paralleled plasma EGCG concentrations, which increased from 2.6±10.9 to 92.8±78.7 ng/ml after acute EGCG (P<0.001), but were unchanged from baseline after two weeks of treatment (3.4±13.1 ng/ml).
EGCG acutely improves endothelial function in humans with coronary artery disease, and may account for a portion of the beneficial effects of flavonoid-rich food on endothelial function.
endothelial function; tea; epigallocatechin gallate; coronary artery disease; catechins; flavonoids
Compelling pre-clinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo controlled trial of Polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3–6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on Polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3–6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease.
Polyphenon E; green tea polyphenols; prostate cancer; chemoprevention
Green tea has shown the role of chemoprevention for cancer. Recently, several studies suggested that green tea intake may have effect on esophageal cancer risk, whereas the results were inconsistent.
We performed a meta-analysis of all English and Chinese language studies of green tea consumption and esophageal cancer risk indexed in Medline, Embase, the Science Citation Index, the Chinese Biomedical Database and Wanfang Data from 1980 to June 2012. After reviewing each study, extracting data, and evaluating heterogeneity (Chi-square-based Q test and Ι2) and publication bias (Begg and Egger test), a meta-analysis was performed to evaluate the association between high/medium/low green tea consumption and non-drinking esophageal cancer risk. Pooled relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs) were calculated using the fixed- or random-effect models.
Ten eligible epidemiologic studies including 33731 participants and 3557 cases for esophageal cancer were included. Eight of which were case–control studies, and two were cohort studies. Overall, there were no association between high/medium/low green tea consumption and non-drinking risk of esophageal cancer (High: highest vs non-drinker: RR/OR = 0.76, 95% CI: 0.49 to 1.02. Medium: drinker vs non-drinker: RR/OR = 0.86, 95% CI: 0.70 to 1.03. Low: lowest vs non-drinker: RR/OR = 0.83, 95% CI: 0.58 to 1.08). When stratified analyses according to study design (case–control and cohort studies), country (China and Japan), participates source (population-based and hospital-based case–control), and gender (female and male), there were significant association between high/medium/low green tea consumption and non-drinking risk of esophageal cancer among female (High: RR/OR = 0.32, 95% CI: 0.10 to 0.54. Medium: RR/OR = 0.43, 95% CI: 0.21 to 0.66. Low: RR/OR = 0.45, 95% CI: 0.10 to 0.79), but not the others.
We did not found significant association between green tea consumption and non-drinking esophageal cancer risk, but an evidence of protective effect was observed among female.
About one third of patients receiving dialysis for end stage renal failure have chronic fluid overload despite advice to restrict their oral fluid intake. To investigate the potential of an angiotensin converting enzyme inhibitor in reducing the urge to drink and consequent gain in weight, a double blind, placebo controlled crossover trial of enalapril was conducted in 25 patients receiving dialysis who had fluid overload. The trial comprised a baseline period of four weeks; two periods of treatment, each of four weeks, during which patients received either placebo or enalapril 5 mg twice each week; and a follow up period of four weeks. Five patients withdrew from the trial, one because of an adverse drug reaction to enalapril. A range of biochemical and behavioural variables was measured during the baseline period, at the completion of periods 1 and 2, and during follow up. These variables included gain in weight between dialysis sessions; blood pressure; plasma concentrations of sodium, angiotensin II, and vasopressin; plasma renin and angiotensin converting enzyme activities; osmolality; and estimations of thirst, intake of fluid, and control of drinking. Enalapril caused a significant reduction in gain in weight between dialysis sessions, thirst, and oral intake of fluid in parallel with significantly increased renin activity, significantly decreased angiotensin converting enzyme activity, and decreased concentrations of angiotensin II. Gain in weight and angiotensin converting enzyme activity returned to baseline values once patients stopped taking enalapril.
These results suggest that enalapril may act on the renin-angiotensin system and reduce intake of fluid by inhibiting angiotensin converting enzyme.
Laboratory studies, and one previous uncontrolled trial, have suggested that retinoids may reverse bronchial atypia, a putatively premalignant condition. Sputum sampling is a simple, non-invasive method of assessing atypia. Smokers with at least a 15 pack-year history were screened for sputum atypia. One hundred and fifty subjects' were randomised to receive the synthetic retinoid etretinate 25 mg orally or identical placebo daily for 6 months. Compliance was measured by performing pill counts and serum sampling every 2 months for etretinate levels. The outcomes assessed were, improvements in sputum atypia and toxicity. At baseline there was no significant difference between the two groups with respect to gender, smoking history or extent of atypia. Four of 75 subjects on etretinate and six of 75 on placebo dropped out before 6 months. Compliance as measured by pill counts and etretinate levels was high. Eighty-six per cent of subjects on etretinate took 90% or more of their prescribed medication and etretinate was detected in 245 of 264 samples. By contrast etretinate was detected in only six of 266 samples in the control group and probably did not represent true contamination. After 6 months on etretinate there was no difference in the degree of atypia between the two treatment arms. Toxicity was mild in both groups with considerable placebo effect noted. Etretinate, at the dose used in this study, had no impact on sputum atypia as detected by sputum sampling.
Although there is a strong relationship between depression and smoking, most nicotine dependence treatment trials exclude depressed smokers. Our objective was to determine if bupropion improves abstinence rates and abstinence-associated depressive symptoms when added to transdermal nicotine replacement therapy (NRT) and group cognitive behavioral therapy (CBT) in smokers with unipolar depressive disorder (UDD). Adult smokers with current (n=90) or past (n=109) UDD were randomly assigned to receive bupropion or placebo added to NRT and CBT for 13 weeks. In the primary analysis, with dropouts considered smokers, 36% (35/97) of those on bupropion and 31% (32/102) on placebo attained biochemically-validated 7-day point-prevalence abstinence at end of treatment (NS). Because of a high drop out rate (50%) and a significant difference in abstinence status at dropout by treatment group, a traditional intent-to-treat (ITT) analysis with last observation carried forward imputation of abstinence status was performed. In this secondary analysis, 56% (54/97) of those on bupropion and 41% (42/102) on placebo met criteria for abstinence at end of trial, Chi2=4.18, p=0.04. NRT usage and absence of a co-morbid anxiety disorder predicted abstinence. Abstinence was associated with increased depressive symptoms, regardless of bupropion treatment. Thus, in the primary analysis, bupropion neither increased the efficacy of intensive group CBT and NRT for smoking cessation in smokers with UDD nor prevented abstinence-associated depressive symptoms. Bupropion appeared to provide an advantage for smoking cessation for those who remained in the trial. The dropout rate was high and was characterized by higher prevalence of current comorbid anxiety disorder. Given the high abstinence rate achieved with CBT plus NRT, a ceiling effect related to the high level of intervention received by all subjects may have prevented an adequate test of bupropion.
Depression; Major Depressive Disorder; Unipolar Depressive Disorder; Nicotine; Smoking Cessation; Bupropion; Cognitive Behavioral Therapy; Nicotine Replacement Therapy; Relapse
People with multiple sclerosis (MS) are at high risk of depression. We undertook a pilot trial of computerised cognitive behavioural therapy (CCBT) for the treatment of depression in people with MS to test the feasibility of undertaking a full trial.
Participants with a diagnosis of MS and clinical levels of depression were recruited through out-patient clinics and postal screening questionnaires at two UK centres and randomised to CCBT or usual care. Clinical outcomes included the Beck Depression Inventory (BDI-II) and Multiple Sclerosis Impact Scale (MSIS-29) at baseline, 8 and 21 weeks. Feasibility outcomes included: recruitment rate; reasons for refusal, withdrawal and dropout; feasibility and acceptability of the proposed outcome measures; sample size estimation and variation in and preferences for service delivery.
Twenty-four participants were recruited. The recruitment rate, calculated as the proportion of those invited to fill in a screening questionnaire who were consented into the trial, was 4.1%. Recruitment through out-patient clinics was somewhat slower than through screening questionnaire mail-out but the overall recruitment yield was similar. Of the 12 patients in the CCBT arm, 9 (75%) completed at least four, and 6 completed all 8 CCBT sessions. For completers, the median time (IQR) to complete all eight CCBT sessions was 15 (13 to 20) weeks. Participants expressed concern about the face validity of the Beck Depression Inventory II for the measurement of self-reported depression in people with MS. The MSIS-29 was the patient-reported outcome measure which participants felt best reflected their concerns. The estimated sample size for a full trial is between 180 and 390 participants. NHS partners were not delivering CCBT in community facilities and participants preferred to access CCBT at home, with no one expressing a preference for use of CCBT in an alternative location.
A definitive trial, with a recruitment window of one year, would require the participation of around 13 MS centres. This number of centres could be reduced by expanding the eligibility criteria to include either other neurological conditions or people with more severe depression. The MSIS-29 should be used as a patient-important outcome measurement.
Four hundred and twenty nine current smokers and ex-smokers who had provided details 12 years previously completed a self administered questionnaire about their present and past smoking habits, and two weeks later current smokers supplied an empty cigarette packet. The tar group and brand name of the current cigarette given on the questionnaire were compared with details on the packet, and the brand alleged to have been smoked 12 years ago was compared with that actually recorded at that time. Only 55% of "low middle" tar cigarettes as indicated by returned packets had been correctly identified in the questionnaire. The brand name was the same in the questionnaire and on the packet in 74% of cases. The recalled brand was confirmed by past records in only 49% of cases. It is concluded that current smokers should be asked to return an empty packet or packets of the cigarette brand or brands usually smoked with a self administered questionnaire and that follow up studies of populations for which brands of cigarette smoked were previously recorded might be more valid than studies relying on recall.
We aimed to conduct a placebo-controlled, double-blind, parallel-group design intervention study to evaluate the therapeutic efficacy of hormone therapy (HT) in postmenopausal women with mild to moderate Alzheimer’s disease (AD). The trial was designed to evaluate the dose-dependent effects of transdermal 17-β estradiol, unopposed and opposed with medroxyprogesterone (MPA, Provera©), for 12 months in 43 postmenopausal women with AD. Participants were assessed using cognitive measures at baseline, months 1, 3, 6, and 12 of treatment and eight weeks post treatment (month 15). The dropout rate was 49% across 12 months. As a result of theWomen’s Health Initiative (WHI) and anticipated increased attrition, the protocolwas modified to examine data only at time points where attrition was less than 30%. The results of sensitivity analyses indicated robust and reliable data collected in the first three months of the trial. Data collected in the first three months of the trial for forty-three participants were analyzed. HT had favorable cognitive effects across multiple cognitive domains, including visual memory (p-values < 0.030) and semantic memory (p-values < 0.037) in postmenopausal women with AD. Moreover, treatment-related changes in plasma estradiol were positively correlated with improvements in visual memory. Short-term HT that includes the use of estradiol has favorable effects on cognition in women with AD.
Alzheimer’s disease; clinical trial; cognition; estradiol; estrogen; hormone therapy; medroxyprogesterone; memory
STUDY OBJECTIVE--To compare responses of blood pressure to the calcium antagonist verapamil and the beta blocker metoprolol in black compared with white diabetics with hypertension and to monitor urinary albumin excretion in relation to fall in blood pressure. DESIGN--Double blind, placebo controlled, random order crossover trial with four week placebo run in period and two six week active phases separated by a two week placebo washout period. SETTING--Outpatient department of a general hospital in a multiethnic health department. Patients--Diabetic patients with hypertension. Four dropped out before randomisation; 25 black and 14 white patients completed the trial. INTERVENTIONS--Patients given slow release verapamil 120 mg or 240 mg twice daily with placebo or metoprolol 50 mg or 100 mg twice daily with placebo. Treatment for diabetes (diet alone or with oral hypoglycaemic drugs) remained unchanged. END POINT--Comparison of changes in blood pressure in the two groups taking both drugs. MEASUREMENTS AND MAIN RESULTS--Metoprolol had little effect on blood pressure in black patients (mean fall 4.0 mm Hg systolic (95% confidence interval -2.5 to 10.4 mm Hg), 4.3 mm Hg diastolic (-0.8 to 9.5)) but more effect in white patients (mean falls 13.4 mm Hg (0.1 to 26.7) and 10.6 mm Hg (4.5 to 16.7) respectively). Verapamil was more effective in both groups, with mean falls of 8.8 mm Hg (2.4 to 15.0) and 8.1 mm Hg (5.0 to 11.2) in black patients and 19.1 mm Hg (5.4 to 32.9) and 11.4 mm Hg (0.9 to 22.0) in white patients. Heart fate fell significantly in black patients taking metoprolol, which suggested compliance with treatment. Metabolic variables were unaltered by either treatment. Plasma renin activity was low in both groups after metoprolol treatment, but change in blood pressure could not be predicted from baseline plasma renin activity. Urinary albumin:creatinine ratio was independently related to baseline blood pressure but not significantly changed by treatment. CONCLUSIONS--beta Blockers alone are not effective in treating hypertension in black diabetics. Verapamil is effective but less so than in white patients. As yet no ideal monotherapy exists for hypertension in black patients.
Tea consumption has been known mostly as a well-drink after water in the world. Tea drink can affect balance of fluids and renal function. In addition, it can cause loss of many viruses in the stomach and can increase or decrease gastrointestinal movements. This research was done to determine the effect of tea on increasing enteral feeding tolerance in ICU patients in Alzahra Hospital.
In this clinical trial study, 45 patients were enrolled in two groups, tea consumption group and the standard method of nutrition as control group. Tea gavage was performed two times in the morning; 100 cc tea used for the study group and the same volume of water was used for the control group. Residual volume was measured before gavage. Data collected for one week. Information sheet had two pages; the first page described how to complete the form and the method of tea gavage and the second page was for data collection. Data were analyzed by t-student test, chi-square, and analysis of variance.
In two groups, 92% of patients tolerated liquid gavage. Their difference by chi-square test was not significant. Average urine volume after black tea gavage was 783.3 L in the study group and 802.2 L in the control group. ANOVA test showed no significant difference.
Although the difference was not statistically significant between the two groups, but in study group consumption of tea was acceptable by patients.
Camellia sinensis; enteral feeding; tea; intensive care
Caffeine, an adenosine A1 and A2A receptor antagonist, is the most popular psychostimulant drug in the world, but it is also anxiogenic. The neural correlates of caffeine-induced anxiety are currently unknown. This study investigated the effects of caffeine on brain regions implicated in social threat processing and anxiety. Participants were 14 healthy male non/infrequent caffeine consumers. In a double-blind placebo-controlled crossover design, they underwent blood oxygenation level-dependent functional magnetic resonance imaging (fMRI) while performing an emotional face processing task 1 h after receiving caffeine (250 mg) or placebo in two fMRI sessions (counterbalanced, 1-week washout). They rated anxiety and mental alertness, and their blood pressure was measured, before and 2 h after treatment. Results showed that caffeine induced threat-related (angry/fearful faces > happy faces) midbrain-periaqueductal gray activation and abolished threat-related medial prefrontal cortex wall activation. Effects of caffeine on extent of threat-related amygdala activation correlated negatively with level of dietary caffeine intake. In concurrence with these changes in threat-related brain activation, caffeine increased self-rated anxiety and diastolic blood pressure. Caffeine did not affect primary visual cortex activation. These results are the first to demonstrate potential neural correlates of the anxiogenic effect of caffeine, and they implicate the amygdala as a key site for caffeine tolerance.
amygdala; anxiety; fMRI; medial prefrontal cortex; periaqueductal gray; social threat