Group Mean Change Research Articles

Visual experiences and pain scores in vitreo‐retinal surgery under local anesthesia

Editor, W e really appreciate the interest in our article (Shin et al. 2010). Following the comments (Tong & Lan 2010), we conducted another statistical analysis regarding BUT changes between the two groups. However, we could not find any differences from the results in the original report. The mean and SD of the BUT value for the post-treatment was 4.00 ± 1.34, not 3.79 ± 1.34 as suggested in the letter. In this context, the mean change in the sham group was 0.29 ± 1.74, not 0.08 ± 1.34. Following your suggestion, we conducted a mock statistical test using an online calculator (Vadum & Rankin) and the result was p = 0.20 in the ttest analysis. This result is similar to the original report (p = 0.1736). Perhaps this error was induced by a misreading of Figure 3. The tick label for the vertical line in the graph has 1.5 intervals between the scales. Therefore, if the tick over the BUT value in the sham group was misinterpreted as 4 (not 4.5), estimates of the BUT value become 3.79 ± 1.34, as suggested in the letter. The authors hope that this explanation is a clear answer to the doubts, and we want to express gratitude again to the commentators for the concerns about our acupuncture research as well as this article.

A Randomized Study of the Effects ofT'ai Chion Muscle Strength, Bone Mineral Density, and Fear of Falling in Women with Osteoarthritis

Individuals with osteoarthritis can experience difficulty walking and poor strength, possibly leading to falls and fractures. Exercise has been found to increase strength and bone mineral density. The purpose of this study was to determine the effects of 6 months of t'ai chi on knee muscle strength, bone mineral density, and fear of falling in older women with osteoarthritis. Eighty-two (82) women with osteoarthritis, recruited from outpatient clinics and community health centers, were randomly assigned to either a t'ai chi group and took part in a t'ai chi program, or a control group. Of these, 30 subjects (mean age = 63 years) in the t'ai chi group and 35 (mean age = 61 years) in the control group completed post-test measures at 6 months. After the 6-month study period, subjects in the t'ai chi program had significantly greater knee extensor endurance (pre- to post-test mean increase = 36.4 W/kg, versus 1.1 W/kg for the controls), and significantly greater bone mineral density in the neck of the proximal femur (mean change = 0.09, versus -0.10 for the controls), Ward's triangle (mean change = 0.04, versus -0.04 for the controls), and trochanter (mean change = 0.07, versus -0.05 for the controls) than the controls. However, knee extensor and flexor strength did not differ significantly between the groups. The fear of falling during daily activities reduced significantly more in the t'ai chi group (mean change = -2.40, versus 0.66 for the controls). T'ai chi increased knee extensor muscle endurance and bone mineral density in older women with osteoarthritis, and decreased their fear of falling during daily activities. Further study with long-term follow-up is needed to substantiate the role of t'ai chi exercise in the prevention of fall and its related fracture.

Hypnosis in refractory alopecia areata significantly improves depression, anxiety, and life quality but not hair regrowth

Hypnosis in refractory alopecia areata significantly improves depression, anxiety, and life quality but not hair regrowth

Laparoscopic Adjustable Gastric Banding in Severely Obese Adolescents

Adolescent obesity is a common and serious health problem affecting more than 5 million young people in the United States alone. Bariatric surgery is being evaluated as a possible treatment option. Laparoscopic adjustable gastric banding (gastric banding) has the potential to provide a safe and effective treatment. To compare the outcomes of gastric banding with an optimal lifestyle program on adolescent obesity. A prospective, randomized controlled trial of 50 adolescents between 14 and 18 years with a body mass index (BMI) higher than 35, recruited from the Melbourne, Australia, community, assigned either to a supervised lifestyle intervention or to undergo gastric banding, and followed up for 2 years. The study was performed between May 2005 and September 2008. Weight loss. Secondary outcomes included change in metabolic syndrome, insulin resistance, quality of life, and adverse outcomes. Twenty-four of 25 patients in the gastric banding group and 18 of 25 in lifestyle group completed the study. Twenty-one (84%) in the gastric banding and 3 (12%) in the lifestyle groups lost more than 50% of excess weight, corrected for age. Overall, the mean changes in the gastric banding group were a weight loss of 34.6 kg (95% CI, 30.2-39.0), representing an excess weight loss of 78.8% (95% CI, 66.6%-91.0%), 12.7 BMI units (95% CI, 11.3-14.2), and a BMI z score change from 2.39 (95% CI, 2.05-2.73) to 1.32 (95% CI, 0.98-1.66). The mean losses in the lifestyle group were 3.0 kg (95% CI, 2.1-8.1), representing excess weight loss of 13.2% (95% CI, 2.6%-21.0%), 1.3 BMI units (95% CI, 0.4-2.9), and a BMI z score change from 2.41 (95% CI, 2.21-2.66) to 2.26 (95% CI, 1.91-2.43). At entry, 9 participants (36%) in the gastric banding group and 10 (40%) in the lifestyle group had the metabolic syndrome. At 24 months, none of the gastric banding group had the metabolic syndrome (P = .008; McNemar chi(2)) compared with 4 of the 18 completers (22%) in the lifestyle group (P = .13). The gastric banding group experienced improved quality of life with no perioperative adverse events. However, 8 operations (33%) were required in 7 patients for revisional procedures either for proximal pouch dilatation or tubing injury during follow-up. Among obese adolescent participants, use of gastric banding compared with lifestyle intervention resulted in a greater percentage achieving a loss of 50% of excess weight, corrected for age. There were associated benefits to health and quality of life. ANZCTR Identifier: 12605000160639.

Effects of Soy Consumption on Serum Lipids and Apoproteins in Peritoneal Dialysis Patients: A Randomized Controlled Trial

Lipid abnormalities, particularly high serum concentration of lipoprotein(a) [Lp(a)], are one of the major risk factors for cardiovascular disease (CVD) in peritoneal dialysis (PD) patients. The present study was designed to investigate the effects of soy consumption on serum lipids and apoproteins, especially Lp(a), in PD patients. ♢ This study was a randomized clinical trial in which 40 PD patients (20 males, 20 females) were randomly assigned to either the soy or the control group. Patients in the soy group received 28 g/day textured soy flour (containing 14 g of soy protein) for 8 weeks, whereas patients in the control group received their usual diet, without any soy. At baseline and the end of week 8 of the study, 5 mL of blood was collected from each patient after a 12- to 14-hour fast and serum triglyceride, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), apoprotein B100 (apo B100), apoprotein AI (apo AI), and Lp(a) were measured. ♢ In the present study, serum Lp(a) concentrations were above the normal range in 86% of the PD patients. Mean serum Lp(a) concentration was reduced significantly, by 41%, in the soy group at the end of week 8 compared to baseline (p < 0.01); the reduction was also significant compared to the control group (p < 0.05). During the study, mean serum Lp(a) concentration did not change significantly in the control group. There were no significant differences between the two groups in mean changes in serum triglyceride, total cholesterol, HDL-C, LDL-C, apo B100, or apoAI. ♢ The results of our study indicate that soy consumption reduces serum Lp(a) concentration, which is a risk factor for cardiovascular disease in peritoneal dialysis patients.

Individual and collective bodies: using measures of variance and association in contextual epidemiology

Background:Social epidemiology investigates both individuals and their collectives. Although the limits that define the individual bodies are very apparent, the collective body’s geographical or cultural limits (eg “neighbourhood”) are more...

Effects of Soy Consumption on Oxidative Stress, Blood Homocysteine, Coagulation Factors, and Phosphorus in Peritoneal Dialysis Patients

We studied the effects of soy consumption on oxidative stress, blood homocysteine, coagulation factors, and phosphorus in peritoneal dialysis patients. This was an unblinded, randomized clinical trial. This study involved peritoneal dialysis centers in Tehran, Iran. We included 40 peritoneal dialysis patients (20 males and 20 females). Peritoneal dialysis patients were randomly assigned to either a soy or control group. Patients in the soy group received 28 g/day textured soy flour (containing 14 g of soy protein) for 8 weeks, whereas patients in the control group received their usual diet, without any soy. Blood oxidized low-density lipoprotein (ox-LDL), homocysteine, phosphorus, fibrinogen concentrations, and the activities of coagulation factors VII, IX, and X were measured at baseline and at the end of week 8 of the study. The percentage of plasma coagulation factor IX activity decreased significantly by 17% in the soy group at the end of week 8 compared with baseline (P < .01), and the reduction was significant compared with the control group (P < .05). There were no significant differences between the two groups in mean changes of blood ox-LDL, homocysteine, phosphorus, fibrinogen concentrations, and the activities of coagulation factors VII and X. Soy consumption reduces plasma coagulation factor IX activity, which is a risk factor for thrombosis in peritoneal dialysis patients.

Improved treatment satisfaction and weight‐related quality of life with exenatide once weekly or twice daily1

AimsTo assess treatment satisfaction and weight-related quality of life (QOL) in subjects with Type 2 diabetes treated with exenatide once weekly (QW) or twice daily (BID).MethodsIn this 52-week randomized, multi-centre, open-label study, 295 subjects managed with diet and exercise and/or oral glucose-lowering medications received either exenatide QW or BID during weeks 1–30; thereafter, subjects receiving exenatide BID were switched to exenatide QW, with 258 total subjects receiving exenatide QW during weeks 30–52. Diabetes Treatment Satisfaction Questionnaire—status (DTSQ-s) and Impact of Weight on Quality of Life—Lite (IWQOL-Lite) were assessed at baseline and weeks 30 and 52. Mean group changes from baseline to week 30 were estimated by ancova; changes from week 30 to week 52 were assessed by Student’s t-test.ResultsStatistically significant improvements from baseline to week 30 were observed in both treatment groups for DTSQ-s and IWQOL-Lite measures, with significantly greater reduction in perceived frequency of hyperglycaemia and greater satisfaction with continuing treatment in the QW group compared with the BID group. Effect sizes for change in DTSQ-s total scores were 0.84 QW, 0.64 BID; for IWQOL-Lite: 0.96 QW, 0.82 BID. Treatment satisfaction and QOL improved significantly between weeks 30 and 52 for those switching from BID to QW. Occurrence of adverse events did not affect patients’ improvements in treatment satisfaction and QOL.ConclusionsPatients treated with exenatide QW or BID experienced significant and clinically meaningful improvements in treatment satisfaction and QOL. Patients who switched from exenatide BID to exenatide QW administration reported further significant improvements.

Predictors of individual visual memory decline after unilateral anterior temporal lobe resection

Different types of neuropsychological visual memory tasks have been created to quantify deficits associated with right hemisphere dysfunction. There are reports of visual memory impairment after right anterior temporal lobe resection (ATR) compared to left ATR for the processing of faces, abstract designs, and spatial locations, but there are also studies showing no between-group differences. One potential reason for the conflicting results is the use of group mean changes, which mask individual differences. Proportions of individual subjects with decline, no change, or improvement in memory for spatial locations, abstract designs, and unfamiliar faces were evaluated in 83 individuals who underwent a standard ATR (47 right, 36 left) and were left hemisphere language dominant. Type of visual memory ability was an important factor as there were differential individual declines found for memory for spatial locations after right ATR compared to left ATR (27.3% vs 5.9%), but not memory for abstract designs or face memory. Logistic regression indicated that the odds of a spatial memory decline were six times higher for patients who underwent right ATR than left ATR. Memory for spatial locations appears to be particularly vulnerable to decline when a patient undergoes right-anterior temporal lobe resection (ATR) and when the patient has better spatial memory before surgery. Results provide proportions of subjects with significant change to help clinicians and patients make better informed decisions about risks associated with undergoing right ATR.

Does urodynamic verification of overactive bladder determine treatment success? Results from a randomized placebo‐controlled study

To determine whether subjects with or with no detrusor overactivity (DO) determined by urodynamic assessment respond differently to treatment with the antimuscarinic agent tolterodine (extended release formulation, ER). Adult subjects with urinary frequency (average >or=8 voids/24 h) and urgency with or without urgency urinary incontinence (UUI) underwent urodynamic assessment and were stratified according to whether they had DO (positive urodynamics) or not (negative urodynamics). Subjects in each urodynamic stratum were randomized to receive tolterodine-ER (4 mg once daily) or placebo for 12 weeks. Diary cards were completed for 7 days before each study visit (at baseline, week 4, and week 12). The volume per void was recorded for 3 of the 7 days. The difference between the positive and negative urodynamic groups in mean change in volume voided between baseline and 12 weeks was 5.38 mL (95% CI, -93 mL to +15.71 mL). This difference is within the pre-stipulated range defined for equivalence (+/-20 mL, P = 0.31). There was also no significant difference in the change from baseline to 12 weeks between the urodynamics groups in mean number of voids per day or UUI episodes. However, there was significant improvement in the treatment group compared with the placebo group, in the number of voids per 24 h (P = 0.003) and in the mean change in volume voided (P = 0.03), from baseline to 12 weeks, but not in UUI episodes (P = 0.35). Urodynamics status could not predict treatment outcomes between patients treated with tolterodine-ER or placebo. The results add support to evidence suggesting that urodynamic assessment is not a prerequisite for the treatment of overactive bladder (OAB). Therefore, we recommend that anticholinergic treatment may be initiated to patients with OAB symptoms without the need for urodynamics studies.

Methylphenidate Extended Release (OROS MPH) for the Treatment of Antidepressant-Related Sexual Dysfunction in Patients With Treatment-Resistant Depression

There are limited data to indicate effective treatment strategies for antidepressant-related sexual dysfunction, in particular for patients with treatment-resistant major depression. We subanalyzed our published data whether augmentation with methylphenidate extended release (OROS MPH) improved sexual dysfunction associated with antidepressants in patients with treatment-resistant major depression. The primary efficacy measure was the change in Arizona Sexual Experiences Survey (ASEX) from baseline to end of treatment in an intent-to-treat analysis with last observation carried forward approach. There were no significant differences between the 2 groups in terms of changes in ASEX scores over time (F1,35 = 1.14; P = 0.32), although the numerical decrease in ASEX score was greater in OROS MPH (mean change, -4.5; 20.1% decrease) than in the placebo group (mean change, -0.6; 2.6% decrease). Augmentation with OROS MPH showed no statistically significant benefit in antidepressant-related sexual dysfunction, although addition of OROS MPH to antidepressants did not worsen preexisting sexual dysfunction. Adequately powered controlled trials are needed to fully evaluate the efficacy of OROS MPH in this area.

Probiotics as adjunctive treatment for chronic rhinosinusitis: A randomized controlled trial

To determine if oral probiotics as adjunctive treatment are more effective than placebo in improving quality of life in patients with chronic inflammatory rhinosinusitis. Prospective, randomized, double-blind, placebo-controlled trial. A total of 77 patients with chronic inflammatory rhinosinusitis were randomly assigned to receive oral probiotic Lactobacillus rhamnosus R0011 strain (500 million active cells/tablet twice daily) (n = 39) or oral placebo treatment (n = 38) for 4 weeks. In the probiotic group, the mean change from baseline in the SNOT-20 scores was significant at 4 weeks (P = 0.002) but not at 8 weeks (P = 0.37). Rhinological domain improved by 9.3 percent (P = 0.004) in probiotics group but returned to baseline level at 8 weeks. No significant differences were found between the probiotic and placebo groups in mean changes from baseline to 4 weeks (P = 0.79) or from baseline to 8 weeks (P = 0.23). No changes in symptom frequency were noted, either within each group or between treatment groups at 4 and 8 weeks. There was no difference in medication use or side effects between the two study groups. Oral use of the probiotic strain L rhamnosus R0011 did not improve sinonasal quality-of-life scores in patients with chronic inflammatory rhinosinusitis compared with placebo.

High and Low Cognitive Risk For Depression: Stability From Late Adolescence to Early Adulthood.

Negative cognitive styles are an important cognitive vulnerability for depression, but stability of high cognitive risk, once developed, is unclear. The current study examined stability of cognitive vulnerability to depression in individuals at high and low cognitive risk (extreme scores on both the CSQ and DAS) over a 7-year period from late adolescence through early adulthood. Cognitive vulnerability showed high relative stability, as evidenced by the moderate to high correlation (r(s) = .62) between cognitive risk status at study onset and at final assessment 7 years later. Consistent with stability, subgroups were identified using growth mixture modeling, and most cognitively high-risk (62.22% for CSQ, 68.89% for DAS) and low-risk (55.05% for CSQ, 57.96% for DAS) participants showed stable trajectories of cognitive vulnerability. Despite this overall pattern of stability, small mean group changes were found, and a minority of participants showed changing trajectories, consistent with regression toward the mean. Predictors of change and implications for risk for depression in high- and low-risk individuals are discussed.

P2. Can One Year Outcomes Predict Two Year Outcomes after Lumbar Fusion Surgery?

BACKGROUND CONTEXT: Clinical outcomes after lumbar fusion are often presented using one-year rather than two-year results. Studies which reported both one and two year outcomes commonly show a lack of significant difference between one-year and two-year outcomes after lumbar fusion. However, these data are presented as changes in group means, not as changes in individual outcomes.

Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: A twelve‐month, multicenter, randomized, double‐blind, placebo‐controlled, phase II clinical trial

RANKL is essential for osteoclast development, activation, and survival. Denosumab is a fully human monoclonal IgG2 antibody that binds RANKL, inhibiting its activity. The aim of this multicenter, randomized, double-blind, placebo-controlled, phase II study was to evaluate the effects of denosumab on structural damage in patients with rheumatoid arthritis (RA) receiving methotrexate treatment. RA patients received subcutaneous placebo (n = 75), denosumab 60 mg (n = 71), or denosumab 180 mg (n = 72) injections every 6 months for 12 months. The primary end point was the change from baseline in the magnetic resonance imaging (MRI) erosion score at 6 months. At 6 months, the increase in the MRI erosion score from baseline was lower in the 60-mg denosumab group (mean change 0.13; P = 0.118) and significantly lower in the 180-mg denosumab group (mean change 0.06; P = 0.007) than in the placebo group (mean change 1.75). A significant difference in the modified Sharp erosion score was observed as early as 6 months in the 180-mg denosumab group (P = 0.019) as compared with placebo, and at 12 months, both the 60-mg (P = 0.012) and the 180-mg (P = 0.007) denosumab groups were significantly different from the placebo group. Denosumab caused sustained suppression of markers of bone turnover. There was no evidence of an effect of denosumab on joint space narrowing or on measures of RA disease activity. Rates of adverse events were comparable between the denosumab and placebo groups. Addition of twice-yearly injections of denosumab to ongoing methotrexate treatment inhibited structural damage in patients with RA for up to 12 months, with no increase in the rates of adverse events as compared with placebo.

Oxcarbazepine in migraine headache

To evaluate the efficacy, safety, and tolerability of oxcarbazepine (1,200 mg/day) vs placebo as prophylactic therapy for patients with migraine headaches. This multicenter, double-blind, randomized, placebo-controlled, parallel-group trial consisted of a 4-week single-blind baseline phase and a 15-week double-blind phase consisting of a 6-week titration period, an 8-week maintenance period, and a 1-week down-titration period, after which patients could enter a 13-week open-label extension phase. During the 6-week titration period, oxcarbazepine was initiated at 150 mg/day and increased by 150 mg/day every 5 days to a maximum tolerated dose of 1,200 mg/day. The primary outcome measure was change from baseline in the number of migraine attacks during the last 28-day period of the double-blind phase. Eighty-five patients were randomized to receive oxcarbazepine and 85 to receive placebo. There was no difference between the oxcarbazepine (-1.30) and placebo groups in mean change in number of migraine attacks from baseline during the last 28 days of double-blind phase (-1.74; p = 0.2274). Adverse events were reported for 68 oxcarbazepine-treated patients (80%) and 55 placebo-treated patients (65%). The majority of adverse events were mild or moderate in severity. The most common adverse events (>or=15% of patients) in the oxcarbazepine-treated group were fatigue (20.0%), dizziness (17.6%), and nausea (16.5%); no adverse event occurred in more than 15% of the placebo-treated patients. Overall, oxcarbazepine was safe and well tolerated; however, oxcarbazepine did not show efficacy in the prophylactic treatment of migraine headaches.

Ferric Gluconate Reduces Epoetin Requirements in Hemodialysis Patients with Elevated Ferritin

The Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study demonstrated the efficacy of intravenous ferric gluconate to improve hemoglobin levels in anemic hemodialysis patients who were receiving adequate epoetin doses and who had ferritin levels between 500 and 1200 ng/ml and transferrin saturation (TSAT) < or = 25%. The DRIVE-II study reported here was a 6-wk observational extension designed to investigate how ferric gluconate impacted epoetin dosage after DRIVE. During DRIVE-II, treating nephrologists and anemia managers adjusted doses of epoetin and intravenous iron as clinically indicated. By the end of observation, patients in the ferric gluconate group required significantly less epoetin than their DRIVE dose (mean change of -7527 +/- 18,021 IU/wk, P = 0.003), whereas the epoetin dose essentially did not change for patients in the control group (mean change of 649 +/- 19,987 IU/wk, P = 0.809). Mean hemoglobin, TSAT, and serum ferritin levels remained higher in the ferric gluconate group than in the control group (P = 0.062, P < 0.001, and P = 0.014, respectively). Over the entire 12-wk study period (DRIVE plus DRIVE-II), the control group experienced significantly more serious adverse events than the ferric gluconate group (incidence rate ratio = 1.73, P = 0.041). In conclusion, ferric gluconate maintains hemoglobin and allows lower epoetin doses in anemic hemodialysis patients with low TSAT and ferritin levels up to 1200 ng/ml.

Comparison of the effect of two types of acupuncture on quality of life in secondary progressive multiple sclerosis: a preliminary single-blind randomized controlled trial

Objective: To compare the effect of two types of acupuncture on the quality of life of individuals with secondary progressive multiple sclerosis and provide preliminary evidence regarding the safety of this intervention for this population. Design: Preliminary single-blind randomized controlled trial. Setting: Outpatient attendance at rehabilitation unit. Participants: Fourteen participants with secondary progressive multiple sclerosis. Interventions: Chinese medical acupuncture or minimal acupuncture. Participants received 10 treatments over five weeks. Measures: Multiple Sclerosis Impact Scale 29, Fatigue Severity Scale and General Health Questionnaire 12 were measured pre and post intervention. Adverse events and other responses during treatment were recorded prospectively. Results: Participants receiving minimal acupuncture demonstrated statistically significant greater improvement in the Multiple Sclerosis Impact Scale 29 psychological subscale compared with those receiving Chinese medical acupuncture in an intention-to-treat analysis (P=0.04), with mean change in Chinese acupuncture group of 6.0 (SD 13.9) and in minimal acupuncture group of 23.0 (SD 21.0). No other statistically significant difference between the groups was found. No major adverse events were noted. Minor adverse events such as lower limb muscle spasms or pain were noted in some participants in both intervention groups. Conclusion: Minimal acupuncture resulted in greater improvement of Multiple Sclerosis Impact Scale 29 psychological subscale compared with Chinese medical acupuncture. No other differences between the groups were found. In view of the small sample these results are not conclusive. This study provides preliminary evidence to suggest that acupuncture is safe for people with secondary progressive multiple sclerosis. A large-scale trial is required to provide more definitive evidence.

Effectiveness of mobile and internet intervention in patients with obese type 2 diabetes

Purpose The present study evaluated whether an intervention using the SMS by personal cellular phone and internet would improve the levels of plasma glucose of obese type 2 diabetes at 3, 6, 9, and 12 months. Methods This is a quasi-experimental design with pre- and follow-up tests. Participants were recruited from the endocrinology outpatient department of tertiary care hospital located in an urban city of South Korea. Eighteen patients were randomly assigned to an intervention group and 16 to a control group. The goal of the intervention was to decrease body weight and keep blood glucose concentrations close to the normal range. Patients were requested to record their blood glucose level in a weekly diary on the website by personal cellular phones or computer internet. The researcher sent optimal recommendations to each patient, by both the cellular phone and the Internet weekly. The intervention was applied for 1 year. Results Glycosylated hemoglobin (HbA 1c) decreased 1.22 percentage points at 3 months, 1.09 percentage points at 6 months, 1.47 percentage points at 9 months, and 1.49 percentage points at 12 months compared with baseline in the intervention group (all time points, p < 0.05). The percentage change in the control group was, however, not significant. Patients in the intervention group had a decrease of 2-h post-prandial test (2HPPT) of 120.1 mg/dl at 3 months, 58.9 mg/dl at 6 months, 62.0 mg/dl at 9 months, and 102.9 mg/dl at 12 months compared with baseline (all time points, p < 0.05). The mean change in the control group was, however, not significant. Conclusion This web-based intervention using SMS of personal cellular phone and Internet improved HbA 1c and 2HPPT at 3, 6, 9, and 12 months in patients with obese type 2 diabetes.

Effect of selective and non-selective β-blockers on body weight, insulin resistance and leptin concentration in chronic heart failure

Chronic heart failure (CHF) is characterized by increased insulin resistance and hyperleptinaemia. We aimed to study effects of selective and non-selective beta-blockers on body weight, insulin resistance, plasma concentrations of leptin and resistin in patients with CHF. Twenty-six non-cachectic beta-blocker-naive patients with CHF were randomized and treated with either carvedilol or bisoprolol. Body weight, plasma concentrations of leptin, resistin, fasting glucose and insulin were measured at baseline and after 6 months of therapy. Insulin resistance was estimated by homeostasis model assessment- estimated insulin resistance (HOMA-IR). Body weight increased significantly in the carvedilol group (mean change + 2.30 kg, p = 0.023) while it did not change in the bisoprolol group (mean change -0.30 kg, p = 0.623) (ns between groups). Plasma leptin concentration increased only in the carvedilol group (mean change + 4.20 ng/ml, p = 0.019) (ns between groups). Fasting glucose and resistin remained unchanged in both groups. After 6 months, mean plasma insulin concentration changed significantly differently (p = 0.015) in the bisoprolol (mean change +3.1 microU/ml) compared to the carvedilol group (mean change -6.3 microU/ml) and HOMA-IR was consequently higher in the bisoprolol compared to the carvedilol group (5.2 +/- 4.2 vs 2.8 +/- 1.6, p = 0.046). This study found different metabolic effects of carvedilol and bisoprolol in non-cachectic patients with CHF. With unchanged fasting plasma glucose concentration after 6 months of treatment, carvedilol significantly decreased plasma insulin concentration and insulin resistance compared to bisoprolol.