Patient Behaviors and Characteristics Related to Weight Regain After Roux-en-Y Gastric Bypass: A Multicenter Prospective Cohort Study.

OBJECTIVE: To identify patient behaviors and characteristics related to weight regain after Roux-en-Y gastric bypass surgery (RYGB). BACKGROUND: There is considerable variation in the magnitude of weight regain after RYGB, highlighting the importance of patient-level factors. METHODS: A prospective cohort study of adults who underwent bariatric surgery in 6 US cities between 2006 and 2009 included presurgery, and 6-month and annual assessments for up to 7 years. Of 1573 eligible participants, 1278 (81%) with adequate follow-up were included (80% female, median age 46 years, median body mass index 46 kg/m). Percentage of maximum weight lost was calculated each year after weight nadir. RESULTS: Weight was measured a median of 8 (25th-75th percentile, 7-8) times over a median of 6.6 (25th-75th percentile, 5.9-7.0) years. ß coefficients, that is, the mean weight regain, compared with the reference, and 95% confidence interval, are reported. Postsurgery behaviors independently associated with weight regain were: sedentary time [2.9% (1.2-4.7), for highest vs lowest quartile], eating fast food [0.5% (0.2-0.7) per meal/wk], eating when feeling full [2.9% (1.2-4.5)], eating continuously [1.6% (0.1-3.1)], binge eating and loss-of-control eating [8.0% (5.1-11.0) for binge eating; 1.6 (-0.1 to 3.3) for loss of control, vs neither], and weighing oneself

Effect of silymarin (milk thistle) on liver disease in patients with chronic hepatitis C unsuccessfully treated with interferon therapy: a randomized controlled trial.

CONTEXT: The botanical product silymarin, an extract of milk thistle, is commonly used by patients to treat chronic liver disease, despite scant and conflicting evidence of its efficacy. OBJECTIVE: To determine the effect of silymarin on liver disease activity in patients with chronic hepatitis C virus (HCV) infection unsuccessfully treated with interferon-based therapy. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blind, placebo-controlled trial conducted at 4 medical centers in the United States. Participants included 154 persons with chronic HCV infection and serum alanine aminotransferase (ALT) levels of 65 U/L or greater who were previously unsuccessfully treated with interferon-based therapy. Enrollment began in May 2008 and was completed in May 2010, with the last follow-up visit completed in March 2011. INTERVENTION: Participants were randomly assigned to receive 420-mg silymarin, 700-mg silymarin, or matching placebo administered 3 times per day for 24 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was serum ALT level of 45 U/L or less (considered within the normal range) or less than 65 U/L, provided this was at least a 50% decline from baseline values. Secondary outcomes included changes in ALT levels, HCV RNA levels, and quality-of-life measures. RESULTS: After 24 weeks of treatment, only 2 participants in each treatment group (P ≥ .99) met the primary outcome measure (3.8% [95% CI, 0.5% to 13.2%] for placebo, 4.0% [95% CI, 0.5% to 13.7%] for 420-mg silymarin, and 3.8% [95% CI, 0.5% to 13.2%] for 700-mg silymarin). The mean decline in serum ALT activity at the end of treatment did not differ significantly (P = .75) across the 3 treatment groups (mean decline, -4.3 [95% CI, -17.3 to 8.7] U/L for placebo, -14.4 [95% CI, -41.6 to 12.7] U/L for 420-mg silymarin, -11.3 [95% CI, -27.9 to 5.4] U/L for 700-mg silymarin); there likewise were no significant differences in HCV RNA levels (mean change, 0.07 [95% CI, -0.05 to 0.18] log10 IU/mL for placebo, -0.03 [95% CI, -0.18 to 0.12] log10 IU/mL for 420-mg silymarin, 0.04 [95% CI, -0.08 to 0.16] log10 IU/mL for 700-mg silymarin; P = .54) or quality-of-life measures. The adverse event profile of silymarin was comparable with that of placebo. CONCLUSION: Higher than customary doses of silymarin did not significantly reduce serum ALT levels more than placebo in participants with chronic HCV infection unsuccessfully treated with interferon-based therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00680342.

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C.

BACKGROUND: Chronic hepatitis C is associated with significant morbidity and mortality as a consequence of progression to cirrhosis, hepatocellular carcinoma, and liver failure. Current treatment for chronic hepatitis C with pegylated interferon (IFN) and ribavirin is associated with suboptimal responses and numerous adverse effects. A number of botanical products have been used to treat hepatic disorders. Silymarin, extracted from the milk thistle plant, Silybum marianum (L) Gaertn. (Asteraceae), has been most widely used for various liver disorders, including chronic hepatitis C, B, and alcoholic liver disease. However, the safety and efficacy of silymarin have not been studied systematically in chronic hepatitis C. PURPOSE: We describe our strategy for a phased approach for studying the impact of silymarin in hepatitis C, in the context of the unique challenges of botanical product clinical trials and the development of specific and curative antiviral therapy. METHODS: This multicenter, randomized, double-masked, placebo-controlled trial was conducted with four clinical centers and a data-coordinating center in the United States, to assess the impact of silymarin therapy in patients with chronic hepatitis C who failed conventional antiviral therapy. RESULTS: Key aspects relevant to performing clinical trials of botanical products include early identification of an appropriate product with standard product chemistry, acquisition of pharmacokinetic and dosing information, selection of the appropriate study group, and choosing rigorous outcome variables. POTENTIAL LIMITATIONS: Trial participants were chronic hepatitis C patients who were nonsustained virologic responders to IFN-based therapy; therefore, the findings are not generalizable to all hepatitis C populations. Further, alanine aminotransferase, a biochemical liver test, rather than hepatitis viral RNA or liver histology was the primary end point. CONCLUSIONS: The challenges identified and addressed during development of this United States multicenter Phase II trial to evaluate silymarin for treatment of patients with chronic hepatitis C infection who had failed to respond successfully to previous IFN-based therapy are common and must be addressed to conduct rigorous trials of botanical products.

Use of cognitive enhancement medication in persons with Alzheimer disease who have a family caregiver: results from the Resources for Enhancing Alzheimer's Caregiver Health (REACH) project.

OBJECTIVE: Aging populations show increased prevalence of cognitive impairment and dementia. Recent efficacy studies report on prescription medications and herbal preparations that affect cognitive functioning, but the prevalence and correlates of cognitive-enhancement (CE) medication use among community-dwelling older persons is not well studied. The authors examined the frequency and appropriateness of use, the importance of a family caregiver in medication decisions for dementia patients, and differences in access to medical care. METHODS: REACH is a multisite feasibility study of several approaches to reducing the negative impacts of caregiving on those living with a family member with dementia. Data on medication use by care-recipients were collected at baseline and 1 year later. RESULTS: At baseline, 31% of 1,222 care-recipients were using a CE medication. Factors independently related to CE use were age, education, functional status, and caregiver vigilance. Within 1 year, 14% started and 30% quit taking CE. Care-recipients more likely to be Starters had spouse-caregivers, more education, and fewer baseline ADL impairments. Quitters had more ADL deficits at baseline and became less able to perform ADL at follow-up than those who continued on CE. CONCLUSIONS: CE medication use among dementia patients with a family caregiver is relatively common, though there is substantial geographic variability. Our findings are mixed with respect to appropriate use of CE medications, suggesting areas for physician education. Our data indicate the importance of the caregiver in CE medication use and suggest that there may be disparities in access to healthcare among people with cognitive impairment.