Parastomal hernia prevention using a novel collagen implant: a randomised controlled phase 1 study

BACKGROUND: Parastomal hernias can be prevented or repaired using synthetic mesh; however, reported complications include infection, fibrosis and potential bowel erosion. The study aim was to assess the safety, feasibility and potential efficacy of using a prophylactic collagen implant. METHODS: Twenty patients undergoing defunctioning stomas were randomised to a conventional procedure or reinforcement with the implant. Follow-up included regular symptom questionnaires, clinical examination, stoma site ultrasound, and serum inflammatory markers. RESULTS: Ten patients (four males; mean BMI 26.3) had a conventional stoma, and ten (three males; mean BMI 26.3) received the implant. At a median of 6.5 months follow-up, a parastomal hernia was clinically evident in three of ten patients without the implant, and in none of ten patients with the implant. There were no clinical complications, ultrasound evidence of chronic seromas or serological evidence of a systemic inflammatory response. CONCLUSIONS: Xenogeneic collagen has been demonstrated to aid soft tissue reinforcement. In this study, in contrast to published data relating to the use of conventional synthetic mesh, there were no complications related to infection or the implant's proximity to the bowel. This trial demonstrates that the implant is safe, feasible to use and has the potential to prevent parastomal herniation.     

Octreotide in refractory functional epigastric pain with nutritional impairment—an open study

AIM: To test the therapeutic efficacy of octreotide administered subcutaneously for the relief of chronic refractory epigastric pain severe enough to provoke nutritional impairment. SUBJECTS AND METHODS: Seventeen patients were enrolled in an open trial. Epigastric pain had lasted from 1 to 8 years (median: 5 years), following anti-reflux surgery in eight patients. Median weight loss was 10% (range 10-15). The initial dose of octreotide was 50 microgram b.d, adjusted during the follow-up visits which were scheduled for months 1, 3, 6, 8, 10, 12 and every 3 months. At each visit, overall symptomatic improvement, frequency and intensity of symptoms were checked on a 10-cm visual analogic scale. RESULTS: At month 1, a progressive improvement of pain intensity was reported in 15 of the 17 patients, while octreotide was a therapeutic failure in two. In four out of 15, the daily dose of octreotide was increased to 100 microgram b.d. In these 15 patients, median follow-up was 7 months (3-27). The symptomatic benefit was maintained in each patient at month 3, with a median weight gain of 3.5 kg.2-5 An attempt to stop octreotide led to recurrence of symptoms in 2-3 days which were as intense as before the treatment. The 11 patients followed-up for at least 6 months reported persistent improvement of symptoms with octreotide and a median weight gain of 4 kg.3-7 Four patients were followed up for more 11-27 months: octreotide was withdrawn gradually in two who remained asymptomatic. Six of the 17 patients experienced minor side-effects, but none developed biliary sludge. CONCLUSIONS: This open study suggests that octreotide could be a promising alternative treatment when all others fail in refractory chronic functional epigastric pain severe enough to limit food intake and to induce nutritional impairment. These results must be tested by a placebo-controlled study.     

Serum Free‐Light Chain Removal by High Cutoff Hemodialysis: Optimizing Removal and Supportive Care

In multiple myeloma the predominant cause of irreversible renal failure is cast nephropathy, secondary to excess κ or λ serum free light chains (FLCs). These molecules are efficiently cleared by hemodialysis (HD) using the Gambro HCO 1100 dialyzer. To optimize the removal of FLCs by this dialyzer we have studied the effect of dialyzers in series, dialyzer change, and hemodiafiltration in 14 patients with multiple myeloma and renal failure. The clearance rates of both κ FLCs and λ FLCs were significantly increased on two dialyzers from 19 (7.3–34)–15.3 (9–28) mL/min to 47 (17–79)–35.5 (20–57) mL/min, respectively. Clearance rates of both FLCs decreased over the course of the dialysis sessions (both P < 0.001). Changing the dialyzer during a HD session increased λ FLC clearance rates (22.5 [6–41] to 37.6 [9–52] mL/min; P < 0.001) and decreased κ FLC clearance rates (39.6 [9–72] to 19 [8–59] mL/min; P < 0.003). Ultrafiltration during HD increased the clearance rates of κ FLCs (R 0.52, P < 0.01) but not λ FLCs (R ?0.25; P < 0.076). Hemodiafiltration increased the clearance rates of both κ (19 [SD 6.8] to 32 [SD 9.8] mL/min) and λ FLCs (15 [SD 7.8] to 20 [SD 7.7] mL/min). Albumin replacement requirements for 8 h of HD increased from 12 g for a single dialyzer to 45 g for two dialyzers in series (P < 0.001). Different protocols are required to optimize the removal of κ and λ FLCs in patients with myeloma and renal failure.     

Poverty and childhood overweight in California Assembly districts

ObjectivesThe goal of the present study was to determine the association between childhood overweight and area-based socioeconomic indicators in California Assembly districts.DesignA cross-sectional ecologic study.ParticipantsCalifornia public school students.Main exposurePoverty and demographic data for California Assembly districts were based on the 2000 Census and obtained from the UCLA Center for Health Policy Research.Outcome measuresOverall and race- and ethnicity-specific rates of childhood overweight for California Assembly districts (n=80) were based on the 2004 statewide Fitnessgram evaluation of California public school students.ResultsPoverty was significantly associated with childhood overweight in California Assembly districts. At the Assembly district scale, childhood overweight was significantly associated with percent residents below poverty for the entire population (r=0.82), and with the race/ethnicity-specific overweight prevalence for African-American (r=0.43), Latino (r=0.61) and White (r=0.54) populations. There was also evidence that childhood overweight in California Assembly districts was spatially clustered. Linear regression models confirmed that percent of residents below poverty was an independent predictor of a higher prevalence of childhood overweight for the entire population. The results of race/ethnicity-specific models confirmed that the association between area poverty and childhood overweight was not explained by differences in the risk of overweight among specific race/ethnicity groups.ConclusionsArea-based measures of socioeconomic status can be used to identify problem areas and can be used for optimal targeting of public health prevention and intervention efforts.     

Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): Additional results from the monthly oral therapy with ibandronate for osteoporosis intervention (MOTION) study

Background: The MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis Intervention) study reported that once-monthly ibandronate was noninferior to once-weekly alendronate in terms of increasing bone mineral density (BMD) at the lumbar spine and total hip over 12 months. On analysis of secondary and exploratory end points in MOTION, which included trochanter and femoral neck BMD, monthly ibandronate was found to be noninferior to weekly alendronate. The coprimary, secondary, and exploratory BMD end points from MOTION have been previously reported.Objective: This report presents additional results from the MOTION study, including response rates in terms of lumbar spine and total hip BMD gains above baseline; findings from a comparison of serum concentrations of bone turnover markers; and tolerability analysis, including adverse events that led to withdrawal and gastrointestinal (GI) adverse events.Methods: MOTION was a 12-month (with 15-day follow-up), randomized, multinational, multicenter, double-blind, double-dummy, parallel-group, nonin-feriority study in postmenopausal women aged 55 to <85 years with osteoporosis. Patients were randomly assigned to receive 150-mg-monthly oral ibandronate and weekly alendronate-matched placebo, or 70-mg-weekly oral alendronate and monthly ibandronate-matched placebo, for 12 months. At baseline, day 7 of treatment, 3 and 6 months, 6 months + 7 days, and 12 months, serum concentrations of markers of bone resorption (C-telopeptide of the a chain of type 1 collagen [sCTX]) and bone formation (serum N-terminal propeptides of type 1 collagen) were measured in a subset of the total trial population. At baseline and month 12, BMD was measured using dual-energy x-ray absorptiometry. Exploratory analyses of patients whose spine, total hip, and trochanter BMD at 12 months were above baseline (responders) were also performed.Results: A total of 1760 women were enrolled (ibandronate, 887 patients; alendronate, 873). The median changes in the trough concentrations of sCTX were ?75.5% with monthly ibandronate and ?81.2% with weekly alendronate. The percentage of patients with mean lumbar spine and total hip BMD gains above baseline (responders) were 90% and 87%, respectively, for ibandronate and 92% and 90%, respectively, for alendronate. GI adverse events were reported in ≤30% of patients per group during this 1-year study.Conclusion: The data from these postmenopausal women with osteoporosis suggest that once-monthly 150-mg ibandronate therapy provided clinically comparable efficacy in terms of BMD response, reductions in bone turnover, and GI tolerability similar to that of weekly 70-mg alendronate.