Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis.

BACKGROUND: Gut microbiota modifiers may have beneficial effects of non-alcoholic fatty liver disease (NAFLD) but randomised controlled trials (RCT) are lacking in children. AIM: To perform a double-blind RCT of VSL#3 vs. placebo in obese children with biopsy-proven NAFLD. METHODS: Of 48 randomised children, 44 (22 VSL#3 and 22 placebo) completed the study. The main outcome was the change in fatty liver severity at 4 months as detected by ultrasonography. Secondary outcomes were the changes in triglycerides, insulin resistance as detected by the homoeostasis model assessment (HOMA), alanine transaminase (ALT), body mass index (BMI), glucagon-like peptide 1 (GLP-1) and activated GLP-1 (aGLP-1). Ordinal and linear models with cluster confidence intervals were used to evaluate the efficacy of VSL#3 vs. placebo at 4 months. RESULTS: At baseline, moderate and severe NAFLD were present in 64% and 36% of PLA children and in 55% and 45% of VSL#3 children. The probability that children supplemented with VSL#3 had none, light, moderate or severe FL at the end of the study was 21%, 70%, 9% and 0% respectively with corresponding values of 0%, 7%, 76% and 17% for the placebo group (P < 0.001). No between-group differences were detected in triglycerides, HOMA and ALT while BMI decreased and GLP-1 and aGLP1 increased in the VSL#3 group (P < 0.001 for all comparisons). CONCLUSIONS: A 4-month supplement of VSL#3 significantly improves NAFLD in children. The VSL#3-dependent GLP-1 increase could be responsible for these beneficial effects. Trial identifier: NCT01650025 (www.clinicaltrial.gov).

Antiandrogen withdrawal in the treatment of hormone-relapsed prostate cancer: single institutional experience.

OBJECTIVES: Locally advanced and metastatic prostate cancer eventually progresses in spite of complete androgen blockade. Second-line therapy is usually disappointing, and further progression is the rule. Laboratory and clinical data have indicated that antiandrogen withdrawal may be a valuable strategy in the treatment of these patients. However, after antiandrogen withdrawal, controversial clinical results have been reported. Therefore every contribution to this therapeutic strategy is useful. METHODS: Herein we present our experience with antiandrogen discontinuation in a series of 44 patients with locally advanced or metastatic prostate cancer treated with complete androgen blockade (CAB). RESULTS: Prostate-specific antigen (PSA) decline was observed in 13 of 44 (29%) and in 11 of these patients the reduction was greater than 50%. No response or further progression after antiandrogen withdrawal was observed in 31 of the 44 patients (71%). Among these patients 14 died due to prostate cancer after a mean period of 5.6 months. No patient in the responding group has died. CONCLUSIONS: Our data indicate that approximately 30% of patients with advanced prostate cancer treated with CAB respond to antiandrogen withdrawal with a reduction in serum PSA levels. Even though it is not clear whether this PSA reduction produces a benefit in terms of survival, we feel that antiandrogen withdrawal must be the first therapeutic maneuver in patients with advanced prostate cancer who progress after CAB. If there is no PSA response within 4 months, second-line treatment is necessary.

Recombinant alpha interferon in metastatic renal cell carcinoma. A cooperative phase II study.

A total of 61 evaluable patients with advanced renal cell carcinoma have been treated with 3 x 10(6) IU per square meter of body surface with recombinant alpha 2b interferon three times a week within a Cooperative Phase II Study. Toxic death for terminal renal failure occurred in 1 patient (1.63%), and toxicities greater than WHO grade 2 were present in 10 cases (16%). The overall response rate after six months of treatment was 13.1% (partial response 4, minor response 4). Two complete responses were obtained at nine and fifteen months (3.3%). Long-lasting stabilization of disease was 13.1 percent.

[Congenital dysplasia of the hip. Preliminary results of a longitudinal study in the first 6 months of life]. / La displasia congenita dell'anca (DCA). Risultati preliminari di uno studio longitudinale nei primi 6 mesi di vita.

The authors report their experience of a serial follow-up for congenital dysplasia of the hip (CDH). 699 babies born during a three-months period were examined on their first day of life, on the forth and at the age of 1 and 6 months. 2 dislocated hips, 222 clicking hips were discovered in the neonatal period. At the first month 1 dislocated hip and only 6 clicking hips were detected. At the sixth month all babies were normal with the exception of two clicking hips. X-ray examination confirmed clinical dislocation diagnosis and showed pathological signs (subluxation and acetabular dysplasia) also in normal and clicking hips. According to their results the authors suggest that clinical examination during the first 6 months of life and X-ray can decrease the incidence of late diagnosis of CDH.