Randomised clinical trial: a herbal preparation of myrrh, chamomile and coffee charcoal compared with mesalazine in maintaining remission in ulcerative colitis--a double-blind, double-dummy study.

BACKGROUND: The herbal treatment with myrrh, dry extract of chamomile flowers and coffee charcoal has anti-inflammatory and antidiarrhoeal potential and might benefit patients with UC. Aminosalicylates are used as standard treatment for maintaining remission in ulcerative colitis (UC). AIM: To compare the efficacy of the two treatments in maintaining remission in patients with ulcerative colitis. METHODS: We performed a randomised, double-blind, double-dummy study over a 12-month period in patients with UC. Primary endpoint was non-inferiority of the herbal preparation as defined by mean Clinical Colitis Activity Index (CAI-Rachmilewitz). Secondary endpoints were relapse rates, safety profile, relapse-free times, endoscopic activity and faecal biomarkers. RESULTS: A total of 96 patients (51 female) with inactive UC were included. Mean CAI demonstrated no significant difference between the two treatment groups in the intention-to-treat (P = 0.121) or per-protocol (P = 0.251) analysis. Relapse rates in total were 22/49 patients (45%) in the mesalazine treatment group and 25/47 patients (53%) in the herbal treatment group (P = 0.540). Safety profile and tolerability were good and no significant differences were shown in relapse-free time, endoscopy and faecal biomarkers. CONCLUSIONS: The herbal preparation of myrrh, chamomile extract and coffee charcoal is well tolerated and shows a good safety profile. We found first evidence for a potential efficacy non-inferior to the gold standard therapy mesalazine, which merits further study of its clinical usefulness in maintenance therapy of patients with ulcerative colitis. EudraCT-Number 2007-007928-18.

Filgrastim (r-metHuG-CSF) and its potential use in the reduction of radiation-induced oropharyngeal mucositis: an interim look at a randomized, double-blind, placebo-controlled trial.

We wished to determine if filgrastim administration to chemotherapy/radiation therapy-naive patients receiving external-beam irradiation for head-and-neck malignancies would reduce the incidence and severity of oral/oropharyngeal mucositis. Patients were randomized to receive subcutaneous injections of either filgrastim or placebo beginning on day 1 of radiation and continuing daily throughout treatment. Study medication was titrated to keep the neutrophil count between 10 x 10(9) and 30 x 10(9)/l. The left and right buccal mucosa, hard palate, and posterior pharyngeal wall were scored weekly, by a blinded evaluator using two different scales, and the most severe score per week was used in data analysis. Fourteen of a planned 54 patients were randomized (8 filgrastim, 6 placebo), and were evaluable for a planned interim analysis. No statistically significant between-group differences were seen in mean worst scores across time using repeated measures analysis of variance (Hickey, p = 0.231; WHO, p= 0.288). At almost all timepoints, however, the worst mean scores were lower in patients treated with filgrastim compared with those in patients treated with placebo, and the number of severe (i.e., grade 3) mucositis scores was significantly lower in the filgrastim-treated group. Filgrastim may decrease the severity of radiation-induced oral/oropharyngeal mucositis.

The prognostic value of PSA levels in radiation therapy of patients with carcinoma of the prostate: the UCLA experience 1988-1992.

BACKGROUND AND OBJECTIVES: Pretreatment prostate-specific antigen (PSA) levels may be of prognostic significance for patients with prostate cancer. Posttreatment PSA data are more limited. This study was undertaken to examine the prognostic role of pretreatment and posttreatment PSA levels in the radiation treatment of patients with carcinoma of the prostate. METHODS: One hundred one patients who received primary radiation therapy at UCLA between 1988 and 1992 for clinical stage A to D1 prostate cancer were analyzed. Included were 4 patients with stage A, 77 with stage B, 16 with stage C, and 4 with stage D. All patients had pretherapy and posttherapy PSA values. Patients received definitive radiation therapy with photons (81), neutrons (13), or interstitial implant (7). Correlations were made with other prognostic factors and treatment outcome. RESULTS: Median follow-up was 28 months. At last follow-up, 64% were without evidence of disease, 17% had rising PSA profiles or failure of PSA to normalize (chemical failure), and 19% had local recurrence and/or distant metastases. The 4-year overall survival was 85%, whereas actuarial survival free of chemical or clinical failure was only 32%. Pretreatment PSA levels and posttreatment PSA level normalization at 6 months correlated significantly with disease-free survival. On univariate analysis, pretreatment PSA levels correlated significantly with stage, high versus low Gleason score, and outcome. Posttreatment PSA level normalization at 6 and 12 months correlated with stage, pretreatment PSA level, and outcome, but not with Gleason score. Only PSA level normalization at 6 months and age were independent variables using multivariate analysis. PSA nadir values differed significantly between patients free of disease and those who failed. CONCLUSIONS: In our analysis, posttreatment PSA levels were independently predictive of outcome, whereas pretreatment PSA levels, while correlating with other prognostic factors, were not independently predictive. Given the prognostic value of posttreatment PSA levels, it is appropriate that chemical failures be included in outcome analyses, although this will lower disease-free survival.

Cutaneous anergy and marrow suppression as complications of gastroplasty for morbid obesity.

Although serious morbidity from gastric restriction for morbid obesity is rare, outflow tract dilation after gastroplasty has become a well-recognized complication, and reoperation to decrease outflow tract size has become increasingly common. We report the case of a patient who developed outflow tract obstruction with subsequent malnutrition, recurrent infections, and marrow suppression. Extensive immunologic evaluation revealed impaired cutaneous reactivity to a battery of recall antigens. Other in vitro T cell functions, B cell functions, neutrophil respiration, and quantification of complements were within normal limits. The patient's immunodeficiency was attributed to protein-calorie malnutrition and was corrected with total parenteral nutrition. Recovery of immune function with renutriture was demonstrated, and coincident resolution of infection and marrow suppression also occurred. Because of the reversibility of the immunologic abnormality with appropriate nutritional therapy, it is important to consider and treat malnourishment in connection with any operation in which oral intake is severely limited.