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PubMed2002

How useful are observational reports in the evaluation of interventions for radiation morbidity?: an analysis of formalin therapy for late radiation proctitis.

BACKGROUND AND PURPOSE: Evidence-based medicine requires the systematic and critical evaluation of published and unpublished trials. Problems arise when a clinical condition is relatively rare and the only available data relate to experiential knowledge. The way forward would be to recommend the development of good quality randomized controlled studies. Until then, we are left with the situation where some information exists, albeit in the form of case reports and small series. Should this information be used and what features would determine its strength? METHODS: Using the example of formalin therapy in haemorrhagic radiation proctitis, a treatment for a rare condition, we were able to identify 16 published studies, 13 of which were retrospective and three of which were prospective. The quality of reporting detail was assessed by comparison to the features in a 'proposed minimum dataset' for an uncontrolled study addressing this topic. RESULTS: The mean score for quality of reporting detail for these studies was 50.6% (range 25-70%). Earlier studies reported a significantly higher response rate than subsequent studies and although there was a tendency for smaller studies to report higher response rates, this was not significant. The score for detail of reporting did not improve with year of publication and the correlation between the size of the study and the detail of reporting was not statistically significant. CONCLUSIONS: The information presented is of exceedingly variable quality. If these studies are to be used, where insufficient controlled trials are available, they should be scored for methodology, and these scores used to assist interpretation of results. This would be facilitated if an accepted reporting format including specific criteria was available.

Evaluation Studies as Topic↗
PubMed2000

Acute radiation proctitis: a sequential clinicopathologic study during pelvic radiotherapy.

PURPOSE: Rectal toxicity is often dose limiting during pelvic radiation therapy. This prospective study examined the sequential development and associations of clinical, endoscopic, and histopathologic rectal toxicity during ongoing radiation therapy. METHODS AND MATERIALS: Thirty-three patients with nongastrointestinal pelvic carcinomas underwent proctoscopy with biopsy before radiation therapy, after 2 weeks treatment, and toward the end of the treatment course (6 weeks). Symptoms of acute toxicity were recorded, and endoscopic changes were graded. Histologic changes in the surface epithelium, glandular layer, and lamina propria were assessed using an ad hoc scoring system. Macrophage accumulation was evaluated in anti-CD68 stained sections. RESULTS: Pretreatment endoscopy and biopsies were unremarkable. Clinical symptoms progressed toward the end of the treatment course. In contrast, endoscopic pathology was maximal at 2 weeks. Biopsies obtained during treatment exhibited atrophy of the surface epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal inflammation. Histologic changes, particularly those in the surface epithelium, were consistently more pronounced at 2 weeks than they were at 6 weeks. CONCLUSION: In contrast to clinical symptoms, endoscopic changes stabilize and histologic changes regress from the 2nd to the 6th week of treatment. These results may have implications for the design and timing of prophylactic and therapeutic interventions to reduce radiation proctitis.

Acute Disease↗
PubMed2002

Local release of human neutrophil lipocalin (HNL), IL-8, and TNF-alpha is decreased as response to topical prednisolone treatment in distal ulcerative colitis and proctitis.

The local release of human neutrophil lipocalin, considered to be highly specific for neutrophil granulocyte activation, and interleukin-8 and tumor necrosis factor-alpha were studied in 11 patients with distal ulcerative colitis and proctitis before and during treatment with steroid enemas. A rectal perfusion technique for sampling and specific immunoassays for analysis were used. In responders (N = 8) the concentrations of all proteins decreased during the study. There was a close correlation between human neutrophil lipocalin concentrations and treatment response. Tumor necrosis factor-alpha showed an initial decline in concentrations irrespective of treatment outcome and preceded the decline of human neutrophil lipocalin and interleukin-8. We conclude that decreased neutrophil degranulation is correlated with treatment outcome. Furthermore, an important role of tumor necrosis factor-alpha in the process of stimulating neutrophil activation and degranulation in ulcerative colitis is suggested.

Acute-Phase Proteins↗
PubMed1997

Comparison of mesalazine suppositories in proctitis and distal proctosigmoiditis.

BACKGROUND: Mesalazine suppositories at 500 mg b.d. are a safe and effective treatment for patients with ulcerative proctitis or distal proctosigmoiditis. Recently a mesalazine 1 g suppository (Pentasa) has been developed. METHODS: Fifty patients with active ulcerative colitis extending not beyond 20 cm from the anus on sigmoidoscopy, participated in a randomized single-blind study comparing the efficacy, tolerance and acceptance of the new Pentasa mesalazine 1 g suppository, given once daily versus Claversal mesalazine 500 mg suppository b.d. RESULTS: After 2 weeks, clinical remission was observed in 16 of 25 (64%) in the Pentasa group and in 7 of 25 (28%) in the Claversal 500 mg b.d. treated group; sigmoidoscopic remission occurred in 13 of 25 (52%) in the Pentasa group and in six of 25 (24%) in the Claversal group (P < 0.01). After 4 weeks, clinical and sigmoidoscopic remission were observed, respectively, in 84 and 76% of patients treated with Pentasa suppositories, and in 80 and 72% of patients treated with Claversal suppositories 500 mg b.d. (P = N.S.). The patients' evaluation for tolerability and practicality showed that the Pentasa suppository was significantly superior to the Claversal suppository. CONCLUSIONS: Pentasa 1 g suppository once daily induces a quicker clinical and sigmoidoscopic remission, and was better tolerated, than the Claversal 500 mg suppository b.d., and it may represent an advance for the topical treatment of distal proctosigmoiditis.

Adult↗
PubMed2003

Epidermal growth factor enemas with oral mesalamine for mild-to-moderate left-sided ulcerative colitis or proctitis.

BACKGROUND: Epidermal growth factor (EGF) is a potent mitogenic peptide produced by salivary glands. We examined whether EGF enemas are an effective treatment for active left-sided ulcerative colitis and ulceration limited to the rectum (proctitis). METHODS: In a randomized, double-blind clinical trial conducted at Leicester Royal Infirmary, 12 patients with mild-to-moderate left-sided ulcerative colitis received daily enemas of 5 microg of EGF in 100 ml of an inert carrier and 12 received daily enemas with carrier alone for 14 days. All also began to receive 1.2 g of oral mesalamine per day or had their dose increased by 1.2 g per day. Patients were assessed clinically at 0, 2, 4, and 12 weeks and by sigmoidoscopy and biopsy at 0, 2, and 4 weeks. The primary end point was disease remission (defined by a St. Marks score of 4 or less without sigmoidoscopic evidence of inflammation) at two weeks. Secondary end points were clinically significant improvements in disease activity (defined by a decrease of more than 3 points in the St. Marks score or the ulcerative colitis disease-activity index) at two and four weeks. Analyses were performed according to the intention-to-treat principle. RESULTS: After two weeks, 10 of the 12 patients given EGF enemas were in remission, as compared with 1 of 12 in the control group (83 percent vs. 8 percent, P<0.001). At the 2-week assessment, disease-activity scores, sigmoidoscopic score, and histologic scores were all significantly better in the EGF group than in the placebo group (P<0.01 for all comparisons), and this benefit was maintained at 4 weeks and at 12 weeks. CONCLUSIONS: This study provides preliminary data suggesting that EGF enemas are an effective treatment for active left-sided ulcerative colitis.

Administration, Oral↗
PubMed2003

Etiology of clinical proctitis among men who have sex with men.

In this retrospective review of cases of clinical proctitis, we identified the frequency of common sexually transmitted diseases (STDs) among men who have sex with men on the basis of reports from the municipal STD clinic in San Francisco. Of note, gonorrhea and chlamydia were the most common STDs, followed by herpes and syphilis. Current STD treatment guidelines recommend empiric treatment for gonorrhea and chlamydia, but treatment for herpes should also be considered. The implications for human immunodeficiency virus (HIV) transmission are also discussed.

Adolescent↗
PubMed1995

Infection with Chlamydia trachomatis lymphogranuloma venereum serovar L1 in homosexual men with proctitis: molecular analysis of an unusual case cluster.

Among 767 rectal isolates of Chlamydia trachomatis obtained from men over the period 1981-1991, 7 were found to be a rare lymphogranuloma venereum serovar, L1. These isolates were from rectal specimens taken from five male patients in 1982-1983. Six of the seven isolates were available for DNA sequencing studies. All six of these isolates shared the same DNA sequence in the major outer membrane protein (MOMP) gene variable domains and had different MOMP sequences than did the prototype L1, L2, and L3 strains, suggesting a point source outbreak. All five patients infected with serovar L-1 were homosexual men who had symptomatic proctitis characterized by rectal pain, discharge, tenesmus, abnormalities seen on anoscopy, and leukocytes seen on gram stains of rectal specimens. We conclude that an unrecognized point source outbreak of the rare chlamydial L1 serovar occurred among homosexual men in Seattle in 1982-1983, and that the clinical manifestations of L1 infection may be less severe than those of L2 infections.

Adult↗
PubMed1982

Herpetic proctitis and meningitis: recovery of two strains of herpes simplex virus type 1 from cerebrospinal fluid.

A patient with simultaneous proctitis and meningitis due to herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) was extensively investigated. In both disease locations the infection was clinically evident and culture-proven. Analysis by sodium dodecylsulfate-polyacrylamide gel electrophoresis of rectal isolates revealed both HSV-1 and HSV-2. The cerebrospinal fluid harbored two apparently different strains of HSV-1, one of which was shown by restriction endonuclease analysis to be identical with the rectal isolate of HSV-1.

Adult↗
PubMed1988

Comparison of beclomethasone dipropionate and prednisolone 21-phosphate enemas in the treatment of ulcerative proctitis.

In a double-blind randomized clinical trial 18 patients with exacerbations of distal ulcerative colitis were treated for 4 weeks with enemas containing either prednisolone 21-phosphate 30 mg (PP) or beclomethasone dipropionate 1 mg (BDP) a surface-active corticosteroid. All 8 patients treated with PP showed clinical and endoscopic improvement in contrast with only 4 of 10 patients treated with BDP. Endocrinologic evaluation showed a significant decrease in morning plasma cortisol, in cortisol increase after synacthen, and in urinary free cortisol excretion after PP therapy, but no changes in these variables after BDP therapy. We conclude that PP enemas are more active in the treatment of ulcerative proctitis, but they cause a suppression of the adrenal cortex, in contrast to BDP.

Adult↗
PubMed2004

Granulocyte, macrophage, monocyte apheresis for refractory ulcerative proctitis.

Refractory ulcerative colitis that fails conventional intense medical treatment often leads to colectomy. Although ciclosporin and infliximab may avert colectomy in certain cases, these treatments come with substantial toxicity and may only act as a bridge to avert emergency surgery. Granulocyte monocyte/macrophage adsorption apheresis is a new treatment and has shown efficacy for refractory colitis in up to 80% of cases in a Japanese study and is apparently only associated with negligible side effects. We report a case of severe refractory proctitis destined for colectomy effectively treated with granulocyte monocyte/macrophage adsorption apheresis. After two of five sessions the patient achieved full clinical remission, which has been sustained with the addition of azathioprine for more than 1 year.

Adult↗
PubMed2004

Argon plasma coagulation in the treatment of hemorrhagic radiation proctitis is efficient but requires a perfect colonic cleansing to be safe.

AIMS: We evaluate prospectively effectiveness, tolerance, predictive factors of failure and complications of argon plasma coagulation (APC) in the treatment of hemorrhagic radiation proctitis (HRP). PATIENTS AND METHODS: Twenty-seven patients were treated by APC for HRP. Eight patients needed blood transfusion before APC. Six patients were anti-coagulated and one had severe thrombocytopenia. APC was performed without sedation in 25/27 patients. Before APC treatment, bowel preparation was performed by enema (n = 19 sessions), polyethylene glycol or sodium phosphate (n = 53 sessions). APC treatment was performed every 5 weeks. Effectiveness of APC was based on clinical and endoscopic score and biological status before and after APC treatment. RESULTS: The mean follow-up was 13.6 months (range, 3-31 months). After one to seven sessions of APC (average, 2.66 sessions), twenty-five patients (92%) had no recurrence of bleeding. The bleeding score decreased from 3.03 to 0.42 (P < 0.001) and the endoscopic score from 3.08 to 0.73 (P < 0.001). Out of the eight patients requiring blood transfusion prior to APC sessions, only one required blood transfusion after APC (P < 0.05). One late relapse was observed and successfully re-treated by APC. Side effects were anal or rectal pain (n = 3) and vagal symptoms (n = 2). Three colonic explosions occurred, with perforation leading to surgery in one case. The incidence of bowel explosion was higher after local preparation (3/19 sessions) compared with oral preparation (0/53 sessions) (P < 0.05). No stricture due to APC appeared, even if telangiectasias coagulated during a session were circumferential. CONCLUSION: Coagulation by APC is an effective and safe treatment of HRP if a complete cleansing preparation is performed to avoid explosion.

Administration, Oral↗
PubMed2006

Colorectal motor and sensitivity features in patients affected by ulcerative proctitis with constipation: a radiological and manometric controlled study.

BACKGROUND AND AIM: Constipation may be present in ulcerative proctitis (UP), but its pathogenesis has not yet been evaluated. The aim of this article is to investigate functional and morphologic features of the anorectal region in patients with UP and constipation. MATERIALS AND METHODS: Eleven patients with quiescent clinical, endoscopic, and histological UP and constipation and 10 patients with functional constipation (FC) underwent radiologic evaluation of intestinal transit time, anorectal manometry, and defecography. Transit time was measured with radiograms at 72 h after ingestion of radiopaque markers. Manometry was carried out using a continuous perfused catheter and a balloon inflated with increasing volumes of air. Defecography was performed after the injection of a barium-sulfate solution in the rectum, with the registration of videotapes during straining, squeezing, and evacuation. RESULTS: Manometry showed in UP significantly lower values of rectal compliance than those in FC (3.10 and 5 mL/mmHg, respectively) (P = 0.03). Rectal sensitivity threshold was increased but without significant differences in UP and FC (30 and 50 mL air, respectively). At defecography, the median value of rectosacral space was increased in UP in comparison with FC (1.30 vs 0.8; P = 0.002). Lateral rectal diameter in UP was lower than in FC (6 and 8.8 cm, respectively; P = 0.016). Nonsymptomatic rectocele, mucosal prolapse, descending perineum, and abdominopelvic dyssynergy were equally present in UP and FC. The majority of UP patients showed a prolonged intestinal transit time similar to FC patients, and, more frequently, they showed low transit in the left colon in comparison with the right colon in comparison with FC patients. CONCLUSIONS: This study suggests that constipation in UP may be correlated with rectal fibrosis, which reduces the transit of stools from the left colon. The concomitance of asymptomatic anorectal organic or functional alteration may contribute to worsen constipation.

Adult↗
PubMed2005

Efficacy and safety of mesalamine 1 g HS versus 500 mg BID suppositories in mild to moderate ulcerative proctitis: a multicenter randomized study.

BACKGROUND: Ulcerative proctitis (UP) usually presents as fresh rectal bleeding. Successful treatment using topical mesalamine 5-aminosalicyclic acid (5-ASA) 500 mg BID suppository led to developing a once-a-day formulation that could contribute to better acceptability and ease of use by patients. The objective of this randomized trial, conducted in 18 centers, was to compare efficacy of 2 modes of treatment with 5-ASA suppositories. METHODS: Ninety-nine patients with mild or moderate UP limited to 15 cm of the anal margin, evidenced by a disease activity index (DAI) between 4 and 11, were randomized to 5-ASA 500 mg suppository (Canasa; Axcan Pharma) BID or 1 g at bedtime (HS) for 6 weeks. The study used a noninferiority hypothesis based on the mean difference in DAI values after 6 weeks of treatment on an intent-to-treat basis using analysis of covariance. DAI was derived from a composite of the measures of stool frequency, rectal bleeding, mucosal visualization at endoscopy, and general well being. RESULTS: There was no difference between groups at baseline for demographic and clinical parameters. Mean DAIs fell from 6.6 +/- 1.5 (SD) to 1.6 +/- 2.3 in the 500 mg BID group (n = 48) and from 6.1 +/- 1.5 to 1.3 +/- 2.2 in the 1 g HS group (n = 39). There was no significant difference (P = 0.74) in mean DAI at week 6 between the 2 groups. Both groups showed a significant reduction (P < 0.0001) in DAI over the course of the 6 weeks. Both formulations showed effectiveness in reducing each individual component of the DAI. There was no significant difference between treatments in adverse events, and both groups had an overall drug compliance of greater than 95%. CONCLUSION: This study showed that 1 g HS and 500 mg BID mesalamine suppository treatments of UP patients were equivalent in all facets of efficacy, safety, and compliance in a 6-week trial.

Adult↗
PubMed1988

Double-blind comparison of 5-aminosalicylic acid and acetyl-5-aminosalicylic acid suppositories in patients with idiopathic proctitis.

Suppositories containing 300 mg 5-aminosalicylic acid (1.96 mmol) or 425 mg acetyl-5-aminosalicylic acid (1.96 mmol) were used in 40 patients with idiopathic proctitis to determine the efficacy of acetyl-5-aminosalicylic acid in treating this bowel inflammation. Each patient was treated with 5-aminosalicylic acid or acetyl-5-aminosalicylic acid suppositories twice daily for 4 weeks in a double-blind trial. Four patients were included twice in the trial. The second time they were treated with the alternative regimen. Six patients in the acetyl-5-aminosalicylic acid group did not complete the trial, four of them because of diarrhoea. Complete clinical remission with normal rectal mucosa on sigmoidoscopy was achieved in 10 out of 18 patients on 5-aminosalicylic acid and in only two out of 15 in the acetyl-5-aminosalicylic acid group (P = 0.03). A favourable histological improvement was demonstrated with 5-aminosalicylic acid suppositories, but the difference with acetyl-5-aminosalicylic acid was not significant (P = 0.059). Three of the four patients who received both drugs recovered with 5-aminosalicylic acid; in none of them was acetyl-5-aminosalicylic acid effective. The results from this study and from previous investigations show that acetyl-5-aminosalicylic acid is not superior to placebo.

Adult↗
PubMed1990

Tripotassium dicitrato bismuthate enemas in the treatment of ulcerative proctitis.

Eleven patients with active proctitis or proctosigmoiditis completed one month's treatment with tripotassium dicitrato bismuthate enemas administered at night. Symptoms, sigmoidoscopic appearances, and the histological grade of acute inflammation were assessed at the commencement of therapy and after one month. An overall score of these features showed improvement in 9 of 11 patients, which encourages further investigation of bismuth in controlled trials for patients with inflammatory bowel disease.

Adult↗
PubMed1993

Pharmacokinetics of budesonide enema in patients with distal ulcerative colitis or proctitis.

Pharmacokinetic data obtained after one dose of a 2-mg budesonide enema were compared with data obtained after the last dose of four weeks of daily treatment in 24 patients with active distal ulcerative colitis or proctitis. This open multicentre study involved 28 eligible patients. Sigmoidoscopy and biopsy scores improved significantly (P < 0.002) during the four-week treatment period. Maximal plasma concentration (Cmax) of budesonide was 2.1 nmol/L 1.3 h after the first dose and 2.5 nmol/L 1.2 h after the last dose; the difference was not significant. The area under the curve (AUC) of plasma concentration vs. time was after the first dose 9.7 nmol h/L and after the last dose 11.6 nmol h/L (P < 0.03). The small increase in AUC may be attributed to improved absorption. During the last dose interval, minimal plasma concentration was below the limit of quantitation in most subjects. The Cmax and AUC of budesonide increased slightly after four weeks of treatment, but budesonide did not accumulate. Mean morning plasma cortisol values did not change significantly during treatment (P = 0.083), although a small change in cortisol levels between the first visit (pre-treatment) and last visit was positively correlated to the Cmax of budesonide measured at the last visit (P = 0.012).

Administration, Topical↗
PubMed2000

Comparative, open, randomized trial of the efficacy and tolerance of slow-release 5-ASA suppositories once daily versus conventional 5-ASA suppositories twice daily in the treatment of active cryptogenic proctitis: French Pentasa Study Group.

OBJECTIVE: The efficacy and tolerance of slow-release 5-ASA suppositories (Pentasa 1 g/day) were compared with those of conventional 5-ASA suppositories (Rowasa 0.5 g b.i.d.). METHODS: Two hundred and fifty-one (251) patients presenting with an exacerbation of cryptogenic proctitis were randomized. Clinical activity and rectal lesions were measured at days 1 and 14 (and at day 21 for patients not in remission at day 14), and each patient had to fill out a daily diary card (checklist). RESULTS: Results are given for slow-release and classical suppositories, respectively. The reduction in symptoms and lesions was identical in both groups. Treatment was continued until day 21 in 36% versus 33% of the patients, and minor or moderate side effects occurred in 5.6% versus 6.3% (NS). The tolerance of the suppositories was rated as satisfactory every day by 77% versus 54% (p = 0.001), and early suppository expulsion occurred in 0.5% versus 3.4% (p = 0.001). CONCLUSIONS: The treatments were equally effective and both were well tolerated. However, the advantages of the slow-release suppositories were that patients exhibited greater tolerance and early expulsion was less frequent.

Adult↗
PubMed2001

Neutrophil and eosinophil granule proteins as markers of response to local prednisolone treatment in distal ulcerative colitis and proctitis.

OBJECTIVE: The pathophysiological role of neutrophil and eosinophil granulocytes in relation to steroid enema treatment was studied in patients with distal ulcerative colitis and proctitis. METHODS: The rectal release of the neutrophil (myeloperoxidase, MPO), and eosinophil (eosinophilic cationic protein, ECP and eosinophil peroxidase, EPO) granule constituents were measured in 11 patients using intraluminal segmental perfusion of the rectum. The released amounts of MPO, ECP, and EPO in the perfusion fluids were determined by radioimmunoassays before and during prednisolone enema treatment and related to clinical, endoscopical, and histopathological data in addition to treatment outcome. RESULTS: Clinical activity and particularly endoscopic activity correlated well with intraluminal MPO concentrations both before and during treatment. At the end of the study, eight of 11 patients fulfilled predefined response criteria; all responding patients had significant decrease of MPO concentrations (p < 0.01). This decline of MPO concentration was seen after 7 days of treatment (p < 0.05) in the response group and often occurred before clinical improvement. There was a nonsignificant trend toward a decrease in the concentrations of ECP and EPO at the end of treatment in responders.

Administration, Topical↗