Randomized clinical trial comparing simple drainage of anorectal abscess with and without fistula track treatment

BACKGROUND AND AIMS: Anal abscess is a frequent acute proctological disorder and whether the underlying fistula should be treated at the same time when the abscess is drained remains controversial. We examined indications for drainage alone versus drainage plus fistulotomy in terms of recurrence and continence. PATIENTS AND METHODS: We carried out a randomized prospective study of 200 consecutive patients with anal abscess. One group received drainage alone, while in the other group drainage plus fistulotomy was performed when a subcutaneous-mucosa, low transsphincteral, or intersphincteral fistula was found. Delayed progressive fistulotomy with suture threads was performed in cases of high transsphincteric or suprasphincteric fistula. RESULTS: The internal opening of the fistula track was found in 83% of the patients. The recurrence rate was related to the surgical technique employed: 29% in the group with drainage alone and 5% in the group for which treatment of the fistula track was attempted. The incontinence rate was also related to the surgical option. In those receiving drainage and treatment of the fistula track incontinence was restricted mostly to patients with delayed fistulotomy (36.7%), compared to 2.8% of patients when simple fistulotomy was performed. There was no incontinence in the drainage alone group. CONCLUSION: Drainage of anal abscess with fistulotomy can be safely performed in cases of subcutaneous, intersphincteral, or low transsphincteral fistulae with a minimal recurrence rate. However, drainage alone and posterior treatment of the fistula track is recommended for high transsphincteral or suprasphincteral fistulae.     

Controlled study comparing treatment with monocomponent insulin and conventional insulin in patients with lipoatrophy

Summary Twenty-one patients with evident lipoatrophy treated with conventional (Conv.) insulin were either allocated to continuation of treatment with previously used insulin (Conv. group, n=10) or were transferred to Lente? MC (monocomponent) insulin with or without supplementary Actrapid? MC insulin (MC group, n=11). On entry and after 3, 6 and 12 months of follow-up, serum insulin-, pancreatic polypeptide- and proinsulin-binding IgGs were determined by radioimmunoelectrophoresis according to the method of Christiansen. Prior to determination of proinsulin-binding IgG, the insulin-binding IgG was removed by means of sepharose-bound insulin according to the method of Heding. In both groups a slight decrease in the titer of insulinbinding IgG was observed: in the Conv. group from 5.33±0.92 (SEM) to 4.66±1.17 mU/ml after 12 months, and in the MC group from 3.22±0.64 to 2.66±0.46 mU/ml, respectively. Due to the small number of patients with pancreatic polypeptide antibody titers above the detection limit no statistical evaluation was carried out. The level of serum proinsulin-binding IgG decreased in the MC group only (from 9.3±2.2 to 1.9±0.6 ng/ml after 12 months), and even showed a slight increase in the Conv. group (the respective titers were: 14.0±4.6 and 14.9±4.6 ng/ml). In the MC group 10 patients (91%) showed improvement and 7 (64%) complete regression of their lipoatrophy corresponding to 6 (60%) and 2 (20%) in the Conv. group. This finding suggests a possible role of proinsulin-binding antibodies in the pathogenesis of insulin lipoatrophy.     

A controlled study of stanozolol in primary Raynaud''s phenomenon and systemic sclerosis.

A double blind, crossover study of fibrinolytic enhancement treatment using stanozolol has been performed in primary Raynaud's phenomenon and in systemic sclerosis. The outcome criteria included subjective evaluation, clinical examination, physiological measurements of peripheral blood flow, and fibrinolytic measurements. Nineteen patients entered and 11 completed the study of primary Raynaud's phenomenon. There was nonsignificant evidence of improvement in peripheral blood flow. Twenty four patients entered and 17 completed the study of systemic sclerosis. There was marked objective but not subjective evidence of improvement in the peripheral microcirculation during the stanozolol treatment period. There was also a nonsignificant improvement in dermal sclerosis. There were improvements in fibrinolytic activity during the stanozolol treatment period. There was no alteration in fibrinolytic reserve as measured by 1-desamino-8-D-arginine vasopressin stimulation, however. Although adverse events were common in both treatment periods, withdrawals predominantly occurred during the period of treatment with stanozolol and were principally due to anabolic problems. There does not seem to be any indication for the use of stanozolol in primary Raynaud's phenomenon. Fibrinolytic enhancement with stanozolol does appear useful in treating the microvascular features of systemic sclerosis.     

Modified lay-open (incision, curettage, partial lateral wall excision and marsupialization) versus total excision with primary closure in the treatment of chronic sacrococcygeal pilonidal sinus

Background and aims The best surgical technique for treating pilonidal sinus disease is controversial. The aim of this study is to compare the modified lay-open technique with primary closure following excision with respect to operating time, healing time, time before return to work, morbidity rate, and recurrence rate.Patients and methods After a pre-study power analysis, 142 patients with chronic sacrococcygeal pilonidal sinus were prospectively and randomly allocated, either to the modified lay-open group (Group A, n=73) or the primary closure group (Group B, n=69). In the former, incision, curettage, partial lateral wall excision, and marsupialization were performed. Single doses of cefazoline (1 g) and metronidazole (500 mg) were given intravenously 15 min before surgery to all patients.Results There were no differences with respect to gender, age, body mass index, and mean operating time between the groups. In Group A, healing failure and early bridging occurred in one patient each. In Group B, wound infection occurred in four patients, wound breakdown in three, one healing failure and hematoma in one patient each. Morbidity and recurrence rates were significantly lower in Group A (2.7 vs. 13%, P=0.028 and 1.4 vs. 17.4%, P<0.001 respectively). The median time before return to work in Group A was significantly shorter than in Group B (3 [range 2–8] vs. 21 [range 14–63] days, P<0.001). The median healing time in Group A was significantly longer than in Group B (7 [range 3–16] weeks vs. 2 [range 2–9] weeks; P<0.001).Conclusion The results of the present study suggest that modified lay-open is superior to excision with primary closure for the surgical treatment of chronic sacrococcygeal pilonidal sinus with regard to morbidity and recurrence rates, and time before return to work, although healing time is longer.     

Double-blind, multicenter controlled trial comparing topical dimethyl sulfoxide and normal saline for treatment of hand ulcers in patients with systemic sclerosis

A prospective, randomized, double-blind trial compared topical therapy with 0.85% normal saline, 2% dimethyl sulfoxide (DMSO), and 70% DMSO for treatment of digital ulcers in 84 patients with systemic sclerosis. There were no statistically significant differences among the 3 treatment groups in the improvement in the total number of open ulcers, total surface area of open ulcers, average surface area per open ulcer, number of infected ulcers, number of inflamed ulcers, or patient pain assessment. While some patients improved during the study, improvement could not be attributed to a specific treatment. Over one-quarter of the patients treated with 70% DMSO were withdrawn for significant skin toxicity.     

A double-blind, controlled study comparing lafutidine with placebo and famotidine in Japanese patients with mild reflux esophagitis

Purpose  

This randomized, double-blind, controlled study examined whether lafutidine is superior to placebo and non-inferior to famotidine in terms of healing rates as assessed by endoscopy in Japanese patients with mild reflux esophagitis. Safety and improvement in symptoms of heartburn were also assessed.     

A randomised controlled study comparing conventional and magnetic guidewires in a two-dimensional branching tortuous phantom simulating angulated coronary vessels.

OBJECTIVES: To directly compare the magnetic navigation system (MNS) guidewires with conventional guidewires in branching tortuous phantoms with operators of varying MNS and percutaneous coronary intervention experience. BACKGROUND: Vessel tortuosity, angulation, and side branches remain limiting factors in coronary interventions. The MNS addresses these limitations by precisely directing the tip of a magnetised guidewire in vivo aided by two permanent adjustable external magnets. METHODS: Crossing and fluoroscopy times of six operators were evaluated in five tortuous Perspex(R) phantom vessels in three consecutive attempts. Standard guidewire (SG) usage was unrestricted. Two 2nd generation magnetic guidewires (MG) were used. Failure was noted if the cross was unsuccessful within 5 min. RESULTS: The magnetic navigation was vastly superior to SG techniques with increasingly tortuous phantoms. It dramatically decreased both the crossing and fluoroscopy times with maximal reduction from 201.7 +/- 111 to 36.4 +/- 13 sec, P < 0.001 and 204.7 +/- 24 to 47.2 +/- 19 sec, P < 0.001, respectively. The MNS had a 98.8% procedural success rate compared to 68% with SG techniques. Moreover it considerably limited the amount of wire usage from 5.5 to 1.3. Operators with prior MG experience performed significantly better than those without, except in the simplest phantom where the difference was nonsignificant (33.8 +/- 13 sec vs. 41.7 +/- 17 sec, P = 0.2). CONCLUSION: MNS significantly reduces both the crossing and fluoroscopy times in tortuous coronary phantom models achieving excellent success rates with dramatic reductions in guidewire usage. Operators with prior MNS experience had an advantage over the inexperienced.     

A randomized, blinded, parallel group, placebo controlled pilot study evaluating the effect of PVAC treatment in patients with diffuse systemic sclerosis

OBJECTIVE: Systemic sclerosis (SSc) is a disorder characterized by progressive thickening of the skin; there is no effective therapy. PVAC, a potential therapeutic agent derived from delipidated, deglycolipidated Mycobacterium vaccae, has shown effects on cutaneous disease in animal models of SSc. We evaluated the safety and possible biologic effect of intradermal injections of PVAC in patients with diffuse SSc. METHODS: Eighteen patients enrolled in this double blind, placebo controlled, randomized, 24 week pilot study. All patients met criteria for diffuse SSc without evidence of significant renal dysfunction, pulmonary fibrosis, pulmonary hypertension, or congestive heart failure. Patients received 8 intradermal injections of 15 microg PVAC, 50 microg PVAC, or placebo at 3 week intervals. The primary efficacy endpoint was the change in Modified Rodnan Skin Score (MRSS) at Week 24. Each of the active drug arms was compared to placebo. RESULTS: Baseline demographic and disease characteristics were similar across the 3 treatment groups. The median age was 48 years and 14 of 18 (78%) patients were female. The regimens were well tolerated with no reported serious adverse events; however, grade 1 or 2 injection site reactions occurred in the majority of patients receiving PVAC. The MRSS improved by 20.6% in the 15 microg PVAC arm, while it worsened by 29.8% in the placebo arm and by 16.7% in the 50 microg arm. Change in physician and patient global assessments followed similar trends. CONCLUSION: In this pilot study, use of PVAC in patients with SSc appeared safe and was associated with a trend toward improved skin scores in the 15 microg treatment group. Additional evaluation of this therapeutic approach is warranted.     

International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C

BACKGROUND/AIMS: The aim of this study was to increase virologic response rates by individualized treatment according to the early virologic response. METHODS: Serum HCV-RNA was frequently quantified in patients with chronic hepatitis C (n=270) treated with peginterferon alfa-2a (180 microg/week) and ribavirin (1000-1200 mg/day). After 6 weeks patients were classified as rapid (RVR), slow (SPR), flat (FPR), or null responders (NUR) and randomized within each viral kinetic class to continue therapy either with an individualized or standard regimen. Individualized therapy comprised peginterferon monotherapy (48 weeks) or shorter combination therapy (24 weeks) for RVR, triple therapy with histamine (1 mg/day) (48 weeks) or prolonged combination therapy (72 weeks) for SPR, triple therapy for FPR, and high-dose peginterferon (360 microg/week) plus ribavirin for NUR patients. RESULTS: Patients were categorized as RVR (n=171), SPR (n=65), FPR (n=10), or NUR (n=22). Overall end-of-treatment and sustained virologic response rates were 77 and 60% in the individualized and 77 and 66% in the standard treatment arm, respectively. Histamine in addition to peginterferon and ribavirin and high-dose peginterferon plus ribavirin did not improve virologic response rates in patients with FPR and NUR, respectively. CONCLUSIONS: An improvement in virologic efficacy was not achieved with the available individualized treatment options.     

Incidence and management of anorectal abscess,fistula and fissure,in patients with ulcerative colitis

Summary and Conclusions During a survey of 465 patients with ulcerative colitis, it was learned that 82 (17.6%) had one or more anorectal complications such as abscess, fistula-in-ano, rectovaginal fistula and fissure-in-ano. These complications were associated with attacks of colitis, which generally were severe. The incidence of fissure-in-ano was significantly greater when colitis was extensive, but that of abscess and fistula varied little with the severity and extent of the disease. All complications occurred most frequently during the year of the first attack; after this the duration of symptoms of colitis had little effect on the incidence of anorectal complications. Treatment of each complication is discussed. Perianal abscess requires immediate incision and drainage. Six cases of spontaneous healing of fistula-in-ano are described. Rectovaginal fistula required excisional surgery. Fissure-in-ano was treated by symptomatic measures alone. It is emphasized that treatment of these complications must be accompanied by vigorous treatment of ulcerative colitis itself.     

An open-labeled, randomized study comparing systemic interferon-α-2A and prednisolone enemas in the treatment of left-sided ulcerative colitis

OBJECTIVE: The aim of this study was to compare the treatment efficacies of subcutaneous interferon-alpha-2A (IFN-alpha-2A) injections versus prednisolone enemas in active left-sided ulcerative colitis in an open-labeled, randomized study. METHODS: Sixteen ulcerative colitis patients received IFN-alpha-2A subcutaneously (dosage: first wk, 9 MIU three times weekly [t.i.w.]; second wk, 6 MIU t.i.w.; wk 3-12, 3 MIU t.i.w.), and 16 received prednisolone enemas for 30 days (100 ml once daily, 0.25 mg of prednisolone/ml). The Powell-Tuck Index, Inflammatory Bowel Disease Questionnaire (IBDQ) score, and rectal histological activities were assessed before and after treatment. Thirteen patients in the IFN-alpha-2A group and all 16 in the prednisolone enema group completed the treatment. RESULTS: IFN-alpha-2A treatment showed significant improvements in the Powell-Tuck Index (p = 0.0002), IBDQ score (p = 0.002), and rectal histological activity scores (p = 0.02). In the enema group, significant improvements were found in the Powell-Tuck Index (p = 0.0009), whereas no significant improvements were detected in the IBDQ scores (p = 0.055) or rectal histological scores (p = 0.052). There were no differences between scores of the two groups either before or after treatment. Only moderate side effects from the IFN-alpha-2A treatment were seen during the first 2-4 wk of treatment. CONCLUSION: IFN-alpha-2A treatment resulted in significant depression of the disease activity as reflected by the Powell-Tuck Index, IBDQ score, and histological disease activity scoring. The preliminary trial thus suggests that IFN-alpha-2A may be effective in the treatment of active left-sided ulcerative colitis. Larger, randomized trials are, however, warranted to confirm this finding, owing to possible type II errors in group comparisons.     

A study of primary care teaching comparing academic and community-based settings

OBJECTIVE: To compare teaching activity and content between academic and community-based practices used in third year medical student primary care training. SETTING: Academic and community-based primary care practices participating in third-year internal medicine, family medicine, and primary care core clerkships. PARTICIPANTS: Five-hundred thirteen preceptor-student encounters involving 32 preceptors and 26 third-year medical students were evaluated. DESIGN: Student-preceptor pairs collected a convenience sample of data from shared patient encounters. Preceptors recorded the content of teaching interventions, and students independently documented learning points received for each clinical encounter. MEASUREMENTS AND MAIN RESULTS: Comparison of problem exposure, frequency and content of teaching interventions, and the effect of patient complexity and patient care workload on teaching frequency was made between the academic and community-based practices. Several small differences were found in the frequency of clinical problem exposure between the 2 settings. The frequency and focus of teaching interventions did not differ by practice type. Teaching by community-based preceptors tended to decrease with increased patient care workload, but increased in academically based practices. CONCLUSIONS: Although several differences exist between educational experiences in community- and academically based primary care practices, they appear to be minor and of minimal educational significance.     

A controlled study comparing cimetidine treatment to an intensive antacid regimen in the therapy of uncomplicated duodenal ulcer

The authors report the results of a randomized study in which comparison was made between two different kinds of treatment in patients affected by uncomplicated duodenal ulcer endoscopically diagnosed. The first group was treated with 1 g of cimetidine per day, during a period of four weeks (200 mg three times a day and 400 mg at bedtime); the second with a liquid Al–Mg antacid compound, 210 ml/day (30 ml, 1 and 3 hr after meals and 30 ml before bedtime) for four weeks. Fifty-one patients were studied, 27 treated with cimetidine, 24 with antacids. At the end of the four-week period, 21 patients (77.7%) in the cimetidine group and 18 patients (75%) in the antacid group were completely healed. Benign side effects were remarked in both types of treatment, none of which made it necessary to suspend treatment. No significant variation of the basal and peak acid output before and after each kind of treatment was observed, while a slight but significant increase in fasting serum gastrin concentration was noted after treatment in the antacid group.