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PubMedDate not supplied

Comparison of five antimicrobial regimens for treatment of mild to moderate inflammatory facial acne vulgaris in the community: randomised controlled trial.

BACKGROUND: We investigated the efficacy and cost-effectiveness of five antimicrobial regimens for mild to moderate facial acne and whether propionibacterial antibiotic resistance affects treatment response. METHODS: In this randomised, observer-masked trial, 649 community participants were allocated one of five antibacterial regimens. Primary outcomes were patients' self-assessed improvement and reduction in inflamed lesions at 18 weeks. Analyses were by intention to treat. FINDINGS: Moderate or greater improvement at 18 weeks was reported in 72 (55%) of 131 participants assigned oral oxytetracycline plus topical placebo, 70 (54%) of 130 assigned oral minocycline plus topical placebo, 78 (60%) of 130 assigned topical benzoyl peroxide plus oral placebo, 84 (66%) of 127 assigned topical erythromycin and benzoyl peroxide in a combined formulation plus oral placebo, and 82 (63%) of 131 assigned topical erythromycin and benzoyl peroxide separately plus oral placebo. Most improvement occurred in the first 6 weeks. Treatment differences for the proportion of people with at least moderate improvement were: minocycline versus oxytetracycline -1.2% (unadjusted 95% CI -13.3 to 10.9); combined erythromycin and benzoyl peroxide versus oxytetracycline 11.1% (-0.7 to 22.9) and versus minocycline 12.3% (0.4 to 24.2); erythromycin and benzoyl peroxide separately versus combined formulation -3.5% (-15.2 to 8.2); benzoyl peroxide versus oxytetracycline 5.0% (-7.0 to 17.0), versus minocycline 6.2% (-5.8 to 18.2), and versus combined formulation -6.1% (-17.9 to 5.7). Benzoyl peroxide was the most cost-effective treatment. Efficacy of both tetracyclines was reduced by pre-existing tetracycline resistance. INTERPRETATION: Topical benzoyl peroxide and benzoyl peroxide/erythromycin combinations are similar in efficacy to oral oxytetracycline and minocycline and are not affected by propionibacterial antibiotic resistance.

Acne Vulgaris↗

PubMed1998

Postal self-exposure treatment of recurrent nightmares. Randomised controlled trial.

BACKGROUND: Many nightmare sufferers do not consult a health care professional. Though behavior and cognitive therapy can help, they have not been tested as a self-treatment method at home using a manual. METHOD: One hundred and seventy adults with primary nightmares were randomised to four weeks' self-exposure or self-relaxation at home using manuals posted to them, or to a waiting-list as a control group for four weeks. Individuals recorded nightmare frequency and intensity in four-week diaries. RESULTS: At one- and six-month follow-up, the self-rated nightmare frequency fell more significantly in exposure subjects than relaxation or waiting-list subjects. The self-exposure group had the most drop-outs but remained superior in an over-cautious intent-to-treat analysis. The individuals' partners confirmed the superiority of self-exposure to self-relaxation at one- and six-month follow-up. CONCLUSIONS: Recurrent nightmare sufferers improved more with self-exposure manuals than with self-relaxation manuals or by being on a waiting-list. Self-exposure may be needed for longer than four weeks in order to reduce nightmare intensity as well as frequency. Despite a high drop-out rate, some sufferers of other conditions may benefit from self-treatment manuals.

Adolescent↗

PubMed2006

A randomised controlled trial of cardiac rehabilitation after revascularisation.

BACKGROUND: It is unclear if psycho-education on top of physical training is of additional value regarding quality of life in revascularised patients. DESIGN: Prospective randomised study comparing two types of cardiac rehabilitation: exercise based versus a more comprehensive approach including psychological therapy. METHODS: One hundred and thirty-seven male patients who underwent an uncomplicated coronary revascularisation procedure and who were mentally in a good condition, were randomised to one of two types of cardiac rehabilitation: physical training plus information about their disease ('Fit' program) during 6 weeks or comprehensive cardiac rehabilitation which, on top of the Fit-program, included weekly psycho-education sessions and relaxation therapy ('Fit-Plus' program) for 8 weeks. One hundred and four patients were analysed. Quality of life was measured by the 'Leiden Quality of Life questionnaire' and by the RAND-36 (quality of life) questionnaire. RESULTS: Quality of life improved in both treatment groups in the course of time up to 9 months after cardiac rehabilitation and there was no difference between the two types of cardiac rehabilitation. Exercise capacity improved likewise, blood lipid profile was unaffected and energy intake decreased in each treatment group but, again, there were no inter-group differences. CONCLUSION: After an uncomplicated revascularisation procedure, physical training plus information results in a comparable outcome on quality of life when compared to a more comprehensive program including additional psycho-education and relaxation therapy.

Adolescent↗

PubMed2005

Effectiveness of providing self-help information following acute traumatic injury: randomised controlled trial.

BACKGROUND: Patients attending an accident and emergency department may exhibit psychological disturbances post-injury. Early interventions have been suggested to reduce the risk of post-injury disorder, including psychoeducation. AIMS: We assessed the efficacy of providing such self-help information. METHOD: Patients who had experienced trauma were randomised to two groups: those given (n=75) and not given (n=67) a self-help booklet. Psychological assessments were completed within 2, 10-12 and 24-26 weeks. RESULTS: Post-traumatic stress disorder (PTSD), anxiety and depression decreased (P < 0.05) with time but there were no group differences in PTSD or anxiety. The controls were less depressed (P < 50.05) at follow-up. There was a reduction in PTSD caseness within the control (50%) compared with the intervention (20%) group which was almost significant (P < 0.06). CONCLUSIONS: This trial failed to support the efficacy of providing self-help information as a preventive strategy to ameliorate PTSD.

Adolescent↗

PubMed2006

Emotional or educational debriefing after psychological trauma. Randomised controlled trial.

BACKGROUND: Recent studies show that individual single-session psychological debriefing does not prevent and can even aggravate symptoms of post-traumatic stress disorder (PTSD). AIMS: We studied the effect of emotional ventilation debriefing and educational debriefing v. no debriefing on symptoms of PTSD, anxiety and depression. METHOD: We randomised 236 adult survivors of a recent traumatic event to either emotional ventilation debriefing, educational debriefing or no debriefing (control) and followed up at 2 weeks, 6 weeks and 6 months. RESULTS: Psychiatric symptoms decreased in all three groups over time, without significant differences between the groups in symptoms of PTSD (P=0.33). Participants in the emotional debriefing group with high baseline hyperarousal score had significantly more PTSD symptoms at 6 weeks than control participants (P=0.005). CONCLUSIONS: Our study did not provide evidence for the usefulness of individual psychological debriefing in reducing symptoms of PTSD, anxiety and depression after psychological trauma.

Acute Disease↗

PubMed2003

Screening for primary angle closure in Mongolia: a randomised controlled trial to determine whether screening and prophylactic treatment will reduce the incidence of primary angle closure glaucoma in an east Asian population.

AIM: To describe the methods used and initial results of a prospective study designed to determine whether screening and prophylactic treatment will reduce the incidence of primary angle closure glaucoma (PACG) in Mongolia. METHODS: A total of 4725 individuals aged 50 years and above were recruited to the study and randomised to intervention or control groups. All subjects had non-mydriatic optic disc examination. The intervention arm had measurement of anterior chamber depth (ACD) by A-scan ultrasound and intraocular pressure (IOP) with Tonopen. Gonioscopy was performed on test positive cases (ACD <2.53 mm or IOP >or=24 mm Hg either eye). Those with occludable angles were offered laser iridotomy. Primary outcome will be incidence of PACG at 5 year follow up. RESULTS: Glaucoma was diagnosed in 128 (2.7%) subjects. Of the remaining 4597, 2293 were randomised to intervention. Intervention as allocated was received by 2280 (99.4%) individuals. 160 (23.4%) of 685 test positive cases had occludable angles, of which 156 were treated with iridotomy. CONCLUSIONS: This trial is a further step in determining whether screening and prophylactic treatment for primary angle closure in east Asian populations will reduce the incidence of glaucoma.

Aged↗

PubMed1998

Cost-effectiveness of a primary care based physical activity intervention in 45-74 year old men and women: a randomised controlled trial.

OBJECTIVE: To assess the cost-effectiveness of a primary care based intervention aimed at increasing levels of physical activity in inactive people aged 45-74. METHODS: A total of 714 inactive people aged 45-74, taken from two west London general practices, were randomised into two groups. Intervention subjects were invited to a consultation with an exercise development officer, and offered a personalised 10 week programme to increase their level of regular physical activity, combining leisure centre and home based activities. Control subjects were sent information on local leisure centres. All subjects were followed up at eight months. RESULTS: There was a net 10.6% (95% confidence interval 4.5 to 16.9%) reduction in the proportion of people classified as sedentary in the intervention group compared with the control group, eight months after the intervention. The intervention group also reported an increase in the mean number of episodes of physical activity per week, as compared with the control group (an additional 1.52 episodes (95% confidence interval 1.14 to 1.95)). The cost of moving a person out of the sedentary group was shown to be less than 650 Pounds. The cost of moving someone to the now commonly recommended level was estimated at almost 2500 Pounds. CONCLUSIONS: Moderate physical activity can be successfully encouraged in previously sedentary men and women aged 45-74 through a primary care based intervention. The process of recruitment was the most important variable cost. A high uptake rate would maximise cost-effectiveness, and sensitivity analysis suggests that unit costs could be halved with a more effective recruitment strategy.

Age Factors↗

PubMed2006

Laparoscopic versus open Burch colposuspension: a randomised controlled trial.

OBJECTIVE: To compare perioperative characteristics, short-term, and long-term outcomes for laparoscopic Burch colposuspension (LBC) and open Burch colposuspension (OBC) for the treatment of urinary stress incontinence. DESIGN: Randomised surgical trial with single blinding. SETTING: Three tertiary level teaching hospitals involving seven surgeons of varying skill levels. POPULATION: Two hundred women with urodynamic stress incontinence (USI). METHODS: The two groups were treated in identical fashion, except for the laparoscopic or open approach to surgery. Attempts were made to blind the subjects and the observers obtaining outcome data to treatment group. Analyses were adjusted for surgeon experience. MAIN OUTCOME MEASURES: Absence of USI 6 months following surgery, postoperative pain, time spent in hospital, and time to return to activities of normal daily living. RESULTS: There were no significant differences in objective and subjective measures of cure and in patient satisfaction at 6 months, 24 months, or 3-5 years of follow up between laparoscopic and open colposuspension groups. Laparoscopic colposuspension took longer time to perform (87 versus 42 minutes, P< 0.0001) but was associated with less blood loss (P = 0.03), less pain (P = 0.02), and quicker return to normal activities (P = 0.01). CONCLUSION: LBC has significant advantages over traditional OBC, without any apparent compromise in short-term and long-term outcomes. To compare perioperative characteristics, short-term, and long-term outcomes for laparoscopic Burch colposuspension (LBC) and open Burch colposuspension (OBC) for the treatment of urinary stress incontinence. Randomised surgical trial with single blinding. Three tertiary level teaching hospitals involving seven surgeons of varying skill levels. Two hundred women with urodynamic stress incontinence (USI). The two groups were treated in identical fashion, except for the laparoscopic or open approach to surgery. Attempts were made to blind the subjects and the observers obtaining outcome data to treatment group. Analyses were adjusted for surgeon experience. Absence of USI 6 months following surgery, postoperative pain, time spent in hospital, and time to return to activities of normal daily living. There were no significant differences in objective and subjective measures of cure and in patient satisfaction at 6 months, 24 months, or 3-5 years of follow up between laparoscopic and open colposuspension groups. Laparoscopic colposuspension took longer time to perform (87 versus 42 minutes, P < 0.0001) but was associated with less blood loss (P= 0.03), less pain (P= 0.02), and quicker return to normal activities (P= 0.01). LBC has significant advantages over traditional OBC, without any apparent compromise in short-term and long-term outcomes.

Female↗

PubMed2001

Psychological therapies for adults with anorexia nervosa: randomised controlled trial of out-patient treatments.

BACKGROUND: Currently, without systematic evidence, psychotherapy for anorexia nervosa in adults draws on psychodynamic, cognitive and systemic theories. AIMS: To assess effectiveness of specific psychotherapies in out-patient management of adult patients with anorexia nervosa. METHOD: Eighty-four patients were randomised to four treatments: three specific psychotherapies - (a) a year of focal psychoanalytic psychotherapy; (b) 7 months of cognitive-analytic therapy (CAT); (c) family therapy for 1 year - and (d) low contact, 'routine' treatment for 1 year (control). RESULTS: At 1 year, there was symptomatic improvement in the whole group of patients. This improvement was modest, several patients being significantly undernourished at follow-up. Psychoanalytic psychotherapy and family therapy were significantly superior to the control treatment; CAT tended to show benefits. CONCLUSIONS: Psychoanalytic and family therapy are of specific value in the out-patient treatment of adult patients with anorexia.

Adult↗

PubMed2001

A randomised controlled trial of screening for adult hearing loss during preventive health checks.

BACKGROUND: Prophylactic strategies to counter acquired hearing impairment may involve routine audiometric screening of asymptomatic working-age adults attending general practice for regular health checks. AIM: To evaluate the effect of adult hearing screening on subsequent noise exposure and hearing. DESIGN OF STUDY: A randomised controlled population-based study of health checks and health discussions in general practice. SETTING: The project was initiated in the district of Ebeltoft, Aarhus county, Denmark. METHOD: Intervention group participants' hearing thresholds were determined audiometrically at 0.5, 1, 2, 3, and 4 kHz in each ear. Participants were advised to get their ears checked if the average hearing loss exceeded 20 dB hearing level (dBHL) in either ear. Noise avoidance was emphasised when thresholds exceeded 25 dBHL bilaterally at 4 kHz. Follow-up included questionnaires and audiometry. RESULTS: Hearing loss was observed among 18.9% of the study sample at baseline. At the five-year follow-up we recorded no significant differences between the control and the intervention groups regarding subjective or objective hearing, or exposure to occupational noise. However, there was a tendency towards reduction in exposure to leisure noise among intervention participants (P = 0.045). Approximately 20% reported hearing problems; 16.5% reported tinnitus-related complaints; 0.8% used hearing aids; 35.0% reported frequent noise exposure; and occluding wax was suspected in 2.1%. CONCLUSION: Preventive health checks with audiometry did not significantly affect hearing, but leisure noise exposure tended to become less frequent. The poor effect may be ascribed to inadequate audiological counselling or a higher priority to other advice, e.g. on cardiovascular risk or lifestyle.

Adult↗

PubMed2002

Influence of failure of primary wound healing on subsequent recurrence of pilonidal sinus. combined prospective study and randomised controlled trial.

OBJECTIVE: To find out whether failure of primary wound healing after excision and primary suture for chronic pilonidal sinus predicts recurrence. DESIGN: Follow-up of one prospective study and one subsequent randomised, multicentre study. SETTING: Three teaching hospitals in WesternNorway. SUBJECTS: A total of 197 consecutive patients operated on for chronic pilonidal sinus. INTERVENTIONS: Fifty two patients in the prospective group were given cloxacillin perioperatively. In the randomised study, 145 patients were randomised to have either a single preoperative dose of cefoxitin 2 g intravenously (n = 73) or no prophylaxis (n = 72). Patients were followed up for a median of 7 years. MAIN OUTCOME MEASURES: Recurrence of pilonidal sinus. RESULTS: In the prospective group there were 10 recurrences (19%). In the randomised study 6 patients (8%) who had been given antibiotic prophylaxis had a recurrence compared with 14 patients (19%) who had not been given prophylaxis (p = 0.09). In both groups, failure of primary normal healing was significantly associated with early recurrence (p = 0.0002). Neither the use of antibiotics nor sex had any significant influence on the incidence of recurrences. Most recurrences occurred within the first year. CONCLUSION: Wound complications significantly influenced the recurrence rate whereas antibiotics did not. Most recurrences were seen early.

Adult↗

PubMed2002

Randomised controlled trial of butterbur and cetirizine for treating seasonal allergic rhinitis.

OBJECTIVES: To compare the efficacy and tolerability of butterbur (Petasites hybridus) with cetirizine in patients with seasonal allergic rhinitis (hay fever). DESIGN: Randomised, double blind, parallel group comparison. SETTING: Four outpatient general medicine and allergy clinics in Switzerland and Germany. PARTICIPANTS: 131 patients were screened for seasonal allergic rhinitis and 125 patients were randomised (butterbur 61; cetirizine 64). INTERVENTIONS: Butterbur (carbon dioxide extract tablets, ZE 339) one tablet, four times daily, or cetirizine, one tablet in the evening, both given for two consecutive weeks. MAIN OUTCOME MEASURES: Scores on SF-36 questionnaire and clinical global impression scale. RESULTS: Improvement in SF-36 score was similar in the two treatment groups for all items tested hierarchically. Butterbur and cetirizine were also similarly effective with regard to global improvement scores on the clinical global impression scale (median score 3 in both groups). Both treatments were well tolerated. In the cetirizine group, two thirds (8/12) of reported adverse events were associated with sedative effects (drowsiness and fatigue) despite the drug being considered a non-sedating antihistamine. CONCLUSIONS: The effects of butterbur are similar to those of cetirizine in patients with seasonal allergic rhinitis when evaluated blindly by patients and doctors. Butterbur should be considered for treating seasonal allergic rhinitis when the sedative effects of antihistamines need to be avoided.

Adult↗

PubMedDate not supplied

Roflumilast--an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation associated with chronic inflammation. There are few treatment options for the disease. This study assessed the efficacy and safety of roflumilast, a phosphodiesterase-4 inhibitor, in patients with moderate to severe COPD. METHODS: This phase III, multicentre, double-blind, randomised, placebo-controlled study was undertaken in an outpatient setting. 1411 patients with COPD were randomly assigned roflumilast 250 microg (n=576), roflumilast 500 microg (n=555), or placebo (n=280) given orally once daily for 24 weeks. Primary outcomes were postbronchodilator FEV1 and health-related quality of life. Secondary outcomes included other lung function parameters and COPD exacerbations. Analyses were by intention to treat. FINDINGS: 1157 (82%) patients completed the study; 32 (11%) withdrew from the placebo group, 100 (17%) from the roflumilast 250 microg group, and 124 (22%) from the roflumilast 500 microg group. Postbronchodilator FEV1 at the end of treatment significantly improved with roflumilast 250 microg (by 74 mL [SD 18]) and roflumilast 500 microg (by 97 mL [18]) compared with placebo (p<0.0001). Improvement in health-related quality of life was greater with roflumilast 250 microg (-3.4 units [0.6]) and roflumilast 500 microg (-3.5 units [0.6]) than with placebo (-1.8 units [0.8]), although the differences between treatment groups were not significant. The mean numbers of exacerbations per patient were 1.13 (2.37), 1.03 (2.33), and 0.75 (1.89) with placebo, roflumilast 250 microg, and roflumilast 500 microg, respectively. Most adverse events were mild to moderate in intensity and resolved during the study. INTERPRETATION: Roflumilast is a promising candidate for anti-inflammatory COPD treatment because it improved lung function and reduced exacerbations compared with placebo. Long-term studies are needed to fully assess the effect on health-related quality of life.

Administration, Oral↗

PubMed2002

Sublingual compared with oral misoprostol in term labour induction: a randomised controlled trial.

OBJECTIVE: To compare the efficacy and patient acceptability of 50 microg of sublingual misoprostol with 100 microg of oral misoprostol in the induction of labour at term. DESIGN: Non-blinded randomised comparative trial. SETTING: Tertiary level UK Hospital. SAMPLE: Two hundred and fifty women at term with indications for labour induction. METHODS: Fifty micrograms of sublingual misoprostol or 100 microg of oral misoprostol was administered every four hours after random allocation, to a maximum of five doses. MAIN OUTCOME MEASURES: Number of patients delivering vaginally within 24 hours of the induction, mode of delivery, neonatal outcomes and patient acceptability. RESULTS: There was no significant difference in the number of women delivering vaginally within 24 hours of the induction in the sublingual group as compared with the oral group (62.8% vs 59%, RR 1.1, 95% CI 0.6-2.1), or in the mean induction to delivery time (21.8 vs 24.1 h, mean difference 2.3 h 95% CI -2.2 to +6.7). There was no difference in the uterine hyperstimulation rates (1.6% in both groups), operative delivery rates or neonatal outcomes. In the sublingual group, 92.6% found the induction acceptable with 15.8% finding the tablets with an unpleasant taste, while in the oral group it was 96.9% and 4%, respectively. More patients in the oral group thought that they would consider the same method of induction again as compared with the sublingual group (58.6% vs 40%, RR 1.4, 95% CI 1.04-1.9). CONCLUSION: Fifty micrograms of sublingual misoprostol every four hours has the same efficacy and safety profile as compared with 100 microg orally, but the oral route might be preferred by women.

Abortifacient Agents, Nonsteroidal↗

PubMed1993

Targeting heavy smokers in general practice: randomised controlled trial of transdermal nicotine patches.

OBJECTIVES: (a) To evaluate the efficacy of transdermal nicotine patches as an aid to stopping smoking when used as an adjunct to brief advice and support in a general practice setting; (b) to see whether an increase in nicotine patch dosage enhances the rate of initial cessation. DESIGN: Randomised double blind placebo controlled parallel group study with one year of follow up. SETTING: 30 general practices in 15 English counties. SUBJECTS: 600 dependent heavy smokers (> or = 15 cigarettes daily) who were well motivated to give up. INTERVENTIONS: Brief general practitioner advice, booklet, and 16 hours per day patch treatment for 18 weeks with brief support and follow up at one, three, six, 12, 26, and 52 weeks. MAIN OUTCOME MEASURES: Self reported complete abstinence for up to one year with biochemical validation at all follow up points. RESULTS: Nicotine patches reduced the severity of craving and adverse mood changes in the first weeks of withdrawal and doubled the rate of initial cessation at week 3 (nicotine group 36% of patients (144/400), placebo group 16.5% of patients (33/200)) and of continuous abstinence throughout one year (nicotine group 9.3% (37), placebo group 5.0% (10)). A dose increase at week 1 among patients experiencing difficulty in quitting increased the proportion who achieved abstinence at week 3. There were no adverse systemic effects attributable to nicotine, but the incidence of moderate or severe local irritation or itching at the patch site was 16.4% (63 patients), compared with 3.8% (seven) with placebo. CONCLUSION: Transdermal nicotine patches used as an adjunct to brief advice and support in a general practice setting are an effective aid to long term cessation of smoking in highly dependent smokers.

Administration, Cutaneous↗

PubMed2005

Cognitive-behavioural therapy for refractory psychotic symptoms of schizophrenia resistant to atypical antipsychotic medication. Randomised controlled trial.

BACKGROUND: There is increasing evidence that cognitive-behavioural therapy can be an effective intervention for patients experiencing drug-refractory positive symptoms of schizophrenia. AIMS: To investigate the effects of cognitive-behavioural therapy on in-patients with treatment-refractory psychotic symptoms. METHOD: Manualised therapy was compared with supportive counselling in a randomised controlled study. Both interventions were delivered by experienced psychologists over 16 sessions of treatment. Therapy fidelity was assessed by two independent raters. Participants underwent masked assessment at baseline, after treatment and at 6 months' follow-up. Main outcome measures were the Positive and Negative Syndrome Scale and the Psychotic Symptoms Rating Scale. The analysis was by intention to treat. RESULTS: Participants receiving cognitive cognitive-behavioural therapy had improved with regard to auditory hallucinations and illness insight at the post-treatment assessment, but these findings were not maintained at follow-up. CONCLUSIONS: Cognitive-behavioural therapy showed modest short-term benefits over supportive counselling for treatment-refractory positive symptoms of schizophrenia.

Adolescent↗

PubMed1999

Randomised controlled trial of corticosteroid regimens in endothelial corneal allograft rejection.

AIM: To determine whether the addition of systemic corticosteroid to local intensive corticosteroid therapy of endothelial corneal allograft rejection improves outcome. METHODS: A prospective randomised treatment trial was carried out at a tertiary referral centre. 36 consecutive corneal graft recipients, presenting with a first episode of endothelial graft rejection, received either (i) one intravenous pulse of methylprednisolone 500 mg in addition to local corticosteroid treatment, or (ii) local treatment only. The regimen of local treatment standardised in all cases for the first 24 hours consisted of one subconjunctival betamethasone 2 mg injection and dexamethasone 0.1% drops in the affected eye every hour for 24 hours. RESULTS: Failure to reverse the graft rejection episode was found in 3/36 (8%) patients. Each of these had been treated with local steroid only. Graft failure from any cause occurred in 9/36 (25%) within 2 years of follow up. No statistically significant difference was found between the two groups with regard to reversal of the graft rejection episode, later recurrence of graft rejection, or graft failure. CONCLUSIONS: In treatment of graft rejection, additional systemic treatment with 500 mg methylprednisolone yields no significant benefit over intensive local corticosteroid alone. Graft survival following treatment of a rejection episode with local corticosteroid treatment alone is good in those patients without other risk factors for graft failure and much higher than reported previously.

Administration, Topical↗

PubMed2001

Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure.

AIMS: To determine the effectiveness and safety of topical glyceryl trinitrate (GTN) in the management of acute anal fissure in children. METHODS: Individual children were randomised to receive GTN paste or placebo for six weeks in addition to oral senna and lactulose. Patients took laxatives alone for a further 10 weeks. Each week a research nurse telephoned families to assess pain scores and give advice. Main outcome measures were validated standardised pain scores and time to painless defaecation. RESULTS: Forty subjects were recruited from 46 eligible children; 31 children completed the trial (13 in the GTN group and 18 in the placebo group). No differences in the proportion of those achieving pain free defaecation with relation to time were seen between the two groups. Similarly, there were no significant differences in pain scores between the two groups over the 16 week study period. However, in both groups pain scores had decreased significantly. There were no differences in the incidence of rectal bleeding, faecal soiling, presence of visible fissure, skin tag, or faecal loading at outpatient review at the time of recruitment, or at 6 weeks and 16 weeks. No serious adverse effects were observed. CONCLUSIONS: This study suggests that 0.2% GTN paste is ineffective in the treatment of acute anal fissures in childhood. However the overall fissure healing rate is high (84%) with associated reduction in pain scores, suggesting that a nurse based treatment programme can achieve a high rate of fissure healing.

Acute Disease↗