Overview and expert assessment of off-label use of misoprostol in obstetrics and gynaecology: review and report by the Collège national des gynécologues obstétriciens français.

The literature suggests that misoprostol can be offered to patients for off-label use as it has reasonable efficacy, risk/benefit ratio, tolerance and patient satisfaction, according to the criteria for evidence-based medicine. Both the vaginal and sublingual routes are more effective than the oral route for first-trimester cervical dilatation. Vaginal misoprostol 800µg, repeated if necessary after 24 or 48h, is a possible alternative for management after early pregnancy failure. However, misoprostol has not been demonstrated to be useful for the evacuation of an incomplete miscarriage, except for cervical dilatation before vacuum aspiration. Oral mifepristone 200mg, followed 24-48h later by vaginal, sublingual or buccal misoprostol 800µg (followed 3-4h later, if necessary, by misoprostol 400µg) is a less efficacious but less aggressive alternative to vacuum aspiration for elective or medically-indicated first-trimester terminations; this alternative becomes increasingly less effective as gestational age increases. In the second trimester, vaginal misoprostol 800-2400µg in 24h, 24-48h after at least 200mg of mifepristone, is an alternative to surgery, sulprostone and gemeprost. Data for the third trimester are sparse. For women with an unripe cervix and an unscarred uterus, vaginal misoprostol 25µg every 3-6h is an alternative to prostaglandin E2 for cervical ripening at term for a live fetus. When oxytocin is unavailable, misoprostol can be used after delivery for prevention (sublingual misoprostol 600µg) and treatment (sublingual misoprostol 800µg) of postpartum haemorrhage. The use of misoprostol to promote cervical dilatation before diagnostic hysteroscopy or surgical procedures is beneficial for premenopausal women but not for postmenopausal women. Nonetheless, in view of the side effects of misoprostol, its use as a first-line treatment is not indicated, and it should be reserved for difficult cases. Misoprostol is not useful for placing or removing the types of intra-uterine devices used in Europe, regardless of parity.

RETIDIAB®: assessment of a continuing medical education website for the improvement of diabetic retinopathy management.

AIM: The aim of this study was to evaluate the efficacy of a continuing medical education (CME) website to improve ophthalmological management of diabetic retinopathy (DR). METHODS: A worldwide website called RETIDIAB® was created in which, to log on for first time, users had to take a preliminary test to evaluate their baseline level of knowledge. This allowed them free access to the entire website at any time with no time obligation. The website comprised a course of theoretical concepts and different types of training, including multiple-choice questionnaires (MCQ) focused on the course content, interpretation of diabetic fundus photographs and case reports. After perusing the entire RETIDIAB® website, users could take a second assessment test. Finally, they were asked to fill in a questionnaire evaluating the entire programme. RESULTS: A total of 137 users were registered and, of these, 109 took only the preliminary test, while 28 took the second test and evaluated the entire website; of the latter, 75% were residents and 25% were practising physicians, and 15 were male and 13 were female, ranging in age from 26 to 42 (30.2 ± 3) years. Statistically significant progress was seen between the first and second evaluations (37.3 ± 14% correct answers vs 64 ± 10%, respectively), and the average time interval between the first and second evaluations was 40 ± 20 days. In addition, users expressed a high level of overall satisfaction with the site. CONCLUSION: This pilot study demonstrated the value and effectiveness of RETIDIAB®, a new CME website exclusively devoted to DR management.

Long-term efficacy and cost-effectiveness of polyethylene glycol 3350 plus electrolytes in chronic constipation: a retrospective study in a disabled population.

OBJECTIVES: The efficacy and safety of treatments for constipation in severely intellectually disabled patients and their associated cost-effectiveness are an under-investigated area of clinical practice. Aiming to address this, the objectives of the study were to evaluate the efficacy and tolerability of polyethylene glycol 3350 plus electrolytes (Movicol; PEG+E) by comparing clinical data collected before and after its introduction to a stable population of residents of a mental health care, long-stay institution. The study also attempted an economic evaluation of the use of PEG+E in this setting. RESEARCH DESIGN AND METHODS: This was a retrospective study of 54/66 severely intellectually and physically disabled residents of a specialist unit at La Milétrie University Hospital, Poitiers, France, who suffered regularly from constipation. A total of 54 residents were treated with PEG+E (1-3 sachets a day) for 24 months. The number of stools, episodes of diarrhoea (defined as frequent stools, not necessarily watery), body weights and blood biochemistry were recorded. Data were compared with those recorded during the 21 months preceding the introduction of PEG+E for 16/54 residents who had been treated regularly with a range of other interventions for the relief of constipation. The monthly use and costs of laxatives, enemas and suppositories was obtained from hospital pharmacy records, and the total hospital costs before and after the introduction of PEG+E treatment was calculated. RESULTS: The mean (+/- standard deviation) number of stools per patient per month was significantly greater following the introduction of PEG+E (24.9 +/- 6.3) compared to before its use (12.4 +/- 3.4) (p < 0.001). The mean (+/- standard deviation) monthly number of episodes of diarrhoea per patient before and after the introduction of PEG+E was 0.1 +/- 0.1 and 6.3 +/- 2.9, respectively (p < 0.001). Treatment with PEG+E was not associated with adverse effects on body weight or blood biochemistry values. Introduction of PEG+E and its increasing use reduced the total hospital medical ward expenditure on laxatives from 3788 to 1767 Euros per month. CONCLUSIONS: PEG+E is effective in the clinical management of constipation in an institutional setting. Furthermore, long-term intensive therapy with PEG+E was not associated with adverse effects on body weight or blood biochemistry values. Although the time periods over which the economic data and the efficacy and safety data were collected did not directly correspond, this study indicates that use of PEG+E in the management of constipation in people with severe intellectual disability may be cost-effective, reducing hospital laxative costs.

Effect of elective antibiotic therapy on resting energy expenditure and inflammation in cystic fibrosis.

Cystic fibrosis (CF) patients often present with malnutrition which may partly be due to increased resting energy expenditure (REE) secondary to inflammation. Both REE and tumour necrosis factor-alpha (TNF-alpha), as other markers of inflammation, are elevated during respiratory exacerbations and decrease after antibiotic treatment. However, the effect of antibiotic therapy on REE and inflammation in patients without respiratory exacerbation is not known. The aim of our study was to determine the effect of such an elective antibiotic therapy on REE, TNF-alpha, and other serum markers of inflammation. Twelve CF patients 5F/7M, age 15.9 +/- 6.1 years, weight for height ratio 89 +/- 8% without clinically obvious exacerbation and treated by intravenous antibiotics were studied. Both before (D0) and after (D14) treatment, pulmonary function tests were performed. REE was measured by indirect calorimetry and blood taken to measure inflammation parameters. Body weight increased by 1.1 kg from D0 to D14 (P < 0.001), composed of 0.3 kg fat mass and 0.8 kg fat-free mass (FFM). The forced expiratory volume at 1 s increased from 43 +/- 15% of predicted at D0 to 51 +/- 15% of predicted at D14 (P < 0.01). Mean REE was 41.1 +/- 7.6 kcal/kg FFM per day at D0 and did not change significantly at D14 (40.6 +/- 8.5 kcal/kg FFM per day). Serum markers of inflammation decreased from D0 to D14: C-reactive protein 17 +/- 17 mg/l to 4 +/- 7 mg/l (P < 0.05), elastase 62 +/- 29 microg/l to 45 +/- 18 microg/l (P < 0.02), orosomucoid acid 1.25 +/- 0.11 g/l to 0.80 +/- 0.15 g/l (P < 0.001), and TNF-alpha 37 +/- 14 pg/ml to 29 +/- 6 pg/ml (P = 0.05). Individual values showed a correlation between changes in REE and in TNF-alpha (P < 0.02). The contribution of inflammation to energy expenditure is possible but appears to be minimal in cystic fibrosis patients treated by antibiotics on a regular basis in the absence of clinically obvious exacerbation.

Systematic removal of catheter 48 hours following transurethral resection and 24 hours following transurethral incision of prostate: a prospective randomized analysis of 213 patients.

The interval before removal of the catheter used in prostatic transurethral surgery depends to a great extent on the surgeon, with a frequently empirical orientation. We conducted a prospective, randomized and controlled study of 213 patients who underwent transurethral surgery for benign prostatic hyperplasia. The catheter was removed systematically 24 hours after transurethral incision and 48 hours after transurethral resection of the prostate (group 1-52 and 54 patients, respectively) or the catheterization interval was determined by each surgeon in accordance with the usual criteria (group 2-52 and 55 patients, respectively). No statistically significant differences were noted between these 2 groups in regard to complications. We conclude that systematic removal of the catheter at the aforementioned periods is cost-effective, safe and comfortable for the patient.

[Percutaneous nephrolithotomy after failure of extracorporeal shockwave lithotripsy. Indications, results, perspectives]. / Néphrolithotomie per-cutanée après échec de lithotritie extra-corporelle par ondes de choc. Indications, résultats, perspectives.

Eighty-one of the 579 extracorporeal lithotripsies (ECL) performed between 1987 and 1992 with an ultrasound-guided hydroelectric lithotriptor required the use of another treatment modality. 53 percutaneous nephrolithotomies (PCNL) were performed in these 81 patients after failure of ECL (21 for non-fragmentation, 32 for residual fragments). The authors analyse the factors responsible for failure in order to select the more appropriate type of treatment for different types of stones. The site of the stones, their size, their radiographic appearance, their chemical composition, the number of ECL sessions and the number of days spent in hospital were compared between the PCNL and ECL groups. Smooth, homogeneous stones denser than bone and larger than 15 mm in diameter were significantly more resistant to ECL, despite an increased number of shock waves. PCNL was successful in 92% of cases of non-fragmented stones (with no residual fragments). The success rate for multiple residual fragments was 64%. In view of the risk of complications associated with residual fragments, regardless of their size, the potential risks of ECL and cost imperatives, the authors recommend that these stones, considered to be resistant, should be treated immediately by PCNL, as the results of PCNL after ECL are less satisfactory.