Randomised, placebo-controlled, double-blind study to investigate the efficacy and safety of the acute use of sodium picosulphate in patients with chronic constipation.

There are few studies supporting the effective and safe use of laxatives for constipation. This study examined the short-term efficacy and safety of sodium picosulphate in patients with chronic constipation. Patients with a history of chronic constipation for at least 3 months were randomised to receive 7 mg sodium picosulphate or placebo for three consecutive nights. Patients recorded stool frequency and consistency, straining, bloating, and pain at baseline and during treatment. Vital signs, haematocrit, serum creatinine and electrolytes were monitored. Primary end-point for efficacy was the occurrence of a response to treatment, defined as improvement in stool frequency and occurrence of straining. All 57 randomised patients (sodium picosulphate n = 29, placebo n = 28; mean age 54.8 and 54.1 years) completed the study. Sodium picosulphate produced a treatment response (improved stool frequency and straining) in 82.8% compared with 50% in the placebo group (p = 0.010) and reduced bloating more often than placebo. There were no serious adverse events and one patient with diarrhoea and another with abdominal pain in each treatment group. There were no cardiovascular effects, changes in serum haematocrit, creatinine or electrolytes in either group. This study confirmed that sodium picosulphate is an effective, well-tolerated and safe laxative in the acute treatment of constipation.

Efficacy and safety of bisacodyl in the acute treatment of constipation: a double-blind, randomized, placebo-controlled study.

BACKGROUND: Although laxatives are a first-line treatment for constipation, there are few randomized placebo-controlled trials assessing their efficacy. AIM: To determine the effect and safety of oral bisacodyl on stool frequency and consistency in patients with idiopathic constipation. METHODS: 55 patients (age 19-89 years) with idiopathic constipation were recruited from eight primary care practices and randomized to receive bisacodyl, 10 mg once daily, or placebo, on three successive days following a 3-day run-in period. Patients recorded stool frequency and consistency and adverse events. RESULTS; In each treatment group, 27 patients were evaluable for efficacy. The mean number of stools per day was significantly greater in the bisacodyl-treated group (1.8/day) compared with placebo (0.95/day) over the treatment phase (P=0.0061). Mean stool consistency score improved from 'hard' (run-in) to between 'soft' and 'well-formed' during bisacodyl treatment, remaining between 'moderately hard' and 'hard' for placebo treatment (P<0.0001). The investigator's global efficacy score was superior for the bisacodyl group compared with placebo. Both treatments were well tolerated. Serum electrolyte levels and incidence of adverse events were comparable between treatment groups. CONCLUSIONS: Bisacodyl is effective and safe in improving stool frequency and consistency in acute treatment of idiopathic constipation.

[Sleep-related breathing disorders and normal or high-tension glaucoma: 35 patients with polysomnographic records]. / Troubles respiratoires nocturnes et glaucome à pression normale ou élevée. A propos de 35 patients hospitalisés pour polysomnographie.

PURPOSE: To look for early stage glaucoma symptoms in patients referred for sleep-related breathing disorders or sleep apnea syndrome. PATIENTS AND METHOD: Thirty-five patients between October 2001 and April 2002 consecutively admitted for polysomnographic evaluation were investigated. Each patient had complete ophthalmologic examination before the nocturnal record. A blue-on-yellow Humphrey computerized perimetry test was given, and a standard perimetry with a color vision test if abnormalities were found. The criteria studied were intraocular pressure, optic nerve cupping and aspect, visual field indices and visual field aspect, which were compared to the respiratory disturbance index. Twenty-seven subjects were included in this analysis, nine women and 18 men. RESULTS: In eight patients, the respiratory disturbance index was higher than 10. All intraocular pressures were normal. Visual field defects were found in two patients with both standard and blue-on-yellow perimetry, and in 12 patients with only blue-on-yellow perimetry. Mean deviation and visual field aspect correlated well with the respiratory disturbance index (p=0.026, p=0.033). Other visual field indices were not correlated with the respiratory disturbance index. CONCLUSION: In this study, we found visual field alterations with blue-on-yellow computerized perimetry that did not exist with standard perimetry. The visual field defects were more frequent when the respiratory disturbance index was poor.

Efficacy and safety of metamizol vs. acetylsalicylic acid in patients with moderate episodic tension-type headache: a randomized, double-blind, placebo- and active-controlled, multicentre study.

We assessed the efficacy and safety of oral single doses of 0.5 and 1 g metamizol vs. 1 g acetylsalicylic acid (ASA) in 417 patients with moderate episodic tension-type headache included in a randomized, double-blind, placebo- and active-controlled, parallel, multicentre trial. Eligibility criteria included 18-65 years of age, history of at least two episodes of tension-type headache per month in the 3 months prior to enrollment, and successful previous pain relief with a non-opioid analgesic. Treatment arms were metamizol 0.5 g (n = 102), metamizol 1 g (n = 108), ASA 1 g (n = 102) and placebo (n = 105). The analgesic efficacy of 0.5 and 1 g metamizol vs. placebo was highly statistically significant (alpha: 0.025; one-sided) for sum of pain intensity differences, maximum pain intensity difference, number of patients with at least 50% pain reduction, time to 50% pain reduction, maximum pain relief and total pain relief. A trend towards an earlier onset of a more profound pain relief of 0.5 and 1 g metamizol over 1 g ASA was noticed. All medications including placebo were almost equally safe and well tolerated.

Efficacy of orally administered extract of red vine leaf AS 195 (folia vitis viniferae) in chronic venous insufficiency (stages I-II). A randomized, double-blind, placebo-controlled trial.

UNLABELLED: Red vine leaf extract (RVLE) is a herbal medicine containing several flavonoids, with quercetin-3-O-beta-glucuronide and isoquercitrin (quercetin-3-O-beta-glycoside) as the main components. OBJECTIVE: To assess the efficacy and safety of once-daily doses of 360 and 720 mg RVLE (pharmaceutical extract code AS 195; Antistax Venenkapseln) compared to placebo in patients with stage I and incipient stage II chronic venous insufficiency (CVI). DESIGN: A 12-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center study. PATIENTS: Male and female outpatients aged 25 to 75 years with stage I to stage II CVI (i.e. without extensive trophic changes), not having any other significant medical conditions and not treated with compression stockings, diuretics or other drugs affecting fluid balance. INTERVENTION: Patients were randomly assigned to a double-blind treatment with placebo, 360 mg AS 195 or 720 mg AS 195 once daily for 12 weeks, preceded and followed by a single-blind 2-week placebo treatment for baseline run-in and end-of-trial washout, respectively. Study criteria were evaluated at baseline, after 6 and 12 weeks of treatment and 2 weeks after discontinuation of treatment. RESULTS: Of the 260 patients enrolled and randomized, 219 completed the study in accordance with the protocol. In the intention-to-treat analysis (N = 257), the mean (+/- SD) lower leg volume (measured by water displacement plethysmography) of the patients treated with placebo (N = 87) increased by 15.2 +/- 90.1 g (displaced water mass) and by 33.7 +/- 96.1 g after 6 and 12 weeks compared to baseline. In contrast, for patients treated with AS 195, lower leg volume decreased, and after 12 weeks of treatment, the difference in mean lower leg volume between the active treatment groups and the placebo group was -75.9 g (95% CI: -106.1 to -45.8 g) and -99.9 g (95% CI: -130.3 to -69.6 g) for the group treated with 360-mg AS 195 (N = 86) and 720-mg AS 195 (N = 84), respectively. The changes in calf circumference showed a similar pattern: in patients treated with AS 195, both the higher dose (720 mg) and, albeit to a lesser extent, the lower dose (360 mg) resulted in a clear reduction in circumference over time, whereas, circumference remained largely unchanged in patients treated with the placebo (95% CI of the estimated treatment effects vs. placebo after 12 weeks: -1.40 to -0.56 cm and -1.73 to -0.88 cm for 360 and 720 mg AS 195, respectively). These differences were statistically significant (p < 0.001). The reductions in ankle circumference were qualitatively similar but quantitatively less marked. Subjectively, there was an improvement in key CVI symptoms (VAS) at 6 weeks with all treatments, but a further improvement at week 12 was seen only in the active treatment groups; at 12 weeks, the changes compared to baseline were significantly greater (p < 0.001) in both active treatment groups than in the placebo group. The treatments were well tolerated; Adverse events were rare and usually mild. Two adverse events (AEs) during treatment with the placebo led to hospitalization and were hence labeled as 'serious'. Three further patients were withdrawn because of AEs which occurred during treatment with the placebo. CONCLUSION: Once-daily doses of 360 and 720 mg AS 195 were confirmed to be safe and effective in the treatment of mild CVI, reducing significantly lower leg edema and circumference whilst improving key CVI-related symptoms to a clinically relevant extent. The edema reduction is at least equivalent to that reported for compression stockings and/or other edema-reducing agents. The higher dose was as well tolerated as the lower dose but resulted in a slightly greater and more sustained improvement.

[Acute pancreatitis and ectopic pancreas]. / Pancréatite aiguë et pancréas ectopique.

We report the case of a 28-year-old woman with a pancreatic heterotopia presenting with a history of acute pancreatitis. Symptoms were epigastric pains. Abdomino-pelvic CT Scan revealed a tumor located in gastro-duodenal area. Exploratory surgery was performed, and the segment containing the mass was resected. Histopathologic examination of the lesion revealed heterotopic pancreatic tissue without malignancy.

[Extra-popliteal localizations of adventitial cysts. Review of the literature]. / Les localisations extra-poplitées des kystes adventitiels. Revue de la littérature.

Cystic adventitial disease is an uncommon vascular anomaly first described in 1947 in the external iliac artery. The preferential localization is the popliteal artery although other arteries and veins may also be involved though not always recognized. There have been 45 extra-popliteal localizations of adventitial cysts reported in the literature. Thirty cases involved an artery an 15 a vein. The iliofemoral axis, with 33 reported cases, is the preferential localization of these extra-popliteal adventitial cysts (including 22 arteries and 11 veins). All the other cases also involved a vessel near an articulation (knee, ankle, elbow, wrist). Despite a preferential popliteal arterial localization only one case involved the popliteal vein. The diagnosis is rarely made before surgery, probably because of the nonspecific clinical presentation. Ultrasonography should allow better recognition of these adventitial cysts, eliminating an aneurysm or a synovial cyst, and evidencing the localization of the cyst within the vessel wall.

[Outcome of surgical treatment of cancer of the stomach. Report of 330 cases]. / Risultati della terapia chirurgica del cancro dello stomaco. A proposito di 330 casi.

The study concerned 330 cases of gastric adenocarcinoma operated from January 1969 to June 1996. Clinical, histological and therapeutic features were analyzed and compared during 3 periods (Group 1: 1969-79, Group 2: 1979-88, Group 3: 1989-96). The aim was to evaluate changes and results occurred in gastric carcinoma. The median age was 65 +/- 11 year (range 25-90), the sex ratio 2. The most common location was in the lower third of the stomach and the cancer was often far advanced (71 percent of stages III and IV). Subtotal gastrectomy was replaced by total gastrectomy and large lymph node dissection was systematically performed in group 3. Curative resection rate increased from 28 to 60 percent between group 1 and group 3. Despite the more radical surgery, post-operative mortality rates decreased respectively 22%, 9%, 8% for the groups 1, 2, 3 (p < 0.01) and global morbidity remained stable while the rate of intra-abdominal infection have changed in group 3 (4.8% vs 2.7% and 2.1% in respectively groups 1 and 2; p = ns). Two year survival rates were 20% for group 1.25% for group 2 and 35% for group 3 (p < 0.01). This results can be considered as encouraging but have to be confirmed at 5 year survival.

[Value of absorbable clips in laparoscopic cholecystectomy. A randomized prospective study]. / Intérêt des clips résorbables dans la cholécystectomie par laparoscopie. Etude prospective randomisée.

Most surgeons use metal clips in laparoscopic cholecystectomy. The aim of this prospective randomized controlled study was to evaluate the efficacy of absorbable clips in elective laparoscopic cholecystectomy. One hundred consecutive patients with symptomatic gallstones without complications were randomized into groups; group T had two metal clips (titan clip ETHICONR), group R (laproclipR Davis and Geck) had one absorbable clip applied on the cystic duct and cystic artery. The patients were followed for one year. There was no difference between the two groups concerning operative time, hospital stay and postoperative complications. The absorbable clips seem to be as effective as metal clips in providing hemostasis in cystic artery and in cystic duct ligation.

Liver grafts can be preserved overnight.

The introduction of University of Wisconsin solution has made liver transplantation a semi-elective procedure. However, many studies have suggested that cold storage must not exceed 12 hours to avoid ischemic-type biliary complications, to reduce the incidence of primary nonfunction and to improve graft and patient survival. The aim of this study was to compare the function of livers transplanted as soon as possible after the liver was harvested and those preserved overnight. Over a 42-month period, we studied 133 elective orthotopic liver transplantation procedures. When cold ischemia started after 6 PM, patients underwent transplantation the following morning (group A), whereas the remainder underwent transplantation immediately (group B). Cold ischemia lasted 13.7 hours and 9.5 hours in groups A and B, respectively (P < .001). The two groups were comparable in terms of initial and late biochemical liver function, the rates of primary nonfunction (6.5% in group A, 6.8% in group B), acute rejection (45.6% in group A, 45.7% in group B), and vascular and infectious complications. No ischemic-type biliary complications were observed. Graft and patient survival were similar in both groups (72.4% v 75.4% and 72.9% v 75.8% in groups A and B, respectively). These results suggest that having taken a cut off at 6 PM to divide the groups into those that underwent transplantation consecutively and those deferred to the morning, the difference between the two groups in terms of storage is relatively modest. Elective liver transplantation can be performed after overnight graft storage without increasing short-term or long-term morbidity or mortality rates.

[Parathyroid adenoma as an ectopic carotid mass. Apropos of a case]. / Adénome parathyroídien en position carotidienne ectopique. A propos d'un cas.

Authors report a case of parathyroid adenoma as lateral palpable cervical mass, with serious hypercalcemia. MRI and ultrasound investigations were performed preoperatively. No other pathological parathyroid gland was found. Surgical treatment did not include the exploration of the four parathyroid glands. Long term follow-up is necessary.

Controlled exposure to mite allergen for a dose-finding of dimethindene maleate (DMM).

The aim of the study was to develop a laboratory system to challenge mite allergic patients with physiological concentrations of Der p I in order to evaluate the efficacy of antiallergic drugs in mite allergic patients. A double-blind, placebo-controlled, cross-over study was designed with three consecutive sessions. Twelve patients with proven sensitivity to dust mite were treated with a single dose of dimethindene maleate in a FOAD formulation (4 and 8 mg vs. placebo) 12 h before a long-term challenge with mite allergen Der p I in the Vienna challenge chamber. Challenge was performed with a constant concentration of 40 ng Der p I per cubic meter of air for 4 h. Nasal parameters were recorded at 15 min intervals during long-term challenge. In comparison to placebo, dimethindene leads to a statistically significant reduction (p < 0.05) of the nasal response at both concentrations tested. The house-dust mite model in the Vienna challenge chamber thus proved to be a useful tool for drug investigations in mite allergies.

[Paraplegia and dissection of the abdominal aorta after closed trauma. Apropos of a case. Current review of the literature (1982-1993)]. / Paraplégie et dissection de l'aorte abdominale après traumatisme fermé. A propos d'un cas. Revue de la littérature récente (1982-1993).

A case of dissection with thrombosis of the subrenal abdominal aorta after blunt trauma led to paraplegia and bilateral ischaemia of the lower limbs in addition to acute abdominal signs. A review of the recent literature (1982-1993) revealed 32 reported cases. The patients were predominantly male and most often victims of an automobile accident (18 cases) or crushing trauma (6 cases). The clinical picture associated diverse degrees of abdominal signs, ischaemia and sensorial-motor impairment of the lower limbs. The diagnosis was established immediately on D0 in only 18 cases, early on days 1 to 7 in 4 cases and was late (day 8 to day 30) in 5 cases or very late (beyond day 30) in 6 cases. The difficulty in immediate diagnosis was related to the absent or incomplete vascular symptomatology or the late onset of the first signs. When a lesion of the aorta was suspected, an arteriography, angioscanner or peroperative exploration led to diagnosis. Neurological signs were frequent (10 cases including 8 with paraplegia) and generally related to ischaemia of the peripheral nerves. They may lead to denate from the diagnosis of vascular lesions. Fractures of the intima (17 cases) was the most frequent aortic lesion which also involved fracture of the media in a number of cases. Dissection was associated in 7 cases and complete or partial thrombosis of the aorta in 7. False aneurysms observed in 6 cases are the usual pathological form in cases of late diagnosis. Nearly all of the lesions were subrenal. Damage to abdominal organs was frequently observed.(ABSTRACT TRUNCATED AT 250 WORDS)

[Clinical development of acute noise-induced acoustic trauma. An evaluation of a study of 250 cases]. / Evolution clinique des traumatismes sonores aigus. Bilan d'une étude de 250 cas.

Traumatic damage on Cochlea (250 cases) induced by assault gun (F.A.M.A.S.) consists in tinitus and hearing impairement on 6000 Hz. Noise's effects are specific to one Cochlea. Dissociated developments of both tinitus and hearing loss show that their anatomical sites are different. Acoustic injury entails definitive haire cells lesions, cellular biochemical and vascular changes. The treatment that reestablishes or raises cochlear blood flow entails recovery in 80% of cases provided that it is given within 48 hours after the trauma.

Dose-related control of allergic rhinitis symptoms by a H1-receptor antagonist. Finding the proper doses [correction of dosis] of dimethindene maleate in patients with allergic rhinitis.

The aim of the study was to evaluate the efficacy and duration of two doses of dimethindene, in a sustained release pellet formulation, with a standardized grass pollen provocation model (Vienna Challenge Chamber, VCC). The study of 12 grass pollen-allergic volunteers (verified by case history, skin prick test and RAST) was carried out in a placebo-controlled, double-blind, cross-over design. 12 h before a 4-hour continuous challenge with permanent 1,000 Dactylis grass pollen/m3 of air in the VCC, 4 or 8 mg of dimethindene (Fenistil pellets) or an identically appearing placebo was administered in three sessions. Nasal flow and resistance, nasal secretion and subjective symptoms were recorded at 15-min intervals during this long-term challenge under reproducible conditions. In comparison to placebo, dimethindene leads to a statistically significant reduction (p < 0.05) in nasal response and clinical symptoms for at least 16 h after treatment. The efficacy of 8 mg dimethindene was superior to that of 4 mg dimethindene; however, the differences between both active treatments were not statistically significant. Therefore 4 mg dimethindene once a day is adequate for usual pollinotic disease conditions.

Pharmacodynamic dose finding of dimetindene in a sustained release formulation.

A sustained release form of dimetindene (dimethindene maleate, Fenistil, CAS 3614-69-5) was developed based on a micropellet technique. Aim of the study was to evaluate the efficacy and duration of two doses of dimetindene in a sustained release pellet formulation with a standardised grass pollen provacation model (Vienna Challenge Chamber; VCC). The study with 12 grass pollen allergic volunteers--verified by case history, skin prick test (SPT), and radio allergo sorbent test (RAST)--was carried out in a placebo controlled, double blind, cross-over design. 12 h before a 4-h-lasting continuous challenge with permanent 1000 dactylis grass pollen in the VCC, administration of dimetindene (Fenistil R Pellets) in doses of 4 mg, 8 mg or identically appearing placebo was scheduled in three sessions. Nasal flow and resistance, nasal secretion and subjective symptoms were recorded at 15-min intervals during this long-term challenge under reproducible conditions. In comparison to placebo, dimetindene leads to a statistically significant reduction (p < 0.05) of nasal response and clinical symptoms for at least 16 h after treatment. The efficacy of 8 mg dimetindene was pronounced over 4 mg, however, the differences between both active treatments were not statistically significant. Therefore 4 mg dimetindene once a day is the adequate treatment for usual pollinotic disease conditions.

[Epidermoid carcinoma of the thyroid. A clinical study and review of the literature. Apropos of a case]. / Carcinome épidermoïde de la thyroïde. Etude clinique et revue de la littérature. A propos d'un cas.

Squamous cell carcinoma of the thyroid is very rare and fatal disease, with most patients dead within one year or less. The tumor may be derivated from metaplastic squamous elements of the thyroid or from transformation of papillary carcinoma. These lesions are usually uncompletely resectable. They also are radioresistant and chemotherapy inconclusive.

[Otorhinolaryngologic manifestation of chronic atrophic polychondritis. Apropos of a case]. / Les manifestations ORL de la polychondrite chronique atrophiante. A propos d'une observation.

Approximately 300 cases of relapsing polychondritis have been reported. The etiology of the disease is still unknown. The pathologist finds a fibrous degeneration of the cartilage of the body. A case relapsing polychondritis is presented and the otolaryngological disorders of the disease are reviewed.

[Sudden infant death and sickle cell anemia in the Sahel region of Africa]. / Mort subite du nourrisson et drépanocytose en Afrique Sahélienne.

The authors investigated the incidence of sudden infant death syndrome (S.I.D.S.) in families of government employees who benefited of free health care. Out of approximately 400 families with around 2000 children, 29 reported at least one infant death meeting the chosen criteria for S.I.D.S. A total of 41 children, mostly males, died between 1 day and 30 months of age, amongst the 149 children born in these families; most of them died during the first 3 months of life. The mothers were generally house wives, aged 26.2 +/- 1.0 years. Sickle cell trait was found in at least one parent of 21 families. In the other 8 families, 11 out of 38 children died, giving a prevalence rate of 6.9/1000 live births for S.I.D.S. in the healthy population. In the sickle cell trait population, the prevalence rate for S.I.D.S. reached 75.0/1000 live births, the prevalence of sickle cell anemia being about 20% in Niger. When very strict criteria were used for diagnosing S.I.D.S., the prevalence rate was 2.5/1000 and 40/1000 live births in the healthy and the sickle trait populations respectively. This study is the first attempt to determine the place of S.I.D.S. in the infant mortality rate in Sahelian Africa. In families with sickle cell disease, the risk of S.I.D.S. was 11.5 times greater than in healthy families. The role of sleep apnea as a cause of S.I.D.S. is discussed. It may represent a common cause of death in both healthy families at risk and sickle cell trait families.