Homoeopathy for delayed onset muscle soreness: a randomised double blind placebo controlled trial

This report describes a technique for the reconstruction of a patellar tendon-tibial tubercle deficiency. This technique uses an easy-to-harvest, low-morbidity graft (autogenous quadriceps tendon), while allowing aggressive rehabilitation as a result of the strength of the graft.     

Effect of psyllium on gastric emptying, hunger feeling and food intake in normal volunteers: a double blind study

OBJECTIVE: To assess whether psyllium, a soluble dietary fibre, could, at an acceptable dose (7.4 g), delay gastric emptying of a low-calorie meal, and reduce hunger feeling and energy intake, without requiring intimate mixing with the meal. DESIGN: A double blind randomized cross over study with 14 normal volunteers, to evaluate the effect of this dose of psyllium on postprandial serum glucose, triglycerides and insulin levels, and on gastric fullness, hunger feeling and food intake. METHODS: Gastric emptying was measured using a standard double-radiolabeled 450 kcal meal and feelings by visual analogic scales. The postprandial serum glucose, triglycerides and insulin levels were also determined. RESULTS: No delay in the gastric emptying of the solid and liquid phases of the meal was observed with psyllium. After the meal, hunger feelings and energy intake were significantly lower during the psyllium session than during the placebo session (13% and 17% lower respectively; P < 0.05). Postprandial increase in serum glucose, triglycerides and insulin levels was less with psyllium than with placebo (P < 0.05). CONCLUSIONS: Psyllium reduces hunger feelings and energy intake in normal volunteers at reasonable dose and without requiring mixing with the meal. It does not act by slowing down the gastric emptying of hydrosoluble nutrients, but by increase in the time allowed for intestinal absorption, as suggested by the flattening of the postprandial serum glucose, insulin and triglycerides curves.     

Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study

In the early eighties we found sex differences in the vomeronasal organ (VNO) and hypothesized that the vomeronasal system (VNS), a complex neural network involved in the control of reproductive behavior, might be sexually dimorphic. At that time sex differences had already been described for some structures that receive VNO input, such as the medial amygdala, the medial preoptic area, the ventromedial hypothalamic nucleus, and the ventral region of the premammillary nucleus. Since then, we have shown sex differences in the accessory olfactory bulb (AOB), the bed nucleus of the accessory olfactory tract (BAOT), and the bed nucleus of the stria terminalis (BST). When new VNS connections were found, all of them ended in nuclei that present sex differences. In general, sex differences in the olfactory system show two morphological patterns: one in which males present greater morphological measures than females, and just the opposite. To explain the morphometric measures of males in the latter, it has been hypothesized that androgens serve as inhibitors. Our work on the involvement of the GABA(A) receptor in the development of AOB and maternal behavior sex differences also suggests that neonatal changes in neuronal membrane permeability to the ion Cl- differences. This might be the first animal model to help us to understand the situation in which human genetic and gonadal sex do not agree with brain and behavioral sex. Finally, we stress that sex differences in the VNS constitute a neurofunctional model for understanding sex differences in reproductive behaviors.     

NIDDM: a rapid progressive disease. Results from a long-term, randomised, comparative study of insulin or sulphonylurea treatment

The objective of the present study was to assess the relative efficacy of insulin or glibenclamide treatment for non-insulin-dependent diabetes mellitus (NIDDM) over 42 months. We performed a randomised, controlled trial allocating patients treated with diet and oral antihyperglycaemic agents to treatment with glibenclamide or insulin to achieve HbAlc levels under 7.5%. We included 36 subjects with established NIDDM of more than 2 years' duration. Mean HbAlc levels were significantly reduced in patients allocated to insulin treatment from 9.1 +/- 1.4% before the start to 7.8 +/- 1.3% (p < 0.05) after 1 year, and did not change significantly thereafter throughout the study period. Mean HbAlc levels increased during the study in the patients allocated to glibenclamide treatment, and 11 of 18 patients had to be switched to insulin treatment due to increasing hyperglycaemia (HbAlc > 10%). Mean body weight increased in the subjects allocated to insulin by 7.2 +/- 4.1 kg during the study period. In conclusion, insulin was more effective than glibenclamide treatment in obtaining control over hyperglycaemia in these patients, and once improved, glycaemic control did not deteriorate over 42 months in the insulin-treated group. Two thirds of the patients allocated to glibenclamide treatment had to be given insulin due to inadequate glycaemic control.     

Effect of inhibition of nitric oxide synthase on chronic tension-type headache: a randomised crossover trial

BACKGROUND: Studies in animals have shown that nitric oxide plays an important part in central sensitisation and that inhibitors of nitric oxide synthase (NOS) decrease sensitisation in models of persistent pain. The efficacy of inhibitors of NOS has not been tested in patients with tension-type chronic headache. We aimed to show whether N(G)-monomethyl-L-arginine hydrochloride (L-NMMA), an inhibitor of NOS, is effective in relieving pain in such patients. METHODS: We undertook a randomised double-blind, crossover trial of 16 patients with chronic-tension-type headache. Patients were assigned intravenous infusion of 6 mg/kg L-NMMA or placebo on 2 days separated by at least 1 week in a randomised order. Headache intensity was measured on a 100 mm visual analogue scale, and on a verbal rating scale at baseline and at 30 min, 60 min, and 120 min after start of treatment. The primary endpoint was reduction of pain intensity on the visual analogue scale by the active treatment compared with placebo. FINDINGS: L-NMMA reduced pain intensity on the visual analogue scale significantly more than placebo: 120 min after start of treatment, the mean pain score was decreased from 49 to 33 with L-NMMA and from 44 to 40 with placebo (p=0.01). Pain intensity on the verbal rating scale was also significantly lower for treatment with L-NMMA than for treatment with placebo (p=0.02). INTERPRETATION: Inhibition of NOS had an analgesic effect in chronic tension-type headache. Further tests are required before clinical application.     

Roxatidine versus ranitidine in the treatment of duodenal ulcer: a randomized, double blind, controlled, multicenter study in Thailand

BACKGROUND: Roxatidine acetate is a novel H2-receptor antagonist and several studies have shown that it is effective in healing duodenal ulcers. We evaluated the efficacy of roxatidine in a non-western society with particular different features and its healing of duodenal ulcers was compared in Thailand with that of ranitidine. METHOD: The design was controlled, randomized, double-blind, and multicenter. The study recruited a total of 215 patients who were endoscoped at the start of the trial and then randomized to receive a single capsule of roxatidine acetate, 150 mg, or an identical capsule containing ranitidine, 300 mg, both to be taken at night. Patients were evaluated at 1, 2, and 4 weeks, including endoscopy at the last session, as well as at 6 weeks with repeat endoscopy if the ulcer had not healed. RESULT: Both drugs relieved pain rapidly, usually within a week, and at repeat endoscopy at 4 weeks most ulcers (78%) were healed, 77.0 and 79.5 per cent in ranitidine and roxatidine, and in those patients in whom healing was not completed the healing rate had risen appreciably to 89.8 and 93.8 per cent respectively at 6 weeks. Small ulcers tended to heal quicker than larger ones, but smoking and alcohol intake had no negative effects on the results. CONCLUSION: The study was valid proof that roxatidine, in a single evening dose of 150 mg, was found to be both safe and effective in the rapid healing of duodenal ulcers when compared with 300 mg ranitidine.     

Bedtime administration of lansoprazole does not modify its greater efficacy vs ranitidine in the acute and long-term treatment of duodenal ulcer. Results from a multicentre, randomised, double blind clinical trial

OBJECTIVE: Although surgical biliary bypass for nonresectable periampullary tumors is superior to endoscopic stent placement, the latter has become popular because of the "minimally invasive" approach. Laparoscopic biliary bypass would appear to offer the advantages of both. However, this technique remains technically difficult using existing instrumentation. This study investigates the efficacy of a new endoscopic device designed for rapidly completing a small-diameter intestinal anastomosis under laparoscopic guidance. METHODS: Eighteen female pigs (mean weight 35 kg, range 31 to 44) were randomly divided into three groups: animals undergoing handsewn (group H) or instrumental transient endoluminally stented anastomosis (TESA; groups P and D) laparoscopic Roux-en-Y choledochojejunostomy. For TESA two different reabsorbable stents were used, polyglycolic acid (PGA; group P) and polyurethane ester (Degrapol; group D). Blood chemistry, weight gain, and abdominal X-rays were taken weekly to document any possible migration or reabsorption of the radio-opaque stents. After 3 months, necropsy was performed. Patency of the biliary bypass and choledochojejunostomy were examined using fluoroscopy and measured by introducing graduated dilators into the anastomosis. RESULTS: Fluoroscopy revealed immediate passage of contrast through the anastomosis in all animals. Weight gain, bilirubin, and alkaline phosphatase were within normal range in all groups. Diameter of the bile duct (group H 10.7 +/- 2.9 mm/group P 9.5 +/- 3.6 mm/group D 11.0 +/- 4.6 mm) and choledochojejunostomy (group H 4.5 +/- 1.1 mm/group P 4.7 +/- 1.8 mm/group D 3.6 +/- 1.9 mm) did not differ. The time required to complete the biliary bypass was significantly decreased when TESA was applied (group H 152 +/- 13 min/group P 86 +/- 14 min, P <0.001/group D 110 +/- 20 min, P <0.002). CONCLUSIONS: Applying TESA, laparoscopic choledochojejunostomy can be performed rapidly and safely, revealing good bypass function over a period of 3 months. With regard to treatment for nonresectable periampullary tumors, TESA may offer a new therapeutic approach combining the benefits of minimally invasive endoscopic stent placement with the functional results and lower readmission of conventional Roux-en-Y choledochojejunostomy.     

Effect of salmeterol treatment on nitric oxide level in exhaled air and dose-response to terbutaline in children with mild asthma

We report the histological, immunohistochemical and ultrastructural findings of an exophytic cutaneous tumor composed of a mixture of typical basal cell carcinoma (BCC) and malignant fibrous histiocytoma. Nine previously reported carcinosarcomas of the skin are reviewed. We prefer the term "sarcomatoid carcinoma" for this rare neoplasm. Only the BCC showed a positive immunoreaction to cytokeratin; the sarcomatous component was negative, but it did express vimentin, and, focally, smooth-muscle-specific actin and KP1 (CD68). Both components showed p53 immunostaining.     

Low dose linomide in Type I juvenile diabetes of recent onset: a randomised placebo-controlled double blind trial

The quinoline-3-carboxamide, linomide, protects non-obese diabetic mice from diabetes. The effects of linomide on insulin needs and beta cell function were studied in recent juvenile Type I diabetes in a double-blind trial. Patients with recent onset diabetes were randomly assigned to treatment with a fixed dose of 2.5 mg linomide (42 patients) or placebo (21 patients) for 1 year, in addition to insulin and diet. Glycated haemoglobin was 10-15% lower at 9 months (p = 0.003) and 12 months (p < 0.05) in the linomide group. The insulin dose was 32-40% smaller in the linomide group at 3 (p < 0.03), 6 (p < 0.02), 9 (p < 0.001) and 12 months (p = 0.01). Insulin doses correlated negatively with C peptide values (p = 0.001-0.002). The trend for higher C peptide values in the linomide group did not reach significance. In a post hoc subgroup analysis performed in 40 patients (25 from the linomide group and 15 from the placebo group) who still had detectable residual beta cell function at entry, linomide was associated with 45-59% higher C peptide value at 6 months (p < 0.05), 9 months (p < 0.05) and 12 months (p < 0.05). The main adverse effects of linomide were mild transitory anaemia (45 vs 10% in the linomide and placebo groups), thrombocytopenia (24 vs 10%), and mild joint discomfort (45 vs 5%) with no clinical signs. In conclusion, low-dose linomide reduced the insulin needs in patients with juvenile Type I diabetes of recent onset and improved beta cell function in patients who still had detectable beta cell function at entry. These results support further clinical and experimental studies to define the effects of linomide in Type I diabetes provided the safety of linomide is reliably established.     

Low dose amitriptyline in ankylosing spondylitis: a short term, double blind, placebo controlled study

OBJECTIVE: To define the effect of low dose amitriptyline on fatigue, pain, and stiffness in patients with ankylosing spondylitis (AS). METHODS: One hundred consecutive patients with AS were randomized to receive low dose amitriptyline up to 30 mg nightly or placebo for 2 weeks. Patients were assessed by the Bath Ankylosing Spondylitis Disease Activity (BASDAI) and Functional (BASFI) Indices pre and post-treatment. RESULTS: Eighty-eight patients (44 amitriptyline, 44 placebo) completed the study. Eight (5 amitriptyline, 3 placebo) stopped treatment because of side effects (e.g., drowsiness, dryness of mouth) and 4 provided insufficient data. Compared to placebo, the patients taking amitriptyline showed significantly greater improvement in restful sleep (66 vs 20%; p < 0.001) and their disease activity scores [BASDAI amitriptyline 1.18 (23%) vs placebo 0.52 (10%); p = 0.024]. All other variables showed a trend to greater improvement by amitriptyline, although the differences were not statistically significant. CONCLUSION: (1) In a 2 week study, low dose amitriptyline significantly improved sleep in AS and was well tolerated; (2) as defined by BASDAI, there was a significant reduction in disease activity with amitriptyline; (3) compared to placebo, there was a nonsignificant trend toward improvement in function; and (4) in spite of improvement in pain, fatigue, and sleep with amitriptyline, stiffness was not increased.     

Acyclovir given as prophylaxis against oral ulcers in acute myeloid leukaemia: randomised, double blind, placebo controlled trial

OBJECTIVES: To evaluate (a) the prophylactic effect of the antiherpetic drug acyclovir on oral ulcers in patients with acute myeloid leukaemia receiving remission induction chemotherapy and thus (b), indirectly, the role of herpes simplex virus in the aetiology of these ulcers. DESIGN: Randomised, double blind, placebo controlled trial. SUBJECTS: 74 herpes simplex virus seropositive patients aged 18-84. Thirty seven patients received acyclovir (800 mg by mouth daily) and 37 placebo. The patients were examined daily for 28 days. MAIN OUTCOME MEASURES: Occurrence of herpes labialis, intraoral ulcers, and acute necrotising ulcerative gingivitis. RESULTS: The two populations were comparable in age, sex, type of antineoplastic treatment, and history of herpes labialis. Acute oral infections occurred in 25 of the acyclovir treated patients and 36 of the placebo treated patients (relative risk 0.69 (95% confidence interval 0.55 to 0.87)). This difference was due to a reduction in the incidence of herpes labialis (one case versus eight cases; relative risk 0.13 (0.02 to 0.95)), intraoral ulcers excluding the soft palate (one case versus 13 cases; relative risk 0.08 (0.01 to 0.56)), and acute necrotising ulcerative gingivitis (one case versus eight cases; relative risk 0.13 (0.02 to 0.95)). However, ulcers on the soft palate were diagnosed with similar frequency in the two groups. Isolation of herpes simplex virus type 1 in saliva was reduced from 15 cases in the placebo group to one case in the acyclovir group (relative risk 0.07 (0.01 to 0.48)). CONCLUSION: Intraoral ulcers excluding the soft palate are most often due to infection with herpes simplex virus, whereas ulcers on the soft palate have a non-herpetic aetiology. The findings suggest that acute necrotising ulcerative gingivitis may also be due to herpes simplex virus. Prophylaxis with acyclovir should be considered for patients with acute myeloid leukaemia during remission induction therapy.     

Colonic preparation with sodium phosphate. Prospective, randomized, placebo-controlled double blind study with various antiemetics

The well established bowel cleansing method using a polyethylene glycol-based solution (Fordtran) is limited by the necessity of large volume intake, which proves difficult for many patients. Therefore, a new method using small volumes (2 x 90 ml) of oral sodium phosphate is employed more and more frequently. Its only disadvantage is the occurrence of considerable nausea or occasional vomiting in about 25% of patients. To ascertain whether nausea could be reduced, 426 patients were given an antiemetic (ondansetron, metoclopramide, cisapride) or placebo on a randomized, double-blind basis, one hour before sodium phosphate intake. Results: sodium phosphate was well tolerated in 69.2% of the patients on placebo, 73.6% on cisapride, 76.5% on metoclopramide and 80.4% on ondansetron. Taking all four groups together, male patients exhibited much better tolerance (86.1%) than females (66.1%). Severe nausea and/or emesis was noted in 22.4% of patients on placebo, 21.7% on cisapride, 17% on metoclopramide and 14% on ondansetron. In over 90% of patients colon cleansing was rated as good to very good. This was largely independent of the severity of nausea. 129 patients who had undergone former polyethylene glycol-based lavage judged sodium phosphate to be more tolerable and easier to complete. Considering known contraindications (symptomatic congestive heart failure and/or renal failure), no serious adverse event was noted in any of the 426 patients investigated. In accordance with several recent studies, we consider sodium phosphate solution at present the procedure of choice for colon cleansing. Compared to Fordtran, patient acceptance is far better and cleansing quality superior. Routine antiemetic comedication for reducing possible nausea/vomiting is not worthwhile. On the other hand, this study confirms our former impression of enhanced colon cleansing after administration of an additional mild laxative before sodium phosphate, without interfering with patient acceptance.     

Comparison of phenytoin with auranofin and chloroquine in rheumatoid arthritis--a double blind study

OBJECTIVE: To evaluate efficacy of phenytoin in modifying the course of rheumatoid arthritis (RA) by comparing it to gold (auranofin) and chloroquine. METHODS: A double blind, randomized study of 6 months' duration was conducted at the Nizam Institute of Medical Sciences, Hyderabad, India. One hundred and thirty-two patients with active RA (defined by the 1987 ARA criteria) were entered into the study and randomized into 3 groups: phenytoin, chloroquine, or auranofin. RESULTS: Full data were evaluable in 100 patients who satisfactorily completed the protocol (phenytoin, 35; auranofin, 30; and chloroquine, 35). Twenty-four patients were noncompliant and did not take medication or return for evaluation; 8 patients had the drug withdrawn because of side effects before study completion. For each of the 3 drugs all clinical and laboratory variables improved when pre and posttreatment values (p < 0.05 to 0.001) were compared. There was a greater reduction in posttreatment mean morning stiffness in the chloroquine group than in the phenytoin and auranofin groups (p < 0.05). Posttreatment grip strength was also greatest in the chloroquine group. On the other hand, there were statistically significant decreases in IgM levels in both the phenytoin and auranofin groups (p < 0.001), but not with chloroquine. Among the 53 patients with a disease history of 3-6 months, global outcome was best with phenytoin (16/17), compared to chloroquine (12/18) and auranofin (12/18) (p < 0.03). However, there was no such difference in the 47 patients in all 3 groups with a disease history longer than 6 months. Eight patients had side effects (phenytoin, auranofin, 2; chloroquine, 1) requiring withdrawal of the drug. However, the incidence of side effects was not significantly different for the 3 drugs. CONCLUSION: Our data indicate that phenytoin is comparable to auranofin and chloroquine in its efficacy in RA and may be considered an alternative disease modifying agent for RA.     

Effect of short-term treatment with low-dose inhaled fluticasone propionate on airway inflammation and remodeling in mild asthma: a placebo-controlled study

In a double-blind, parallel-group study, we examined the effect of short-term treatment with inhaled fluticasone propionate (FP) in a group of 20 nonsmoking asthmatic patients who required only beta2-agonists to control their symptoms. We administered FP (250 microg twice daily) or matched placebo for 6 wk. Methacholine challenge was performed before treatment, after 3 wk, and at the end of treatment. Each patient underwent bronchoscopy with bronchoalveolar lavage (BAL) and bronchial biopsy before and after treatment. Eight patients in the placebo group and nine patients in the FP group completed the study. Bronchial responsiveness to methacholine decreased significantly only after 6 wk of treatment with FP (p < 0.05). When we compared the FP group with the placebo group, we observed a significant decrease only in the number of cells expressing intracellular adhesion molecule-1 (ICAM-1) and MAC-1 (p < 0.04 and p < 0.03, respectively). Moreover, we saw that the tryptase level in BAL decreased (p < 0.001), whereas the eosinophil cationic protein (ECP) level did not change significantly. Additionally, the number of eosinophils and mast cells in the lamina propria in bronchial biopsies specimens was significantly smaller in the FP group than in the placebo group (p < 0.02 and p < 0.01, respectively). Additionally, in the FP group, we found that basement-membrane thickness was significantly decreased when compared with that of the placebo group (p < 0.05). In conclusion, our results show that short-term treatment with low-dose FP reduces inflammatory cell infiltration into the lamina propria in bronchial biopsy specimens. Moreover, short-term low-dose FP treatment might control the intensity of airway remodeling in mild asthma.     

The effect of salmeterol on nocturnal symptoms, airway function, and inflammation in asthma

STUDY OBJECTIVE: To determine the efficacy of salmeterol alone in a group of patients with moderate asthma with nocturnal worsening of symptoms. DESIGN: Double-blind, randomized, placebo-controlled crossover study. SETTING: Tertiary care hospital specializing in respiratory diseases. PARTICIPANTS: Ten patients with nocturnal asthma. INTERVENTIONS: Subjects were randomized to salmeterol, 100 micrograms twice daily, or placebo for 6 weeks with a 1-week washout between treatment periods. Symptoms, nocturnal awakenings, and beta 2-agonist use were recorded daily. Spirometry was performed at weeks 1 and 6 of each period at bedtime and at 4 AM, and methacholine challenge was performed at 4 AM followed by bronchoscopy with BAL. BAL fluid analysis included cell count and differential count, eosinophil cationic protein, Charcot-Leyden crystal protein, leukotriene B4, and thromboxane B2. RESULTS: The percentage of nights with awakenings decreased significantly with salmeterol (69.8 +/- 8.7% vs 30.6 +/- 10.8% for placebo and salmeterol, respectively; p = 0.02). The percentage of 24-h days with supplemental inhaled beta 2-agonist use significantly decreased with salmeterol (85.9 +/- 9.4% vs 70.4 +/- 10.1% for placebo and salmeterol, respectively; p = 0.04). There were no significant differences in bronchial reactivity, 4 AM FEV1, overnight percentage change in FEV1, or indexes of airway inflammation. CONCLUSIONS: Salmeterol alone improves the number of nocturnal awakenings and supplemental 24-h beta 2-agonist use in nocturnal asthma without significantly altering lung function and airway inflammation.     

Symptomatic treatment of neurolathyrism with tolperisone HCL (Mydocalm): a randomized double blind and placebo controlled drug trial

Birth hypoxia, asphyxia and ischemia have often been thought to be major causes of early hearing loss or deafness. The purpose of the present review is to focus on the role of these particular factors for perinatal auditory disorders. On the whole, only a small proportion of neonatal hearing loss is caused by perinatal factors. The exact etiology of neonatal hearing loss in children with complicated deliveries is difficult to evaluate due to the large number of causative factors that might be involved. After reviewing the literature covering the past 15-20 years, it is not possible to say that we understand the relative importance of different factors and their interactions. However, in the majority of studies, birth asphyxia is not correlated with hearing loss in babies with complicated deliveries Prolonged artificial ventilation, the presence of severe hypoxic ischemic encephalopathy or persistent pulmonary hypertension are important factors. The brain is more susceptible to anoxia than the ear and both are more likely to be damaged after prolonged pre-, peri- and postnatal hypoxia-ischemia than pure hypoxia during delivery. Perinatal hypoxia is more likely to cause a temporary hearing loss than a permanent one. Preterm babies are more vulnerable than term babies. The total number of risk factors, e.g. medicated by total length of stay in the neonatal intensive care unit and length of artificial ventilation, is the best predictor of risk for hearing loss of perinatal origin. The similarities between hearing loss and cerebral palsy are pointed out; only 8% of the cases of cerebral palsy are considered to be caused by conditions during delivery.     

Biofeedback training in treatment of childhood constipation: a randomised controlled study

BACKGROUND: Because abnormal defaecation dynamics, which can be modified by biofeedback, are considered to be the underlying problem in constipation, biofeedback training may be a useful treatment for constipation. This treatment has mainly been studied in uncontrolled trials. We evaluated defaecation dynamics and clinical outcome in chronically constipated children in a randomised study comparing conventional treatment and conventional treatment with biofeedback training. METHODS: Patients, 5 to 16 years old, were referred to the Academic Medical Center in Amsterdam by general practitioners, school doctors, paediatricians, and psychiatrists. They had to fulfil at least two of four criteria for paediatric constipation and were included if they had been treated medically for at least one month before randomisation. Patients had a medical history, abdominal and rectal examination, and anorectal manometry at the start and end of the 6-week intervention period. The conventional group received laxative treatment with additional dietary advice, toilet training, and maintenance of a diary of bowel habits. The biofeedback group received the same conventional treatment and additionally five biofeedback training sessions. During the first 3 weeks, patients visited the outpatient clinic weekly; two subsequent visits were twice monthly. FINDINGS: 94 patients were randomised to conventional treatment (CT) and 98 to conventional treatment with additional biofeedback training (CT+BF). Normal defaecation dynamics increased in the CT group from 41% to 52% (not significant) and in the CT+BF group from 38% to 86% (p = 0.001). At 6 weeks, more patients in the CT+BF group showed normal defaecation dynamics, compared to the CT group (p < 0.001). This result was unaltered by controlling for baseline status in a logistic regression model. At 1 year, successful treatment (defaecation frequency > or = 3/week, soiling and/or encopresis < 2/month, and no laxatives) was accomplished in 59% of the CT and 50% of the CT+BF group (p = 0.24). The results were maintained after 1 1/2 years follow-up. No association was found between achievement of normal defaecation dynamics and clinical outcome. INTERPRETATION: Additional biofeedback training compared to conventional therapy did not result in higher success rates in chronically constipated children. Furthermore, achievement of normal defaecation dynamics was not associated with success: abnormal defaecation dynamics seem not to play a crucial role in the pathogenesis of childhood constipation. Intensive conventional laxative treatment should remain the first choice in chronically constipated children.     

Effect of temazepam on oxygen saturation and sleep quality at high altitude: randomised placebo controlled crossover trial

OBJECTIVE: To determine the effects of temazepam on the quality of sleep and on oxygen saturation during sleep in subjects at high altitude. DESIGN: Randomised, blinded, crossover, placebo controlled trial. SETTING: Base camp at Mount Everest (altitude 5300 m). SUBJECTS: 11 members of British Mount Everest Medical Expedition recently arrived at base camp. INTERVENTION: Participants were randomly allocated to receive either temazepam 10 mg or placebo on their first night at base camp and the other treatment on the second night. MAIN OUTCOME MEASURES: Quality of sleep (assessed subjectively), mean arterial oxygen saturation value, and changes in saturation values (as measure of periodic breathing) while participants taking temazepam or placebo. RESULTS: All participants noted subjective improvements in sleep. Mean saturation value remained unchanged when temazepam was compared with placebo (74.65% v 75.70%, P = 0.5437). There were fewer changes in oxygen saturation when participants took temazepam and when measured as decreases > 4% below the mean value of saturation each hour (P = 0.0036, paired Student's t test (two tailed)). CONCLUSIONS: Participants taking temazepam at 5300 m showed no significant drop in mean oxygen saturation values during sleep. Both the number and severity of changes in saturation during sleep decreased and the quality of sleep improved. This may be a result of a reduction in the number of awakenings and might lead to greater respiratory stability and fewer episodes of periodic breathing. This has the effect of improving the quality of sleep and reducing the number of periods of desaturation during sleep.