The effect of biofeedback pelvic floor training with ACTICORE1 on fecal incontinence A prospective multicentric cohort pilot study.

INTRODUCTION: Fecal incontinence refers to the inability to pass stool in a localized and timely manner resulting in the involuntary loss of intestinal contents such as air, intestinal mucus or stool. The prevalence of fecal incontinence in the general population is approximately 2-21%. Women are more frequently affected than men. Physiotherapeutically guided pelvic floor training, otherwise known as Kegel exercise, is the mainstay of treatment for fecal incontinence. The objective of this study was to evaluate the feasibility and potential benefits of a new biofeedback training, which uses a non-insertable pelvic floor sensor with digital interface, called ACTICORE1. METHODS: From January 2020 to April 2021, we conducted a prospective non-randomized multicentric clinical pilot study at the Alexianer St. Hedwig Hospital Berlin (Germany), private clinic Strack (Germany) and the University Hospital Magdeburg (Germany). Patients with fecal incontinence, defined as a Wexner score >2, were recruited and asked to either perform biofeedback training with ACTICORE1 (6 min daily for 16 weeks) or daily Kegel exercise (Physiotherapeutic guidance weekly for the first 6 weeks; biweekly for the remaining 10 weeks). The primary outcome was severity of fecal incontinence after 16 weeks of training assessed using the Wexner score. Secondary outcomes were severity of fecal incontinence after 12 weeks and patients' quality of life assessed using the EQ-5D-3L questionnaire after 16 weeks of training. The two-one-sided t-tests (TOST) procedure was used to determine if training with ACTICORE1 has equivalent or noninferior efficacies compared to Kegel exercise. RESULTS: A total of 40 individuals were included. Dropout occurred in 4 cases. The final sample included 19 patients who performed the ACTICORE1 training (ACTICORE-group) and 17 patients who performed guideline-based physiotherapy (PHYSIO-group). Univariate analysis of biometric parameters showed no statistically significant differences. Individuals in the ACTICORE-group were younger (M=46,6 (SD=18,9) years vs. M=57,1 (SD=17,3) years, p=0.093). In terms of endpoint evaluation, a non-inferiority of ACTICORE1 compared to the therapy standard (Kegel exercise) was detected. Both groups showed a statistically significant intraindividual improvement in fecal incontinence as measured by Wexner scoring after 16 weeks. The TOST detected a non-inferiority of ACTICORE1 training (98% confidence interval with equivalence bounds 5 for low and high; Results: 1.36, upper 6.75). CONCLUSION: Pelvic floor training with ACTICORE1 may enable sufficient pelvic floor training as a digital health application. The study at hand revealed a non-inferiority of ACTICORE1 training compared to Kegel exercise.

Acute facial palsy in children--a 2-year follow-up study with focus on Lyme neuroborreliosis.

OBJECTIVE: Acute facial palsy in children is believed to be a rather benign neurological condition. Follow-up-studies are sparse, especially including a thorough otoneurological re-examination. The aim of this study was to examine children with a history of facial palsy in order to register the incidence of complete recovery and the severity and nature of sequelae. We also wanted to investigate whether there was a correlation between sequelae and Lyme Borreliosis, treatment or other health problems. METHODS: Twenty-seven children with a history of facial palsy were included. A re-examination was performed by an Ear-Nose-Throat (ENT) specialist 1-2.9 years (median 2) after the acute facial palsy. The otoneurological examination included grading the three branches of the facial nerve with the House-Brackman score, otomicroscopy and investigation with Frenzel glasses. A paediatrician interviewed the families. Medical files were analysed. RESULT: The incidence of complete recovery was 78% at the 2-year follow-up. In six out of 27 children (22%), the facial nerve function was mildly or moderately impaired. Four children reported problems with tear secretion and pronunciation. There was no correlation between sequelae after the facial palsy and gender, age, related symptoms, Lyme neuroborreliosis (NB), treatment, other health problems or performance. CONCLUSION: One fifth of children with an acute facial palsy get a permanent dysfunction of the facial nerve. Other neurological symptoms or health problems do not accompany the sequelae of the facial palsy. Lyme NB or treatment seems to have no correlation to clinical outcome. Factors of importance for complete recovery after an acute facial palsy are still not known.

[Munchausen syndrome by proxy. Child abuse by falsification of symptoms]. / "Münchausen syndrome by proxy". Barnmisshandel genom förfalskning av symtom.

Münchausen syndrome by proxy (MSbP) is a potentially lethal form of child abuse. Mortality rates around 10 percent have been reported. A knowledge of the characteristics of MSbP is needed in order to reveal the diagnosis and to handle the management correctly. Swedish experience is in accordance with international reports.

Slight steroid-sparing effect of intravenous immunoglobulin in children and adolescents with moderately severe bronchial asthma.

Twenty subjects (aged 6-20 years) with moderately severe bronchial asthma participated in an open controlled trial with intravenous immunoglobulin (IVIG) given as five monthly infusions with a mean dose of 0.8 g/kg body weight. A follow-up was performed 4 and 14 months after the treatment period. Nine of 14 children in the treatment group completed the trial. Two children experienced severe headache after the first infusion, another two patients were taken off the study for reasons unrelated to the IVIG therapy, and one patient dropped out from lack of motivation. In six of the IVIG-treated children, there was a reduction in the daily intake of inhaled steroids at an unchanged or reduced histamine reactivity. Of the remaining three children, two showed a reduction in bronchial hyperreactivity, but their steroid dose was not reduced. Six patients participated in a reference group to determine seasonal variations of symptoms. One of them improved during the study period, and the condition of the other five deteriorated, as indicated by increased medication without reduced histamine reactivity. After 14 months, there were no significant differences in clinical symptoms, nor in sensitivity to histamine between the treated patients and the controls, as the condition had improved also in the latter. We have thus been able to confirm, in a group larger than those in previously published reports, some clinical improvement of asthma by IVIG therapy at a lower dose than previously used and in children with only moderately severe disease. The effect was still present 4 months after the termination of IVIG therapy but not after 14 months.(ABSTRACT TRUNCATED AT 250 WORDS)

Prediction and detection of allergy development: influence of genetic and environmental factors.

The prevalence of atopic diseases is increasing in northwestern Europe and probably also in the rest of the Western world. Detecting cord blood IgE, in combination with obtaining a family history of atopic disease, seems to be the most valuable method of predicting all forms of atopic disease; however, this will identify only a small proportion of children with subsequent development of atopic disease. Determination of cord blood IgE cannot, without modifications, be recommended as a single test for identifying infants for allergy prevention programs. Skin prick reaction to egg white during the first year of life seems to identify a majority of children in whom allergic disease is going to develop during infancy. Other methods, such as genetic markers of an atopic constitution, eventually may facilitate early identification of infants at risk of atopic disease.

Natural history of bronchial asthma in childhood. A prospective study from birth up to 12-14 years of age.

In a cohort of 1654 consecutively born children followed from birth, the cumulated incidence of asthma up to 11 years was 5.3% and the prevalence 3% between 10 and 11 years of age. The asthma début was prior to 1.5 years in 1/3 and before 3 years in 1/2 of the children. Among 59 children examined at 11.5-14.5 years of age, 16 (27%) had no prevalent asthma. On the other hand, inadequate medication was found in 13, undiagnosed chest deformity in four, and wheezing in seven children. All 54 tested children including those with no prevalent asthma had a PC20 histamine less than 8 mg/ml. Tread mill test gave a significant reaction in 15 children. Animal danders and pollens were the most common allergens giving reactions at skin prick test. Compared to one earlier Swedish study an increase in mite sensitivity was found. Cord-blood IgE concentration and a positive immediate family history of atopic disease had no predictive value for the severity of asthma at this follow-up. A new total asthma score including number of days with functional impact of asthma during the last year and present medication was used for group comparisons. Children with a high score at 11.5-14.5 years had more exercise-induced asthma, more concomitant allergic diseases, earlier asthma start, more chest deformity, hyperreactivity both on tread mill and histamine challenge tests, elevated IgE, positive Phadiatop and more reactions at skin prick test, especially to animals and mites. Bronchial asthma was found more often in children born during August through October, possibly due to unsuitable indoor climate and more virus infections during their first 6 months of life. The severity of the asthma was, however, not influenced by the month of birth. No significant differences were found between boys and girls regarding the age at début, asthma severity at follow-up, or bronchial histamine threshold levels.

Development of asthma in children.

Asthma is a multifactorial disease on genetic basis. Its development is influenced by maternal and environmental factors, i.e. allergens and adjuvants. Early identification of candidates at high risk for development of asthma will enable giving recommendations on preventive measures focussing on exposure to tobacco smoke and other pollutants, indoor and outdoor allergens and possibly viral infections during infancy.

Prediction of allergy in infancy.

There is still no test that can predict allergy in infancy with 100% accuracy. For practical purposes, the best we can do is combine a carefully taken family history with a blood sample in early infancy, preferably during the first week of life, on which a sensitive IgE test is applied. If cord blood samples are used, contamination with maternal blood must be avoided as far as possible and samples with high IgE should be checked for possible contamination with maternal blood. Certainly, predictive tests are of no value unless there is a possibility of offering prophylactic measures that prevent or at least delay the onset of the symptoms of allergy. A search for ideal prophylactic measures and screening methods is in progress.

Theophylline pharmacokinetics in children, comparing sustained release spheres (Theo-Dur sprinkle) with elixir.

A new sustained release theophylline preparation (Theo-Dur Sprinkle, TDS) was given b.i.d. and a theophylline elixir t.i.d. to eight children with bronchial asthma, 4-10 years of age, in an open study with a randomized cross over design. The serum concentration curves of theophylline were compared. The individual theophylline dose was close to 20 mg/kg body weight per day. On day 3 of each regimen, blood samples were taken 11 times over 24 h. There were great differences between morning concentrations of theophylline, with a range from 0.9-10.7 mg/l in children given elixir, while corresponding values for children given TDS were 4.1-19.3 mg/l. Fluctuation during a dosing interval was 276% for elixir but only 54% in the case of TDS. The morning theophylline levels on two consecutive days did not differ significantly when the children were treated with TDS. The bioavailability of theophylline from TDS was 94% (range 54%-121%). Parents preferred TDS in seven of the eight cases. TDS showed satisfactory sustained release properties but the study confirmed the need for individually tailored dosage of theophylline based on monitoring of symptoms and serum concentrations.

Cost-effectiveness of neonatal IgE-screening for atopic allergy before 7 years of age.

Obvious atopic diseases developed in 18% of 1651 non-selected children before 7 years of age. More than 80% of newborns with high IgE concentrations in cord blood developed atopic diseases before this age. Although the sensitivity of the IgE test is rather low (40%), most cases (94%) of severe, long-lasting atopic disease show a high neonatal IgE concentration, and the specificity of the test is high (94%). Calculations of total costs of screening were made on the basis of family history alone compared with neonatal IgE-screening in two groups: all newborn infants, or infants with a family history of atopic disease. The cost of preventive measures and treatment costs were included in the calculations. Results were compared with the cost of conventional treatment. Provided that preventive measures delay onset of symptoms in atopic-risk subjects (and assuming total patient compliance) then IgE-screening was cost-effective in both groups, which screening solely on a basis of family history was not. In Sweden there was a total saving of approx. 20 million SEK or 3 million US$ per annum. Thus, IgE-screening of cord blood to select newborns for preventive measures is also economically worthwhile.

Terbutaline slow-release tablets in children with asthma. A comparison with t.i.d. beta 2-agonist therapy.

The effects of 5 mg slow-release terbutaline sulphate tablets (Bricanyl Depot) given twice daily were compared with those of ordinary oral beta 2-agonist treatment given three times daily. The study was open, randomized and cross-over and was carried out over 8 weeks in 18 children with bronchial asthma. Compared with ordinary medication, the slow-release tablets obtained higher morning expiratory peak flow values and an improvement in the asthma symptoms during the night and during exercise (P less than 0.05). No differences were found in side effects in spite of a higher total daily dose during the period with terbutaline slow-release tablets. The slow-release tablets were preferred by 15 of 18 children and their families when the effects, side effects and dosage were evaluated.

Predictors of atopic disease: cord blood IgE and month of birth.

The cumulated incidence of atopic disease before 7 years of age was highly influenced by the cord blood IgE concentration and moderately influenced by the month of birth: obvious atopic disease was more than twice as common in children with high cord blood IgE and born in May than in children with a similar IgE and born in November (P less than 0.05). There was no similarly increased risk for atopic disease among those born in May with low cord blood IgE. Environmental factors thus seem important merely for a high risk population. The findings lend support to family planning when there is especially high genetic risk for atopic disease.

Changes in nutritional assessment variables caused by total parenteral nutrition in anorexia nervosa.

Nutritional assessment variables were measured weekly in 10 young women with severe anorexia nervosa during treatment with total parenteral nutrition (TPN) for a 5 week period. Before the start of treatment the patients had lost 25-53% of their habitual weight, triceps skin fold (TSF) and arm muscle circumference (AMC) measurements were below the 5th percentile and all were anergic in the delayed hypersensitivity (DH) response. Plasma protein levels were normal except in fibronectin and prealbumin where levels below the reference interval was found in five patients. During TPN the body weight increased most likely due to rehydration and increase in lean body mass. Significant increases were seen in body weight weekly, but in TSF and AMC only after 4 and 3 weeks respectively. TSF and AMC were still below or at the 5th percentile after 5 weeks of TPN. DH response as well as fibronectin and prealbumin levels normalised in all patients. Despite only partial recovery in body cell mass the clinical picture had changed markedly so that the patients now were amenable to psychotherapy and had an adequate intake of food orally, enabling further nutritional therapy to be completed without parenteral support.

Severe anorexia nervosa treated with total parenteral nutrition. Clinical course and influence on clinical chemical analyses.

Severe anorexia nervosa in which psychiatric treatment has failed is a life-threatening condition since the degree of emaciation can be profound. Nine young women with a weight loss of 25-50% of their habitual weights were given total parenteral nutrition (TPN) over 3-8 weeks through a tunneled central venous silicone catheter. They initially received a mean of 55 kcal/kg body weight/24 hours increasing to 65-70 kcal/kg body weight during the first week. The initial bradycardia and hypotension were normalized and body weight increased with a mean of 2.5 kg/week. All patients showed a general somato-psychic improvement after two weeks of TPN. The electrolyte disturbances seen at the beginning were normalized during the first weeks of treatment and the previously reported life-threatening electrolyte disturbances and dehydration in connection with TPN treatment were not seen. The only adverse effect registered was a rise in liver enzymes in two patients who were given greater than 80 kcal/kg and day. With a reduction of the caloric supply these changes normalized, and TPN could be continued. After 3-8 weeks the oral intake had normalized and TPN was discontinued. This study confirms that TPN can be used successfully and with minimal risk in severe anorexia nervosa until the patients have normalized their oral intake.

Diagnosis and immunotherapy of mould allergy. I. Screening for mould allergy.

In order to screen for mould allergy, extracts of five common atmospheric moulds (Cladosporium, Alternaria, Penicillium, Aspergillus and Mucor) from various manufacturers were investigated in 130 patients (5-60 years old) with clinical symptoms indicating possible mould allergy. The patients were screened by skin prick test (SPT) and radioallergosorbent test (RAST). SPT seemed to be more sensitive than RAST as a diagnostic screening procedure (80% positive reactions to one or more species compared to 50%). With a partially purified, standardized preparation of Cladosporium herbarum more positive reactions were obtained than with crude extracts without evidence of any unspecific reactions. The difference between commercial and standardized extracts is most probably a result of a variation of both the biological potency of allergenic determinants and the allergenic composition. A considerable number of negative RAST reactions with standard discs were found in patients with positive skin reactions to partially purified Cladosporium, but RAST seemed to be more sensitive than SPT with the other commercial mould extracts. Based on the screening, a very convincing tendency to IgE-reactivity to other moulds was found in patients reacting to Cladosporium, the most common cause of mould allergy. The results confirm the inadequacy of most mould extracts used in diagnostic procedures and strengthen the value of using standardized extracts.

Cord blood IgE determination for allergy prediction--a follow-up to seven years of age in 1,651 children.

Among 1,651 children, 80.2% of those with high cord blood IgE concentrations (greater than or equal to 0.9 kU/l) developed atopic disease before six years of age. Only 3.5% of children with no atopic disease showed high neonatal IgE concentrations. Of children with early-developing and long-lasting symptoms, 93.7% showed high cord blood IgE concentrations.

IgE screening in 1701 newborn infants and the development of atopic disease during infancy.

IgE screening was done using the Phadebas IgE PRIST technique on the cord blood of 1701 newborn infants. Of these 8.3% developed obvious or probable atopic disease, predominantly atopic dermatitis and bronchial asthma, during the first 18 months of life. Of infants with a family history of atopic disease 10.5% developed such illness; the corresponding figure for infants with an initially high IgE concentration was 70%. Atopic disease developed in 73% of infants with a high IgE concentration in cord blood and a family history, but in only 3% of infants with a low IgE and no family history. A high IgE concentration in cord blood was associated with a high IgE and a positive radioallergosorbent test at between ages 18 and 24 months more often than was a low initial IgE level, indicating that in man as in animals there are high and low IgE responders already genetically coded at birth. IgE screening in cord blood is recommended if there is obvious atopy in both parents or if severe atopic disease if present in a sibling or in one parent.

Salbutamol by powder or spray inhalation in childhood asthma.

Forty-three children from 3-16 years of age suffering from moderate bronchial asthma completed a double-blind cross-over study on the clinical effect of inhaled salbutamol (Ventoline) powder (0.2 mg/dosis) compared with spray (0.1 mg/dosis) over two 4-week periods. Both administrations gave significant improvement in air flow meter (AFM) results. There was no significant difference between the periods on active powder or spray regarding daily symptom scores, adjuvant medication or AFM values. The powder caused cough in four children but in 12 of 28 children it was considered as easy or easier to accept as the spray; nine of these 12 children were younger than 10 years of age. It is concluded that salbutamol inhaled as a powder is a useful alternative when using a spray is difficult or unwanted.