Context: Hepatorenal syndrome is a condition that occurs in people with chronic liver disease (such as alcoholic hepatitis, advanced cirrhosis, or fulminant liver failure) and portal hypertension. The prognosis is dismal, often with a survival of weeks to months. Hepatorenal syndrome is characterised by the development of intense splanchnic vasodilation favouring ascites and hypotension leading to renal vasoconstriction and acute renal failure. Therefore, treatment attempts focus on improving arterial pressure through the use of vasopressors, paracentesis, and increasing renal perfusion pressure. Several authors have reported that the placement of transjugular intrahepatic portosystemic shunts (TIPS) may be a therapeutic option because it decreases portal pressure and improves arterial and renal pressures. However, the evidence is not clearly documented and TIPS may cause adverse events. Accordingly, it is necessary to evaluate the evidence of the benefits and harms of TIPS to assess its value in people with hepatorenal syndrome.

To evaluate the benefits and harms of transjugular intrahepatic portosystemic shunts (TIPS) in adults with hepatorenal syndrome compared with sham, no intervention, conventional treatment, or other treatments.

We included only randomised clinical trials with a parallel-group design, which compared the TIPS placement with sham, no intervention, conventional therapy, or other therapies, in adults aged 18 years or older, regardless of sex or ethnicity, diagnosed with chronic liver disease and hepatorenal syndrome. We excluded trials of adults with kidney failure due to causes not related to hepatorenal syndrome, and we also excluded data from quasi-randomised, cross-over, and observational study designs as we did not design a separate search for such studies.

Transjugular intrahepatic portosystemic shunting versus paracentesis plus albumin for refractory ascites in cirrhosis.

Abstract:
The transjugular intrahepatic portosystemic shunt (TIPS) has been shown to be more effective than repeated paracentesis plus albumin in the control of refractory ascites. However, its effect on survival and healthcare costs is still uncertain.

Seventy patients with cirrhosis and refractory ascites were randomly assigned to TIPS (35 patients) or repeated paracentesis plus intravenous albumin (35 patients). The primary endpoint was survival without liver transplantation. Secondary endpoints were complications of cirrhosis and costs.

Twenty patients treated with TIPS and 18 treated with paracentesis died during the study period, whereas 7 patients in each group underwent liver transplantation (mean follow-up 282 +/- 43 vs. 325 +/- 61 days, respectively). The probability of survival without liver transplantation was 41% at 1 year and 26% at 2 years in the TIPS group, as compared with 35% and 30% in the paracentesis group (P = 0.51). In a multivariate analysis, only baseline blood urea nitrogen levels and Child-Pugh score were independently associated with survival. Recurrence of ascites and development of hepatorenal syndrome were lower in the TIPS group compared with the paracentesis group, whereas the frequency of severe hepatic encephalopathy was greater in the TIPS group. The calculated costs were higher in the TIPS group than in the paracentesis group.

In patients with refractory ascites, TIPS lowers the rate of ascites recurrence and the risk of developing hepatorenal syndrome. However, TIPS does not improve survival and is associated with an increased frequency of severe encephalopathy and higher costs compared with repeated paracentesis plus albumin.

A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites.

Abstract:
In patients with cirrhosis and ascites, creation of a transjugular intrahepatic portosystemic shunt may reduce the ascites and improve renal function. However, the benefit of this procedure as compared with that of large-volume paracentesis is uncertain.

We randomly assigned 60 patients with cirrhosis and refractory or recurrent ascites (Child-Pugh class B in 42 patients and class C in 18 patients) to treatment with a transjugular shunt (29 patients) or large-volume paracentesis (31 patients). The mean (+/-SD) duration of follow-up was 45+/-16 months among those assigned to shunting and 44+/-18 months among those assigned to paracentesis. The primary outcome was survival without liver transplantation.

Among the patients in the shunt group, 15 died and 1 underwent liver transplantation during the study period, as compared with 23 patients and 2 patients, respectively, in the paracentesis group. The probability of survival without liver transplantation was 69 percent at one year and 58 percent at two years in the shunt group, as compared with 52 percent and 32 percent in the paracentesis group (P=0.11 for the overall comparison, by the log-rank test). In a multivariate analysis, treatment with transjugular shunting was independently associated with survival without the need for transplantation (P=0.02). At three months, 61 percent of the patients in the shunt group and 18 percent of those in the paracentesis group had no ascites (P=0.006). The frequency of hepatic encephalopathy was similar in the two groups. Of the patients assigned to paracentesis in whom this procedure was unsuccessful, 10 received a transjugular shunt a mean of 5.5+/-4 months after randomization; 4 had a response to this rescue treatment.

In comparison with large-volume paracentesis, the creation of a transjugular intrahepatic portosystemic shunt can improve the chance of survival without liver transplantation in patients with refractory or recurrent ascites.

Degree of hepatic dysfunction and improvement of renal function predict survival in patients with HRS type I: a retrospective analysis.

Abstract:
Hepatorenal syndrome (HRS) is a frequent complication of end-stage liver cirrhosis. HRS type I has a very poor prognosis. From which of the more or less established therapies, such as use of vasoconstrictors together with albumin or placement of a Transjugular Intrahepatic Portosystemic Shunt patients might profit remains elusive. Therefore, it is important to define parameters that predict an improved outcome in respect to kidney function and survival.

The clinical charts of 91 patients with cirrhosis and HRS type I were studied. The parameters associated with response to therapy, defined as a decrease in serum creatinine of more than 1.5 mg/dl on day 14 after diagnosis of HRS, and those associated with survival were assessed by multivariate analysis.

The median survival was 2.7 (1.5-3.8) months. Three independent predictive factors for survival were identified: Child-Pugh score (P = 0.05), Model of End-Stage Liver Disease (MELD) score less than 20 (P = 0.01), and response to therapy (P = 0.02). The Child-Pugh score (P = 0.00) and MELD score less than 20 (P = 0.02) were the parameters independently associated with the response to therapy, which occurred in 26% of the patients.

Our data of this large monocentric series with HRS type I confirm the poor prognosis in these patients, especially in those with high Child-Pugh and MELD scores, and in those in whom kidney function does not improve within 2 weeks.

Transjugular intrahepatic portosystemic stent-shunt for hepatorenal syndrome.

Long term outcome after transjugular intrahepatic portosystemic stent-shunt in non-transplant cirrhotics with hepatorenal syndrome: a phase II study.

Abstract:
Recent small studies on hepatorenal syndrome (HRS) indicate some clinical benefit after transjugular intrahepatic portosystemic stent-shunt (TIPS) but sufficient long term data are lacking.

We studied prospectively feasibility, safety, and long term survival after TIPS in 41 non-transplantable cirrhotics with HRS (phase II study).

HRS was diagnosed using current criteria (severe (type I) HRS, n=21; moderate (type II) HRS, n=20). Thirty one patients (14 type I, 17 type II) received TIPS (8-10 mm) while advanced liver failure excluded shunting in 10. During follow up (median 24 months) we analysed renal function and survival (Kaplan-Meier).

TIPS markedly reduced the portal pressure gradient (21 (5) to 13 (4) mm Hg (mean (SD)); p<0.001) with one procedure related death (3.2%). Renal function deteriorated without TIPS but improved (p<0.001) within two weeks after TIPS (creatinine clearance 18 (15) to 48 (42) ml/min; sodium excretion 9 (16) to 77 (78) mmol/24 hours) and stabilised thereafter. Following TIPS, three, six, 12, and 18 month survival rates were 81%, 71%, 48%, and 35%, respectively. As only 10% of non-shunted patients survived three months, total survival rates were 63%, 56%, 39%, and 29%, respectively. Multivariate Cox regression analysis revealed bilirubin (p<0.001) and HRS type (p<0.05) as independent survival predictors after TIPS.

TIPS provides long term renal function and probably survival benefits in the majority of non-transplantable cirrhotics with HRS. These data warrant controlled trials evaluating TIPS in the management of HRS.

Inpatient Mortality Benefit with Transjugular Intrahepatic Portosystemic Shunt for Hospitalized Hepatorenal Syndrome Patients.

Abstract:
It has been reported that transjugular intrahepatic portosystemic shunting (TIPS) might be utilized as a salvage option for hepatorenal syndrome (HRS), while randomized controlled trials are pending and real-world contemporary data on inpatient mortality is lacking.

We conducted an observational retrospective cohort study from the National Inpatient Sample from 2005 to 2014. We included all adult patients admitted with HRS and cirrhosis, using ICD 9-CM codes. We excluded cases with variceal bleeding, Budd-Chiari, end-stage renal disease, liver transplant and transfers to acute-care facilities. TIPS' association with inpatient mortality was assessed using multivariable mixed-effects logistic regression, as well as exact-matching, thus mitigating for TIPS selection bias. The exact-matched analysis was repeated among TIPS-only versus dialysis-only patients.

A total of 79,354 patients were included. Nine hundred eighteen (1.2%) underwent TIPS. Between TIPS and non-TIPS groups, mean age (58 years) and gender (65% males) were similar. Overall mortality was 18% in TIPS and 48% in dialysis-only cases (n = 10,379; 13.1%). Ninety six (10.5%) TIPS patients underwent dialysis. In-hospital mortality in TIPS patients was twice less likely than in non-TIPS patients (adjusted odds ratio [aOR] = 0.43, 95% CI 0.30-0.62; p < 0.001), with similar results in matched analysis [exact-matched (em) OR = 0.39, 95% CI 0.17-0.89; p < 0.024; groups = 96; unweighted n = 463]. Head-to-head comparison showed that TIPS-only patients were 3.3 times less likely to succumb inpatient versus dialysis-only patients (contrast aOR = 0.31, 95% CI 0.20-0.46; p < 0.001), with similar findings post-matching (emOR = 0.22, 95% CI 0.15-0.33; p < 0.001; groups = 54, unweighted n = 1457).

Contemporary, real-world data reveal that TIPS on its own, and when compared to dialysis, is associated with decreased inpatient mortality when utilized in non-bleeders-HRS patients. Further randomized studies are needed to establish the long-term benefit of TIPS in these patients.

Transjugular intrahepatic portosystemic shunt for cirrhosis and ascites: Effects in patients with organic or functional renal failure.

Abstract:
A transjugular intrahepatic portosystemic shunt (TIPS) is increasingly being used for treatment of patients with refractory ascites and functional renal failure. In contrast, organic renal disease is commonly considered a relative contraindication for TIPS placement. The aim of this pilot study was to investigate the effects of TIPS in patients with refractory ascites and organic or functional renal impairment.

A TIPS was placed for refractory or intractable ascites in 10 consecutive patients with liver cirrhosis and impaired renal function (serum creatinine > 1.5 mg/100 ml). Four of them had organic kidney disorders. Of these patients, three had moderate renal impairment, and one had end-stage renal disease and needed hemodialysis every other day. The other six patients had functional renal impairment due to the underlying liver disease.

TIPS was effective in reducing ascites in 8 of 10 patients, including all patients with organic renal disease. Furthermore, after TIPS the renal function improved in all patients. Serum creatinine and serum urea levels decreased significantly from 1.8 +/- 0.1 to 1.5 +/- 0.1 mg/100 ml (P < 0.05) and from 107 +/- 13 to 78 +/- 14 mg/100 ml (P < 0.05), respectively. The renal function of the three patients with organic renal failure improved similarly, as observed in the six patients with functional renal failure. In the patient on hemodialysis, TIPS was effective in reducing the frequency of paracenteses.

TIPS may be useful in patients with functional and in patients with organic renal disease, resulting in improvement of ascites and renal function.

Gender Disparity in Inpatient Mortality After Transjugular Intrahepatic Portosystemic Shunt Creation in Patients Admitted With Hepatorenal Syndrome: A Nationwide Study.

Abstract:
The aim of this study was to evaluate inpatient mortality after transjugular intrahepatic portosystemic shunt (TIPS) creation compared with medical management (MM) in patients with hepatorenal syndrome (HRS).

Patients with cirrhosis admitted with HRS between 2005 and 2014 were identified using associated International Classification of Diseases, Ninth Revision, codes in the National Inpatient Sample (n = 153,112). Non-TIPS candidates and patients with parenchymal renal disease were excluded (n = 73,454). The remaining admissions were assigned to groups of TIPS (International Classification of Diseases, Ninth Revision, code 39.1; n = 971) or MM (n = 78,687). Inpatient mortality was analyzed by treatment type and patient gender using χ

Baseline patient demographics were similar. Patients treated medically had higher baseline disease severity (median mortality risk score, 8.3 with MM versus 6.1 with TIPS; P < .01). Inpatient mortality was strongly modified by patient gender. TIPS creation conferred inpatient mortality benefit in men (28% of the MM group versus 10% of the TIPS group, P < .01) independent of all covariates (odds ratio, 0.4; 95% confidence interval, 0.17-0.78; P < .01). Women treated with TIPS creation experienced no mortality benefit (29% MM versus 32% TIPS; odds ratio, 1.5; 95% confidence interval, 0.75-3.23; P = .23).

TIPS creation is associated with reduced inpatient mortality in men, but not women, admitted with HRS. Drivers of this gender-based disparity are currently unclear and warrant focused investigation.

Midodrine, octreotide, albumin, and TIPS in selected patients with cirrhosis and type 1 hepatorenal syndrome.

Abstract: Hepatorenal syndrome (HRS) is a functional renal disorder complicating decompensated cirrhosis. Treatments to date, except liver transplantation, have been able to improve but not normalize renal function. The aim of this study was to determine the efficacy of transjugular intrahepatic portosystemic stent shunt (TIPS) as a treatment for type 1 HRS in ascitic cirrhotic patients, following improvement in systemic hemodynamics with a combination of midodrine, octreotide, and albumin (medical treatment). Fourteen ascitic cirrhotic patients with type 1 HRS received medical therapy until their serum creatinine reached below 135 micromol/L for at least 3 days, followed by a TIPS if there were no contraindications. Patients were assessed before and after medical treatment, as well as at 1 week and 1, 3, 6, and 12 months post-TIPS with measurements of renal function, sodium handling, systemic hemodynamics, central blood volume, and hormonal markers. Medical therapy for 14 +/- 3 days improved renal function (serum creatinine: 233 +/- 29 micromol/L vs. 112 +/- 8 micromol/L, P =.001) and renal sodium excretion (5 +/- 2 mmol/d vs. 9 +/- 2 mmol/d, P =.002) in 10 of the 14 patients. TIPS insertion in five of the responders further improved renal function and sodium excretion, so that by 12 months post-TIPS, glomerular filtration rate (96 +/- 20 mL/min, P <.01 vs. pre-TIPS) and urinary sodium excretion (119 +/- 15 mmol/d, P <.01 vs. pre-TIPS) were normal, associated with normalization of plasma renin and aldosterone levels and elimination of ascites. In conclusion, TIPS is an effective treatment for type 1 HRS in suitable patients with cirrhosis and ascites, following the improvement of renal function with combination therapy of midodrine, octreotide, and albumin.


Context: Pain, when treated inadequately, puts preterm infants at a greater risk of developing clinical and behavioural sequelae because of their immature pain system. Preterm infants in need of intensive care are repeatedly and persistently exposed to noxious stimuli, and this happens during a critical window of their brain development with peak rates of brain growth, exuberant synaptogenesis and the developmental regulation of specific receptor populations. Nearly two-thirds of infants born at less than 29 weeks' gestation require mechanical ventilation for some duration during the newborn period. These neonates are endotracheally intubated and require repeated endotracheal suctioning. Endotracheal suctioning is identified as one of the most frequent and most painful procedures in premature infants, causing moderate to severe pain. Even with improved nursing performance and standard procedures based on neonatal needs, endotracheal suctioning remains associated with mild pain.

To evaluate the benefits and harms of non-pharmacological interventions for the prevention of pain during endotracheal suctioning in mechanically ventilated neonates. Non-pharmacological interventions were compared to no intervention, standard care or another non-pharmacological intervention.

We included randomised controlled trials (RCTs), quasi-RCTs and cluster-RCTs that included term and preterm neonates who were mechanically ventilated via endotracheal tube or via tracheostomy tube and required endotracheal suctioning performed by doctors, nurses, physiotherapists or other healthcare professionals.

The effect of facilitated tucking during endotracheal suctioning on procedural pain in preterm neonates: a randomized controlled crossover study.

Abstract:
Premature infants not only feel and understand the pain, but also respond more intensively compared with term infants. Non-pharmacological methods of pain control are suitable to relieve pain in painful procedures. The facilitated tucking position is considered as a non-pharmacological method of pain control in infants; however, its impact on frequent and repeated procedural pain such as endotracheal suctioning remains to be studied.

This paper is the report of a study that examined the impact of facilitated tucking position on behavioral pain during suctioning in premature neonates.

This was a clinical trial study with a crossover design.

The study was conducted in a level II Neonatal Intensive Care Unit, located in a teaching hospital, affiliated to Tehran University of Medical Sciences, Tehran, Iran.

Thirty four infants were enrolled in this study based on the following inclusion criteria: age between 29 to 37 weeks of gestational age, birth weight 1200 grams or more, having an endotracheal tube, no congenital anomalies, no seizures diagnosis, no chest tubes, no intracranial hemorrhage higher than degree II, not receiving opiates and sedatives four hours before intervention and not receiving any painful procedure at least half an hour before the intervention.

The samples were randomly received a sequence of suctioning with/without or suctioning without/with facilitated tucking. Preterm Infant Pain Profile (PIPP) was used to collect the data. SPSS version 16.0 for Windows (SPSS Inc., Chicago, IL, USA) was used for statistical analysis.

While 38.2% of infants experienced severe pain during suctioning without intervention, only 8.8% of them experienced severe pain during suctioning with intervention. The results of the paired t-test show that there is a statistically significant difference in the mean scores of pain between non-intervention and intervention cases (p < 0.001), and the mean pain score substantially reduced in cases with intervention.

Given the multiplicity of endotracheal suctioning frequency and the impossibility of frequent use of pharmacological methods of pain relief, the facilitated tucking position can be used as a safe non-pharmacological method for procedural pain management.

The effect of facilitated tucking position during endotracheal suctioning on physiological responses and coping with stress in premature infants: a randomized controlled crossover study.

Abstract:
Premature infants respond more intensively to pain compared with term infants. Facilitated tucking position as a non-pharmacological method of pain in infants has been suggested; however, its effect on acute procedural pain such as endotracheal suctioning remains to be studied. This study examined the effect of facilitated tucking position during suctioning on physiological responses and coping with stress in premature infants.

This was a randomized controlled crossover study. Thirty-four premature infants received an order of either suctioning with intervention - suctioning without intervention, or suctioning without intervention - suctioning with intervention. Neonatal Infant Pain Scale (NIPS) was used to collect the data.

No statistical significant difference was seen between intervention and non-intervention cases in terms of the average time duration to reach the pain score to one or zero, and also, in the average of changes in oxygen saturation. However, changes in heart rate were less in intervention cases.

The effect of facilitated tucking position on coping with stress was not found in this study. This non-pharmacological strategy can be suggested because of its effect on reducing changes in heart rate during painful procedure. It is suggested to replicate the study with larger number of samples.

'Facilitated tucking by parents' in pain management of preterm infants-a randomized crossover trial.

Abstract:
There is a need for a safe and effective non-pharmacological pain management method for preterm infants. The parents could be given an active role in the pain management which may help the parents to cope with the stress related to painful situations of the infant.

To examine the effectiveness of a method called 'facilitated tucking by parents' (a parent holds the infant in a flexed position) in pain management during endotracheal/pharyngeal suctioning of preterm infants. In addition, the parental perception of the method was studied.

A randomized crossover trial.

Twenty preterm infants with one of their parents participated in the study. Infants' gestational age ranged from 24 to 33 (median 28) weeks and postnatal age from 6 to 37 days (median 15 days).

The primary outcome was the Neonatal Infant Pain Scale (NIPS) score. Heart rate and oxygen saturation were recorded. Parents completed a questionnaire about their perception of the procedure.

The highest NIPS score was median 3 (range from 2 to 6) using 'facilitated tucking by parents' and median 5 (range from 2 to 7) without tucking during suctioning (p < 0.001). The infants calmed down more quickly after 'facilitated tucking by parents' (5 s vs. 17 s, p = 0.024). Nineteen out of twenty parents preferred facilitated tucking during suctioning compared to control care.

Facilitated tucking by parents is an effective and safe pain management method during suctioning of preterm infants. This study shows that parents can be given an active role in the pain care of their preterm infants.

Endotracheal suctioning in preterm infants using four-handed versus routine care.

Abstract:
To evaluate the effect of four-handed care on preterm infants' physiologic and behavioral responses to and recovery from endotracheal suctioning versus routine endotracheal (ETT) suctioning.

Randomized crossover design with infants as their own controls.

Single-family-room newborn intensive care unit in an academic health center.

Ten intubated infants on conventional ventilation with inline suctioning who were fewer than 37 weeks gestation at birth, and less than one week of age.

Each infant was observed twice on a single day. One observation involved routine ETT suctioning and one involved four-handed care. Physiologic and behavioral response data were collected.

No differences were noted when comparing baseline heart rate (HR) or oxygen saturation (SpO(2)) data to those obtained during and after suctioning while in the routine care condition. In the four-handed care condition, mean SpO(2) increased from preobservation 95.49 to during observation saturation 97.75 (p = .001). Salivary cortisol levels did not differ between groups at baseline or postsuctioning. No significant difference in behavior state was observed between the two conditions. More stress and defense behaviors occurred postsuctioning when infants received routine care as opposed to four-handed care (p = .001) and more self-regulatory behaviors were exhibited by infants during (p = .019) and after suctioning (p = .016) when receiving four-handed care. No statistical difference was found in the number of monitor call-backs postsuctioning.

Four-handed care during suctioning was associated with a decrease in stress and defense behaviors and an increase in self-regulatory behaviors.

Effect of Expressed Breast Milk versus Swaddling versus Oral Sucrose Administration on Pain Associated with Suctioning in Preterm Neonates on Assisted Ventilation: A Randomized Controlled Trial.

Abstract:
The objective of our study was to assess the pain associated with suctioning in preterm neonates on assisted ventilation and comparing the use of expressed breast milk (EBM), sucrose, and swaddling to alleviate pain.

Study design: A randomized controlled clinical trial.

Preterm neonates on assisted ventilation.

Major congenital anomalies and severe encephalopathy.

6 months in level III neonatal Intensive Care Unit. In the first phase, we used premature infant pain profile (PIPP) score to assess pain associated with suctioning in preterm neonates on assisted ventilation. In the second phase, the effect of EBM, swaddling, and sucrose on pain relief during suctioning in neonates on assisted ventilation was assessed.

There was a significant increase in pain associated with suctioning in preterm neonates on assisted ventilation (preprocedure PIPP score 7.90 ± 2.50; procedural PIPP score 13.63 ± 2.57;

Suctioning is painful for preterm neonates on assisted ventilation. There was no difference between EBM, swaddling, and sucrose in relieving pain associated with suctioning.

The effect of gentle human touch during endotracheal suctioning on procedural pain response in preterm infant admitted to neonatal intensive care units: a randomized controlled crossover study.

Abstract:
Neonates in the neonatal intensive care unit are frequently subjected to painful procedures. Non-pharmacological pain control techniques are useful for reducing procedural pain. Touch as one of the aspects of developmental care used to reduce neonatal pain. The purpose of this study was to determine the effect of gentle human touch during endotracheal suctioning on procedural pain response in preterm neonates.

This was a clinical trial study with a crossover design. The study was conducted in a level III NICU in a hospital, affiliated to Iran University of Medical Sciences. Thirty-four neonates were enrolled in this study based on inclusion criteria. The samples were randomly received a sequence of suctioning with/without or suctioning without/with gentle human touch. Preterm Infant Pain Profile (PIPP) was used to collect the data. SPSS version 22 for Windows (SPSS Inc., Chicago, IL, USA) was used for statistical analysis.

85.3% of neonates experienced moderate and 8.8% severe pain during suctioning without intervention, and only 64.7% of them experienced moderate and 2.9% severe pain during suctioning with intervention. The results of the paired

Results from this study showed that the pain due to suctioning procedure is considerably reduced by applying Gentle Human Touch. And nurses can use this method as one of the non-pharmacological methods of pain management.

The Effect of Endotracheal Suctioning Using the Four-handed Care on Physiological Criteria and Behavioral Responses of the Preterm Infants: Randomized Crossover Clinical Trial.

Comparison the Effect of Breast Milk Smell, White Noise and Facilitated Tucking Applied to Turkish Preterm Infants During Endotracheal Suctioning on Pain and Physiological Parameters.

Abstract:
This study aimed to determine the effect of the breast milk smell, white noise and facilitated tucking during endotracheal suctioning (ES) on pain and physiological findings.

The present study was conducted as a randomized, controlled experimental trial study. The sample of the study was composed of a total of 80 preterm infants. Pain was measured with PIPP-R pain scale. rMANOVA and bonferroni tests were used in the comparison of the pain scores of the groups.

It was determined that white noise and facilitated tucking were more effective in relieving infants before ES procedure (p < .05). No statistically significant difference was found between the groups in reducing the pain during ES procedure (p > .05). After the procedure, facilitated tucking was determined more effective in the recovery of preterm infants (p < .05).

It is recommended to use facilitated tucking and white noise for decreasing pain of ventilated preterm infants during the ES procedure.

White noise and facilitated tucking were effective in relieving pain before procedure and facilitated tucking recovery in preterm infants after the ES procedure.

The efficacy of facilitated tucking for relieving procedural pain of endotracheal suctioning in very low birthweight infants.

Abstract:
This study compared the efficacy of a behavioral pain reducing intervention (facilitated tucking) with standard neonatal intensive care unit (NICU) care for decreasing procedural pain (endotracheal suctioning) in very low birthweight (VLBW) infants.

A prospective randomized crossover design with infants as their own controls were used. The sample consisted of 40 VLBW infants, 23-32 weeks gestation, and weighing 560-1498 g with tracheal intubation. The infants were observed twice during each endotracheal suctioning experience; one suctioning was done according to normal nursery routine; another was done using facilitated tucking (the caregiver "hand-swaddling" the infant by placing a hand on the infant's head and feet while providing flexion and containment). The Premature Infant Pain Profile (PIPP) measured the infant's pain response, and severity of illness of each infant was measured by the Score for Neonatal Acute Physiology (SNAP) and the NTISS (Neonatal Therapeutic Intervention Scoring System). Repeated measures analysis of variance (RMANOVA) determined the efficacy of facilitated tucking for reducing procedural pain (PIPP) and the effects of order of intervention vs. control. Regression analyses examined the relationship of gestational age, severity of illness, and number of painful procedures to the pain response.

There was a significant difference between the PIPP scores for tucking and nontucking positions (p = 0.001) and a nonsignificant interaction with order (p = 0.64) as well as a nonsignificant main effect for order (p = 0.46). In the regression analyses, all predictors taken together did not significantly predict PIPP scores in the tucked position (p = 0.11) or nontucked position (p = 0.57).

Facilitated tucking is a developmentally sensitive, nonpharmacological comfort measure that can relieve procedural pain in VLBW infants. Nurses need to be increasingly aware of infant pain during daily care taking, and to use validated pain assessment instruments. Further clinical research on individual pain assessment is needed for better understanding of the quality and significance of pain for each infant, and the factors that affect pain expression.


Context: Hip and knee replacement surgery is a well-established means of improving quality of life, but is associated with a significant risk of bleeding. One-third of people are estimated to be anaemic before hip or knee replacement surgery; coupled with the blood lost during surgery, up to 90% of individuals are anaemic postoperatively. As a result, people undergoing orthopaedic surgery receive 3.9% of all packed red blood cell transfusions in the UK. Bleeding and the need for allogeneic blood transfusions has been shown to increase the risk of surgical site infection and mortality, and is associated with an increased duration of hospital stay and costs associated with surgery. Reducing blood loss during surgery may reduce the risk of allogeneic blood transfusion, reduce costs and improve outcomes following surgery. Several pharmacological interventions are available and currently employed as part of routine clinical care.

To determine the relative efficacy of pharmacological interventions for preventing blood loss in elective primary or revision hip or knee replacement, and to identify optimal administration of interventions regarding timing, dose and route, using network meta-analysis (NMA) methodology.

We included RCTs of people undergoing elective hip or knee surgery only. We excluded non-elective or emergency procedures, and studies published since 2010 that had not been prospectively registered (Cochrane Injuries policy). There were no restrictions on gender, ethnicity or age (adults only). We excluded studies that used standard of care as the comparator. Eligible interventions included: antifibrinolytics (tranexamic acid (TXA), aprotinin, epsilon-aminocaproic acid (EACA)), desmopressin, factor VIIa and XIII, fibrinogen, fibrin sealants and non-fibrin sealants.

Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial.

Abstract:
A phase-III trial that included fifty-three patients undergoing unilateral primary total knee arthroplasty with cement was conducted to investigate the hemostatic efficacy of fibrin sealant.

Following cementing of the joint, 10 mL of fibrin sealant was sprayed onto the wound before tourniquet deflation and wound closure. No placebo was used in the control group. All patients received drains.

Within twelve hours after the surgery, the amount of bloody drainage was 184.5 +/- 28.9 mL (mean and standard error) in the fibrin-sealant group (information available for twenty-three patients) and 408.3 +/- 54.6 mL in the control group (information available for twenty-three patients) (p = 0.002, after adjustment for variance in the time that the drainage was measured). On the first postoperative day, the hemoglobin level had decreased by 20.1 +/- 2.1 g/L in the fibrin-sealant group (information available for twenty-two patients) and by 27.3 +/- 2.1 g/L in the control group (information available for twenty-four patients). After adjustment for baseline values, the decrease in the hemoglobin level was 28.9% less in the fibrin-sealant group than in the control group (p = 0.005, 95% confidence limits = 10.2, 43.7). There were no seroconversions in the fibrin-sealant group.

These results suggest that fibrin sealant can safely reduce bloody drainage following total knee arthroplasty while maintaining higher hemoglobin levels.

[Aprotinin (Antilysin Spofa)--its effect on decreasing hemorrhage in the postoperative period in hip arthroplasty].

Abstract:
Aprotinin is a non-specific inhibitor of serine proteases with hemostyptic and hemostatic properties. The effect covers suppression of fibrinolysis and support of the role of thrombocytes in coagulation. In a prospective randomized study we verified whether the application of aprotinin (Antilysin Spofa, Czech Republic) in the dosage effective in cardiosurgical patients reduces blood loss and the need for blood transfusion for orthopaedic patients.

42 patients indicated to the primary THA were randomly selected into the study and control groups. Excluded were allergic patients and those who used aprotinin before.

Administration of 2.10(6) KIU of aprotinin was started preoperatively and is continued in the course of the first hour of surgery. In the operated on patients we recorded prior to operation and in the first post-operative morning the level of hemoglobin in blood and hematocrit, the number of infusions and blood transfusion units administered in the course of the surgery and in the post-operative period until the first post-operative morning. We recorded blood loss in the period between the surgery and the first post-operative morning. Data acquired in the patients of the studied and control groups were compared by means of ANOVA test for repeated measuring and with the use of Mann-Whitney and chi 2-test, the level of significance p < or = 0.05. During the hospitalization we the patients were checked for symptoms of deep venous trombosis and tromboembolic or other adverse events.

Hemoglobinemia and hematocrit in both groups significantly decreased after the operation (p < 0.0005), the differences between the studied and control groups were not significant. The number of administered blood units did not differ in the examined and control groups. The frequency of blood transfusions was postoperatively higher in the control group (59.1% as compared to 30%), however, the difference was not statistically significant (p = 0.059). Blood loss in the post-operative period was higher in the control group (p = 0.048). Patients from the control group got in total blood transfusion more frequently (p = 0.032). Differences in the total frequency of blood transfusion and in the amount of post-operative blood loss were statistically significant. In the course of hospitalisation no signs of deep phlebothrombosis or thromboembolic condition were encountered in either group of patients. Complications were not recorded.

Our results correspond with most of the published data. Blood loss of the operated on patients who were administered prior to and at the beginning of the operation in total 2.10(6) KIU of aprotinin (Antilysin Spofa) in infusion was on average by 33% less in the post-operative period and in the whole peropetive period they required less frequently blood transfusion (40% vs 73%).

Infusion of aprotinin (Antilysin Spofa) in the dosage of the order of 106 KIU significantly reduces post-operative blood loss and frequency of transfusion in the peroperative period in patients undergoing THA.

Aprotinin versus placebo in major orthopedic surgery: a randomized, double-blinded, dose-ranging study.

Abstract:
We conducted a prospective, multicenter, double-blinded, dose-ranging study to compare the risk/benefit ratio of large- and small-dose aprotinin with placebo after major orthopedic surgery. Fifty-eight patients were randomized into three groups: Large-Dose Aprotinin (4 M kallikrein inactivator unit [KIU] bolus before surgery followed by a continuous infusion of 1 M KIU/h until the end of surgery), Small-Dose Aprotinin (2 M KIU bolus plus 0.5 M KIU/h), and Placebo. Bleeding was measured and calculated. Bilateral ascending venography was systematically performed on the third postoperative day. Measured and calculated blood loss decreased in the Large-Dose Aprotinin group (calculated bleeding, whole blood, hematocrit 30%, median [range], 2,023 mL [633-4,113] as compared with placebo, 3,577 mL [1,670-21,758 mL]). The total number of homologous and autologous units was also significantly decreased in the Large-Dose Aprotinin group (2 U [0-5 U] as compared with placebo, 4 U [0-42 U]). No increase in deep vein thrombosis or pulmonary embolism was observed in the aprotinin groups. Large-dose aprotinin was safe and effective in dramatically reducing the measured and calculated bleeding and the amount of transfused red blood cell units after major orthopedic surgery.

Large doses of aprotinin decrease blood loss and transfusion amount in major orthopedic surgery.

Antifibrinolytic therapy and perioperative blood loss in cancer patients undergoing major orthopedic surgery.

Abstract:
Aprotinin has been reported to reduce blood loss and transfusion requirements in patients having major orthopedic operations. Data on whether epsilon amino-caproic acid (EACA) is effective in this population are sparse.

Sixty-nine adults with malignancy scheduled for either pelvic, extremity or spine surgery during general anesthesia entered this randomized, double-blind, placebo-controlled trial, and received either intravenous aprotinin (n = 23), bolus of 2 x 10(6) kallikrein inactivator units (KIU), followed by an infusion of 5 x 10(5) KIU/h, or EACA (n = 22), bolus of 150 mg/kg, followed by a 15 mg/kg/h infusion or saline placebo (n = 24) during surgery. Our goal was to determine whether prophylactic EACA or aprotinin therapy would reduce perioperative blood loss (intraoperative + first 48h) >30% when compared to placebo.

The mean age of the study population was 52 +/- 17 yr. The groups did not differ in age, duration of surgery, perioperative blood loss or number of packed erythrocyte units transfused. When compared to the placebo group, the two treated groups had a significantly lower D-Dimer level immediately after surgery, P < 0.01.

Under the conditions of this study, we were unable to find a clinical benefit to using aprotinin or EACA to reduce perioperative blood loss or transfusion requirements during major orthopedic surgery in cancer patients.

Experience improves successful use of fibrin sealant in total knee arthroplasty: implications for surgical education.

Abstract: This study evaluating fibrin sealant application in total knee arthroplasty (TKA) found significant differences in the decline in adjusted hemoglobin loss at 48 hours postoperatively in the treatment group (FS) relative to the control group (C) when the groups were segregated into early and late subgroups. The decline between the late C, 3.53 +/- 0.22 g/dL, and the late FS, 3.01 +/- 0.20 g/dL, was 0.52 g/dL (p = 0.04). The decline between the early C, 3.51 +/- 0.21 g/dL, and the early FS, 3.25 +/- 0.22 g/dL, was 0.26 g/dL (p = 0.34). This study demonstrates the importance of experience and education in successful application of tissue adhesives.

A pilot study of the effects of Vivostat patient-derived fibrin sealant in reducing blood loss in primary hip arthroplasty.

Abstract: A pilot study evaluated the effectiveness of Vivostat patient-derived fibrin sealant in reducing blood loss in patients who underwent primary hip arthroplasty. Eighty adult patients undergoing elective surgery were randomized to receive either Vivostat sealant or control (no additional hemostatic treatment). Patients allocated Vivostat sealant donated 120 mL of blood, which was then processed perioperatively to produce a fibrin sealant that was applied to the bleeding wound surfaces just before closure. Transfusion requirements, blood loss during surgery, drain volumes, and daily hematocrit and hemoglobin levels were measured. Hospitalization times, adverse events, and postoperative wound complications were also monitored. Blood loss during surgery and wound drainage volume was lower in the Vivostat group than in the control group, although the differences were not significantly different. Transfusion requirements (median, 270 mL of packed red blood cells) and hospitalization times (both median 7 days) were the same for both groups. No adverse events related to the use of Vivostat occurred. There were indications of a possible reduction in the incidence of postoperative wound oozing (15% vs 25%) and hematomas (6% vs 11%) with the use of Vivostat compared with the control group, although differences were not statistically significant. In conclusion, in this pilot study, use of Vivostat patient-derived fibrin in hip arthroplasty was not associated with a significant reduction in blood loss. Further studies, with larger numbers of patients, may be warranted to investigate a possible benefit of Vivostat in reducing postoperative wound complications.

[Does aprotinin lessen intraoperative blood loss?].

The effect of an intravenous bolus of tranexamic acid on blood loss in total hip replacement.

Abstract: Tranexamic acid is a fibrinolytic inhibitor which reduces blood loss in total knee replacement. We examined the effect on blood loss of a standardised intravenous bolus dose of 1 g of tranexamic acid, given at the induction of anaesthesia in patients undergoing total hip replacement and tested the potential prothrombotic effect by undertaking routine venography. In all, 36 patients received 1 g of tranexamic acid, and 37 no tranexamic acid. Blood loss was measured directly per-operatively and indirectly post-operatively. Tranexamic acid reduced the early post-operative blood loss and total blood loss (p = 0.03 and p = 0.008, respectively) but not the intraoperative blood loss. The tranexamic acid group required fewer transfusions (p = 0.03) and had no increased incidence of deep-vein thrombosis. The reduction in early post-operative blood loss was more marked in women (p = 0.05), in whom this effect was dose-related (r = -0.793). Our study showed that the administration of a standardised pre-operative bolus of 1 g of tranexamic acid was cost-effective in reducing the blood loss and transfusion requirements after total hip replacement, especially in women.

The effect of desmopressin on blood loss in patients with rheumatoid arthritis undergoing hip arthroplasty.

Abstract:
Blood loss is an important issue for patients with rheumatoid arthritis undergoing hip surgery. We hypothesised that intraoperative desmopressin treatment would result in a reduction in blood loss in rheumatoid patients undergoing total hip arthroplasty.

Seventy-five patients scheduled for elective total hip arthroplasty were randomised to three groups to receive 0.4 microg/kg desmopressin (D 0.4), 0.2 microg/kg desmopressin (D 0.2) or placebo intraoperatively in a double-blind fashion. Blood transfusions were based on calculated safe allowable blood loss and haemoglobin measurements (trigger 90 g/l, 5.59 mmol/l). The primary endpoint was the total blood loss measured till the end of the fourth post-operative day. Secondary endpoints included red cell transfusion requirements and haemoglobin.

Total blood loss during the study period was not significantly different between the groups (D 0.4 1829 +/- 1068; D 0.2 2240 +/- 843 and placebo 2254 +/- 1040 ml; P= 0.50). The total amount of red cell transfusions was fewer in group D 0.4 (3.6 +/- 1.6 U) when compared with D 0.2 (4.4 +/- 1.7 U; P=0.009) and placebo (4.5 +/- 2.0 U; P= 0.011) groups. Haemoglobin concentration was lower in the placebo group in the first (5.42 +/- 1.16 vs. 5.98 +/- 0.47 mmol/l; P=0.033) and the second (6.28 +/- 0.66 vs. 6.69 +/- 0.47 mmol/l; P=0.033) post-operative mornings compared with group D 0.4.

Despite a lack of difference in the primary outcome, total blood loss, intraoperative administration of 0.4 microg/kg desmopressin resulted in fewer total red cell transfusion requirements in rheumatoid patients undergoing total hip arthroplasty when compared with 0.2 microg/kg treatment and placebo.

Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial.

Abstract:
Topical application of tranexamic acid to bleeding wound surfaces reduces blood loss in patients undergoing some major surgeries, without systemic complications. The objective of the present trial was to assess the efficacy and safety of the topical application of tranexamic acid on postoperative blood loss in patients undergoing primary unilateral total knee arthroplasty with cement.

In a prospective, double-blind, placebo-controlled trial, 124 patients were randomized to receive 1.5 or 3.0 g of tranexamic acid in 100 mL of normal saline solution or an equivalent volume of placebo (normal saline solution) applied into the joint for five minutes at the end of surgery. The primary outcome was blood loss calculated from the difference between the preoperative hemoglobin level and the corresponding lowest postoperative value or hemoglobin level prior to transfusion. The safety outcomes included Doppler ultrasound in all patients and measurement of plasma levels of tranexamic acid one hour after release of the tourniquet.

Twenty-five patients were withdrawn for various reasons; therefore, ninety-nine patients were included in the intention-to-treat analysis. The postoperative blood loss was reduced in the 1.5 and 3-g tranexamic acid groups (1295 mL [95% confidence interval, 1167 to 1422 mL] and 1208 mL [95% confidence interval, 1078 to 1339 mL], respectively) in comparison with the placebo group (1610 mL [95% confidence interval, 1480 to 1738 mL]) (p < 0.017). The postoperative hemoglobin levels were higher in the 1.5 and 3.0-g tranexamic acid groups (10.0 g/dL [95% confidence interval, 9.5 to 10.4 g/dL] and 10.1 g/dL [95% confidence interval, 9.8 to 10.5 g/dL], respectively) in comparison with the placebo group (8.6 g/dL [95% confidence interval, 8.2 to 9 g/dL]) (p < 0.017). With the numbers studied, there was no difference in the rates of deep-vein thrombosis or pulmonary embolism between the three groups. Minimal systemic absorption of tranexamic acid was observed.

At the conclusion of a total knee arthroplasty with cement, topical application of tranexamic acid directly into the surgical wound reduced postoperative bleeding by 20% to 25%, or 300 to 400 mL, resulting in 16% to 17% higher postoperative hemoglobin levels compared with placebo, with no clinically important increase in complications being identified in the treatment groups.


Context: Pilonidal sinus disease is a common and debilitating condition. Surgical treatment remains the mainstay for managing chronic disease, with options including midline and off-midline wound closure methods. However, the optimal approach remains uncertain. Recent developments in tension-free midline techniques require further exploration.

To assess the effects of midline and off-midline wound closure methods for pilonidal sinus, and to determine the optimal off-midline flap procedures.

We included parallel RCTs involving participants undergoing midline closure without flap techniques and off-midline closure for pilonidal sinus treatment. We excluded quasi-experimental studies and studies that enroled participants presenting with an abscess.

Treatment of pilonidal sinus by primary closure with a transposed rhomboid flap compared with deep suturing: a prospective randomised clinical trial.

Abstract:
To assess two techniques of primary closure after excision of pilonidal sinus.

Prospective randomised study.

University department of surgery, United Arab Emirates.

46 patients with chronic pilonidal sinus disease, 24 treated by rhomboid flap transposition, and 22 by deep suturing technique.

Early mobility and recurrence.

All patients in the rhomboid flap transposition group healed their wounds primarily compared with 17 in the primary deep suturing group (77%). (P = 0.02). Five patients wounds broke down as a result of haematoma and infection (23%). The mean hospital stay for the rhomboid flap technique was 6 days compared with 9 days after deep suturing, and the mean follow up for both groups was 18 months, the rhomboid flap group returned to work a mean of nine days earlier than the deep suturing group (23 days). No recurrence has been identified yet in the rhomboid flap group, while 2 recurrences have developed in the deep suturing group (9%).

Primary closure after excision of pilonidal sinus with a transposed rhomboid flap is successful in the management of pilonidal sinus and is superior to primary closure by deep suturing.

Randomized clinical trial comparing primary closure with the Limberg flap in the treatment of primary sacrococcygeal pilonidal disease.

Abstract:
The purpose of the study was to compare the outcome of excision and primary closure with that of rhomboid excision and the Limberg flap procedure in patients with primary sacrococcygeal pilonidal disease (SPD).

Two hundred consecutive patients with SPD were randomly allocated to undergo either excision and primary closure (group 1, n = 100) or rhomboid excision and the Limberg flap procedure (group 2, n = 100). Duration of operation, postoperative pain, time to first mobilization, length of hospital stay, postoperative complications, time to resumption of work, recurrence and time to recurrence were recorded for all patients.

: Duration of operation was longer in group 2 than in group 1 (P = 0.001). However, postoperative pain was less (P < 0.001), mobilization earlier (P < 0.001), duration of hospital stay shorter (P < 0.001), time to resumption of work shorter (P < 0.001) and postoperative complications fewer (P < 0.001) in group 2. During a median follow-up of 28 months, no recurrence was detected in patients in group 2 versus 11 patients in group 1 (P = 0.001).

Because of its low complication rate and acceptable long-term results, rhomboid excision and the Limberg flap procedure is preferable to simple excision and primary closure in the treatment of SPD.

Does technique alter quality of life after pilonidal sinus surgery?

Abstract:
Pilonidal sinus is a common disease in young adults that carries high postoperative morbidity and patient discomfort. Controversy still exists about the best surgical technique for the treatment of the disease in terms of recurrence rate and patient discomfort.

From January 2000 to November 2003, 100 consecutive age- and sex-matched patients with chronic pilonidal sinus disease were randomized to receive surgical treatment in the forms of either excision and primary closure or rhomboid excision and Limberg flap. Time to return to work and to complete healing were recorded. To evaluate quality of life and patient comfort, all patients were asked to complete a questionnaire including short form 36, Visual Analogue Scale, time to sitting on toilet without pain, and time to walking without pain 3 months after surgery.

Each group was composed of 50 patients. Mean follow-up was 19 months. There was a significant difference between the groups in terms of length of hospital stay (P=.005), time to complete healing (P<.001), time off work (P<.001), and wound infection rate (P=.03). Statistically significant differences were noted between the groups in items of general health perception (71.1+/-11.7 vs 78.2+/-14.1; P=.008), social functioning (87.3+/-32.8 vs 110.4+/-33.8; P=.001), and pain (54.5+/-14.0 vs 67.5+/-18.4; P<.001). Times to sitting on toilet and walking without pain showed significant differences between the groups (P=.006 and P<.001, respectively). The mean postoperative Visual Analogue Scale scores were 6.5+or= 1.7 and 7.4+/- 1.4, respectively (P<.001).

Shorter hospital stay, earlier healing, shorter time off work, lower ratio of complications, lower pain perception, and improved general health perception are the main advantages of te Limberg flap technique in pilonidal sinus surgery. All together, these parameters add to patient comfort and satisfaction after surgical treatment.

Multicenter prospective randomized trial comparing modified Limberg flap transposition and Karydakis flap reconstruction in patients with sacrococcygeal pilonidal disease.

Abstract:
There is still no consensus as to the optimal treatment for sacrococcygeal pilonidal disease (SPD). Many recommend off-midline closure, if any excisional procedure is to be selected.

The authors prospectively studied 145 patients with SPD who presented at 3 hospitals. Patients were randomly assigned to undergo either modified Limberg flap (MLF) transposition (n = 72) or Karydakis flap reconstruction (n = 73). Surgical findings, complications, recurrence rates, and degree of patient satisfaction, evaluated via a standardized telephone interview, were compared.

Operation time was longer in the MLF group. There were no significant differences between the two groups in terms of complication rate, length of stay, or recurrence rate. Patients in the Karydakis group reported feeling completely healed more quickly postoperatively. The two groups reported similar rates of satisfaction. Mandatory patient withdrawal from a given study arm because of the orifice straying from the midline occurred more frequently in the Karydakis group.

The MLF technique and the Karydakis procedure appear to generate comparable outcomes. With laterally situated orifices, however, the applicability of the Karydakis method may be limited.

Randomized comparison of Limberg flap versus modified primary closure for the treatment of pilonidal disease.

Abstract:
The best surgical technique for sacrococcygeal pilonidal disease is still controversial. The aim of this randomized prospective trial was to compare both the results of Limberg flap procedure and primary closure.

A total of 260 patients with sacrococcygeal pilonidal disease were assigned randomly to undergo Limberg flap procedure or tension-free primary closure.

Success of surgery was achieved in 84.62% of Limberg flap patients versus 77.69% of primary closure (P = .0793). Surgical time for primary closure was shorter. Wound infection was more frequent in the primary closure group (P = .0254), which experienced less postoperative pain (P < .0001). No significant difference was found in time off from work (P = .672) and wound dehiscence. Recurrence was observed in 3.84% versus 0% in the primary closure versus Limberg flap group (P = .153).

Our results do not show a clear benefit for surgical management by Limberg flap or primary closure. Limberg flap showed less convalescence and wound infection; our technique of tension-free primary closure was a day case procedure, less painful, and shorter than Limberg flap.

Superiority of asymmetric modified Limberg flap for surgical treatment of pilonidal disease.

Abstract:
Cases treated surgically using wide excision plus classic Limberg flap or wide excision plus asymmetric modified Limberg flap were compared with respect to complications and patient comfort in the postoperative period.

In this prospective, randomized study, 68 of 70 patients were followed for a mean of 29.22 (range, 6-44) months after wide excision plus classic Limberg flap (Group 1, n=35) and after asymmetric modified Limberg flap closure (Group 2, n=33).

There were significantly more macerations in Group 1 (P<0.001). All macerations were detected on the lower part of the incision left on the intergluteal sulcus, and infections occurred subsequent to maceration. The infection rate was statistically higher in Group 1 than in Group 2 (P=0.028). We noted that as a result of these complications, time to suture removal (P=0.001), discharge from hospital (P=0.001), and time off from work (P=0.001) were significantly longer for Group 1 than for Group 2. There were two recurrences in the inferior part of the suture line in Group 1 and none in Group 2, which showed no statistical difference (P=0.493).

The deep intergluteal sulcus and midline gap were slightly flattened over the anococcygeal region. The vacuum effect was decreased, and there were less macerations and fewer infections. Time off from work and discharge time from hospital were shortened by eliminating the moisture effect and reducing complications by lateralizing the lower part of the suture line.

Comparison of the short-term results after Limberg and Karydakis procedures for pilonidal disease: randomized prospective analysis of 100 patients.

Abstract:
The study was designed to compare the early postoperative results of the commonly used two surgical flap procedures in pilonidal disease: Karydakis and Limberg.

One hundred patients were randomized into two groups and standard Limberg or Karydakis procedures were performed. All had primary sinus orifices. Infected cases and the ones with secondary orifices over 2 cm distant from primary were excluded. Data were recorded concerning complications, need for analgesia and wound dressing, periods of time off work and off driving. Patients were asked to classify their first defecation manner after the operation and also pain according to a Visual Analogue Scale with range of 1-10.

There was a significantly higher wound infection rate in the Karydakis group than in the Limberg group (13/50 and 4/50 respectively). This also resulted in significantly higher values for wound dressings and need for analgesia. The time off work and off driving and also the Visual Analogue Scale scores were not significantly different between the two groups.

Both procedures can be safely performed in pilonidal disease with a standard length of stay in hospital and a similar loss of productive power. However, the Karydakis flap seems to have a significant higher infection rate and this probably increases the cost.

Short and long-term results of the Karydakis flap versus the Limberg flap for treating pilonidal sinus disease: a prospective randomized study.

Abstract:
Pilonidal sinus is a common disease that mostly affects young people. Although various surgical techniques have been described for treating sacrococcygeal pilonidal disease (SPD), controversy still exists as to the best surgical technique. The purpose of this study was to compare the efficiency and short-term and long-term results of the Karydakis flap with that of the Limberg flap for treating SPD.

In this prospective randomized study, 269 patients with SPD were recruited to undergo either the Karydakis flap (n = 135) or the Limberg flap (n = 134) procedure between September 2004 and September 2008.

The mean operative time for the Karydakis group (42.32 ± 8.64 minutes) was shorter than that for the Limberg group (50.14 ± 6.96 minutes) (P = .01). The complication rate for the Karydakis group (n = 15 [11.1%]) was lower than that for the Limberg group (n = 28 [20.8%]) (P = .029). The visual analogue scale score for postoperative pain at the operation site on the 30th day was lower in the Karydakis group than in the Limberg group (2.22 ± 1.01 vs 3.23 ± 1.14, P = .01). The visual analogue scale score for satisfaction with the cosmetic appearance of the scars in the Karydakis group was 7.08 ± 1.75, whereas it was 3.16 ± 1.40 in the Limberg group at the 3rd month (P = .01). Length of hospital stay was significantly shorter in the Karydakis group than in the Limberg group (3.40 ± .94 vs 3.8 ± 1.19 days, P = .03). Only 4 patients in the Karydakis group developed recurrence (3%), whereas 9 patients (6.9%) did so in the Limberg group (P = .151).

The Karydakis flap procedure should be chosen instead of the Limberg flap for treating uncomplicated SPD because of its lower postoperative complication rate, lower pain scores, shorter operation time and length of hospital stay, and good cosmetic satisfaction. However, no differences existed between the 2 surgical procedures in terms of recurrence prevention.

Comparison of modified Limberg flap and Karydakis flap operations in pilonidal sinus surgery: prospective randomized study.

Abstract: The best surgical technique for pilonidal sinus disease (PSD) is still disputed. The objective of this prospective randomized study is to compare the short and long-term results of modified Limberg flap and Karydakis flap surgeries that have been widely used in recent years. Ninety one patients were included in the study. The patients were divided into two groups: modified Limberg flap (MLF; n = 46) and Karydakis flap (KF; n = 45). Preoperative findings of the patients, their surgical findings, and short and long-term postoperative findings were recorded and statistically compared. While no significant difference was discovered between the groups in terms of postoperative analgesic need, hospital stay, postoperative infection rate, drain stay time, painless sitting time, painless toilet-sitting time, and painless walking time, return to work or school time was shorter in the MLF group compared with the KF group (20.61 ± 7.89 days, 23.29 ± 6.42, respectively; P < 0.05). Cosmetically, the visual analog scale (VAS) of the KF group was significantly higher than that of the MLF group (VAS score 7.12 ± 1.28, 5.45 ± 1.77, respectively; P < 0.05). Considering recurrence rates, no statistically significant difference was found between the groups. Our study found out that short and long-term results of the MLF and KF procedures are similar. We believe both methods can be safely used in surgical PSD treatment given that in the MLF procedure, shorter return-to-work time is achieved, while the procedure provides better cosmetic results.

Early results with the Mutaf technique: a novel off-midline approach in pilonidal sinus surgery.

Abstract:
The objective of the present study was to compare different off-midline techniques in terms of their advantages and disadvantages.

A total of 81 patients were included in this prospective, controlled, randomized study. Patients in group 1 were treated with the Limberg flap, and patients in group 2 were treated with Mutaf technique. Patients were followed up for 9 months postsurgically and assessed at regular intervals.

A total of 41 and 40 patients received surgical treatment with Limberg or Mutaf techniques, respectively. The 2 groups were similar in terms of age, gender, body mass index, and Tezel pilonidal sinus classification. Also, the 2 groups were comparable with regard to the frequency of preoperative discharge from the wound site, history of abscess formation, and the resultant antibiotic use. Early results showed similar recurrence rates and surgical-site complications between the 2 groups. Although a lower visual analogue scale score was found in group 2 at postoperative day 1, seroma persistence, time to withdrawal of surgical drains, and wound healing were more prolonged.

In this study, Mutaf technique was comparable to Limberg flap in the treatment of pilonidal sinus. Therefore, Mutaf technique may be offered as a viable surgical therapeutic option among off-midline closure approaches.


Context: Clinical practice guidelines recommend testosterone replacement therapy (TRT) for men with sexual dysfunction and testosterone deficiency. However, TRT is commonly promoted in men without testosterone deficiency and existing trials often do not clearly report participants' testosterone levels or testosterone-related symptoms. This review assesses the potential benefits and harms of TRT in men presenting with complaints of sexual dysfunction.

To assess the effects of testosterone replacement therapy compared to placebo or other medical treatments in men with sexual dysfunction.

We included randomized controlled trials (RCTs) in men (40 years or over) with sexual dysfunction. We excluded men with primary or secondary hypogonadism. We compared testosterone or testosterone with phosphodiesterase-5 inhibitors (PDEI5I) to placebo or PDE5I alone.

Dehydroepiandrosterone in the treatment of erectile dysfunction: a prospective, double-blind, randomized, placebo-controlled study.

Abstract:
In 1994, the Massachusetts Male Aging Study presented an inverse correlation of the serum levels of dehydroepiandrosterone (DHEA) and the incidence of erectile dysfunction (ED). We evaluated the efficacy of DHEA replacement in the treatment of ED in a prospective, double-blind, randomized, placebo-controlled study.

The inclusion criteria included ED, normal physical and neurologic examinations, serum levels of testosterone, dihydrotestosterone, prolactin, and prostate-specific antigen (PSA) within the normal range, and a serum DHEA sulfate level below 1.5 micromol/L. Also all patients had a full erection after a pharmacologic erection test with 10O microg prostaglandin E1; pharmacocavernosography showed no visualization in corporeal venous structures. Forty patients from our impotence clinic were recruited and randomly divided into two groups of 20 patients each. Group 1 was treated with an oral dose of 50 mg DHEA and group 2 with a placebo one time a day for 6 months. The International Index of Erectile Function (IIEF), a 15-item questionnaire, was used to rate the success of this therapy.

Therapy response was defined as the ability to achieve or maintain an erection sufficient for satisfactory sexual performance according to the National Institutes of Health Consensus Development Panel on Impotence. DHEA treatment was associated with higher mean scores for all five domains of the IIEF. There was no impact of DHEA treatment on the mean serum levels of PSA, prolactin, testosterone, the mean prostate volume, and the mean postvoid residual urine volume.

Our results suggest that oral DHEA treatment may be of benefit in the treatment of ED. Although our patient data base is too small to do relevant statistical analysis, we believe that our data show a biologically obvious trend that justifies further extended studies.

The effects of transdermal dihydrotestosterone in the aging male: a prospective, randomized, double blind study.

Abstract: The objective of the study was to investigate the effects of dihydrotestosterone (DHT) gel on general well-being, sexual function, and the prostate in aging men. A total of 120 men participated in this randomized, placebo-controlled study (60 DHT and 60 placebo). All subjects had nocturnal penile tumescence once per week or less, andropause symptoms, and a serum T level of 15 nmol/liter or less and/or a serum SHBG level greater than 30 nmol/liter. The mean age was 58 yr (range, 50-70 yr). Of these subjects, 114 men completed the study. DHT was administered transdermally for 6 months, and the dose varied from 125-250 mg/d. General well-being symptoms and sexual function were evaluated using a questionnaire, and prostate symptoms were evaluated using the International Prostate Symptoms Score, transrectal ultrasonography, and assay of serum prostate-specific antigen. Early morning erections improved transiently in the DHT group at 3 months of treatment (P < 0.003), and the ability to maintain erection improved in the DHT group compared with the placebo group (P < 0.04). No significant changes were observed in general well-being between the placebo and the DHT group. Serum concentrations of LH, FSH, E2, T, and SHBG decreased significantly during DHT treatment. Treatment with DHT did not affect liver function or the lipid profile. Hemoglobin concentrations increased from 146.0 +/- 8.2 to 154.8 +/- 11.4 g/liter, and hematocrit from 43.5 +/- 2.5% to 45.8 +/- 3.4% (P < 0.001). Prostate weight and prostate-specific antigen levels did not change during the treatment. No major adverse events were observed. Transdermal administration of DHT improves sexual function and may be a useful alternative for androgen replacement. As estrogens are thought to play a role in the pathogenesis of prostate hyperplasia, DHT may be beneficial, compared with aromatizing androgens, in the treatment of aging men.

AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function.

Abstract: Testosterone replacement in hypogonadal men improves body composition, mood, and sexual functioning. In this 90-d study, we compared the pharmacokinetics and treatment effectiveness of a topical testosterone gel (AA2500) at two concentrations, 50 mg/d and 100 mg/d, to a testosterone patch and placebo gel in 406 hypogonadal men. Pharmacokinetic profiles were obtained, body composition was measured, and mood and sexual function were monitored. AA2500 treatments resulted in dose-dependent improvements in all pharmacokinetic parameters, compared with testosterone patch and placebo. Mean average concentrations at d 90 T were 13.8, 17.1, 11.9, and 7.3 nmol/liter for 50 mg/d AA2500, 100 mg/d AA2500, testosterone patch, and placebo, respectively. At d 90, the 100 mg/d AA2500 treatment improved lean body mass by 1.7 kg and percentage of body fat by 1.2% to a significantly greater degree than either control treatment. Significant improvements in spontaneous erections, sexual desire, and sexual motivation were also evidenced with the 100 mg/d AA2500 dose in comparison with placebo. Testosterone gel was well tolerated; however, the testosterone patch resulted in a high rate of application site reactions. Overall, AA2500 is an effective, well tolerated treatment for hypogonadism.

Testosterone supplementation in men with type 2 diabetes, visceral obesity and partial androgen deficiency.

Abstract: The objective of this study was to assess the effects of oral testosterone supplementation therapy on glucose homeostasis, obesity and sexual function in middle-aged men with type 2 diabetes and mild androgen deficiency. Forty-eight middle-aged men, with type 2 diabetes, (visceral) obesity and symptoms of androgen deficiency, were included in this open-label study. Twenty-four subjects received testosterone undecanoate (TU; 120 mg daily, for 3 months); 24 subjects received no treatment. Body composition was analyzed by bio-impedance. Parameters of metabolic control were determined. Symptoms of androgen deficiency and erectile dysfunction were scored by self-administered questionnaires. TU had a positive effect on (visceral) obesity: statistically significant reduction in body weight (2.66%), waist-hip ratio (-3.96%) and body fat (-5.65%); negligible changes were found in the control group. TU significantly improved metabolic control: decrease in blood glucose values and mean glycated hemoglobin (HbA1c) (from 10.4 to 8.6%). TU treatment significantly improved symptoms of androgen deficiency (including erectile dysfunction), with virtually no change in the control group. There were no adverse effects on blood pressure or hematological, biochemical and lipid parameters, and no adverse events. Oral TU treatment of type 2 diabetic men with androgen deficiency improves glucose homeostasis and body composition (decrease in visceral obesity), and improves symptoms of androgen deficiency (including erectile dysfunction). In these men, the benefit of testosterone supplementation therapy exceeds the correction of symptoms of androgen deficiency and also includes glucose homeostasis and metabolic control.

Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone.

Abstract:
We compare the efficacy of testosterone gel (T-gel) versus placebo as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone.

A randomized, placebo controlled, double-blind, parallel group, multicenter study was performed. A total of 75 hypogonadal men (18 to 80 years old, morning serum total testosterone 400 ng/dl or less) with confirmed lack of response to sildenafil monotherapy were randomized (1:1) to receive a daily dose of 1% T-gel or 5 gm placebo gel as adjunctive therapy to 100 mg sildenafil during a 12-week period. Subjects were evaluated for sexual function, primarily based on the International Index of Erectile Function (IIEF), quality of life and serum testosterone levels at baseline and weeks 4, 8 and 12.

Testosterone treated subjects had greater improvement in erectile function compared to those who received placebo, reaching statistical significance at week 4 (4.4 vs 2.1, p = 0.029, 95.1% CI 0.3, 4.7). Similar trends were observed for improvements in orgasmic function, overall satisfaction, total IIEF score and percentage of IIEF responders. T-gel significantly (p < or =0.004) increased total and free testosterone levels throughout the study, although no significant correlations were made between testosterone levels and the IIEF at end point.

T-gel taken with sildenafil may be beneficial in improving erectile function in hypogonadal men with erectile dysfunction who are unresponsive to sildenafil alone.

Restorative increases in serum testosterone levels are significantly correlated to improvements in sexual functioning.

Abstract: It is recognized that testosterone (T) levels decrease in men with age, as does sexual function. We hypothesize that T supplementation in hypogonadal men with sexual dysfunction will restore certain elements of sexual function. Hypogonadal male subjects (total T < or = 300 ng/dL, n = 406, mean age 58 years) reporting one or more symptoms of low testosterone were randomized to T gel (50 mg/d and 100 mg/d), T patch, or placebo. Twenty-four-hour pharmacokinetic profiles for T were obtained. The 3 primary end points evaluated at 30 and 90 days posttreatment included a significant change in the frequency of intercourse and nighttime erections per 7-day week as well as a change in sexual desire measured on a Likert-type scale and calculated as a mean daily score. At day 30, a significant increase from baseline in sexual desire was noted for those on 100 mg/d T gel compared with those on 50 mg/d T gel, T patch, or placebo (1.2 vs 0.4, 0.7, and 0.4, respectively). A significant increase from baseline in the frequency of nighttime erections was also noted for those on 100 mg/d T gel compared with those on 50 mg/d T gel or placebo (51% of subjects in the 100 mg/d T gel group had an increase in frequency vs 30% for the 50 mg/d T gel group and 26% in the placebo group). Finally, a significant increase from baseline in the frequency of intercourse was evidenced for those on 100 mg/d T gel compared with those on T patch or placebo (39% of subjects in the 100 mg/d T gel group had an increase in frequency vs 21% for the T patch group and 24% in the placebo group). Similar results were seen for 100 mg/d T gel at day 90 for sexual desire and nighttime erections vs placebo. These data demonstrate a clear relationship between restoring serum T concentrations and improvement in certain parameters of sexual function. We propose that threshold T levels are needed in order to significantly affect improvements in sexual functioning.

Effect of 12 month oral testosterone on testosterone deficiency symptoms in symptomatic elderly males with low-normal gonadal status.

Abstract:
Relative androgen deficiency in ageing males is assumed to have adverse health effects. This study assessed the effect of 12 months' standard dose, oral testosterone, on symptoms attributed to testosterone deficiency in older men with plasma testosterone levels in the low-normal range for young men.

Testosterone undecanoate (TU, 80 mg bid) or placebo was administered for one year to 76 healthy men, 60 years or older, with a free testosterone index (FTI) of 0.3-0.5 and significant symptoms on a questionnaire designed to evaluate androgen deficiency (ADAM). The ADAM was completed at baseline, 6 and 12 months. Hormone and safety data were collected at baseline, 1, 3, 6 and 12 months.

After 12 months, plasma total testosterone was unchanged in both groups and sex hormone binding globulin decreased in the testosterone group (P = 0.01). FTI and calculated bioavailable testosterone (cBT) were greater in the testosterone group as compared with the placebo group (P = 0.021 and 0.025, respectively). There was no significant difference in total symptom score between testosterone and placebo groups after 12 months of oral TU. However, there were trends toward improvements in sadness/grumpiness (P = 0.063), reduced erection strength (P = 0.059) and decreased work performance symptoms (P = 0.077), particularly in men with baseline cBT levels below 3.1 nmol/l.

This study concludes that 80 mg bid oral TU does not improve overall ADAM questionnaire scores in older men with low-normal gonadal status. Oral TU may preserve mood and erectile function, as assessed by this questionnaire, particularly in men with the lowest testosterone levels.

Difficulties in measuring the effect of testosterone replacement therapy on muscle function in older men.

Abstract: Muscle wasting in older men may be related to androgen deficiency. We have assessed the effect of testosterone replacement therapy on muscle function in the upper and lower limbs of older (age > 60 years) men with blood testosterone levels < 14 nmol/L. Subjects (n = 7 per group) received testosterone enanthate 200 mg i.m. or placebo every 2 weeks in a double blind study over a 12-week period and underwent muscle testing every 4 weeks. A significant increase in blood levels of testosterone and a reduction in levels of sex hormone binding globulin occurred in the treatment group. Total body mass, haemoglobin and packed cell volume also increased significantly (p < 0.05). No improvements in handgrip strength, isometric strength of knee flexors and extensors or leg extensor power were seen in either group. Wide variability in all measures of muscle function were observed in these elderly men suggesting that very large study groups would be required to determine potential treatment benefits on muscle function.

Testosterone improves rehabilitation outcomes in ill older men.

Abstract:
To determine whether testosterone supplementation improves rehabilitation outcomes in ill older men.

A randomized, placebo-controlled, double-blind study.

A Geriatric Evaluation and Management (GEM) unit based at a university- affiliated Veterans Affairs Medical Center.

Fifteen men aged 65 to 90 years admitted to the GEM for rehabilitation.

Subjects were randomized to receive weekly intramuscular injections with testosterone enanthate 100 mg or placebo.

Task-specific performance using the Functional Independence Measure (FIM) and grip strength was measured at the onset of the study and at the time of discharge from the GEM.

At baseline, FIM scores were similar between the placebo and the testosterone group (73.7 vs 70.7, P = .637), as was grip strength (49.7 vs 55.3 pounds, P = .555). At discharge from the GEM, testosterone-treated patients had improved FIM scores compared with baseline (93.6 vs 70.7; P = .012) and grip strength (68.7 vs 55.3 pounds; P = .033). In the placebo group there was no significant improvement of FIM scores compared with baseline (78.0 versus 73.7; P = .686) or of grip strength (48.9 vs 49.7 pounds; P = .686).

Testosterone supplementation may improve rehabilitation outcomes in ill older men.

Effects of anabolic precursors on serum testosterone concentrations and adaptations to resistance training in young men.

Abstract: The effects of androgen precursors, combined with herbal extracts designed to enhance testosterone formation and reduce conversion of androgens to estrogens was studied in young men. Subjects performed 3 days of resistance training per week for 8 weeks. Each day during Weeks 1, 2, 4, 5, 7, and 8, subjects consumed either placebo (PL; n = 10) or a supplement (ANDRO-6; n = 10), which contained daily doses of 300 mg androstenedione, 150 mg DHEA, 750 mg Tribulus terrestris, 625 mg Chrysin, 300 mg Indole-3-carbinol, and 540 mg Saw palmetto. Serum androstenedione concentrations were higher in ANDRO-6 after 2, 5, and 8 weeks (p <.05), while serum concentrations of free and total testosterone were unchanged in both groups. Serum estradiol was elevated at Weeks 2, 5, and 8 in ANDRO-6 (p <.05), and serum estrone was elevated at Weeks 5 and 8 (p <.05). Muscle strength increased (p <.05) similarly from Weeks 0 to 4, and again from Weeks 4 to 8 in both treatment groups. The acute effect of one third of the daily dose of ANDRO-6 and PL was studied in 10 men (23 +/- 4 years). Serum androstenedione concentrations were elevated (p <.05) in ANDRO-6 from 150 to 360 min after ingestion, while serum free or total testosterone concentrations were unchanged. These data provide evidence that the addition of these herbal extracts to androstenedione does not result in increased serum testosterone concentrations, reduce the estrogenic effect of androstenedione, and does not augment the adaptations to resistance training.


Context: Rates of asthma are high in children and adolescents, and young people with asthma generally report poorer health outcomes than those without asthma. Young people with asthma experience a range of challenges that may contribute to psychological distress. This is compounded by the social, psychological, and developmental challenges experienced by all people during this life stage. Psychological interventions (such as behavioural therapies or cognitive therapies) have the potential to reduce psychological distress and thus improve behavioural outcomes such as self-efficacy and medication adherence. In turn, this may reduce medical contacts and asthma attacks.

To determine the efficacy of psychological interventions for modifying health and behavioural outcomes in children with asthma, compared with usual treatment, treatment with no psychological component, or no treatment.

We included randomised controlled trials (RCTs) comparing psychological interventions of any duration with usual care, active controls, or a waiting-list control in male and female children and adolescents (aged five to 18 years) with asthma.

Health effects of written emotional disclosure in adolescents with asthma: a randomized, controlled trial.

Abstract:
To test the effects of written emotional disclosure on the health of adolescents with asthma and to examine how language in disclosures predicts outcomes.

We randomized 50 adolescents with asthma to write for 3 days at home about stressful events (disclosure) or control topics. At baseline and 2 months after writing, we assessed symptoms, affect, disability, internalizing behavior problems, and lung function; parents independently rated internalizing behavior and disability.

Compared with control writing, disclosure writing led to improved positive affect and internalizing problems. Disclosure also decreased asthma symptoms and functional disability among adolescents with baseline elevations of these difficulties. Lung function was not changed. Disclosures with more negative emotion, insight, and causal words--and increased causal or insight words over days--predicted improved health.

Written emotional disclosure improves emotional and behavioral functioning among adolescents with asthma, particularly those whose writings suggest emotional processing and cognitive restructuring.

Feasibility and impact of a school-based intervention for families of urban adolescents with asthma: results from a randomized pilot trial.

Abstract: The purpose of this study was to test the feasibility and short-term outcomes of Asthma: It's a Family Affair!, a school-based intervention for adolescents with asthma and their caregivers. Twenty-four ethnic minority families with a middle school student with asthma were randomized to immediate intervention or no-treatment control. Intervention students received six group sessions on prevention and management of asthma. Caregivers received five group sessions teaching child-rearing skills to support the youth's autonomy and asthma self-management. All students attended all sessions; caregivers attended an average of three. Two months post-intervention, relative to controls, intervention caregivers reported better problem-solving with children. Intervention students were more responsible for carrying medication, took more prevention steps, and woke fewer nights from asthma. The intervention resulted in positive short-term changes in family relations, asthma management by students, and health status.

Effect of relaxation-breathing training on anxiety and asthma signs/symptoms of children with moderate-to-severe asthma: a randomized controlled trial.

Abstract:
Emotional stress triggers and exacerbates asthma in children. Reducing anxiety in adults by relaxation-breathing techniques has been shown in clinical trials to produce good asthma outcomes. However, more evidence is needed on using this intervention with asthmatic children.

To evaluate the effectiveness of combined self-management and relaxation-breathing training for children with moderate-to-severe asthma compared to self-management-only training.

Two-group experimental design.

Pediatric outpatient clinic of a medical center in central Taiwan. Participants were 48 children, ages 6-14 years, with moderate-to-severe asthma and their parents.

Participants were randomly assigned to an experimental or comparison group and matched by gender, age, and asthma severity. Both groups participated in an asthma self-management program. Children in the experimental group were also given 30 min of training in a relaxation-breathing technique and a CD for home practice. Data on anxiety levels, self-perceived health status, asthma signs/symptoms, peak expiratory flow rate, and medication use were collected at baseline and at the end of the 12-week intervention. Effects of group, time, and group-time interaction were analyzed using the Mixed Model in SPSS (12.0).

Anxiety (especially state anxiety) was significantly lower for children in the experimental group than in the comparison group. Differences in the other four physiological variables were also noted between pre- and post-intervention, but these changes did not differ significantly between groups.

A combination of self-management and relaxation-breathing training can reduce anxiety, thus improving asthmatic children's health. These results can serve as an evidence base for psychological nursing practice with asthmatic children.

Hypnosis for asthma--a controlled trial. A report to the Research Committee of the British Tuberculosis Association.

Abstract: An investigation of hypnosis in asthma was made among patients aged 10 to 60 years with paroxysmal attacks of wheezing or tight chest capable of relief by bronchodilators. One group of patients was given hypnosis monthly and used autohypnosis daily for one year. Comparisons were made with a control group prescribed a specially devised set of breathing exercises aimed at progressive relaxation. Treatment was randomly allocated and patients were treated by physicians in nine centres. Results were assessed by daily diary recordings of wheezing and the use of bronchodilators, and by monthly recordings of F.E.V.(1) and vital capacity. At the end of the year independent clinical assessments were made by physicians unaware of the patients' treatment.There were 252 patients (127 hypnosis and 125 controls) accepted for analysis, but a number of them did not continue the prescribed treatment for the whole year: 28 hypnosis and 22 control patients failed to co-operate, left the district, or had family problems; one hypnosis and one control patient died. Seven hypnosis and 17 control patients were withdrawn as treatment failures, the difference between the two groups being statistically significant.As judged by analyses based on the daily "score" of wheezing recorded in patients' diaries, by the number of times bronchodilators were used, and by independent clinical assessors, both treatment groups showed some improvement Among men the assessments of wheezing score and use of bronchodilators showed similar improvement in the two treatment groups; among women, however, those treated by hypnosis showed improvement similar to that observed in the men, but those given breathing exercises made much less progress, the difference between the two treatment groups reaching statistical significance. Changes in F.E.V.(1) and V.C. between the control and hypnosis groups were closely similar.Independent clinical assessors considered the asthma to be "much better" in 59% of the hypnosis group and in 43% of the control group, the difference being significant There was little difference between the sexes. Physicians with previous experience of hypnosis obtained significantly better results than did those without such experience.

A randomized, controlled trial of a community-based support program for families of children with chronic illness: pediatric outcomes.

Abstract:
Children with chronic illnesses have a heightened risk for mental health problems.

To develop, implement, and evaluate child outcomes of a 15-month, community-based, family-support intervention designed to reduce risk for poor adjustment and mental health problems in children with 1 of 4 chronic illnesses (diabetes mellitus, sickle cell anemia, cystic fibrosis, or moderate to severe asthma) and their mothers.

Randomized, controlled clinical trial design with multiple measures of mental health based on both child and parent reports taken 1 year apart.

Community-based intervention linked to subspecialty and general pediatric clinics and practices in Baltimore, Md.

One hundred thirty-six mothers and children aged 7 to 11 years with diabetes mellitus, sickle cell anemia, cystic fibrosis, or moderate to severe asthma.

The program, provided by "experienced mothers" and child life specialists, included telephone contacts, face-to-face visits, and special family events.

Outcomes were measured using the following instruments: the Personal Adjustment and Role Skills Scale III, the Children's Depression Inventory, the Revised Children's Manifest Anxiety Scale, and the Self-Perception Profile for Children.

The experimental group's mean adjustment score increased over the intervention period while the control group's mean adjustment score decreased. Analysis of variance demonstrated that the intervention had a significant main effect on postintervention adjustment controlling for baseline scores (P =.01). Using a cutoff score indicating maladjustment, the percentage of experimental group children in the maladjustment range fell from 19% at baseline to 10% after the intervention; the percentage of control group children in the maladjustment range rose from 15% at baseline to 21% after the intervention. The effect of the intervention was more pronounced for children who had low physical self-esteem than for those who had moderate to high physical self-esteem at the beginning of the program.

Our results demonstrate modest positive effects of a family support intervention in promoting the adjustment of children with selective chronic health conditions. Including child life specialists in a community-based intervention may be especially salient for children with chronic illnesses who have low physical self-esteem. The intervention had a similar outcome for all diagnostic groups, suggesting that it could be effective for children with any chronic illness and implemented in a variety of pediatric settings.

Children with asthma have improved pulmonary functions after massage therapy.

Abstract: Thirty-two children with asthma (16 4- to 8-year-olds and 16 9- to 14-year-olds) were randomly assigned to receive either massage therapy or relaxation therapy. The children's parents were taught to provide one therapy or the other for 20 minutes before bedtime each night for 30 days. The younger children who received massage therapy showed an immediate decrease in behavioral anxiety and cortisol levels after massage. Also, their attitude toward asthma and their peak air flow and other pulmonary functions improved over the course of the study. The older children who received massage therapy reported lower anxiety after the massage. Their attitude toward asthma also improved over the study, but only one measure of pulmonary function (forced expiratory flow 25% to 75%) improved. The reason for the smaller therapeutic benefit in the older children is unknown; however, it appears that daily massage improves airway caliber and control of asthma.

Asthma severity, psychophysiological indicators of arousal, and immune function in asthma patients undergoing biofeedback-assisted relaxation.

Abstract: Asthma is characterized by airway hyper-responsiveness, inflammation, and reversible obstruction. Respiratory tract infection, allergies, air pollution, and psychosocial factors impact the severity and frequency of asthma symptoms. Pharmacotherapy and self-care are the major components in the management of asthma, but behavioral interventions also have the potential to affect asthma morbidity. We conducted a small, randomized controlled study, examining the effects of biofeedback-assisted relaxation in 16 nonsmokers with nonsteroid-dependent mild asthma. Data were collected on asthma symptoms, pulmonary function, indicators of arousal, and cellular immune factors. The trained group evidenced a decrease in forehead muscle tension in comparison to the controls, but no changes in peripheral skin temperature. Decreases in asthma severity and bronchodilator medication usage for the experimental group were observed. Pulmonary function testing revealed a significant difference between groups in FEV1/FVC at posttest, with the E group having a higher ratio than the controls. The cellular immune data showed no significant group differences in total white blood cell or lymphocyte counts, but decreases over time were observed. Significant differences were observed in the numbers of neutrophils and basophils in the trained group compared to controls, which supports the concept of decreased inflammation. Results of delayed-type hypersensitivity skin testing suggested enhanced function, but they were not conclusive. These findings, though limited by size of population, suggest a positive effect of biofeedback-assisted relaxation in young, nonsteroid-dependent asthmatics. The mechanisms underlying linkages between psychological, behavioral, and immune responses in asthma require further study.

Controlled trial of hypnosis in the symptomatic treatment of asthma.

Behaviour therapy in bronchial asthma: a controlled study.

Excessive breathlessness through emotional imagery in asthma.

Abstract: Breathlessness and negative emotions during asthma attacks interact in complex patterns. This study tested the influence of emotional imagery on breathlessness during voluntary breath holding. Adolescents with and without asthma (n = 36 + 36) were assigned to positive imagery, negative imagery, or no imagery. There were four trials with close to thresholds for breath holding combined with imagery. Breathlessness and quality of imagery were measured by the end of breath holding. Additional measures were lung function and anxiety. The results showed that positive and negative imagery were only influencing breathlessness in participants with asthma. Although threshold duration for the groups were not significantly different, participants with asthma reported more breathlessness. The intensity of imagery enhanced breathlessness but diminished the accuracy of symptom perception. Positive imagery diminished breathlessness in participants with asthma, but also the difference in breathlessness between 75% and 95% of threshold duration. Breathlessness did not correlate with lung function, anxiety or other variables. It was concluded that emotional imagery during asthma attacks distracts from accurate introspection or enhances breathlessness, irrespective of anxiety.