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Differential effects of maternal betamethasone and cortisol on lung maturation and growth in fetal sheep.

OBJECTIVES: We asked whether maternal or fetal cortisol treatments induced fetal lung maturation and growth restriction compared with betamethasone and whether medroxyprogesterone (MPA) influenced lung maturation. STUDY DESIGN: Pregnant sheep were randomized to receive MPA or saline solution at 100 days of gestation. At 117 days of pregnancy, ewes were randomized to receive maternal or fetal treatments with 0.5 mg/kg betamethasone, four injections of hydrocortisone given over 4.5 hours or saline solution. Body weight and lung maturation were evaluated at 125 days. RESULTS: Maternal betamethasone decreased in birth weight by 16% and induced lung maturation. Fetal cortisol or betamethasone induced only lung maturation. Maternal cortisol caused neither growth restriction nor lung maturation. MPA did not alter lung function in control lambs or in betamethasone-treated preterm lambs. CONCLUSIONS: Maternal cortisol treatments had no apparent effects on the fetus, suggesting that growth restriction caused by betamethasone may result from unidentified effects on the maternal-placental unit.

Animals↗

Systemic administration of betamethasone delays endotoxin-induced preterm labor in the murine model.

OBJECTIVE: The purpose of this study was to determine whether the administration of betamethasone decreases the endotoxin-induced preterm parturition rate and inhibits the risk of cytokines in the murine model. STUDY DESIGN: Endotoxin was administered intraperitoneally at gestational day 15 (75% of gestation). In phase I, the duration of gestation was measured in 36 gravid C3H/HeOu mice that were equally divided into four treatment groups: control, endotoxin only, and two different dose regimens of betamethasone followed by endotoxin. In phase II, maternal serum and amniotic fluid concentrations of cytokines (interleukin-1alpha, tumor necrosis factor-alpha, and interleukin-6) were measured at 4 hours after endotoxin injection in 44 gravid mice divided equally in the four treatment groups. RESULTS: The group that was exposed only to endotoxin was delivered at a significantly earlier gestational age compared with the control group (16.2 +/- 0.4 days vs 19.6 +/- 0.2 days; P <.01). The two groups that were pretreated with betamethasone before the endotoxin were delivered at gestational ages similar to the control group. There was a marked increase of tumor necrosis factor-alpha and interleukin-6 levels in amniotic fluid of mice that were treated with endotoxin only compared with the control group (P <.001). No difference in cytokine levels was found in those mice that were premedicated with betamethasone compared with the control group. CONCLUSION: Antenatal administration of betamethasone to mice delayed preterm parturition that was induced by endotoxin. Elevations of amniotic fluid cytokine concentrations that were observed with endotoxin were not observed with pretreatment with betamethasone.

Amniotic Fluid↗

Betamethasone effects on chorioamnionitis induced by intra-amniotic endotoxin in sheep.

OBJECTIVE: Intra-amniotic administration of endotoxin in sheep is a model of subclinical chorioamnionitis. Intrauterine inflammation alters lung development to improve postnatal lung function and may predispose the infant to lung and brain injury. We describe the effects of intra-amniotic endotoxin on cytokines and white cell responses in the membranes and amniotic fluid and investigate the hypothesis that betamethasone treatment suppresses these responses. STUDY DESIGN: Pregnant ewes were allocated at random to receive either intra-amniotic saline solution (control animals), maternal intramuscular betamethasone, intra-amniotic endotoxin by ultrasound guidance (10 mg Escherichia coli 055:B5), or a combination of the betamethasone and endotoxin treatments. Lambs were delivered abdominally at 110 to 125 days of gestation at time points that ranged from 2 hours to 15 days after treatment. RESULTS: When compared with saline solution-injected control animals, the intra-amniotic injection of endotoxin increased white cell counts in amniotic fluid. Levels of interleukin-8, but not interleukin-6, were significantly increased in amniotic fluid from 5 hours to 15 days after intra-amniotic endotoxin injection, and interleukin-8 levels were not decreased by concurrent treatment with betamethasone. After endotoxin treatment, interleukin-1beta and interleukin-8 messenger RNA were expressed in chorion, and interleukin-6 messenger RNA expression was localized to chorionic blood vessel epithelium. The half-life of endotoxin in the amniotic fluid was 1.7 days, and levels remained measurable 15 days after injection. CONCLUSION: These findings confirm that the fetus can survive within amniotic fluid that contains endotoxin, white cells, and cytokines for periods of weeks or more. Betamethasone treatment can suppress the initial inflammation in the amnion-chorion, but interleukin-8 levels and inflammatory cells in amniotic fluid were not suppressed 5 and 15 days after betamethasone treatment, presumably because of the slow clearance of bioactive endotoxin from the amniotic fluid.

Amnion↗

Calcitriol shows greater persistence of treatment effect than betamethasone dipropionate in topical psoriasis therapy.

OBJECTIVE: To establish the efficacy and duration of remission post-treatment of calcitriol 3 micro g/g ointment in comparison with betamethasone dipropionate 0.05% ointment. METHODS: A randomized, multicentre trial was conducted in 258 adult patients with chronic plaque psoriasis. Calcitriol 3 microg/g ointment or betamethasone dipropionate 0.05% ointment was applied twice daily for 6 weeks or until complete clearance of lesions. Patients whose psoriasis cleared or were significantly improved and did not require treatment continuation at treatment endpoint were contacted over the following 8 weeks to determine whether relapse had occurred. RESULTS: Both treatments were efficacious; improvement in psoriasis or clearance of lesions (residual erythema was allowed) was recorded for 79% and 82% of patients receiving calcitriol or betamethasone dipropionate, respectively. Global improvement and global severity scores at treatment endpoint showed statistically significant differences in favour of betamethasone dipropionate (p<0.05); however, the absolute reduction in mean PASI (psoriasis area and severity index) was comparable between the groups. A statistically significantly (p<0.01) higher proportion of responders remained in remission (no worsening of the disease warranting new treatment) following calcitriol therapy (48%) than betamethasone therapy (25%). This is of potential importance to patients, physicians and healthcare suppliers. CONCLUSION: Twice-daily applications of either calcitriol 3 microg/g ointment or betamethasone dipropionate 0.05% ointment can be used to good effect in the treatment of chronic plaque psoriasis. However, the beneficial effect is likely to persist for longer following calcitriol treatment.

Administration, Cutaneous↗

Interaction between betamethasone and vecuronium.

A possible interaction between betamethasone and vecuronium was examined in 20 rat phrenic nerve-hemidiaphragm preparations. Ten preparations were bathed in a physiological solution with betamethasone 1 mumol litre-1 added and, after a 30-min period were exposed to vecuronium at concentrations of 4, 6, 8 and 10 mumol litre-1 with vecuronium free washings between each exposure. Ten control experiments were performed also using a betamethasone-free bathing solution. In comparison with control, the betamethasone group had significantly (P = 0.0008) less depression of muscle contraction (twitch) force at all concentrations of vecuronium. The calculated ED50 (50% depression of muscle contraction force) was 5.65 mumol litre-1 for controls and 7.39 mumol litre-1 for betamethasone-pretreated preparations. This study confirms our previous clinical observations that an interaction occurs between vecuronium and betamethasone which is characterized by resistance to neuromuscular block.

Animals↗

The effect of antenatal betamethasone on cord blood concentrations of retinol-binding protein, transthyretin, transferrin, retinol, and vitamin E.

We assessed the effect of short-term (less than or equal to 1 week) and prolonged (greater than 1 week) exposure to antenatal betamethasone on umbilical cord serum concentrations of retinol-binding protein (serum t 1/2 = 12 h), transthyretin (t 1/2 = 2 days), transferrin (t 1/2 = 8 days), retinol (vitamin A), and vitamin E in appropriate-for-gestational-age preterm newborn infants of less than 36 weeks' gestation. A group of 30 infants whose mothers received a single course of betamethasone less than or equal to 1 week prior to delivery had significantly elevated mean retinol-binding protein and transthyretin but not transferrin concentrations when compared with a group of 30 gestational age- and birth weight-matched infants with no exposure to antenatal betamethasone. A group of eight infants whose mothers received multiple (more than two) weekly courses of betamethasone prior to delivery had significantly elevated mean serum concentrations of all three proteins when compared with eight gestational age- and weight-matched control infants with no betamethasone exposure. Serum retinol and vitamin E concentrations were measured in a group of 21 infants exposed to short-term prenatal betamethasone and were significantly greater than in a group of 21 control infants without steroid exposure. We conclude that antenatal steroids increase the umbilical cord serum concentrations of retinol-binding protein, transthyretin, transferrin, retinol, and vitamin E. The effect on the various serum proteins is dependent on the duration of exposure to steroids.

Betamethasone↗

Pimecrolimus cream 1% vs. betamethasone 17-valerate 0.1% cream in the treatment of seborrhoeic dermatitis. A randomized open-label clinical trial.

BACKGROUND: Seborrhoeic dermatitis is a chronic inflammatory disease with remissions and exacerbations, characterized by erythema, scaling and pruritus primarily on the face, scalp and chest. Corticosteroids and antifungals are the mainstay of therapy. However, chronic use of corticosteroids is associated with side-effects such as skin atrophy and telangiectasia. Pimecrolimus, an inhibitor of calcineurin, has been used successfully in one patient with seborrhoeic dermatitis. OBJECTIVES: The objective of this randomized open-label clinical trial was to compare the efficacy and tolerability of pimecrolimus in comparison with a potent corticosteroid (betamethasone 17-valerate) in the treatment of seborrhoeic dermatitis. METHODS: Twenty patients with seborrhoeic dermatitis were included in this study, 11 patients in the pimecrolimus 1% cream group and nine patients in the betamethasone 17-valerate 0.1% cream group. Patients were instructed to use a thin layer of the study products twice daily at the lesional area and to discontinue treatment as soon as symptoms were absent. Clinical measures assessed were erythema, scaling and pruritus which were evaluated using a four-point scale (0-3). RESULTS: Both pimecrolimus and betamethasone were highly effective in the treatment of seborrhoeic dermatitis. Betamethasone reduced all three parameters, erythema, scaling and pruritus, faster than pimecrolimus, but the differences in reduction were not statistically significant. Relapses were observed more frequently and were more severe with betamethasone than with pimecrolimus. Moreover, pruritus was not observed after discontinuation of treatment from day 15 and beyond in the pimecrolimus group, whereas it was reported in most patients of the betamethasone group. This difference was statistically significant. CONCLUSIONS: It appears that pimecrolimus, a nonsteroidal topical treatment, may be an excellent alternative therapeutic modality for treating seborrhoeic dermatitis.

Administration, Cutaneous↗

Non-linear changes of electrocortical activity after antenatal betamethasone treatment in fetal sheep.

We determined the effects of betamethasone on the fetal sheep electrocorticogram (ECoG) using linear (power spectral) and non-linear analysis. For non-linear analysis we used an algorithm based on the Wolf algorithm for the estimation of the leading Lyapunov exponent which calculates a prediction error based on the course of the time series in the phase space. A high prediction error stands for low predictibility or low regularity and vice versa. After 48 h of baseline recordings, vehicle (n = 6) or betamethasone (n = 7) at 10 microg h(-1) was infused over 48 h to the sheep fetus at 128 days gestational age (0.87 of gestation). ECoG spectral analysis revealed no difference in power spectrum between vehicle- and betamethasone-treated fetuses. The prediction error of the ECoG during REM sleep was higher than during non-REM or quiet sleep in both groups (P < 0.0001) revealing lower causality of brain activity during REM sleep. During REM sleep, prediction error significantly decreased 18-24 h after onset of betamethasone treatment (P < 0.05) and returned to baseline values within the following 24 h of continued betamethasone treatment. No ECoG changes were found during quiet sleep. Non-linear ECoG changes during metabolically active REM sleep accompanied the previously described decrease in cerebral blood flow. These results suggest that betamethasone in doses used in perinatal medicine acutely alters complex neuronal activity.

Algorithms↗

Pharmacokinetic interaction studies of atosiban with labetalol or betamethasone in healthy female volunteers.

OBJECTIVES: In two separate trials, we studied the concomitant administration of atosiban with labetalol and betamethasone to determine any possibility of a clinically relevant pharmacokinetic interaction. DESIGN: Study 1 was an open-label, single dose atosiban, multiple dose labetalol, interaction study. Study 2 was an open-label, randomised, three-period crossover pharmacokinetic study. SETTING: The studies were carried out at the Clinical Pharmacology Unit of AAI Deutschland GmbH & Co KG, Neu-Ulm, Germany. POPULATION: The study population consisted of healthy female volunteers. METHODS: In Study 1, 14 healthy female volunteers participated. On study day 1, a 12-hour intravenous infusion of 114.75 mg atosiban was administered; on days 2-4, participants received labetalol orally (100 mg twice daily), and on study day 5 they received the combined treatment. In Study 2, a total of 18 healthy female volunteers received, on three separate occasions, a 12-hour intravenous infusion of 114.75 mg atosiban, a single intramuscular injection of 12 mg betamethasone or the two drugs in combination. MAIN OUTCOME MEASURE: For Study 1, the outcome parameter for atosiban was area under the plasma concentration-time curve (AUC); the study parameters for labetalol were AUC, maximum plasma concentration (C(max)) and time to C(max) (t(max)). In Study 2, AUC, C(max) and time to C(max) (t(max)) were assessed for atosiban and betamethasone. RESULTS: Labetalol had no clinically relevant influence on the bioavailability (AUC) of atosiban. For labetalol, the co-administration with atosiban did not affect the extent of bioavailability, however, C(max) decreased by 36% and t(max) increased by 45 minutes. The C(min) was not affected by atosiban. The betamethasone and atosiban combination led to similar mean plasma concentration-time curves as the administration of each substance alone. Pharmacokinetic parameters (AUC, C(max), t(max)) did not differ markedly between treatments and all 90% CIs for ratios between treatments were fully within limits (80-125%). The co-administration of atosiban with labetalol or betamethasone resulted in similar tolerability to each substance alone. CONCLUSION: The co-administration of atosiban with betamethasone or labetalol had no clinically relevant influence on their bioavailability or tolerability.

Adult↗

Transient immunologic effects of betamethasone in human pregnancy after suppression of preterm labor.

Maternal immune suppression is a potentially significant adverse effect when betamethasone is used to hasten lung maturation of the fetus at risk for preterm delivery. However, increased incidence of infection has not been observed consistently after betamethasone treatment of pregnant women. This study was designed to determine if the cellular immune response to steroids may be modified during pregnancy in a way that would diminish the infection risk associated with steroid treatment. The effect of betamethasone on immunocytes among patients with preterm labor or in nonpregnant subjects were determined following administration of 12 mg of betamethasone intramuscularly. We measured serially the circulating leukocytes, lymphocytes, T lymphocytes, and their subsets. Measurements were also made of localized leukocyte mobilization to serum-filled skin chambers covering experimental inflammatory sites. Patients in preterm labor had increased WBC counts prior to treatment with betamethasone but no additional leukocytosis was induced nor was mobilization of leukocytes to the skin chambers decreased. Lymphopenia and depression of T cells was more transient among pregnant patients compared to nonpregnant. Thus, the pregnant patients studied had diminished or more transient potentially adverse immunocyte responses to betamethasone as compared to nonpregnant subjects.

Betamethasone↗

Cardiac effects of a single course of antenatal betamethasone in preterm infants.

AIM: To show the effects of a single course of antenatal betamethasone on cardiac measurements and systolic functions in premature newborn infants. METHODS: Seventy six newborn infants with a gestational age of 25-33 weeks were included in the study. They were first classified according to their gestational age: 25-29 weeks (n = 28) and 30-33 weeks (n = 48). They were then reclassified as betamethasone positive (mother received one course of betamethasone) or betamethasone negative (mother did not receive any antenatal glucocorticoid treatment). Cross sectional M mode echocardiographic scans were performed during the first three postnatal days and at the end of the first and third weeks. Left interventricular septum (IVS), left ventricular posterior wall (LVPW), left ventricular end diastolic (LVED), and left ventricular end systolic (LVES) dimensions, aortic root (AO), and left atrial diameters (LAs) were measured. The IVS to LVPW ratio was calculated to identify asymmetrical septal hypertrophy. RESULTS: In neither group was any statistically significant difference noted in IVS, LVED, LVES, LVPW, LA, and AO measurements during the three cardiac ultrasonography scans. Systolic function, as assessed by fractional shortening, was not significantly different in infants who received betamethasone antenatally, in either age group. There was no difference in the IVS/LVPW ratios between those who received antenatal steroid and those who did not for the 25-29 week and 30-33 week groups during these three consecutive scans. CONCLUSION: One course of antenatal betamethasone did not affect the cardiac wall thicknesses and systolic function in premature infants.

Aging↗

Study of the tolerance of infliximab infusions with or without betamethasone premedication in patients with active rheumatoid arthritis.

OBJECTIVES: To assess the incidence of infusion reactions in patients with rheumatoid arthritis (RA) receiving infliximab treatment with and without betamethasone premedication. To determine whether patients with an atopic diathesis had a better response to corticosteroid pretreatment than those without, and the course of patients' functional capacity and quality of life. PATIENTS AND METHODS: A prospective, multicentre, randomised, double blind phase 4 study of 355 patients with RA in two groups: group A received betamethasone and group B placebo, before a 36 week infusion treatment with infliximab. Incidence and severity of infusion reactions from infliximab treatment were assessed. RESULTS: The incidence of reactions to infliximab infusion was <5%. More infusion reactions occurred with betamethasone pretreatment than with placebo. Response to infliximab of patients with atopic backgrounds did not differ in the presence or absence of betamethasone from that of non-atopic patients. Mean Health Assessment Questionnaire score improved by 47% at week 24, quality of life assessed by Short Form-36 improved in mental and physical component subscales. CONCLUSIONS: Incidence of infusion reactions with infliximab was low and their severity generally mild, but betamethasone pretreatment did not decrease the incidence and severity of infusion reactions. Betamethasone, therefore, is not recommended as a systematic prophylactic measure, even in atopic patients.

Adult↗

Effect of betamethasone on airway obstruction and bronchial response to salbutamol in prednisolone resistant asthma.

Twelve patients with chronic severe asthma, having previously shown an FEV1 increase of less than 20% of the predicted value with prednisolone treatment (20-60 mg daily for 10 days), took part in a double blind crossover comparison of equipotent anti-inflammatory doses of betamethasone and prednisolone. Betamethasone (8 mg) and prednisolone (40 mg) were administered daily for 10 days with a washout period of 10 days between. In this first part of the study betamethasone was administered intramuscularly and prednisolone orally. Placebo injections and tablets were used. Mean FEV1 was not significantly different before each period. There was a significant increase in FEV1 while they were taking betamethasone but not prednisolone. Individual analysis of the data showed that FEV1 increased with betamethasone in nine patients and remained stable or decreased in three. During treatment with prednisolone baseline FEV1 increased moderately in three patients (FEV1 0.3, 0.5 and 0.6 l) and remained stable or decreased in nine. There was no significant difference between the bronchodilator responses to cumulative doses of inhaled salbutamol when they were measured immediately before, on the last day of treatment with each steroid, and between steroid treatment periods. The same protocol was followed four months later in five of the 12 patients but both drugs were administered orally on this occasion. Similar results were obtained. The greater effect of betamethasone on bronchial obstruction may be due to its longer biological half life or to some unidentified property of its metabolites. The bronchial response to inhaled beta 2 agonist appears not to be influenced by either steroid in these patients.

Adult↗

Prenatal betamethasone exposure results in pituitary-adrenal hyporesponsiveness in adult sheep.

Fetal exposure to synthetic glucocorticoids in sheep results in increased fetal hypothalamic-pituitary-adrenal (HPA) activity persisting to one year of age. We aimed to determine the effects of single or repeated maternal or fetal betamethasone injections on offspring HPA activity at 2 and 3 yr of age and whether changes in adrenal mediators of steroidogenesis contribute to changes in pituitary-adrenal function. Pregnant ewes or their fetuses received either repeated intramuscular saline or betamethasone injections (0.5 mg/kg) at 104, 111, 118, and 124 days of gestation (dG) or a single betamethasone injection at 104 dG followed by saline at 111, 118, and 124 dG. Offspring were catheterized at 2 and 3 yr of age and given corticotrophin-releasing hormone + arginine vasopressin challenges. Adrenal tissue was collected for quantitative RT-PCR mRNA determination at 3.5 yr of age. In 2-yr-old offspring, maternal betamethasone injections did not alter basal ACTH or cortisol levels, but repeated injections elevated ACTH responses. At 3 yr of age, basal ACTH was elevated, and both basal and stimulated cortisol levels were suppressed by repeated maternal injections. Basal and stimulated cortisol-to-ACTH ratios and basal cortisol-to-cytochrome P-450 17alpha-hydroxylase (P450c17) mRNA ratios were suppressed by repeated injections. Repeated fetal betamethasone injections attenuated basal ACTH and cortisol levels in offspring at 2 but not 3 yr of age. Plasma changes were not associated with altered adrenal P450c17, ACTH receptor, beta-hydroxysteroid dehydrogenase, or glucocorticoid receptor mRNA levels. These data suggest that maternal, but not fetal, betamethasone administration results in adrenal suppression in adulthood.

11-beta-Hydroxysteroid Dehydrogenase Type 2↗

Effect of betamethasone on Na-K-ATPase activity and basal and lateral cell membranes in proximal tubular cells during early development.

The mechanism by which betamethasone induces Na-K-ATPase activity in developing tissue was studied in homogenates of proximal tubular cells from 10-day-old rats. A significant increase in Na-K-ATPase activity occurred after 5 micrograms . 100 g-1 . 12 h-1 X 2 beta-methasone and a maximal increase after 15-60 micrograms . 100 g-1 . 12 h-1 X 2. Following a single dose of 60 micrograms . 100 g-1 betamethasone Na-K-ATPase activity increased significantly after 16 h and maximally after 24-30 h. The 16-h time lag suggests that betamethasone does not act only directly on Na-K-ATPase synthesis. Betamethasone 60 micrograms . 100 g-1 increases Na-K-ATPase activity significantly in kidneys in which glomerular filtration rate is reduced by ureteral ligation, but the increase is significantly less pronounced than in kidneys with intact ureters, suggesting that the induction is not mediated only by alterations in sodium supply. Twenty-four hours after 10-60 micrograms . 100 g-1 betamethasone there was no significant increase in glucose-6-phosphatase and Mg-ATPase activity in 10-day-old rats or in Na-K-ATPase activity in 40-day-old rats. The basal and lateral cell membranes of the proximal tubular cells were not significantly increased 24 h after 60 micrograms . 100 g-1 betamethasone. Accordingly, structural development is not a prerequisite for enzymatic differentiation.

Aging↗

Comparison of intramuscular betamethasone and oral prednisone in the prevention of relapse of acute asthma.

OBJECTIVE: To compare the relapse rate after a single intramuscular injection of a long acting corticosteroid, betamethasone, with oral prednisone in patients discharged from the emergency department (ED) for acute exacerbations of asthma. PATIENTS AND METHODS: Patients with acute exacerbations of asthma who were suitable for discharge from the ED were enrolled in a double-blind, randomized, placebo controlled pilot study. At discharge, patients were randomly assigned to receive either intramuscular betamethasone 12 mg and placebo capsules, or a placebo intramuscular injection and prednisone 50 mg daily for seven days. At days 7 and 21, patients were contacted by telephone to determine relapse. Relapse was defined as an unscheduled visit to a physician for treatment of continuing or worsening symptoms of asthma. RESULTS: One hundred and seventy-one patients were enrolled, of whom 87 were randomly assigned to the betamethasone group and 84 to the prednisone group. Baseline characteristics were matched evenly between the groups, with the exception of asthma duration (15.5 versus 21.2 years, respectively) and use of inhaled corticosteroids (46% versus 64.3% respectively) (P<0.05). Using intention-to-treat analysis, the relapse rates for betamethasone and prednisone at day 7 were 14.9% (13 of 87 patients) and 25% (21 of 84 patients), respectively (P=0.1), and at day 21, the rates were 36.8% (32 of 87 patients) and 31% (26 of 84 patients), respectively (P=0.4). There were no differences in symptom score, peak flows and adverse effects between the two groups at days 7 and 21. CONCLUSIONS: A single dose of intramuscular betamethasone 12 mg was safe and as efficacious as prednisone in preventing the relapse of acute asthma. There was a trend toward a reduced relapse rate at seven days. In select ED patients discharged for acute asthma, intramuscular betamethasone may be an effective alternative to prednisone.

Acute Disease↗

A prospective, double-blind, randomized clinical trial comparing subacromial injection of betamethasone and xylocaine to xylocaine alone in chronic rotator cuff tendinosis.

BACKGROUND: Rotator cuff tendinosis is a common problem with significant health and economic effects. Nonoperative management includes the widespread use of subacromial steroid injections despite the lack of evidence of its efficacy. HYPOTHESIS: A subacromial injection of betamethasone will be more effective than xylocaine alone in improving the quality of life, impingement sign, and range of motion in patients who have chronic rotator cuff tendinosis or partial rotator cuff tears. STUDY DESIGN: Randomized controlled clinical trial; Level of evidence, 1. METHODS: Patients with rotator cuff tendinosis or partial cuff tear with symptoms longer than 6 months, with failure of 6 weeks of physical therapy and 2 weeks of nonsteroidal anti-inflammatory drugs, who were older than 30 years of age, and who showed >50% improvement with the Neer impingement test were stratified for Workplace Safety and Insurance Board status and previous injection. Outcome measures--the Western Ontario Rotator Cuff Index; American Shoulder and Elbow Surgeons standardized form; Disabilities of the Arm, Shoulder and Hand; active forward elevation; active internal rotation; active external rotation; and the Neer impingement sign--were assessed at 2, 6, 12, and 24 weeks after injection. The injection into the subacromial space contained either 5 mL of 2% xylocaine alone or 4 mL of 2% xylocaine and 1 mL (6 mg) of betamethasone in an opaque syringe. RESULTS: In 58 patients (betamethasone group, n = 30; xylocaine group, n = 28), the authors found no statistically significant difference between the 2 treatment groups for all outcomes and time intervals. The scores for the Western Ontario Rotator Cuff Index at 3 months were xylocaine = 45.4% +/- 13% and betamethasone = 56.3% +/- 17% (P = .13). At 6 months, the scores were xylocaine = 51% +/- 32% and betamethasone = 59% +/- 26% (P = .38). All other outcomes showed similar values. As well, similar results were found for 2 and 6 weeks after injection. Both groups showed improvement from baseline in all outcomes. CONCLUSIONS: With the numbers available for this study, the authors found betamethasone to be no more effective in improving the quality of life, range of motion, or impingement sign than xylocaine alone in patients with chronic rotator cuff tendinosis for all follow-up time intervals evaluated.

Anesthetics, Local↗

Maternal glucocorticoid in unplanned premature labor. Controlled study on the effects of betamethasone phosphate on the phospholipids of the gastric aspirate and on the adrenal cortical function of the newborn infant.

The effects of betamethasone on surfactant composition and neonatal adrenal function were compared with placebo in a double-blind study, which included 74 patients at risk for premature delivery. The overall incidence of respiratory distress syndrome was low, and no differnce was observed between the betamethasone and placebo groups. The phospholipid pattern (lecithin/sphingomyellin ratio, acetone precipitated lecithin, phosphatidylinositol/sphingomyelin ratio, and phosphatidylglycerol/sphingomyelin ratio) from gastric aspirates of newborn infants was similar in the betamethasone and placebo groups, suggesting a similarity in lung surfactant. The responsiveness of the adrenal cortex of the newborn infants, evaluated by a 2-hr adrenocorticotropic hormone test at the age of 24 hr, did not differ between infants whose mothers had received either betamethasone or placebo. The low incidence of respiratory distress syndrome in the betamethasone and placebo groups was ascribed in part to a high incidence of prolonged rupture of fetal membranes. Our results do not exclude the possibility that antenatal maternal administration of betamethasone could prevent respiratory distress syndrome in other defined high-risk infants.

Adrenal Cortex↗