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1 Single-dose studies were conducted to investigate the relative potency of prednisolone and betamethasone in suppressing adrenocortical function. 2 Betamethasone produced more profound suppression of plasma cortisol than an equivalent anti-inflammatory dose of prednisolone.
Twenty patients with psoriasis were treated with the vitamin D3 analogue MC903 and betamethasone ointment in a double-blind trial with a left-right comparison. In addition to the clinical severity scores, Ks8.12 binding which detects keratin 16 expression and the DNA synthesis were quantified using flow cytometry. Both markers decreased significantly with treatment, but remained above the normal range even in those who had total clearance of the lesions. Treatment with MC903 with regard to Ks8.12 binding was significantly better than with betamethasone.
Topical betamethasone-17-valerate inhibits the vasodilatation response to local non-pathological heating of rat skin. We have shown that this effect can also be demonstrated in man. Topical betamethasone-17-valerate significantly inhibited the increase in human forearm cutaneous blood flow in response to heat of 44 degrees C, as measured by laser-Doppler velocimetry. This suggests that the effects of topical steroids upon skin blood flow in the rat and in man are similar, and supports the use of the animal model as a paradigm for studying human skin blood flow, and changes in response to anti-inflammatory steroids.
BACKGROUND: Psoriasis is a common disease and may have a significant impact on patients' quality of life (QoL). OBJECTIVES: To assess the impact on QoL of a new two-compound product (TCP) (Daivobet/Dovobet; LEO Pharma) which combines the topical vitamin D analogue calcipotriol (50 microg g(-1)) and the World Health Organization group III corticosteroid betamethasone dipropionate (0.5 mg g(-1)) in a single ointment vs. calcipotriol monotherapy using a placebo-controlled study design. METHODS: The Psoriasis Disability Index and the EuroQoL 5D questionnaire and visual analogue scale (VAS) were used in this study, which enrolled 828 patients with psoriasis vulgaris for treatment lasting up to 4 weeks. These QoL instruments were completed by patients before and after treatment with the TCP of calcipotriol and betamethasone dipropionate used once or twice daily, calcipotriol alone twice daily and vehicle twice daily. RESULTS: The TCP used once or twice daily and calcipotriol used twice daily were found to have statistically significant beneficial effects on patients' QoL over the course of treatment, and each was demonstrated to have a statistically significant benefit on QoL over vehicle. The TCP, applied once daily, was superior to calcipotriol twice daily in terms of reductions on the EuroQoL 5D questionnaire and VAS. CONCLUSIONS: The results suggest that calcipotriol twice daily and the new TCP applied twice daily have a substantial effect on QoL. Once-daily application of the TCP is superior to calcipotriol twice daily terms of QoL, which reflects the superior efficacy of this combination and the advantage of once-daily application when compared with twice-daily application.
A double-blind trial of the topically active corticosteroid, betamethasone valerate in aerosol form, in the control of chronic asthma is reported. The results show that this is an extremely effective therapeutic agent in non-steroid dependent but nonetheless moderately severe asthmatics. Patients were well controlled on 800 mug of betamethasone valerate daily and control was maintained over a 12-month period. This form of treatment has few undersirable side effects but there is probably an increased incidence of oropharyngeal and laryngeal candidiasis. In particular, adrenocortical suppression was not noted.
Disk-shaped adhesive tablets, for treatment of mouth lesions, were prepared by direct compression of a mix of high viscosity sodium carboxymethyl-cellulose and 0.061% betamethasone valerate. They were evaluated in six healthy volunteers. The tablets hydrated rapidly, increased their wet weight fourfold in 15 min and maintained contact with the oral mucosa for at least 4 h. Erosion of the tablets was variable with only minor losses in one subject at all times tested, whereas over 80% tablet weight loss occurred in two subjects after 2.5 h. These differences were not solely related to differences in salivary flow. Loss of betamethasone occurred in parallel with the loss of weight from the tablet suggesting that drug release was mainly by erosion of the gelled polymer and not by diffusion from the matrix. The tablets provided prolonged contact with the mucosa but the intersubject variability and drug loss should be addressed to improve the formulation.
In a double-blind group comparative study, 36 adult, birch pollen-allergic outpatients with seasonal rhinoconjunctivitis, were treated with either oral prednisolone 7.5 mg daily for 3 weeks or an injection with 2 ml suspension of betamethasone dipropionate and betamethasone disodium phosphate (Diprospan) immediately prior to the birch pollen season. Both treatments were able to prevent an increase in symptoms from the nose and the eyes during the 3-week birch pollen season. There was no significant difference in symptom score or nasal peak flow between the two treatments. However, there was a significant suppression of adrenal gland function after oral prednisolone treatment in contrast to Diprospan treatment. Unless there are contraindications for treatment with depot steroid injections (children, pregnant women, patients suffering from peptic ulcer, tuberculosis, eye disease, herpes, hypertension or diabetes) it seems to be a reasonable alternative to oral prednisolone in hay fever patients.
A double-blind, double-dummy comparative study was made of 30 adult birch pollen-allergic outpatients with seasonal rhinoconjunctivitis. They were treated with either topically applied beclomethasone dipropionate 100 micrograms in each nostril twice daily for 4 weeks, placebo, or an injection of 2 ml of a suspension containing 5 mg betamethasone dipropionate and 2 mg betamethasone disodium phosphate per ml (Diprospan) immediately prior to the birch pollen season. Placebo- and topical steroid-treated patients experienced an increase in rhinoconjunctivitis symptoms, i.e. nasal blockage, nasal itching, rhinorrhea, sneezing and eye symptoms, and placebo-treated patients used significantly more antihistamine tablets during the pollen season. Diprospan-treated patients experienced fewer symptoms on all measured parameters. We concluded that one injection of Diprospan immediately prior to the birch pollen season produces significantly fewer rhinoconjunctivitis symptoms than does placebo and topical steroid treatment.
An attempt was made to determine whether or not the steroid hormones, aldosterone and betamethasone, increased the Na-K-ATPase activity and the surface density of baso-lateral cell membranes in the juxtamedullary proximal convoluted tubules of young and adult mice. The results showed that aldosterone and betamethasone increase the enzyme activity in young mice but not in adult mice. However, the surface density of the baso-lateral cell membranes did not increase either in the young or in the adult mice. Further, the induction ratio for the Na-K-ATPase activity did not differ between the two hormone-treated groups in young mice. The results suggest that a difference in hormone sensitivity exists between the proximal convoluted tubular cells of young mice and those of adult mice.
A case of leukemoid reaction in a premature baby whose mother was antenatally treated by betamethasone is reported. The neonatal and maternal factors which might lead to leukocytosis or leukemoid reaction were excluded. The presented case is the last in a series of eight previously reported cases of leukemoid reaction, in which the common denominator was the antenatal administration of betamethasone.
1. Both the circadian and stress-induced changes in plasma corticosterone concentration were abolished by the inclusion of betamethasone in the drinking water of rats.2. Adrenal sensitivity to exogenous corticotrophin (ACTH) was unimpaired by the betamethasone treatment.3. The normal circadian rhythm in plasma corticosterone returned within 1 day of withdrawal of the steroid, but the response to stress was normal only after 3 days.4. The possible significance of these observations is discussed.
1. The effects of ether stress on noradrenaline (NA) and dopamine levels in different regions of the rat brain were studied. 2. Exposure to ether vapour (90 s) caused a significant decrease in the concentration of hypothalamic NA but had no effect on catecholamine (CA) concentrations in the other regions studied. 3. Treatment with betamethasone alone (20 microgram/ml) given in the drinking water for 24 h, had no effect on CA levels in the cerebral cortex, midbrain or hypothalamus. However, pretreatment with this dose of steroid prevented the decreases in hypothalamic NA which were normally seen after ether stress and also induced significant increases in the concentration of midbrain NA. 4. The data provide further support for the involvement of NA in the regulation stress-induced corticotrophin (ACTH) release and indicate that centres other than the hypothalamus may be involved in mediating the inhibitory action of betamethasone on the response to ether stress.
In this study, betamethasone was found to significantly inhibit the binding of immunoglobulin-coated O Rh-positive red cells to fetal macrophages. At a dose of 0.15 mg%, betamethasone depressed immune rosette formation to 44% of controls (p less than 0.01); and a dose of 0.60 mg% resulted in an average depression to 22%. This in vitro effect may reflect important alterations in in vivo immune function in infants delivered from mothers who have received antenatal corticosteroids.
The white blood cell counts of 84 premature infants were included in a retrospective study of 45 infants treated antenatally with betamethasone and 39 non-treated infants. A significant increase in neutrophil and immature neutrophil forms was found in the treated group when the drug was administered to the mother close to delivery. This effect lasted for three days. Afterwards, although the counts were not significantly high compared to the control group, their physiological decrease was delayed. This study indicates that the known stimulating effect of steroids on total leukocyte and neutrophil counts in adult humans and fetal lambs, also occurs in premature infants. This fact supports recent reports which propose the antenatal maternal administration of betamethasone as a cause of leukemoid reaction or leukocytosis after birth.
The penetration of betamethasone 17-valerate and fusidic acid through dog skin was measured in vitro. In order to detect the small amounts of diffused compounds, a liquid chromatography-mass spectrometric method was developed with sensitivity limits for both compounds of 5 ng/ml. After application to the skin surface of a topical gel preparation containing these compounds at the anticipated therapeutic dose rate, about 10 per cent of the betamethasone 17-valerate penetrated the skin over a 24-hour period, with no significant metabolism of the ester. About 1.3 per cent of the applied dose of fusidic acid was similarly recovered. The results demonstrated rapid penetration of both compounds through the epidermis.
Maternal plasma progestagen concentrations increase about 20 days before parturition. The major contributors to the increase are reduced metabolites (ie 5 alpha-pregnanes). Precocious increases (ie less than 310 days of gestation) in these metabolites may occur in abnormal pregnancies. The effects of CRH, ACTH or betamethasone administered to the foetus at gestational ages ranging from about 250 to 320 days were examined. Sixteen healthy pony mares were used for foetal injection employing aseptic techniques. Water or normal saline were used as controls. Maternal plasma progestagen concentrations were measured using a commercial radioimmunoassay (RIA) progesterone kit and results were confirmed using gas chromatography-mass spectrometry (GC-MS). Results demonstrated clearly that an increase in maternal plasma progestagen concentrations occurred after injection of ACTH, CRH or betamethasone to the foetus, irrespective of gestational age. A comparable increase was not observed in the control animals. Of the 16 mares in which the foetus was injected, 13 produced viable foals at gestational ages ranging from 307 to 339 days whereas 3 mares delivered non-viable foals at 284 to 306 days gestation. The results support the hypothesis that the pre-parturient rise in progestagens occurring in the mare is the result of foetal adrenocortical activity.
The effects of 1 gold salt, of betamethasone, and of acetylsalicylate on the chemotaxis of human neutrophils were compared in normal volunteers by means of a modified Boyden chamber. The gold salt inhibited chemotaxis by reducing both cell migration capacity and the capacity of plasma to attract the cell. Betamethasone reduced cell migration capacity, but not the chemoattractant capacity of plasma. Acetylsalicylate had no effect on these functions.
The aim of this double-blind randomised prospective study was to assess the effect of subconjunctival Betnesol (betamethasone sodium phosphate 0.1%) on the recovery of the blood aqueous barrier (BAB) following cataract surgery in uncomplicated eyes. Twenty patients [10 male, mean age 71.4 (SD 12.7) years] admitted for routine cataract surgery were randomised into two groups. All patients recruited into the study were free of other ocular disease and were not taking any anti-inflammatory medication. Group A received a subconjunctival injection of cefuroxime (125 mg) alone while group B received a subconjunctival injection of both cefuroxime and Betnesol. All surgery was performed by a single surgeon using a standardised surgical technique and all patients received the same postoperative medication. The Kowa laser flare cell meter was used to measure aqueous flare and cells preoperatively and on the first, second, and seventh postoperative day, and at 1 and 3 months following surgery. The code was broken only after all patients had been followed-up for 3 months postoperatively. There was no significant difference between the two groups in aqueous flare and cells at any of the postoperative visits. In this study we were unable to demonstrate any beneficial effect of subconjunctival betamethasone on damage to and recovery of the BAB following cataract surgery in the uncomplicated eye.