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A clinical study of the prophylactic use of betamethasone valerate and sodium cromoglycate in the treatment of seasonal allergic rhinitis.

The prophylactic use of betamethasone valerate and sodium cromoglycate in seasonal allergic rhinitis has been investigated in 20 patients in an open study. The subjective assessment of the symptoms recorded on a daily record card was significantly lower in the betamethasone valerate group compared with the sodium cromoglycate group. Patients' and physician's overall assessment of the treatment favoured the steroid aerosol. No clinically significant side effects were noted.

Aerosols↗

The response of psoriasis to betamethasone valerate and clobetasol propionate. A 6-month controlled study.

Twelve patients with symmetrical psoriasis were studied for a period of 6 months. Clobetasol propionate 0-05% ointment was applied to the lesions on one side and betamethasone valerate 0-1% ointment to those on the other side as a double-blind controlled trial of these two treatments. All the patients showed a relative improvement on the side treated with clobetasol propionate. Clobetasol propionate-treated lesions tended to clear for longer than the corresponding betamethasone valerate treated lesions. The condition of five of the patients was better at the end of the study period than at the beginning.

Adult↗

Six-month controlled study of effect of desoximetasone and betamethasone 17-valerate on the pituitary-adrenal axis.

Twenty-two patients were treated with desoximetasone emollient cream 0.25% twice daily without occlusion for 6 months. Patients applied the medication to approximately one-third of their body over psoriatic lesions. Corticosteroid plasma cortisol values decreased to below normal limits in nine patients before the 6-month study was terminated. In four of these the plasma cortisol spontaneously returned to normal despite therapy; in four other patients, however, the plasma cortisol was still suppressed at the end of 5 months of continual therapy but returned to normal within 7 days of discontinuation of the medication. In one patient, lost to further follow-up at 5 1/2 months of therapy, the trend at the fourth month was an increase in plasma cortisol to within one unit of normal range. Betamethasone 17-valerate 0.1% cream applied twice daily did not suppress plasma cortisol in twenty-three patients similarly tested. The clinical response to desoximetasone emollient cream was significantly better than to betamethasone valerate cream. This study closely approximates the way in which many patients with steroid-responsive dermatoses use potent topical steroids, namely over a long time period and without occlusion.

Adolescent↗

The combined use of betamethasone valerate and sodium cromoglycate in the treatment of asthma.

A double-blind comparison of betamethasone valerate, sodium cromoglycate and the combination of these two treatments was carried out in twenty-two adult patients with asthma. Regular fortnightly assessments were made in the clinic throughout the study and adrenal function was monitored and found to be normal. All patients measured their peak expiratory flow rates in the morning and evening and monitored their symptoms daily on a record card as well as recording bronchodilator usage. Assessment using these parameters indicated that treatment with betamethasone valerate compared with sodium cromoglycate resulted in an improvement in the patients' asthma which was stitistically significant (P less than 0-001). Overall the combined treatment produced a better response than sodium cromoglycate (P less than 0-02) but a poorer response compared with the steroid aerosol given alone (P greater than 0-05). In only two patients was the response to the combined therapy significantly greater than to either drug given alone.

Adolescent↗

Betamethasone valerate compared with sodium cromoglycate in asthmatic children.

A double-blind, cross-over study was undertaken to compare inhalation of betamethasone valerate (BV, 800 microgram daily) with sodium cromoglycate (SCG, 80 mg daily) in twenty children requiring bronchodilators for perennial asthma. Each treatment period lasted 4 weeks but statistical comparisons were made only in respect of the last 14 days of each therapy. When the children were using BV they required not only less of the bronchodilator drugs but had fewer symptoms and higher daily peak expiratory flow rates when taking SCG. Statistically, all these differences were highly significant. For 2 weeks before the main trial each child was given a placebo aerosol (single-blind) to assess severity of asthma. In comparison with this period, SCG was associated with a significantly increased peak expiratory flow rate a lower symptom score by day but not by night, but their usage of bronchodilators followed a similar pattern. When the BV period was compared with the placebo period, patients had an even more significant rise in peak expiratory flow rate, less day and night symptoms, and took hardly any bronchodilators. The response to the two drugs did seem to depend upon which was given first. No monilial infections were found, nor any measurable defect in adrenal response from either treatment. Betamethasone valerate is considered to be superior to sodium cromoglycate as a treatment for childhood asthma insufficiently controlled on bronchodilators.

Adolescent↗

Influence of topically applied betamethasone-17-valerate on cell cycle kinetics of human anagen hair determined by DNA flow cytometry.

In 47 healthy volunteers betamethasone-17-valerate (0.1% solution and cream) was topically applied twice daily on the scalp skin. After 7 and 14 days treatment, anagen hairs were plucked in each volunteer from both treated and untreated contralateral scalp areas. Cell cycle analysis of plucked anagen hairs was performed by means of DNA flow cytometry. Already after topical betamethasone-17-valerate application for 7 days, cell kinetic changes were found showing a slightly significant decrease of S and G2 + M cell percentages and a significant increase of G0/1 cell percentages. The present study demonstrates the possibilities of DNA flow cytometry to study the pharmacological effects on cell kinetics of plucked human anagen hairs.

Administration, Topical↗

Topical treatment with urea-hydrocortisone in atopic dermatitis. A controlled study against betamethasone 17-valerate.

When comparing 1% hydrocortisone in a stabilized 10% urea cream with 0.1% betamethasone 17-valerate cream in a double-blind study on 49 patients with atopic dermatitis or atopic winter feet, betamethasone cream was found to be the most potent. The study also showed that in approximately 60% of the patients the clinical response was equal. It is suggested that the urea-hydrocortisone combination may have its place in the long-term topical treatment of atopic dermatitis on account of its water-binding effect.

Administration, Topical↗

A double-blind comparison of 0.25% and 0.05% desoxymethasone, 0.1% betamethasone valerate and 1% hydrocortisone creams in the treatment of eczema.

The efficacy and acceptability of 0.25% and 0.05% desoxymethasone, 0.1% betamethasone valerate and 1% hydrocortisone creams were compared in patients with eczema. A double-blind parallel group multi-centre design was employed in which 96 patients were recruited by four centres. Patients used one cream for a 3-week period and follow-up assessment visits were made at weekly intervals. Efficacy variables were: erythema/redness, scaling, itching and extent of area affected. These variables were assessed by both the investigator and the patient. The 0.25% desoxymethasone was the most effective treatment, producing the greatest degree of improvement in all clinical parameters, hydrocortisone was the least effective and 0.05% desoxymethasone was of intermediate effectiveness. The 0.1% betamethasone produced similar results to 0.25% desoxymethasone for half the assessments; for the other half the results were similar to 0.05% desoxymethasone. No adverse effects were reported during the study. The results are discussed in terms of physical properties of the vehicles and corticosteroid potency.

Administration, Topical↗

A double-blind comparison of 1% hydrocortisone plus 10% urea ('Alphaderm') and 0.1% betamethasone 17-valerate in the treatment of non-infective inflammatory dermatoses.

A double-blind controlled trial was carried out over a period of 3 weeks to assess the effectiveness of 1% hydrocortisone, in a specialized carbamide drug delivery system, compared with 0.1% betamethasone 17-valerate cream in the treatment of 21 patients with bilateral, symmetrical, non-infective inflammatory dermatoses. The trial preparations were applied topically twice daily, each to one side only during the trial. Although overall patient preference tended to favour betamethasone 17-valerate, the physician's assessment of clinical improvement, based on severity rating scores, indicated that both preparations were equally effective and there were no significant differences between the calculated mean percentage clinical improvements at the end of each week.

Administration, Topical↗

Efficacy of bufexamac cream versus betamethasone valerate cream in contact dermatitis: a double-blind trial.

A double-blind controlled study was carried out in 72 patients with atopic or contact dermatitis, who were randomly allocated to receive treatment with either 5% bufexamac, 0.1% betamethasone valerate or placebo creams. Patients applied the cream twice daily for 2 weeks. Assessments of the degree of severity of inflammation, induration, lichenification, crusts, scaling, and pruritus were made before and after treatment. The results showed that both active preparations were equally effective in improving the skin condition in the majority of the patients. In younger patients, however, the improvement with betamethasone valerate appeared to be somewhat better than that with bufexamac, particularly in relation to pruritus.

Administration, Topical↗

Plasma cortisol levels in normal volunteers receiving either betamethasone valerate or desoximetasone by topical application.

Desoximetasone (Topisolon; Hoechst), a new topical steroid, and betamethasone 17-valerate were compared with respect to their effects on hypothalamic-pituitary-adrenal function as evidenced by plasma cortisol concentrations. Three grams of each test preparation were applied daily for 21 days to intact skin of the ventral aspects of alternate forearms of 15 normal volunteers. Five received betamethasone 17-valerate 0.1%, 5 desoximetasone 0.05%, and 5 desoximetasone 0.25%. Plasma cortisol levels were determined before and after the initial applications on days 1, 3, 10, 17, 22, 24 and 28. These values were compared with the mean control values by analysis of covariance. There was no significant difference in plasma cortisol levels. The value of performing similar studies on larger skin areas and with larger doses is discussed.

Administration, Topical↗

The treatment of psoriasis with 0.1% domoprednate (a D-homocorticosteroid) and 0.1% betamethasone valerate ointment. A double-blind, randomized trial.

In 85 patients with psoriasis vulgaris the efficacy and tolerance of domoprednate and betamethasone valerate were studied in a double-blind, randomized trial lasting 4 weeks. Complete or satisfactory remission was obtained in 36% in the domoprednate group and in 53% in the betamethasone group. This difference is not statistically significant (p greater than 0.10). 3 patients on each treatment experienced some local irritation. No laboratory abnormalities were found during the study.

Adolescent↗

Management of eczematous dermatitis with amcinonide or betamethasone valerate. A double-blind comparative study.

A new topical corticosteroid formulation, 0.1 percent amcinonide cream, was compared with 0.1 percent betamethasone valerate cream in a double-blind, parallel study of the management of eczematous dermatitis. Both treatment groups showed statistically significant improvement in most symptoms and in overall disease status after one and two weeks of treatment. The amcinonide group had greater improvement in individual symptoms and significantly greater overall improvement than did the betamethasone valerate group. Side effects were few and minor in both groups. The amcinonide cream was found to be both safe and effective for the management of eczematous dermatitis.

Adolescent↗

Intranasal betamethasone valerate in seasonal rhinitis.

A double-blind study comparing betamethasone valerate and placebo aerosols was carried out in 40 patients with a history of seasonal allergic rhinitis and positive skin tests to grass pollens. Analysis of the symptoms recorded on a daily record card for a period of one month indicated that the mean monthly symptom-score was lower for all symptoms in the group on active therapy and that this reached statistical significance for the symptom of sneezing. Significantly more antihistamine tablets were used by the placebo group as compared with the active group (p less than 0-05). The patients' assessment of their treatment was in favour of betamethasone valerate (p less than 0-05). No clinically significant side-effects were associated with the treatment, which was well tolerated.

Administration, Intranasal↗

Glucocorticoid treatment for nasal polyps. The use of topical budesonide powder, intramuscular betamethasone, and surgical treatment.

BACKGROUND: The treatment of nasal polyps is controversial, and medical treatment alone has been little investigated to our knowledge. OBJECTIVE: To examine the efficacy of therapy using only topical budesonide powder and topical budesonide powder supplemented with surgical removal or intramuscular betamethasone. DESIGN: Randomized, double-blind comparison of 2 dosages and additional treatment, if therapy failed. After 1 year, treatment with medication was stopped, and the demand for renewed treatment was monitored for another year. PATIENTS: Patients with bilateral nasal polyps who demanded treatment were consecutively enrolled in a hospital outpatient clinic or specialty private practice. During a 15-month period from 1990 to 1992, a total of 126 patients entered the 2-year study. INTERVENTIONS: In phase 1, randomized and double-blind treatment with a topical medication, budesonide powder, 800 micrograms or 400 micrograms daily, or a placebo was given for 1 month. In phase 2, randomized and double-blind treatment with budesonide powder, 800 micrograms or 400 micrograms daily, was given. At the end of phase 1, failed therapy was supplemented by randomly assigned treatment of either surgical removal or a single injection of sustained released betamethasone. In phase 3, treatment with the medication was discontinued, and patients were monitored for another year. The time when treatment was required again was noted. The present article deals with phases 2 and 3. MAIN OUTCOME MEASURES: Patients' scores of treatment efficacy as well as symptoms and signs. Semiquantitative measurement of sense of smell and calculation of peak expiratory flow rate index based on nasal and oral peak expiratory flow. RESULTS: In all outcome measures, a comparison of the data before treatment with the corresponding figures during phase 2 showed statistically significant efficacy. The clinical course was described at the end of phase 2. About 85% of the patients, including those who received additional therapy because the initial therapy failed, rated total or substantial control over the symptoms. The 2 dosages investigated showed equal results. These findings were consistent with the signs recorded and the peak expiratory flow rate index. The results of phase 3 showed that 50% of patients had demanded treatment after 4 months, while 34% managed without medication after 1 year. CONCLUSIONS: The clinical course in this study showed that most patients with nasal polyps do well with medical treatment. Therefore, surgery was required in few patients. However, the potential of medical treatment should be further explored in future studies.

Administration, Inhalation↗

Differentiation of betamethasone and dexamethasone using liquid chromatography/positive electrospray tandem mass spectrometry and multivariate statistical analysis.

Betamethasone and dexamethasone are two corticosteroids differing in the stereoisomery of their C-16 methyl group. These two compounds are imperfectly separated by reversed-phase liquid chromatography and their mass spectra are very similar, leading to a difficult unambiguous identification according to European criteria. A method is proposed for differentiating betamethasone and dexamethasone using liquid chromatography/tandem mass spectrometry and multivariate statistical analysis. Multiple analysis of variance was used for the justification and the selection of diagnostic ions. Principal component analysis permitted the suitability of the approach to be tested on a large number of samples. Discriminant factorial analysis was finally performed to build a decisional model based on the six most significant ions. This novel utilization of mass spectrometric data appeared efficient for the unambiguous identification of the target analytes in urine samples.

Animals↗

Stabilization and HPLC analysis of betamethasone sodium phosphate in plasma.

The analysis of corticosteroid prodrugs in pharmacokinetic (PK) studies poses the risk of overestimation of corticosteroid concentrations due to in vitro hydrolysis of prodrugs after sample collection. This study tests the effectiveness of enzyme inhibitors as stabilizers for betamethasone sodium phosphate (BSP) in pregnant sheep plasma samples collected during PK studies with betamethasone (BET) and provides simultaneous high-performance liquid chromatography analysis of BSP and BET. A rapid, sensitive, and specific ion-paired reversed-phase high-performance liquid chromatography assay for simultaneous measurement of BET and BSP in plasma was developed. This assay was used for analyzing samples from an in vitro prodrug hydrolysis study. Enzyme inhibitors tested were sodium arsenate (Na(2)HAsO(4)) and ethylenediaminetetraacetic acid. The BSP was administered intramuscularly to three pregnant sheep to assess in vivo PK. Samples were split with part treated with Na(2)HAsO(4) and part left natural. In vitro hydrolysis of BSP in plasma to BET could be completely inhibited by Na(2)HAsO(4), but not by ethylenediaminetetraacetic acid. The PK study showed lower concentrations of BET in samples with Na(2)HAsO(4) compared with natural samples. This study demonstrates that artifacts in PK profiles of corticosteroids due to in vitro prodrug hydrolysis can be prevented by sample treatment with enzyme inhibitors.

Animals↗

Selective photometric determination of betamethasone benzoate and other 21-hydroxycorticosteroids.

Condensation of the glyoxal obtained by cupric acetate oxidation of 21-hydroxycorticosteroids with acetous phenylhydrazine reagent affords a near UV chromophore. All of the tested corticosteroids, including triamicinolone acetonide, which gives low color yields in the Porter-Silber reaction and its Lewbart-Mattox modification, gave similar absorption maxima (362-370 nm) and molar absorptivities (epsilon = 17,000-20,500). Since corticosteroid 21-esters and oxidation products do not undergo the reaction, the assay method based on it is stability indicating for betamethasone benzoate and the other test compounds. Procedures are described for the assay of two topical betamethasone benzoate preparations and hydrocortisone and prednisolone tablets; recovery and precision data are given.

Betamethasone↗