|Year : 2020 | Volume
| Issue : 2 | Page : 81-84
Safety and efficacy of one week oral steroid therapy in the treatment of common eczemas: An open label randomized controlled pilot study
Vikrant Abhay Saoji1, Arun L Bhat2
1 Department of Dermatology, JNMC, Wardha, Maharashtra, India
2 Dr Saoji's Skin Clinic, Nagpur, Maharashtra, India
|Date of Submission||23-Oct-2019|
|Date of Decision||18-Dec-2020|
|Date of Acceptance||18-Dec-2020|
|Date of Web Publication||28-Dec-2020|
Vikrant Abhay Saoji
22, Dandige Layout, Shankar Nagar, Nagpur - 440 010, Maharashtra
Source of Support: None, Conflict of Interest: None
Introduction: Oral steroids are not commonly used because of fear of side effects. A study was conducted to find out if a short course of 1 week of oral steroid without tapering is effective and safe for the treatment of common eczemas. Materials and Methods: Patients with common eczemas were included in the study. There were five groups. One group each received tablet prednisolone 15 mg morning and 10 mg after dinner for 7 days, tablet methylprednisolone 16 mg morning and 8 mg night for 7 days, and tablet betamethasone 2 mg morning and 1 mg night for 7 days. One group received tablet betamethasone 3 mg once a day as a single morning dose for 7 days and the last group received tablet deflazacort 18 mg morning and 12 mg night for 7 days only. All the patients also received topical clobetasol propionate cream for 1 month. However, the maximum permissible amount of topical clobetasol propionate was 30 g in a month. Basal serum cortisol at 8 am along with ACTH stimulation test was carried out in all the patients on day 10th. The tests were repeated on 30th day if negative on day 10th. Results: In all groups, rapid improvement was seen at visit 2, which further continued at visit 3. No suppressive effect on hypothalamic–pituitary–adrenal (HPA) axis was seen. Conclusion: A short course of oral steroid of 25 mg of prednisolone equivalent for a period of 7 days was found to be effective and safe, and 7 days of oral steroids do not need tapering.
Keywords: Eczema, oral steroid, short course
|How to cite this article:|
Saoji VA, Bhat AL. Safety and efficacy of one week oral steroid therapy in the treatment of common eczemas: An open label randomized controlled pilot study. Indian J Drugs Dermatol 2020;6:81-4
|How to cite this URL:|
Saoji VA, Bhat AL. Safety and efficacy of one week oral steroid therapy in the treatment of common eczemas: An open label randomized controlled pilot study. Indian J Drugs Dermatol [serial online] 2020 [cited 2021 Mar 8];6:81-4. Available from: https://www.ijdd.in/text.asp?2020/6/2/81/305129
| Introduction|| |
Topical steroids are commonly used for the treatment of common eczemas. The barrier function of the skin is the main obstruction for the penetration of topical steroid, resulting in only small quantity of topically applied steroid reaching the dermis,, the site of inflammation in skin, resulting in poor therapeutic response. Systemic steroids, owing to its potential side effects, are not used frequently by the dermatologists in steroid-responsive localized or widespread dermatoses. Most of the time, when topical corticosteroids are used instead of oral corticosteroids, the response is not satisfactory unlike systemic corticosteroids. We conducted a pilot study to find out if short course of oral steroids for 1 week without tapering is safe and effective in the treatment of common inflammatory diseases such as eczema.
| Materials and Methods|| |
The study was carried out in a private clinic in central Maharashtra after obtaining permission from the independent ethics committee. Adult patients (18–60 years) suffering from common eczemas who are willing to participate in the study were included. Patients of diabetes and hypertension whose disease was under control were included in the study. Exclusion criteria were children and pregnant females, patients with active serious infection, patients with serious systemic diseases, patients who had systemic steroids in last 1 month, and patients who had received topical steroids in the last 2 weeks.
There were five groups. The first group received tablet prednisolone 15 mg after breakfast and 10 mg after dinner. The second group received tablet methyl prednisolone 12 mg after breakfast and 8 mg after dinner (5 mg prednisone = 4 mg methyl prednisolone). The third group received tablet betamethasone 2 mg after breakfast and 1 mg after dinner (5 mg prednisone = 0.6 mg of betamethasone). The fourth group received tablet betamethasone (same dose) 3 mg in single (OD) dose. All these patients received treatment for 7 days. Fifth group received tablet deflazacort 18 mg morning and 12 mg after dinner for 7 days (5 mg prednisolone = 6 mg deflazacort). The dose of oral steroid used was equivalent of 25 mg of prednisolone. Patients were randomly assigned to any one of the five groups. Every patient also received topical clobetasol propionate 0.05% cream application at bedtime with a maximum permissible limit of 30 g for a period of 1 month.
The study involved three visits. At visit 1, detailed history was taken. Severity of the disease was measured on the basis of eczema area severity index (EASI). Visit 2 was planned on the 10th (+2) day allowing a washout period of 2 days. During visit 2, side effects if any were recorded; vital signs were recorded along with the evaluation of EASI. Fasting serum cortisol at 8 am was done along with posttetracosactid (Synecthin®, synthetic analog of ACTH) serum cortisol (1 h after injection synecthin® 250 microgram). Fasting blood glucose was also done in diabetic patients. After completing 1-week course of oral steroids, the patients were asked to continue application of topical steroid cream till the next visit (day 30). Visit 3 was planned on day 30 (+3 day). EASI was recorded. In case of negative test at visit 2, basal serum cortisol and ACTH stimulation test was repeated.
| Results|| |
A total of 93 patients of various types of eczema were recruited in the study. Thirteen were irregular in follow-up and are considered as dropouts. The total number of patients available for analysis was 80, which included 15 patients of asteatotic eczema, thirty patients of nummular eczema, and 35 patients of eczema due to other causes. [Table 1] provides the descriptive statistics of characteristics of patients treated with different medications. All groups were equivalent at the baseline.
|Table 1: Descriptive statistics of patient characteristics treated with five different medications|
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A comparative evaluation of mean EASI levels obtained at visit 2 and 3 for patients in each treatment group with reference to baseline was carried out independently using Friedman ANOVA. [Figure 1] shows the line plot showing the trends in each treatment group. It is evident from the table that a statistically significant reduction in the mean EASI levels was achieved in each group. The reduction was maximum, i.e., 89.4% in betamethasone (divided dose) group, while minimum in deflazocort group (78.28%). The difference of mean EASI levels at visit 2 and 3 across treatment groups was found statistically insignificant.
|Figure 1: Line diagram showing mean eczema area severity index of five treatment groups at different visits *Obtained using Kruskal–Wallis test; † Obtained using Friedman test; HS: Highly Significant; NS: Not significant|
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Mean basal serum cortisol level at visit 2 in patients who received prednisolone was 9.77 μg/dl, methylprednisolone was 11.49 μg/dl, betamethasone (divided dose) was 5.88 μg/dl, and betamethasone single morning dose was 13.67 μg/dl and in 10 patients of deflazacort group 12.94 μg/dl (normal value for serum cortisol is 5–25 μg/dl). The mean basal cortisol levels and post-ACTH cortisol levels in different treatment groups is shown in [Figure 2]. In the methylprednisolone, betamethasone OD, and deflazacort groups, the mean cortisol level, post stimulation could be achieved beyond the threshold of 20 μg/dL. In the betamethasone group (divided dose) and prednisolone (divided) group, the mean level was below the threshold at visit 2. All patients with 8 am-basal serum cortisol value of more than 10 μg/dl showed normal post-ACTH test. Normal value for serum cortisol is 5–25 μg/dl.
|Figure 2: Bar chart showing mean basal cortisol and post-ACTH cortisol levels for different treatment groups at visit 2|
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At visit 2, ACTH stimulation test was negative in 12 patients that included eight patients on betamethasone therapy, three patients on prednisolone therapy, and one patient on methylprednisolone therapy (all divided doses). Out of these 12 patients with negative ACTH stimulation test, 11 patients also had low basal serum cortisol levels. A total of three patients had low basal serum cortisol but had normal ACTH stimulation test. All 12 patients with negative test at visit 2 showed normal tests at visit 3 implying that effect on hypothalamic–pituitary–adrenal (HPA) was short lived or reversible at the end of 30 days.
All vitals were unaffected including pulse rate, respiratory rate, and temperature. No significant change in weight was observed in any patient. Blood pressure recorded in all the patients (including three hypertensive patients) during all visits was normal.
A few side effects were also noted. Increased appetite was seen in 17 patients (21.25%), mooning of face 9 patients (11.25%), constipation in 11 patients (13.75%), gastritis in 1 patient, and sleep disturbance in 8 patients (10%). Two patients developed acneiform eruptions.
| Discussion|| |
We have used oral steroids for a period of 1 week without tapering. Tapering of steroids is usually done to prevent HPA axis suppression. Basal serum cortisol (8 am) gives a general idea of HPA functioning. In normal conditions, a person can survive with a low serum cortisol, but during stress, body's requirement of cortisol increases, and if the adrenal gland is suppressed (or atrophied), it will not be able to increase cortisol production leading adrenal crisis. ACTH stimulation test measures the stress response of the adrenal. Normal functioning of HPA axis is indicated by ACTH stimulation value of more than 20 μg/dl of serum cortisol as per our lab reference.
In another study, when prednisone 25 mg bd (doubled the dose of prednisolone as was used in our study) was used for 5 days, the average serum cortisol, post-ACTH was 13.3μg/dl (low value) when tested 3 days after the last dose but recovered when tested after 10 days indicating that high dose of oral steroids used in divided doses for a shorter duration of a week, HPA axis recovery is fast. On the contrary, a dose of more than 7.5 mg of prednisolone for longer than 3 weeks can lead to adrenal atrophy, indicating that as the duration of steroid therapy increases the chances of HPA axis suppression also increases. Hence for safety, the duration of steroid should be kept to minimum.
Basal cortisol and ACTH stimulation tests done at visit 3 were normal in all the patients with negative tests at visit 2 indicating all types of steroids including prednisolone, methylprednisolone, and betamethasone in single or divided doses are safe if used for up to 1 week and does not cause any long-term HPA axis suppression hence does not need tapering. Because of long half-life, only betamethasone was used for a single day dose. The safety of OD dose betamethasone indicates that other more short-acting steroids such as prednisolone and methylprednisolone will also be equally safe if used in OD dose, for short period of 1 week.
All the patients recorded normal blood pressure during all the visits indicating short-course steroids can also be used safely in hypertensive patients. Drugs with low mineralocorticoid action such as methylprednisolone and betamethasone or dexamethasone should be preferred in hypertensive patients.
To assess the efficacy of the regimen, EASI was used. The excellent response is noted in all our patients. Over 70% reduction in EASI in just a week indicates that the dose of 25 mg of prednisone is sufficient to treat common inflammatory skin diseases such as eczema. We preferred corticosteroids in divided doses to have a sustained anti-inflammatory effect throughout the day. In a study done on rheumatoid arthritis, the dose required to control the disease activity was 20% higher when used in OD dose than in divided doses indicating better efficacy of divided doses. With betamethasone OD dose (versus divided doses), the safety improved though the efficacy was found to be little less (65.64% vs. 75.17%). Different steroids were used during this study to compare efficacy and safety in equivalent doses. Rebound flare of eczema upon steroid withdrawal may be a concern but was not seen in our patient, probably because of the continuation of topical steroids. Topical steroids if used in large quantity can cause HPA axis suppression; however, topical clobetasol propionate was a common factor for all the groups, hence unlikely to affect the study outcome. Normal tests at 3rd visit indicate topical clobetasol propionate if used up to 30 g over 30 days does not affect endogenous steroid.
The side effects seen during our study were mostly mild and manageable. By keeping the steroids treatment course short (1 week), many of the serious side effects are avoided. This study confirms the safety and the efficacy of 1-week steroid (25 mg prednisolone equivalent) and should help the dermatologist manage the common inflammatory skin diseases such as eczema in a better way.
This study has a few limitations. As this was a pilot study, the sample size was less. More studies with larger sample size are needed to evaluate safety and efficacy of a shorter duration of oral corticosteroids regimen. Further double-blind, randomized controlled studies with only 1-week oral corticosteroids are recommended.
| Conclusion|| |
Thus, it can be concluded in our study that a short course of oral steroid of 25 mg of prednisolone equivalent for a period of 7 days was found to be effective and safe and 7 days of oral steroids do not need tapering.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]