Volume 6, Issue 1, March 2017, Pages 19–25
Open Access
- a Department of Ophthalmology, Otorhinolaryngology and Dermatology of Korean Medicine, Kyung Hee University, Seoul, Korea
- b Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Korea
- Received 5 October 2016, Revised 7 December 2016, Accepted 9 January 2017, Available online 17 January 2017
- Open Access funded by Korea Institute of Oriental Medicine
- Under a Creative Commons license
Abstract
Background
Patients
with atopic dermatitis (AD) exhibit various symptoms, especially
itching. Recently, herbal medicines (HMs) are being used in combination
with antihistamines for the treatment of AD in Korea. While oral
antihistamines can alleviate itching, HMs appear to exert
anti-inflammatory effects with minimal side effects. However, there is
little evidence regarding the effectiveness and safety of using HMs in
combination with antihistamines for AD.
Methods
To
observe the effectiveness and safety of combination treatment with HMs
and antihistamines, we performed a retrospective chart review of
inpatients with AD who received this combination treatment for at least
7 days in a hospital.
Results
Of
163 inpatients, 40 met the inclusion criteria. All patients received
HMs three times, and one or two antihistamines, a day after HM intake. A
large proportion of patients received first-generation antihistamines.
HMs comprised a mixture of an average of 20.69 different herbs in
decoction. The mean total, objective, and subjective SCORing Atopic
Dermatitis scores showed a significant decrease after combination
treatment. Changes in the mean levels of aspartate transaminase, alanine
transaminase, blood urea nitrogen, and creatinine were not
statistically significant among treatments. There were no adverse events
of pseudoaldosteronism or interstitial pneumonia.
Conclusion
We
observed that the short-term use of HMs in combination with oral
antihistamines was safe and effective, with a low risk of adverse
reactions. This study was limited by its retrospective design, and
prospective studies with long-term follow-up periods are warranted to
further elucidate the safety of this combination treatment for AD.
Keywords
- antihistamines;
- atopic dermatitis;
- herbal medicine;
- herb–drug interactions;
- retrospective chart review
1. Introduction
Atopic
dermatitis (AD) is a common pruritic inflammatory skin disease with an
increasing prevalence in industrialized countries. The worldwide
prevalence of AD is 5–20%.1
AD is characterized by pruritus, eczematous lesions accompanied by
excessive infiltration of inflammatory cells, eosinophilia in the
peripheral blood, and high levels of serum immunoglobulin E (IgE).2
Inflammatory
skin changes accompanying itching are the most important manifestations
of AD. Therefore, treatment should address the epidermal barrier as
well as immunomodulation or infection; AD treatment typically includes
anti-inflammatory agents, antipruritic agents, and occasionally,
antiseptic agents.3
Antihistamines
are frequently used for the management of itching in AD. This class of
drugs can block H1 receptors on afferent C nerve fibers and inhibit the
release of pruritic mediators.4
Antihistamines exhibit several adverse side effects related to their
antihistaminic actions. However, these are usually mild and can be
rapidly reversed with the discontinuation of treatment or a decrease in
the dose.5 Their relative safety probably relates to their use in low doses for a short time period.
Herbal
medicines (HMs) are medicinal plants used for the prevention and
treatment of disease. In East Asia, herbs are widely used for the
treatment of AD because of their efficacy and minimal side effects.
Several studies have provided scientific evidence for the clinical
efficacy and safety of HMs for the treatment of AD.6; 7 ; 8
HMs
and conventional treatments are generally prescribed independently for
AD; however, for some patients with uncontrolled itching, these agents
are routinely combined in clinical practice for faster relief from
itching. However, no study has evaluated the combined use of HMs and
oral antihistamines for AD. Therefore, we performed a retrospective
chart review to observe the safety and effectiveness of short-term
combination therapy with HMs and oral antihistamines for inpatients with
AD in Seoul, Republic of Korea.
2. Methods
2.1. Patients and study design
We
conducted a retrospective chart review of inpatients treated at the
Department of Dermatology of Korean Medicine, Kyung Hee University
Hospital, Seoul, Korea, between January 2011 and May 2016. Using
electronic medical records (EMRs, NeoMed, Hyundai Information
Technology, Seoul, South Korea), patients were selected on the basis of
the following criteria.
The
inclusion criteria were as follows: hospitalization for AD; combined
use of HMs and oral antihistamines for at least 7 days; availability of
SCORing Atopic Dermatitis (SCORAD) scores, total serum IgE level data,
and eosinophil counts before and after treatment; availability of
results of blood tests for the evaluation of liver and renal function
before and after treatment; and access to medical records of adverse
events, including pseudoaldosteronism and interstitial pneumonia. The
exclusion criteria were as follows: use of systemic steroids,
immunosuppressants, and antibiotics during hospitalization; and use of
topical steroids and calcineurin inhibitors during hospitalization. This
study was approved by the Institutional Review Board of Kyung Hee
University Hospital (KHNMC-OH-IRB 2014-05-003).
2.2. Combination treatment
Data
regarding patient demographics and treatment regimens were collected
from EMRs, with a focus on HM prescriptions and antihistaminic use. We
also reviewed individual patients who received herbs with previously
reported potential for hepatotoxicity, pseudoaldosteronism, or
interstitial pneumonia (Table 1).9; 10 ; 11
- Table 1. Herbs with previously reported potential for hepatotoxicity, pseudoaldosteronism, or interstitial pneumonia.
Name of herb Hepatotoxicity Radix Polygoni multiflori Turcz Dictamnus dasycarpus Cortex Ulmus davidiana Radix Puerariae Fructus Psoraleae Aloe Vera Cortex Cudraniae Ceramium kondoi Radix Smilacis chinae Corydalis speciosa Max Pseudoaldosteronism Radix Glycyrrhizae Interstitial pneumonia Radix Scutellariae Radix Bupleuri
2.3. Assessment of effectiveness and safety
To
observe the effectiveness and safety of combination treatment, we
assessed the SCORAD score; total serum IgE level; eosinophil count;
levels of aspartate transaminase (AST), alanine transaminase (ALT),
blood urea nitrogen (BUN), and creatinine; and adverse events, including
pseudoaldosteronism and interstitial pneumonia.
2.4. Statistical analyses
We
analyzed the collected data using SPSS version 18.0 for Windows (SPSS
Inc., Chicago, IL, USA). Data are presented as mean ± standard deviation
or number (%). The paired t test was used to evaluate statistically
significant changes in SCORAD score; total serum IgE level; eosinophil
count; and AST, ALT, BUN, and creatinine levels after treatment. A p
value < 0.05 was considered statistically significant.
3. Results
3.1. Patient selection and characteristics
We
collected patient data from EMRs dated between January 2011 and May
2016. During the study period, 95 of 163 inpatients were diagnosed with
and hospitalized for AD. Among these, 40 patients fulfilled all the
inclusion and exclusion criteria (Fig. 1). The clinical characteristics of patients on the day of admission are summarized in Table 2.
All patients were younger than 38 years. Their body weights were very
diverse. The mean durations of admission and combination treatment were
12.7 days and 11.7 days, respectively.
- Fig. 1.Selection process of retrospective chart review.SCORAD, SCORing Atopic Dermatitis.
- Table 2. Clinical characteristics of 40 patients who received combination treatment with herbal medicines and oral antihistamines.
Patient characteristics Sex (M/F) 14/26 Age, y 21.7 (2–38) Children (2–19 y) 18 Adults (over 19 y) 22 Body weight, kg 54.7 (12.0–78.5) Duration of AD, y 7.6 (0.17–20) Duration of admission, d 12.7 (8–26) Duration of combination treatment, d 11.7 (7–18) - AD, atopic dermatitis; F, female; M, male.
Data are presented as n or mean (range).
3.2. Combination treatment with HMs and oral antihistamines
All
patients received HMs thrice a day after meals and one or two
antihistamines once or twice a day within 30 minutes after HM intake.
Among the 40 included patients, 31 received one type of antihistamine, 5
received two different types, and 4 received altered types due to a
lack of relief from itching. A large proportion of patients received
first-generation antihistamines. Details of the treatment regimens are
summarized in Table 3.
- Table 3. Types of antihistamines prescribed for relief from itching caused by atopic dermatitis.
Case (n) Age (y) Type of antihistamines Dosage Duration (d) 24 11–38 Hydroxyzine HCl only 5–20 mg 7–26 3 10, 21 Pseudoephedrine HCl & Triprolidine HCl 30 mg, 1.25 mg 8, 18 28 60 mg, 2.5 mg 7 2 26 Hydroxyzine HCl, Ebastine 10 mg, 10 mg 14 38 30 mg, 10 mg 13 2 6 Hydroxyzine HCl
→ Pseudoephedrine HCl & Triprolidine HCl6 mg
→ 30 mg, 1.25 mg7(2 → 5) 7 2 15 Cetirizine HCl 10 mg 9 19 10 1 18 Hydroxyzine HCl
→ Hydroxyzine HCl, Ebastine10 mg
→ 20 mg, 10 mg11 (2 → 9) 1 31 Hydroxyzine HCl, Bepotastine besilate
→ Hydroxyzine HCl only10 mg each 7
(5 → 2)1 22 Ebastine, Bepotastine besilate 10 mg each 18 1 32 Hydroxyzine HCl, Cetirizine HCl 10 mg each 11 1 21 Ebastine, Levocetirizine HCl 10 mg, 5 mg 10 1 7 Mequitazine 4 mg 10 1 2 Ketotifen Furamate 1.38 mg 11 - Bepotastine besilate, Talion; Cetirizine HCl, Zyrtec; Ebastine, Ebastel; Hydroxyzine HCl, Ucerax; Ketotifen Furamate, Ketotifen; Levocetirizine HCl, Letirizine; Mequitazine, Primalan; Pseudoephedrine HCl & Triprolidine HCl, Actifed.
HMs
comprised a mixture of an average of 20.69 different herbs in
decoction. A total of 98 different herbs were used for the 40 patients.
The mean dry mass of HM per patient was 259.82 g/d. The 11 most commonly
used herbs are listed in Table 4. From the 13 herbs listed as potentially causing hepatotoxicity, pseudoaldosteronism, or interstitial pneumonia in Table 1, Radix Glycyrrhizae was prescribed to 35 patients, Radix Scutellariae to 31, Rhizoma Smilacis to 30, Radix Bupleuri to 18, Radix Puerariae Radix to eight, Turcz Dictamnus dasycarpus to three, Cortex Cudraniae to two, and Radix Polygoni multiflora to one ( Table 4 ; Table 5).
- Table 4. Eleven most commonly used herbs for the 40 patients included in this study.
Scientific name Patient number (n) Used dose (g/d) Radix Rehmanniae 38 37.90 (8–60) Radix Glycyrrhizae 35 10.82 (4–12) Akebiae caulis 33 12.00 (8–16) Radix Astragali 32 16.50 (4–24) Rhizoma Atractylodis 31 12.52 (8–20) Radix Scutellariae 31 11.4 (4–12) Rhizoma Smilacis 30 12.97 (12–20) Radix Angelicae gigantis 28 10.79 (8–16) Radix Adenophorae 28 14.43 (12–16) Radix Gentianae scabrae 28 12.14 (12–16) Semen Plantaginis 28 12.00 (8–16) - Data are presented as mean (range).
- Table 5. Patients who received herb(s) with previously reported potential for hepatotoxicity, pseudoaldosteronism, or interstitial pneumonia.
Patient number (n) Used dose (g/d) Radix Polygoni multiflori 1 4 Turcz Dictamnus dasycarpus 3 10.67 (8–12) Cortex Ulmus davidiana 0 0 Radix Puerariae 8 13 (12–16) Fructus Psoraleae 0 0 Aloe Vera 0 0 Cortex Cudraniae 2 10 (8–12) Ceramium Kondoi 0 0 Radix Smilacis chinae 30 12.97 (12–20) Corydalis speciosa Max 0 0 Radix Glycyrrhizae 35 10.82 (4–12) Radix Scutellariae 31 11.4 (4–12) Radix Bupleuri 18 8.96 (6–16) - Data are presented as mean (range).
3.3. Concomitant medications
Included
patients sometimes used emollients and lotions. In addition, an
ointment that contains herbs was used during hospitalization. Jawoongo
(Shiunko in Japanese), which is composed of Radix Angelicae gigantis and Radix Lithospermi, was used for excoriation, lichenification, and dryness. 12 ; 13
3.4. Assessment of effectiveness and safety
The mean total, objective, and subjective SCORAD scores showed a significant decrease after combination treatment (p < 0.001).
However, total serum IgE level increased and eosinophil counts
decreased slightly, but the changes in the two values were not
clinically meaningful when considering the reference range. Moreover,
changes in the mean levels of AST, ALT, and creatinine after treatment
were not statistically significant (p > 0.05). Levels of BUN
also slightly decreased, but the change was not clinically meaningful
when considering the reference range. The results are summarized in Table 6 and Fig. 2. There were no adverse reports of pseudoaldosteronism or interstitial pneumonia.
- Table 6. Effectiveness and safety outcomes for combination treatment with herbal medicines and oral antihistamines for atopic dermatitis.
Before treatment After treatment Reference range p Mean ± SD
Total SCORAD score (0–103) 64.4 ± 15.2 34.8 ± 14.5 <0.0001* Objective SCORAD score (0–83) 50.8 ± 13.7 28.5 ± 11.6 <0.0001* Subjective SCORAD score (0–20) 13.7 ± 4.4 6.3 ± 4.9 <0.0001* Eosinophil count 1310.3 ± 1816.4 1099.2 ± 1580.7 30–350/μL 0.039* Serum total IgE level 2320.2 ± 2672.4 2483.3 ± 2935.1 <100 IU/mL 0.155 AST level 26.5 ± 8.7 25.3 ± 7.1 <40 U/L 0.408 ALT level 18.9 ± 11.1 19.8 ± 9.6 <40 U/L 0.628 BUN level 10.2 ± 3.0 9.0 ± 2.2 8–20 mg/dL 0.023* Creatinine level 0.7 ± 0.17 0.63 ± 0.18 0.5–0.9 mg/dL 0.058 - ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; IgE, immunoglobulin E; SCORAD, SCORing Atopic Dermatitis; SD, standard deviation.
-
- *
- Using paired t test.
- Fig. 2.Changes in SCORing Atopic Dermatitis scores after combination treatment with herbal medicines and oral antihistamines.SCORAD, SCORing Atopic Dermatitis.*p < 0.05 by paired t test.
4. Discussion
HMs
are widely used in many countries, particularly East Asian countries,
for the treatment of AD. Some herbs have exhibited anti-inflammatory
effects in human studies.14
In more recent randomized, placebo- or active drug-controlled studies
on HMs, Xiao-Feng-San, TJ-15, and TJ-17 resulted in significantly
improved clinical symptom scores and pruritus scores.6 ; 15 Furthermore, some individual herbs that benefit AD patients include St John’s wort, licorice, and mahonia.16; 17 ; 18
The most commonly proposed mechanism of HMs is an anti-inflammatory
effect through suppression of the Th2 response and/or modulation of the
Th1 response.19
For
AD patients with uncontrolled itching, combination treatment with HMs
and oral antihistamines is routinely employed in clinical practice in
Korea. Antihistamines are frequently used for the management of itching
in AD. Antihistamines exhibit several adverse side effects related to
their antihistaminic actions, including sedation, impaired motor
function, dizziness, dry mouth and throat, blurred vision, urinary
retention, and constipation. However, these side effects are usually
mild and can be rapidly reversed with discontinuation of treatment or a
decrease in dose.5
Antihistamines rarely cause liver injury. Their relative safety
probably relates to their use in low doses for short time periods.20
HMs
also exhibit some side effects, including hepatotoxicity,
pseudoaldosteronism, and interstitial pneumonia, which may occasionally
arise after treatment in certain patients.9; 10 ; 11 According to previous studies, the incidence of HM-induced liver injury is less than 1%,21 and it is related to prolonged dosing and/or overdose of certain herbs such as Radix Polygoni multiflori. 22 Prolonged use of excessive doses of Radix Glycyrrhizae
can lead to pseudoaldosteronism, which includes potassium depletion,
sodium retention, edema, hypertension, and weight gain. However, it may
occur when an herb is used for more than 6 weeks or when taken in
excessive doses over 50 g/d.23 There are few studies regarding interstitial pneumonia associated with Radix Scutellaria baicalensis and Radix Bupleuri and/or interferon. 10 However, these studies have been reported in patients with hepatitis.
Despite
the common combinational use of HMs and conventional medicine, studies
documenting the efficacy and safety of these combinations are sparse.
One review article describing interactions between herbs and prescribed
drugs showed that specific herbs such as St John’s wort, gingko, and
ginseng interact with certain drugs such as warfarin, aspirin, and
cyclosporine.29 In that review, herbal mixtures, antihistamines, and patients with skin disease were not included.
A
recent study showed that combinatorial use of oral herbal medication
with conventional treatment reduced exposure to corticosteroids among
children with AD in Taiwan.24
In Japan, Sipmipaedoksan (Jumihaidokuto in Japanese, Shiweibadusan in
Chinese), a Kampo formula, decreases the disease activity of
palmoplantar pustulosis when used with topical corticosteroids and oral
antihistamines.25
However, few reported studies regarding the combinatorial use of HMs
and oral antihistamines for AD have been published in the English
literature. As we discussed above, both HMs and oral antihistamines are
relatively safe under careful and professional medical practice.
Furthermore, AD patients are usually young, with a liver function that
does not differ from that of healthy people. In the 1990s, a few studies
claimed a relationship between AD and abnormal liver function in
infants. To the best of our knowledge, there are no reports showing that
liver function is more vulnerable in AD patients than in healthy
people.
During the study period, 40 of 163 inpatients fulfilled the inclusion criteria. Similar to a recent study,26
all patients were younger than 38 years. The mean durations of
admission and combination treatment were 12.7 days and 11.7 days,
respectively. All patients received HMs three times after meals and one
or two antihistamines once or twice a day within 30 minutes after HM
intake. HMs comprised a mixture of an average of 20.69 different herbs,
and a total of 98 different herbs were used for the included patients.
The most commonly used herbs, including Radix Rehmanniae and Radix Glycyrrhizae, are listed in Table 4. Except Radix Rehmanniae,
the dose range for each herb in a decoction is 10–16 g. For the
majority of commonly used herbs, the range is 6–15 g for a 1-day dose.
Some herbs like Radix Rehmanniae are used at considerably
higher dosages for a decoction, whereas some herbs are used in much
lower dosages due to their side effects or toxicity. 27
In this study, because many patients received herbs with the potential
for hepatotoxicity, pseudoaldosteronism, or interstitial pneumonia, the
herbs were dosed at less than 20 g/d.
The
mean objective SCORAD score decreased from 50.8 to 28.5 during 11 days
of the combination treatment. Depending on the classification of
severity of AD, < 15 objective SCORAD score are mild, 15–40 are
moderate, and > 40 are severe.28
In this study, the mean score of objective SCORAD score decreased from
severe to moderate. The changes in SCORAD scores observed in the present
study were similar to those observed in a previous study by the
authors, which was a retrospective chart review of inpatients with
severe AD.8
In that study, the objective SCORAD score of 29 patients was reduced
from 48.38 to 30.46 during an average of 9.79 days of inpatient
treatment with herbal medicines, acupuncture, and herbal wet wrap
dressing. Among the 29 patients of the previous study, 5 used
antihistamines. Antihistamines are selectively used when itching is not
controlled.
However;
eosinophil counts statistically significant decreased, and serum total
IgE level slightly increased, but not all of them were clinically
meaningful changes considering the reference range. Although elevated
serum total IgE levels and eosinophil counts have been reported in AD
patients, also these may reflect the severity of AD or may play as
prognostic factors, there are yet many opinions that are opposed. In
addition, the study period of 12.7 days could be short to change the
hematology results.
In
the present study, there were no significant changes in liver or renal
function after combination treatment with HMs and oral antihistamines.
There were also no adverse event reports of pseudoaldosteronism or
interstitial pneumonia.
We
observed that the concurrent use of one or two antihistamines once or
twice a day within 30 minutes of HM intake for a relatively short period
of time improved clinical symptoms without liver and renal function
changes through this retrospective chart review. No significant
reductions in serum total IgE levels and eosinophil counts were observed
in this study.
The
present study has several limitations. First, the number of observed
patients was relatively small. During hospitalization, we managed all
treatment-related processes except those provided by the hospital, which
is the advantage of inpatient care. However, this decreased the number
of patients who met inclusion criteria for this study. Therefore, our
study may have a low statistical power to observe the effectiveness of
HMs with antihistamines for AD. Second, this is a retrospective chart
review of AD patients who received HM with antihistamines and does not
include a control group to compare the effectiveness and safety. In
addition, due to the retrospective nature of this study, there may have
been a selection bias that arises from the selection of a particular
population. In addition, by observing only the recorded information,
information bias may have occurred due to the limitation of the quality
and quantity of medical records. Information bias may have affected
safety assessments.
Because
of these limitations, it is difficult to generalize the results of this
study. Finally, the patients did not undergo a long-term treatment with
HMs in combination with oral antihistamines. Patients who have chronic
diseases such as AD tend to use HMs for a longer time period, and this
may be associated with liver injury.
Despite
these limitations, to the best of our knowledge, this is the first
report regarding the effectiveness and safety of combination treatment
with HMs and oral antihistamines for the treatment of AD, and our
results may serve as the basis for further studies.
In
summary, the results of our study suggest that the short-term
combination treatment of AD with HMs and oral antihistamines is safe and
effective, with a low risk of adverse reactions. Further prospective
studies with long-term follow-up periods are necessary to further
clarify our findings.
Conflicts of interest
The authors declare that they have no competing interests.
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© 2017 Korea Institute of Oriental Medicine. Published by Elsevier.
