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Randomized Trial of Aromatherapy: Successful Treatment for Alopecia Areata

Authors:
Randomized Trial of Aromatherapy
Successful Treatment for Alopecia Areata
Isabelle C. Hay, MRCP; Margaret Jamieson, SRN; Anthony D. Ormerod, FRCP
Objective: To investigate the efficacy of aromatherapy
in the treatment of patients with alopecia areata.
Design: A randomized, double-blind, controlled trial of
7 months’ duration, with follow-up at 3 and 7 months.
Setting: Dermatology outpatient department.
Participants: Eighty-six patients diagnosed as having
alopecia areata.
Intervention: Eighty-six patients were randomized into
2 groups. The active group massaged essential oils (thyme,
rosemary, lavender, and cedarwood) in a mixture of car-
rier oils (jojoba and grapeseed) into their scalp daily. The
control group used only carrier oils for their massage,
also daily.
Main Outcome Measures: Treatment success was
evaluated on sequential photographs by 2 dermatolo-
gists (I.C.H. and A.D.O.) independently. Similarly, the
degree of improvement was measured by 2 methods: a
6-point scale and computerized analysis of traced areas
of alopecia.
Results: Nineteen (44%) of 43 patients in the active
group showed improvement compared with 6 (15%) of
41 patients in the control group (P= .008). An alopecia
scale was applied by blinded observers on sequential
photographs and was shown to be reproducible with
good interobserver agreement (k= 0.84). The degree of
improvement on photographic assessment was signifi-
cant (P= .05). Demographic analysis showed that the 2
groups were well matched for prognostic factors.
Conclusions: The results show aromatherapy to be a
safe and effective treatment for alopecia areata. Treat-
ment with these essential oils was significantly more
effective than treatment with the carrier oil alone
(P= .008 for the primary outcome measure). We also
successfully applied an evidence-based method to an
alternative therapy.
Arch Dermatol. 1998;134:1349-1352
WITH THE recent re-
surgence of inter-
est in alternative
medicine, aroma-
therapy (aroma,
from the Greek meaning spice) has at-
tracted great public interest in its health-
promoting or medicinal properties. With
herbalism as its basis, aromatherapy in-
volves the use of essential oils and es-
sences derived from plants, flowers, and
wood resins, which are generally mas-
saged into the skin. These essential oils
have been used to complement tradi-
tional medicine with some benefit.1As with
other forms of alternative medicine, sci-
entific bases for the claims made are few,2,3
but in dermatologic studies, physiologi-
cal and psychological benefits were found
after treatment of psoriasis with aroma-
therapy.4Significant, consistent improve-
ment in behavior occurred in 1 of 4 pa-
tients with dementia5in 10 repeated
experiments. Aromatherapy is also use-
ful in hospice care.6
As examples of proven therapeutic
benefit, use of sandalwood oil has been
shown to significantly inhibit skin papil-
lomas in mice.7Tea tree oil is an effective
bacteriocide8and fungicide, especially for
Malassezia furfur.9Use of essential oils can
also alter the barrier functions of the skin10
and induce contact dermatitis.11
Cedarwood, lavender, thyme, and
rosemary oils have hair growth–
promoting properties. These oils have been
anecdotally used to treat alopecia for more
than 100 years. To date, there have been
no controlled trials to evaluate this treat-
ment. Our experience using aroma-
therapy provides anecdotal evidence that
several patients have had marked improve-
ment with this form of therapy. Our aim
in this study was to test the hypothesis that
pharmacologically active stimulants for
hair growth are present in these oils and
that use of these oils can be therapeutic
in patients with alopecia.
Alopecia areata is a common con-
dition affecting 1% of the Western
world. It can cause substantial social
and psychological distress and is often
highly detrimental to the patient’s well-
being and self-esteem. In 1 study,12
STUDY
From the Department of
Dermatology, Aberdeen Royal
Infirmary, Foresterhill,
Aberdeen, Scotland.
ARCH DERMATOL / VOL 134, NOV 1998
1349
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patients with alopecia areata had an increased risk of
developing a psychiatric illness. An autoimmune
cause is widely accepted. However, it is thought that
stress can affect its course. Current conventional treat-
ments have limited success or unacceptable toxic
effects. The course of alopecia areata is unpredictable,
but factors affecting prognosis are well established.
A poor prognosis is indicated by the long duration
of the condition (.1 year), associated autoimmune
conditions (eg, thyroid disease), atopy, and family
history.13-16
RESULTS
Eighty-four patients entered the trial; 28 (68%) of the pa-
tients in the control group and 35 (81%) of the patients
in the active group completed the trial (Figure 2). The
patients were well matched for the important demo-
graphic indicators that might affect response to therapy
(Table 1). The distribution of patients by the 4-point
scale was similar in both groups.
The improvement was statistically significant in all as-
sessments undertaken. The primary outcome measure of im-
provement vs no improvement showed improvement with
essential oils (P= .008, x2)(Table 2). The degree of im-
provement shown in the photographs was assessed by the
Mann-Whitney Utest and was significant (P= .05). The re-
sults of the alopecia scale, which scored the degree of im-
provement (from 1-6), are illustrated in Figure 3. The mea-
surement of traced areas, which could be performed in only
32 patients, showed a mean±SD reduction in area affected
of 103.9 ± 140.0 cm2compared with −1.8 ± 155.0 cm2in the
control group (Figure 4). This was significant, with P= .05
(Student ttest). A relative risk of 2.6 (95% confidence lim-
its, 1.2, 5.6) was calculated for the likelihood of improving
on the active therapy. Weighted kstatistic was 0.84
for agreement between scorers on the assessment of the pho-
tographic scale, showing good interrater correlation.
This indicates that this is a reproducible method of
assessment. One patient who received active treatment
and had an excellent response (ie, a score of 6 on our
scale) is pictured in Figure 5.
PATIENTS, MATERIALS,
AND METHODS
PATIENTS
Eighty-six patients diagnosed as having alopecia areata were
invited to take part in this randomized, controlled trial. These
patients were interviewed, and they completed a question-
naire. Patients with a medical history of hypertension, epi-
lepsy, or pregnancy were excluded. Two of 86 patients were
excluded because they had androgenic alopecia. Topical
medication and intralesional corticosteroid therapy for the
alopecia were discontinued before the trial.
Eighty-four patients were randomized into 2 groups
by the aromatherapist (M.J.). All patients signed a written
consent form before the trial.
The trained aromatherapist explained how to use the
oils and demonstrated the technique of scalp massage. The
oils were massaged into the scalp for a minimum of 2 min-
utes. A warm towel was then wrapped around the head to
aid absorption of the oils. Patients were advised to use this
technique every night.
There were 2 arms to the trial. The active group re-
ceived the essential oils: Thyme vulgaris (2 drops, 88 mg),
Lavandula agustifolia (3 drops, 108 mg), Rosmarinus offi-
cinalis (3 drops, 114 mg), and Cedrus atlantica (2 drops,
94 mg). These oils were mixed in a carrier oil, which was
a combination of jojoba, 3 mL, and grapeseed, 20 mL, oils.
The control group received the same carrier oils with-
out added essential oils, and the oils were identical except
in smell, which could not be mimicked in the control.
MEASUREMENT AND EVALUATION
Initial and 3- and 7-month assessments were made by 3
methods:
1. A 4-point scale, such as that described by MacDon-
ald Hull and Norris,17 was used to check that the severity was
similar in active and control groups, as follows: 1 indicates
vellus hair or no hair; 2, sparse pigmented or nonpigmented
terminal hair; 3, terminal regrowth with patches of alopecia
areata; and 4, terminal regrowth in all areas.
2. A standardized professional photographic assess-
ment of each volunteer was taken at the initial interview
and after 3 and 7 months. Changes in these photographic
assessments formed the primary outcome measure, with
improvement as the most important factor. These changes
were scored independently by 2 dermatologists (I.C.H. and
A.D.O.) who were unaware of the therapy administered.
Improvement in photographic assessment was graded us-
ing a numerical scale (Figure 1).
3. A further secondary outcome measure was per-
formed. A map was traced onto transparent film wherever
the alopecia occurred in patches. These tracings were then
transferred onto flat acetate sheets. A computerized image
analyzer was used to calculate the areas of alopecia at the
initial assessment and after 3 and 7 months.
STATISTICAL METHODS
We calculated that if improvement occurred in 20% more
patients with active treatment than in the control group it
would require 47 active and 47 control patients to detect
improvement at a 5% significance level with a power of
80%.18 Statistical analysis was performed on an intention-
to-treat basis. A pooled variance estimate Student ttest for
independent samples was used to test improvement in the
patients’ alopecia with the map-tracing method. The x2test
was used to detect improvement in the active and control
groups. A Mann-Whitney Utest, corrected for ties, was used
to assess the significance of the degree of improvement in
scored photographic assessment. The level of agreement
of the alopecia scoring scale between 2 assessors was ex-
amined using the Cohen weighted kstatistic.
The trial was approved by the Joint Ethical Commit-
tee for the Grampian Health Board and by the University
of Aberdeen, Aberdeen, Scotland.
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COMMENT
The responses were variable but showed a clear and sta-
tistically significant advantage to treatment with this stan-
dardized regimen of aromatherapy. Although the tradi-
tion of aromatherapy is to combine several oils, it seems
likely that 1 of these agents has a stimulatory effect on hair
growth. One male patient also had severe androgenic alo-
pecia, which was not included in the assessment of effi-
cacy, and within this area there was some moderate re-
growth of hair and improvement in alopecia areata.
There was a higher dropout rate in the control group,
which could be explained by the fact that the volunteers be-
came discouraged with the 7-month protocol. The control
oil was not odorless because the carrier oils have some smell,
and patients did not know what aroma to expect. However,
they may have surmised that their treatment was inactive
and withdrew from the trial. The control group’s relative lack
of response again suggests a pharmacoactive property of the
topically applied therapy as opposed to an effect arising from
the comforting, relaxing effect of massage and of the appli-
cation procedure, which was the same for both groups.
Previous studies of alopecia therapies have used only
subjective scales of improvement, such as those de-
scribed by MacDonald Hull and Norris.17 We found these
scales less helpful because there are large intervals be-
tween the points in the alopecia scale. We validated the
method of sequential photography with a standardized
approach using a professional photographer’s studio. Im-
ages were judged by blinded observers and showed good
agreement. This proved to be the most blinded and un-
biased approach because there was no possibility of smell-
ing which treatment had been applied.
We encountered no significant adverse events from
this treatment, which makes the therapeutic ratio high
Scale Description Hair Regrowth, %
1 Worse NA
2 No Change NA
3 Slight but Definite Improvement 10-30
4 Marked Improvement 31-50
5 Very Good Improvement 51-80
6 Excellent Improvement 81-100
Figure 1.
The scale used in the photographic assessment to measure
changes in hair growth after intervention with active essential oils compared
with the control. NA indicates not applicable.
Registered Patients
(N
=
86)
Randomization
Not Randomized
(n
=
2)
Reason: Did Not Have
Alopecia Areata
Standard Intervention (n
=
41)
Did Not Receive (n
=
0)
Followed Up (n
=
28)
Withdrawn (n
=
13)
Completed Trial (n
=
28)
Withdrawn (n
=
8)
Completed Trial (n
=
35)
Followed Up (n
=
35)
Intervention (n
=
43)
Did Not Receive (n
=
0)
Control Active
Figure 2.
Flow diagram showing the randomization of patients to the active
and control groups.
No. of Patients
20
15
10
5
065
Active Treatment
Control
4321
Improvement Score
Figure 3.
Results of the photographic assessment of the degree of
improvement in alopecia on a 6-point scale (see Figure 1).
Reduction in Area Affected, cm2
300
200
100
0Active Group Control Group
Figure 4.
Results of computerized analysis of traced areas of alopecia in
active and control groups. Bars indicate SD.
Table 1. Demographic and Prognostic Factors
in the Active and Control Groups*
Active Group Control Group Total
Age, mean ± SD, y 38.9 ± 14.6 39.3 ± 13.6 . . .
Associated conditions
Thyroid disease 14.0 12.2 13.1
Atopy 18.6 17.1 17.9
Stress 48.8 53.7 51.2
Family history
Alopecia areata 18.6 17.1 17.9
Autoimmune thyroid disease 18.6 24.4 21.4
*
Values are expressed as percentages unless otherwise indicated. Ellipses
indicate not applicable.
Table 2. Contingency Table of Improvement With Each
Intervention: Active Essential Oils vs Control Carrier Oil Alone*
Improved Not Improved Total
Active 19 16 35
Control 6 22 28
Total 25 38 63
*P
= .008 (
x
2
).
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compared with other therapies, such as diphency-
prone,14,16 squaric acid dibutylester,19 and systemic or in-
tralesional corticosteroid injections.
Populations in other trials may differ in prognostic
factors. Shapiro et al20 and Gordon et al14 found a 38%
success rate in producing cosmetically acceptable re-
growth in patients with alopecia using diphencyprone.
A review of psoralen–UV-A therapy for alopecia areata
by Taylor and Hawk21 revealed that phototherapy was dis-
appointing, with minimal benefit. Therefore, this aro-
matherapy trial, with an improvement rate of 44%, is com-
parable to and possibly of more benefit than trials of
conventional therapies for alopecia areata. Compared with
these other treatments, its safety is also greater, offering
a better therapeutic ratio.
Accepted for publication April 16, 1998.
The Soropotomists International of Aberdeen, Scot-
land, provided financial support for the trial.
We thank Jill Mollison, BSc, for statistical advice and
the members of the Aberdeen Alopecia Self Help Group for
their participation.
Corresponding author: Isabelle C. Hay, MRCP, De-
partment of Dermatology, Ward 48, Aberdeen Royal Infir-
mary, Foresterhill, Aberdeen AB25 2ZN, Scotland (e-mail:
ad.ormerod@abdn.ac.uk).
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Figure 5.
A patient showing an excellent response (6 on the scoring scale) to essential oil therapy.
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... However, drug interventions with EOs are not well established in the scientific literature. 13Chamomile and rosemary are known to improve hair growth and prevent hair loss.8,11,65,66 Rosemary oil showed tonic skin properties, promoting a calming effect and hair growth, and the scalp stimulation, thus becoming a proper treatment for both dandruff and oily hair.67 ...
... Restore the scalp ecoflora 62Shampoo, gel or lotion.improve blood flow; anti-hair loss; anti-dandruff agent 33Promote hair growth66 ; stimulate blood circulation of the scalp, strength the hair roots, alleviate dandruff and antihair loss33 % values to be used incorporated in cosmetic formulations.used according to their state; hair quality; habit of taking care of the hair, specific problems, among others. ...
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Thirty-six patients with alopecia areata of 1–54 years duration entered a study of treatment with the contact allergen diphencyprone for 8 months. Following sensitization the diphencyprone was applied to one half of the scalp at weekly intervals, the other half acting as a control. Once hair growth was established on one side, the other side was treated. Seven patients did not continue treatment and one patient showed spontaneous regrowth. Of the remaining 28 patients who persisted with treatments, fourteen (50%) regrew hair on the treated side; eight (29%) had a cosmetically acceptable result with the regrowth of terminal hair over the whole scalp. No statistically significant differences were found in age or duration of alopecia between those who regrew and those who did not. We have found diphencyprone to be an effective stimulator of hair growth in patients with severe and long-standing alopecia areata.
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There is a general move towards greater emphasis on point and interval estimates of treatment effect in reporting of clinical trials, so that significance testing plays a lesser role. In this article we examine a number of issues which affect the use and interpretation of conventional estimation methods. Should we accept or avoid the stereotypes of 95 per cent confidence? Should the abstract of a trial report include confidence intervals for major endpoints? Are frequentist confidence intervals being interpreted correctly, and should Bayesian probability intervals be more widely used in trial reports? Does the timing of publication, such as early stopping because of a large observed treatment difference, lead to exaggerated point and interval estimates? How can we produce realistic estimates from subgroup analyses? Is publication bias seriously affecting our ability to obtain unbiased estimates? Is the emphasis on estimation methods a powerful tool for encouraging larger sample sizes? Can we resolve the controversy concerning fixed or random effects models for estimation in overviews of related trials? Our arguments are illustrated by results from recent trials in cardiovascular disease.
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Thirty-six patients with alopecia areata of 1-54 years duration entered a study of treatment with the contact allergen diphencyprone for 8 months. Following sensitization the diphencyprone was applied to one half of the scalp at weekly intervals, the other half acting as a control. Once hair growth was established on one side, the other side was treated. Seven patients did not continue treatment and one patient showed spontaneous regrowth. Of the remaining 28 patients who persisted with treatments, fourteen (50%) regrew hair on the treated side; eight (29%) had a cosmetically acceptable result with the regrowth of terminal hair over the whole scalp. No statistically significant differences were found in age or duration of alopecia between those who regrew and those who did not. We have found diphencyprone to be an effective stimulator of hair growth in patients with severe and long-standing alopecia areata.
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Forty-two patients with alopecia areata were treated with local applications of dinitrochlorobenzene (DNCB); We used DNCB in two forms, an acetone solution applied weekly or a cream used every day, employing a wide range of DNCB concentrations. The concentration used was varied at the time of each application to produce a contact dermatitis. Seven patients experienced complete and lasting hair regrowth, 17 had poor results, and in 18 patients the treatment was a failure. Acquired tolerance to DNCB was observed in six patients; in five it was abolished by the administration of cimetidine. Certain factors such as the delay in appearance and the intensity of the sensitization reaction influence the hair regrowth. Poor prognostic criteria for treatment effect included a history of previous systemic corticosteroid therapy, atopy, and the presence of alopecia areata in close relatives.
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The relationship between psychiatric disorders and alopecia areata has not been well studied. Although previous reports have been unable to correlate psychiatric illness with hair loss, a recent study determined that 74% of patients with alopecia areata (AA) under evaluation had one or more lifetime psychiatric diagnoses. Two hundred and ninety-four community-based patients with alopecia areata responded to a detailed questionnaire distributed by Help Alopecia International Research, Inc. The prevalence of psychiatric disorders was determined using diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-IIIR). Major depression, generalized anxiety disorder, social phobia, and paranoid disorder were all present in patients with alopecia areata at rates significantly higher than in the general population. Alopecia areata patients are at a higher risk of developing psychiatric comorbidity during their clinical course.
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Topical diphenylcyclopropenone (DPCP) and minoxidil have been used in the treatment of alopecia areata with variable results. This study was designed to evaluate the efficacy of DPCP alone or in combination with topical 5% minoxidil for the treatment of chronic severe alopecia areata. The effect of therapy on cutaneous T-cell and Langerhans cell subpopulations and intercellular adhesion molecule-1 (ICAM-1) expression was also examined. Fifteen patients with chronic (more than 2 years), severe (more than 50% scalp involvement) alopecia areata participated in a 24-week trial. Half of the scalp was treated with DPCP once weekly and with either 5% minoxidil solution or a vehicle solution twice daily in a randomized double-blind design. Skin biopsy specimens from each half of the scalp were obtained before therapy and after 12 and 24 weeks of therapy for histologic and immunophenotypic analysis. Thirteen patients completed the study. Five of 13 patients (38%) showed marked regrowth of coarse terminal hair after 24 weeks of treatment with DPCP. The addition of topical 5% minoxidil did not produce any significant clinical benefit in this 24-week trial. Immunophenotypic analysis showed no differences between responders and nonresponders at baseline. During treatment, Leu-4, Leu-2, Leu-3, and keratinocyte ICAM-1 expression were significantly reduced in biopsy specimens of responders versus nonresponders. DPCP treatment showed a 38% success rate in producing cosmetically acceptable regrowth in patients with chronic severe alopecia areata.