Hindawi Publishing Corporation

Evidence-Based Complementary and Alternative Medicine

Volume 2014, Article ID 549721, 7 pages
http://dx.doi.org/10.1155/2014/549721

Research Article
Effect of Pumpkin Seed Oil on Hair Growth in Men
with Androgenetic Alopecia: A Randomized, Double-Blind,
Placebo-Controlled Trial

Young Hye Cho,1 Sang Yeoup Lee,1,2 Dong Wook Jeong,1 Eun Jung Choi,1 Yun Jin Kim,3
Jeong Gyu Lee,3 Yu Hyeon Yi,3 and Hyeong Soo Cha4
1
Family Medicine Clinic and Research Institute of Convergence of Biomedical Science and Technology,
Pusan National University Yangsan Hospital, Beomeo-ri, Mulgeum-eup, Yangsan 770-626, Gyeongsangnam-do, Republic of Korea
2
Medical Education Unit, Pusan National University School of Medicine, Yangsan 626-870, Republic of Korea
3
Department of Family Medicine, Pusan National University Hospital, Busan 602-739, Republic of Korea
4
Centum Family Clinic, Busan 612-020, Republic of Korea

Correspondence should be addressed to Sang Yeoup Lee; saylee@pnu.edu

Received 13 February 2014; Accepted 4 April 2014; Published 23 April 2014

Academic Editor: Rainer W. Bussmann

Copyright © 2014 Young Hye Cho et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Pumpkin seed oil (PSO) has been shown to block the action of 5-alpha reductase and to have antiandrogenic effects on rats. This
randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of PSO for treatment
of hair growth in male patients with mild to moderate androgenetic alopecia (AGA). 76 male patients with AGA received 400 mg
of PSO per day or a placebo for 24 weeks. Change over time in scalp hair growth was evaluated by four outcomes: assessment
of standardized clinical photographs by a blinded investigator; patient self-assessment scores; scalp hair thickness; and scalp hair
counts. Reports of adverse events were collected throughout the study. After 24 weeks of treatment, self-rated improvement score
and self-rated satisfaction scores in the PSO-treated group were higher than in the placebo group (𝑃 = 0.013, 0.003). The PSO-
treated group had more hair after treatment than at baseline, compared to the placebo group (𝑃 < 0.001). Mean hair count increases
of 40% were observed in PSO-treated men at 24 weeks, whereas increases of 10% were observed in placebo-treated men (𝑃 < 0.001).
Adverse effects were not different in the two groups.

1. Introduction practice [6–8]. Oral finasteride was found to decrease libido

and ejaculate volume or cause erectile dysfunction, whereas
Androgenetic alopecia (AGA) is the most common cause of topical minoxidil can cause scaling and itching of the scalp.
hair loss in men and affects up to 70% of men in later life Due to these adverse effects, patients seem to be drawn
and especially those aged over 50 years [1–3]. Genetic factors to alternative treatments with fewer side effects. In this
and androgens primarily underlie the pathogenesis of AGA. context, many natural products have been tested as potential
Hair follicles become gradually miniaturized and spend less alternative therapies for hair loss. Some products, such as
time in the active phase (the anagen phase) and more time green tea and saw palmetto, have demonstrated therapeutic
in the resting phase (the telogen phase) of hair growth [4]. potential for the treatment of AGA and benign prostatic
Furthermore, it is known that dihydrotestosterone (DHT) is hyperplasia (BPH) via the inhibition of 5𝛼-reductase activity
a major player in the process [5]. [9, 10]. Pumpkin seed oil (PSO) has also been reported to be
Topical minoxidil and oral finasteride have been ap- an effective treatment for symptomatic BPH [11]. Its actions
proved by the FDA for the treatment of AGA, but only about have been suggested to be due to phytosterols, which are
30% of patients persist with medication over a year in private known to inhibit 5𝛼-reductase and to have antiandrogenic
2 Evidence-Based Complementary and Alternative Medicine

effects in rats [12]. However the effects of PSO on AGA 2.3. Measurements. Body mass index was defined as weight
have not been established. We hypothesized that PSO is an (kg) divided by height squared (m2 ). A mercury sphygmo-
effective, safe agent for the treatment of men with AGA, manometer was used to measure blood pressure (BP) in the
and thus we evaluated the efficacy and tolerability of PSO sitting position after a 10-minute rest period. Two readings of
for treatment of hair growth in male patients with mild to systolic and diastolic BP were recorded at 3-minute intervals,
moderate AGA. and averages were included in the analysis.
Blood samples were taken at baseline and after 24 weeks
2. Materials and Methods of treatment after a 12 h fasting. Fasting blood sugar was
measured using a glucose oxidase test method (LX-20,
2.1. Study Design. This study had a randomized, placebo- Beckman Coulter, Fullerton, CA, USA). Serum AST, ALT, 𝛾-
controlled, double-blind, controlled design. The study was glutamyltransferase (GGT), and creatinine were determined
approved by the Institutional Review Board at Pusan National using a Toshiba TBA200FR biochemical analyzer (Toshiba
University Yangsan Hospital and was performed in accor- Co. Ltd., Tokyo). Serum-free testosterone was measured
dance with the principles of the Declaration of Helsinki. using a Coat-A-Count radioimmunoassay with gamma-10
Written informed consent was obtained from all subjects, (Shin Jin Medics, Korea).
which were recruited by advertising, before enrollment.
Eligible patients had mild to moderate hair loss classified
2.4. Patient Self-Assessment. After 12 and 24 weeks of treat-
as the Norwood-Hamilton type II, III, III Vertex, IV, and
ment, patient self-assessment of the efficacy of the treat-
V [13]. Ninety adults between the ages of 20 and 65 years
ment (self-rated improvement score) was based on a self-
with mild to moderate AGA were initially enrolled at a
tertiary hospital in Yangsan. The subjects had not applied administered hair growth, using a Visual Analogue Scale
any topical treatment or taken any medication or supplement (VAS), ranging from zero (representing the worst imaginable
for hair loss, including finasteride, any other 5𝛼-reductase state) to 10 (the best imaginable state). Self-rated satisfaction
inhibitor, minoxidil, steroids, or hormonal products, during with treatment was also measured using a 10-point VAS with
the 3 months prior to study commencement. For safety 0 and 10 representing the lowest and highest satisfaction level,
reasons, candidates with an aspartate aminotransferase (AST) respectively.
or alanine aminotransferase (ALT) serum level greater than
60 mg/dL or a creatinine level greater than 1.5 mg/dL were 2.5. Investigator Assessments. Pictures were taken of the
excluded. Four participants met the exclusion criteria and vertex and superior frontal scalp of each patient at base-
ten participants declined to participate. Finally 76 (84.4%) line and after 24 weeks of treatment using a standardized
participants were enrolled. After taking baseline measure- technique, as previously described [14]. A blinded investi-
ments, participants were randomly assigned to one of two gator rated changes in scalp appearance relative to baseline
groups: the intervention group (𝑛 = 37), members of (immediately prior to treatment commencement) in blinded
which received 400 mg of PSO (Octa Sabal PlusⓇ ) per day fashion using a standardized 7-point rating scale as follows:
in the form of capsules, or the control group (𝑛 = 39), greatly decreased (score of −3), moderately decreased (−2),
members of which received a placebo. Two capsules (100 mg slightly decreased (−1), unchanged (0), slightly increased
per capsule) of PSO were taken by subjects in the intervention (+1), moderately increased (+2), and greatly increased (+3)
group 30 minutes before breakfast and dinner (total of 4 [15]. Investigator assessments were performed at 12 and 24
capsules per day) for a period of 24 weeks. Subjects in the weeks.
control group were given the same quantity of placebos two
times per day for 24 weeks. Capsules were supplied with 2.6. Hair Analysis by Phototrichography. Hair changes includ-
visually identical forms by Dreamplus Co., Ltd. (Cheonan, ing hair counts and diameters were assessed after 12 and
Korea). Five participants in the intervention group and 7 24 weeks of treatment versus baseline by phototrichography
in the control group dropped out during the study. The (Scalp & Hair Polarizing system, KC Technology, Seoul,
characteristics of these 12 participants were similar to those Korea). Hair analysis using a phototrichography was per-
that completed the study. Subjects were assessed with respect formed by one technician. At baseline, the most severe site
to safety and compliance at every clinic visit (after 1, 4, and of baldness was recorded as target area of hair changes and
12 weeks of treatment). Compliance was assessed by pill the center of the phototrichogram probe was placed at this
count. Reports of adverse events were collected throughout site. After 12 and 24 weeks of treatment, hair analysis was
the study. performed with confirmation of recorded target area. Hair
counts were then recorded using a ×60 lens and the thickest
2.2. Randomization. Participants were assigned to the inter- hair diameter was recorded using a ×150 lens.
vention and control groups using random numbers tables,
and assigned identification numbers on recruitment. Ran- 2.7. Statistical Analysis. The primary outcome variables were
domization codes were held by Dreamplus Co., Ltd. The indi- blinded investigator assessment and patient self-assessment
vidual responsible for deciding on study eligibility and the scores. Secondary outcomes variables were changes in hair
individuals that conducted the measurements were unaware thickness and hair count. The calculated sample size was 35
of the results of randomization. patients per group for an 80% power to detect a difference
Evidence-Based Complementary and Alternative Medicine 3

Table 1: Basal characteristics of subjects.

Treatment (𝑁 = 37) Placebo (𝑁 = 39) 𝑃 value∗

Age (years) 45.6 ± 9.9 46.8 ± 10.3 0.615
Age of onset of hair loss (years) 34.2 ± 8.6 36.8 ± 9.8 0.223
The Norwood-Hamilton grade 0.373
Stage 2 8 (21.6) 4 (10.3)
Stage 3 5 (13.5) 2 (5.1)
Stage 3V 11 (29.7) 15 (38.5)
Stage 4 7 (18.9) 8 (20.5)
Stage 5 6 (16.2) 10 (25.6)
Family history of androgenetic alopecia 27 (73.0) 27 (69.2) 0.719
Smoking (pack-year) 5.9 ± 8.8 2.6 ± 6.4 0.067
Body mass index (kg/m2 ) 24.7 ± 2.9 24.5 ± 2.9 0.734
Data are expressed as means ± SD or frequency (percent).
∗
Two-sample Student’s 𝑡-test or chi-square test.

Table 2: Clinical and biochemical characteristics at the start of the study and after 24 weeks of treatment.

Treatment (𝑁 = 37) Placebo (𝑁 = 39)

Variables 𝑃 value∗ 𝑃 value†
Week 0‡ Week 24 Δ 24−0 weeks Week 0‡ Week 24 Δ 24−0 weeks
Body weight (kg) 72.9 ± 10.1 72.4 ± 10.2 −0.5 ± 1.6 71.1 ± 10.6 71.0 ± 10.8 0.1 ± 2.3 0.079, 0.747 0.419
WC (cm) 89.0 ± 7.3 85.8 ± 6.7 −3.3 ± 3.6 87.1 ± 6.1 83.7 ± 6.5 −3.4 ± 6.1 0.000, 0.001 0.890
Systolic BP (mmHg) 125.6 ± 15.5 124.4 ± 13.8 −1.2 ± 11.3 128.3 ± 14.6 129.3 ± 13.8 1.0 ± 15.8 0.518, 0.710 0.496
Diastolic BP (mmHg) 84.1 ± 12.8 84.0 ± 10.7 −0.1 ± 10.0 85.9 ± 13.6 85.2 ± 10.7 −0.8 ± 13.9 0.948, 0.731 0.813
Fasting glucose (mg/dL) 109.9 ± 30.0 112.9 ± 14.9 3.1 ± 27.2 104.4 ± 16.4 114.5 ± 22.4 10.1 ± 23.4 0.499, 0.011 0.229
AST (IU/L) 22.0 ± 3.9 22.9 ± 4.6 0.9 ± 4.7 22.7 ± 4.1 25.7 ± 6.4 3.0 ± 5.8 0.246, 0.002 0.091
ALT (IU/L) 20.3 ± 8.5 22.7 ± 11.6 2.3 ± 10.4 23.5 ± 8.7 27.2 ± 13.3 3.6 ± 11.1 0.183, 0.049 0.603
GGT (IU/L) 33.0 ± 29.7 31.4 ± 17.6 −1.6 ± 18.5 38.5 ± 25.3 40.3 ± 27.4 1.8 ± 12.6 0.603, 0.378 0.351
Creatinine (mg/dL) 0.92 ± 0.13 0.91 ± 0.14 −0.01 ± 0.08 0.96 ± 0.13 0.96 ± 0.14 −0.00 ± 0.11 0.290, 0.827 0.658
Free testosterone (pg/mL) 8.5 ± 3.2 9.5 ± 3.1 0.9 ± 3.7 10.9 ± 3.6 10.2 ± 3.4 −0.7 ± 3.5 0.135, 0.235 0.055
AST: aspartate transaminase; ALT: alanine transaminase; BP: blood pressure; GGT: gamma-glutamyltransferase; WC: waist circumference.
Data are means ± SD. Δ 24-0 weeks and difference compared with baseline.
∗
Paired Student’s 𝑡-test within group.
†
Two-way repeated measures ANOVA over time between groups.

in the mean investigator assessment score of 0.3, assuming a 3. Results

standard deviation of 0.5 in the primary outcome variables
and an alpha error of 5%. When test data was unavailable, 3.1. General Characteristics of the Study Subjects. Compliance
the last recorded data entry was entered in the analysis (the was satisfactory and participants took more than 95% of the
last observation carried forward method). Efficacy analysis supplements in the intervention and control groups. Ran-
was performed on an intention to treat (ITT) basis on domization was successful, as the two groups generated were
participants that received at least one dose of PSO or placebo comparable for most variables, and no significant differences
and that underwent at least one assessment postbaseline. were observed in baseline demographic, anthropometric, or
The D’Agostino Pearson test was used to test for variable clinical characteristics between the intervention and control
normality. Intergroup comparisons of baseline character- groups (Tables 1 and 2). Furthermore, no statistically sig-
istics and of their changes after 24 weeks of treatment nificant intergroup differences were observed for age at the
were performed using the two-sample Student’s 𝑡-test for onset of hair loss, family history of alopecia, or laboratory
continuous variables or the chi-square test for categorical data at baseline. During the study period, the double-blind
variables. Intragroup comparisons were performed using the requirement was well maintained.
paired Student’s 𝑡-test. Repeated-measures ANOVA was used
to evaluate intergroup differences in variables. 𝑃 values of
less than 0.05 were considered statistically significant. SPSS 3.2. Patient Self-Assessment. No significant intergroup differ-
version 18.0 was used for the analysis. ences were observed for self-rated improvement (𝑃 = 0.514)
4 Evidence-Based Complementary and Alternative Medicine

Table 3: Patients assessments of clinical response.

Treatment (𝑁 = 37) Placebo (𝑁 = 39) 𝑃 value∗

12 weeks 24 weeks 12 weeks 24 weeks Weeks 12 and 24
Self-improvement1 2.9 ± 2.5 3.4 ± 2.7 2.5 ± 2.8 2.1 ± 2.0 0.514, 0.013
Self-satisfaction1 3.4 ± 2.9 3.5 ± 2.9 2.6 ± 2.6 2.3 ± 2.0 0.214, 0.003
Data are expressed as mean with SD.
1
Patients provided ratings of improvement from 0 (no change or worse) to 10 (complete recovery) and satisfaction from 0 (complete disappointment) to 10
(full satisfaction) on Visual Analogue Scales.
∗
Two-sample Student’s 𝑡-test between groups.

1.0

∗
0.5
Mean score

Week
(a)
0 12 24
0.0

−0.5

Treatment
Placebo
(b)
Figure 1: Investigator assessment of clinical response using a
standardized 7-point rating scale during 24 weeks after study start.
Data are expressed as mean with SE. ∗ 𝑃 < 0.001 by repeated-
measures ANOVA. A standardized 7-point rating scale of hair
growth compared with baseline (−3 = greatly decreased, −2 =
moderately decreased, −1 = slightly decreased, 0 = no change, +1 =
slightly increased, +2 = moderately increased, and +3 = greatly
increased). Photographs of scalp hair were taken for hair counts and
for assessments of hair growth by an expert panel.
(c)

Figure 2: Representative photographs of patients at baseline and

or self-rated satisfaction scores (𝑃 = 0.214) for hair after 24 weeks of treatment with PSO.
growth at 12 weeks. However, after 24 weeks, the self-rated
improvement score in the intervention group was higher than
in the control group (3.4±2.9 in the intervention group versus
2.1 ± 2.0 in the control group, mean ± SD), and this difference were rated as unchanged relative to baseline and 44.1% (17/37)
was significantly different (𝑃 = 0.013 by the two sample were rated as slightly or moderately improved (Figure 2).
Student’s 𝑡-test). In addition, group self-rated satisfaction On the other hand, at 24 weeks, 28.2% (11/39) of subjects
scores were also significantly different at 24 weeks (3.5±2.9 in in the control group were assessed to have worsened based
the intervention group versus 2.3 ± 2.0 in the control group, on the investigator; 64.1% (25/39) were rated as unchanged
𝑃 = 0.003) (Table 3). relative to baseline and 7.7% (3/39) were rated as slightly
or moderately improved. These results showed significant
intergroup differences (data not shown, 𝑃 = 0.002 by chi-
3.3. Investigator Assessment Using Photographs. Based on
square test).
blinded investigator assessments, treatment with PSO was
superior to treatment with placebo with respect to hair
growth at 12 and 24 weeks (𝑃 < 0.001, all comparisons). In 3.4. Hair Analysis Using Phototrichography. Hair changes,
the control group, there was no initial improvement during that is, hair counts and hair diameters, were measured by
the first 12 weeks, and then hair growth plateaued during phototrichography at baseline and at 12 and 24 weeks. There
the second 12 weeks (Figure 1). At 24 weeks, 2.7% (1/37) were statistically significant differences in hair count changes
of subjects in the intervention group were assessed to have during 24 weeks in the intervention group and the control
worsened by blinded investigator assessments; 51.4% (19/37) group (Δ hair count per field of view using a ×60 lens; 6.2±6.5
Evidence-Based Complementary and Alternative Medicine 5

200 ∗ 550

175 ∗
450

Hair thickness (%)

150
Hair count (%)

350
125
250
100

75 150

50 50

Baseline 12 weeks 24 weeks Baseline 12 weeks 24 weeks

Treatment Treatment
Placebo Placebo
(a) (b)

Figure 3: Changes in hair count (a) and thickness (b) during 24 weeks after study start. Data are expressed as mean with SD. Change (%) =
(parameter at week 12 or 24-parameter at baseline)/(parameter at baseline) × 100. ∗ 𝑃 < 0.001 by repeated-measures ANOVA.

Table 4: Abnormal clinical findings at the start of the study and after 24 weeks of treatment.

Treatment (𝑁 = 37) Placebo (𝑁 = 39) 𝑃 value

Week 0 Week 24 Week 0 Week 24 Weeks 0 and 24
SBP ≥ 140 or DBP ≥ 90 mmHg∗ 13 (35.1) 13 (33.3) 12 (32.4) 13 (33.3) 0.764, 0.933
Fasting glucose ≥ 126 mg/dL∗ 6 (16.2) 8 (21.6) 5 (12.8) 10 (25.6) 0.674, 0.680
AST or ALT ≥ 1.5 × upper limit of normal∗∗ 0 (0.0) 1 (2.7) 0 (0.0) 2 (5.1) NA, 0.520
Creatinine ≥ 1.5 mg/dL∗∗ 0 (0.0) 1 (2.7) 0 (0.0) 0 (0.0) NA, 0.487
AST: aspartate transaminase; ALT: alanine transaminase; DBP: diastolic blood pressure; SBP: systolic blood pressure.
Data are expressed as frequency (percent). ∗ Chi-square test or ∗∗ Fisher’s exact test.

versus 1.8 ± 6.2; 𝑃 = 0.004). However, changes in hair 4. Discussion

thickness during 24 weeks were similar in the groups (Δ hair
thickness per field of view using a ×150 lens; 0.34 ± 0.03 To our knowledge, this is the first randomized, double-
versus 0.34 ± 0.02; 𝑃 = 0.991). At 12 and 24 weeks, there were blind, placebo-controlled trial to investigate the efficacy and
30% and 40% mean increases in hair counts from baseline tolerability of PSO in men with mild to moderate AGA. This
in PSO-treated men and 5% and 10% increases in hair count study shows that PSO supplement during 24 weeks has a
in placebo-treated men, which resulted in significant net positive anabolic efect on hair growth and that this is due to
increase of 25% and 30% (both, 𝑃 < 0.001) at weeks 12 and the possible efects of 5-reductase inhibition in patients with
24, respectively, in the intervention group as compared with mild to moderate male pattern hair loss.
the placebo group (Figure 3). AGA is the most common type of hair loss to affect
both males and females after puberty. Although AGA is
not a serious health problem, there is a strong demand for
3.5. Safety. Most of the subjects completed the protocol with- treatment and prevention due to the high level of interest
out adverse symptoms. One subject in the intervention group people have in personal appearance in modern society. It
and one subject in the control group complained of a whole is well known that finasteride and minoxidil are effective
body itching sensation. One subject in the intervention group treatments for androgenetic alopecia and both have been
complained of mild abdominal discomfort. No changes in approved by the FDA for this purpose, but some patients
liver enzyme or creatinine were observed in the intervention do not like taking medicine in the long term, because of
group. Serum-free testosterone levels were unchanged in possible side effects. For example, finasteride can decrease
both groups (Table 3). No intergroup differences in blood libido and ejaculate volume or cause erectile dysfunction,
pressure or glucose were observed during the study period whereas minoxidil can cause scaling and itching of the scalp
(Table 4). [6, 7].
6 Evidence-Based Complementary and Alternative Medicine

Herbal therapies have been used to treat baldness since required to elucidate the mechanism responsible for the
ancient times in the Ayurveda, Chinese, and Unani tra- positive effects of PSO on AGA.
ditional medicinal systems [4]. Natural products, such as
grape seed and rosemary oil, have been shown to be Conflict of Interests
possible alternative treatments for AGA due to improved
scalp blood flow [16, 17]. Several studies have reported that The authors declare that there is no conflict of interests.
the polyphenols in green tea might be useful for treating
AGA by inhibiting 5𝛼-reductase activity [9, 10]. Cuscuta
Acknowledgments
reflexa exhibited hair growth promotion via 5𝛼-reductase
inhibitory effect and this herbal extract was highlighted as This study was supported by a grant from Dreamplus Co., Ltd.
a potential treatment for hair loss [18]. Soymetide-4 was (2012).
one of the herbal product-suppressing alopecia and ginseng
(Panax ginseng) was also used for scalp treatment limiting
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