Prospective observational study to evaluate the efficacy and safety of the pollen extract Sérélys ® in the management of women with menopausal symptoms

Abstract

Safety concerns or contraindications to the use of hormones have resulted in a rise of the use of herbal medicinal products for the management of menopausal symptoms. The pollen extract Sérélys® represents, due to its ingredients and mode of action, a new and innovative alternative for the management of these symptoms. The aim of the present study was to demonstrate the efficacy and safety of Sérélys®. A prospective, open, observational, and multicentre study was performed on 104 menopausal women. The patients received over 3 months the pollen extract Sérélys® containing the extracts PI82 and GC Fem in a dosage of twice 160 mg extract and 5 mg vitamin E. Using a validated menopausal rating score, the improvement of menopausal symptoms was recorded. A significant decrease of different menopausal symptoms was observed between the starting point of the study and after 12 weeks (p < .0001). Hot flashes were reduced by 48.5%, sleep disturbance by 50.1%, depressive mood by 51.2%, irritability by 47.9%, fatigue by 47.8%, vaginal dryness by 39.63% and muscles and joint pain by 27.4%. The pollen extract Sérélys® reduced significant menopausal symptoms showing a very low side effect profile.

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Gynecological Endocrinology
ISSN: 0951-3590 (Print) 1473-0766 (Online) Journal homepage: https://www.tandfonline.com/loi/igye20
Prospective observational study to evaluate the
efficacy and safety of the pollen extract Sérélys®
in the management of women with menopausal
symptoms
Tomas Fait, Manuela Sailer & Pedro-Antonio Regidor
To cite this article: Tomas Fait, Manuela Sailer & Pedro-Antonio Regidor (2019): Prospective
observational study to evaluate the efficacy and safety of the pollen extract Sérélys® in the
management of women with menopausal symptoms, Gynecological Endocrinology, DOI:
10.1080/09513590.2018.1538347
To link to this article: https://doi.org/10.1080/09513590.2018.1538347
Published online: 10 Feb 2019.
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ORIGINAL ARTICLE
Prospective observational study to evaluate the efficacy and safety of the pollen
extract S
er
elys
V
R
in the management of women with menopausal symptoms
Tomas Fait
a
, Manuela Sailer
b
and Pedro-Antonio Regidor
b
a
Department of Obstetrics and Gynaecology, 2nd Faculty of Medicine, Charles University Prague, Prague, Czech Republic;
b
Exeltis Healthcare,
Ismaning, Germany
ABSTRACT
Safety concerns or contraindications to the use of hormones have resulted in a rise of the use of herbal
medicinal products for the management of menopausal symptoms. The pollen extract S
er
elys
V
R
repre-
sents, due to its ingredients and mode of action, a new and innovative alternative for the management
of these symptoms. The aim of the present study was to demonstrate the efficacy and safety of S
er
elys
V
R
.
A prospective, open, observational, and multicentre study was performed on 104 menopausal women.
The patients received over 3 months the pollen extract S
er
elys
V
R
containing the extracts PI82 and GC Fem
in a dosage of twice 160 mg extract and 5 mg vitamin E. Using a validated menopausal rating score, the
improvement of menopausal symptoms was recorded. A significant decrease of different menopausal
symptoms was observed between the starting point of the study and after 12weeks (p<.0001). Hot
flashes were reduced by 48.5%, sleep disturbance by 50.1%, depressive mood by 51.2%, irritability by
47.9%, fatigue by 47.8%, vaginal dryness by 39.63% and muscles and joint pain by 27.4%. The pollen
extract S
er
elys
V
R
reduced significant menopausal symptoms showing a very low side effect profile.
ARTICLE HISTORY
Received 25 July 2018
Revised 3 October 2018
Accepted 16 October 2018
Published online 6 February
2019
KEYWORDS
Pollen extract; menopause;
non-estrogenic activity
Introduction
Menopausal hormone therapy (MHT) is, according to the
International Menopausal Society (IMS), the most effective treat-
ment of vasomotor symptoms in menopause. The basis of this
treatment is the application of estrogens alone or in combination
with progestogens. Many women still have contraindications to
these hormones or prefer a non-hormonal approach to the man-
agement of these vasomotor symptoms. Safety issues play, on the
other side, also an important role in the management of this dis-
order that affects up to 70% of the women entering menopause
[1]. Upon others, anti-depressants, phytoestrogens, acupuncture,
traditional Chinese medicine have been used as non-hormonal
methods against vasomotor symptoms [2]. Even though the
NAMS position statement of 2015 described the data situation of
herbal therapies as insufficient regarding clinical data [3].
Nevertheless, pollen extracts and Vitamin E were mentioned in
this report adding the fact that more data should be gener-
ated [3].
Intensity and frequency of hot flashes and night sweating are
directly related to sleep disturbance and emotional instability,
leading to stress which again re-increases sensitivity to hot
flashes [4].
Although MHT is the most effective treatment for these prob-
lems after the publications of the Womens Health Initiative
study in 2002 [5], a constant decrease in the number of users of
hormones can be registered. In the United States, the use of
MHT fell from 38.3% in 2000 to 6.7% in 2010 within the age
group 50 and 59 [6]. In addition to the consumer’s fears, MHT
is contraindicated for women with breast cancer, cardiovascular
diseases like thrombotic events or strokes in their clinical history
or hepatic diseases [2]. However, even phytoestrogens with a low
efficacy activate estrogen receptors creating safety concern in
regard of its mode of action especially for women with breast
cancer in their history [7]. Daidzein and genistein in high con-
centration stimulate the growth of breast cancer cells [8].
Selective serotonin reuptake inhibitors (SSRI) inhibit the activity
of the enzyme CYP2D6 and thus reduce the conversion of the
prodrug tamoxifen to the biological drug endoxifen [9,10]; even
if those anti-depressants are commonly used by women with
breast cancer.
In this context the use of a special pollen extract (S
er
elys
V
R
)
represents an alternative and promising tool in the management
of vasomotor symptoms in the menopause. After extraction of
the active ingredients of the pollen, only the content of the intine
(=purified cytoplasm of pollen) of the pollen grain is used. Due
to this technique, the risk of allergic reactions is reduced.
While some widely used bee products containing whole pol-
len grain and they are a variable blend of different plants pollen,
the patented pollen extracts PI82/GC Fem (S
er
elys
V
R
) are exactly
defined monocultures. The monocultures used contains pollen
from rye (secale cereal), scots pine (pinus sylvestris), cock’s-foot
(dactylis glomerata) and maize (zea mays). During the cultivation
processes, pesticides and artificial fertilizers are not used. About
5 g of extract is obtained from 1 kg of flowers.
Muntzig et al. [11] could describe that these two extracts
show no biological estrogenic activity as the used uterotropic test
on rats was negative.
These pollen extracts exert their mode of action like SSRI as
they inhibit the reuptake intake of tritiated serotonin in rat cor-
tical synaptosomes. This mechanism is supposed to influence the
sleep and the thermoregulation. However, in contrast to the clas-
sical SSRI S
er
elys
V
R
does not influence the enzymes responsible
for the metabolism of tamoxifen [12].
CONTACT Pedro-Antonio Regidor pedro-antonio.regidor@exeltis.com Exeltis Healthcare, Adalperostr. 84, 85737 Ismaning, Germany
ß2019 Informa UK Limited, trading as Taylor & Francis Group
GYNECOLOGICAL ENDOCRINOLOGY
https://doi.org/10.1080/09513590.2018.1538347

The aim of this study was therefore to perform a prospective,
open evaluation of the effectiveness of the pollen extract S
er
elys
V
R
in
the improvement of vasomotor symptoms upon menopausal women.
Patients and methods
A multicentre study of the clinical effect of the pollen extract
PI82/GC Fem (S
er
elys
V
R
) took place in the Czech Republic and
Slovak Republic from October 2016 till March 2017. A total of
104 women between 50 and 70 years of age with the climacteric
syndromes were included. The patients used twice per day
S
er
elys
V
R
(160 mg of PCP and 5 mg of vitamin E per tablet) for 3
months. To assess the efficacy of the treatment, the menopausal
rating scale score from Heinemann et al. [13] was used. At the
beginning and then at the end of each month the study partici-
pants answered the questions of this score system.
Ratings were as follows: 0 points ¼no menopausal symptoms,
1 point ¼moderate menopausal symptoms, 2 points ¼medium
menopausal symptoms, 3 points ¼strong menopausal symptoms,
4 points ¼very strong menopausal symptoms.
The data were processed by disposable descriptive statistics
with determination of pvalues. Standard deviation values were
evaluated and are shown in the figures.
Results
A highly significant decrease (p<.0001) in the extent of com-
plaints was recorded for the following symptoms:
Hot flashes
A global reduction by 48.5% was observed after a 3-month treat-
ment. The starting score was 2.81 points and the final evaluated
score was 1.37 (SD ¼0.51). The sleep disturbance improvement
was 50.1% with a reduction in the score from 2.59 points to 1.3
points (SD ¼0.48). The symptom depressive mood improved by
51.2% (from 2.09 points to 1.07 points with a SD of 0.40 (see
Figure 1). The symptom irritability improved by 47.9% (point
reduction from 2.19 to 1.14 with a SD of 0.24. The symptom
fatigue improved by 47.8% (point reduction from 2.09 to 1.0
points with a SD of 0.41 (see Figure 2). The recorded symptom
vaginal dryness improved by 39.63% (point reduction from 1.65
to 0.65 with a SD of 0.16) and the symptoms muscles and joint
pain by 27.4% (point reduction from 1.46 to 0.4 with a SD of
1.6; see Figure 3).
No difference was recorded between women neither in the
Czech Republic and the Slovak Republic. No undesirable side
effects were recorded.
The results are summarized in Table 1.
Discussion
Initially, the extract administered in doses of 160, mg twice a day
was studied in women with a premenstrual syndrome. In this mul-
ticentre, placebo-controlled, double-blind prospective study with
an intervention period of 2 months a statistically significant
improvement of the symptoms was proved in the group of 32
patients when active ingredient was given against placebo [14].
The efficacy in women with a premenstrual syndrome was
also proven in another study were a double-blind, randomized,
placebo-controlled, prospective protocol compared 50 women
receiving the extract and 51 women receiving placebo for 4
months [15].
After proving efficacy in women with a premenstrual syn-
drome the first data suggesting that vasomotor symptoms could
be treated was shown in by Winther et al. [16]. Using a meno-
pausal rating scale, a significant decrease in hot flashes by 23%
since the end of the 2
nd
month of the treatment (p<.001 com-
paring to the initial value and p<.026 comparing to placebo)
was observed due to the use of S
er
elys
V
R
[16].
Following this trial in a French open multicentre placebo-con-
trolled study, 417 post-menopausal women received S
er
elys
V
R
twice per day. After 3 months, a significant improvement regard-
ing hot flashes both in frequency (65%) (p¼.0659) and intensity
(64%) (p¼.0003) was described. Other symptoms like sweating,
irritability and fatigue also improved considerably [17].
Druckmann et al. [18] could also show in an open multicentre
study, a significant improvement of the classical vasomotor
symptoms and other menopausal-related symptoms after the use
of S
er
elys
V
R
against placebo over 90 d. A significant decrease
(p<.0001) was recorded for hot flashes, irritability. In addition,
72% of women reported a better quality of life with high toler-
ance to the extract (98.7%) [18].
Figure 1. Improvement of the symptoms hot flashes, sleep disturbances and depression after 3months of treatment with the pollen extract S
er
elys (p<.0001).
2 T. FAIT ET AL.

The presented data of this open study reaffirms the existing
data. S
er
elys
V
R
not only improved the menopausal symptoms but
also sowed minimal side effects.
The only weakness of this trial was that it was not a placebo
controlled one. But if we assume that a placebo effect especially
in the reduction of vasomotor symptoms can reach up to 33% of
the starting point [19], the obtained results are still above this
and in the range of the results observed when placebo was com-
pared to the use of SSRI. A reduction of almost 50% for the
symptom’s hot flashes, irritability, sleeping disorders and depres-
sion also explain the postulated mode of action via inhibition of
serotonin reuptake.
The relevance of these findings is that a non-hormonal treat-
ment option for the improvement of menopausal symptoms is
available even for women that have suffered a breast cancer.
S
er
elys
V
R
can be considered as a safe product as it has no effect of
the growth of cell cancer lines. Seeger et al. [20] could recently
show that breast cancer cell lines with and without the progester-
one membrane component-1 (PGRMC-1) exhibit no growth when
treated even with ultra-high dosages of the pollen extract [20].
One unanswered question is, if long-term users of S
er
elys
V
R
still will benefit from this herbal product or if with the time a
lack of efficacy can occur. Therefore, long-term studies must be
performed to answer this question.
Figure 2. Improvement of the symptoms irritability and fatigue after 3 months of treatment with the pollen extract S
er
elys (p<.0001).
Figure 3. Improvement of the symptoms vaginal dryness and muscular pain after 3 months of treatment with the pollen extract S
er
elys (p<.0001).
Table 1. Developement of the scores of all investigated symptoms.
Observed symptom Before therapy 1
st
month 2
nd
month 3
rd
month
Overall
improvement
Improvement
in % pvalue
Hot flashes 2.82 2.28 1.8 1.46 1.37 48.5 7.21E-11
Sleep disturbance 2.59 2.09 1.57 1.33 1.3 50.1 1.88E-07
Depression 2.09 1.77 1.37 1.02 1.07 51.2 3.55E-07
Irritability 2.19 1.73 1.42 1.05 1.14 47.9 7.46E-08
Fatigue 2.09 1.73 1.39 1.09 1.0 47.9 3.56E-07
Vaginal dryness 1.64 1.38 1.19 0.96 0.65 39.6 1.73E-20
Muscles and joint pain 1.46 1.37 1.12 1.06 0.4 27.4 1.76E-20
GYNECOLOGICAL ENDOCRINOLOGY 3

Conclusion
In this prospective, open, multicentre study S
er
elys
V
R
,asan
herbal product, was able to reduce significantly menopausal
symptoms as vasomotor symptoms, fatigue, irritability, depres-
sion, or vaginal dryness. In view of the zero-estrogenic activity of
the extract, the therapy is suitable even for women for whom
receiving estrogens are contraindicated or can be dangerous due
to possible side effects.
Disclosure statement
Manule Sailer and Pedro-Antonio Regidor are employees of Exeltis
Healthcare. Thomas Fait has no conflict of interest.
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