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Original Research Paper Commerce Medical Science Development And Testing of New Herbal Ointment for the Treatment of Stress Urinary Incontinence-A Preliminary Study

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  • ORESCANIN Ltd., A. Jaksica 30, Zagreb, Croatia, http://orescanin.webnode.com/
  • Ustanova za zdravstvenu skrb

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The purpose of this work was development, formulation and testing of new herbal ointment for the treatment of stress urinary incontinence and its related symptoms. 50 women in the age range from 36 to 73 years were treated 8 weeks with vaginal ointment (2 g/day) which consisted of the following ingredients: oil macerates of the plants Capsella bursa-pastoris, Urtica diodica, Quercus robur, Quercus infectoria, Corylus avellana, Ocimum basilicum, Salvia officinalis, Achillea millefolium, Calendula officinalis, Matricaria chamomilla, Hypericum perforatum, Alchemilla vulgaris, Thymus serpyllum, Plantago major, Symphytum officinale; essential oils of the plants Melaleuca alternifolia, Cymbopogon martinii, Cinnamomum camphora ct. cineol, Eugenia caryophylata, Thymus vulgaris ct. tymol, Origanum vulgare; honey; glycerin and Cera flava. The degree of incontinence and its impact on the quality of life prior and after the therapy was assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), where maximum score of 21 represents permanent incontinence and 0 no leakage of urine. Sexual gratification was assessed by the Pelvic organ prolepses / urinary Incontinence / Sexual Questionnaire (PISQ-12). The variables with the highest, statistically significant influence onto degree of incontinence and its impact on the quality of life were were Urine leak and related symptoms, Menopause, Frequent urinary tract infections, Age and Number of childbirth. Significant improvement concerning both, incontinence (p<0.0001) and sexuality (p<0.0003) was observed following two weeks of the application. In the end of the study the mean value of ICIQ-UI score decreased from 10.3±4.2 to 1.1±1.0 while PISQ-12 increased from 21.0±2.9 to 28.4±3.2. Following the eight weeks of the therapy 66% of the patients were completely dry, while other 34% exhibited only slight problems (ICIQ-UI score range 1-3). After only 7 days of the application the symptoms like burning, vaginal discharge, vaginal dryness and painful sexual intercourse decreased significantly while in the end of the treatment disappeared completely. ABSTRACT KEYWORDS : herbal ointment, stress urinary incontinence, olive oil extracts, medicinal plants, essential oils INTRODUCTION The International Continence Society Standardization of Terminology of Lower Urinary Tract Dysfunction established clinical definition of stress urinary incontinence (SUI) as the complaint of involuntary leakage during effort or exertion, or on sneezing or coughing (Luber, 2004). Its prevalence ranged between 4% and 35% depending on the country with age, obesity, and smoking as the most significant risk factors (Luber, 2004). Nygaard and Heit, 2004 reported that SUI occurs at least weekly in one third of adult women. Among 20,000 Chinese women in the age range from 20 to 99 years the prevalence of SUI was 18.9% (Zhu et al., 2009) and the significant risk factors are age, vaginal delivery, multiparty, alcohol consumption, central obesity constipation, chronic pelvic pain, history of respiratory disease, gyne-cological events, pelvic surgery, and perimenopause and postmeno-pause status. Among 1700 French women employed in academic hospital, 12.4% of them reported SUI (Peyrat et al., 2002). The pregnancy , particularly previous vaginal delivery and hysterectomy represented the significant risk factors. The prevalence of SUI reported by Minassian et al., 2008 among 2,875 adult women was 23.7%. The obtained significant risk factors were age, ethnic background, weight, parity and hysterectomy. Among 83,355 American nurses at the age range from 37 to 54 years 43% of them reported incontinence. Identified risk factors were age, race/ethnicity, body mass index, parity, smoking, type 2 diabetes mellitus, and hysterectomy (Danforth et al., 2006). A world wide survey conducted by McPhil, 2004 reviled the highest percentages of women with SUI in UK (41%) and Canada (42%) and the lowest percentage was obtained in Spain (23%) while the mean value for all tested countries was 32%. Two-thirds of the symptomatic women were younger than 50. Higher prevalence of SUI (Brown, et al., 1999) was obtained among postmenopausal women (56%).
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IF : 3.62 | IC Value 70.36
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Volume-5, Issue-7, July - 2016 • ISSN No 2277 - 8160
Original Research Paper Commerce Medical Science
Development And Testing of New Herbal Ointment for the
Treatment of Stress Urinary Incontinence-A Preliminary
Study
Oreščanin Višnja
OREŠČANIN Ltd., A. Jakšića 30, 10000 Zagreb, Croatia
Findri Guštek
Štefica
Findri-Guštek Centre for gynecology, urology and occupational
medicine, Ninska 5, Sesvete, Croatia
The purpose of this work was development, formulation and testing of new herbal ointment for the treatment of stress
urinary incontinence and its related symptoms. 50 women in the age range from 36 to 73 years were treated 8 weeks
with vaginal ointment (2 g/day) which consisted of the following ingredients: oil macerates of the plants Capsella
bursa-pastoris, Urtica diodica, Quercus robur, Quercus infectoria, Corylus avellana, Ocimum basilicum, Salvia officinalis, Achillea millefolium,
Calendula officinalis, Matricaria chamomilla, Hypericum perforatum, Alchemilla vulgaris, Thymus serpyllum, Plantago major, Symphytum
officinale; essential oils of the plants Melaleuca alternifolia, Cymbopogon martinii, Cinnamomum camphora ct. cineol, Eugenia caryophylata,
Thymus vulgaris ct. tymol, Origanum vulgare; honey; glycerin and Cera flava. The degree of incontinence and its impact on the quality of life
prior and after the therapy was assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
(ICIQ-UI SF), where maximum score of 21 represents permanent incontinence and 0 no leakage of urine. Sexual gratification was assessed by the
Pelvic organ prolepses / urinary Incontinence / Sexual Questionnaire (PISQ-12). The variables with the highest, statistically significant influence
onto degree of incontinence and its impact on the quality of life were were Urine leak and related symptoms, Menopause, Frequent urinary
tract infections, Age and Number of childbirth. Significant improvement concerning both, incontinence (p<0.0001) and sexuality (p<0.0003)
was observed following two weeks of the application. In the end of the study the mean value of ICIQ-UI score decreased from 10.3±4.2 to 1.1±1.0
while PISQ-12 increased from 21.0±2.9 to 28.4±3.2. Following the eight weeks of the therapy 66% of the patients were completely dry, while other
34% exhibited only slight problems (ICIQ-UI score range 1-3). After only 7 days of the application the symptoms like burning, vaginal discharge,
vaginal dryness and painful sexual intercourse decreased significantly while in the end of the treatment disappeared completely.
ABSTRACT
KEYWORDS : herbal ointment, stress urinary incontinence, olive oil extracts, medicinal
plants, essential oils
INTRODUCTION
The International Continence Society Standardization of Terminolo-
gy of Lower Urinary Tract Dysfunction established clinical definition
of stress urinary incontinence (SUI) as the complaint of involuntary
leakage during effort or exertion, or on sneezing or coughing (Luber,
2004). Its prevalence ranged between 4% and 35% depending on the
country with age, obesity, and smoking as the most significant risk
factors (Luber, 2004). Nygaard and Heit, 2004 reported that SUI occurs
at least weekly in one third of adult women. Among 20,000 Chinese
women in the age range from 20 to 99 years the prevalence of SUI
was 18.9% (Zhu et al., 2009) and the significant risk factors are age,
vaginal delivery, multiparty, alcohol consumption, central obesity
constipation, chronic pelvic pain, history of respiratory disease, gyne-
cological events, pelvic surgery, and perimenopause and postmeno-
pause status. Among 1700 French women employed in academic
hospital, 12.4% of them reported SUI (Peyrat et al., 2002). The preg-
nancy, particularly previous vaginal delivery and hysterectomy rep-
resented the significant risk factors. The prevalence of SUI reported
by Minassian et al., 2008 among 2,875 adult women was 23.7%. The
obtained significant risk factors were age, ethnic background, weight,
parity and hysterectomy. Among 83,355 American nurses at the age
range from 37 to 54 years 43% of them reported incontinence. Iden-
tified risk factors were age, race/ethnicity, body mass index, parity,
smoking, type 2 diabetes mellitus, and hysterectomy (Danforth et
al., 2006). A world wide survey conducted by McPhil, 2004 reviled
the highest percentages of women with SUI in UK (41%) and Canada
(42%) and the lowest percentage was obtained in Spain (23%) while
the mean value for all tested countries was 32%. Two-thirds of the
symptomatic women were younger than 50. Higher prevalence of SUI
(Brown, et al., 1999) was obtained among postmenopausal women
(56%).
The most common treatment aproaches are pelvic floor muscle train-
ing pelvic floor muscle training, bladder training, vaginal devices, and
urethral inserts. Better results were obtained by surgical treatment.
However, those methods were associated with more risk compared to
the conventional treatment (Nygaard and Heit, 2004).
The purpose of this work was development, formulation and testing
of new herbal ointment for the treatment of stress urinary inconti-
nence and its related symptoms as posible alternative to conventional
or surgical methods.
MATERIALS AND METHODS
Study Design
Among 437 patients in the age range from 18 to 78 reported to the
center during October 2015th, 184 had the symptoms of urinary in-
continence (UI). All the patients signed informed consent and com-
pleted three questioners. Among 184 incontinent patients, stress
urinary incontinence (SUI) was confirmed in 98 of them. Those pa-
tients were subjected to Pap test, cervical swabs for the presence
of aerobic bacteria, yeasts, Ureaplasma urealyticum, Chlamydia
trachomatis, Mycoplasma, and hrHPV DNA. The sample prepa-
ration and analysis was described in details in our previous work
(Findri Gustek et al., 2012). The patients with confirmed cervical le-
sions or bacterial/yeasts/viral infections were withdrawn from the
study and subjected to conventional treatment depending on the
diagnosis. The pregnant patients were also excluded. After all ex-
clusions the rest of the 50 patients represented our target group.
The patients were treated with herbal ointment (2 g/day) for eight
weeks. The ointment was inserted deep into vagina before bed-
time. The patients were advised to make daily notes about all the
changes occurred during the course of the therapy. The interview of
each patient was done twice a month. The degree of incontinence
and its impact on the quality of life prior and after the therapy was
assessed by the International Consultation on Incontinence Ques-
tionnaire - Urinary Incontinence Short Form (ICIQ-UI SF), where
maximum score of 21 represents permanent incontinence and 0 no
leakage of urine. The results of the ICIQ-UI SF may be divided into
the following four severity categories: slight (1-5), moderate (6-12),
severe (13-18) and very severe (19-21). Sexual gratification was as-
sessed by the Pelvic organ prolapses / urinary Incontinence / Sexual
Questionnaire (PISQ-12).
Preparation of the Ointment
For the production of the macerate the following plants were
used: Capsella bursa-pastoris (10%), Urtica diodica (10%),
Quercus robur (10%), Quercus infectoria (10%), Corylus avel-
lana (10%), Ocimum basilicum (10%), Salvia officinalis (10%),
Achillea millefolium (10%), Calendula officinalis (5%), Planta-
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go major (5%), Matricaria chamomilla (2%), Hypericum perfo-
ratum (2%), Alchemilla vulgaris (2%), Thymus serpyllum (2%),
Symphytum officinale (2%). The macerate was prepared from
the dried plants obtained from herbal pharmacy and extra virgin
olive oil with solid/liquid ratio = 1:5. The plants were macerat-
ed 30 days on 500C and filtered. 80% of the macerate was mixed
with 4.3% of chestnut honey and 5% of glycerin and the mixture
was heated to 800C. 10% of melted Cera flava was added into
the mixture, homogenized and heated for additional 10 minutes
and allowed to cool to the room temperature. The essential oils
of Melaleuca alternifolia (0.2%), Cympobogon martini (0.1%),
Thymus vulgaris (0.1%), Eugenia caryophylata (0.1%), Cin-
namomum camphora (0.1%) and Origanum vulgare L (0.1%)
were added into cooled mixture, mixed thoroughly and packed.
Statistical Analysis
For statistical evaluation Statistica 11.0 software package was
employed. The description of the treated population was done
by basic statistics and frequency tables. Statistical significance
was set to p<0.05 in all the tests performed. The differences in
the percentage of each parameter between prior and after the
therapy were assessed by χ2 test. The influence of the predictor
variables on the degree of incontinence was tested by Multiple
regression method (Orescanin et al., 2015a).
RESULTS AND DISCUSSION
Description of the Population
The study group ranged from 36 to 73 years (54.68±10.89) with
the highest percentage of women (28%) ranging from 51 to 60
years. Equal distribution was obtained in the groups ranging
from 41 to 50 years and 61 to 70 years (20%) while the women
younger than 40 and older than 70 were represented with 18%
and 10%, respectively.
According to the education level, 60% of the patients finished sec-
ondary school, 16% primary school while 10%, 12% and 2% of them
had higher education, university diploma and PhD, respectively.
Postmenopausal women represented 64% of the population (Table
1). Among the tested population 88% of them had at least one child-
birth. The women with two childbirths prevailed (42%) followed by
three births (26%). 9 of 50 patients had one or two miscarriages and
11 (18%) of them had 1 to 3 induced abortions (22%).
Frequent gynecological problems were reported by 62% of the par-
ticipants (Table 1). Among them the problems like inflammation,
burning, vaginal discharge, unpleasant odor, vaginal dryness, painful
sexual intercourse, and frequent infections prevailed.
Frequent urinary tract infections persisted in 44% of the patients (Ta-
ble 1). Urine leakage, frequent urination, urine retention, dysuria, pain
and burning prevailed among incontinence symptoms.
ICIQ-UI SF score ranged from 3 to 16 (10.25±4.19). Among them
20% had slight problems, 40% of them reported moderate and
other 40% severe incontinence problems. According to the re-
sults of multiple regression analysis ICIQ-UI SF score showed
statistically significant correlation with selected predictor varia-
bles (R = 0.79; p<0.0027). Among the variables with the highest,
statistically significant correlations were Urine leak and related
symptoms (p=0.0015), Menopause (p=0.0123), Frequent uri-
nary tract infections (0.0382), Age (0.0418) and No. of childbirth
(0.0481).
Incontinence problems combined with the vaginal dryness and
painful intercourse had also significant impact on the sexual
gratification. PISQ-12 score before the therapy (Fig. 2) ranged
from 14 to 26 (21±2.91). The results of Multiple regression
analysis reviled significant correlation between predictor
variables and PISQ-12 score (R = 0.88; p<0.0381). ICIQ-UI SF
score (p=0.0021), Urine leak and related symptoms (p=0.0104),
Menopause (p=0.0372), Gynecological problems (p=0.0414) and
age (p=0.0448) had statistically significant contribution. Those
results confirmed that urinary incontinence had highly signifi-
cant impact on the quality of sex life.
Table 1. Frequencies tables for selected categorical vari-
able of the tested population
Variable Category N %
Menopause Yes 32 64
No 28 36
No. of childbirth
0 6 12
1 6 12
2 21 42
3 13 26
5 2 4
8 2 4
No. of miscarriages
0 41 82
1 3 6
2 6 12
No. of induced abortions
0 39 78
1 6 12
2 3 6
3 2 4
Gynecological problems No 31 62
Yes 19 38
Frequent urinary tract
infections
Yes 22 44
No 28 56
Urine leakage and other
symptoms
No 0 0
Yes 50 100
The Outcome of the Therapy
The first signs of the improvement in the case of incontinence ap-
peared after 7 days of the treatment with the herbal ointment. The
improvement was reflected in the lower number of urination during
the day and night, the possibility of complete emptying of the blad-
der half an hour after the application of the ointment, ability to retain
the urine much longer, lower volume and frequency of the escaped
urine during coughing, sneezing and physical activity and pleasant
feeling of vaginal lubrication.
As presented in Fig. 1 ICIQ-UI SF score decreased almost linearly dur-
ing the course of therapy with the value of 7.2±1.8 after two weeks,
4.3±1.5 after four weeks, 2.7±1.4 following the 6 weeks and finally
1.1±1.0 in the end of eight week. Significant difference was found
between the mean value of ICIQ-UI SF score before the therapy and
each follow up period since P value were in all cases <0.0001. In the
end of the therapy 66% of the patients were completely dry while in
other 34% of them only slight discomfort persisted with ICIQ-UI SF
score ranged from 1-3.
Figure 1. The results of International Consultation on In-
continence Questionnaire - Urinary Incontinence Short
Form (ICIQ-UI SF) prior and after each follow up peri-
od.*-statistically significant at p<0.05
Multiple regression analysis showed no obvious, statistically significant con-
tribution of the predictor variable to the outcome of the therapy expressed
as ICIQ-UI SF score (R=0.60; p=0.1571). None of the tested predictor varia-
ble showed statistically significant contribution.
PISQ-12 score was significantly higher for each follow up period (Fig. 2)
compared to the period before the therapy (p <0.0001) which pointed out
to the improvement in sexual gratification.
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Figure 2. The results of Pelvic organ prolepses / urinary
Incontinence / Sexual Questionnaire (PISQ-12) prior and
after each follow up period.*-statistically significant at
p<0.05
The mean values increased from 23.2±3.0 after two weeks of the
therapy to 28.4±3.2 in the end of the treatment period. Linear regres-
sion showed excellent correlation between the ICIQ-UI SF and PISQ-
12 scores (R2=0.998; p<0.00001) during the course of the therapy
confirming once again a significant influence of incontinence on the
sexual gratification. The symptoms and problems like vaginal dryness,
inflammation, burning, vaginal discharge, painful intercourse, and
unpleasant odor disappeared completely in the end of the therapy.
Gynecological examination also confirmed significant improvement in
the appearance of vaginal mucosa in postmenopausal women follow-
ing the therapy.
Significant improvement following the therapy could be explained by
the composition of the ointment containing the plants like Capsel-
la bursa-pastoris and Urtica diodica that induced contraction of
smooth muscles (Al-Snafi, 2015; Grosso et al., 2011; Broncano et al.,
1987), and consequently, enhanced both bladder and uterine muscle
tonus significantly.
The bioactive components extracted from the plants with confirmed
uterotonic activity (Matricaria chamomilla, Calendula officinalis,
Plantago major, Symphytum officinale, Capsella bursa pastoris,
and Hypericum perforatum) also contributed to the improvement of
uterine muscle tonus (Shipochliev, 1981).
Besides, the tannins rich plants with well known astringent activity
like Quercus robur, Quercus infectoria, Corylus avellana, Ocimum
basilicum had also positive effect on vaginal mucosa trough their
strong wound healing, anti-inflammatory and antioxidative poten-
tial (EMA, 2009; Ahmad et al., 2011; Oliveira et al., 2007; Dubey and
Pathak, 2015).
Beneficial effects of the oil extracts of the plants Salvia officinalis,
Achillea millefolium Calendula officinalis, Plantago major, Mat-
ricaria chamomilla, Hypericum perforatum, Alchemilla vulgaris,
Thymus serpyllum and Symphytum officinale onto vaginal muco-
sa was described in details in our previous papers (Orescanin et al.,
2015a, Orescanin et al., 2015a, Orescanin and Findri Gustek, 2015c).
In short, the selected plants act in the formulation as free radical
scavenging, metal chelating, and reactive oxygen quenching agents,
thus protecting vaginal mucosa from the damage caused by highly
reactive species present in intracellular space. The main wound heal-
ing and anti-inflammatory mechanism could be explained by inter-
action of bioactive components of the extracts with host membrane
signaling pathways that promote the synthesis of collagen fibers and
anti-inflammatory proteins trough numerous cascade reactions. Con-
sequently, it results with wound closure and re-epithelization of the
damaged area and decrease of inflammatory changes of the vaginal
mucosa. Another anti-inflammatory mechanism could be explained
by the inhibition of host membrane signaling pathways, and conse-
quently the inhibition of the synthesis of pro-inflammatory mediators.
Furthermore, the above mentioned plants macerate in the combina-
tion with essential oils of Melaleuca alternifolia, Thymus vulgaris,
Cymbopogon martinii, Origanum vulgare, Cinnamomum campho-
ra and Eugenia caryophyllata showed a strong antibacterial, antifun-
gal and antiviral activity against wide range of genital pathogens. So,
they maintain the healthy balance of very complex vaginal flora by
preventing uncontrolled growth of the pathogens that can cause in-
fection and also serve as natural preservatives in the ointment (Ores-
canin and Findri Gustek, 2015c).
Honey with its antimicrobial, prebiotic and probiotic activity provides
healthy balance of the vaginal flora by preventing the transition of
the vaginal flora from comensal to pathogenic form. It encourages
the development of normal vaginal flora and establishes normal acid-
ic pH of the vagina (Orescanin and Findri Gustek, 2015c).
Cera flava was used in the ointment formulation as supporting ma-
terial and also as the component which forms protective layer on the
genital tract membranes and prevent irritations while glycerol was
used in the ointment formulation as moisturizer (Orescanin and Findri
Gustek, 2015c).
CONCLUSIONS
The prevalence of stress urinary incontinence among the women re-
ported to the center was 22.4%. The most frequent symptoms/con-
ditions prior to the therapy were: frequent urination (up to 30 times
per day), inability to sustain urine, urine retention, frequent bladder
infections, vaginal dryness, painful intercourse, loss of sexual desire.
The variables with the highest, statistically significant influence onto
degree of incontinence and its impact on the quality of life were were
Urine leak and related symptoms, Menopause, Frequent urinary tract
infections, Age and No. of childbirth. Significant improvement con-
cerning both, incontinence (P < 0.0001) and sexuality (P < 0.0003)
was observed following two weeks of the application. In the end of
the study the mean value of ICIQ-UI score decreased over 9 times
while PISQ-12 increased for app. 1.4 times. In the end of the therapy
66% of females had no leakage of urine, while other 34% exhibited
only slight symptoms (mean ICIQ-UI score = 1.1; range 1-3). After
only 7 days of the application the symptoms like burning, vaginal dis-
charge, vaginal dryness and painful sexual intercourse decreased sig-
nificantly while in the end of the treatment disappeared completely.
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... timol oil and 0.1% of Origanum compactum Benth. oil, homogenized once again and packed into 50 mL tubes (Oreščanin and Findri Guštek., 2016;2017). All essential oils were of pharmaceutical grade produced by Pranarom International, Ghislenghien, Belgium. ...
... Obtained results could be correlated with the presence of herbal ingredients with proven haemostatic activity such as C. bursa-pastoris (EMA, 2010), A. millefolium (Rauchensteiner et al., 2004), P. major (Samuelsen, 2000), A. vulgaris (Shrivastava et al., 2007) and P. aviculare C. bursa-pastoris, A. millefolium and A. vulgaris also acting as vasoconstrictor and Q. robur, S. officinalis, A. vulgaris and O. europaea as an astringent (Oreščanin and Findri Guštek, 2016) all of which resulted in reduced bleeding. Furthermore, C. officinalis, Salvia officinalis L., Achilea millefolium L. and Alchemilla vulgaris L. have also spasmolytic effect and contributed to the reduction of spasticity and pain (Oreščanin and Findri Guštek., 2016). ...
... Obtained results could be correlated with the presence of herbal ingredients with proven haemostatic activity such as C. bursa-pastoris (EMA, 2010), A. millefolium (Rauchensteiner et al., 2004), P. major (Samuelsen, 2000), A. vulgaris (Shrivastava et al., 2007) and P. aviculare C. bursa-pastoris, A. millefolium and A. vulgaris also acting as vasoconstrictor and Q. robur, S. officinalis, A. vulgaris and O. europaea as an astringent (Oreščanin and Findri Guštek, 2016) all of which resulted in reduced bleeding. Furthermore, C. officinalis, Salvia officinalis L., Achilea millefolium L. and Alchemilla vulgaris L. have also spasmolytic effect and contributed to the reduction of spasticity and pain (Oreščanin and Findri Guštek., 2016). All these herbal ingredients including all essential oils used due to their powerful antimicrobial effect (Oreščanin et al., 2015) prevented the development of infection with anaerobic bacteria in particular, which is very common during and after the Table 1. ...
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The purpose of this work was the development and application of a new herbal ointment and pessaries for the topical treatment of menorrhagia using macerates and essential oils of medicinal plants as active ingredients. Fifty subjects with proven menorrhagia ranging from 32 to 54 years were divided into two groups (each had 25 participants) of similar age, health status and lifestyle. The first group used 2 g of ointment every eight hours while the second group used pessaries instead. The results were obtained at baseline and following the third menstrual cycle. In both groups a significant decrease was observed for all the symptoms (p<0.05). Significantly better results were obtained in the case of the ointment compared to the pessaries as expected due to the higher percentage of the active ingredients. The average duration of bleeding was reduced from 7.4 to 4.7 days in the case of the ointment and from 7.3 to 5.1 days in the group who used pessaries. The average number of painkillers is reduced from 22.1 to 10.6 and from 22.9 to 13.1 in the group using the ointment and pessaries, respectively. Decrease in other symptoms ranged from 71.4% up to 88.2% in the group using the ointment and from 57.3% to 73.7% in the case of pessaries usage. The obtained results could be correlated with the use of active ingredients with proven haemostatic, vasoconstrictor, astringent and spasmolytic activity.
... The degree of incontinence and its impact on the quality of life prior and after the treatment was assessed by the International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-UI SF), where maximum score of 21 represents permanent incontinence and 0 no leakage of urine. The results of the ICIQ-UI SF may be divided into the following four severity categories: slight (1-5), moderate (6)(7)(8)(9)(10)(11)(12), severe (13)(14)(15)(16)(17)(18) and very severe (19)(20)(21). The residual urine volume was measured before the treatment and in the end of the treatment immediately after the patient returned from the toilet. ...
... All the participants reported improvement which was reflected in lower number of urination during the day and night, the possibility of complete emptying of the bladder half an hour after the application of the ointment, ability to retain the urine much longer, lower volume and frequency of the escaped urine during coughing, sneezing and physical activity. (Oreščanin and Findri Guštek, 2016). After two weeks of the application of 2.0 g of ointment once a day the mean value of ICIQ-UI SF score decreased from 10.3±4.2 to 7.2±1.8 ...
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Objectives: The purpose of this work was development, formulation and testing of new herbal ointment for the treatment of stress urinary incontinence and its related symptoms and comparison of its efficiency with the results of pelvic muscle training. The influence of the treatment or training onto vulvo-vaginal disorders was also determined. Materials and methods: 132 women in the age range from 32 to 77 years were randomly selected into experimental and control group. The experimental group was treated two weeks with Bioapigyn ointment for pelvic muscle tonus (2 g/day) which consisted of the following ingredients: honey; glycerol, Cera flava, oil macerates of the plants Capsella bursa-pastoris, Urtica diodica, Quercus robur, Salvia officinalis, Achillea millefolium, Alchemilla vulgaris, Calendula officinalis, Matricaria chamomilla, Plantago major; essential oils of the plants Melaleuca alternifolia, Thymus vulgaris ct. tymol, Origanum vulgare. Control group was subjected to pelvic muscle training during 24 weeks (three times a week). The degree of incontinence and its impact on the quality of life prior and after the treatment or training was assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF), where maximum score of 21 represents permanent incontinence and 0 no leakage of urine. The volume of residual urine, perineometry and vaginal pH were also determined before and after the treatment or training. For statistical evaluation STATISTICA 11.0 package was used. Results: The variables with the highest, statistically significant influence onto degree of incontinence and its impact on the quality of life were body mass index and menopause. Significant decrease following the treatment with Bioapigyn ointment was found for ICIQ-UI SF score (from 12.43±4.83 to 8.61±4.92, p<0.00001), residual urine volume (from 8.73±11.18 to 2.78±5.93 mL, p=0.0002) and vaginal pH (from 6.30±0.63 to 5.59±0.50, p= 0.0000). The increase in the muscle strength was also confirmed. In the end of the treatment all the symptoms of vulvo-vaginal disorders disappeared completely in all 66 participants. Control group also showed some improvement in the values of ICIQ-UI SF score, residual urine and perineometry results. However, those changes were not statistically significant. There was no improvement concerning the vaginal pH and the symptoms of vulvo-vaginal disorders. Conclusion: Preliminary study confirmed the efficiency of Bioapigyn ointment for pelvic muscle tonus in the treatment of stress urinary incontinence as well as the symptoms of vulvo-vaginal disorders due to its components with smooth muscle contraction activity, uterotonic activity as well as pH adjusting, coating, moisturizing and soothing effect. Significantly better results for most of the variables were found in the experimental compared to the control group.
... 5 There has been increasing interest in the development of new types of effective and nontoxic herbal antimicrobial products. 5,7 The purpose of this work was to examine the efficacy of new herbal vaginal ointment prepared from the macerates and essential oils of medicinal plants in the combination with honeybees products for the topical treatment of lower genital tract infections in females. caryophyllata (0.1%). ...
... The macerate and ointment preparation were described in details in our previous papers. 5,7 The difference in the treatment efficiency between the groups was assessed by χ 2 test using STATISTICA 11.0 software and statistical significance was set to p<0.05. The influence of the predictor variable on the outcome of the therapy was assesses by multiple regression and general regression model. ...
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Objective: The purpose of this work was development and testing of new herbal ointment for the treatment of lower genital tract infections in females. Material and Methods: 80 female patients with positive swabs to at least one microorganism (U. urealyticum, M. hominis, E. coli and Candida sp.) were randomly divided into three treatment groups. First group was treated 12 days (twice a day) with doxycycline antibiotic and 2 g of Bioapigyn vaginal ointment (once a day), second group with 2 g of ointment only and third group with antibiotic only (12 days; twice a day). Results: Following the therapy all the swabs were negative to M. hominis regardless of the treatment group. Eradication of U. urealyticum was 100%, 87% and 62% and E. coli 75%, 67% and 33% in antibiotic + herbal ointment, herbal ointment only and antibiotic only group, respectively. None of the patients in the first and second group developed antibiotic-associated candidiasis compared to 80% positive swabs in the antibiotic only group. Conclusion: Bioapigyn vaginal ointment has significant antimicrobial potential against common vaginal pathogens which is even better compared to standard antibiotic.
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Objective/Purpose: The purpose of this work was the assessment of the clinical efficacy and safety of Bioapigyn® vaginal ointment for pelvic muscle tonus compared to pelvic floor muscle training in alleviating the symptoms of stress, urge and mixed urinary incontinence and vulvo-vaginal disorders in child-bearing and menopausal & postmenopausal women. Materials and Methods: The experimental group consisted of 66 women was treated 28 days with Bioapigyn® ointment for pelvic muscle tonus (2.5 mL/day). The control group also consisted of 66 participants was subjected to pelvic floor muscle training during 28 days (five times a day). ICIQ-UI SF score, the residual urine volume, perineometry, the total score of vulvo-vaginal symptoms and vaginal pH were determined before and after the treatment or training. Results: Following the treatment with Bioapigyn® ointment ICIQ-UI-SF score decreased 54.9%, perineometry parameters increased between 31.5 and 34.3%, residual urine decreased for 76.9% and vaginal pH for 14.2%. All the symptoms of vulvo-vaginal disorders disappeared completely in all participants. The control group showed no changes in vaginal pH or the improvement concerning the vulvo-vaginal complaints. ICIQ-UI-SF score decreased for 4.3%, residual urine volume for 9.1% while perineometry parameters increased between 4.3 and 8.3%. Conclusion/Discussion: Bioapigyn® vaginal ointment for pelvic muscle tonus alleviate the symptoms of incontinence by tightening and firming of the smooth muscles of the pelvic floor thanks to the ingredients with smooth muscles contraction/relaxation and astringent properties. Low pH, high osmolarity, viscosity, greasiness and coating effect of the ointment eradicated vulvo-vaginal complaints.
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Objectives: The purpose of this work was development, formulation and testing of new herbal ointment for the treatment of mild to severe atopic dermatitis in infants and children (4 to 56 months old) as possible alternative therapy to standard corticosteroids and immunomodulants. Patients and methods: 50 patients were treated 8 weeks (every four hours) with the ointment containing the following ingredients: Avena sativa, Nigella sativa, Argania spinosa, Prunus amygdalus, Daucus carota, Helichrysum italicum, Calendula officinalis, Matricaria chamomilla, Bellis perennis, Lavandula officinalis, Achillea millefolium,Thymus serpyllum, Salvia officinalis, Symphytum officinale, Plantago major, Olea europaea, Melaleuca alternifolia, Cera alba, honey, and glycerol. The severity of the disease prior and after the therapy was assessed by SCORAD index. Results: The total score before the therapy ranged from 23.1 to 99.4 (66.50±23.43). Among the tested patients 76%, 20% and 4% had severe, moderate and mild symptoms, respectively. Following the eight weeks treatment the extent, intensity and subjective symptoms decreased significantly. The total score decreased more than 20 times compared to the initial values and ranged from 0 to 14 (13.18±4.29). The intensity parameters (swelling, oozing/crusting and scratch marks) as well as subjective parameters (itch and sleeplessness) disappeared completely following two months therapy. Conclusion: Two months of the topical treatment with Bioapifit® herbal anti-inflammatory ointment resulted in complete remission of the symptoms in 56% of the patients while in another 44% of them only mild symptoms persisted. Such excellent results could be atributed to the ointment’s formulation containing emollients, strong anti-inflammatory, immunomodulating, wound healing and antimicrobial agents of herbal origin that simultaneously targeted the multiple mechanisms involved in AD pathogenesis. This ointment could be used as alternative therapy to the topical corticosteroids and immunomodulants.
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The purpose of this work was to test the efficiency of newly developed herbal pessaries for the treatment of the squamous endocervical metaplasia compared to the conventional treatment with albothyl pessaries. The influence of the predictor variables on the outcome of the therapy was also assessed. 192 women in the age range from 20 to 59 years (38.2±8.2) represented experimental group and 30 women ranging from 24 to 59 years (39.4±7.9) represented control group, both diagnosed with squamous endocervical metaplasia were included in the study. The patients from the experimental group were treated locally for 10 days with herbal pessaries containing macerates (Calendula officinalis, Matricaria chamomilla, Lavandula officinalis, Hypericum perforatum L., Achilea millefolium, Thymus serpyllum, Salvia officinalis, Mentha piperita L., Symphytum officinale, Plantago major L., Alchemilla vulgaris) and essential oils (Melaleuca alternifolia, Thymus vulgaris, Pelargonium graveolens, Cympobogon martinii, and Origanum vulgare L.) The patients were treated 10 days with either albothyl (control group) or herbal pessaries (experimental group). New herbal pessaries showed significantly higher efficiency ( =8.39; P=0.0038) in eradication of metaplasia compared to albothyl. Total clearance was observed in 91.15% and 66.67% of the patients in the xperimental and control group, respectively. Among the predictor variables, health status of the patients had the highest, statistically significant influence on the outcome of the therapy. The synergistic effect of the medicinal plants with well known wound healing, anti-inflammatory, antimicrobial and antiviral properties could be responsible for high treatment potential of the pessaries. This new product could present good alternative to the conventional treatment of squamous endocervical metaplasia due to high treatment efficiency and no observed side effects during the therapy.
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The main purpose of this work was to test the efficiency of newly developed herbal pessaries to prevent antibiotic-associated yeast infection during the treatment of Ureaplasma urealytium with doxycycline. Besides, the influence of the pessaries on the efficacy of the treatment of other bacterial, yeast and viral infections as well as low grade cervical intraepithelial lesions was also assessed. 93 women in the age range from ranged 19 to 64 years (34.4±9.3) represented experimental group and 97 women ranging from 22 to 60 years (32.7±6.3) represented control group, both infected with Ureaplasma urealytium were included in the study. The patients from the experimental group were treated with doxycycline for 12 days and locally for 10 days with new herbal pessaries while the control group was treated with doxycycline and gyno-daktarin pessaries. Significantly higher efficiency was obtained for the experimental group (x2=8.39; P=0.0038) in eradication of U. urealytium (91.5%) compared to the control group (69.1%). Besides, complete eradication of M. hominis and C. trachomatis was also observed in the experimental group. All the swabs were negative to Candida sp. following the treatment with herbal pessaries compared to 26.8% positive swabs in the case of gyno-daktarin treatment. A significant improvement was also observed in the results of Pap test following the treatment with new herbal pessaries (x2 = 23.3; P < 0.0000). Among the predictor variables, the type of the therapy had the highest, statistically significant influence on the outcome of the therapy. The synergistic effect of the medicinal plants with well known wound healing, anti-inflammatory, antimicrobial and antiviral properties could be responsible for high treatment potential of the pessaries. This new product is superior to miconazole in the prevention of antibiotic-associated yeast infection.
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Aqueous extracts of leaves of different hazel (Corylus avellana L.) cultivars (Cv. M. Bollwiller, Fertille de Coutard and Daviana), were analysed by reversed-phase HPLC/DAD for the definition of their phenolic composition. Antioxidant potential was assessed by the reducing power assay, and the scavenging effect on DPPH (2,2-diphenyl-1-picrylhydrazyl) radicals and β-carotene linoleate model system. Their antimicrobial capacity was also tested against Gram positive (Bacillus cereus, Bacillus subtilis, Staphylococcus aureus) and Gram negative bacteria (Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae) and fungi (Candida albicans, Cryptococcus neoformans). Eight phenolic compounds were identified: 3-, 4- and 5-caffeoylquinic acids, caffeoyltartaric acid, p-coumaroyltartaric acid, myricetin-rhamnoside, quercetin 3-rhamnoside and kaempferol 3-rhamnoside. A p-coumaric acid, three myricetin and one quercetin derivatives were also detected. The hazel leaves extract presented high antioxidant activity in a concentration-dependent way, in general with similar behaviour of all cultivars. Gram positive bacteria revealed to be very sensitive to hazel leaf extract (MIC 0.1 mg/ml for B. cereus and S. aureus and 1 mg/ml for B. subtilis). However, Gram negative and the fungi displayed much lower sensitivity, being P. aeruginosa and C. albicans resistant at 100 mg/ml. Cv. M. Bollwiller exhibited the most potent antimicrobial activity.
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The objective of this study was determination of causative factors of the genital infections and their correlation with various predictor variables. Secondary objectives included: (1) determination of the presence and the type of low molecular weight metabolites in the samples of vaginal secretion formed in vivo, (2) determination of the concentration of 2-phenylethanol formed in vitro for each Candida species, (3) determination of the relationship between fungal/bacterial/viral infections with the metabolites formed in vivo using multivariate analysis. One hundred and ninety-seven women in the age range from 18 to 65 years were included in the study. After the completion of questionnaire, all the patients were subjected to Pap test, cervical swabs for the presence of aerobic bacteria, yeasts, Ureaplasma urealyticum, Chlamydia trachomatis, Mycoplasma, and hrHPV DNA. The presence and the concentration of low-molecular weight metabolites in vitro and in vivo were determined by gas chromatography-mass spectrometry (GC-MS) method. Multivariate analysis methods were used for statistical evaluation. The most important risk factors of fungal/bacterial/viral infections were determined. The presence of 2-phenylethanol in vivo was confirmed in 14 of 74 tested samples and connected with the Candida species. The presence of symptoms, hrHPV DNA and Ureaplasma urealyticum are the predictor variables with the highest influence on the formation of the metabolite in vivo. The results in vitro confirmed that various Candida species produced 2-phenylethanol with the concentrations ranging from 0.6 to 4.64 μg/mL. The medical exposure to irradiation, marital status, and number of partners as well as stress factors (miscarriages, chronic, viral, or tumor illnesses) had the highest influence on the development of the bacterial/fungal/viral infections. The formation of 2-phenylethanol, both in vivo and in vitro, was confirmed and connected with Candida species. Besides, according to statistical tests, it seems that presence of symptoms, hrHPV DNA, and Ureaplasma urealyticum had also significant role on the formation of 2-phenylethanol in vivo.
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Objective: To determine the prevalence of stress, urge, and mixed urinary incontinence and associated risk factors in postmenopausal women. Methods: Before enrollment in a 4-year, randomized trial of combination hormone therapy to prevent coronary heart disease, 2763 participants completed questionnaires on prevalence and type of incontinence. We measured factors potentially associated with incontinence including demographics, reproductive and medical histories, height, weight, and waist-to-hip circumference ratio. We used multivariate logistic models to determine independent associations between those factors and weekly incontinence by type. Results: The mean (+/- standard deviation [SD]) age of the participants was 67 +/- 7 years; 89% were white and 8% were black. Fifty-six percent reported weekly incontinence. In multivariate analyses, the prevalence of weekly stress incontinence was higher in white than black women (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.6, 5.1), in women with higher body-mass index (BMI) (OR 1.1 per 5 units, 95% CI 1.0, 1.3), and higher waist-to-hip ratio (OR 1.2 per 0.1 unit, 95% CI 1.0, 1.4). The prevalence of weekly urge incontinence was higher in older women (OR 1.2 per 5 years, 95% CI 1.1, 1.3), diabetic women (OR 1.5, 95% CI 1.1, 2.0) and women who had reported two or more urinary tract infections in the prior year (OR 2.0, 95% CI 1.1, 3.6). Conclusion: Stress and urge incontinence are common in postmenopausal women and have different risk factors, suggesting that approaches to risk-factor modification and prevention also might differ and should be specific to types of incontinence. (C) 1999 by The American College of Obstetricians and Gynecologists.
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Abnormalities in the process of uterine muscle contractility during pregnancy and birth can have major clinical implications, including preterm labour, which is the single largest cause of maternal and prenatal mortality in the Western world and a major contributor to childhood developmental problems. In contrast, induction of labour may be necessary in certain conditions. Currently used interventional therapies to suppress (tocolytic agents) or to induce (uterotonic agents) uterine contractions lack potency and/or selectivity and can have harmful side effects for mother and baby. Nature's diversity has always been, and still is, one of the biggest resources of therapeutic lead compounds. Many natural products exhibit biological activity against unrelated targets, thus providing researchers with starting points for drug development. In this review we will provide an overview of uterine muscle physiology, describe currently available biological screening procedures for testing of uterotonic plant compounds and will summarise traditionally-used uterotonic plants, their active components and their mechanisms, primarily focusing on uterotonic active circular plant peptides called cyclotides. Finally we will comment on the discovery of novel cyclotide-producing plant species and the possibility for the development of novel plant-derived uterotonic and tocolytic drugs.
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The aim of this study was to evaluate the prevalence and associated risk factors of urinary incontinence (UI) in Chinese women. In the cross-sectional survey, 20,000 Chinese women 20 years or older were randomly selected and interviewed with modified Bristol Female Lower Urinary Tract Symptoms questionnaires to estimate population prevalence rates and identify potential risk factors. A total of 19,024 women were included in the analysis and 976 excluded; qualified rate is 95% (19,024/20,000). Of the Chinese women aged from 20 to 99 years (mean +/- SD, 45 +/- 16 y), the overall prevalence rate of UI was 30.9%. Estimates of stress urinary incontinence (SUI), urge urinary incontinence, and mixed urinary incontinence prevalence were 18.9%, 2.6%, and 9.4%, with a corresponding proportional distribution of 61%, 8%, and 31%, respectively. The prevalence of mixed urinary incontinence increased with aging, whereas the prevalence of SUI peaked in the group of women aged 50 years and that of urge urinary incontinence in the group of women aged 70 years. Only 25% of women have consulted doctors on this issue. Through multivariable logistic regression analysis, we identified age, vaginal delivery, multiparity, alcohol consumption, central obesity (women's waist circumference, >/=80 cm), constipation, chronic pelvic pain, history of respiratory disease, gynecological events, pelvic surgery, and perimenopause and postmenopause status as potential risk factors for SUI, among which age, vaginal delivery, and multiparity are three major risk factors. Our findings suggest that the prevalence of UI is high in China, with SUI as the most common subtype. Age, vaginal delivery, and others are risk factors for SUI.
Article
Water extracts (infusions) from a group of medicinal plants were studied in terms of their activity enhancing the uterine tonus in a series of experiments with a preparation of an isolated rabbit and guinea pig uterine horn. In a final extract concentration of 1 to 2 mg crude drug per 1 cm3 the plants ranked in the following descending order with regard to their tonus-raising effect on the uterus: camomile (Matricaria chamomilla L.), potmarigold calendula (Calendula officinalis L.) cockscomb (Celosia cristata L.), plantain (Plantago lanceolata L. et Plantago major L.), symphytum (Symphytum officinale L.), shepherdspurse (Capsella bursa pastoris L.), St.-John's wort (Hypericum perforatum L.). No effect showed the infusions of flax seeds (Linum usitatissimum L.) and bearberry leaves (Arctostaphylos uva-ursi L.). The combined preparation 'Antiinflamin', consisting of a pooled freeze-dried extract from three plants and chemotherapeutic agents produced a good enhancing effect, in the form of 'comprets' for intrauterine application at the rate of one compret per 2500 cm3.
Article
Objective To assess the prevalence of and risk factors for urinary incontinence (UI) in young and middle-aged women. Subjects and methods During 1998 the prevalence of overall, stress, urge and mixed UI was assessed in women working in a French academic hospital. Women (2800) received a questionnaire at the same time as their yearly interview with a staff physician in occupational medicine. The usual risk factors for constitutional events, i.e. increasing age, obesity (defined as a body mass index of 25), obstetric events (pregnancy, previous Caesarean delivery, previous vaginal delivery, postpartum incontinence) and gynaecological events (hysterectomy) were evaluated. Results Of the 1700 women (mean age 40.0 years) who returned the questionnaire, 467 (27.5%, 95% confidence interval, CI, 25.4–29.7) reported UI, comprising 210 (12.4%, 10.8–14.0) with stress UI, 28 (1.6%, 1.1–2.4) with urge UI and 229 (13.5%, 11.9–15.2) with mixed UI. Thirty-eight women (8.1%) had frequent urinary leakage, comprising one (0.5%), four (14.3%) and 33 (14.4%) with stress, urge and mixed UI. The prevalence of UI increased significantly with age 40 years, with a relative risk (95% CI) of 2.16 (1.86–2.57), and with pregnancy (2.22, 1.71–2.87), previous vaginal delivery (2.15, 1.72–2.69), postpartum incontinence (2.57, 2.22–2.97), and hysterectomy (1.52, 1.11–2.08). Obesity (1.14, 0.99–1.32) and previous Caesarean delivery (2.15, 1.72–2.69) did not significantly increase the risk of UI. The risk factors for stress UI were age 40 years, pregnancy, previous vaginal delivery, postpartum incontinence and hysterectomy, but there was no relationship between stress UI and obesity or previous Caesarean delivery. Conclusion There was a high prevalence of UI among young adult and middle-aged women hospital workers who had easy access to medical resources. Gynaecological and obstetric events (pregnancy, particularly previous vaginal delivery and hysterectomy) were the most prominent risk factors, especially for stress UI.