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The effect of Calendula officinalis versus metronidazole on bacterial vaginosis in women: A double-blind randomized controlled trial

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Bacterial vaginosis (BV) is a common disorder among women of reproductive age. This study aimed to compare the effect of a Calendula officinalis extract-based cream and metronidazole on BV among women of reproductive age. In this study, 80 women of reproductive age with BV were randomly assigned to the C. officinalis (n = 40) or metronidazole (n = 40). Diagnosis of BV was confirmed when at least 3 of the 4 Amsel criteria were met (pH> 4.5, whitish grey or thin homogeneous discharge, release of a fishy odor on adding 10% KOH, and detection of clue cells on microscopic examination). For each group, either a methanol extract of C. officinalis or metronidazole vaginal cream (5 g) was used for 1 week intravaginally, and all signs and symptoms were assessed 1 week after treatment completion. Before the intervention, the two groups did not differ significantly with regard to vaginal burning, odor, dysuria, and dyspareunia, but itching was significantly more common in the C. officinalis group than in the metronidazole group (22.5% vs. 2.5%, P = 0.01). One week after the intervention, all women in both groups were free of symptoms, including vaginal itching and burning sensation, odor, dysuria, and dyspareunia. None of the women in either group suffered any side effects from C. officinalis or metronidazole. C. officinalis was effective for the treatment of BV in women of reproductive age, without any side effects. This herb could be recommended for women of reproductive age who uncomfortable with the potential side effects of synthetic drugs.
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The eect of Calendula ocinalis versus metronidazole
on bacterial vaginosis in women: A double‑blind
randomized controlled trial
Abstract
Bacterial vaginosis (BV) is a common disorder among women of reproductive age.
This study aimed to compare the effect of a Calendula officinalis extract‑based cream
and metronidazole on BV among women of reproductive age. In this study, 80 women
of reproductive age with BV were randomly assigned to the C. officinalis (n = 40) or
metronidazole (n = 40). Diagnosis of BV was confirmed when at least 3 of the 4 Amsel
criteria were met (pH >4.5, whitish grey or thin homogeneous discharge, release of a
fishy odor on adding 10% KOH, and detection of clue cells on microscopic examination).
For each group, either a methanol extract of C. officinalis or metronidazole vaginal
cream (5 g) was used for 1 week intravaginally, and all signs and symptoms were
assessed 1 week after treatment completion. Before the intervention, the two groups did
not differ significantly with regard to vaginal burning, odor, dysuria, and dyspareunia,
but itching was significantly more common in the C. officinalis group than in the
metronidazole group (22.5% vs. 2.5%, P = 0.01). One week after the intervention, all
women in both groups were free of symptoms, including vaginal itching and burning
sensation, odor, dysuria, and dyspareunia. None of the women in either group suffered
any side effects from C. officinalis or metronidazole. C. officinalis was effective for the
treatment of BV in women of reproductive age, without any side effects. This herb
could be recommended for women of reproductive age who uncomfortable with the
potential side effects of synthetic drugs.
Key words: Bacterial, Calendula officinalis, metronidazole, vaginitis
Zahra Pazhohideh,
Solmaz Mohammadi1,
Nosrat Bahrami2, Faraz Mojab3,
Parvin Abedi4, Elham Maraghi5
Department of Midwifery, Faculty
of Medical Sciences, Shushtar,
1Department of Midwifery, Ahvaz
Jundishapur University of Medical
Sciences, 4Department of Midwifery,
Menopause Andropause Research
Center, Ahvaz Jundishapur University
of Medical Sciences, 5Department of
Biostatistics and Epidemiology, School
of Public Health, Ahvaz Jundishapur
University of Medical Sciences, Ahvaz,
2Faculty of Nursing and Midwifery,
Dezful University of Medical Sciences,
Dezful, 3Pharmaceutical Sciences
Research Center, Shahid Beheshti
University of Medical Sciences,
Tehran, Iran
J. Adv. Pharm. Technol. Res.
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www.japtr.org
DOI:
10.4103/japtr.JAPTR_305_17
INTRODUCTION
Bacterial vaginosis (BV) is a common disorder among
reproductive-aged women, and its underlying cause is
primarily a change in vaginal ora.[1] BV is characterized
by the suppression of the normal vaginal ora (hydrogen
peroxide-producing Lactobacillus) and an increase in
facultative and anaerobic bacteria.[2] The main cause of BV is
unclear; however, it is more commonly seen with anaerobic
bacteria than with aerobic bacteria.[3]
The prevalence of BV was reported to be 29.2% in a large
study in the United States, which corresponds to 21.4 million
women.[4] One study in Iran showed that the prevalence of
BV among reproductive-aged women was 16.2%[5] while
another study in Iran found a prevalence of 15.6% among
these women.[6]
Address for correspondence:
Dr. Parvin Abedi,
13th East Kianpars Ave, 1st Maroon St., No: 46, Ahvaz, Iran.
E‑mail: parvinabedi@ymail.com This is an open access article distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
others to remix, tweak, and build upon the work non‑commercially, as long as
the author is credited and the new creations are licensed under the identical
terms.
For reprints contact: reprints@medknow.com
How to cite this article: Pazhohideh Z, Mohammadi S, Bahrami N,
Mojab F, Abedi P, Maraghi E. The eect of Calendula ocinalis versus
metronidazole on bacterial vaginosis in women: A double-blind
randomized controlled trial. J Adv Pharm Technol Res 2017;9:15-9.
original articlE
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Pazhohideh, et al.: Calendula ocinalis and bacterial vaginosis
16 Journal of Advanced Pharmaceutical Technology & Research | Volume 9 | Issue 1 | January‑March 2018
Because of the unpleasant odor associated with BV,
most women experience embarrassment and feel dirty
and believe that the smell can be detected by others.
In addition, women with BV have low self-esteem and
lower sexual satisfaction.[7] BV can be treated with a
variety of antimicrobial agents, such as ampicillin,
penicillin, and metronidazole. However, metronidazole
in the form of tablets, gel, or suppositories used for
7 days shows beer results.[8] The use of antimicrobial
agents has been associated with drug resistance and in
some patients, recurrence of BV.[9] Furthermore, using
metronidazole during pregnancy and while breastfeeding
may pose some risks to the fetus and infant.[10] Therefore,
researchers are looking for alternative treatment for BV.
One alternative is the use of herbal medicine, which is
associated with fewer complications and which could
preserve the natural flora of the body.[11] Calendula
ocinalis L (pot marigold) is a herbaceous plant from
the Asteraceae family that contains phytochemicals such
as avonoids, saponins, carotenoids, triterpenoids, and
tannins, which possess antibacterial activity.[12] Bissa and
Bohra studied the antibacterial potential of the leaves,
roots, and owers of C. ocinalis and found good activity
against Escherichia coli, Salmonella, Klebsiella pneumoniae,
Enterobacter aerogenes, and Agrobacterium tumefaciens.[13]
The anti-inammatory, antifungal, and antioxidant eects
of C. ocinalis have been demonstrated, but there is a
lack of studies regarding its eect on BV. Therefore,
the aim of this study was to compare the eect of C.
ocinalis and metronidazole vaginal cream on BV among
reproductive-aged women.
MATERIALS AND METHODS
This was a double-blind randomized controlled trial
for which 80 nonpregnant reproductive-aged women
in Dezful, Iran, were recruited. The study setting
was a public health center in Dezful, Iran (Health
center no: 3). The study protocol was approved by the
Ethics Commiee of Ahvaz Jundishapur University of
Medical Sciences (Ref no. IR.AJUMS.REC.1394.302).
In addition, the protocol was registered in the Iranian
Registry for Randomized Controlled Trials (Ref no.
IRCT2015082921414N3). Written informed consent
was obtained from all women before data collection.
This study was started in early May 2016 and ended in
late July 2016. The inclusion criteria were women aged
18–45 years who were married and had BV. Women who
complained of other types of vaginitis or were pregnant
were excluded from the study.
Sample size
The required sample size with regard to recovery after
using metronidazole and C. ocinalis (70 and 80%),[14] with
a maximum acceptable error of 0.3 either side and a 20%
arition rate, was calculated to be 40 for each group.
Herbal extract
The fresh owers of C. ocinalis were purchased from an
Iranian herbal market, and they were converted to a powder
at the Pharmacy School of Shahid Beheshti University
of Medical Sciences. The C. ocinalis vaginal cream was
made using the stages of extraction and formulation. The
rst and second stages of extraction were as follow: the
minimum inhibitory concentration (MIC) was determined
and the vaginal cream was prepared. All drug preparation
processes were performed in the Bacteriology Department
of Shahid Beheshti University of Medical Sciences, Tehran,
Iran. The mean MIC (0.07 µmol/ml) was considered against
particular bacterial strains in this study. The direct method,
in which the concentration of the extract was determined
and the drug then added, was used to add the plant extract
to the culture. Considering the antibacterial potency of the
methanol extract (MIC = 0.079 µmol/ml) compared to that of
the ethanol extract (MIC = 0.125 µmol/ml) and considering
the lower cost of methanol, the methanol extract was
chosen for the formulation. Composition of base cream was
cetostearyl alcohol, petroleum jelly, glycerin, mineral oil,
preservative, and antioxidant. After preparation, 80 tubes of
cream were made in two stages with the necessary testing
done in each stage.
Randomization
A total of 80 women with BV were randomized into the
C. ocinalis and metronidazole groups. Permuted block
randomization with a block size of 4 (using a random
permutation table) was used. The metronidazole and C.
ocinalis labels were encoded as A or B by a person who
was not aware of the purpose of the study. The C. ocinalis
and metronidazole formulations were similar in appearance
and consistency. The person who distributed metronidazole
and C. ocinalis was not aware of the purpose of study.
Intervention
A detailed history was taken from all patients who were
seen at the health centers and a physical examination was
performed. Vaginal pH was measured using pH strips.
A Pap smear was then performed on all women who gave
consent. Clinical signs and symptoms such as edema,
inflammation, and changes in vaginal discharge were
recorded for each participant. Next, a sample of vaginal
discharge was obtained to look for clue cells and perform a
whi test using 10% KOH. Diagnosis of BV was conrmed
when at least 3 of the 4 Amsel criteria were met (pH >4.5,
whitish gray or thin homogenous discharge, release of a
shy odor on adding 10% KOH, and presence of clue cells
in microscopy). Women who were diagnosed with BV
were randomly treated with metronidazole or C. ocinalis
coded as A or B. All women in both groups received advice
regarding avoiding intercourse, using coon underwear,
changing underwear regularly, keeping the perineum dry,
and instruction on washing the applicator before starting
treatment and after each use. Each woman in both groups
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Pazhohideh, et al.: Calendula ocinalis and bacterial vaginosis
17
Journal of Advanced Pharmaceutical Technology & Research | Volume 9 | Issue 1 | January‑March 2018
received a tube of cream containing 50 g C. ocinalis or
placebo, and women were instructed to use one applicator
of vaginal cream (5 g) before sleep for 1 week. The eect
of treatment was assessed 1 week after completion of the
treatment through an interview, observation, and laboratory
testing of vaginal discharge. If a patient did not aend the
follow-up, one of the investigators called her, and if she still
did not aend, she was considered a dropout. The vaginal
discharge samples were assessed using a microscope and
appropriate tests. All data were entered in the medical
records of the patients. All women were asked to report
any side eects of the treatment.
Statistical analysis
All data were entered in Chicago, Illinois: SPSS Inc., USA.
The normal distribution of data was evaluated using the
Shapiro–Wilk test. The independent t-test or Mann–Whitney
test was used for comparing continuous data between the
two groups while the Chi-square test was used for categorical
data. P < 0.05 was considered statistically signicant.
RESULTS
None of the participants withdrew from the study [Figure 1].
Table 1 shows the sociodemographic characteristics of the
participants of the two groups. The median age of the
women in the metronidazole and C. ocinalis groups was
31 and 32.38 years, respectively. Almost all women (99.9%)
in both groups used one method of contraception. The
method that most women used was withdrawal (used by
35% of women in each group). Women did not show any
signicant dierence in age, marriage age, body mass index,
parity, amount of coitus per month, job, history of BV, and
method of contraception.
Before the intervention, most women in both groups had
symptoms such as vaginal burning, itching, and discharge;
odor; and dysuria, with dysuria being the most common
in both groups. Itching was signicantly more common
in the C. ocinalis group than in the metronidazole group
(22.5% vs. 2.5%, P = 0.01). The two groups did not show
any signicant dierence with regard to other symptoms
before intervention. One week after intervention, all women
in both groups were free of symptoms [Table 2]. None of
the women in either group suered any side eects from
C. ocinalis or metronidazole.
DISCUSSION
This study aimed to compare the eect of C. ocinalis and
metronidazole on BV in reproductive-aged women. Our
results showed that both C. ocinalis and metronidazole
could eliminate all symptoms of BV in women. In support
of our ndings, Roopashree et al. showed that an aqueous
extract of C. ocinalis had an antibacterial eect against both
Gram-positive and Gram-negative strains.[15] In addition,
C. officinalis has shown that antifungal activity was as
eective as clotrimazole in women with a Candida albicans
infection.[16] In the present study, we used fresh owers
of C. ocinalis. Other studies have shown that all types of
extracts (aqueous, alcoholic, chloroform, and petroleum
ether) of the leaves and owers of C. ocinalis were more
active than extracts of the roots of this plant.[13]
In a study, Tedeschi et al. found that vaginal gel comprising
isoavones, Lactobacillus sporogenes, and C. ocinalis could
signicantly reduce the signs and symptoms of vaginal
dystrophy (itching, burning, vulvovaginal erythema, and
vaginal dryness) compared to placebo in postmenopausal
women.[17] Palmieri et al. found that a mixture containing
Saliva, Melaleuca, and Calendula plants had a very good
eect on the vaginal surface of women with damage to their
vaginal mucosa. Furthermore, they found that Calendula
could enhance the body’s defense against external agents
and exert anti-inflammatory, antioxidant, and wound
healing effects.[18] The results of the aforementioned
studies are in line with ours. In the present study, we used
a methanol extract of C. ocinalis, and other studies have
shown that the methanol extract of C. ocinalis had beer
antimicrobial activity than that of the ethanol extract.[19] Our
study showed that women in both groups did not suer
any side eects from metronidazole or C. ocinalis. Other
studies have also demonstrated that the methanol extract
of C. ocinalis has very few side eects on the skin, such
as skin irritation, with no sensitization or phototoxicity.[20]
Figure 1: Flowchart of recruitment and retention and participants
in the study
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Pazhohideh, et al.: Calendula ocinalis and bacterial vaginosis
18 Journal of Advanced Pharmaceutical Technology & Research | Volume 9 | Issue 1 | January‑March 2018
Table 1: Demographic characteristics of participants in two groups of metronidazole and Calendula
ofcinalis
Variables Median (IQR); Range or n (%) P
Calendula officinalis (n=40) Metronidazole (n=40)
Age (year) 32.38 (26.2‑37.5); 29 31 (28‑36); 22 0.63
Marriage duration (year) 9.5 (5.25‑15); 32 11 (5.2‑17.7); 26 0.96
Body mass index (kg/m2)27.6 (24.3‑31.1); 26 26.7 (24.1‑29.4); 17 0.29
Gravida 2.03 (1‑2.75); 8 2 (1‑3); 6 0.28
Para 1 (1‑2); 8 2 (1‑3); 5 0.09
Number of children 1 (1‑2); 5 2 (1‑3); 5 0.06
Number of coitus per month 10 (8‑13.5); 20 10 (7.25‑14); 20 0.92
Job
Housewife 37 (92.5) 39 (97.5) 1
Employee 3 (7.5) 1 (2.5)
Mode of delivery
Normal vaginal delivery 15 (37.5) 26 (65) 0.71
Cesarean 25 (62.5) 14 (37.8)
History of bacterial vaginosis
Yes 22 (55) 29 (72.5) 0.16
No 18 (45) 11 (27.5)
Method of contraception
Oral contraception pills 2 (5.7) 4 (10.8) 0.73
Depot medroxyprogesterone acetate 3 (8.6) 0
Condom 6 (17.1) 7 (18.9)
Tubal ligation 3 (8.6) 3 (8.1)
Withdrawal 14 (37.8) 14 (40)
Vasectomy 1 (2.9) 1 (2.7)
Intrauterine device 6 (17.1) 8 (21.6)
No contraception 5 (12.5) 3 (7.5)
The
P
values are based on the results of Mann‑Whitney U‑test or Pearson’s Chi‑square test. IQR: Interquartile range (25th‑75th percentiles)
Table 2: Clinical signs and symptoms before and after treatment in two groups of Calendula
ofcinalis and metronidazole
Variables Calendula officinalis (n=40) Metronidazole (n=40) P value before intervention
Before, n (%) After, n (%) Before, n (%) After, n (%)
Burning
Yes 13 (32.5) 018 (45) 0 0.35
No 27 (67.5) 40 (100) 22 (55) 40 (100)
Itching
Yes 9 (22.5) 01 (2.5) 0 0.01
No 31 (77.5) 40 (100) 39 (97.5) 40 (100)
Vaginal discharge
Yes 11 (27.5) 024 (60) 0 0.06
No 29 (72.5) 40 (100) 16 (40) 40 (100)
Bad odor
Yes 21 (52.5) 016 (40) 0 0.37
No 19 (47.5) 40 (100) 24 (60) 40 (100)
Dysuria
Yes 39 (97.5) 040 (100) 0 1
No 1 (2.5) 40 (100) 040 (100)
Dyspareunia
Yes 0 0 3 (7.5) 0 0.24
No 40 (100) 27 (92.5)
pH* 4.7±0.25 (4.5‑5.5) 4.7±0.23 (3.5‑4.5) 4.9±0.28 (4.5‑5.5) 4.1±0.28 (3.5‑4.5) 0.58
*The values are expressed as mean±SD (range). The
P
values are based on the results of Fisher’s exact test or independent
t
‑test. SD: Standard deviation
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Journal of Advanced Pharmaceutical Technology & Research | Volume 9 | Issue 1 | January‑March 2018
Strengths and limitations of study
Although other studies have shown that C. ocinalis is
eective against vaginal candidiasis,[15] to the best of our
knowledge, this is the first time that C. officinalis was
compared with metronidazole for the treatment of BV. We
relied on participant responses regarding how the vaginal
cream was used and the presence of symptoms. These
answers might have been aected by recall bias.
CONCLUSION
C. officinalis is effective for the treatment of BV in
reproductive-aged women without any side eects. The
use of this herb could be recommended in women who are
uncomfortable with the potential side eects of conventional
pharmaceuticals.
Acknowledgment
We would like to thank Ahvaz Jundishapur University of
Medical Sciences for nancial support of this study. Thanks
also extended to women who participated in this study.
Financial support and sponsorship
This study nancially supported by Ahvaz Jundishapur
University of Medical Sciences.
Conicts of interest
There are no conicts of interest.
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... The prevalence of BV as per the study conducted in Iran was 16.2% among reproductiveaged women (Pazhohideh et al., 2018). Peebles et al. in their systemic review and metaanalysis found that globally the prevalence ranges from 23% to 29% in different regions such as 24% in East Asia, and Caribbean, 23% in Europe and Central Asia (Peebles, Velloza, Balkus, McClelland, & Barnabas, 2019) and it varies from 17.8% to 63.7% in India as per National AIDS Control Programme III (Rao et al., 2016). ...
... Rao et al. that BV was most common in 24-29 years (Rao et al., 2016) because of high sexual acquaintance, and at this age is the utmost reproductively active age group. Hence, it is more common in the childbearing age group (Bhilwar, Lal, Sharma, Bhalla, & Kumar, 2015;Pazhohideh et al., 2018;Ranjit et al., 2018). However, a study showed that above 45 years of age BV was highest because of alkaline pH in women, the decline in estrogen level, as a result, an ideal state is created for the growth of anaerobic bacteria in place of lactobacilli (Bitew, Abebaw, Bekele, & Mihret, 2017;Mascarenhas et al., 2012) (Fig. 3.1). ...
... • A randomized comparative study of C. officinalis cream (5 g) vs metronidazole in reproductive age with BV for a week intravaginally. The results showed that after a week of intervention in both groups all women were free of symptoms proving their efficacy in BV without any efficacy (Pazhohideh et al., 2018). • Jahufer and Begum conducted an RCT to evaluate the efficacy of Acacia nilotica bark in BV that included 45 patients (2:1). ...
Chapter
The commonest vaginal infection seen in the Gynecological OPDs in reproductive age is bacterial vaginosis (BV) that causes abnormal vaginal discharge and if not treated, it is allied to severe problems or complications. It is a polymicrobial syndrome categorized by normal vaginal florareplacement that leads to a significant absence or reduction of normal “hydrogen peroxide” producing lactobacillus species and an upsurge in anaerobic bacteria (Atopobium vaginae, Prevotella spp., Gardnerella vaginalis, Mobiluncus spp., and Mycoplasma hominis). The incidence of BV varies from 4% to 61% from asymptomatic to symptomatic women who visits sexually transmitted disease clinics. Its prevalence among reproductive-aged women globally ranges from 23% to 29% in different regions such as 24% in East Asia, 23% in Europe and Central Asia and it varies from 17.8% to 63.7% in India. The risk factors are age, marital status, race and ethnicity, education, socioeconomic status, excessive perineal hygiene, sexual behavior, contraceptive methods, cigarette smoking, alcohol intake, stress, HIV, and dietary factor. The clinical features are abnormal vaginal discharge, which is malodorous, and occasionally leads to irritation that impacts activity in society and also affect sexual life. The diagnosis of BV includes Nugent score system (NSS), Amsel's criteria, Spiegel's criteria, anaerobic culture, Hays/Ison system, Schmidt's scoring system, gas–liquid chromatography, sialidase activity, and DNA probes for Gardnerella vaginalis. Metronidazole is the first line for the management of BV. The positive effect of herbal medicines such as Zataria multiflora, Nigella sativa, Hypericum perforatum vaginal gel 3%, Myrtus communis L. or Berberis vulgaris along with metronidazole, Hypercum perforatum, Calendula officinalis, Saugella lavanda, garlic, pepper vaginal gel, P. ferulacea, B. vulgaris, and Allium sativum are reported. Therefore, herbal medicine is considered probable to combat bacterial vaginosis. Further, phase III and post-marketing trials in large sample sizes are recommended to prove the efficacy of herbal medicines.
... The prevalence of BV as per the study conducted in Iran was 16.2% among reproductiveaged women (Pazhohideh et al., 2018). Peebles et al. in their systemic review and metaanalysis found that globally the prevalence ranges from 23% to 29% in different regions such as 24% in East Asia, and Caribbean, 23% in Europe and Central Asia (Peebles, Velloza, Balkus, McClelland, & Barnabas, 2019) and it varies from 17.8% to 63.7% in India as per National AIDS Control Programme III (Rao et al., 2016). ...
... Rao et al. that BV was most common in 24-29 years (Rao et al., 2016) because of high sexual acquaintance, and at this age is the utmost reproductively active age group. Hence, it is more common in the childbearing age group (Bhilwar, Lal, Sharma, Bhalla, & Kumar, 2015;Pazhohideh et al., 2018;Ranjit et al., 2018). However, a study showed that above 45 years of age BV was highest because of alkaline pH in women, the decline in estrogen level, as a result, an ideal state is created for the growth of anaerobic bacteria in place of lactobacilli (Bitew, Abebaw, Bekele, & Mihret, 2017;Mascarenhas et al., 2012) (Fig. 3.1). ...
... • A randomized comparative study of C. officinalis cream (5 g) vs metronidazole in reproductive age with BV for a week intravaginally. The results showed that after a week of intervention in both groups all women were free of symptoms proving their efficacy in BV without any efficacy (Pazhohideh et al., 2018). • Jahufer and Begum conducted an RCT to evaluate the efficacy of Acacia nilotica bark in BV that included 45 patients (2:1). ...
Chapter
Alzheimer's disease (AD) is a neurological disease caused by the growth of protein in the brain that affects people older than 65 years. It is a degenerative disease that affects not only patients but also their caregivers. Although researchers are actively studying the disease, there is no cure; thus, the focus is now on early detection. Using subjective methods for early prediction is quite difficult; there is only one cognitive tool that can accurately predict AD, the Mini Mental State Examination (MMSE). As such, machine learning methods are now being used to diagnose AD, but these too have limitations. For example, these methods can only use past patient data. Deep learning methods, however, can learn automatically from real-time data and thus are being developed to overcome the challenges of machine learning in predicting AD. In this chapter, we propose hand gesture recognition for the prediction of AD. In our model, data are collected and processed using deep learning algorithms such as convolutional neural network (CNN), recurrent neural network (RNN), and long short-term memory (LSTM). We used the proposed deep learning model for both static image and dynamic image processing of real-time videos of hand movements. Results show the proposed system detected AD with an accuracy of 90% from static images and an accuracy of 87% from dynamic images.
... The entire process of extraction and preparation was realized in the Department of Bacteriology of the University of Medic Sciences Shahid Beheshi, Iran. The bottles and the solidity of the two preparation were similar [13] . For diagnosing BV, they used three standards: ph>4,5, whitish discharge or whitish gray or thin; dissipation of fish odor through additioning of 10% of KOH and the presence of pista cell in the microscopy. ...
... When diagnosed, by a randomly way, the women received extracts of calendula or metronidazole [13] . Pazhohide et al supported their research on Roosphashire's et al. ...
... Pazhohide et al supported their research on Roosphashire's et al. Evidence that acknowleged an anti-bacterial effect of the Calendula officinalis aqueous extract on Grampositives strains, this way, they confirmed their results when they realized that both groups were free of odor, pruritus [13] . Previously, the two participant groups of the study presented symptoms equated to the odor, vaginal discharge, dyspareunia and dysprudia, however, the pruritus was analysed by considerable way in the group that received the Calendula officinalis, that is the calendula is as efficient as the metronidazole for actioning against bacterium action. ...
... The samples did not affect S. pneumoniae, while their activity was significant against E. coli. Pazhohideh et al. [35] showed that the topical formulation with pot marigold extract is effective in the treatment of bacterial vaginosis in women of reproductive age, without any side effects. Saffari et al. [36] confirmed that the Calendula vaginal cream is effective in the treatment of vaginal candidiasis. ...
Article
Pot marigold flower extract (Calendula officinalis L.) has pharmacological properties due to the presence of various bioactive compounds. It is known that the extract has antioxidant, anti-inflammatory, antitumor, antibacterial, antifungal, antiviral, antimutagenic, antidermatitis properties, etc. The aim of this study was to improve the quality of the selected topical formulation by adding the ethanolic extract of pot marigold flower, as well as to monitor its stability. The topical formulation was water-in-oil emulsion prepared using the hot/hot emulsification process with an oil phase consisting of Vaseline, lanolin, and almond oil. The extract, prepared by ultrasound-assisted extraction, had an antioxidants content of 3.512 g gallic acid equivalent per 100 g-1 of dry weight and the half-maximal inhibitory concentration of 0.14 mg mL-1 determined by the DPPH assay. Chemical stability studies have shown that daylight has no significant effect on the stability of antioxidants in the extract, while an increase in temperature leads to their degradation. The shelf-life of the extract is about 8 months at 4 °C and 3 months at 22 °C (room temperature). The prepared uncategorized topical formulations containing 1% and 2% (w/w) pot marigold extract were stable at different temperatures during the storage. The uncategorized formulations showed antioxidant activity, but the activity of the extract in the formulations decreased with increasing storage temperature. Pot marigold flower extract and the developed uncategorized formulations showed an inhibitory effect on Gram-positive (Staphylococcus aureus) and Gram-negative bacteria (Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae), as well as on Candida albicans. The uncategorized formulations with this activity can be used in the treatment of skin infection.
... [7] Calendula officinalis contains phytochemicals such as flavonoids, saponins, carotenoids, triterpenoids, and tannins, which possess antibacterial activity. [8] Bissa and Bohra [9] studied the antibacterial potential of C. officinalis and found good activity. So the aim of this study was to compare the antibacterial activity of sodium hypochlorite and C. officinalis as root canal irrigating solution. ...
... In Pazhohideh et al. study, women with BV were divided into two groups that received either methanolic extract of C. officinalis vaginal cream or metronidazole vaginal cream for seven days. All subjects in both groups were without symptoms 1 week after treatment completion [22]. ...
Article
Vaginosis is a condition experienced by most women at least once in their lifetime. This condition arises due to the imbalance in the microbiome of the vaginal ecosystem. Most of the pathogens of this disease are organisms which are commonly found in a normal healthy vagina. The vaginal microbiome is important as they act as a primary defence against secondary infections and Sexually transmitted diseases and infections (STDs and STIs). The vagina is mostly dominated by Lactobacillus along with other microbes including Gardnerella vaginalis, Atopobium vaginae., Prevotella spp., Mobiluncus spp., etc. Vaginal microbiome also includes Candida albicans and other species of the genus. The ratio in which these species are present varies from person to person and the dominant species decides the whether a vagina is “normal” or not. Lactobacillus dominated vagina is considered normal and if dominated by Gardnerella and such it is considered to be Bacterial vaginosis (BV) and similarly for Vulvovaginal Candidiasis (VVC). The microbiome also undergoes changes during menstrual cycles and menopausal stages. Due to the dynamic nature of this microbiome, it is tough to perfectly restore the balance. But several treatments are currently available with antibiotics like Clindamycin and derivatives of 5-nitroimidazole drugs like Metronidazole. The extensive use and the non-adherence to the treatment regimen has led to drug resistance through biofilm formation, efflux pumps, single nucleotide polymorphisms and resulting recurrent episode of vaginosis in women. Alternative medicines, preparations from plant sources, anti-microbial peptides and nano formulations are also being explored. Most of these medicines tend to focus on reducing the pathogen load rather than restoring the balance of the ecosystem. Vaginal microbiome transplant, an effort to restore the normalcy in the vaginal environment is becoming a popular treatment. In this review we discuss about the types of vaginosis, available treatments, challenges in treating the condition and the new drugs that are under investigation.
Article
Objective : This study was aimed to compare the effect of an Oak Gall extract‑based cream and a metronidazole Gel on the bacterial vaginosis among women in reproductive age. Material and methods This was a double-blind, randomized controlled trial performed on 84 women with BV in reproductive age. Accordingly, the women were randomly assigned to the Oak Gall (n = 42) or metronidazole (n = 42) groups. Diagnosis of BV was confirmed when at least 3 of the 4 Amsel criteria were met by the participants (whitish-grey or thin homogeneous discharge, pH ≥ 4.5, the release of a fishy odor on the addition of 10% KOH, and detection of clue cells > 20% in the microscopic examination). For each group, either a methanol extract of Oak Gall vaginal cream or a metronidazole vaginal gel (5 g) was used as intravaginal for 5 consecutive days, and all the signs or symptoms were assessed by passing 4-7 days from the treatment completion. Results At baseline, the two groups were homogenous in terms of the vaginal burning, odor, dysuria, dyspareunia, and itching. Also, all women in both groups were free of symptoms (vaginal itching and burning sensation, bad odor, dysuria, and dyspareunia) by passing one week from the intervention (p < 0.001). The percent of bacterial vaginosis treatment was in 33(82.1%) patients in terms of Oak Gall group and in 34(87.5%) patients of Metronidazole group (p=0.56). Notably, Oak Gall was as effective and safe as metronidazole in the treatment of BV in reproductive-aged women. Conclusion Oak Gall could be recommended for women in reproductive age who are uncomfortable with the potential side effects of synthetic drugs.
Article
Bacterial vaginosis is a prevalent vaginal infection that affects women of all ages. Presenting symptoms include a vaginal discharge that is thin and white and has a fishy odor. This infection is associated with the acquisition of other sexually transmitted infections as well as premature labor and preterm birth. Recurrence rates after treatment are high, and medication adverse effects are common, leading many women to seek alternative therapies to manage and prevent recurrence. Many of these treatments are searchable online, and ingredients are easily obtainable. The purpose of this article is to review the state of the science regarding the safety and efficacy of alternative therapies for the treatment of bacterial vaginosis in nonpregnant women.
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This triple-blind trial examined the effects of Calendula officinalis vaginal cream on the treatment of vaginal Candidiasis (primary outcome) and sexual function (secondary outcome). Married women aged 18–45 years with vaginal Candidiasis (n = 150) were recruited from April to October 2014 and randomized into Calendula and clotrimazole groups, using 5-gram vaginal cream every night for 7 nights. Clinical and laboratory assessments were conducted at 10–15 and 30–35 days after intervention and the female sexual function index was assessed at 30–35 days. Six women were lost to follow-up. The frequency of testing negative for Candidiasis in the Calendula group was significantly lower at the first (49% vs. 74%; Odds Ratio (OR) 0.32; 95% confidence interval (CI) 0.16–0.67) but higher at the second (77% vs. 34%; OR 3.1; 95% CI 1.5–6.2) follow-up compared to the clotrimazole group. The frequency of most signs and symptoms were almost equal in the two groups at the first follow-up but were significantly lower in the Calendula group at the second follow-up. Sexual function had almost equal significant improvement in both groups. Calendula vaginal cream appears to have been effective in the treatment of vaginal Candidiasis and to have a delayed but greater long-term effect compared to clotrimazole.
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The folk ethno-medicine describes some useful herbal remedies for vaginal hygiene, whose knowledge goes back to previous centuries; unfortunately, only few of them have been submitted to clinical trials and fulfilled the evidence-based medicine rules thus being successfully introduced into the routine use; as a matter of fact actually the consumer is quite sensitive to the message that historical natural active principles revisited by positive recent investigations can have a role in the disease prevention and treatment. Salvia, Melaleuca and Calendula have been selected by us among a certain number of natural compounds to be introduced in the formula of our vaginal gel, because their complementary properties synergize each other, achieving, altogether the best clinical results. The mechanism of actionof the 3 herbs extracts in combination, takes control of the vaginal surface integrity and mucosa restoration after mechanical, chemical or microbiological damage, especially through the well-known Calendula contributes to body defenses against external agents, has anti-inflammatory, antioxidant and healing properties; Salvia expresses altogether a wide and selective control, supports the natural mechanism for body´s purification and promotes the toxin elimination; Melaleuca expresses altogether a wide and selective control of pathogenic microflora enclosing the often relapsing Candida albicans super-infections.
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Bacterial vaginosis is a common vaginal infection, causing an abnormal vaginal discharge and/or odour in up to 50% of sufferers. Recurrence is common following recommended treatment. There are limited data on women's experience of bacterial vaginosis, and the impact on their self-esteem, sexual relationships and quality of life. The aim of this study was to explore the experiences and impact of recurrent bacterial vaginosis on women. A social constructionist approach was chosen as the framework for the study. Thirty five women with male and/or female partners participated in semi-structured interviews face-to-face or by telephone about their experience of recurrent bacterial vaginosis. Recurrent bacterial vaginosis impacted on women to varying degrees, with some women reporting it had little impact on their lives but most reporting it had a moderate to severe impact. The degree to which it impacted on women physically, emotionally, sexually and socially often depended on the frequency of episodes and severity of symptoms. Women commonly reported that symptoms of bacterial vaginosis made them feel embarrassed, ashamed, 'dirty' and very concerned others may detect their malodour and abnormal discharge. The biggest impact of recurrent bacterial vaginosis was on women's self-esteem and sex lives, with women regularly avoiding sexual activity, in particular oral sex, as they were too embarrassed and self-conscious of their symptoms to engage in these activities. Women often felt confused about why they were experiencing recurrent bacterial vaginosis and frustrated at their lack of control over recurrence. Women's experience of recurrent bacterial vaginosis varied broadly and significantly in this study. Some women reported little impact on their lives but most reported a moderate to severe impact, mainly on their self-esteem and sex life. Further support and acknowledgement of these impacts are required when managing women with recurrent bacterial vaginosis.
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Vaginal dystrophy due to hypo-oestrogenism takes advantage of local and systemic oestrogens to balance the vaginal ecosystem and improve tissue hydration. Women who do not accept/tolerate hormone therapy can use intravaginal isoflavones to relieve vaginal dryness. The aim of this study was to investigate the clinical effect of a vaginal gel formulation containing isoflavones compared with no topical treatment in women with vaginal dystrophy. In a multicentre, controlled, parallel-group study, menopausal women with vaginal dystrophy were randomized to vaginal gel (EG) or no topical treatment (NT) for 4 weeks. EG contained isoflavones, Lactobacillus sporogenes, Calendula officinalis extract and lactic acid (Estromineral Gel, Rottapharm-Madaus). All patients received daily oral isoflavones plus L. sporogenes. Clinical evaluations were performed at time 0, 2 and 4 weeks. Results: 186 women were recruited, 103 in the EG group and 83 in the NT group, mean age 53.7 years, postmenopausal for 4.1 years. The severity of itching, burning, vulvovaginal erythema, vaginal dryness and dyspareunia were significantly reduced during EG treatment compared with the NT group. The combination of oral and topical isoflavones was shown to be more effective than oral treatment alone in reducing the problems of postmenopausal vaginal dystrophy.
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Bacterial vaginosis is one of the most common causes of reproductive tract infection (RTI), it's prevalence is influenced by many factors. The aim of this study is to determine the prevalence of bacterial vaginosis and impact of sexual and genital hygienie practices and socio-demographic characteristics in non pregnant women of Zanjan province in Iran. 500 non-pregnant, married women were randomly selected for this study. This is a descriptive-analytic study conducted among non-pregnant referred to primry healthcare centres in Zanjan between May to August 2006. Following gynecological examination and vaginal sample collection by physicians, bacterial vaginosis was confirmed by Nugent criteria, tricomoniasis by direct microscopy and candidiasis by direct microscopic observation and evaluation of presenting clinical signs of vulvovaginitis. The prevalence of RTI was 27.6%. Out of which 16.2% was devoted to bacterial vaginosis (BV), 6.6% to trichomoniasis and 4.8% to Vulvovaginal candidiasis (VVC). In contrast to coital hygiene, there was a significant correlation between menstrual and individual vaginal hygiene and BV (p<0.01 and p<0.001) respectively. There was a significant correlation between BV and education (p<0.025), number of pregnancy (p<0.05) and method of contraception (p<0.005). No significant correlation was observed between age, age of marriage and abortion. The data obtained suggests that the prevalence rate of BV is relatively high and could be affected by hygiene behaviors and certain socio-demographic characteristics, which indicate the need for comprehensive, scheduled programs of healthcare educations, aimed at reducing BV prevalence.
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Plants continue to be an important therapeutic aid for alleviating the ailments of humankind. In the present research work different parts (root, leaf and flowers) of Calendula officinalis were screened for potential antibacterial activity against some important bacterial strains, namely Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Enterobacter aerogenes and Agrobacterium tumefaciens. The antibacterial activity was determined in aqueous, alcohol, chloroform and petroleum ether extracts using agar disc diffusion method. Although all the plant parts showed significant anti microbial activity but the highest antibacterial activity was observed in petroleum ether extract of dried leaves against Klebsiella pneumoniae. Phytochemical analysis was also done.
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In view of increasing resistance to existing antimicrobial agents, herbal drugs are being looked as very importance sourcefor discovery of new agents for treating various ailments related to bacterial infections. Cassia tora, Calendula officinalis andMomordica charantia are well known plants in Asia including India which posses wide range of pharmacological activities. Thesedrugs have been used in India as folk remedy in the form of decoctions and infusions to treat bacterial infections and also claimed tobe an effective against variety of skin conditions like psoriasis, acne, wounds etc. The present investigation was carried out to studythe unexplored area of these drugs towards their antibacterial activity with respect to their traditional use as antipsoriatic agents. Theherbs were subjected to successive extraction using different solvents and the extracts were subjected to antibacterial evaluationagainst both gram positive and gram negative organisms by cup plate technique. Among the various extracts, aqueous extracts werefound to be more effective against all the bacteria. Staphyllococcus aureus was more susceptible to the aqueous extracts among thetested organisms.