J O U R N A L R E A D I N G

Effect Of Vaginal Suppository On Bacterial

Vaginitis Based On Persian Medicine
( I R A N I A N T R A D I T I O N A L M E D I C I N E ) : A R A N D O M I S E D D O U B L E B L I N D C L I N I C A L S T U D Y

Oleh : Melvita Mentari Kurniawan

Pembimbing : dr.Jacobus Jeno Wibisono, Sp.OG

 Journal
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T H I S S T U D Y W A S R E G I S T E R E D A T I R A N I A N R E G I S T R Y O F C L I N I C A L T R I A L S W I T H T H E

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Introduction
B A C T E R I A L V A G I N O S I S

Bacterial Vaginosis (BV) is a common

problem in women especially of

childbearing age.

Prevalence of BV ranges from 4%

(in asymptomatic women) to 61%

in women referred to sexually

transmitted disease (STD) clinics.

 Replacement of normal vaginal lactobacilli

with anaerobic microorganisms causes

dysbiosis in the vaginal microflora leading to

a pathophysiologic process with discharge

The clinical criteria for diagnosing BV are

BV -> Associated with preterm births, pelvic
the presence of 3 of the Amsel's Criteria
inflammatory disease (PID), an increased susceptibility

to HIV infection, and other chronic health problems.

BV can be a self-limiting infection but can often
recur and may become chronic

Common antibiotics for the treatment of BV include :

Metronidazole

Tinidazole

Clindamycin.

Unfortunately, treatments often occur with a

recurrence and failure.

Therefore alternative treatments are necessary.

"Hundreds of plants are used in traditional "Many natural treatments are recommended for

medicine as treatments for bacterial this condition in Persian Traditional Medicine

infections in the world." Sources."

Foeniculum vulgare
Tribulus terrestris

One of them is vaginal suppository

Antimicrobial Activities

"Forzejeh"
Myrtus commuis Tamarindus indica
 To compare the effect of

Aim
Forzejeh with Metronidazole

vaginal suppository in the

Of
treatment of bacterial

vaginosis.

This Study :
Materials and Methods
- Simple Random Sampling (SRS) method.
Study Design - Randomised Double-Blind Placebo-Controlled

Time & Place

- June 2016 - October 2016

- Women's Comprehensive Hospital (Moheb Yas) of Tehran University

of Medical Science in Tehran Iran

Study Subject - Outpatient women (aged 18-50 years) with symptoms of genital

tract infection

Intervention - Forzejeh Vaginal Supp for 7 days

- Metronidazole Vaginal Supp for 7 days

Exclusion Criteria
- Presence of uterine or ovarian cancer or other malignancies

- Chronic Diseases

- Immunosuppressive disorders

- HIV, Herpes, Trichomoniasis, Candidiasis, Gonorrhoea

- Those who were taking interfering medication

Analysis plan
Result & Discussion
 There were no statistically significant differences in baseline characteristics

between the two groups

Baseline Characteristics
There were statistically significant differences in amount of discharge and discharge odour,

pelvic pain, and cervical inflammation in Forzejeh group and also in metronidazole group

after treatment. (p=<0.001)

compared to the baseline.

There were no statistically significant differences in the amount of discharge, discharge

odour, and cervical inflammation between metronidazole and Fozjeh group.

 There were significant differences in the pH, the whiff test, the presence of clue cells, and

the Gram Positive Bacteria before (at the baseline) and on the 14th day after intervention

in the Forzejeh group (p<=0.001) and the metronidazole group (p<= 0.001).

There were no significant differences in the pH, the whiff test, the presence of clue cells, and

the Gram Positive Bacteria on the 14th day between the 2 group.
In Addition presence of clue cells decreased notably in gram-satined smear

of vaginal discharge after treatment in two groups.

 Discussion
Bacterial vaginosis is the most common vaginal infection in women

Treatments : limited, only 65%-85% of the patients cure completely

Metronidazole remain one of the most effective treatments, and DOC for BV

Metronidazole side effects : Metallic taste, nausea, transient neutropenia,

and also in many cases BV relapse after treatment.

Therefore, new therapeutic alternatives are essential

Discussion
This study showed that FORZEJEH , a persian traditional medication, is as effective as

metronidazole in the treatment of BV.

There was no significant difference between the efficacy of FORZEJEH and metronidazole on

BV and also FORZEJEH had not any serious side effects.

As the result, the treatment of BV by herbal remedies such as FORZEJEH can alternatively be

recommended in case there is a resistance to treatment recurring BV upon treatment with

metronidazole.
+ Both the participants and the
physicians were blinded and the
- The Follow-Up period was
short in this study.
study was randomised.

Strength & Limitation

Conclusions

This study showed that Persian Traditional medication including the

combination of Tribulus terrestris, Myrtus commuis, Foeniculum vulgare
and Tamarindus indica has a therapeutic effect on bacterial vaginosis, the
same as metronidazole, and can be recommended in cases of resistance to
treatment and relapsing disease.
thank you.