Health Professional Products

Relactagel

Relactagel® is a lactic acid gel which:

• restores and maintains the natural acidity of the vagina creating a suitable environment for the growth of lactobacilli
• relieves abnormal vaginal discharge & odour
• treats and prevents Bacterial Vaginosis
• contains no preservatives
• can be use during pregnancy

More Information

Bacterial Vaginosis (BV)

Bacterial Vaginosis is the most common form of vaginal infection. Bacterial Vaginosis is caused by an imbalance in the naturally occurring microbial flora where lactic acid producing Lactobacillus species predominate. Bacterial Vaginosis should not be confused with yeast infection (Candidiasis), or infection with Trichomonas vaginalis (Trichomoniasis) which are not caused by bacteria. It is not generally considered to be sexually transmitted infection.

Causes

A healthy vagina normally contains many microorganisms primarily Lactobacillus species such as Lactobacillus crispatus and Lactobacillus jensenii. Lactobacillus (LB) are a genus of commensal (benign) bacteria that colonise the mucosal surface of the vagina where they convert natural lactose and other sugars to lactic acid creating an acidic environment in which they thrive. Lactobacilli form a crucial component of the innate immune system and are found in the vagina and GI tract where they inhibit the growth of pathogenic species of bacteria by:

• Competing for fermentation substrates
• Lowering pH through production of lactic acid
• Production of natural bactericides e.g. hydrogen peroxide (H₂0₂)

Lactobacilli are highly sensitive to changes in their natural environment often brought about by physiological and external factors such as: falling oestrogen levels; antibiotic therapy; exposure to detergents; smoking; stress; sexual activity and the use of IUDs. This altered environment can lead to an overgrowth of pathogenic species of bacteria such as Garderella vaginalis, Mobiluncus, Bacteroides, and Mycoplasma. These bacteria are often found at low levels in the vagina however, given an opportunity to proliferate they do so. Upon reaching significant numbers Bacterial Vaginosis associated bacteria begin to produce toxins that interfere with the mucosal immune system, and break down the protective mucus layer leading to a characteristic discharge.

Symptoms and Signs

The most common symptom is a thin homogeneous white or grey malodorous discharge which is characteristic of Bacterial Vaginosis. On examination, this discharge is observed to coat the walls of the vagina. Most women present with no symptoms, however Bacterial Vaginosis may be diagnosed when vaginal swabs are taken for other indications. In contrast, a 'normal' discharge is odourless and will vary in consistency and amount with the menstrual cycle.

Complications associated with Recurrent Bacterial Vaginosis

Bacterial Vaginosis was previously considered to be a minor infection. However, recurrent Bacterial Vaginosis is associated with serious gynaecological complications including:

• Preterm birth
• Late Miscarriage
• Postpartum endometritis
• Pelvic Inflammatory Disease (PID)

Recent research has shown that recurrent Bacterial Vaginosis is associated with increased susceptibility to sexually transmitted infections including HIV.

Diagnosis of Bacterial Vaginosis

A healthcare professional seeing a woman present with vaginal discharge may consider the following conditions:

• Discharge is normal
• Candidiasis (Thrush)
• Trichomoniais, an infection caused by Trichomonas vaginalis
• Bacterial Vaginosis

Simple test can be done to make a proper diagnosis. During a speculum examination some swabs should be taken from high in the vagina to confirm Bacterial Vaginosis. Under certain circumstances a diagnosis of Bacterial Vaginosis can be made and treatment initiated without further investigations on the basis of:

• A history of recurring Bacterial Vaginosis
• Symptoms and signs including an assessment of the discharge
• Measuring the pH of the vaginal fluid using pH paper (pH > 4.5 indicative of BV)

Investigations

High vaginal swabs should be performed if the woman:

• Has had recurrent episodes of Bacterial Vaginosis (four or more per year)
• Has recently given birth or has a history of preterm birth, late miscarriage or postpartum endometritis
• Has had recent gynaecological surgery
• Is at risk of sexually transmitted infection (STI)
• Displays symptoms non characteristic of bacterial vaginosis, or Trichomoniasis

The 'gold standard' criteria for diagnosis are based on Amsel's criteria. An alternative is to use a Gram-stained vaginal smear, with the Hay/Ison criteria or the Nugent score. However these are not always practical in primary care.

It is important that a referral is considered where:

• A co-existent STI is suspected
• Bacterial Vaginosis symptoms persist or frequently recur despite management in primary care
• There is recurrent Bacterial Vaginosis during pregnancy especially where there is a history of previous idiopathic preterm delivery or second trimester loss
• Where a gynaecological cancer is suspected

Management of Recurrent Bacterial Vaginosis

The conventional prescribed treatment is a course of antibiotics (metronidazole or clindamycin) which are available as a course of oral tablets or as a topical treatment.

The recurrence rate of Bacterial Vaginosis with antibiotic therapy can be as high as 70% and it has been suggested that the most successful approach to managing recurrent Bacterial Vaginosis would be a combined one where vaginal pH is maintained at 4.5, the overgrowth of Bacterial Vaginosis associated bacteria is controlled and lactobacilli restored.

Restoring Vaginal pH to 4.5

Intervention with a lactate gel has been shown to lower vaginal pH. The primary goal of lactate gel therapy is the restoration and maintenance of the vaginal pH at 4.5 to prevent or inhibit overgrowth of pathogens, until such time as the lactobacilli have become re-established and can maintain vaginal pH unassisted.

Relactagel is a natural approach to the management of Bacterial Vaginosis through the regulation of vaginal pH.

Relactagel is a registered medical device which is available from hospital and community pharmacies. Relactagel is available on NHS prescription.

RELACTAGEL^®

Relactagel^® is a lactic acid gel which:

• restores and maintains the natural pH of the vagina creating a suitable environment for the growth of Lactobacilli 
• relieves abnormal vaginal discharge & odour
• treats and prevents Bacterial Vaginosis
• contains no preservatives
• safe to use during pregnancy

DOSAGE

Relactagel^® comes in a 5mL single use tube.

For treatment:

1 tube per day for 7 days at bedtime (one week’s course).

For prevention:

1 tube per day for 2-3 days at bedtime after menstruation. 

BV Irish Medical News Mar 09

Relactagel Pharmacy in Focus Apr 09