W. Steven Pray, Ph.D., R.Ph., Professor of Nonprescription Products and Devices, School of Pharmacy, Southwestern Oklahoma State University, Weatherford, OK

U.S. Pharmacist (26)9 2001. © 2001 Jobson Publishing Corp.
 

Introduction
Vaginitis with vaginal discharge is a common problem, causing 10 million women each year to visit a physician's office for care.[1] The three most common causes of vaginitis are bacterial, trichomonal, and fungal. In as many as 75% of females with vaginitis, vulvovaginal candidiasis is the cause.[2] Since nonprescription antifungals first became available over a decade ago, numerous female patients have sought advice from a pharmacist about self-care. The number may well dwarf those who have made physician appointments.
 

Recognizing Bacterial Vaginitis
Bacterial vaginitis may be caused by a host of organisms, including Gardnerella vaginalis (the most common), Mobiluncus species, Mycoplasma hominis, Prevotella, Bacteroides, and Peptostreptococcus.[1] Three points help confirm bacteria as the source of vaginitis: (1) The discharge is thin, homogeneous, white, and resembles skim milk adhering to vaginal walls; (2) The pH is above 4.5 (normal vaginal pH is 3.8-4.4); (3) When a sample of the discharge is mixed with 10% KOH, it will produce a typical "fish-like" odor (this is indicative of an increase in anaerobic activity, which yields amines such as cadaverine and putrescine).

Trichomonal vaginitis causes a frothy, copious discharge that is yellowish or greenish and may have a fishy odor.[1] The vaginal pH exceeds 5-6. While many patients are asymptomatic, others report vaginal and vulvar discomfort, soreness, burning, and dyspareunia (pain during sexual intercourse). Patients who report manifestations of these symptoms must be referred to a physician for prescription medications.
 

Candidal Vaginitis
As many as 15%-20% of females with vaginal yeast infections are asymptomatic.[3] The reported symptoms of vaginal candidal infection are fairly characteristic and duplicative upon recurrence. They include vulvar and/or vaginal pruritus (which may be intense), burning soreness (especially when urinating), irritation, dyspareunia, and the well-known curd-like discharge that adheres to the vaginal walls.[4] Several noninfectious etiologies can produce similar symptoms, as illustrated in Table 1. In order to confirm Candida as the cause, the physician should test vaginal pH, and should treat a vaginal specimen with 10% KOH.[5] The alkaline pH of KOH does not affect the chitinous components of the fungi, whereas all nonchitinous elements in the specimen (white blood cells, bacteria, epithelial cells) are dissolved. Microscopy reveals the characteristic architecture of fungal organisms (yeast buds and hyphae). Another clue is the presence of a rash with a prominent border, similar to that seen in candidally infected diaper rash. The rash may spread outward from the vulvar area to involve the groin. The patient may also have satellite lesions outside the visible border.[6] In worse cases, the patient may also experience excoriations, formation of pustules, and fissures of the labia.[5]

Species of Candida
Candida albicans is able to adhere to vaginal epithelium more readily than other Candida species, which is probably why it causes about 80% of yeast infections. Other, less common, causes are C. glabrata, C. parapsilosis, C. guilliermondii, and C. tropicalis.[6] These latter organisms may not respond as readily to nonprescription therapy. Unfortunately, there is no reliable clinical method of differentiating the various Candida organisms.[6] It may be that treatment failures point to the presence of a non-albicans infection. Researchers hypothesize that the widespread home use of nonprescription antifungal medications has caused the emergence of more resistant strains, and that the number of chronic and recurrent cases will eventually increase as a result.[4]
 

Risk Factors for Candidal Infection
Estrogen augments Candida's propensity to adhere to intravaginal tissues. Thus, both pregnancy and oral contraceptives can increase the risk of vaginal yeast infections.[3] Oral contraceptives containing 75-150 micrograms of estrogen are most likely to cause the problem; low-dose products are seldom implicated.

Immunocompromise can also induce candidal infection; use of systemic corticosteroids and having AIDS are both associated with infection. Diabetes, glucosuria, lupus, thyroid dysfunction, and obesity are all thought to be possible predisposing factors.[1]

Use of antibiotics is widely perceived to be a risk factor for Candida vaginitis through alteration of the intravaginal flora. High-risk antibiotics that more commonly lead to candidal infection are reportedly ampicillin, tetracyclines, clindamycin, and the cephalosporins.[3] In one study, researchers found that virtually all gynecology and internal medicine textbooks repeat this as though it were a proven fact.[7] The researchers also explore the theory that the reciprocal balance between normal vaginal organisms is upset through eradication of bacteria. In a prospective study, they followed 250 asymptomatic obstetric patients, 46% of whom received an antibiotic during their pregnancies. Surprisingly, there appeared to be a slightly lower risk of developing a yeast infection when the female took antibiotics. There was no association between any specific antibiotic class and greater susceptibility to vaginal candidiasis. Since this group consisted of pregnant women, however, tetracycline was not one of the prescribed antibiotics. The authors suggested that tetracycline use might have altered the results.

Certain types of clothing may predispose for Candida. Females should be cautioned to avoid wearing tight-fitting clothes and synthetic underwear.[1] Frequent coitus and the use of intrauterine devices may also be contributing factors.

Patients should be counseled against frequent bathing in hot tubs or Jacuzzis, as well as to avoid any situation in which the outer vaginal area is exposed to prolonged moisture, such as wearing a wet bathing suit throughout a long summer day at a pool or water park. The chemically treated water in hot tubs and overly chlorinated water in indoor pools may also be causal through irritation of delicate vulvar/vaginal tissues.[1]

Anecdotal evidence implicates such factors as stress, proximity to the onset of menses, and various dietary components (e.g., too great an intake of milk products, refined carbohydrates, or artificial sweeteners), but there is little evidence to support these hypotheses.[1,3]

Sexual Transmission
Although it would be tempting to assume that Candida infection can be sexually transmitted, there are few data to support that theory. Concomitant treatment of the male sexual partner seldom yields any benefit in lowering the incidence of reinfection.[1] For this reason, most authorities do not suggest that a woman's partner be treated. Further, many females who contracted a vaginal yeast infection were not sexually active at the time proximate to the infection.[3]
 

Treatment Considerations
Patients with candidal vaginitis should be counseled on appropriate care of the vulvar region. They should avoid use of harsh soap and perfumes and should keep the vulvar area dry to discourage overgrowth.[1] Vulvar itching may be controlled by careful application of one of the topical vaginal antifungals. Nonprescription hydrocortisone may enhance the effectiveness of the antifungal.[1]

Topical nonprescription antifungals are a good first-line therapy for candidal vaginitis. Adverse reactions are generally mild, and included burning, stinging and irritation. Pharmacists must counsel sexually active patients, however, that use of many vaginal products, such as antifungals or hydrocortisone ointments, may damage certain barrier contraceptives, such as diaphragms and condoms. Manufacturer toll-free lines cannot answer whether the products degrade polyurethane products such as the Trojan Supra Condom or the Reality Female Pouch. Miconazole (Monistat) and clotrimazole (Gyne-Lotrimin) are available as vaginal suppositories/tablets and cream, in a 7-day or 3-day option. Butoconazole (Femstat 3, Mycelex-3) is available as a cream or tablet in a 3-day product. Tioconazole (Vagistat-1, Monistat 1) is a 1-day product that is available in a prefilled applicator containing the ointment. Within this group, tioconazole appears to be most effective in treating non-albicans cases. Shorter courses of treatment may result in higher recurrence rates.[3]

The primary source of the inflammation can help to guide which treatment to use. If the problem is mainly intravaginal, a suppository/tablet may be superior, while if the problem is primarily vulvar the creams may be preferable.[3] For patients with both areas affected, the combination packs offering a vaginal suppository/tablet in combination with a small tube of cream may be the better option.
 

Homeopathic Products
Homeopathic products that purport to relieve the burning and itching of vaginal yeast infections actually contain diluted extracts of Candida parapsilosis and Candida albicans. They lack scientifically valid proof of efficacy, and are not covered under the 1938 Federal Food, Drug, and Cosmetic Act.
 

Vaginal Infections Are Common, But Often Misunderstood
Vaginitis, the collective term for all vaginal infections, is the most common reason women in the U.S. see their doctors, accounting for 10 million office visits each year. Most women (80%), however, do not recognize the signs of bacterial vaginitis (BV)-the most common and potentially serious form of infection. They may confuse the signs of BV for a yeast infection and thus self-treat inappropriately with OTCs meant to eradicate candidal infection.
 

Patient Information

Vaginal Fungal (Yeast) Infections
Vaginal fungal infections are a common and troubling nuisance for many women. Since 1990, safe and effective nonprescription products that can cure the problem have been available. There are specific instructions and precautions you must know and follow before you attempt self-treatment.
 

What Are Some Typical Symptoms?
A fungal infection causes severe vulvar itching, often along with a thick, curd-like vaginal discharge. Your vulvar tissues may be red, swollen, and you may have burning with urination. The symptoms are the same from episode to episode. However, it is easy to misdiagnose your symptoms or to mistake another, more serious, condition (such as an allergy or an STD like herpes) for vaginal fungus. Also, there are other things besides vaginal fungus that cause discharge. For this reason, you must have had at least one physician-diagnosed vaginal fungal infection before you can self-treat the next ones.
 

Available Products
The first products that were available without a prescription were Gyne-Lotrimin and Monistat 7. Both require seven days of therapy. Each is available as either a cream or a vaginal suppository/tablet. With either one, you must insert one applicatorful of cream or one suppository/tablet into the vagina for seven consecutive nights, preferably at bedtime. You should continue to use them if your period starts, but you should be sure to use pads rather than tampons to prevent absorption of the medication into the tampon. If you wish, you may place some of the cream directly on vulvar tissues while itching is severe.Several manufacturers also make three-day treatments, such as Monistat 3 Suppositories, Gyne-Lotrimin 3 Cream, Femstat 3 Cream, and Mycelex-3 Cream. They are used for three consecutive days. The newest vaginal products are one-dose prefilled applicators, such as Vagistat-1 and Monistat 1. They are easier to use than the three-day and seven-day products. The three-day and one-day products may not work as well as the seven-day products, however.
 

How Long Before the Product Works?
All of these products (one-day, three-day, and seven-day) generally produce some relief from symptoms in fewer than three days, and should effect a cure in seven days or less. If the product you are using fails to do either of these things, you may have another condition. If this is the case, you should immediately make an appointment to see a physician.
 

What Should Be Done If the Condition Returns?
Vaginal fungal infections often return. However, if you experience infection within two months of use of the product, you may be pregnant or have a serious underlying condition, such as AIDS or diabetes. A physician appointment should be made if this occurs.
 

Who Should Not Use Nonprescription Antifungals?
Girls under the age of 12 and pregnant women should not use nonprescription antifungals. If you have abdominal pain, oral temperature over 100° F, chills, nausea, vomiting, diarrhea, foul-smelling vaginal discharge, or pain in the back or shoulder, do not use these products. Instead, you should make an appointment to see a physician.

Remember, if you have questions, Consult Your Pharmacist.
 

Table 1. Situations That Mimic Vaginal Candidal Infection
Condition Possible Causes
Contact dematitis Soaps, deodorants, underwear, detergents, spermicides, douche, solutions, vaginal lubricants, perfumed cleansing wipes
Irritant vulvitis Excessive use of minipads
Vulvovaginitis Adverse reaction to vaginal antifungal product
Change in vaginal mucus Normal change that occurs at ovulation
Coitus-related vaginitis Allergy to partner's sperm

Source: References 1-7
 

References

1. Haefner HK. Current evaluation and management of vulvovaginitis. Clin Obstet Gynecol. 1999;42(2):184-195.
2. Eckert LO, Hawes SE, Stevens CE, et al. Vulvovaginal candidiasis: Clinical manifestations, risk factors, management algorithm. Obstet
   Gynecol. 1998;92(5):757-765.
3. Carr P, Felsenstein D, Friedman RH. Evaluation and management of vaginitis. J Gen Intern Med. 1998;13(5):335-346.
4. Roe VA. Pharmacologic management of sexually transmitted diseases. J Nurse Midwifery. 1997;42(3):275-289.
5. Sobel JD. Vulvovaginitis. Dermatol Clin. 1998;16(4)763-768. Hay RJ. The management of superficial candidiasis. J Am Acad Dermatol.
   1999;40(6) Pt 2:535-542.
6. Glover DD, Larsen B. Longitudinal investigation of Candida vaginitis in pregnancy: Role of superimposed antibiotic use. Obstet
    Gynecol. 1998;91(1); 115-118.