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Vulvovaginitis: The role of patient compliance in treatment success
Vulvovaginitis: The role of patient compliance in treatment success * Sam A. Nixon, MD Houston, Texas Vulvovaginitis caused by Candida organisms accounts for a large number of annual office visits to physicians, often for recurrent infection. Despite the availability of many effective antifungal preparations, treatment failures continue to occur because of poor compliance with therapy. Several factors may foster noncompliance. Those involving the patient include denial of illness, misconceptions regarding the nature of the infection or its treatment, a misunderstanding of symptomatic relief versus microbiologic cure, dislike of the dosage form, nonsupport of the sexual consort, or intolerance of side effects. The cost of treatment, inconvenient dosage form, and prolonged duration of therapy may also contribute to noncompliance. This article offers suggestions for optimizing compliance and successful treatment. Two perceived means to this end are improved patient education and the use of short-term therapy in convenient dosage form. (AM J OSSTET GYNECOL 1991 ;165:1207-9.)
Key words: Patient compliance, vaginal mycoses, vulvovaginitis The increasing frequency of vulvovaginitis has been traced to a number of diverse factors, including the widespread use of oral contraceptive pills and antibiotic administration. Whatever the underlying reasons, no one regards vulvovaginitis as a trivial disorder, because a large number of office visits to gynecologists are for the treatment of its symptoms. Such an overwhelming caseload translates into enormous morbidity among women and an ongoing challenge to clinicians. A significant proportion of office visits for vulvovaginitis represent repeat visits by patients with chronic or recurrent infections despite the availability of seemingly effective therapeutic agents. Thus the question naturally arises, "Why are there so many therapeutic failures ?" Aside from host factors, the most likely answer is poor patient compliance, which can compromise even the most effective treatment regimen. Hence the real challenge to physicians may not lie in diagnosing this condition, but rather in effecting better patient compliance. This article explores the factors contributing to poor drug compliance and some of the options available to physicians for overcoming these problems.
Therapeutic regimen and compliance It is generally held that the more precisely a therapeutic agent meets the needs of a specific patient, the From The University of Texas Health Science Center at Houston. R eprint requests: Sam A. Nixon, MD, Director, Division of Continuing Education, The University of Texas Health Science Center at Houston, 1100 Holcombe Blvd., Houston, TX 77030. *Dr. Nixon's presentation was updated from a talk given previously and published in the Journal of Clinical Practice in Sexuality. 6/0/33247
more likley he or she is to comply with the prescribed regimen. The main patient factors to consider in selecting a therapeutic treatment for vulvovaginitis are listed in Table 1. When such factors as dosage form and regimen, occupational or personal requirements, or prior patient experience with adverse effects such as burning or itching are taken into consideration by the clinician, the chances of patient compliance increase. For example, some patients may prefer the consistency of vaginal creams to suppositories or be less capable of complying with a 7-day regimen than a shorter regimen because of personal or business constraints. Thus the choice of therapeutic regimen can have a dramatic effect on compliance. In general , the ideal therapeutic agent for vulvovaginitis is regarded as one that would (1) permit singledose administration, (2) act rapidly, (3) be free of side effects, (4) be safe for use during pregnancy, and (5) offer a high long-term rate of efficacy. I. 2 Problems with patient compliance have spurred efforts by pharmaceutical companies to improve treatment courses along these lines.
Psychosocial factors and compliance Failure to comply with a full treatment regimen and subsequent treatment failure may stem not only from a less than optimal therapeutic choice but from numerous psychosocial factors. These are often a result of negative social influences and lack of information.' These factors can include denial of the problem because of embarrassment, mistaking symptomatic relief for a cure, and in some cases even failing to understand anatomy and the nature of the infection. Another reason can be deferral to the preferences of a sex partner,
1207
1208 Nixon
Table I. Patient considerations in choosing an antifungal agent for vulvovaginitis Age General health Occupational requirements Personal habits Likelihood of compliance with instructions for use Dosage form Cost of treatment Limitations imposed by concurrent therapy for other diseases Prior experience with adverse effects Modified from Jones HE. Med Clin NorthAm 1982;66:873-
93 .
who may find intercourse during treatment objectionable. The cost of treatment can also profoundly affect compliance. This is especially true if friends or pharmacists inform the patient of less expensive over-thecounter preparations that are available. Because such information may discourage or alienate an otherwise cooperative patient, it is important for physicians to discuss their therapeutic recommendation in light of the availability of over-the-counter drugs. Overcoming noncompliance
The chances for long-lasting resolution of symptoms and a microbiologic cure can be improved if physicians take a systematic approach to patient communication and education regarding dosing, side effects, and safety. It is essential that physicians take into consideration factors that influence convenience for the individual patient (Table II), because choosing regimens that control symptoms without disrupting daily life are more likely to be followed.' For example, once-daily administration at bedtime has the advantage of facilitating drug retention, avoiding leakage onto daytime clothing, and coinciding with other nighttime rituals that afford a reminder to self-medicate. In addition, choosing a short therapeutic regimen can minimize the opportunities for noncompliance. However, troublesome side effects can undermine even the most brief regimens. Fortunately, only a small percentage (:57%) of women using the imidazole antifungal cream preparations experience adverse reactions such as pruritus, burning, or irritation, which also characterize the infection itself.' It is important that physicians apprise their patients of these limited effects. Pregnant patients can be reassured about the safety of treatment during the second and third trimesters, because its use has not been associated with any adverse fetal effects. However, imidazole and triazole antifungal drugs are not recommended for use during the first trimester, because embryotoxicity has been reported in some laboratory animals.
October 1991 Am J Obstet Gynecol
Table II. Factors influencing convenience of therapy in cases of vulvovaginitis Factor
Recommendation
Daily timing of dose Frequency of administration Length of treatment course Dosage form Use with menses Sexual intercourse
Bedtime dosing Once-daily administration Short term (1-3 days) Topical! oral agents Advised for rapid response* Preferably abstain during short-course therapy or use condoms Follow above for no disruption of daily life
Relation to regular daily routines
Modified from Sobel]. In: SobelJ, ed. Clinical perspectives: terconazole, an advance in vulvovaginal candidiasis therapy. New York: BMI/McGraw Hill, 1988. *If menses remain a major barrier to patient cooperation, physicians should allow treatment to be postponed rather than risk noncompliance.
Cooperative decision making
Involving the patient in decisions regarding drug choices can go a long way toward improving patient communication and ensuring patient compliance. What may seem like a perfectly reasonable therapeutic approach to the physician may cause difficulties for the patient, and unless such matters are discussed, compliance may suffer. Fortunately, many aspects of treatment lend themselves to mutual decision making. A patient's acceptance of a dosage form, for example, is governed by ease of use and the physical properties of the drug. Product consistency, the volume of application, color, scent, and applicator size all bear on the acceptability of therapy. Where possible, patients should be offered a choice of formulations, if there is no trade-off in efficacy or treatment duration. Although sexual transmission of Candida vulvovaginitis remains to be definitively shown, I believe that sexual abstinence should be encouraged because it avoids compromising treatment and eliminates potential reinfection. Because effective treatment can often be achieved with a single dose or a 3-day regimen, sexual abstinence is usually not a problem and can be discussed cooperatively with the patient. Education and communication
Misconceptions about the nature of vulvovaginitis and its treatment may also contribute to poor compliance with therapy. Thus patients should be told that treatment should be continued during the menses because topical medications are formulated to adhere to the vaginal mucosa even during menstruation. Further, discussing the effect of the menses on the vaginal pH and flora may dispel the reluctance of some patients to proceed with therapy. However, if it appears that menstruation is a major barrier to cooperation, it is better
The role of patient compliance
Volume 165 Number 4, Part 2
to agree to the postponement of treatment rather than risk noncompliance. Even when treatment has been optimal, the tendency exists for some infections to recur. Patients should be counseled about this possibility and informed about the nature of resistance. This can minimize the development of negative feelings about themselves, their therapy, or their physicians. Similarly, women must be instructed to continue therapy even after achieving symptomatic relief. This is vital, because many currently available agents provide relief within hours of initial use, and symptomatic relief does not necessarily equate with ultimate treatment success. Therapeutic compliance is also enhanced when patients trust their physician and his or her staff. Women who develop confidence in the skills of the health-care team to provide a correct diagnosis and appropriate treatment are more likely to comply with the recommended regimen. Also, the more patients trust their physicians, the less likely they are to be influenced by family or friends who may have had a negative experience with similar therapeutic regimens . This trust can be fostered through displays of mutual respect, frankness, concern, and willingness to impart information and answer questions. Recent studies have shown that patients who are encouraged to ask questions of their physician not only do so but feel less anxious about their visit, are in better control of matters, and are more satisfied with both the visit and the information they received .6-9 Printed materials can also play an important role in promoting compliance because they allow patients an opportunity to review relevant information at their leisure. Moreover, these educational adjuncts enhance the perception of quality care. 7
1209
Finally, it is important to inform patients that despite the best efforts of all parties, vulvovaginitis may recur. When this occurs, it is the physician's responsibility to determine if faulty compliance, microbial resistance, or some other factor is to blame. Follow-up visits for second treatment should include continued patient education to help decrease the chances for noncompliance. Appreciation for assistance in preparing this paper is expressed to the staff of Gardiner-Caldwell SynerMed. REFERENCES 1. Weisberg M. Considerations in therapy for vulvovaginal candidiasis: when and whom to treat. In: Sobel], ed. Clinical perspectives: terconazole and advance in vulvovaginal candidiasis therapy. New York: BMIIMcGraw-Hill, 1988: 1-8. 2. Odds FC. Candida and candidosis: a review and bibliography. 2nd ed. London Balliere-Tindall, 1988:124-35. 3. Rausch KD , Girardi MR, Korte W. Advantages of shortterm therapy in vaginal mycoses from a socio-psychological viewpoint (in German). Fortschr Med 1982; 100: 393-5. 4. Hunt 1M, Jordan B, Irwin S, Browner CH . Compliance and the patient's perspective: controlling symptoms in everyday life. Cult Med Psychiatry 1989;13:315-34. 5. Gilman AG, Rail TW, Nies AS, Taylor P, eds. Goodman and Gilman's the pharmacologic basis of therapeutics. 8th ed. Elmsford, N.Y.: Pergamon Press, 1990:1176. 6. Thompson SC, Nanni C, Schwankovsky L. Patient-oriented intervention to improve communication in a medical office visit. Health Psychol 1990;9:390-404. 7. Troller J. A drug information system. The patient's responses. Aust Fam Physician 1989;18:28-30. 8. Rost K, Carter W, Inui T. Introduction of information during the initial medical visit: consequences for patient follow-through with physician recommendations. Soc Sci Med 1989;28:315-21. 9. Falvo D, Tippy P. Communicating information to patients: patient satisfaction and adherence as associated with resident skill.] Fam Pract 1988;26:643-7.
Key words: Patient compliance, vaginal mycoses, vulvovaginitis The increasing frequency of vulvovaginitis has been traced to a number of diverse factors, including the widespread use of oral contraceptive pills and antibiotic administration. Whatever the underlying reasons, no one regards vulvovaginitis as a trivial disorder, because a large number of office visits to gynecologists are for the treatment of its symptoms. Such an overwhelming caseload translates into enormous morbidity among women and an ongoing challenge to clinicians. A significant proportion of office visits for vulvovaginitis represent repeat visits by patients with chronic or recurrent infections despite the availability of seemingly effective therapeutic agents. Thus the question naturally arises, "Why are there so many therapeutic failures ?" Aside from host factors, the most likely answer is poor patient compliance, which can compromise even the most effective treatment regimen. Hence the real challenge to physicians may not lie in diagnosing this condition, but rather in effecting better patient compliance. This article explores the factors contributing to poor drug compliance and some of the options available to physicians for overcoming these problems.
Therapeutic regimen and compliance It is generally held that the more precisely a therapeutic agent meets the needs of a specific patient, the From The University of Texas Health Science Center at Houston. R eprint requests: Sam A. Nixon, MD, Director, Division of Continuing Education, The University of Texas Health Science Center at Houston, 1100 Holcombe Blvd., Houston, TX 77030. *Dr. Nixon's presentation was updated from a talk given previously and published in the Journal of Clinical Practice in Sexuality. 6/0/33247
more likley he or she is to comply with the prescribed regimen. The main patient factors to consider in selecting a therapeutic treatment for vulvovaginitis are listed in Table 1. When such factors as dosage form and regimen, occupational or personal requirements, or prior patient experience with adverse effects such as burning or itching are taken into consideration by the clinician, the chances of patient compliance increase. For example, some patients may prefer the consistency of vaginal creams to suppositories or be less capable of complying with a 7-day regimen than a shorter regimen because of personal or business constraints. Thus the choice of therapeutic regimen can have a dramatic effect on compliance. In general , the ideal therapeutic agent for vulvovaginitis is regarded as one that would (1) permit singledose administration, (2) act rapidly, (3) be free of side effects, (4) be safe for use during pregnancy, and (5) offer a high long-term rate of efficacy. I. 2 Problems with patient compliance have spurred efforts by pharmaceutical companies to improve treatment courses along these lines.
Psychosocial factors and compliance Failure to comply with a full treatment regimen and subsequent treatment failure may stem not only from a less than optimal therapeutic choice but from numerous psychosocial factors. These are often a result of negative social influences and lack of information.' These factors can include denial of the problem because of embarrassment, mistaking symptomatic relief for a cure, and in some cases even failing to understand anatomy and the nature of the infection. Another reason can be deferral to the preferences of a sex partner,
1207
1208 Nixon
Table I. Patient considerations in choosing an antifungal agent for vulvovaginitis Age General health Occupational requirements Personal habits Likelihood of compliance with instructions for use Dosage form Cost of treatment Limitations imposed by concurrent therapy for other diseases Prior experience with adverse effects Modified from Jones HE. Med Clin NorthAm 1982;66:873-
93 .
who may find intercourse during treatment objectionable. The cost of treatment can also profoundly affect compliance. This is especially true if friends or pharmacists inform the patient of less expensive over-thecounter preparations that are available. Because such information may discourage or alienate an otherwise cooperative patient, it is important for physicians to discuss their therapeutic recommendation in light of the availability of over-the-counter drugs. Overcoming noncompliance
The chances for long-lasting resolution of symptoms and a microbiologic cure can be improved if physicians take a systematic approach to patient communication and education regarding dosing, side effects, and safety. It is essential that physicians take into consideration factors that influence convenience for the individual patient (Table II), because choosing regimens that control symptoms without disrupting daily life are more likely to be followed.' For example, once-daily administration at bedtime has the advantage of facilitating drug retention, avoiding leakage onto daytime clothing, and coinciding with other nighttime rituals that afford a reminder to self-medicate. In addition, choosing a short therapeutic regimen can minimize the opportunities for noncompliance. However, troublesome side effects can undermine even the most brief regimens. Fortunately, only a small percentage (:57%) of women using the imidazole antifungal cream preparations experience adverse reactions such as pruritus, burning, or irritation, which also characterize the infection itself.' It is important that physicians apprise their patients of these limited effects. Pregnant patients can be reassured about the safety of treatment during the second and third trimesters, because its use has not been associated with any adverse fetal effects. However, imidazole and triazole antifungal drugs are not recommended for use during the first trimester, because embryotoxicity has been reported in some laboratory animals.
October 1991 Am J Obstet Gynecol
Table II. Factors influencing convenience of therapy in cases of vulvovaginitis Factor
Recommendation
Daily timing of dose Frequency of administration Length of treatment course Dosage form Use with menses Sexual intercourse
Bedtime dosing Once-daily administration Short term (1-3 days) Topical! oral agents Advised for rapid response* Preferably abstain during short-course therapy or use condoms Follow above for no disruption of daily life
Relation to regular daily routines
Modified from Sobel]. In: SobelJ, ed. Clinical perspectives: terconazole, an advance in vulvovaginal candidiasis therapy. New York: BMI/McGraw Hill, 1988. *If menses remain a major barrier to patient cooperation, physicians should allow treatment to be postponed rather than risk noncompliance.
Cooperative decision making
Involving the patient in decisions regarding drug choices can go a long way toward improving patient communication and ensuring patient compliance. What may seem like a perfectly reasonable therapeutic approach to the physician may cause difficulties for the patient, and unless such matters are discussed, compliance may suffer. Fortunately, many aspects of treatment lend themselves to mutual decision making. A patient's acceptance of a dosage form, for example, is governed by ease of use and the physical properties of the drug. Product consistency, the volume of application, color, scent, and applicator size all bear on the acceptability of therapy. Where possible, patients should be offered a choice of formulations, if there is no trade-off in efficacy or treatment duration. Although sexual transmission of Candida vulvovaginitis remains to be definitively shown, I believe that sexual abstinence should be encouraged because it avoids compromising treatment and eliminates potential reinfection. Because effective treatment can often be achieved with a single dose or a 3-day regimen, sexual abstinence is usually not a problem and can be discussed cooperatively with the patient. Education and communication
Misconceptions about the nature of vulvovaginitis and its treatment may also contribute to poor compliance with therapy. Thus patients should be told that treatment should be continued during the menses because topical medications are formulated to adhere to the vaginal mucosa even during menstruation. Further, discussing the effect of the menses on the vaginal pH and flora may dispel the reluctance of some patients to proceed with therapy. However, if it appears that menstruation is a major barrier to cooperation, it is better
The role of patient compliance
Volume 165 Number 4, Part 2
to agree to the postponement of treatment rather than risk noncompliance. Even when treatment has been optimal, the tendency exists for some infections to recur. Patients should be counseled about this possibility and informed about the nature of resistance. This can minimize the development of negative feelings about themselves, their therapy, or their physicians. Similarly, women must be instructed to continue therapy even after achieving symptomatic relief. This is vital, because many currently available agents provide relief within hours of initial use, and symptomatic relief does not necessarily equate with ultimate treatment success. Therapeutic compliance is also enhanced when patients trust their physician and his or her staff. Women who develop confidence in the skills of the health-care team to provide a correct diagnosis and appropriate treatment are more likely to comply with the recommended regimen. Also, the more patients trust their physicians, the less likely they are to be influenced by family or friends who may have had a negative experience with similar therapeutic regimens . This trust can be fostered through displays of mutual respect, frankness, concern, and willingness to impart information and answer questions. Recent studies have shown that patients who are encouraged to ask questions of their physician not only do so but feel less anxious about their visit, are in better control of matters, and are more satisfied with both the visit and the information they received .6-9 Printed materials can also play an important role in promoting compliance because they allow patients an opportunity to review relevant information at their leisure. Moreover, these educational adjuncts enhance the perception of quality care. 7
1209
Finally, it is important to inform patients that despite the best efforts of all parties, vulvovaginitis may recur. When this occurs, it is the physician's responsibility to determine if faulty compliance, microbial resistance, or some other factor is to blame. Follow-up visits for second treatment should include continued patient education to help decrease the chances for noncompliance. Appreciation for assistance in preparing this paper is expressed to the staff of Gardiner-Caldwell SynerMed. REFERENCES 1. Weisberg M. Considerations in therapy for vulvovaginal candidiasis: when and whom to treat. In: Sobel], ed. Clinical perspectives: terconazole and advance in vulvovaginal candidiasis therapy. New York: BMIIMcGraw-Hill, 1988: 1-8. 2. Odds FC. Candida and candidosis: a review and bibliography. 2nd ed. London Balliere-Tindall, 1988:124-35. 3. Rausch KD , Girardi MR, Korte W. Advantages of shortterm therapy in vaginal mycoses from a socio-psychological viewpoint (in German). Fortschr Med 1982; 100: 393-5. 4. Hunt 1M, Jordan B, Irwin S, Browner CH . Compliance and the patient's perspective: controlling symptoms in everyday life. Cult Med Psychiatry 1989;13:315-34. 5. Gilman AG, Rail TW, Nies AS, Taylor P, eds. Goodman and Gilman's the pharmacologic basis of therapeutics. 8th ed. Elmsford, N.Y.: Pergamon Press, 1990:1176. 6. Thompson SC, Nanni C, Schwankovsky L. Patient-oriented intervention to improve communication in a medical office visit. Health Psychol 1990;9:390-404. 7. Troller J. A drug information system. The patient's responses. Aust Fam Physician 1989;18:28-30. 8. Rost K, Carter W, Inui T. Introduction of information during the initial medical visit: consequences for patient follow-through with physician recommendations. Soc Sci Med 1989;28:315-21. 9. Falvo D, Tippy P. Communicating information to patients: patient satisfaction and adherence as associated with resident skill.] Fam Pract 1988;26:643-7.