For a graduate level Research Methods class, I recently completed a small (micro) non- clinical research study that evaluated why some people infected with HSV (herpes) choose alternative methods to manage outbreaks. For the study, alternative was defined as anything other than acyclovir, Valtrex ® (valacyclovir) and Famvir ® (famciclovir). What I discovered surprised me. Most of the participants don’t or no longer take these medicines. So, I put this article together that you’re reading now that includes most of the report and finishes up with some links to information about acyclovir, Valtrex, and Famvir. The participants in the study will forever remain anonymous, as I promised them. They were chat room folks like you and I who struggle with herpes on a daily basis. If you have any questions or need additional information, you can contact me by email @: Domestic Bent

While I did review over 500 informational pieces for this project, I’m not a doctor and I don’t play one on TV (smile). Any opinions expressed are my own and shouldn’t be construed as advice from a medical doctor. References cited in the study are found at the very end of this article. Parts of it may put you to sleep but that’s the nature of a research report.

The Centers for Disease Control (CDC) classifies Herpes Simplex Virus (HSV) as a sexually transmitted disease (STD). It is one of a family of viruses (herpesviruses) that share certain traits. This family includes varicella zoster virus (which causes chicken pox), Epstein-Barr virus (which causes mononucleosis), shingles and roseola. The 1998 Guidelines for Treatment of Sexually Transmitted Disease published by the CDC points out that two serotypes of HSV have been identified: HSV-1 and HSV-2. Most cases of recurrent genital herpes (GH) are caused by HSV-2. HSV-1 generally causes lesions or fever blisters on the mouth or face (oral herpes). HSV-2 typically causes lesions in the genital area. However, both viral types can cause either genital or oral infections. While authoritative literature reviewed distinguished between HSV 1 and 2, symptomatic outbreaks of HSV were generally referred to as GH. The literature appeared to focus on outbreaks below the waist without regard to type. The CDC reported in its 1998 Guidelines that five percent to 30% of first-episode cases of GH are caused by HSV-1, but clinical recurrences are much less frequent for HSV-1 than HSV-2 genital infection.

HSV occurs worldwide and is a major public health problem for which there is no adequate control (CDC, October 1997). According to Wagner, the CDC reported in 1991 that more than 30 million people in the United States were infected with GH, and the numbers were rising by 500,000 each year. In January 1998, the CDC reported that serologic studies showed that genital HSV-2 infection had been diagnosed in at least 45 million persons in the United States. Wagner points out that estimates indicate as many as one in four American's between the age of 15 and 74 are infected with either HSV 1 or 2. Once infected with HSV, people remain infected for life because there is currently no cure.

Symptoms of GH are usually referred to as an outbreak. The severity of outbreaks can vary greatly from person to person. Some do not have noticeable symptoms. Typically, an outbreak begins anywhere from two to 20 days after the initial contact with HSV. For the majority of HSV infected people, the first outbreak is usually the worst with subsequent outbreaks shorter in duration and less severe. Wagner identifies six phases of an outbreak as (a) prodrome (warning symptoms such as fatigue, headaches, flu-like symptoms, itching, tingling and numbness which indicate the virus is becoming active), (b) inflammation, (c) blisters, (d) ulcers (as the skin breaks on the blisters), (e) crust (the sores begin to dry, scab and crust over and usually marks the beginning of the healing process), and (f) healing (new skin, if formed, may look slightly red or silver). After healing, the virus becomes inactive and retreats along the nerve pathways to its home in the spinal cord ganglia.

For many years, people diagnosed with GH had to cope with recurrent symptoms without the benefit of any medications able to target herpes itself. The advent of FDA approved antiviral medications in the early 1980s gave infected people new options for gaining some measure of control over the infection. Currently, management of GH, as recommended by the CDC, focuses primarily on antiviral therapy. The CDC regimens cover both episodic (first episode and subsequent episodes) and suppressive therapy and include only FDA-approved antiviral medications available to the general public - acyclovir, Valtrex ® (valacyclovir) and Famvir ® (famciclovir).

The FDA approved acyclovir, as an antiviral drug effective in the treatment of HSV infection, in 1984 under the name Zovirax ®. It is now available as a generic drug. During an initial outbreak of GH, acyclovir decreases viral shedding (virus sheds or passes through the skin) from lesions; reduces lesion formation; increases lesion healing rates; and, reduces time to cessation of pain (1998 Guidelines, CDC). In one study, acyclovir also reduced the severity of some of the systemic complications of primary infection (New Antivirals, Dermatology Times, 8/1/96). For episodic treatment, acyclovir reduces the duration of lesions as well as the duration of viral shedding. The CDC reports that daily suppressive therapy reduces the frequency of outbreaks by greater than or equal to 75% among patients who have six or more recurrences per year. In addition, safety and efficacy (effectiveness) have been documented among patients receiving daily therapy with acyclovir for as long as six years. A British study found taking acyclovir for suppressive therapy reduced asymptomatic viral shedding (virus passes through the skin with no visible symptoms or lesions) but the effect on transmission (passing it on to others) was unclear (British Medical Journal, January 1997).

Valtrex and Famvir were both FDA-approved for management of GH in 1995. The CDC reported (1998 Guidelines, CDC) that “few comparative studies of valacyclovir and famciclovir with acyclovir have been conducted. The results of these studies suggest that valacyclovir and famciclovir are comparable to acyclovir in clinical outcome. However, valacyclovir and famciclovir may provide increased ease in administration, which is an important consideration for prolonged treatment.” The CDC regimen for these two drugs indicates less frequent daily dosing. Why? Because Valtrex and Famvir have better bioavailability than acyclovir. That means more of it gets into your blood stream and therefore stays there for a longer period of time. See the links to reports on Valtrex and Famvir below.

The purpose of this study was to determine why some HSV infected persons elect alternative suppressive or episodic therapy to manage outbreaks. For this study, alternative therapy is defined as taking medicines or treatments other than those recognized and approved in the medical community, as expressed in the (acyclovir) regimen recommend by the CDC. During Internet chat sessions at herpes chat sites, the author frequently noted various chat participants make statements to the effect that they had never taken or no longer took acyclovir, Famvir or Valtrex. In some instances, they seemed to have stopped taking antiviral medications, choosing to wait until an outbreak had run its course. In other instances, they were trying something different they had seen advertised at an Internet web site or had been told about by a friend.

Corresponding comments occasionally indicated some of these chat participants still experienced uncomfortable outbreaks. This led the researcher to wonder why some HSV infected people elect not to follow clinically proven, recognized and available regimens of antiviral medications to manage HSV symptoms. Finding the answer could be significant because it might provide a better understanding of coping skills and those factors that affect the quality of life in those that struggle with HSV.

One limitation of this study was a review of the literature. The author reviewed over 500 informational items including articles from professional journals, books, research and other reports, abstracts, drug data sheets, and news articles written for various disciplines within the fields of medicine and psychology. Online searches of topics and subjects relevant to HSV, alternative medicine and human behavior were conducted in the libraries at [specific universities and colleges omitted for privacy reasons]. Databases searched included FirstSearch, ABI/Inform, Periodical Abstracts, AskERIC, MEDLINE, and CARL UnCover. In addition, similar searches were conducted over the Internet. Only three informational items that were identified during database searches at the above educational institutions and that appeared authoritative and relevant to the specific problem were used. Less than ten other informational items relevant to the specific problem weren’t available. Full text research papers studying HSV primarily dealt with the physical and psychosocial consequences of the disease; the disease as a risk factor for human immunodeficiency virus (HIV) infection; and, the recurrent nature of the disease and those factors that trigger outbreaks. Only two studies and one report were found that touched either on the concept of treatment alternatives to the acyclovir regimen or addressed those factors that prolong STD infections.

recurrent GH. Thirty-one individuals with recurrent GH were randomly assigned to one of three conditions: psychosocial intervention, social support, or waiting list control. Psychosocial interventions included providing HSV information, relaxation training, stress management instructions, and an imagery technique. Those in the social support group explored interpersonal conflict areas, especially sexual and emotional topics related to having herpes. No relaxation, stress management or imagery technique was taught. The waiting list group was offered treatment toward the end of the testing period. The study reported that psychosocial intervention significantly reduced HSV frequency rates, episode duration, and episode severity as compared with the other two conditions.

In another study, the incurable nature of GH was cited in the introduction as one reason alternative treatments were pursued. The acyclovir regimen was considered palliative. Acyclovir could reduce viral shedding and the frequency and severity of recurrences but not cure GH. “Consequently, a range of alternative treatments has been described (largely in anecdotal reports) such as vitamins, topical applications, and stress- reduction.” (Swanson, Dibble and Chenitz, 1995). These introductory comments and the recent date of the study suggest the reason some HSV infected persons elect alternative suppressive or episodic therapy to manage outbreaks still is not clear.

One report reviewed cited barriers to health care as factors that prolong STD infections. This would include prolonging HSV outbreaks. The SIECUS Report suggested that reducing the duration of infection from a STD can be accomplished primarily by early diagnosis, treatment, and reducing the barriers to diagnostic and treatment services. Major barriers cited in the report were failure to comply with a full course of medication; inadequate access to health care; lack of health care seeking behavior; inadequate training of health care professionals; inadequate financial and physical access to laboratory tests; and geographic factors.

In order to investigate the problem of why some HSV infected people elect alternative therapies to manage outbreaks, the author developed four questions to answer based on the assumptions made above.

1. Do perceptions of confidence in a physician’s ability to diagnose, counsel and prescribe management for HSV influence how individuals manage the disease?
2. Do perceptions of confidence in the ability of alternative treatments to either cure HSV or manage recurrences influence how individuals manage the disease?
3. Do economic resources such as health insurance and ability to pay for the recommended medication influence how individuals manage the disease?
4. Does knowledge of HSV issues influence how individuals manage the disease?

In order to answer the questions posed in this micro-research study, the author selected the questionnaire method because face-to-face contact with the participants wasn’t deemed essential and funds were limited.

The author delimited the participants of this study to those volunteering to participate. The author solicited study participants from two Internet chat forums used by herpes sufferers. One is named &H-Chat ICQ. This chat room uses a software program known as ICQ that is freely available over the Internet at http://www.mirabilis.com. The software facilitates group and private one-to-one chat sessions. The other chat forum is known as H-Chat Room and is found at http://www.herpes.com/chat.html. Both chat forums allow individuals to use nicknames to maintain their anonymity.

The instrument used in this study was a questionnaire developed by the author. It contained 21 questions designed around the four basic questions identified above. While HSV is a STD, the questionnaire contained no questions regarding sexual practices. The author believed sexual practices to be sensitive areas that might have impacted participation in the study and would not have contributed to the research objectives.

While reviewing the literature and observing chat participant responses in the two chat forums mentioned above, the author developed the study objectives and questions identified above. The questionnaire was then prepared, based on the study objectives and questions. All chat participants were informed that the study concerned herpes and alternative treatment for herpes. They were also told that their identities and responses would remain confidential. In one solicitation, the author sent a request for volunteers by email to known email addresses of chat participants. Other solicitations were made publicly at various times in the two chat rooms during chat sessions. In the public solicitation, the author provided an email address and asked chat participants to respond to the email address or respond in a private message with their email addresses if they were willing to participate in a research study. A private message is one that others cannot see and is a feature of both chat rooms. Fourteen questionnaires were emailed and 11 completed questionnaires were returned reflecting a 79% response rate.

Once the questionnaires were all received, they were printed and each one assigned a numerical identifier. Then, numerical identifiers were assigned to most responses to allow for analysis. Exceptions were those questions already requiring a numerical response such as age, time and number of events for specified time periods, and those responses requiring a description or name for items. The responses were then entered into columns and rows of a spreadsheet program called Excel. The program was used to compute statistical data.

Results (Note: Parts of this section are a little boring. Also, be aware that in a research project, the author doesn’t make subjective conclusions about the results. Only the results are reported. Conclusions or opinions are made in the section called “Discussion”)

Participants included four male subjects (MS) and seven female subjects (FS) together with a mean age of 33.2 years (range 24 to 45 years). The mean number of years infected with HSV was 8.2 years (range 1.2 to 17 years). The mean, median and mode number of months since last outbreak was 8.3, 1 and 1, respectively. The mean number of outbreaks experienced in the previous 12 and 24 months was 3.5 and 6.1, respectively. Regarding initial outbreaks, seven (64%) experienced moderate to extremely severe discomfort. The three reporting severe to extremely severe discomfort were FSs. The remaining four reported little discomfort. Subsequent outbreaks, overall, were less discomforting with nine (84%) reporting little discomfort and one FS and MS each reporting moderate discomfort.

Regarding diagnosis of HSV, seven (64%) responded they had HSV2, one (9%) had both HSV 1 & 2, while two (27%) weren’t sure. While medical professionals had diagnosed nine subjects (82%) (two were self-diagnosed), only seven (64%) had lab test confirmations (lesion culture test) of HSV. One subject was medically diagnosed by observation only while another couldn’t remember how the diagnosis was made. Nine (82%) subjects (including all seven FSs) didn’t seek a second opinion subsequent to a medical/self diagnosis of HSV although 4 (36%) (1 MS, 3 FSs) had first been medically diagnosed with another problem.

Do perceptions of confidence in a physician’s ability to diagnose, counsel and prescribe management for HSV influence how individuals manage the disease?

Eighty-two percent of Ss were confident to extremely confident regarding their medical practitioner’s ability to diagnose HSV. However, only 64% of the Ss were confident to extremely confident in their medical practitioner’s ability to prescribe effective disease management strategies and to offer wise counsel that will help guide them through the social and emotional issues of having herpes. Six subjects did not take the prescription medicines (acyclovir, Famvir or Valtrex). Out of the remaining five, three have used more than one of the above drugs. The author compared the responses of how HSV was diagnosed, discomfort levels experienced during outbreaks, and levels of confidence in the medical practitioner to the responses indicating what prescription antiviral medications were taken. No correlation was suggested.

Do perceptions of confidence in the ability of alternative treatments to either cure HSV or manage recurrences influence how individuals manage the disease?

Subjects were asked what other treatments they had tried to prevent outbreaks. Nine (82%) responded they had tried different topical, oral, physical or mental regimens. Four (36%) were extremely confident these treatments prevented outbreaks, one (9%) was only a little confident while six (55%) no longer followed any treatments to prevent outbreaks or took nothing to manage the disease. Subjects were then asked what treatments they had tried to relieve the symptoms of an outbreak. Eight (73%) responded they had tried no other treatments and therefore didn’t express a confidence level. Only one subject reported taking a treatment to cure HSV.

Do economic resources such as health insurance and ability to pay for the recommended medication influence how individuals manage the disease?

Subjects were given eight different statements regarding health insurance and/or ability to pay and asked to identify which statements best fit their situation. Five (45%) responded that health insurance or ability to pay for the medicines isn’t an issue for them. Four of these five don’t take the prescription medicines and two of the five used alternative treatments. Five (45%) indicated insurance covered most or all the expense and they had little out of pocket expense. Four of these five took the prescribed antiviral regimen. The remaining subject indicated the “other” category. The explanation given was that insurance would cover the medicines, but the subject had not asked for them because the current doctor didn’t know the subject has herpes.

Does knowledge of HSV issues influence how individuals manage the disease?

Subjects were asked to rate their knowledge about HSV. Eight (73%) responded that they were somewhat knowledgeable about HSV but would like to learn more. One responded that he/she was as knowledgeable as a physician. Out of these nine subjects, five didn’t take the prescription medicines while the other four did take the medicines. Another subject responded that he/she had the same knowledge level as the general public and took no drugs or alternative treatment. The eleventh responded that he/she was highly self educated and knew more than some doctors but less than others. This subject followed the prescribed regimen.

This study had some limitations. It did not query participants regarding their educational background or ethnography. These factors might have contributed a better understanding of participants’ responses in all areas. It didn’t consider whether participants had ever had adverse reactions to the acyclovir regimen used in disease management of HSV. While the literature reviewed indicated that few side effects were experienced with the acyclovir, the participants were not asked whether they had adverse reactions to the acyclovir. In addition, the study didn’t measure mental reservations about taking drugs requiring prescription. Finally, while the questionnaire inquired about seeking second opinions, it did not measure health care seeking behavior.

The results suggest that those diagnosed with HSV by a medical professional were confident in the diagnosis of HSV. Although four respondents were originally diagnosed with another problem, the majority of respondents didn’t seek a second opinion. Eighty- two percent of the respondents were confident to extremely confident that the medical community can diagnose HSV. However, only 64% expressed the same level of confidence when they were asked to rate their medical practitioner’s ability to prescribe effective disease management strategies and to offer wise counsel that will help guide them through the social and emotional issues of having herpes. While the drop in confidence is noticeable, it is not clear whether this correlates to choosing alternative disease management strategies.

While 82% of the subjects tried alternative treatment approaches to prevent outbreaks, only 36% were extremely confident these approaches worked. Six (55%) no longer followed any treatments to prevent outbreaks or took nothing to manage the disease. This suggests that for a cross section of internet users, if an approach works, then it will be followed.

The most amazing finding identified was that six (55%) of the subjects do not take the prescribed antiviral medications. Four of these subjects indicated that health insurance or ability to pay for the medicines was not an issue for them. Perhaps knowledge about HSV is a factor that influences decisions about disease management approaches to HSV. Eight (73%) responded that they were somewhat knowledgeable about HSV but would like to learn more. Further research is needed to measure the relationship between how knowledgeable one is in managing a disease versus the approaches taken to manage that disease. [END OF STUDY]

The above study didn’t specifically identify the reason folks preferred to endure the discomfort of outbreaks rather than take the antiviral medicines. And, the results weren’t statistically representative of all people who have herpes. The results were only true for the study participants and perhaps could be applied to a cross-section of our internet “H-Chat” friends. I will leave you with a question: Are you managing herpes on outdated, inaccurate or incomplete information?

The links below will take you to recent articles that highlight the findings of an international forum on herpes and the results of clinical research studies using Valtrex and Famvir to manage HSV. If you’re experiencing six or more outbreaks a year, my suggestion is to consider suppressive therapy, as recommended by the CDC. Don’t suffer needlessly because you’re functioning on bad information.

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General information:

1. Herpes Education Essential to Controlling Disease, Says Forum Disturbing findings identified by The International Herpes Management Forum (IHMF)

-- 60 per cent of afflicted patients have symptoms or signs of genital herpes infection which remain unrecognized.
-- Only 20 per cent of herpes patients have recognized symptoms.
-- Of the patients who consult a physician, only 27 per cent receive effective antiviral treatment to help manage the disease. LINK1

Reports on studies about Valtrex:

1. The study shows that once-daily treatment with the anti-viral drug Valtrex (valaciclovir) is as effective and well tolerated as twice-daily treatment. LINK2

2. Once daily dosing of Valtrex was shown in a one-year study to have comparable efficacy to twice daily Zovirax (acyclovir) in suppressing outbreaks. LINK3 and LINK4

Reports on Studies about Famvir:

1. More effective than acyclovir in preventing recurrence of outbreaks after the cessation of treatment for first episode genital herpes. LINK5

2. The study showed that famciclovir is effective in suppressing (preventing) future recurrences of genital herpes.LINK6

3. After four months of treatment, 90 percent of patients who were administered 250 mg of Famvir twice daily were recurrence-free compared to only 48 percent of placebo-treated patients. LINK7

4. Drug Reduces Asymptomatic Viral Shedding In Herpes Patients

"In the first randomized, double-blind, placebo controlled, parallel-group study of asymptomatic viral shedding in patients with recurrent genital herpes, 177 women with frequently recurring genital herpes were treated with Famvir (125 mg or 250 mg three times daily) or placebo for four months.

Patients swabbed their genital regions daily and recorded lesions and other symptoms in a diary. Investigators evaluated the proportion of days when asymptomatic and symptomatic viral shedding occurred. Patients treated with Famvir had approximately an 80-90 percent reduction in days with asymptomatic viral shedding and an 87-97 percent reduction in days with symptomatic viral shedding, compared with placebo."
LINK8

REFERENCES USED IN RESEARCH PROJECT

Centers for Disease Control, Division of STD Prevention (October 1997). Genital Herpes. [On-Line]. Available: CDC1

Centers for Disease Control, Division of STD Prevention (January 1998). 1998 Guidelines for Treatment of Sexually Transmitted Diseases. [On-Line]. Available: CDC2

Longo D., Clum G (1989). Psychosocial Factors Affecting Genital Herpes Recurrences: Linear VS. Mediating Models. Journal of Psychosomatic Research Vol. 33, No. 2, pp. 161-166.

New Antivirals Offer Hope for HSV Patients. (August, 1996) Dermatology Times [On-line serial]. Available: Dermatology Times

Patel R, Cowan FM, Barton SE (January 1997). Advising patients with genital herpes. British Medical Journal [On-line]. Available: British Medical Journal

Suppressive Therapy Reduces Genital Herpes Recurrences. (November, 1996). Dermatology Times [On-line serial]. Available: Dermatology Times

Sex Information and Education Council of the U.S., Inc. (Feb/Mar1997). The Hidden Epidemic: Confronting Sexually Transmitted Diseases. SIECUS Report , pp. 4-14 from Executive Summary. [On-line]. Available: Article No. 109, SIRS Reseacher.

Tyring SK, Douglas JM Jr, Corey L, Spruance SL, Esmann J (Feb 1998). A randomized, placebo-controlled comparison of oval valacyclovir and acyclovir in immunocompetent patients with recurrent genital herpes infections. The valaciclovir International Study Group [On-line]. Abstract from: PubMed Document: UID9487210. Available: PubMed

Wagner, Dianne B. (April 1997). Genital Herpes. [On-Line]. Available: D Wagner