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Oral topiramate effective for alcoholism
Oral topiramate is effective in the treatment of alcohol dependence. Patients taking topiramate consumed less alcohol, had fewer heavy drinking days, and had more days abstinent within a 12-week period. This medication adds a significant adjunct to our current treatment of alcoholism and can be considered for use in treating those alcoholics who desire sobriety.
Oral topiramate is effective in the treatment of alcohol dependence. Patients taking topiramate consumed less alcohol, had fewer heavy drinking days, and had more days abstinent within a 12-week period. This medication adds a significant adjunct to our current treatment of alcoholism and can be considered for use in treating those alcoholics who desire sobriety.
Oral topiramate is effective in the treatment of alcohol dependence. Patients taking topiramate consumed less alcohol, had fewer heavy drinking days, and had more days abstinent within a 12-week period. This medication adds a significant adjunct to our current treatment of alcoholism and can be considered for use in treating those alcoholics who desire sobriety.
Which postmenopausal women should be offered combined HRT?
Recent studies have demonstrated a small but significant risk of adverse effects from combined hormone replacement therapy (HRT), including cardiovascular disease, thromboembolic disease, and breast cancer. Time-limited HRT will control intolerable menopausal symptoms and prevent risk of fractures in newly menopausal women. However, HRT achieves its maximum efficacy in 35 years, and the risk of adverse outcomes increases as time progresses. Women considering HRT, particularly those at higher risk for vascular disease and breast cancer, should be informed of the potential risks.
There is inadequate evidence to determine the extent of these risks in women who have had a hysterectomy and are taking unopposed estrogen (strength of recommendation: A, based on large randomized controlled trials).
Evidence summary
The Women’s Health Initiative (WHI),1 the largest randomized trial of HRT, showed that long-term use of HRT poses more risks than benefits for healthy postmenopausal women. WHI studied the use of estrogen plus progestin for prevention of coronary heart disease in 16,608 postmenopausal women age 50–79 years. After 5 years of follow-up, this arm of the study was stopped because of the adverse effects of the intervention. The researchers found that HRT increases the risk of several events:
- coronary heart disease events (number needed to harm [NNH]=1428)
- invasive breast cancer (NNH=1250)
- stroke (NNH=1250)
- venous thromboembolic events (NNH=555)
- pulmonary embolism (NNH=1250).
An ongoing arm of WHI is studying estrogen alone in postmenopausal women who have had a hysterectomy.
The Heart and Estrogen/progestin Replacement Study (HERS)2 examined the effects of HRT in postmenopausal women with coronary artery disease. HERS was a large randomized controlled trial of 2763 women with an average follow-up time of 4.1 years. It showed no statistically significant difference between the HRT (estrogen plus medroxyprog-esterone) group compared with the placebo group in either the primary outcomes (nonfatal myocardial infarction or coronary heart disease death) or in the secondary outcomes (coronary revascularization, unstable angina, congestive heart failure, resuscitated cardiac arrest, stroke or transient ischemic attack, and peripheral arterial disease). The findings of the WHI and HERS trials have been summarized in a recent meta-analysis done for the United States Preventive Services Task Force.3
Both the WHI and HERS trials demonstrated some benefits for HRT. WHI found a reduced risk of colorectal cancer (number needed to treat [NNT]=1667) and a decreased risk of any osteoporotic fracture (NNT=228). The HERS group found that HRT improved the quality of life of women with postmenopausal symptoms, particularly flushing.
Evidence indicates that women who take HRT for 3 years and then stop achieve as much protection from osteoporotic fractures as women who continue their HRT beyond 3 years.4
Continuing HRT beyond 5 years dramatically increases the risk of coronary heart disease, stroke, thromboembolic events, breast cancer, and cholecystitis.3
Recommendations from others
The American College of Obstetricians and Gynecologists has convened a multispecialty panel of experts to draft new recommendations for HRT in light of the WHI findings.
Laura Hansen, PharmD, BCPS
University of Colorado, Boulder
The WHI and HERS trials demonstrated that long-term use of HRT (>5 years) incurs significantly more risks than benefits for a postmenopausal woman who has not undergone hysterectomy. However, these trials did not evaluate postmenopausal symptoms or quality of life as primary endpoints.
Most women experience postmenopausal symptoms for more than 1 year but have resolution of symptoms within a few years after menopause. Since HRT remains the most effective therapy for hot flushes, short-term use of HRT (<5 years) may be offered to women experiencing postmenopausal symptoms.
Physicians may instruct women to attempt HRT discontinuation each year because the duration of symptoms can be variable. Discontinuation should be performed using gradual dose reductions to prevent rapid return of postmenopausal symptoms.
1. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321-33.
2. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA 1998;280:605-13.
3. Nelson HD, Humphrey LL, Nygren P, Teutsch SM, Allan JD. Postmenopausal hormone replacement therapy: scientific review. JAMA 2002;288:872-81.
4. Greendale GA, Espeland M, Slone S, Marcus R, Barrett-Connor E. Bone mass response to discontinuation of long-term hormone replacement therapy: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) Safety Follow-up Study. Arch Intern Med 2002;162:665-72.
Recent studies have demonstrated a small but significant risk of adverse effects from combined hormone replacement therapy (HRT), including cardiovascular disease, thromboembolic disease, and breast cancer. Time-limited HRT will control intolerable menopausal symptoms and prevent risk of fractures in newly menopausal women. However, HRT achieves its maximum efficacy in 35 years, and the risk of adverse outcomes increases as time progresses. Women considering HRT, particularly those at higher risk for vascular disease and breast cancer, should be informed of the potential risks.
There is inadequate evidence to determine the extent of these risks in women who have had a hysterectomy and are taking unopposed estrogen (strength of recommendation: A, based on large randomized controlled trials).
Evidence summary
The Women’s Health Initiative (WHI),1 the largest randomized trial of HRT, showed that long-term use of HRT poses more risks than benefits for healthy postmenopausal women. WHI studied the use of estrogen plus progestin for prevention of coronary heart disease in 16,608 postmenopausal women age 50–79 years. After 5 years of follow-up, this arm of the study was stopped because of the adverse effects of the intervention. The researchers found that HRT increases the risk of several events:
- coronary heart disease events (number needed to harm [NNH]=1428)
- invasive breast cancer (NNH=1250)
- stroke (NNH=1250)
- venous thromboembolic events (NNH=555)
- pulmonary embolism (NNH=1250).
An ongoing arm of WHI is studying estrogen alone in postmenopausal women who have had a hysterectomy.
The Heart and Estrogen/progestin Replacement Study (HERS)2 examined the effects of HRT in postmenopausal women with coronary artery disease. HERS was a large randomized controlled trial of 2763 women with an average follow-up time of 4.1 years. It showed no statistically significant difference between the HRT (estrogen plus medroxyprog-esterone) group compared with the placebo group in either the primary outcomes (nonfatal myocardial infarction or coronary heart disease death) or in the secondary outcomes (coronary revascularization, unstable angina, congestive heart failure, resuscitated cardiac arrest, stroke or transient ischemic attack, and peripheral arterial disease). The findings of the WHI and HERS trials have been summarized in a recent meta-analysis done for the United States Preventive Services Task Force.3
Both the WHI and HERS trials demonstrated some benefits for HRT. WHI found a reduced risk of colorectal cancer (number needed to treat [NNT]=1667) and a decreased risk of any osteoporotic fracture (NNT=228). The HERS group found that HRT improved the quality of life of women with postmenopausal symptoms, particularly flushing.
Evidence indicates that women who take HRT for 3 years and then stop achieve as much protection from osteoporotic fractures as women who continue their HRT beyond 3 years.4
Continuing HRT beyond 5 years dramatically increases the risk of coronary heart disease, stroke, thromboembolic events, breast cancer, and cholecystitis.3
Recommendations from others
The American College of Obstetricians and Gynecologists has convened a multispecialty panel of experts to draft new recommendations for HRT in light of the WHI findings.
Laura Hansen, PharmD, BCPS
University of Colorado, Boulder
The WHI and HERS trials demonstrated that long-term use of HRT (>5 years) incurs significantly more risks than benefits for a postmenopausal woman who has not undergone hysterectomy. However, these trials did not evaluate postmenopausal symptoms or quality of life as primary endpoints.
Most women experience postmenopausal symptoms for more than 1 year but have resolution of symptoms within a few years after menopause. Since HRT remains the most effective therapy for hot flushes, short-term use of HRT (<5 years) may be offered to women experiencing postmenopausal symptoms.
Physicians may instruct women to attempt HRT discontinuation each year because the duration of symptoms can be variable. Discontinuation should be performed using gradual dose reductions to prevent rapid return of postmenopausal symptoms.
Recent studies have demonstrated a small but significant risk of adverse effects from combined hormone replacement therapy (HRT), including cardiovascular disease, thromboembolic disease, and breast cancer. Time-limited HRT will control intolerable menopausal symptoms and prevent risk of fractures in newly menopausal women. However, HRT achieves its maximum efficacy in 35 years, and the risk of adverse outcomes increases as time progresses. Women considering HRT, particularly those at higher risk for vascular disease and breast cancer, should be informed of the potential risks.
There is inadequate evidence to determine the extent of these risks in women who have had a hysterectomy and are taking unopposed estrogen (strength of recommendation: A, based on large randomized controlled trials).
Evidence summary
The Women’s Health Initiative (WHI),1 the largest randomized trial of HRT, showed that long-term use of HRT poses more risks than benefits for healthy postmenopausal women. WHI studied the use of estrogen plus progestin for prevention of coronary heart disease in 16,608 postmenopausal women age 50–79 years. After 5 years of follow-up, this arm of the study was stopped because of the adverse effects of the intervention. The researchers found that HRT increases the risk of several events:
- coronary heart disease events (number needed to harm [NNH]=1428)
- invasive breast cancer (NNH=1250)
- stroke (NNH=1250)
- venous thromboembolic events (NNH=555)
- pulmonary embolism (NNH=1250).
An ongoing arm of WHI is studying estrogen alone in postmenopausal women who have had a hysterectomy.
The Heart and Estrogen/progestin Replacement Study (HERS)2 examined the effects of HRT in postmenopausal women with coronary artery disease. HERS was a large randomized controlled trial of 2763 women with an average follow-up time of 4.1 years. It showed no statistically significant difference between the HRT (estrogen plus medroxyprog-esterone) group compared with the placebo group in either the primary outcomes (nonfatal myocardial infarction or coronary heart disease death) or in the secondary outcomes (coronary revascularization, unstable angina, congestive heart failure, resuscitated cardiac arrest, stroke or transient ischemic attack, and peripheral arterial disease). The findings of the WHI and HERS trials have been summarized in a recent meta-analysis done for the United States Preventive Services Task Force.3
Both the WHI and HERS trials demonstrated some benefits for HRT. WHI found a reduced risk of colorectal cancer (number needed to treat [NNT]=1667) and a decreased risk of any osteoporotic fracture (NNT=228). The HERS group found that HRT improved the quality of life of women with postmenopausal symptoms, particularly flushing.
Evidence indicates that women who take HRT for 3 years and then stop achieve as much protection from osteoporotic fractures as women who continue their HRT beyond 3 years.4
Continuing HRT beyond 5 years dramatically increases the risk of coronary heart disease, stroke, thromboembolic events, breast cancer, and cholecystitis.3
Recommendations from others
The American College of Obstetricians and Gynecologists has convened a multispecialty panel of experts to draft new recommendations for HRT in light of the WHI findings.
Laura Hansen, PharmD, BCPS
University of Colorado, Boulder
The WHI and HERS trials demonstrated that long-term use of HRT (>5 years) incurs significantly more risks than benefits for a postmenopausal woman who has not undergone hysterectomy. However, these trials did not evaluate postmenopausal symptoms or quality of life as primary endpoints.
Most women experience postmenopausal symptoms for more than 1 year but have resolution of symptoms within a few years after menopause. Since HRT remains the most effective therapy for hot flushes, short-term use of HRT (<5 years) may be offered to women experiencing postmenopausal symptoms.
Physicians may instruct women to attempt HRT discontinuation each year because the duration of symptoms can be variable. Discontinuation should be performed using gradual dose reductions to prevent rapid return of postmenopausal symptoms.
1. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321-33.
2. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA 1998;280:605-13.
3. Nelson HD, Humphrey LL, Nygren P, Teutsch SM, Allan JD. Postmenopausal hormone replacement therapy: scientific review. JAMA 2002;288:872-81.
4. Greendale GA, Espeland M, Slone S, Marcus R, Barrett-Connor E. Bone mass response to discontinuation of long-term hormone replacement therapy: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) Safety Follow-up Study. Arch Intern Med 2002;162:665-72.
1. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321-33.
2. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA 1998;280:605-13.
3. Nelson HD, Humphrey LL, Nygren P, Teutsch SM, Allan JD. Postmenopausal hormone replacement therapy: scientific review. JAMA 2002;288:872-81.
4. Greendale GA, Espeland M, Slone S, Marcus R, Barrett-Connor E. Bone mass response to discontinuation of long-term hormone replacement therapy: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) Safety Follow-up Study. Arch Intern Med 2002;162:665-72.
Evidence-based answers from the Family Physicians Inquiries Network
Watchful waiting is reasonable for gallstone symptoms
Not all patients with symptomatic cholelithiasis require surgery. Nearly half of patients with symptomatic but uncomplicated gallstone disease can be managed successfully with observation and minor dietary changes. This option is a safe one we can offer our patients.
Not all patients with symptomatic cholelithiasis require surgery. Nearly half of patients with symptomatic but uncomplicated gallstone disease can be managed successfully with observation and minor dietary changes. This option is a safe one we can offer our patients.
Not all patients with symptomatic cholelithiasis require surgery. Nearly half of patients with symptomatic but uncomplicated gallstone disease can be managed successfully with observation and minor dietary changes. This option is a safe one we can offer our patients.
What is the best treatment for patients with symptomatic mild-to-moderate hallux valgus (bunions)?
BACKGROUND: Approximately 33% of adults have some degree of hallux valgus deformity (bunion of the great toe). Surgery for hallux valgus is one of the most commonly performed orthopedic surgeries. However, there are no previous studies comparing surgery with conservative treatment that includes orthosis or watchful waiting.
POPULATION STUDIED: This study was conducted in 4 orthopedic outpatient clinics in Finland. Patients were referred by family physicians for orthopedic evaluation of hallux valgus. The study participants were 209 adults with a mean age of 48 years. Most (93%) were women, and all had painful bunions with a hallux valgus angle of 35° or less. The study groups were similar at baseline. Four control subjects underwent surgery, but were still analyzed as being in the control group (intention-to-treat analysis).
STUDY DESIGN AND VALIDITY: The study patients were randomly assigned, using a random number table and sealed envelopes (concealed assignment), to a surgical (n=71), orthosis (n=69), or control group (n=69). The surgery group received the chevron procedure. Following the surgery, the patients used an abduction toe-hold splint for 6 weeks. Those in the orthosis group had functional foot orthoses made by the negative-cast technique. Patients in the control group were asked to simply avoid surgical or orthotic therapy during the 12-month follow-up period. All study participants were administered a questionnaire at baseline and again at 6 and 12 months after randomization. Statistical analysis was performed on an intention-to-treat basis.Overall, the study was well designed. However, a major limitation is that all patients were aware of their treatment (ie, they were not blinded). Since all of the outcomes are subjective (eg, pain, quality of life) and self-reported by the patients, there is a large risk of this awareness coloring the outcome scores negatively or positively. The researchers queried study participants after randomization about their expectations for outcomes in the 3 study arms. Patients felt that at 1 year 100% of the surgery group, 83% of the orthosis group, and 18% of the control group would have less foot pain.
OUTCOMES MEASURED: The measured outcomes were patient self-report on duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, health-related quality-of-life index, satisfaction with treatment, and global assessment. Costs related to foot care were also calculated.
RESULTS: At the 12-month follow-up, patients in the surgery group reported less pain and disability than those in either the orthosis group or the control group. There was no significant difference between the orthosis group and the control group at 1 year, although subjects receiving orthotics reported less pain and disability than the control group at the 6-month evaluation. Surgery was significantly more expensive. The mean amount of sick time leave from work was 53 days in the surgical group, 0 days in the orthosis-treated patients, and 12 days in the control group. Patient satisfaction with treatment and global assessments were higher for the surgery group than for patients receiving orthotics or no treatment. However, under the study protocol, patients could not be blinded to treatment.
Surgical treatment of mild-to-moderate hallux valgus results in less pain and disability than either the use of orthotics or watchful waiting. However, as outcome assessments were done by patients who were not blinded to their treatment, it is possible that a patient’s previous belief that surgery is a better treatment than orthosis or watchful waiting had a profound effect on their assessment of their own improvement. The patient expectations noted by the researchers would seem to increase that possibility. Therefore, the conclusion of these researchers (orthopedic surgeons) that surgery is the preferred treatment choice is probably overstated. Although surgery provided superior outcomes, its cost and workday losses are a significant detriment. A trial of orthotics or watchful waiting remains a viable option.
BACKGROUND: Approximately 33% of adults have some degree of hallux valgus deformity (bunion of the great toe). Surgery for hallux valgus is one of the most commonly performed orthopedic surgeries. However, there are no previous studies comparing surgery with conservative treatment that includes orthosis or watchful waiting.
POPULATION STUDIED: This study was conducted in 4 orthopedic outpatient clinics in Finland. Patients were referred by family physicians for orthopedic evaluation of hallux valgus. The study participants were 209 adults with a mean age of 48 years. Most (93%) were women, and all had painful bunions with a hallux valgus angle of 35° or less. The study groups were similar at baseline. Four control subjects underwent surgery, but were still analyzed as being in the control group (intention-to-treat analysis).
STUDY DESIGN AND VALIDITY: The study patients were randomly assigned, using a random number table and sealed envelopes (concealed assignment), to a surgical (n=71), orthosis (n=69), or control group (n=69). The surgery group received the chevron procedure. Following the surgery, the patients used an abduction toe-hold splint for 6 weeks. Those in the orthosis group had functional foot orthoses made by the negative-cast technique. Patients in the control group were asked to simply avoid surgical or orthotic therapy during the 12-month follow-up period. All study participants were administered a questionnaire at baseline and again at 6 and 12 months after randomization. Statistical analysis was performed on an intention-to-treat basis.Overall, the study was well designed. However, a major limitation is that all patients were aware of their treatment (ie, they were not blinded). Since all of the outcomes are subjective (eg, pain, quality of life) and self-reported by the patients, there is a large risk of this awareness coloring the outcome scores negatively or positively. The researchers queried study participants after randomization about their expectations for outcomes in the 3 study arms. Patients felt that at 1 year 100% of the surgery group, 83% of the orthosis group, and 18% of the control group would have less foot pain.
OUTCOMES MEASURED: The measured outcomes were patient self-report on duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, health-related quality-of-life index, satisfaction with treatment, and global assessment. Costs related to foot care were also calculated.
RESULTS: At the 12-month follow-up, patients in the surgery group reported less pain and disability than those in either the orthosis group or the control group. There was no significant difference between the orthosis group and the control group at 1 year, although subjects receiving orthotics reported less pain and disability than the control group at the 6-month evaluation. Surgery was significantly more expensive. The mean amount of sick time leave from work was 53 days in the surgical group, 0 days in the orthosis-treated patients, and 12 days in the control group. Patient satisfaction with treatment and global assessments were higher for the surgery group than for patients receiving orthotics or no treatment. However, under the study protocol, patients could not be blinded to treatment.
Surgical treatment of mild-to-moderate hallux valgus results in less pain and disability than either the use of orthotics or watchful waiting. However, as outcome assessments were done by patients who were not blinded to their treatment, it is possible that a patient’s previous belief that surgery is a better treatment than orthosis or watchful waiting had a profound effect on their assessment of their own improvement. The patient expectations noted by the researchers would seem to increase that possibility. Therefore, the conclusion of these researchers (orthopedic surgeons) that surgery is the preferred treatment choice is probably overstated. Although surgery provided superior outcomes, its cost and workday losses are a significant detriment. A trial of orthotics or watchful waiting remains a viable option.
BACKGROUND: Approximately 33% of adults have some degree of hallux valgus deformity (bunion of the great toe). Surgery for hallux valgus is one of the most commonly performed orthopedic surgeries. However, there are no previous studies comparing surgery with conservative treatment that includes orthosis or watchful waiting.
POPULATION STUDIED: This study was conducted in 4 orthopedic outpatient clinics in Finland. Patients were referred by family physicians for orthopedic evaluation of hallux valgus. The study participants were 209 adults with a mean age of 48 years. Most (93%) were women, and all had painful bunions with a hallux valgus angle of 35° or less. The study groups were similar at baseline. Four control subjects underwent surgery, but were still analyzed as being in the control group (intention-to-treat analysis).
STUDY DESIGN AND VALIDITY: The study patients were randomly assigned, using a random number table and sealed envelopes (concealed assignment), to a surgical (n=71), orthosis (n=69), or control group (n=69). The surgery group received the chevron procedure. Following the surgery, the patients used an abduction toe-hold splint for 6 weeks. Those in the orthosis group had functional foot orthoses made by the negative-cast technique. Patients in the control group were asked to simply avoid surgical or orthotic therapy during the 12-month follow-up period. All study participants were administered a questionnaire at baseline and again at 6 and 12 months after randomization. Statistical analysis was performed on an intention-to-treat basis.Overall, the study was well designed. However, a major limitation is that all patients were aware of their treatment (ie, they were not blinded). Since all of the outcomes are subjective (eg, pain, quality of life) and self-reported by the patients, there is a large risk of this awareness coloring the outcome scores negatively or positively. The researchers queried study participants after randomization about their expectations for outcomes in the 3 study arms. Patients felt that at 1 year 100% of the surgery group, 83% of the orthosis group, and 18% of the control group would have less foot pain.
OUTCOMES MEASURED: The measured outcomes were patient self-report on duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, health-related quality-of-life index, satisfaction with treatment, and global assessment. Costs related to foot care were also calculated.
RESULTS: At the 12-month follow-up, patients in the surgery group reported less pain and disability than those in either the orthosis group or the control group. There was no significant difference between the orthosis group and the control group at 1 year, although subjects receiving orthotics reported less pain and disability than the control group at the 6-month evaluation. Surgery was significantly more expensive. The mean amount of sick time leave from work was 53 days in the surgical group, 0 days in the orthosis-treated patients, and 12 days in the control group. Patient satisfaction with treatment and global assessments were higher for the surgery group than for patients receiving orthotics or no treatment. However, under the study protocol, patients could not be blinded to treatment.
Surgical treatment of mild-to-moderate hallux valgus results in less pain and disability than either the use of orthotics or watchful waiting. However, as outcome assessments were done by patients who were not blinded to their treatment, it is possible that a patient’s previous belief that surgery is a better treatment than orthosis or watchful waiting had a profound effect on their assessment of their own improvement. The patient expectations noted by the researchers would seem to increase that possibility. Therefore, the conclusion of these researchers (orthopedic surgeons) that surgery is the preferred treatment choice is probably overstated. Although surgery provided superior outcomes, its cost and workday losses are a significant detriment. A trial of orthotics or watchful waiting remains a viable option.