Topiramate의 신경성 폭식증 치료효과: 국내외 보고된 임상연구결과 및 치험사례 중심으로 Topiramate for the Treatment of Binge Eating Disorder or Bulimia Nervosa : A Systemic Review of Human Clinical Studies and Case Reports원문보기
지난 20 여 년 간 서구 선진사회에서는 식사장애(Eating disorder) 중에서 신경성 폭식증(Bulimia nervosa)의 발병률이 급격히 상승하였고, 우리나라는 특히 젊은 여성층에서 발병률이 빠르게 상승하고 있다. 치료약물로는 주로 항우울제가 선택되지만, 치료효과가 미흡한 바, 항경련제인 topiramate가 효과가 있다는 보고들이 있어 이를 신경성 폭식증치료에 적극 사용할 수 있는가에 관심이 고조되었다. 본 연구는 topiramate가 지닌 신경성 폭식증 치료효과에 대한 최신 지견을 얻고자, 1990년부터 2006년 사이 MEDLINE과, 한국의학논문데이터베이스에 등재된 국내외 자료를 binge eating disorder, bulimia nervosa, topiramate라는 3개의 주요어휘로 검색하여 추출한 자료중에서, 대조군이 사용된 무작위 배정, 이중맹검임상연구 및 치험사례 만을 선별하여 임상적유용성을 평가하였다. 국외 임상연구 및 치험사례에 따르면, topiramate가 신경성 폭식증에 수반되는 유해한 증상의 발생빈도를 경감시키는데 유효함을 나타내었다. 국내에는 아직 topiramate의 신경성 폭식증 치료효과를 검증한 체계화된 임상연구나 치험사례가 보고된 바 없었다. 피험자의 규모가 작다는 한계에도 불구하고, 일일 투여량 25 mg로 시작하여 점차 증량후 최대 600 mg까지 투여한 국외의 연구결과는, topiramate가 신경성 폭식증 치료에 유효한 결과를 보인다고 사료되므로, 국내 신경성 폭식증 임상치료와 연구에 반영되기를 기대한다.
지난 20 여 년 간 서구 선진사회에서는 식사장애(Eating disorder) 중에서 신경성 폭식증(Bulimia nervosa)의 발병률이 급격히 상승하였고, 우리나라는 특히 젊은 여성층에서 발병률이 빠르게 상승하고 있다. 치료약물로는 주로 항우울제가 선택되지만, 치료효과가 미흡한 바, 항경련제인 topiramate가 효과가 있다는 보고들이 있어 이를 신경성 폭식증치료에 적극 사용할 수 있는가에 관심이 고조되었다. 본 연구는 topiramate가 지닌 신경성 폭식증 치료효과에 대한 최신 지견을 얻고자, 1990년부터 2006년 사이 MEDLINE과, 한국의학논문데이터베이스에 등재된 국내외 자료를 binge eating disorder, bulimia nervosa, topiramate라는 3개의 주요어휘로 검색하여 추출한 자료중에서, 대조군이 사용된 무작위 배정, 이중맹검 임상연구 및 치험사례 만을 선별하여 임상적유용성을 평가하였다. 국외 임상연구 및 치험사례에 따르면, topiramate가 신경성 폭식증에 수반되는 유해한 증상의 발생빈도를 경감시키는데 유효함을 나타내었다. 국내에는 아직 topiramate의 신경성 폭식증 치료효과를 검증한 체계화된 임상연구나 치험사례가 보고된 바 없었다. 피험자의 규모가 작다는 한계에도 불구하고, 일일 투여량 25 mg로 시작하여 점차 증량후 최대 600 mg까지 투여한 국외의 연구결과는, topiramate가 신경성 폭식증 치료에 유효한 결과를 보인다고 사료되므로, 국내 신경성 폭식증 임상치료와 연구에 반영되기를 기대한다.
The clinical investigations above suggest that topiramate may be an effective agent in the treatment of BED or BN by reducing binging/purging episodes, improving the HRQOL, and decreasing weight. The case report and case series also support these findings. However, there are several limitations in t...
The clinical investigations above suggest that topiramate may be an effective agent in the treatment of BED or BN by reducing binging/purging episodes, improving the HRQOL, and decreasing weight. The case report and case series also support these findings. However, there are several limitations in the above studies and cases. All these had relatively small sample size, and two of them were only 10-week-period studies. Optimal duration of treatment with topiramate in patients with BED or BN is unknown. As most clinicians treat the patient with BED or BN for 6 to 12 months and then reassess, at least 6 months period is needed to show its efficacy. One of studies included only women in the patient group. In the case series, all patients had severe comorbid mood disorders such as major depression and bipolar disorder besides BN. Therefore, notwithstanding its clinical usefulness, additional researches are needed to define the role and the benefits of topiramate in the treatment of BED or BN more thoroughly.
The clinical investigations above suggest that topiramate may be an effective agent in the treatment of BED or BN by reducing binging/purging episodes, improving the HRQOL, and decreasing weight. The case report and case series also support these findings. However, there are several limitations in the above studies and cases. All these had relatively small sample size, and two of them were only 10-week-period studies. Optimal duration of treatment with topiramate in patients with BED or BN is unknown. As most clinicians treat the patient with BED or BN for 6 to 12 months and then reassess, at least 6 months period is needed to show its efficacy. One of studies included only women in the patient group. In the case series, all patients had severe comorbid mood disorders such as major depression and bipolar disorder besides BN. Therefore, notwithstanding its clinical usefulness, additional researches are needed to define the role and the benefits of topiramate in the treatment of BED or BN more thoroughly.
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제안 방법
Another study assessed the effect of topiramate on binging and purging behavior, body weight, and the health-related quality of life (HRQOL) in patients with BN.9) The researchers conducted a 10-week randomized, double-blind, placebo-controlled study. One hundred two women aged 18 years or older who had been suffering from DSM-IV BN for at least 12 months were included in the study.
Topiramate was titrated from an initial dose of 25 mg/ day up to 600 mg/day. During the extension trial, patients were evaluated every 4 weeks. A 1-sample paired t-test was used to evaluate the weekly frequency of bingeeating episodes before each clinic visit.
071), although that did not meet statistical significance. The limitations of the study were the small sample size and short treatment period. According to the results of the study, topiramate may be potential for the treatment of BN.
001). The study has several limitations, i.e., an uncontrolled, open-label trial with a small sample size and high attrition rate. Despite these limitations, the study suggests that topiramate may be effective for patients with BED and obesity.
No serious side effects were reported during the study. The study suggests that topiramate is a safe and effective agent for improving the binging/purging behavior and the HRQOL in patients with BN, but there are limitations in the study. The sample size was relatively small and only women were included in the study.
1) conducted a 14-week, single-center, randomized, double-blind, placebo-controlled study in 61 patients with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders; Version IV, published in 1994) BED and obesity (BMI>30 kg/m2). The study was followed by an open-label, 42-week extension study for patients who completed the placebo-controlled trial. Topiramate was titrated from an initial dose of 25 mg/ day up to 600 mg/day.
대상 데이터
9) The researchers conducted a 10-week randomized, double-blind, placebo-controlled study. One hundred two women aged 18 years or older who had been suffering from DSM-IV BN for at least 12 months were included in the study. Sixty patients were randomly assigned to receive topiramate (topiramate group [TG]; n=30) or a placebo (control group [CG]; n=30).
In 3 out of the 5 cases in the series, topiramate almost completely eliminated binging and purging behavior. One of the patients discussed was a 36-year-old woman with BN and depression. She was prescribed citalopram 120 mg, gabapentin 800 mg, olanzapine 30 mg, lamotrigine 150 mg (all given at bedtime), and dextroamphetamine, 10 mg twice daily.
A 1-sample paired t-test was used to evaluate the weekly frequency of bingeeating episodes before each clinic visit. Thirty one patients entered the open-label extension trial. Fifteen patients received topiramate during the double-blind study and 16 patients received placebo.
데이터처리
During the extension trial, patients were evaluated every 4 weeks. A 1-sample paired t-test was used to evaluate the weekly frequency of bingeeating episodes before each clinic visit. Thirty one patients entered the open-label extension trial.
이론/모형
Sixty patients were randomly assigned to receive topiramate (topiramate group [TG]; n=30) or a placebo (control group [CG]; n=30). The nonparametric Mann-Whitney U test was performed to evaluate the primary outcome measures of changes in the frequency of binging/purging, in body weight, and in the HRQOL by using the SF-36 Health Survey (SF- 36) scales. The SF-36 consists of a questionnaire with 36 items that are categorized according to several subject areas.
성능/효과
After a 3-week period, improvements were seen in eating habits and obsessive and compulsive behavior. After 28 weeks of therapy, her weight decreased fom 75 kg (BMI= 26.57) to 63 kg (BMI= 22.32). In this case, topiramate was associated with improvement in the treatment of binge eating disorder associated obesity.
Topiramate was given 25 mg twice daily for 3 weeks followed by a 25 mg increase every 3 weeks up to 100 mg twice daily without concomitant treatment. After a 3-week period, improvements were seen in eating habits and obsessive and compulsive behavior. After 28 weeks of therapy, her weight decreased fom 75 kg (BMI= 26.
A 2-group t test with a 5% significance level was used to analyze the efficacy of topiramate. The researchers found that topiramate was associated with a greater percent reduction in mean weekly number of binge and/or purge days (44.8% from baseline with topiramate versus 10.7% with placebo, p=0.004). The mean weekly number of binge days decreased 48.
후속연구
According to the results of the study, topiramate may be potential for the treatment of BN. However, larger and longer studies are needed to confirm these results.
In the case series, all patients had severe comorbid mood disorders such as major depression and bipolar disorder besides BN. Therefore, notwithstanding its clinical usefulness, additional researches are needed to define the role and the benefits of topiramate in the treatment of BED or BN more thoroughly.
The sample size was relatively small and only women were included in the study. Thus, additional study is needed to establish the effects of topiramate in both men and women with BN and how long-lasting the benefits are (Table 1).
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