Sertraline

Sertraline

PEP Topic 
Hot Flashes
Description 

Sertraline is in the selective serotonin reuptake inhibitors (SSRIs) class of antidepressants. It works by increasing the amounts of serotonin in the brain. Sertraline has been examined as an intervention for depression, hot flashes, and fatigue in patients with cancer.

Effectiveness Not Established

Research Evidence Summaries

Kimmick, G.G., Lovato, J., McQuellon, R., Robinson, E., & Hyman, B.M. (2006). Randomized double-blind, placebo-controlled, crossover study of sertraline (Zoloft) for the treatment of hot flashes in women with early stage breast cancer taking tamoxifen. Breast Journal, 12, 114–122.

doi:10.1111/j.1075-122X.2006.00218.x
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Study Purpose:

This study assessed the effect of sertraline on the frequency and severity of hot flashes, mood status, and health-related QOL in women with breast cancer.

Intervention Characteristics/Basic Study Process:

Patients were randomized to receive 50 mg sertraline each morning for six weeks, followed by six weeks of a placebo tablet each morning, or to six weeks of a placebo followed by six weeks of sertraline. Before starting the medication, a one-week pretreatment period was included during which patients recorded baseline measurements of hot flashes in a daily diary.

Sample Characteristics:

The study enrolled adult women with localized breast cancer (stages 0–IIIB) who were receiving adjuvant tamoxifen therapy and had at least one hot flash per day.

  • Inclusion criteria: Normal hepatic function with total bilirubin of less than 2 mg/dl and aspartate aminotransferase (AST) greater than or equal to two times normal within six months of study entry.
  • Exclusion criteria:
    • Women who were pregnant or breastfeeding; had a history of seizure disorder; hepatic or renal insufficiency.
    • Concurrent or planned therapy with estrogen, progestational agents, corticosteroids, androgens, or other antidepressant therapy.
    • Monoamine oxidase inhibitors or other SSRI use had to have been discontinued at least 14 days before entering the study.

Setting:

The study was conducted in an oncology clinic in a tertiary care center.

Study Design:

This was a randomized, double-blind, placebo-controlled, crossover study.

Measurement Instruments/Methods:

Participants maintained a daily hot flash diary to record hot flash frequency and severity. Other instruments included:

  • The Center for Epidemiologic Studies depression scale
  • Functional Assessment of Cancer Therapy-Breast (FACT-B) 

Measurements were assessed at baseline, 6 weeks, and 12 weeks.

Results:

The baseline daily hot flash frequency and score were 5.8 and 11.5. At the end of six weeks, frequency of hot flashes decreased by 50% in a greater proportion of those taking sertraline than those in the control group. In crossover analysis, sertraline was significantly more effective that placebo: (p= 0.03 ). Forty-eight percent preferred the sertraline period, 11% preferred the placebo period, and 41% had no preference (p = 0.006). Measures of depression and QOL were unchaged within treatment groups.

Limitations:

Limitations included:

  • Small sample size less than 100
  • Unable to detect statistically significant difference in the effect of sertraline versus placebo on hot flashes at six weeks

Wu, M.F., Hilsenbeck, S. G., Tham, Y. L., Kramer, R., Elledge, R. M., Chang, J. C., & Friedman, L. C. (2009). The efficacy of sertraline for controlling hot flashes in women with or at high risk of developing breast cancer. Breast Cancer Research and Treatment, 118(2), 369-375.

doi:10.1007/s10549-009-0425-y
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Study Purpose:

The study evaluate the efficacy of sertraline for controlling hot flashes in women with or at high risk of breast cancer.

Intervention Characteristics/Basic Study Process:

The study was organized by periods:

  • Week 1: baseline
  • Week 2: single-blind placebo run-in; those reporting hot flash score reductions of greater than 50% were then excluded.
  • The remaining women received placebo or sertraline 25 mg/day and titrated weekly as needed to a maximum of 100 mg/day for weeks 3–6.

Sample Characteristics:

The study enrolled women aged 18 or older with personal or family history of carcinoma in situ or invasive breast cancer with reported hot flashes and a weekly hot flash score of greater than 15.

  • N = 57 (randomized eligible) 
  • N=53 (run-in phase)
  • N=46 (assigned treatment)
  • N = 41 completed treatment

Mean participant age was 55.8 years, and 95% had abreast cancer diagnosis.

Exclusion criteria included: progressive metastatic breast cancer, documented history of medication or treatment noncompliance, acute suicidal or homicidal ideation, any unstable clinically significant psychiatric condition including major depressive disorder, or concomitant use or use within 14 days of a monoamine oxidase inhibitor or another antidepressant drug, history of intolerable adverse reaction to sertraline, reduction of a weekly hot flash score by greater than 50% after placebo run-in.

Setting:

A university cancer center hosted the study.

Study Design:

The study was randomized, double-blind, placebo-controlled.

Measurement Instruments/Methods:

Participants maintained a hot flash diary to record the number and severity of hot flashes per day.

Results:

Hot flash frequencies and scores suggested greater decline, but not statistically significant, in the sertraline-treated group compared with the placebo group.

Limitations:

The study was limited by its small sample size with reported insufficient statistical power to detect modest differences in hot flashes between groups. Study design did not take into account the possibility of pharmacokinetic interaction between sertraline and tamoxifen


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