Barton, D.L., LaVasseur, B.I., Sloan, J.A., Stawis, A.N., Flynn, K.A., Dyar, M., ... & Loprinzi, C.L. (2010). Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9. Journal of Clinical Oncology, 28, 3278-3283.

DOI Link

Study Purpose

To evaluate three different doses of citalopram for management of hot flashes

Intervention Characteristics/Basic Study Process

Women were randomly assigned to receive 10, 20, or 30 mg citalopram or corresponding number of placebo pills daily for six weeks. Treatment was titrated weekly to achieve the target dose.

Sample Characteristics

  • N = 196  
  • MEAN AGE = 55.6 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: 55% were on aromatase inhibitors, and 38% were on naloxifene or tamoxifen.
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority had over four hot flash episodes per day.  

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: United States of America

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

Placebo controlled RCT

Measurement Instruments/Methods

  • Hot flash scores calculated by assigning 1 (mild) to 4 (severe) points for severity of each daily hot flash episode and adding these scores for a daily hot flash score. 
  • Profile of Mood States
  • Hot Flash Related Daily Interference Scale
  • National Cancer Institute Common Toxicity Criteria version 3.0

Results

There was some improvement in hot flash interference with several areas, and those on 20 and 30 mg of citalopram had significant improvement in sleep interference compared to placebo (p ≤ .01). There were no group differences in overall POMS scores. Adverse effects on sexual health were greater with 30 mg compared to placebo, but this difference was not statistically significant.

Conclusions

Findings show that citalopram in a dose as low as 10 mg daily can significantly improve hot flash symptoms and is not associated with toxicity. Further benefits were seen with higher doses.

Limitations

  • Risk of bias (no blinding)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Relatively short duration of treatment, particularly for adverse effects

Nursing Implications

Findings show that citalopram was beneficial to reduce hot flash severity. The duration of treatment in this study was only six weeks, so longer term efficacy is not clear. Patients on any longer term management with citalopram need to be monitored for side effects of the medication.