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Role of paroxetine in the management of hot flashes in gynecological cancer survivors: Results of the first randomized single-center controlled trial.
Gynecol Oncol. 2016 Dec; 143(3):584-588.GO

Abstract

OBJECTIVES

To examine the effects of paroxetine supplementation on hot flashes and sleep in gynecological cancer survivors.

METHODS

In a randomized, double-blind, placebo-controlled study, postmenopausal women with a prior history of stage 0-III gynecological cancer who had completed active cancer treatment (including hormonal therapy) were randomly assigned 1:1 to either 7.5mg oral paroxetine or placebo daily for 16weeks. Sleep and hot flashes were assessed at baseline, week 4 and week 16.

RESULTS

Eighty women (91%) completed the study. We found out a statistically significant difference in weekly reductions in VMS frequency and severity for paroxetine 7.5mg than for placebo on week 4 and 16. Regarding sleep characteristics, the analysis of data through week 16 reported a statistically significant reduction in the number of nighttime awakenings attributed to VMS among participants receiving paroxetine than among participants receiving placebo on baseline and weeks. The duration of sleep per night increased significantly more among participants receiving paroxetine than among those receiving placebo at all post baseline time points. No significant differences in sleep-onset latency were noted between the two treatment arms during the course of the study. Paroxetine was well-tolerated with a high level of compliance. In our cohort of patients, no serious adverse events have been reported.

CONCLUSIONS

This is the first randomized placebo-controlled study in gynecological cancer survivors that demonstrates that paroxetine significantly reduces hot flashes in weekly frequency and severity and the number of nighttime awakenings attributed to vasomotor symptoms, increasing sleep duration.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy. Electronic address: 3452572851s.capriglione@unicampus.it.Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27751589

Citation

Capriglione, Stella, et al. "Role of Paroxetine in the Management of Hot Flashes in Gynecological Cancer Survivors: Results of the First Randomized Single-center Controlled Trial." Gynecologic Oncology, vol. 143, no. 3, 2016, pp. 584-588.
Capriglione S, Plotti F, Montera R, et al. Role of paroxetine in the management of hot flashes in gynecological cancer survivors: Results of the first randomized single-center controlled trial. Gynecol Oncol. 2016;143(3):584-588.
Capriglione, S., Plotti, F., Montera, R., Luvero, D., Lopez, S., Scaletta, G., Aloisi, A., Serra, G. B., & Angioli, R. (2016). Role of paroxetine in the management of hot flashes in gynecological cancer survivors: Results of the first randomized single-center controlled trial. Gynecologic Oncology, 143(3), 584-588. https://doi.org/10.1016/j.ygyno.2016.10.006
Capriglione S, et al. Role of Paroxetine in the Management of Hot Flashes in Gynecological Cancer Survivors: Results of the First Randomized Single-center Controlled Trial. Gynecol Oncol. 2016;143(3):584-588. PubMed PMID: 27751589.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Role of paroxetine in the management of hot flashes in gynecological cancer survivors: Results of the first randomized single-center controlled trial. AU - Capriglione,Stella, AU - Plotti,Francesco, AU - Montera,Roberto, AU - Luvero,Daniela, AU - Lopez,Salvatore, AU - Scaletta,Giuseppe, AU - Aloisi,Alessia, AU - Serra,Giovan Battista, AU - Angioli,Roberto, Y1 - 2016/10/15/ PY - 2016/08/13/received PY - 2016/09/30/revised PY - 2016/10/03/accepted PY - 2016/10/19/pubmed PY - 2017/5/30/medline PY - 2016/10/19/entrez KW - Cancer survivors KW - Gynecological cancers KW - Hot flashes KW - Menopause KW - Non hormonal KW - Paroxetine SP - 584 EP - 588 JF - Gynecologic oncology JO - Gynecol Oncol VL - 143 IS - 3 N2 - OBJECTIVES: To examine the effects of paroxetine supplementation on hot flashes and sleep in gynecological cancer survivors. METHODS: In a randomized, double-blind, placebo-controlled study, postmenopausal women with a prior history of stage 0-III gynecological cancer who had completed active cancer treatment (including hormonal therapy) were randomly assigned 1:1 to either 7.5mg oral paroxetine or placebo daily for 16weeks. Sleep and hot flashes were assessed at baseline, week 4 and week 16. RESULTS: Eighty women (91%) completed the study. We found out a statistically significant difference in weekly reductions in VMS frequency and severity for paroxetine 7.5mg than for placebo on week 4 and 16. Regarding sleep characteristics, the analysis of data through week 16 reported a statistically significant reduction in the number of nighttime awakenings attributed to VMS among participants receiving paroxetine than among participants receiving placebo on baseline and weeks. The duration of sleep per night increased significantly more among participants receiving paroxetine than among those receiving placebo at all post baseline time points. No significant differences in sleep-onset latency were noted between the two treatment arms during the course of the study. Paroxetine was well-tolerated with a high level of compliance. In our cohort of patients, no serious adverse events have been reported. CONCLUSIONS: This is the first randomized placebo-controlled study in gynecological cancer survivors that demonstrates that paroxetine significantly reduces hot flashes in weekly frequency and severity and the number of nighttime awakenings attributed to vasomotor symptoms, increasing sleep duration. SN - 1095-6859 UR - https://www.unboundmedicine.com/medline/citation/27751589/Role_of_paroxetine_in_the_management_of_hot_flashes_in_gynecological_cancer_survivors:_Results_of_the_first_randomized_single_center_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0090-8258(16)31476-7 DB - PRIME DP - Unbound Medicine ER -