A Review of Paroxetine for the Treatment of Vasomotor Symptoms

Slaton, Rachel M.; Champion, Megan N.; Palmore, Kayla B.

doi:10.1177/0897190014544785

Cited by 11 publications

(15 citation statements)

References 19 publications

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“…This is in addition to the three wide‐ranging reviews conducted before the licensing of Brisdelle . Both of these recent reviews included most of the six trials we identified, plus some others, and reached similar conclusions . However, our review has several advantages over the others that enhance the reliability and interpretation of the data.…”

Section: Discussionsupporting

confidence: 55%

“…Thirdly, we have used the GRADE approach to rate the quality of evidence, which helps in the interpretation of the results of the systematic review. Although the results of the two recent reviews and this review are similar, the interpretation using GRADE clarifies the evidence.…”

Section: Discussionmentioning

confidence: 57%

“…Recently, two reviews have been published in peer‐review journals concerning the effectiveness and safety of paroxetine for VMS . This is in addition to the three wide‐ranging reviews conducted before the licensing of Brisdelle .…”

Section: Discussionmentioning

confidence: 99%

“…Paroxetine is also used at higher doses as an anti‐depressant, and the adverse effect profile, including suicidal ideation, is well established . Some primary studies have explored the effect and safety of paroxetine for VMS, summarised in a narrative review . We conducted a systematic review and meta‐analysis reliably to evaluate the efficacy and safety of paroxetine for VMS in menopausal women.…”

Section: Introductionmentioning

confidence: 99%

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Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta‐analysis

Wei

Chen

et al. 2016

BJOG

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Background Paroxetine is the first non-hormone therapy for vasomotor symptoms (VMS) approved based on the results of two phase 3, randomised, placebo-controlled trials by the Food and Drug Administration (FDA) in 2013.Objective To confirm the effect and safety of paroxetine for vasomotor symptoms (VMS).Search strategy MEDLINE, EMBASE, PsycINFO, CENTRAL, WHO International Clinical Trials Registry Platform (ICTRP) and four Chinese databases was searched from the date of their inception to 7 June 2014.Selection criteria We included RCTs on the effect of paroxetine compared with placebo or no treatment for perimenopausal and postmenopausal women who experienced moderate-to-severe vasomotor symptoms.Data collection and analysis Two reviewers screened records and extracted the information independently. The included studies were appraised by two independent reviewers using the Cochrane risk of bias tool. We synthesised the data in random-effects models and rated the quality of evidence using GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach.Main results Five articles with six RCTs (1571 participants) were included. Paroxetine significantly reduced the frequency of hot flushes by 8.86 per week (95% confidence interval (CI) 5.69-12.04, P < 0.00001, I 2 = 83%) at week 4 and 7.36 per week (95% CI, 4.25-10.46, P < 0.00001, I 2 = 62%) at week 12. The quality of the evidence on the effect of paroxetine for VMS was moderate.Conclusions There was moderate quality of evidence supporting the effectiveness of paroxetine for vasomotor symptoms; however, it causes nausea and dizziness.Keywords GRADE, low dose paroxetine salt, meta-analysis, paroxetine, vasomotor symptoms.

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Section: Discussionsupporting

confidence: 55%

Section: Discussionmentioning

confidence: 57%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta‐analysis

Wei

Chen

et al. 2016

BJOG

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“…For this reason, the North American Menopause Society described paroxetine as a first-choice drug for those non-suitable patients and for those who refuse hormonal therapy [25]. Together with VMS, paroxetine has been reported to be useful also in decreasing chronic pelvic pain in pre, peri-, and postmenopausal women, leading to an improvement of social relationships, sexuality, and mental health [26,27,28,29,30,31,32]…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Low-Dose Paroxetine for the Treatment of Hot Flushes in Surgical and Physiological Postmenopausal Women: Systematic Review and Meta-Analysis of Randomized Trials

et al. 2019

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Background and Objectives: Hot flushes and sleep disturbances are the most common vasomotor symptoms (VMS) reported by postmenopausal women. Hormonal treatment is to date referred to as the gold standard approach but not suitable for all the patients. Alternative treatments are needed in case of a contraindication to menopausal hormone therapy (MHT), adverse side effects, and poor compliance. Paroxetine salt is the only nonhormonal medication approved by the US Food and Drug Administration for the management of VMS. Nonetheless, few trials with low consensus are available about this topic. In this review, we aimed to evaluate the efficacy of low-dose paroxetine therapy in the treatment of vasomotor hot flushes and night sleep disturbances in postmenopausal women. Materials and Methods: We performed an electronic search from the beginning of all databases to July 2019. All results were then limited to a randomized trial. Restrictions for language or geographic location were not utilized. Inclusion criteria were randomized clinical trials of physiological or surgical postmenopausal women experiencing hot flushes and sleep disturbances who were randomized to either low-dose paroxetine or placebo (i.e., formulations without active ingredients). The primary outcome evaluated was the mean weekly reduction of hot flushes. Results: Five randomized clinical trials, including 1482 postmenopausal women, were analyzed. Significant heterogeneity (I2 = 90%) between studies was noted. Hot flushes episodes were significantly reduced in the treatment arm compared to placebo (mean difference (MD) −7.97 [−10.51, −5.92] episodes/week). Results on the improvement on sleep were limited by being reported in only two studies; however, no significant reduction of night-time awakenings was observed (MD, −0.40 awakenings/night [−1.38, 0.58 CI]). Conclusions: Low-dose paroxetine is an effective treatment for vasomotor menopause symptoms, including hot flushes.

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Role of the pharmacist in the management of postmenopausal breast cancer treatment with vasomotor symptoms: A case report

Undeberg,

Barash,

McKeirnan

2023

Exploratory Research in Clinical and Social Pharmacy

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A Review of Paroxetine for the Treatment of Vasomotor Symptoms

Abstract: Paroxetine (mesylate or hydrochloride) is an effective alternative to HRT for the reduction in VMS in menopausal women. Future head-to-head studies with active medications are needed in order to identify the best algorithm of treatment for this condition.

Cited by 11 publications

References 19 publications

Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta‐analysis

Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta‐analysis

Efficacy of Low-Dose Paroxetine for the Treatment of Hot Flushes in Surgical and Physiological Postmenopausal Women: Systematic Review and Meta-Analysis of Randomized Trials

Role of the pharmacist in the management of postmenopausal breast cancer treatment with vasomotor symptoms: A case report

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