Use of Guarana for Hot Flashes after Breast Cancer: Randomized, Double-Blind, Placebo-Controlled Phase II Trial

Abstract

Background: Hot flashes are common in menopausal women and significantly affect the quality of life of many patients diagnosed with breast cancer for which hormone replacement therapy is not indicated. In a previous uncontrolled study, guarana (Paullinia cupana) showed significant decreases in the amount and intensity of hot flashes in this group of women. Hypothesis/Purpose: The main objective was to reduce the intensity and frequency of hot flashes with the use of PC-18, compared with placebo in women who survived breast cancer without current evidence of disease. Study Design: The present study consists of a double-blind, randomized, placebo-controlled, uni-institutional, two-arm phase II clinical trial. Methods: The experimental group received the purified dry extract of Paullinia cupana (PC-18) at a dose of 37.5 g twice daily, while the other group received placebo, also twice daily. Results: The study included 40 patients who had completed surgical, chemotherapeutic and/or radiotherapeutic treatment for more than 3 months and who were on adjuvant hormone therapy at the time of inclusion, 20 in each arm. Both groups showed significant reductions in the number and intensity of hot flashes, with no significant difference between the arms. There was a higher intensity and frequency of hot flashes in patients receiving tamoxifen compared with those who received aromatase inhibitors. The toxicities observed were not very significant. Conclusion: This concludes that PC-18 did not demonstrate significantly greater capacity than placebo for control of hot flashes in women with a history of breast cancer and adjuvant hormone therapy.

The Effects of Pharmacological and Non-Pharmacological Interventions on Symptom Management and Quality of Life among Breast Cancer Survivors Undergoing Adjuvant Endocrine Therapy: A Systematic Review

“…While earlier studies showed that pharmacological interventions using clonidine could lead to significant reduction in hot flashes score, frequency and intensity [28,29], other studies reported non-significant differences (p ≥ 0.54) in the changes of these parameters between the intervention and control group at pre-and post-intervention [25][26][27]. Notably, both the intervention and control participants reported a decrease in these parameters from baseline to post-intervention [25,26], which demonstrates why non-significant differences were observed. Interestingly, in a cross-over study on a pharmacological intervention using the anti-depressant sertraline, significant between-group differences were observed in hot flashes frequency and hot flashes score after cross-over at Week 12 of the intervention, despite the lack of such difference before the cross-over at Week 6 [27].…”

“…De Sousa Vieira et al [25] reported that a pharmacological intervention using a medicinal plant extract (Guarana) did not have significant effect on increasing sex drive among the participants. Likewise, an exercise training intervention did not exhibit significant enhancement of sexual functioning or sexual enjoyment among participants [32].…”

“…de Sousa Vieira et al, 2019 [25] Physical activity intervention Supervised combined exercise training intervention • No significant time × group interaction for sexual functioning (p = 0.77) or sexual enjoyment (p = 0.16) scores.…”

“…Five studies reported the effect of pharmacological interventions on addressing hot flashes among the participants [25][26][27][28][29]. While earlier studies showed that pharmacological interventions using clonidine could lead to significant reduction in hot flashes score, frequency and intensity [28,29], other studies reported non-significant differences (p ≥ 0.54) in the changes of these parameters between the intervention and control group at pre-and post-intervention [25][26][27]. Notably, both the intervention and control participants reported a decrease in these parameters from baseline to post-intervention [25,26], which demonstrates why non-significant differences were observed.…”

“…de Sousa Vieira et al, 2019 [25] Pharmacological intervention with a homeopathic medicine named Actheane ®…”