Journal of Natural Remedies

Abna Faustina de Sousa Vieira ¹, Vitor Augusto Queiroz Mauad ¹, Daniel Cubero ¹, Patrícia Xavier Santi ¹, Auro del Giglio ¹

Affiliations
1 (School of Medicine of the ABC Foundation), AV Lauro Gomes, 2000, Santo Andre, SP - 09060-870, BR

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.

Keywords

Breast Neoplasia, Guarana, Hot Flashes, Paullinia cupana.

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Renan Sordi ¹, Suellen Nastri Castro ¹, Andrea Thaumaturgo Lera ¹, Macilon Nonato Irene ¹, Marilia de Melo Farinazzo ¹, Claudia Sette ², Daniel de Iracema Gomes Cubero ², Ana Luisa de Castro Baccarin ², Auro del Giglio ²

Affiliations
1 Medical Residents of Clinical Oncology of the Brazilian Institute of Cancer Control, BR
2 Department of Clinical Oncology, Brazilian Institute of Cancer Control; and Hematology and Oncology Sector, School of Medicine of ABC, BR

Abstract

Introduction: Aromatase inhibitors (AI) are widely used in adjuvant breast cancer treatment, and diffuse articular pain secondary to AI use is the most common cause of treatment discontinuation. Uncaria tomentosa (cat’s claw) has antiinflammatory activity and is used to treat arthrosis and arthritis. Patients and Methods: This prospective, single-center, double-blind, randomized, placebo-controlled phase II study analyzed 70 patients with breast cancer undergoing AI therapy with complaints of arthralgia. The patients received 100 mg of the dry extract of Uncaria tomentosa three times daily for 4 weeks. At the beginning and end of the study, patients answered the Brief Pain Inventory (BPI), Disability Arm, Shoulder, and Hand (DASH), Lequesne, SF-36 Quality of Life questionnaires, completed a visual analog scale (VAS) for pain, and underwent laboratory testing. Results: U. tomentosa was not more effective than the placebo. No evidence of grade 3 or 4 toxicity was found. In addition, no significant differences were seen in laboratory results or inflammatory markers between the two study groups. Conclusion: Dry extract of U. tomentosa was safe but ineffective in reducing AI-induced arthralgia compared with the placebo. Furthermore, the plant extract had no detectable anti-inflammatory activity.

Keywords

Aromatase Inhibitor, Arthralgia, Cat's Claw, Uncaria tomentosa.

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