Pau d ' Arco (Tabebuia avellanedae)治疗原发性痛经的安全性和耐受性:一项针对18-45岁成年人的单臂、开放标签试验

IF 1.7 Q2 Medicine Advances in integrative medicine Pub Date : 2022-09-01 DOI:10.1016/j.aimed.2022.04.003
C. McClure , M. Bollen , L. Buttolph , E. Stack , B.O. Langley , D. Hanes , K.M. Wright , D. Tibbitts , R. Bradley
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引用次数: 0

摘要

目的评价胶囊化阿韦兰他布亚在18-45岁原发性痛经女性患者中的安全性和耐受性。方法采用单臂、开放标签试验,对12名年龄在18-45岁的健康女性,给予1050 mg/d胶囊化阿韦兰他布亚(Pau d’arco),持续8周。主要结局是安全性和耐受性,通过标准化不良事件量表和实验室标志物的系列收集来评估一般健康状况、凝血酶原时间和贫血的存在或不存在。次要结果包括疼痛强度、生活质量和疼痛干扰,分别由视觉模拟量表(VAS)、患者报告结果测量信息系统(PROMIS) 29调查和PROMIS视觉性功能和满意度:干扰因素调查测量。探索性结果包括作为全身性炎症标志的高敏c反应蛋白的血清浓度。75%的参与者(n = 9/12)完成了研究。75%的研究参与者(n = 9/12)报告了不良事件,其中大多数是轻微的,没有一个被确定为食品和药物管理局(FDA)的严重不良事件。大多数实验室标志物在整个研究期间保持在正常范围内,只有少数临床轻度异常。与基线相比,第一次给药后疼痛强度显著降低(p <.01),治疗4周后(p <.01),治疗8周后(p <. 01)。在8周的干预期内,疼痛干扰、生活质量、性功能和满意度评分无显著改善,hs-CRP无显著下降。结论对18-45岁原发性痛经的健康女性,补充1050 mg/天剂量,持续8周是安全的,具有中等耐受性,并与疼痛强度评分显著改善相关。未来研究他伯布亚治疗原发性痛经的安全性和有效性是有必要的。
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Safety and tolerability of Pau d′ Arco (Tabebuia avellanedae) for primary dysmenorrhea: A single-arm, open-label trial on adults ages 18–45

Objectives

To evaluate the safety and tolerability of encapsulated Tabebuia avellanedae in generally healthy women aged 18–45 with primary dysmenorrhea.

Methods

A single arm, open-label trial was conducted in which 1050 mg/day of encapsulated Tabebuia avellanedae (Pau d′Arco) was administered to twelve healthy women aged 18–45 for eight weeks. The primary outcome was safety and tolerability as measured by standardized adverse events scales and serial collection of laboratory markers to assess general health, prothrombin times, and the presence or absence of anemia. Secondary outcomes included pain intensity, quality of life, and pain interference measured by the Visual Analog Scale (VAS), the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 survey, and the PROMIS Visual Sexual Function and Satisfaction: Interfering Factors survey, respectively. Exploratory outcomes included serum concentration of high-sensitivity C-reactive protein as a marker of systemic inflammation.

Results

Seventy-five percent of participants (n = 9/12) completed the study. Seventy-five percent of study participants (n = 9/12) reported an adverse event, most of which were characterized as mild, and none were determined to be a Food and Drug Administration (FDA) serious adverse event. Most laboratory markers stayed within normal limits throughout the study period with a few clinically mild abnormalities. There was a significant decrease in pain intensity compared to baseline after the first dose (p < .01), after 4 weeks of treatment (p < .01), and after 8 weeks of treatment (p < .01). Over the 8-week intervention period, pain interference, quality of life, and sexual function and satisfaction scores improved nonsignificantly and hs-CRP decreased nonsignificantly.

Conclusions

Tabebuia avellanedae supplementation of 1050 mg/day dose for eight weeks in generally healthy women aged 18–45 with primary dysmenorrhea was generally safe, associated with moderate tolerability, and associated with significant improvements in pain intensity scores. Future studies examining the safety and efficacy of Tabebuia avellanedae on primary dysmenorrhea are warranted.

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来源期刊
Advances in integrative medicine
Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
3.20
自引率
11.80%
发文量
0
审稿时长
15 weeks
期刊介绍: Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.
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