Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial

Abstract

Objective

To evaluate the safety and tolerability of an oral herbal supplement containing glucosinolates, phytosterols, and citrus flavonoids (Warmi®, Lima Perú;) in otherwise healthy adult women.

Methods

This was a phase-I, randomized parallel three arms, double-blinded, and a placebo-controlled clinical trial. A total of 55 participants aged 18-40 were randomly assigned to one of three groups to receive for three months: (1) an oral herbal supplement of 1650 mg/day; (2) an oral herbal supplement of 3300 mg/day; or (3) an oral placebo 3300 mg/day. The primary endpoints were oral safety and tolerability of the supplement. The secondary endpoint was its effect on vital functions, anthropometrics, and laboratory tests. We used an exploratory approach by covariance analysis (ANCOVA) adjusted for the variables’ baseline value for the secondary outcomes.

Results

All women completed three months of follow-up, reporting no side effects. Our exploratory analysis revealed that treatment with the herbal supplement of 1650 mg/day was associated with increased glucose and uric acid levels. In comparison, the herbal supplement 3300 mg/day was associated with reduced breathing rate, increased basal temperature, and systolic blood pressure, both compared to the placebo group. However, despite significant differences, none of these was clinically significant.

Conclusion

The oral herbal supplement had a favorable safety and tolerability profile in studied women. There is a need to study its potential as an option to treat menopausal symptoms.

含有芥子油甙、植物甾醇和柑橘类黄酮的天然补充剂在成年女性中的安全性和耐受性:一项随机I期、安慰剂对照、多臂、双盲临床试验 摘要

目的：评价含有芥子油甙、植物甾醇和柑橘类黄酮的口服草药补充剂在健康的成年女性中的安全性和耐受性。

方法：这是一项I期随机平行三组、双盲、安慰剂对照临床试验。共有55名18-40岁的参与者被随机分配到三个组中的一个, 接受为期三个月的治疗：（1）1650 mg/天的口服草药补充剂；（2）3300 mg/天的口服草药补充剂；或（3）口服安慰剂3300 mg/天。主要终点是补充剂的口服安全性和耐受性。次要终点是其对重要功能、人体测量和实验室检测的影响。我们通过协方差分析（ANCOVA）采用探索性方法, 对次要结果的变量基线值进行调整。

结果：所有女性都完成了三个月的随访, 报告没有副作用。我们的探索性分析显示, 每天1650 mg的草药补充剂治疗与血糖和尿酸水平升高有关。相比之下, 与安慰剂组相比, 每天服用3300 mg草药补充剂与呼吸频率降低、基础体温升高和收缩压升高有关。然而, 尽管有显著差异, 这些都没有临床意义。

结论：口服草药补充剂在被研究的女性中具有良好的安全性和耐受性。有必要研究它作为治疗更年期症状的一种选择的潜力。

Keywords:

• Herbal supplement
• glucosinolates
• phytosterols
• citrus flavonoids
• safety
• tolerability
• adult women

Acknowledgement

The authors thank Dr. Stefano Malaga-Correa for presenting the preliminary analysis of this research as a poster in the 15^th World Congress on Menopause (IMS), 28th September to 1^st October 2016, Prague, Czech Republic.

Disclosure statement

The authors report no conflicts of interest and are alone responsible for the content and writing of this manuscript.

Additional information

Funding

Laboratorios Hersil S.A, Lima Perú, supported this research.