塞内加尔卡雅楝制剂卡普雷吉西克对痛经和经期不适女性的安全性和有效性研究：一项随机、双盲、安慰剂对照试验。
An Examination into the Safety and Efficacy of Khapregesic, a Khaya Senegalensis Preparation, on Women Experiencing Menstrual Pain and Menstrual Distress: A Randomized, Double-Blind, Placebo-Controlled Trial.
作者信息
Lopresti Adrian L, Smith Stephen J, Ferdinands Frederick R
机构信息
Clinical Research Australia, Perth, Western Australia, 6023, Australia.
College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, 6150, Australia.
出版信息
Int J Womens Health. 2025 Jul 12;17:2025-2038. doi: 10.2147/IJWH.S521349. eCollection 2025.
PURPOSE
In traditional medicine, Khaya senegalensis has been used to treat menstrual pain, dysmenorrhea, and digestive pain and discomfort. However, there are no human clinical trials examining its safety and efficacy for the treatment of menstrual distress. Therefore, the purpose of this two-arm, parallel-group, randomized, double-blind, placebo-controlled trial was to examine the safety and efficacy of supplementation with a Khaya senegalensis preparation (Khapregesic) on menstrual pain and menstrual distress in menstruating women.
METHODS
Eighty-four women experiencing menstrual pain and distress were supplemented 3g daily with this Khaya senegalensis preparation or a placebo for one menstrual cycle. Changes in menstrual pain and other symptoms of menstrual distress were examined through daily ratings and validated self-report questionnaires. Moreover, changes in the use of rescue medications, C-reactive protein, and safety blood measures were examined.
RESULTS
Compared to the placebo, this Khaya senegalensis preparation was associated with greater reductions in daily menstrual pain ratings (p=0.033) and reductions in overall menstrual distress (p=0.042). Improvements in emotional wellbeing were also identified, along with reductions in the use of rescue medications, although this latter finding requires confirmation in future trials. No changes in C-reactive protein were identified. This Khaya senegalensis preparation was well-tolerated and there were no significant changes in safety blood markers.
CONCLUSION
This study provides evidence supporting the safety and efficacy of a Khaya senegalensis preparation on menstrual pain and menstrual distress in women. Further investigations will be important to confirm and expand on the current findings and to help identify its potential mechanisms of action.
TRIAL REGISTRATION
ANZCTR, ACTRN12624000731594p. Registered 14 June 2024, https://www.anzctr.org.au/ACTRN12624000731594p.aspx.
目的
在传统医学中，塞内加尔卡雅楝已被用于治疗痛经、月经失调以及消化疼痛和不适。然而，尚无人体临床试验研究其治疗月经不适的安全性和有效性。因此，本双臂、平行组、随机、双盲、安慰剂对照试验的目的是研究补充塞内加尔卡雅楝制剂（Khapregesic）对经期女性月经疼痛和月经不适的安全性和有效性。
方法
84名经历月经疼痛和不适的女性每天补充3克这种塞内加尔卡雅楝制剂或安慰剂，持续一个月经周期。通过每日评分和经过验证的自我报告问卷来检查月经疼痛和其他月经不适症状的变化。此外，还检查了急救药物使用情况、C反应蛋白和安全血液指标的变化。
结果
与安慰剂相比，这种塞内加尔卡雅楝制剂与每日月经疼痛评分的更大幅度降低（p = 0.033）以及整体月经不适的减轻（p = 0.042）相关。还发现情绪健康有所改善，同时急救药物的使用减少，不过后一项发现需要在未来试验中得到证实。未发现C反应蛋白有变化。这种塞内加尔卡雅楝制剂耐受性良好，安全血液指标无显著变化。
结论
本研究提供了证据，支持塞内加尔卡雅楝制剂对女性月经疼痛和月经不适的安全性和有效性。进一步的研究对于确认和扩展当前发现以及帮助确定其潜在作用机制至关重要。
试验注册
澳大利亚和新西兰临床试验注册中心，ACTRN12624000731594p。于2024年6月14日注册，https://www.anzctr.org.au/ACTRN12624000731594p.aspx。
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