The role of anti-proliferative effects of atorvastatin on uterine fibroids: findings from a clinical study

Abstract

Aim

Uterine myomas/fibroids are one of the most common benign tumors of the reproductive system in women. Given pleiotropic effects of statins, the aim of this study is to evaluate the therapeutic effects of atorvastatin on uterine fibroids in women of reproductive age.

Materials and Methods

This randomized clinical study included 90 women aged 35–45 years with uterine fibroids. The patients were randomly allocated into the intervention group (received one tablet, 20 mg of atorvastatin every day for three months) and placebo. Ultrasound was performed every month, and the change in the size of fibroids was recorded for each patient. At the end of the study, the data obtained were analyzed using SPSSv22 and a p value < .05 was considered statistically significant.

Results

The mean age in the placebo and intervention group was 39.63 ± 36.3 and 40.35 ± 3.32 years, respectively. The number and location of the tumor was comparable for the two groups. We observed a statically significant reduction in fibroid size from the treatment initiation until completion of three months, (41.06 ± 6.68 mm³ vs 35.16 ± 6.67 mm³) p = .0001. However, the decrease in fibroid size from 1st month to the 3rd month was not statistically significant, p = .189 (36.71 ± 5.54 mm³ vs 35.16 ± 6.67 mm³).

Conclusion

This study shows that treatment with atorvastatin might positively reduce the size of fibroids. The decrease was only statistically significant during the first month. Further studies with a detailed analysis of the intervention's clinical impact are required to consider statins as a therapeutic tool.

阿托伐他汀抗子宫肌瘤增殖作用的临床研究 摘要

目的：子宫肌瘤/肌瘤是女性生殖系统最常见的良性肿瘤之一。鉴于他汀类药物的多效性, 本研究的目的是评价阿托伐他汀对育龄妇女子宫肌瘤的治疗效果。材料和方法：这项随机临床研究包括90名年龄在35-45岁的子宫肌瘤患者。将患者随机分为干预组(每天服用阿托伐他汀20 mg, 每日1片, 连续3个月)和安慰剂。每月进行超声检查, 并记录每个患者肌瘤大小的变化。在研究结束时, 使用SPSSv22对获得的数据进行分析, p值<0.05被认为具有统计学意义。结果：安慰剂组和干预组的平均年龄分别为39.63±36.3岁和40.35±3.32岁。肿瘤的数量和位置在两组中具有可比性。我们观察到, 从治疗开始到完成三个月, 肌瘤的体积有了显著缩小, (41.06 ± 6.68 mm³ vs 35.16 ± 6.67 mm³) p = .0001。然而, 肌瘤体积从1个月到3个月的缩小没有统计学意义, p = .189 (36.71 ± 5.54 mm³ vs 35.16 ± 6.67 mm³)。结论：本研究表明阿托伐他汀治疗可能有助于缩小肌瘤的体积。这一下降仅在第一个月有统计学意义。需要对干预的临床影响进行详细分析的进一步研究, 才能考虑将他汀类药物作为一种治疗工具。

Keywords:

• Uterine
• fibroid
• atorvastatin
• antiproliferative effects
• fibroids
• reproductive

Ethical approval

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Consent to participate

Written consent was obtained from all the patients

Author contributions

Dr. Masoumeh Ghafarzadeh: conceptualized and designed the study, drafted the initial manuscript, and reviewed and revised the manuscript.

Dr. Amir Shakarami and Dr. Zahra Marzban rad: Designed the data collection instruments, collected data, carried out the initial analyses, and reviewed and revised the manuscript.

Dr. Fatemeh Yari: Coordinated and supervised data collection, and critically reviewed the manuscript for important intellectual content.

Disclosure statement

The authors deny any conflict of interest in any terms or by any means during the study.

Data availability statement

Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.