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帕扎尔片对绝经后骨质减少女性骨重塑生化指标的影响:一项随机双盲安慰剂对照试验

Effect of Padzahr Tablet on Biochemical Indices of Bone Remodeling in Postmenopausal Females with Osteopenia: A Randomized Double-Blind Placebo-Controlled Trial.

作者信息

Rafiee Shabnam, Hossein-Nezhad Arash, Maghbooli Zhila, Zargaran Arman, Emamgholipour Solaleh, Ghasemi Afsaneh, Ahmadi Mehrnoosh, Esmaeeli Hadi, Karimi Mehrdad

机构信息

Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.

Section of Endocrinology, Diabetes, Nutrition, and Weight Management, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.

出版信息

Galen Med J. 2024 Feb 8;13:e2950. doi: 10.31661/gmj.v12i.2950. eCollection 2024.

Abstract

BACKGROUND

Osteoporosis is a complex disease that poses major global public health challenges. Many individuals with osteoporosis turn to complementary and alternative medicine (CAM) for prevention and management. Due to its mineral contents, Padzahr, a type of clay used in traditional Persian medicine, is believed to have bone-forming properties. This study examined the impact of Padzahr on bone remodeling in postmenopausal women with low bone density.

MATERIALS AND METHODS

In this randomized double-blind and placebo-controlled clinical trial, 48 postmenopausal women with osteopenia were included. The participants were divided into two groups, with 24 participants in each group. One group received Padzahr, and the other group received a placebo. The participants took their assigned treatment for 12 weeks. Blood samples were taken from participants at the study's beginning and end to compare the two groups' serum levels of bone remodeling biomarkers.

RESULTS

At the outset of the study, the two groups were similar and there were no significant differences in any of the measured variables. Additionally, the levels of bone turnover markers were not significantly different between the two groups at the start of the study (P0.05). After 12 weeks of treatment, the results of the ANCOVA analysis showed no significant changes in the serum levels of bone turnover indices when comparing the Padzahr group to the placebo group (P0.05).

CONCLUSION

A clinical trial of 3 months of Padzahr treatment in postmenopausal women with osteopenia did not show significant changes in serum markers of bone turnover.

摘要

背景

骨质疏松症是一种复杂的疾病,给全球公共卫生带来重大挑战。许多骨质疏松症患者转向补充和替代医学(CAM)进行预防和管理。由于其矿物质成分,帕扎尔(Padzahr),一种传统波斯医学中使用的粘土,被认为具有成骨特性。本研究考察了帕扎尔对骨密度低的绝经后女性骨重塑的影响。

材料与方法

在这项随机双盲安慰剂对照临床试验中,纳入了48名绝经后骨质减少的女性。参与者被分为两组,每组24人。一组接受帕扎尔治疗,另一组接受安慰剂。参与者接受指定治疗12周。在研究开始和结束时采集参与者的血样,以比较两组骨重塑生物标志物的血清水平。

结果

在研究开始时,两组相似,所有测量变量均无显著差异。此外,在研究开始时,两组的骨转换标志物水平也无显著差异(P>0.05)。治疗12周后,协方差分析结果显示,将帕扎尔组与安慰剂组进行比较时,骨转换指标的血清水平无显著变化(P>0.05)。

结论

对骨密度低的绝经后女性进行为期3个月的帕扎尔治疗的临床试验未显示骨转换血清标志物有显著变化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4c3e/11568423/830625a9b9ba/GMJ-13-e2950-g1.jpg

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