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

Effect of Padzahr Tablet on Biochemical Indices of Bone Remodeling

Authors

  • Shabnam Rafiee Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran
  • Arash Hossein-nezhad Section of Endocrinology, Diabetes, Nutrition, and Weight Management, Department of Medicine, Boston University School of Medicine, Boston, MA, USA
  • Zhila Maghbooli MS Research Center, Neurosciences Institute of Tehran University of Medical Sciences, Tehran, Iran
  • Arman Zargaran Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran
  • Solaleh Emamgholipour Department of Clinical Biochemistry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
  • Afsaneh Ghasemi Shahid Akbarabadi Clinical Research Development Unit ( ShACRDU), School of Medicine, Iran University of Medical Sciences, Tehran, Iran
  • Mehrnoosh Ahmadi Shahid Akbarabadi Clinical Research Development Unit ( ShACRDU), School of Medicine, Iran University of Medical Sciences, Tehran, Iran
  • Hadi Esmaeeli Quality Assurance Department, NIAK Pharmaceutical Company, Golestan, Iran
  • Mehrdad Karimi Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran

DOI:

https://doi.org/10.31661/gmj.v13i.2950

Keywords:

Padzahr, Women, Osteopenia, Clay, Persian Medicine, Bone

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 (P>0.05). 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 (P>0.05).
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.

References

Kanis JA, Melton LJ, Christiansen C, Johnston CC, Khaltaev N. The diagnosis of osteoporosis. J Bone Miner Res. 1994;9(8):1137-41.

https://doi.org/10.1002/jbmr.5650090802

PMid:7976495

Sözen T, Özışık L, Başaran NÇ. An overview and management of osteoporosis. Eur J Rheumatol. 2017;4(1):46-56.

https://doi.org/10.5152/eurjrheum.2016.048

PMid:28293453 PMCid:PMC5335887

An J, Yang H, Zhang Q, Liu C, Zhao J, Zhang L et al. Natural products for treatment of osteoporosis: The effects and mechanisms on promoting osteoblast-mediated bone formation. Life Sci. 2016;147:46-58.

https://doi.org/10.1016/j.lfs.2016.01.024

PMid:26796578

Demir B, Haberal A, Geyik P, Baskan B, Ozturkoglu E, Karacay O et al. Identification of the risk factors for osteoporosis among postmenopausal women. Maturitas. 2008;60(3):253-6.

https://doi.org/10.1016/j.maturitas.2008.07.011

PMid:18778903

Gerend MA, Erchull MJ, Aiken LS, Maner JK. Reasons and risk: factors underlying women's perceptions of susceptibility to osteoporosis. Maturitas. 2006;55(3):227-37.

https://doi.org/10.1016/j.maturitas.2006.03.003

PMid:16650699

Al-Raddadi R, Bahijri S, Borai A, AlRaddadi Z. Prevalence of lifestyle practices that might affect bone health in relation to vitamin D status among female Saudi adolescents. Nutrition. 2018;45:108-13.

https://doi.org/10.1016/j.nut.2017.07.015

PMid:29129230

Schnatz PF, Marakovits KA, O'Sullivan DM. Assessment of postmenopausal women and significant risk factors for osteoporosis. Obstet Gynecol Surv. 2010;65(9):591-6.

https://doi.org/10.1097/OGX.0b013e3181fc6d30

PMid:21144090

Levine JP. Pharmacologic and nonpharmacologic management of osteoporosis. Clin Cornerstone. 2006;8(1):40-53.

https://doi.org/10.1016/S1098-3597(06)80064-5

PMid:17591575

Tu KN, Lie JD, Wan CKV, Cameron M, Austel AG, Nguyen JK et al. Osteoporosis: A Review of Treatment Options. P T. 2018;43(2):92-104.

Bilezikian JP. Efficacy of bisphosphonates in reducing fracture risk in postmenopausal osteoporosis. Am J Med. 2009;122(2):S14-S21.

https://doi.org/10.1016/j.amjmed.2008.12.003

PMid:19187808

Iversen MD, Vora RR, Servi A, Solomon DH. Factors affecting adherence to osteoporosis medications: a focus group approach examining viewpoints of patients and providers. J Geriatr Phys Ther. 2011;34(2):72-81.

Mak JC, Faux S. Complementary and alternative medicine use by osteoporotic patients in Australia (CAMEO-A): a prospective study. J Altern Complement Med. 2010;16(5):579-84.

https://doi.org/10.1089/acm.2009.0425

PMid:20491514

Gomes CdSF. Healing and edible clays: a review of basic concepts, benefits and risks. Environ Geochem Health. 2018;40(5):1739-65.

https://doi.org/10.1007/s10653-016-9903-4

PMid:28150053

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior research methods. 2007;39(2):175-91.

https://doi.org/10.3758/BF03193146

PMid:17695343

Knishinsky R. The clay cure. Natural healing from the earth: Simon and Schuster; 1998.

Pepa GD, Brandi ML. Microelements for bone boost: the last but not the least. Clin Cases Miner Bone Metab. 2016;13(3):181-5.

Meier C, Kränzlin ME. Calcium supplementation, osteoporosis and cardiovascular disease. Swiss Med Wkly. 2011;141:w13260.

https://doi.org/10.4414/smw.2011.13260

Castiglioni S, Cazzaniga A, Albisetti W, Maier JA. Magnesium and osteoporosis: current state of knowledge and future research directions. Nutrients. 2013;5(8):3022-33.

https://doi.org/10.3390/nu5083022

PMid:23912329 PMCid:PMC3775240

Voskaridou E, Terpos E. New insights into the pathophysiology and management of osteoporosis in patients with beta thalassaemia. Br J Haematol. 2004;127(2):127-39.

https://doi.org/10.1111/j.1365-2141.2004.05143.x

PMid:15461618

Hott M, de Pollak C, Modrowski D, Marie PJ. Short-term effects of organic silicon on trabecular bone in mature ovariectomized rats. Calcif Tissue Int. 1993;53(3):174-9.

https://doi.org/10.1007/BF01321834

PMid:8242469

Rico H, Gallego-Lago J, Hernandez E, Villa L, Sanchez-Atrio A, Seco C et al. Effect of silicon supplement on osteopenia induced by ovariectomy in rats. Calcif Tissue Int. 2000;66(1):53-5.

https://doi.org/10.1007/s002230050010

PMid:10602845

Kim GJ, Kim D, Lee KJ, Kim D, Chung KH, Choi JW et al. Effect of Nano-Montmorillonite on Osteoblast Differentiation, Mineral Density, and Osteoclast Differentiation in Bone Formation. Nanomaterials (Basel). 2020;10(2):230.

https://doi.org/10.3390/nano10020230

PMid:32013042 PMCid:PMC7075198

Spałek K, Spielvogel I. The use of medicinal clay from Silesia "Terra sigillata Silesiaca", Central Europe-a new chance for natural medicine? Biomed J Sci Tech Res. 2019;20(3):15057-61.

https://doi.org/10.26717/BJSTR.2019.20.003457

Ferrell Jr RE. Medicinal clay and spiritual healing. Clays Clay Miner. 2008;56(6):751-60.

https://doi.org/10.1346/CCMN.2008.0560613

Hosseinkhani A, Montaseri H, Mohagheghzadeh A, Seradj H, Sodaifi M. Armenian bole: a historical medicinal clay. Pharm Hist (Lond). 2014;44(4):98-100.

Efimenko NV, Abramtsova AV, Kaysinova AS. [The investigation of immunological effects of the new balneotherapeutic preparation glinofir used for the treatment of adjuvant arthritis]. Vopr Kurortol Fizioter Lech Fiz Kult. 2016;93(4):56-9.

https://doi.org/10.17116/kurort2016456-59

PMid:27500680

Miller MJ, Mehta K, Kunte S, Raut V, Gala J, Dhumale R et al. Early relief of osteoarthritis symptoms with a natural mineral supplement and a herbomineral combination: a randomized controlled trial [ISRCTN38432711]. J Inflamm (Lond). 2005;2:11.

https://doi.org/10.1186/1476-9255-2-11

PMid:16242032 PMCid:PMC1276811

Evans M, Wilson D, Guthrie N. Efficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study. Open Access Rheumatol. 2014;6:91-103.

https://doi.org/10.2147/OARRR.S71161

PMid:27790038 PMCid:PMC5045117

Morrison KD, Misra R, Williams LB. Unearthing the Antibacterial Mechanism of Medicinal Clay: A Geochemical Approach to Combating Antibiotic Resistance. Sci Rep. 2016;6(1):19043.

https://doi.org/10.1038/srep19043

PMid:26743034 PMCid:PMC4705759

Williams LB, Haydel SE. Evaluation of the medicinal use of clay minerals as antibacterial agents. Int Geol Rev. 2010;52(7-8):745-70.

https://doi.org/10.1080/00206811003679737

PMid:20640226 PMCid:PMC2904249

Jumbam ND. Geophagic materials: the possible effects of their chemical composition on human health. Trans R Soc S Afr. 2013;68(3):177-82.

https://doi.org/10.1080/0035919X.2013.843606

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Published

2024-02-08

How to Cite

Rafiee, S., Hossein-nezhad, A., Maghbooli , Z., Zargaran, A., Emamgholipour, S., Ghasemi, A., … Karimi , M. (2024). Effect of Padzahr Tablet on Biochemical Indices of Bone Remodeling in Postmenopausal Females with Osteopenia: A Randomized Double-Blind Placebo-Controlled Trial: Effect of Padzahr Tablet on Biochemical Indices of Bone Remodeling. Galen Medical Journal, 13, e2950. https://doi.org/10.31661/gmj.v13i.2950

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