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
DOI:
https://doi.org/10.31661/gmj.v13i.2950Keywords:
Padzahr, Women, Osteopenia, Clay, Persian Medicine, BoneAbstract
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.
Published
Issue
Section
License
Copyright (c) 2024 Galen Medical Journal
This work is licensed under a Creative Commons Attribution 4.0 International License.