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Endocrine
Published in: Endocrine 2/2023

03-12-2022 | Thyroid Disease | Original Article

Assessment of the reporting quality of randomised controlled trials for vitamin D supplementation in autoimmune thyroid disorders based on the CONSORT statement

Authors: Christos Vrysis, Eirini Beneki, Elias Zintzaras, Chrysoula Doxani

Published in: Endocrine | Issue 2/2023

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Abstract

Background—Purpose

Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine, yet their quality is often suboptimal. The Consolidated Standards of Reporting Trials (CONSORT) statement is a list of advice to upgrade the quality of RCTs. The aim of this study was the assessment of the quality of RCTs for vitamin D supplements in thyroid autoimmunity according to the revised CONSORT 2010 checklist.

Methods

Databases were searched for RCTs involving patients with autoimmune thyroid disorders (AITDs) who received vitamin D supplements published from 2011 to 2021. A list of 37-items was used and adherence ≥75% was considered of optimal quality. The primary outcome was the mean CONSORT adherence of studies. Secondary outcomes were the estimation of compliance per CONSORT item and the examination for possible determinants of the reporting quality.

Results

Thirteen eligible trials were finally included. The mean compliance was 61.15% ± 14.86%. Only threeof the studies (23%) achieved a good reporting quality (≥75%), while ten (77%) were presented with inadequate reporting (<75%). Randomization and blinding were mainly poorly reported. Impact Factor (IF) of journal was associated with the reporting quality in the univariate analysis [p = 0.033, OR = 1.65, 95%CI = (1316, 1773)]. Sample size (p = 0.067), number of authors (p = 0.118) and number of citations (p = 0.125) were marginally not significant. None of the factors showed significant results in multivariate analysis. Reporting quality and IF were strongly positively correlated [Pearson’s r = 0.740, p = 0.04].

Conclusion

This study shows that mean CONSORT adherence of RCTs for Vitamin D supplementation in AITDs is moderate, reflecting that study quality and transparency could be improved with better adherence to CONSORT rules.
Literature
1.
D.S.A. McLeod, D.S. Cooper, The incidence and prevalence of thyroid autoimmunity. Endocrine 42(2), 252–265 (2012)PubMedCrossRef
2.
R. Zhao, W. Zhang, C. Ma, Y. Zhao, R. Xiong, H. Wang et al. Immunomodulatory function of vitamin D and its role in autoimmune thyroid disease. Front. Immunol. 12, 574967 (2021)PubMedPubMedCentralCrossRef
3.
C. Mele, M. Caputo, A. Bisceglia, M.T. Samà, M. Zavattaro, G. Aimaretti et al. Immunomodulatory effects of vitamin D in thyroid diseases. Nutrients 12(5), 1444 (2020)PubMedPubMedCentralCrossRef
4.
M.T. Cantorna, Vitamin D and autoimmunity: is vitamin D status an environmental factor affecting autoimmune disease prevalence? Proc. Soc. Exp. Biol. Med. 223(3), 230–233 (2000)PubMedCrossRef
5.
Á. Gil, J. Plaza-Diaz, M.D. Mesa, Vitamin D: classic and novel actions. Ann. Nutr. Metab. 72(2), 87–95 (2018)PubMedCrossRef
6.
M. Bellan, G. Guzzaloni, M. Rinaldi, E. Merlotti, C. Ferrari, A. Tagliaferri et al. Altered glucose metabolism rather than naive type 2 diabetes mellitus (T2DM) is related to vitamin D status in severe obesity. Cardiovascular Diabetol. 13(1), 57 (2014)CrossRef
7.
C. di Somma, E. Scarano, L. Barrea, V. Zhukouskaya, S. Savastano, C. Mele et al. Vitamin D and neurological diseases: an endocrine view. Int. J. Mol. Sci. 18(11), 2482 (2017)PubMedPubMedCentralCrossRef
8.
D. Gallo, L. Mortara, M.B. Gariboldi, S.A.M. Cattaneo, S. Rosetti, L. Gentile et al. Immunomodulatory effect of vitamin D and its potential role in the prevention and treatment of thyroid autoimmunity: a narrative review. J. Endocrinological Investig. 43(4), 413–429 (2020)CrossRef
9.
10.
S. Kivity, N. Agmon-Levin, M. Zisappl, Y. Shapira, E.V. Nagy, K. Dankó et al. Vitamin D and autoimmune thyroid diseases. Cell. Mol. Immunol. 8(3), 243–247 (2011)PubMedPubMedCentralCrossRef
11.
G. Muscogiuri, D. Mari, S. Prolo, L. Fatti, M. Cantone, P. Garagnani et al. 25 hydroxyvitamin D deficiency and its relationship to autoimmune thyroid disease in the elderly. Int. J. Environ. Res. Public Health 13(9), 850 (2016)PubMedPubMedCentralCrossRef
12.
D.Y. Shin, K.J. Kim, D. Kim, S. Hwang, E.J. Lee, Low serum vitamin D is associated with anti-thyroid peroxidase antibody in autoimmune thyroiditis. Yonsei Med. J. 55(2), 476 (2014)PubMedPubMedCentralCrossRef
13.
R. Goswami, R.K. Marwaha, N. Gupta, N. Tandon, V. Sreenivas, N. Tomar et al. Prevalence of vitamin D deficiency and its relationship with thyroid autoimmunity in Asian Indians: a community-based survey. Br. J. Nutr. 102(3), 382–386 (2009)PubMedCrossRef
14.
G. Muscogiuri, G. Tirabassi, G. Bizzaro, F. Orio, S.A. Paschou, A. Vryonidou et al. Vitamin D and thyroid disease: to D or not to D? Eur. J. Clin. Nutr. 69(3), 291–296 (2015)PubMedCrossRef
15.
G. Bizzaro, Y. Shoenfeld, Vitamin D and thyroid autoimmune diseases: the known and the obscure. Immunologic Res. 61(1–2), 107–109 (2015)CrossRef
16.
J. Yasmeh, F. Farpour, V. Rizzo, S. Kheradnam, I. Sachmechi, Hashimoto thyroiditis not associated with vitamin D deficiency. Endocr. Pract. 22(7), 809–813 (2016)PubMedCrossRef
17.
G. Effraimidis, K. Badenhoop, J.G.P. Tijssen, W.M. Wiersinga, Vitamin D deficiency is not associated with early stages of thyroid autoimmunity. Eur. J. Endocrinol. 167(1), 43–48 (2012)PubMedCrossRef
18.
S. Wang, Y. Wu, Z. Zuo, Y. Zhao, K. Wang, The effect of vitamin D supplementation on thyroid autoantibody levels in the treatment of autoimmune thyroiditis: a systematic review and a meta-analysis. Endocrine 59(3), 499–505 (2018)PubMedCrossRef
19.
J. Zhang, Y. Chen, H. Li, H. Li, Effects of vitamin D on thyroid autoimmunity markers in Hashimoto’s thyroiditis: systematic review and meta-analysis. J. Int. Med. Res. 49(12), 030006052110606 (2021)CrossRef
20.
G. Bonadonna, P. Valagussa, Influence of clinical trials on current treatment strategy for Hodgkin’s disease. Int. J. Radiat. Oncol.*Biol.Phys. 19(1), 209–218 (1990)PubMedCrossRef
21.
H.O. Stolberg, G. Norman, I. Trop, Randomized controlled trials. Am. J. Roentgenol. 183(6), 1539–1544 (2004)CrossRef
22.
K.F. Schulz, Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA: J. Am. Med. Assoc. 273(5), 408–412 (1995)CrossRef
23.
C. Begg, Improving the quality of reporting of randomized controlled trials. JAMA 276(8), 637 (1996)PubMedCrossRef
24.
D. Moher, The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285(15), 1987 (2001) Apr 18PubMedCrossRef
25.
D. Moher, S. Hopewell, K.F. Schulz, V. Montori, P.C. Gøtzsche, P.J. Devereaux et al. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. Int. J. Surg. 10(1), 28–55 (2012)PubMedCrossRef
26.
A. Stevens, L. Shamseer, E. Weinstein, F. Yazdi, L. Turner, J. Thielman et al. Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines: systematic review. BMJ (Clin. Res. ed.) 348, g3804 (2014). Jun 25
27.
D. Rikos, E. Dardiotis, A-M Aloizou, V. Siokas, E. Zintzaras, G.M. Hadjigeorgiou. Reporting Quality of Randomized Controlled Trials in Restless Legs Syndrome Based on the CONSORT Statement. Tremor and other hyperkinetic movements (New York, NY). 2019;9
28.
M. Kodounis, I.N. Liampas, T.S. Constantinidis, V. Siokas, A.-F.A. Mentis, A.-M. Aloizou et al. Assessment of the reporting quality of double-blind RCTs for ischemic stroke based on the CONSORT statement. J. Neurological Sci. 415, 116938 (2020). AugCrossRef
29.
I. Liampas, A. Chlinos, V. Siokas, A. Brotis, E. Dardiotis, Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement. J. Thrombosis Thrombolysis 48(4), 542–553 (2019)CrossRef
30.
M. Elcivan, A. Kowark, M. Coburn, H. A. Hamou, B. Kremer, H. Clusmann, et al. A retrospective analysis of randomized controlled trials on traumatic brain injury: evaluation of CONSORT Item Adherence. Brain Sci. 11(11), 1504 (2021)PubMedPubMedCentralCrossRef
31.
D. Rikos, E. Dardiotis, A.-M. Aloizou, V. Siokas, E. Zintzaras, G.M Hadjigeorgiou. Reporting Quality of Randomized Controlled Trials in Restless Legs Syndrome Based on the CONSORT Statement. Tremor and other hyperkinetic movements (New York, NY). 2019;9
32.
E. Beneki, C. Vrysis, E. Zintzaras, C. Doxani, Analysis of the quality of reporting of randomized controlled trials in anticoagulant versus antiplatelet medication for venous thromboembolism prophylaxis as governed by the CONSORT statement. J. Thrombosis Thrombolysis 52(1), 138–147 (2021)CrossRef
33.
S. Hopewell, M. Clarke, D. Moher, E. Wager, P. Middleton, D.G. Altman et al. CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration. PLoS Med. 5(1), e20 (2008)PubMedPubMedCentralCrossRef
34.
D.C. Ziogas, E. Zintzaras, Analysis of the quality of reporting of randomized controlled trials in acute and chronic myeloid leukemia, and myelodysplastic syndromes as governed by the CONSORT statement. Ann. Epidemiol. 19(7), 494–500 (2009)PubMedCrossRef
35.
L. García-Molina, A.M. Lewis-Mikhael, B. Riquelme-Gallego, N. Cano-Ibáñez, M.J. Oliveras-López, A. Bueno-Cavanillas, Improving type 2 diabetes mellitus glycaemic control through lifestyle modification implementing diet intervention: a systematic review and meta-analysis. Eur. J. Nutr. 59(4), 1313–28. (2020)PubMedCrossRef
36.
E. Sainsbury, N.V. Kizirian, S.R. Partridge, T. Gill, S. Colagiuri, A.A. Gibson, Effect of dietary carbohydrate restriction on glycemic control in adults with diabetes: A systematic review and meta-analysis. Diabetes Res Clin. Pr. 139, 239–252 (2018)CrossRef
37.
G. Formoso, E. Perrone, S. Maltoni, S. Balduzzi, J. Wilkinson, V. Basevi, et al. Short-term and long-term effects of tibolone in postmenopausal women. Cochrane Database Syst. Rev. 10(10), CD008536 (2016)PubMed
38.
H. Balshem, M. Helfand, H.J. Schünemann, A.D. Oxman, R. Kunz, J. Brozek et al. GRADE guidelines: 3. Rating the quality of evidence. J. Clin. Epidemiol. 64(4), 401–406 (2011)PubMedCrossRef
39.
L. Saric, K. Vucic, K. Dragicevic, M. Vrdoljak, D. Jakus, I. Vuka et al. Comparison of conference abstracts and full-text publications of randomized controlled trials presented at four consecutive World Congresses of Pain: Reporting quality and agreement of results. Eur. J. Pain. (Lond., Engl.) 23(1), 107–116 (2019)CrossRef
40.
F. Song, S. Parekh, L. Hooper, Y.K. Loke, J. Ryder, A.J. Sutton et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol. Assess. (Winch., Engl.) 14(8), 1–193 (2010)
41.
42.
R. Chahardoli, A.-A. Saboor-Yaraghi, A. Amouzegar, D. Khalili, A.Z. Vakili, F. Azizi, Can supplementation with vitamin D modify thyroid autoantibodies (Anti-TPO Ab, Anti-Tg Ab) and thyroid profile (T3, T4, TSH) in Hashimoto’s thyroiditis? a double blind, randomized clinical trial. Horm. Metab. Res. = Horm.- und Stoffwechselforschung = Hormones et. Metab. 51(5), 296–301 (2019)CrossRef
43.
M. Nodehi, A. Ajami, M. Izad, H. AsgarianOmran, R. Chahardoli, A. Amouzegar et al. Effects of vitamin D supplements on frequency of CD4+ T-cell subsets in women with Hashimoto’s thyroiditis: a double-blind placebo-controlled study. Eur. J. Clin. Nutr. 73(9), 1236–1243 (2019)PubMedCrossRef
44.
P. VahabiAnaraki, A. Aminorroaya, M. Amini, F. Momeni, A. Feizi, B. Iraj et al. Effect of Vitamin D deficiency treatment on thyroid function and autoimmunity markers in Hashimoto’s thyroiditis: A double-blind randomized placebo-controlled clinical trial. J. Res. Med. Sci.: Off. J. Isfahan Univ. Med. Sci. 22, 103 (2017)CrossRef
45.
P.V. Anaraki, A. Aminorroaya, M. Amini, A. Feizi, B. Iraj, A. Tabatabaei, Effects of Vitamin D deficiency treatment on metabolic markers in Hashimoto thyroiditis patients. J. Res. Med. Sci.: Off. J. Isfahan Univ. Med. Sci. 22, 5 (2017)CrossRef
46.
Y. Simsek, I. Cakır, M. Yetmis, O.S. Dizdar, O. Baspinar, F. Gokay, Effects of Vitamin D treatment on thyroid autoimmunity. J. Res. Med. Sci.: Off. J. Isfahan Univ. Med. Sci. 21, 85 (2016)CrossRef
47.
S. Chaudhary, D. Dutta, M. Kumar, S. Saha, S.A. Mondal, A. Kumar, et al. Vitamin D supplementation reduces thyroid peroxidase antibody levels in patients with autoimmune thyroid disease: An open-labeled randomized controlled trial. Ind. J. Endocrinol. Metab. 20(3), 391–398 (2016)CrossRef
48.
K. K. Behera, G. K. Saharia, D. Hota, D. P. Sahoo, M. Sethy, A. Srinivasan, Effect of vitamin D supplementation on thyroid autoimmunity among subjects of autoimmune thyroid disease in a coastal province of india: a randomized open-label trial. Niger Med. J. 61(5), 237–240 (2020)PubMedPubMedCentralCrossRef
49.
D. Grove-Laugesen, S. Malmstroem, E. Ebbehoj, A.L. Riis, T. Watt, K.W. Hansen et al. Effect of 9 months of vitamin D supplementation on arterial stiffness and blood pressure in Graves’ disease: a randomized clinical trial. Endocrine 66(2), 386–397 (2019)PubMedCrossRef
50.
D. Grove-Laugesen, P.K. Cramon, S. Malmstroem, E. Ebbehoj, T. Watt, K.W. Hansen et al. Effects of supplemental vitamin D on muscle performance and quality of life in graves’ disease: a randomized clinical trial. Thyroid.: Off. J. Am. Thyroid. Assoc. 30(5), 661–671 (2020)CrossRef
51.
X. Mei, J. Zeng, W.-X. Dai, H.-L. Yang, Y. Li, M.-W. Tang et al. Prevalence of hyperthyroidism with hypercalcemia in Xindu district and the efficacy of vitamin D3 treatment in these patients: a randomized trial. Ann. Palliat. Med. 10(9), 9640–9649 (2021)PubMedCrossRef
52.
K.V. Knutsen, A.A. Madar, M. Brekke, H.E. Meyer, Å.R. Eggemoen, I. Mdala et al. Effect of vitamin D on thyroid autoimmunity: a randomized, double-blind, controlled trial among ethnic minorities. J. Endocr. Soc. 1(5), 470–479 (2017)PubMedPubMedCentralCrossRef
53.
D. Purnamasari, S. Djauzi, S. Setiati, A. Harahap, T. GdePemayun, J. Prihartono et al. Effects of oral alfacalcidol on maturation of dendritic cells in graves’ disease patients: a double-blinded randomized clinical trial. Asian J. Pharm. Clin. Res. 10(6), 100 (2017)CrossRef
54.
B. Ucan, M. Sahin, M. Sayki Arslan, N. Colak Bozkurt, M. Kizilgul, A. Güngünes et al. Vitamin D treatment in patients with hashimoto’s thyroiditis may decrease the development of hypothyroidism. Int. J. Vitam. Nutr. Res. InternationaleZeitschrift fur Vitam.- und Ernahrungsforschung J. Int. de. vitaminologie et. de. Nutr. 86(1–2), 9–17 (2016)CrossRef
Metadata
Title
Assessment of the reporting quality of randomised controlled trials for vitamin D supplementation in autoimmune thyroid disorders based on the CONSORT statement
Authors
Christos Vrysis
Eirini Beneki
Elias Zintzaras
Chrysoula Doxani
Publication date
03-12-2022
Publisher
Springer US
Published in
Endocrine / Issue 2/2023
Print ISSN: 1355-008X
Electronic ISSN: 1559-0100
DOI
https://doi.org/10.1007/s12020-022-03270-x

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