Effect of fluvoxamine on preventing neuropsychiatric symptoms of post COVID syndrome in mild to moderate patients, a randomized placebo-controlled double-blind clinical trial

{ 'indexed': {'date-parts': [[2023, 4, 1]], 'date-time': '2023-04-01T04:55:27Z', 'timestamp': 1680324927459}, 'reference-count': 34, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2023, 3, 31]], 'date-time': '2023-03-31T00:00:00Z', 'timestamp': 1680220800000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2023, 3, 31]], 'date-time': '2023-03-31T00:00:00Z', 'timestamp': 1680220800000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [ { 'DOI': '10.13039/501100013778', 'name': 'Aja University of Medical Sciences', 'doi-asserted-by': 'publisher'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>Shortly after the Coronavirus disease 2019 (COVID-19) pandemic, a ' 'considerable number of recovered patients reported persisting symptoms, especially ' 'neuropsychological manifestations, which were later named post-COVID syndrome (PCS). Immune ' 'dysregulation was suggested as one of the main mechanisms for PCS. Fluvoxamine, a selective ' 'serotonin reuptake inhibitor (SSRI) that is mostly used to treat depression, anxiety ' 'disorders, and obsessive–compulsive disorder, has been suggested as an anti-COVID drug due to ' 'its anti-inflammatory effects, mainly through the sigma-1 receptor. Therefore, we aimed to ' "evaluate fluvoxamine's effect on PCS neuropsychiatric symptoms.</jats:p>\n" ' </jats:sec><jats:sec>\n' ' <jats:title>Method</jats:title>\n' ' <jats:p>In this double-blind randomized clinical trial, we included confirmed ' 'mild to moderate COVID-19 outpatients using polymerase chain reaction (PCR) by an infectious ' 'disease specialist. The presence of severe COVID-19 symptoms was evaluated by the infectious ' 'disease specialist and included dyspnea, SpO2\u2009&lt;\u200994% on room air, PaO2/FiO2\u2009' '&lt;\u2009300\xa0mm Hg, a respiratory rate\u2009&gt;\u200930 breaths/min, and lung ' 'infiltrates\u2009&gt;\u200950%. Then we performed permuted block randomization and assigned ' 'patients 1:1 into two groups to either receive fluvoxamine 100\xa0mg tablet or a placebo ' 'daily for 10\xa0days. Eligible patients were evaluated after 12\xa0weeks for the presence of ' 'fatigue, as the primary, and other PCS symptoms as secondary outcomes.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>We screened a total of 486 patients from March to June 2022. After ' '12\xa0weeks, 42 patients receiving fluvoxamine and 43 patients receiving Placebo were ' 'evaluated for PCS. Patients had a mean age of 38.5\u2009±\u200914.1 and 48% of them were ' 'women. Fatigue was significantly lower in the fluvoxamine group ' '(<jats:italic>p</jats:italic>-value 0.026). No significant differences were observed in other ' 'symptoms.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusion</jats:title>\n' ' <jats:p>We concluded that taking fluvoxamine during active COVID-19 can ' 'reduce the chance of fatigue but the advantage of fluvoxamine was not observed for other ' 'symptoms. Further studies are necessary to confirm these preliminary results.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1186/s12879-023-08172-5', 'type': 'journal-article', 'created': {'date-parts': [[2023, 3, 31]], 'date-time': '2023-03-31T13:03:25Z', 'timestamp': 1680267805000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Effect of fluvoxamine on preventing neuropsychiatric symptoms of post COVID syndrome in mild to ' 'moderate patients, a randomized placebo-controlled double-blind clinical trial', 'prefix': '10.1186', 'volume': '23', 'author': [ {'given': 'Ramin Hamidi', 'family': 'Farahani', 'sequence': 'first', 'affiliation': []}, {'given': 'Ali', 'family': 'Ajam', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alireza Ranjbar', 'family': 'Naeini', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2023, 3, 31]]}, 'reference': [ { 'issue': '1', 'key': '8172_CR1', 'doi-asserted-by': 'publisher', 'first-page': '87', 'DOI': '10.2214/AJR.20.23034', 'volume': '215', 'author': 'S Salehi', 'year': '2020', 'unstructured': 'Salehi S, Abedi A, Balakrishnan S, Gholamrezanezhad A. Coronavirus ' 'disease 2019 (COVID-19): A systematic review of imaging findings in 919 ' 'patients. AJR Am J Roentgenol. 2020;215(1):87–93.', 'journal-title': 'AJR Am J Roentgenol'}, { 'issue': '9', 'key': '8172_CR2', 'doi-asserted-by': 'publisher', 'first-page': '1449', 'DOI': '10.1002/jmv.25822', 'volume': '92', 'author': 'Y Cao', 'year': '2020', 'unstructured': 'Cao Y, Liu X, Xiong L, Cai K. Imaging and clinical features of patients ' 'with 2019 novel coronavirus SARS-CoV-2: A systematic review and ' 'meta-analysis. J Med Virol. 2020;92(9):1449–59.', 'journal-title': 'J Med Virol'}, { 'issue': '4', 'key': '8172_CR3', 'doi-asserted-by': 'publisher', 'first-page': '601', 'DOI': '10.1038/s41591-021-01283-z', 'volume': '27', 'author': 'A Nalbandian', 'year': '2021', 'unstructured': 'Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, et ' 'al. Post-acute COVID-19 syndrome. Nat Med. 2021;27(4):601–15.', 'journal-title': 'Nat Med'}, { 'issue': '6', 'key': '8172_CR4', 'doi-asserted-by': 'publisher', 'first-page': '603', 'DOI': '10.1001/jama.2020.12603', 'volume': '324', 'author': 'A Carfì', 'year': '2020', 'unstructured': 'Carfì A, Bernabei R, Landi F. Persistent symptoms in patients after ' 'acute COVID-19. JAMA. 2020;324(6):603–5.', 'journal-title': 'JAMA'}, { 'issue': '30', 'key': '8172_CR5', 'doi-asserted-by': 'publisher', 'first-page': '993', 'DOI': '10.15585/mmwr.mm6930e1', 'volume': '69', 'author': 'MW Tenforde', 'year': '2020', 'unstructured': 'Tenforde MW, Kim SS, Lindsell CJ, Billig Rose E, Shapiro NI, Files DC, ' 'et al. Symptom duration and risk factors for delayed return to usual ' 'health among outpatients with Covid-19 in a multistate health care ' 'systems network - United States, March-June 2020. MMWR Morb Mortal Wkly ' 'Rep. 2020;69(30):993–8.', 'journal-title': 'MMWR Morb Mortal Wkly Rep'}, { 'key': '8172_CR6', 'unstructured': 'Centers for Disease Control and Prevention, Long COVID or Post-COVID ' 'Conditions.\xa02022.\xa0Retrieved from ' 'https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html.\xa0'}, { 'issue': '5', 'key': '8172_CR7', 'doi-asserted-by': 'publisher', 'first-page': '2621', 'DOI': '10.3390/ijerph18052621', 'volume': '18', 'author': 'C Fernandez-de-Las-Penas', 'year': '2021', 'unstructured': 'Fernandez-de-Las-Penas C, Palacios-Cena D, Gomez-Mayordomo V, Cuadrado ' 'ML, Florencio LL. Defining Post-COVID Symptoms (Post-Acute COVID, Long ' 'COVID, Persistent Post-COVID): An Integrative Classification. Int J ' 'Environ Res Public Health. 2021;18(5):2621.', 'journal-title': 'Int J Environ Res Public Health'}, { 'key': '8172_CR8', 'doi-asserted-by': 'publisher', 'first-page': '117179', 'DOI': '10.1016/j.jns.2020.117179', 'volume': '419', 'author': 'T Wijeratne', 'year': '2020', 'unstructured': 'Wijeratne T, Crewther S. Post-COVID 19 Neurological Syndrome (PCNS); a ' 'novel syndrome with challenges for the global neurology community. J ' 'Neurol Sci. 2020;419:117179.', 'journal-title': 'J Neurol Sci'}, { 'issue': '5', 'key': '8172_CR9', 'doi-asserted-by': 'publisher', 'first-page': 'e2111417', 'DOI': '10.1001/jamanetworkopen.2021.11417', 'volume': '4', 'author': 'T Nasserie', 'year': '2021', 'unstructured': 'Nasserie T, Hittle M, Goodman SN. Assessment of the frequency and ' 'variety of persistent symptoms among patients with COVID-19: A ' 'systematic review. JAMA Netw Open. 2021;4(5):e2111417.', 'journal-title': 'JAMA Netw Open'}, { 'issue': '3', 'key': '8172_CR10', 'doi-asserted-by': 'publisher', 'first-page': 'e13746', 'DOI': '10.1111/ijcp.13746', 'volume': '75', 'author': 'M Kamal', 'year': '2021', 'unstructured': 'Kamal M, Abo Omirah M, Hussein A, Saeed H. Assessment and ' 'characterisation of post-COVID-19 manifestations. Int J Clin Pract. ' '2021;75(3):e13746.', 'journal-title': 'Int J Clin Pract'}, { 'key': '8172_CR11', 'doi-asserted-by': 'publisher', 'first-page': '594', 'DOI': '10.1016/j.bbi.2020.07.037', 'volume': '89', 'author': 'MG Mazza', 'year': '2020', 'unstructured': 'Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, et al. ' 'Anxiety and depression in COVID-19 survivors: Role of inflammatory and ' 'clinical predictors. Brain Behav Immun. 2020;89:594–600.', 'journal-title': 'Brain Behav Immun'}, { 'issue': '7', 'key': '8172_CR12', 'first-page': '355', 'volume': '34', 'author': 'JA McCain', 'year': '2009', 'unstructured': 'McCain JA. Antidepressants and suicide in adolescents and adults: a ' 'public health experiment with unintended consequences? P T. ' '2009;34(7):355–78.', 'journal-title': 'P T'}, { 'issue': '478', 'key': '8172_CR13', 'doi-asserted-by': 'publisher', 'first-page': '5266', 'DOI': '10.1126/scitranslmed.aau5266', 'volume': '11', 'author': 'DA Rosen', 'year': '2019', 'unstructured': 'Rosen DA, Seki SM, Fernández-Castañeda A, Beiter RM, Eccles JD, Woodfolk ' 'JA, et al. Modulation of the sigma-1 receptor–IRE1 pathway is beneficial ' 'in preclinical models of inflammation and sepsis. Sci Transl Med. ' '2019;11(478):5266.', 'journal-title': 'Sci Transl Med'}, { 'issue': '22', 'key': '8172_CR14', 'doi-asserted-by': 'publisher', 'first-page': '2292', 'DOI': '10.1001/jama.2020.22760', 'volume': '324', 'author': 'EJ Lenze', 'year': '2020', 'unstructured': 'Lenze EJ, Mattar C, Zorumski CF, Stevens A, Schweiger J, Nicol GE, et ' 'al. Fluvoxamine vs placebo and clinical deterioration in outpatients ' 'with symptomatic COVID-19: A randomized clinical trial. JAMA. ' '2020;324(22):2292–300.', 'journal-title': 'JAMA'}, { 'issue': '4', 'key': '8172_CR15', 'doi-asserted-by': 'publisher', 'first-page': '1898', 'DOI': '10.1038/s41380-021-01432-3', 'volume': '27', 'author': 'Y Hashimoto', 'year': '2022', 'unstructured': 'Hashimoto Y, Suzuki T, Hashimoto K. Mechanisms of action of fluvoxamine ' 'for COVID-19: a historical review. Mol Psychiatry. 2022;27(4):1898–907.', 'journal-title': 'Mol Psychiatry'}, { 'key': '8172_CR16', 'doi-asserted-by': 'publisher', 'first-page': '652688', 'DOI': '10.3389/fphar.2021.652688', 'volume': '12', 'author': 'VP Sukhatme', 'year': '2021', 'unstructured': 'Sukhatme VP, Reiersen AM, Vayttaden SJ, Sukhatme VV. Fluvoxamine: A ' 'review of its mechanism of action and its role in COVID-19. Front ' 'Pharmacol. 2021;12:652688.', 'journal-title': 'Front Pharmacol'}, { 'key': '8172_CR17', 'unstructured': 'COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) ' 'Treatment Guidelines. National Institutes of Health. Available at ' 'https://www.covid19treatmentguidelines.nih.gov/. Accessed 08 Apr\xa0' '2022.'}, { 'issue': '20', 'key': '8172_CR18', 'doi-asserted-by': 'publisher', 'first-page': '2191', 'DOI': '10.1001/jama.2013.281053', 'volume': '310', 'author': 'World Medical Association Declaration of Helsinki', 'year': '2013', 'unstructured': 'World Medical Association Declaration of Helsinki. ethical principles ' 'for medical research involving human subjects. JAMA. ' '2013;310(20):2191–4.', 'journal-title': 'JAMA'}, { 'issue': '4', 'key': '8172_CR19', 'doi-asserted-by': 'publisher', 'first-page': 'e226269', 'DOI': '10.1001/jamanetworkopen.2022.6269', 'volume': '5', 'author': 'TC Lee', 'year': '2022', 'unstructured': 'Lee TC, Vigod S, Bortolussi-Courval E, Hanula R, Boulware DR, Lenze EJ, ' 'et al. Fluvoxamine for outpatient management of COVID-19 to prevent ' 'hospitalization: A systematic review and meta-analysis. JAMA Netw Open. ' '2022;5(4):e226269.', 'journal-title': 'JAMA Netw Open'}, { 'issue': '12', 'key': '8172_CR20', 'doi-asserted-by': 'publisher', 'first-page': '6566', 'DOI': '10.1002/jmv.27198', 'volume': '93', 'author': 'B Kayaaslan', 'year': '2021', 'unstructured': 'Kayaaslan B, Eser F, Kalem AK, Kaya G, Kaplan B, Kacar D, et al. ' 'Post-COVID syndrome: A single-center questionnaire study on 1007 ' 'participants recovered from COVID-19. J Med Virol. 2021;93(12):6566–74.', 'journal-title': 'J Med Virol'}, { 'issue': '8', 'key': '8172_CR21', 'doi-asserted-by': 'publisher', 'first-page': '1943', 'DOI': '10.1007/s11606-021-07242-1', 'volume': '37', 'author': 'F Desgranges', 'year': '2022', 'unstructured': 'Desgranges F, Tadini E, Munting A, Regina J, Filippidis P, Viala B, et ' 'al. PostCOVID19 syndrome in outpatients: a Cohort Study. J Gen Intern ' 'Med. 2022;37(8):1943–52.', 'journal-title': 'J Gen Intern Med'}, { 'key': '8172_CR22', 'doi-asserted-by': 'publisher', 'first-page': '279', 'DOI': '10.1348/1359107041557048', 'volume': '9', 'author': 'De Vries', 'year': '2004', 'unstructured': 'Vries De, Michielsen H, Van Heck GL, Drent M. Measuring fatigue in ' 'sarcoidosis: the Fatigue Assessment Scale (FAS). Br J Health Psychol. ' '2004;9:279–91. http://www.ncbi.nlm.nih.gov/pubmed/15296678.', 'journal-title': 'Br J Health Psychol'}, { 'issue': '10', 'key': '8172_CR23', 'doi-asserted-by': 'publisher', 'first-page': 'e135', 'DOI': '10.1111/epi.16683', 'volume': '61', 'author': 'E Carroll', 'year': '2020', 'unstructured': 'Carroll E, Neumann H, Aguero-Rosenfeld ME, Lighter J, Czeisler BM, ' 'Melmed K, et al. Post-COVID-19 inflammatory syndrome manifesting as ' 'refractory status epilepticus. Epilepsia. 2020;61(10):e135–9.', 'journal-title': 'Epilepsia'}, { 'issue': '11', 'key': '8172_CR24', 'doi-asserted-by': 'publisher', 'first-page': '1448', 'DOI': '10.1016/j.cmi.2020.07.028', 'volume': '26', 'author': 'B Davido', 'year': '2020', 'unstructured': 'Davido B, Seang S, Tubiana R, de Truchis P. Post-COVID-19 chronic ' 'symptoms: a postinfectious entity? Clin Microbiol Infect. ' '2020;26(11):1448–9.', 'journal-title': 'Clin Microbiol Infect'}, { 'issue': '1', 'key': '8172_CR25', 'doi-asserted-by': 'publisher', 'first-page': '50', 'DOI': '10.1002/npr2.12154', 'volume': '41', 'author': 'S El Sayed', 'year': '2021', 'unstructured': 'El Sayed S, Shokry D, Gomaa SM. Post-COVID-19 fatigue and anhedonia: A ' 'cross-sectional study and their correlation to post-recovery period. ' 'Neuropsychopharmacol Rep. 2021;41(1):50–5.', 'journal-title': 'Neuropsychopharmacol Rep'}, { 'issue': '3', 'key': '8172_CR26', 'doi-asserted-by': 'publisher', 'first-page': '378', 'DOI': '10.1016/j.jinf.2021.01.004', 'volume': '82', 'author': 'O Moreno-Perez', 'year': '2021', 'unstructured': 'Moreno-Perez O, Merino E, Leon-Ramirez JM, Andres M, Ramos JM, ' 'Arenas-Jimenez J, et al. Post-acute COVID-19 syndrome. Incidence and ' 'risk factors: A Mediterranean cohort study. J Infect. 2021;82(3):378–83.', 'journal-title': 'J Infect'}, { 'issue': '1', 'key': '8172_CR27', 'doi-asserted-by': 'publisher', 'first-page': '50', 'DOI': '10.1111/j.2044-8341.1959.tb00467.x', 'volume': '32', 'author': 'M Hamilton', 'year': '1959', 'unstructured': 'Hamilton M. The assessment of anxiety states by rating. Br J Med ' 'Psychol. 1959;32(1):50–5.', 'journal-title': 'Br J Med Psychol'}, { 'issue': '2–3', 'key': '8172_CR28', 'doi-asserted-by': 'publisher', 'first-page': '159', 'DOI': '10.1016/S0165-0327(00)00309-8', 'volume': '66', 'author': 'P Bech', 'year': '2001', 'unstructured': 'Bech P, Rasmussen NA, Olsen LR, Noerholm V, Abildgaard W. The ' 'sensitivity and specificity of the Major Depression Inventory, using the ' 'Present State Examination as the index of diagnostic validity. J Affect ' 'Disord. 2001;66(2–3):159–64.', 'journal-title': 'J Affect Disord'}, { 'key': '8172_CR29', 'doi-asserted-by': 'publisher', 'unstructured': 'Chow S-C, Shao J, Wang H, Lokhnygina Y. Sample Size Calculations in ' 'Clinical Research (3rd ed.). Chapman and Hall/CRC; 2017. ' 'https://doi.org/10.1201/9781315183084.', 'DOI': '10.1201/9781315183084'}, { 'issue': '1', 'key': '8172_CR30', 'doi-asserted-by': 'publisher', 'first-page': 'e42', 'DOI': '10.1016/S2214-109X(21)00448-4', 'volume': '10', 'author': 'G Reis', 'year': '2022', 'unstructured': 'Reis G, dos Santos Moreira-Silva EA, Silva DCM, Thabane L, Milagres AC, ' 'Ferreira TS, et al. Effect of early treatment with fluvoxamine on risk ' 'of emergency care and hospitalisation among patients with COVID-19: the ' 'TOGETHER randomised, platform clinical trial. Lancet Glob Health. ' '2022;10(1):e42–51.', 'journal-title': 'Lancet Glob Health'}, { 'issue': '1', 'key': '8172_CR31', 'doi-asserted-by': 'publisher', 'first-page': '56', 'DOI': '10.1097/01.jcp.0000195042.62724.76', 'volume': '26', 'author': 'GI Papakostas', 'year': '2006', 'unstructured': 'Papakostas GI, Perlis RH, Scalia MJ, Petersen TJ, Fava M. A ' 'meta-analysis of early sustained response rates between antidepressants ' 'and placebo for the treatment of major depressive disorder. J Clin ' 'Psychopharmacol. 2006;26(1):56–60.', 'journal-title': 'J Clin Psychopharmacol'}, { 'issue': '3', 'key': '8172_CR32', 'doi-asserted-by': 'publisher', 'first-page': '344', 'DOI': '10.4088/JCP.07m03780', 'volume': '70', 'author': 'A Szegedi', 'year': '2009', 'unstructured': 'Szegedi A, Jansen WT, van Willigenburg AP, van der Meulen E, Stassen HH, ' 'Thase ME. Early improvement in the first 2 weeks as a predictor of ' 'treatment outcome in patients with major depressive disorder: a ' 'meta-analysis including 6562 patients. J Clin Psychiatry. ' '2009;70(3):344–53.', 'journal-title': 'J Clin Psychiatry'}, { 'issue': '11', 'key': '8172_CR33', 'doi-asserted-by': 'publisher', 'first-page': '1217', 'DOI': '10.1001/archpsyc.63.11.1217', 'volume': '63', 'author': 'MJ Taylor', 'year': '2006', 'unstructured': 'Taylor MJ, Freemantle N, Geddes JR, Bhagwagar Z. Early onset of ' 'selective serotonin reuptake inhibitor antidepressant action: systematic ' 'review and meta-analysis. Arch Gen Psychiatry. 2006;63(11):1217–23.', 'journal-title': 'Arch Gen Psychiatry'}, { 'issue': '2', 'key': '8172_CR34', 'doi-asserted-by': 'publisher', 'first-page': '148', 'DOI': '10.4088/JCP.v66n0201', 'volume': '66', 'author': 'MA Posternak', 'year': '2005', 'unstructured': 'Posternak MA, Zimmerman M. Is there a delay in the antidepressant ' 'effect? A meta-analysis J Clin Psychiatry. 2005;66(2):148–58.', 'journal-title': 'A meta-analysis J Clin Psychiatry'}], 'container-title': 'BMC Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-023-08172-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1186/s12879-023-08172-5/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-023-08172-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 3, 31]], 'date-time': '2023-03-31T13:05:48Z', 'timestamp': 1680267948000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-023-08172-5'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 3, 31]]}, 'references-count': 34, 'journal-issue': {'issue': '1', 'published-online': {'date-parts': [[2023, 12]]}}, 'alternative-id': ['8172'], 'URL': 'http://dx.doi.org/10.1186/s12879-023-08172-5', 'relation': {}, 'ISSN': ['1471-2334'], 'subject': ['Infectious Diseases'], 'container-title-short': 'BMC Infect Dis', 'published': {'date-parts': [[2023, 3, 31]]}, 'assertion': [ { 'value': '24 July 2022', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '17 March 2023', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '31 March 2023', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'Informed consent was obtained from all study participants. The protocol of this ' 'study is by the 2013 Helsinki declaration and was approved by the Ethics ' 'Committee of AJA University of Medical Sciences (AJAUMS), Ethics ID: ' 'IR.AJAUMS.REC.1400.302. This RCT was registered in the Iranian registry of ' 'clinical trials (IRCT), a primary registry in the WHO registry network ' '(registration number: IRCT20220526054990N1) on 01/06/2022.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'Not applicable.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'The authors declare no competing interests.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '197'}