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The effects of probiotic Lactobacillus acidophilus and colchicine on the control of symptoms, duration, and disease progression of mild and moderate cases of COVID-19: A randomized controlled clinical trial

Hassan et al., Research Square, doi:10.21203/rs.3.rs-3049708/v1
Jun 2023  
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Hospitalization -40% Improvement Relative Risk Recovery 4% Recovery time 0% no CI Colchicine  Hassan et al.  EARLY TREATMENT  RCT Is early treatment with colchicine beneficial for COVID-19? RCT 100 patients in Egypt (July 2021 - August 2022) Trial underpowered for serious outcomes c19early.org Hassan et al., Research Square, June 2023 Favorscolchicine Favorscontrol 0 0.5 1 1.5 2+
Colchicine for COVID-19
5th treatment shown to reduce risk in September 2020
 
*, now with p = 0.00000031 from 56 studies.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19early.org
RCT 150 patients in Egypt showing no significant difference in outcomes with colchicine. SOC included vitamin C, D, and zinc. Colchicine 0.5mg tid days 1-3, bid days 4-7.
Study covers colchicine and probiotics.
risk of hospitalization, 40.0% higher, RR 1.40, p = 0.76, treatment 7 of 50 (14.0%), control 5 of 50 (10.0%).
risk of no recovery, 3.6% lower, RR 0.96, p = 1.00, treatment 27 of 50 (54.0%), control 28 of 50 (56.0%), NNT 50.
recovery time, no change, relative time 1.00, treatment 50, control 50.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Hassan et al., 13 Jun 2023, Randomized Controlled Trial, Egypt, preprint, 6 authors, study period July 2021 - August 2022. Contact: dr.samar.osama@med.asu.edu.eg.
This PaperColchicineAll
The effects of probiotic Lactobacillus acidophilus and colchicine on the control of symptoms, duration, and disease progression of mild and moderate cases of COVID-19: A randomized controlled clinical trial
Samar Osama Ahmed Hassan, Ahmed Nour El-Din Hassan, Manal Sabry Mohamed, Mohamed Nabil Badawy Al Ashram, Mina Michael Nesim, Mohamed Farouk Allam
doi:10.21203/rs.3.rs-3049708/v1
Background Coronavirus disease 2019 (COVID-19) is a newly emerging human disease caused by a novel coronavirus, causing a global pandemic crisis. Probiotics and/or colchicine may be considered as options for treatment since they have anti-viral, anti-in ammatory, and immunomodulatory effects. Objective To assess the effectiveness of probiotic supplements (Lactobacillus acidophilus) and colchicine on symptoms, duration, and progression of mild and moderate cases of COVID-19 infection. Methods A three-arm randomized controlled clinical trial was carried out in the triage clinic of the family medicine department at Ain Shams University Hospitals on 150 participants who had been diagnosed as COVID-19 patients with mild and moderate severity. Patients aged below 18 years or above 65 years with any comorbidities, pregnant or lactating females, and severe COVID-19 con rmed cases were excluded. Randomization was done by using sealed envelopes containing codes for intervention or control. Patients are followed up for improvement of their symptoms with no development of new symptoms over the course of two weeks. Results A total of 150 patients with mild and moderate severity of COVID-19 were enrolled in the study, 50 patients in each arm; around one third (34.7%) of the participants were aged between 29 and 39 years; one-quarter (24.7%) were aged between 18 and 28 years and 40.6% were aged 40 years and above. The mean duration of symptoms improvement was 12, 11 and 12 in the colchicine, probiotic, and control groups, respectively. Improvement of in ammatory markers over time occurred in each of the three groups, with no statistically signi cant difference between them. Conclusion Probiotic Lactobacillus acidophilus and colchicine shows no signi cant effect on the symptoms, duration, and progression of mild and moderate cases of COVID-19.
Declarations Author contributions: Each author declares having participated in the activities. Funding: None. Figure 1 See image above for gure legend.
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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