BACKGROUND

Convalescent plasma therapy (CPT) has been utilized as an emergency and last-resort treatment for viral infections, particularly in the absence of vaccine. During the COVID-19 pandemic, CPT was implemented worldwide based on its potential to provide passive immunity through SARS-CoV-2 antibodies. While numerous studies explored the effectiveness of CPT to cure COVID-19 patients, there has no research specifically focused on superiority of CPT impact on the length of hospitalization.

OBJECTIVE

This study aimed to evaluate the effect of CPT on the length of hospital stay among patients with moderate COVID-19.

METHODS

This is a single blind randomized controlled trial (RCT) study involved 30 moderate-grade COVID-19 patients age 18-75 years with positive PCR result treated at Unggul Karsa Medika Hospital Bandung from February 2 to May 31, 2022. Moderate-grade COVID-19 defined by clinical pneumonia symptoms based on World Health Organization (WHO) criteria. Eligible patients were randomly assigned (1:1 ratio) and outcome assessors were blinded, while care providers and patients were not due to the intervention nature. The intervention arm (n=15) received 200 ml of high-titer CPT within 24 hours of admission with standard care and the control arm (n=15) received standard care only. The primary outcome measured was the length of stay (LOS) in both the Emergency Room (ER) and COVID-19 High Care Unit (HCU). Data were analyzed using independent T-tests.

RESULTS

Thirty (30) eligible patients (mean age 40 years; 53% female) were analyzed for the primary outcome and all completed follow-ups. The CPT group had significantly shorter LOS than controls (mean difference for ER:-32.7 hours [95% CI:-45.0,-20.4]; HCU:-33.3 hours [95% CI:- 45.8,-20.8]; p

CONCLUSION

The administration of CPT may reduce the LOS in moderate COVID-19 patients. However, the small sample size can limit the generalizability of this result and larger sample studies are needed to strengthen this finding. Early CPT implementation may improve patient management and optimize healthcare resource utilization during the pandemic.

Pandemics ; Polymerase Chain Reaction ; Randomized Controlled Trial ; Emergency Service, Hospital ; Hospitalization ; Emergencies ; Covid-19 ; Length Of Stay ; Antibodies

BACKGROUND

Convalescent plasma therapy (CPT) has been utilized as an emergency and last-resort treatment for viral infections, particularly in the absence of vaccine. During the COVID-19 pandemic, CPT was implemented worldwide based on its potential to provide passive immunity through SARS-CoV-2 antibodies. While numerous studies explored the effectiveness of CPT to cure COVID-19 patients, there has no research specifically focused on superiority of CPT impact on the length of hospitalization.

OBJECTIVE

This study aimed to evaluate the effect of CPT on the length of hospital stay among patients with moderate COVID-19.

METHODS

This is a single blind randomized controlled trial (RCT) study involved 30 moderate-grade COVID-19 patients age 18-75 years with positive PCR result treated at Unggul Karsa Medika Hospital Bandung from February 2 to May 31, 2022. Moderate-grade COVID-19 defined by clinical pneumonia symptoms based on World Health Organization (WHO) criteria. Eligible patients were randomly assigned (1:1 ratio) and outcome assessors were blinded, while care providers and patients were not due to the intervention nature. The intervention arm (n=15) received 200 ml of high-titer CPT within 24 hours of admission with standard care and the control arm (n=15) received standard care only. The primary outcome measured was the length of stay (LOS) in both the Emergency Room (ER) and COVID-19 High Care Unit (HCU). Data were analyzed using independent T-tests.

RESULTS

Thirty (30) eligible patients (mean age 40 years; 53% female) were analyzed for the primary outcome and all completed follow-ups. The CPT group had significantly shorter LOS than controls (mean difference for ER:-32.7 hours [95% CI:-45.0,-20.4]; HCU:-33.3 hours [95% CI:- 45.8,-20.8]; p

CONCLUSION

The administration of CPT may reduce the LOS in moderate COVID-19 patients. However, the small sample size can limit the generalizability of this result and larger sample studies are needed to strengthen this finding. Early CPT implementation may improve patient management and optimize healthcare resource utilization during the pandemic.

Pandemics ; Polymerase Chain Reaction ; Randomized Controlled Trial ; Emergency Service, Hospital ; Hospitalization ; Emergencies ; Covid-19 ; Length Of Stay ; Antibodies

INTRODUCTION

Documenting a research participant’s awareness of the bill of rights is achieved with an informed consent. In recent years, the informed consent document has increasingly become confounding to research participants in its complexity. As such, the awareness of research participants’ bill of rights has emerged as a lingering issue since studies that test awareness of research participants’ bill of rights are limited. Hence, this study aimed to determine the participants’ awareness of the bill of rights after an educational intervention.

METHODS

A quasi-experimental study was done where participants’ awareness of clinical trial participants’ bill of rights was determined after an educational intervention.

RESULTS

There was a significant difference (pCONCLUSIONS

Significant difference in the awareness of bill of rights was observed after the educational intervention. Additional intervention could be given to participants who are females, of older age group (middle age and older), did not complete high school, and the unemployed when they participate in clinical trials to ensure their awareness of the bill of rights of clinical trial participants. Varied learning materials must be given to participants to emphasize the clinical research objectives and activities as well.

Human ; Clinical Trial ; Informed Consent

OBJECTIVE: Observational studies have found associations between inflammatory bowel disease (IBD) and the risk of dementia, including Alzheimer's dementia (AD) and vascular dementia (VD); however, these findings are inconsistent. It remains unclear whether these associations are causal. METHODS: We conducted a meta-analysis by systematically searching for observational studies on the association between IBD and dementia. Mendelian randomization (MR) analysis based on summary genome-wide association studies (GWASs) was performed. Genetic correlation and Bayesian co-localization analyses were used to provide robust genetic evidence. RESULTS: Ten observational studies involving 80,565,688 participants were included in this meta-analysis. IBD was significantly associated with dementia (risk ratio [ <i>RRi>] =1.36, 95% <i>CIi> = 1.04-1.78; <i>Ii> ² = 84.8%) and VD ( <i>RRi> = 2.60, 95% <i>CIi> = 1.18-5.70; only one study), but not with AD ( <i>RRi> = 2.00, 95% <i>CIi> = 0.96-4.13; <i>Ii> ² = 99.8%). MR analyses did not supported significant causal associations of IBD with dementia (dementia: odds ratio [ <i>ORi>] = 1.01, 95% <i>CIi> = 0.98-1.03; AD: <i>ORi> = 0.98, 95% <i>CIi> = 0.95-1.01; VD: <i>ORi> = 1.02, 95% <i>CIi> = 0.97-1.07). In addition, genetic correlation and co-localization analyses did not reveal any genetic associations between IBD and dementia. CONCLUSION Our study did not provide genetic evidence for a causal association between IBD and dementia risk. The increased risk of dementia observed in observational studies may be attributed to unobserved confounding factors or detection bias.
Humans ; Mendelian Randomization Analysis ; Inflammatory Bowel Diseases/complications* ; Dementia/etiology* ; Observational Studies as Topic ; Genome-Wide Association Study

OBJECTIVE: This study aims to assess the effectiveness of unilateral ST 36 stimulation using Japanese acupuncture technique in the early return of bowel function after intrabdominal surgery compared with placebo in children between 3-18 years of age undergoing general anesthesia.

METHODOLOGY: This is a single-center, prospective, randomized controlled trial (RCT) among American Society of Anesthesiologists (ASA) I-III children aged 3-18 admitted for elective intraabdominal surgery under general anesthesia. Thirty-eight subjects were randomly assigned to non-acupuncture or acupuncture group. Press tack needle was placed on the right ST 36 point of the subject and stimulated on five occasions. Bowel motility, time to first flatus, first sips of water, start of solid food, first defecate, and length of hospital stay were the outcomes recorded.

RESULTS: The acupuncture group had earlier normal bowel sounds appreciated, and faster time to first flatus and defecate. Time to start sips of water, initiate feeding, and discharged from the hospital were earlier in the non-acupuncture group. Nonetheless, these were all statistically insignificant (p=0.188, 0.270, 0.307, 0.472, 0.085, and 1.0). Return of bowel sounds per minute was found to be prompter in the acupuncture group compared to non-acupuncture, which was statistically significant on the first day postoperatively with a p value of=0.045.

CONCLUSION: Unilateral ST 36 stimulation using Japanese acupuncture can help with early recovery of normoactive bowel sounds on the first day after intraabdominal surgery. However, this was ineffectual in enhancing overall bowel function following intraabdominal operation. Larger, homogeneous abdominal surgery is advised for future investigations.

Human ; Male ; Female ; Child Preschool: 2-5 Yrs Old ; Child: 6-12 Yrs Old ; Adolescent: 13-18 Yrs Old ; Acupuncture ; Anesthesia, General ; Randomized Controlled Trial ; General Surgery

OBJECTIVE

This study aimed to determine if selenium supplementation for a period of six months can decrease signs and prevent worsening of mild Graves’ ophthalmopathy among Filipino patients.

METHODS

We conducted an open-label, assessor-masked, randomized controlled trial involving adult patients diagnosed with mild Graves’ ophthalmopathy. Participants were divided into two groups: one group received standard care (eye drops) alone (control group), while the other group received an additional 200 mcg/day oral selenium supplementation alongside standard care. Inclusion criteria encompassed adult patients with Graves’ hyperthyroidism presenting at least one sign of mild ophthalmopathy and a disease duration of less than 18 months. Statistical analyses were performed using independent sample t-test, Mann-Whitney U test and Fisher’s Exact/Chi-square test to compare means, ranks and frequencies between the two intervention groups. Paired sample t-test, Wilcoxon signed rank test and McNemar test were employed to assess changes from baseline to the third and sixth month observations.

RESULTS

A significant difference in clinical activity score (CAS) was observed between the selenium supplementation group and the control group. Initially, 14 eyes (33.33%) in the selenium group exhibited a CAS score of 0, which increased to 27 eyes (64.29%) at the third month of treatment and slightly decreased to 26 eyes (61.9%) at the sixth month. Conversely, the control group had 11 eyes with a CAS score of 0 at baseline, which increased to 16 eyes (38.1%) at three months and decreased to 14 eyes (33.33%) at the sixth month. The improvement in CAS was significantly associated with reductions in caruncle and plica swelling (p = 0.040). Further analysis revealed a statistically significant difference in CAS between the treatment and control groups (p = 0.017) at the sixth month mark.

CONCLUSION

Selenium supplementation provided significant benefit in reducing the signs and preventing deterioration of mild Graves’ ophthalmopathy, as indicated by improved CAS scores. Future research exploring baseline and end of treatment selenium concentrations in the Philippines is recommended to further substantiate these findings.

Human ; Female ; Randomized Controlled Trial ; Tertiary Care Centers

Background: Virgin coconut oil (VCO) has anti-viral and anti-inflammatory properties, making it a potential therapeutic candidate against COVID-19 infection. Objective: To determine the efficacy and safety of VCO as adjunctive therapy for hospitalized patients with COVID-19. Methods: We conducted a randomized, open-label controlled trial involving laboratory-confirmed COVID-19 patients admitted at the Philippine General Hospital. The study participants were randomized to the intervention group who received virgin coconut oil with local standard of care, or to the control group who received local standard of care alone. Results: We enrolled 39 participants into the VCO group and 38 participants into the control group. Significantly fewer participants in the VCO group had abnormal CRP levels at the end of treatment compared to control. (relative risk [RR] 0.75, 95% confidence interval [CI] 0.58 to 0.95; p=0.02) No significant difference was found in the duration of hospital stay (mean 9.33 days for VCO vs. 10.29 days for control; p=0.45) and time to symptom resolution (mean 6.8 days for VCO, vs. 6.74 days for control; p=0.91). Although the proportion of patients who developed the secondary outcomes of mortality, need for ICU admission, need for invasive ventilation, and negative viral conversion was lower in the VCO group, results did not reach statistical significance. The VCO group had larger reduction in the inflammatory markers ferritin, lactate dehydrogenase, TNF-alpha, IP-10 and IL-6, but results did not reach statistical significance. Adverse events were significantly higher in the VCO group (RR 4.87, 95% CI 1.14 to 20.79; p=0.03). Conclusion This clinical trial on hospitalized patients showed significant benefit in CRP levels of participants given VCO compared to control. There was no significant benefit in the use of VCO as adjunctive therapy in reducing duration of hospital stay. Larger studies are needed to conclusively demonstrate the effect of VCO on other clinical outcomes and inflammatory markers.
COVID-19 ; Clinical Trial

A case control study is a type of observational study. In this study design, participants are selected to participate depending on their outcome status. Cases are participants with outcome of interest whereas controls are participants who do not have the outcome of interest. These studies estimate the odds ratio or the odds between the exposure and health outcome, however they cannot prove causality. Advantages of case control studies include the following: inexpensive, easy to design and implement, and are used to study rare outcomes. Case control studies are prone to certain research bias but can be addressed by the investigator through careful designing and planning. This paper describes the case control studies, their advantages, bias in case control studies and how to address them, and discuss the steps in how to conduct this type of study design.

Case-control Studies ; Odds Ratio ; Observational Study

Background: Avascular necrosis (AVN) of the femoral head results from intraosseous pathology causing functional impairment. Early diagnosis allows conservative treatment like core decompression, delaying total hip arthroplasty. Objective: This meta-analysis aims to summarize platelet-rich plasma's (PRP) impact as an adjunct to core decompression (CD) on treatment outcomes and femoral head preservation in hip AVN. Methods: The study conducted a comprehensive literature search using PubMed, Cochrane Library, Science Direct, Google Scholar and Med Line, including randomized controlled trials (RCTs) and previous meta-analyses from various databases. Using a random effects model, it compared PRP+CD with bone grafting to CD with bone grafting alone in AVN patients, evaluating function, pain scores, disease progression and the need for hip surgery. Results: The meta-analysis examined 1041 records and included three studies. The primary outcomes were function and pain scores using Harris Hip Scoring (HHS) and Visual Analog Scale (VAS). Postoperative HHS scores at final follow-up favored the PRP+CD group significantly over CD alone. Postoperative VAS scores showed a trend towards higher scores in the CD alone group. The PRP+CD group demonstrated higher survival from disease progression compared to CD alone. Overall, the study suggests that PRP+CD led to better functional outcomes and disease progression outcomes than CD alone in AVN of the hip. Conclusion The PRP+CD treatment group showed significant benefits in AVN patients compared to CD alone, including higher HHS scores, improved disease progression survival and reduced need for hip surgery. Although PRP+CD resulted in decreased VAS scores, the difference was not statistically significant.
Osteonecrosis ; Femur Head ; Platelet-Rich Plasma ; Randomized Controlled Trial

Background: Polycystic ovarian syndrome (PCOS) is a common, reproductive endocrinopathy associated with ovarian dysfunction, cardiovascular disorders, obesity, and infertility. Myo-inositol is a novel treatment for women with PCOS that claimed to have improved fertility rate in this population. This systematic review and meta-analysis examined the effect of myo-inositol on pregnancy rate, menstrual cycle, and adverse effects from randomized controlled trials (RCTs). Methods: RCTs that evaluated the efficacy of myo-inositol in improving pregnancy rate and regulation of menstrual cycle in women with PCOS. Electronic databases were searched and studies published up to October 24, 2021 were included in the systematic review and meta-analysis. Study selection and assessment of quality were conducted independently by two review authors. Results: Seven studies with 729 patients treated with myo-inositol and 677 patients treated with placebo and/or metformin were included in the analysis. The research groups did not diverge significantly in terms of basic characteristics, such as age, adnexal or uterine pathology, body mass index, and duration of infertility. In the myo-inositol group, regulation of the normal menstrual cycle is at 20%, significantly higher than the metformin group at 12%, (p<0.001). However, there is no significant difference in the pregnancy rate between myoinositol and placebo (p=0.42) and/or metformin (p=0.17). Conclusion This systematic review and meta-analysis showed that myo-inositol can be an alternative treatment for PCOS in terms of regulation of menses and may improve the success of spontaneous pregnancies. However, additional randomized, double-blind controlled trials with larger sample sizes, low heterogeneity, and uniform inclusion criteria are recommended to establish the effects of myo-inositol on PCOS treatment and pregnancy rate.
Polycystic Ovary Syndrome|pregnancy Rate|menstrual Cycle|randomized Controlled Trial