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.

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.

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.

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.

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.

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

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.

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.

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

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

This paper provides the summaries on nine (9) important and clinically relevant publications in the field of uveitis. The first is on the standardization of uveitis nomenclature, more popularly known by its acronym - SUN, which was a result of an international workshop participated by uveitis experts in 2004. Five (5) papers were large, multicenter, clinical trials that demonstrated safety and efficacy of two (2) corticosteroids delivery devices (dexamethasone implant [Ozurdex] and fluocinolone acetonide implant [RetisertTM]) and one (1) immunomodulatory drug (adalimumab). The POINT trial compared various delivery approaches when using corticosteroids for the treatment of uveitic macular edema. The FAST trial compared two (2) durable and commonly-prescribed steroidsparing immunosuppressants, methotrexate and mycophenolate mofetil, for the treatment of non-infectious uveitis. Lastly, the SITE study, which was a large retrospective cohort study, determined the risks of overall and malignancy-related deaths among patients with inflammatory eye diseases receiving systemic immunosuppressants. Findings of these studies provide basis and rationale for the care and management of patients with uveitis and lay the groundwork for future research.
Uveitis ; Clinical Trial ; Review ; Adrenal Cortex Hormones

Background: Psoriasis is a chronic, complex, inflammatory disease that needs safe and effective treatment options to decrease its disease burden.

Objectives: To determine the efficacy and safety of sunflower oil in mild to moderate plaque-type psoriasis at the outpatient department of a tertiary hospital.

Methods: This was an 8-week, single-center, randomized, double-blind controlled trial that compared the efficacy and safety of sunflower oil + placebo cream (Group SO), betamethasone valerate cream + placebo oil (Group BC), sunflower oil + betamethasone valerate cream (Group SOBC) in mild to moderate plaque-type psoriasis. Psoriasis Area Severity Index (PASI) was used to measure the extent of psoriasis by assessing the erythema, induration, scaling, and body surface area involvement. The difference from baseline PASI was recorded. The Dermatology Life Quality Index (DLQI) questionnaire was used to measure the impact of psoriasis on the patient's quality of life.

Results: Fifty-one patients were randomized and blinded to three treatment arms; evaluated at baseline, week 4 and 8. The proportion of patients who achieved PASI ?50 at week 4 was 29% in Group SO, 38% in Group BC, and 60% in Group SO-BC. By week 8, Groups SO and BC achieved 80% while Group SO-BC achieved 93%. There was significant decline of PASI at week 4 and week 8 compared to baseline. The mean percentage change of PASI was highest at Group SO-BC followed by Group BC and lastly Group SO at week 4 and week 8. The mean reduction in score for scaling was significantly higher in Group SO-BC. Mean reduction in induration and erythema was not statistically significant across the three groups. There was 40-50% improvement in DLQI scores in all groups. There were no adverse events.

Conclusion: This study showed that sunflower oil is effective and safe in mild to moderate plaque-type psoriasis.

PURPOSE: To compare the visual acuity and retinal thickness in patients with an idiopathic epiretinal membrane (ERM) after vitrectomy and membranectomy using two different methods.METHODS: This retrospective observational study included 77 eyes (32 eyes in the diamond-dusted membrane scraper [DDMS] group, and 45 eyes in the intraocular forceps [IOF] group) of 77 patients with idiopathic ERM who underwent pars plana vitrectomy and membranectomy. The main outcome measures were best-corrected visual acuity (BCVA, logMAR) and mean retinal thickness.RESULTS: In the IOF group, the BCVA at postoperative 1 week was significantly lower than at baseline and had improved at 12 weeks after surgery. In the DDMS group, the BCVA at postoperative 1 week showed no significant difference at baseline and had improved at 4 weeks after surgery. The central macular thickness at postoperative 6 months was significantly lower than at baseline (all, p < 0.001); there was no significant difference between the two groups (p = 0.400). The postoperative macular thickness of the DDMS group was significantly lower than that of the IOF group in the inner inferior and outer inferior areas at postoperative 12 weeks and 4 weeks (p = 0.046 and p = 0.039, respectively). Five eyes of the DDMS group and 15 eyes of the IOF group developed cystoid macular edema, 14 eyes of that improved without treatment.CONCLUSIONS: In patients with ERM, the use of DDMS or IOF for vitrectomy and membranectomy both resulted in improved visual acuity and decreased mean retinal thicknesses.
Epiretinal Membrane ; Humans ; Macular Edema ; Membranes ; Observational Study ; Outcome Assessment (Health Care) ; Retinaldehyde ; Retrospective Studies ; Surgical Instruments ; Visual Acuity ; Vitrectomy

Guidance and reference are provided for protocol designer. The classification of laser medical devices are introduced. The key points such as the selection of control group, evaluation indicators and method, criteria of inclusion and exclusion, and application of blinded, etc. are discussed, and the importance of management of defects in medical device is emphasized.
Clinical Trial Protocols as Topic ; Equipment and Supplies ; Lasers ; Research Design