Women of reproductive age seeking care at the Gynecology Clinic/Hung Vuong Hospital who were HSV-2 (+). Study subjects were randomized to receive either Hoa Long or placebo for oral administration in 12 days, then examined at 1, 3, 6 and 12 months after treatment. Findings: During the first year, 30.6% and 55.6% of the women allocated to HL and GD groups, respectively, had at least one episode of recurrent herpes. In addition, count and proportion of lymphocytes were higher in HL than in GD group. At 3, 6 and 12 months after treatment, CD 4 counts were 806.9, 701.2 and 800.1, respectively, for HL group, compared with 629.2, 584.2 and 629.3, respectively, for GD group. Similarly, CD 8 counts at 3, 6 and 12 months were 771.2, 614.7 and 824.1, respectively, for HL group, compared with 689.1, 489.3 and 596.4, respectively, for GD group. Among HSV-2 (+) women, Hoa Long increases CD 4 and CD 8 counts and reduces the recurrence rate of herpes during the first year after treatment
Therapeutics ; prevention & control ; Herpesviridae ; Randomized Controlled Trial

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.

BACKGROUND: One out of 10 Filipino children suffer from bronchial asthma. Its increasing prevalence over the past decades causes significant morbidity to the patients and their families, especially when it is uncontrolled. In developing countries, the form of medicine, cost and access to medications are significant factors in achieving good control of symptoms. No study has been done to determine if the use of low dose oral corticosteroid is a safe and effective alternative treatment for children with asthma.

OBJECTIVE: To compare the safety and efficacy of oral versus inhaled corticosteroid in moderate persistent asthma.

METHODS: An open label randomized controlled trial was carried out in 40 patients 6 to 15 years old with newly diagnosed moderate persistent asthma. They were assigned to either inhaled or oral corticosteroid group. Efficacy of treatment based on daytime and nighttime coughing, limitation of activity, use of bronchodilators, FEV1, PEFR and level of asthma control were assessed. Safety of both treatment options were evaluated by the occurrence of corticosteroid induced hypertension, adrenal insufficiency and diabetes.

RESULTS: The use of inhaled and oral corticosteroid showed improvement in daytime and nighttime cough, need for bronchodilators, limitation of activity, FEV1, PEFR and level of control. Furthermore, both treatment options had comparable safety profile.

CONCLUSION: There was no significant difference on the safety and efficacy of oral versus inhaled corticosteroid in the longterm treatment of moderate persistent bronchial asthma.

Preterm birth represents a major obstetric complication. This study aimed to assess the efficacy of a meditation programme in the prevention of preterm birth. This study was a randomized controlled trial without blinding. The study was performed at Udonthani Hospital in Northeast Thailand. A total of 199 eligible participants were randomly assigned to a five-step mindfulness meditation programme (n=84) or a control group (n=115). The control group received routine prenatal care. The meditation and control group subjects did not differ on a wide variety of sociodemographic characteristics, or in terms obstetric history and prior meditation experience. The data were analyzed on an intention-to-treat basis after delivery, using less than 37 weeks as the criterion for a preterm birth. Other outcome variables included a subjective measure of symptoms of stress. The preterm birth rate for the meditation group was significantly less than that for the control group (6.0% vs. 15.7%, p=0. 037). The stress scores reported by the meditation group markedly decreased over time (p<0.001), while the control group scores showed no change (p=0.375). The results confirm and strengthen the findings of past research indicating that participation in a meditation programme can reduce symptoms of stress. Meditation appears to be a promising technique for reducing the incidence of preterm birth. Recommendations are made for future research in this area.
Meditation ; Premature Birth ; Randomized Controlled Trial ; prevention & control

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

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

Introduction: It is important to wean mechanically-ventilated patients as early as possible to avoid complications such as ventilator-associated pneumonia. Supplementing the diet with additional protein may help to stimulate muscle protein synthesis which may enhance respiratory muscle function and ventilator drive. This study aims to determine the effect of whey protein supplementation on the duration of mechanical ventilation in intensive care unit patients of Ospital ng Makati. Methods: We enrolled forty eligible patients in this openlabel randomized controlled trial and were assigned into two groups: Group A (N=20): patients were given enteral feeding using commercial formula with added whey protein, given as one serving every eight hours (equivalent to 18 g of additional protein per day) and Group B (N=20): patients were given enteral feeding using commercial formula alone. Weaning was started as soon as the patient fulfilled the criteria of spontaneous breathing trial and was considered successful if the patient maintained these criteria for 48 hours after extubation. Results: Our study’s results showed that the mechanically intubated patients in Group A have lesser ventilatordependent days with an average of 5.4 days as compared to those in Group B with an average of 7.45 days (p=0.00). Patients in Group A were also noted to have statistically significant higher increase in serum albumin, mid-arm circumference and triceps skin fold from baseline. Twentyfive percent of patients in Group B developed ventilator acquired pneumonia and none in Group A. No mortality was noted in both groups. Conclusion Whey protein supplementation in mechanically ventilated patients can be recommended to facilitate early weaning because of its effect on early muscle protein synthesis leading to improvement of lung function and ventilator drive. It can also help in preventing malnutrition and nosocomial infections during critical illness. With all these benefits of whey protein, its use can potentially lead to shorter duration of mechanical ventilation and hospital stay which can also mean less cost of care delivery.
Whey Proteins ; Weaning ; Respiration, Artificial ; Intensive Care Units ; Randomized Controlled Trial

To analyze the registered clinical trial protocols of traditional Chinese medicine(TCM) for the prevention and treatment of coronavirus disease 2019(COVID-19), in order to provide information for improving the quality of research design. The website of the Chinese Clinical Trial Registry(www.chictr.org.cn) and the American Clinical Trial Registry(clinicaltrials.gov) were searched to collect protocols of TCM for COVID-19. Documents were screened following the inclusion criteria, and data were extracted in regard to registration date, study objective, type of design, sponsor, patient, sample size, intervention, and evaluation index. Descriptive analysis was conducted. A total of 49 clinical trial protocols of TCM for COVID-19 were included. Primary sponsors were mainly hospitals or universities in places like Hubei, Beijing, Zhejiang and other regions. The implementation units are mainly in Hubei, Guangdong, Zhejiang, Henan and other regional hospitals. The types of study design were mainly experimental studies(40), including 30 randomized parallel controlled trials, 7 non-randomized controlled trials, 2 single arm trials and 1 consecutively recruited trial; besides, there were also 6 observational studies, 2 health service studies and 1 preventive study. The sample size reached a total of 30 562 cases, with a maximum of 20 000 for a single study and a minimum of 30. The 49 trials subjects included healthy people(3), isolation and observation cases(1), suspected cases(10),confirmed COVID-19 patients(31) and COVID-19 recovery patients(4). Of the 31 trials planned to include confirmed COVID-19 patients, 16 protocols no definite disease classification, 3 with a clear exclusion of severe subjects, 4 with common subjects, 2 with light, common or severe subjects, 1 with light and common subjects, 1 with common or severe subjects, 3 with severe subjects, and 1 with severe or critical subjects. The experimental interventions included Chinese patent medicine(Lianhua Qingwen Capsules/Granules, Huoxiang Zhengqi Dropping Pills/Oral Liquid, Babao Dan, Gubiao Jiedu Ling, Jinhao Jiere Granules, Compound Yu-xingcao Mixture, Jinye Baidu Granules, Shufeng Jiedu Capsuless, Shuanghuanglian Oral Liquid, Tanreqing Injection, Xuebijing Injection, Reduning Injection, Xiyanping Injection), Chinese medicinal decoction and taichi. The primary evaluation outcomes mainly included antipyretic time, clinical symptom relief, novel coronavirus nucleic acid turning to negative, conversion rate of severe cases and chest CT. There was a quick response of clinical research on the prevention and treatment of COVID-19 with TCM, with the current registered protocols covers the whole process of disease prevention, treatment and rehabilitation. However, issues need to be concerned, including unclear definition of patient's condition, unclear research objectives, unclear intervention process and inappropriate outcomes, etc. In addition, researchers should consider the actual difficulties and workload of doctors in epidemic response environment, and make effort to optimize the process and improve the operability of research protocols under the principle of medical ethics.
Betacoronavirus ; COVID-19 ; China ; Clinical Trial Protocols as Topic ; Coronavirus Infections/drug therapy* ; Drugs, Chinese Herbal/therapeutic use* ; Humans ; Medicine, Chinese Traditional ; Pandemics ; Pneumonia, Viral/drug therapy* ; Randomized Controlled Trials as Topic ; Research Design ; SARS-CoV-2 ; COVID-19 Drug Treatment

Clinical epidemiology is defined as a method for investigating the distribution and determinants of diseases and for applying this knowledge in their prevention, and simply means application of epidemiological methods for medical research. In evidence-based medicine, randomized controlled trials (RCT) are the gold standard for assessing efficacy and safety of the intervention, while it is commonly impractical because of many limitations, such as ethical/legal problems and weak external-validity. High internal-validity of RCT permits to assess the direct efficacy of intervention without interference with bias and confounder; however, it has less generalizability or applicability to the real-life practice. Evidence-based practical guidelines are developed for patient management and decision making in real-life practice; paradoxically, the evidence of the guidelines does not come from real life, but from strict trial life. To overcome these limitations, pragmatic clinical trials for assessing the effectiveness of intervention in real-life practice or high-quality observational studies would be the best alternatives or could add more strong evidence. This article provides an overview of clinicoepidemiological research designs in the field of childhood allergic diseases and their strength/weakness.
Bias (Epidemiology) ; Child ; Decision Making ; Epidemiologic Methods ; Epidemiology ; Evidence-Based Medicine ; Humans ; Hypersensitivity ; Pragmatic Clinical Trial ; Pragmatic Clinical Trials as Topic ; Research Design*

pragmatic clinical trial. At the final phase of the trial, we invited 698 potentially-involved care providers in the survey regarding their willingness to use 2-mSv CT. Multivariable logistic regression analyses were performed to identify factors associated with willingness. Nine months after the completion of the trial patient recruitment, we surveyed whether the hospitals were using 2-mSv CT in usual practice.RESULTS: The analyses included responses from 579 participants (203 attendings and 376 trainees; 221 radiologists, 196 emergency physicians, and 162 surgeons). Regarding the willingness to immediately change their standard practice to 2-mSv CT, 158 (27.3%), 375 (64.8%), and 46 (7.9%) participants responded as “yes” (consistently), “partly” (selectively), and “no”, respectively. Willingness varied considerably across the hospitals, but only slightly across the participants' departments or job titles. Willingness was significantly associated with attendings (p = 0.004), intention to maintain the dedicated appendiceal CT protocol (p < 0.001), belief in compelling evidence on the carcinogenic risk of conventional-dose CT radiation (p = 0.028), and hospitals having more than 1000 beds (p = 0.031). Fourteen of the 20 hospitals kept using 2-mSv appendiceal CT in usual practice after the trial.CONCLUSION: Despite the extensive efforts over the years of this clinical trial, many care providers were willing to use 2-mSv CT selectively or not willing to use.]]>
Adolescent ; Appendicitis ; Emergencies ; Humans ; Intention ; Logistic Models ; Patient Selection ; Pragmatic Clinical Trial ; Prospective Studies ; Radiation Dosage ; Surgeons ; Surveys and Questionnaires ; Young Adult