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Meal challenge buffet energy intake | There was no significant difference in total energy intake (AL 2887 [194] kJ, SB 3185 [196] kJ; Proportion of total energy contributed by core and discretionary foods at buffet | PMC9614749 |
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Discussion | appetite suppression, satiety | As rates of overweight and obesity continue to rise throughout the developed world, it is important to understand the mechanisms that regulate eating behaviours. Satiation and satiety are important factors in regulating food intake by suppressing hunger and hence food intake [Our study demonstrates that the consumption of almonds resulted in a smaller C-peptide response and a larger GIP, GLP-1 (timepoint comparisons only), glucagon and PP response compared to consuming an isocaloric carbohydrate-rich snack bar. Similar results have been reported in other studies investigating the effects of consuming nut (walnuts and pistachios) on appetite-regulating hormones [The nutritional profile of nuts, which includes high levels of protein, fibre, and unsaturated fatty acids, has been suggested to contribute to their satiating properties [Glucose-dependent insulinotropic polypeptide (GIP) is a pancreatic hormone with receptors in the β-cells of the pancreas which promote insulin secretion [GLP-1 is secreted in the ileum in response to carbohydrate and fat [Pancreatic polypeptide (PP) is secreted from endocrine cells in the pancreas in response to carbohydrate, protein and fat, with fat being the most potent stimulus and carbohydrate the least potent [Although we observed significant effects of AL on C-peptide, GIP, GLP-1, glucagon and PP responses compared to SB, these responses alone without significant changes in other appetite-regulating hormones (e.g. CCK, PYY and ghrelin) may have been insufficient to trigger a meaningful appetite suppression. Therefore, it is not unexpected to see no differences in self-reported appetite sensations, or subsequent energy intake. However, appetite regulation is complex, and while the effects of the appetite hormones that we measured are well-characterised, there is not a direct correlation between appetite hormones, self-reported appetite ratings and subsequent energy intake within the literature [Although not significant, the AL group consumed 300 kJ less energy in the meal challenge than the SB group, 270 kJ of which came from discretionary foods, which may be a clinically important benefit in weight management. This occurred despite no significant difference in subjective appetite ratings. Ratings of appetite may reflect motivation or drive to eat, but the amount of food eaten may be influenced by factors other than motivation such as habit, expectations or availability [ | PMC9614749 |
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Strengths and limitations | weight gain, adiposity, overweight or obesity | ADIPOSITY, BROWN | This study was conducted prior to and during the COVID-19 pandemic, and restrictions on clinical research which occurred once the pandemic began prevented the study team from continuing the food buffet protocol. Thus, only those participants who completed the study prior to the onset of the pandemic completed the buffet meal component.This study included participants with overweight or obesity, an important population group for appetite management. However, as individuals with elevated adiposity may respond differently, future research should examine differences between weight categories, specifically in a healthy weight population for the prevention of weight gain. While matching test foods for energy is important, future studies should also match on volume. The discrepancy between volume of almonds, half the gram amount of the snack bar, may have had an impact on results (See supplementary Table 1). Short-term, acute/early phase satiety responses were measured over a 2-h period. Brown et al. demonstrated that reduced energy intake occurred over 24 h and appetite effects may therefore need to be measured over a longer period [ | PMC9614749 |
Conclusion | obesity, weight loss, fullness, diabetes | OBESITY, DIABETES | Foods that promote satiety help to regulate energy balance and may assist with weight management. Future studies should consider test food dose and composition carefully as the volume of food, its sensory qualities, and the acceptance of the food respective of usual meal patterns, may be important in eliciting a feeling of fullness and satisfaction.Appetite hormone responses may be skewed in obesity, so testing in a healthy weight population may provide additional insight into population-based differences. In addition, measures of glucose and insulin would be useful to further explore metabolic responses, and testing in populations with diabetes is warranted.This study focuses on early phase satiety, so measuring responses over the long-term and after weight loss will better model the studies relating nut consumption to weight management. | PMC9614749 |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (PDF 191 KB)We would like to thank the research staff, placement students and volunteers for their involvement in the study. | PMC9614749 |
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Author contributions | RECRUITMENT | AMC was the principal investigator for the study. AMC, JDB, AMH, S-YT, GBR were co-investigators on the grant application and as such were involved with the original design. SC, AMH, JDB, AMC were involved with study coordination and were responsible for the day to day running of the trial, recruitment and sample collection. All authors (SC, AMH, JDB, S-YT, GBR, AMC) contributed to the conceptualization, data curation, analysis, statistical interpretation, writing and preparation of this manuscripts for publication. | PMC9614749 |
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Funding | Open Access funding enabled and organized by CAUL and its Member Institutions. This work was funded by the Almond Board of California. This funding source had no role in the design of this study or the analysis and interpretation of the data. | PMC9614749 |
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Declarations | PMC9614749 |
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Conflict of interest | AMC has consulted for Nuts for Life (an initiative of the Australian Tree Nut Industry). S-YT has previously been involved in studies funded by the Californian Walnut Commission. AMC, JDB and S-YT have previously been involved in studies funded by International Nut and Dried Fruit Council. | PMC9614749 |
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References | PMC9614749 |
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Subject terms | SARS-COV-2 INFECTION | The efficacy of Hydroxychloroquine (HCQ) as post-exposure prophylaxis (PEP) for the prevention of COVID-19 was contentious. In this randomized control double-blind clinical trial, asymptomatic individuals with direct contact with laboratory-confirmed COVID-19 cases were randomized into PEP/HCQ (N = 574) and control/placebo (N = 594) group. The PEP/HCQ group received tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks, and the control/Placebo group received matching Placebo. The incidence of COVID-19 was similar (p = 0.761) in PEP [N = 24 out of 574, (4.2%)] and control [N = 27 out of 594, (4.5%)] groups. Total absolute risk reduction for the incidence of new-onset COVID-19 was -0.3% points with an overall relative risk of 0.91 (95% confidence interval, 0.52 to 1.60) and the number needed to treat (NNT) was 333 to prevent the incident of one case of COVID-19. The study found that, PEP with HCQ was not advantageous for the prevention of COVID-19 in asymptomatic individuals with high risk for SARS-CoV-2 infection. Though HCQ is a safer drug, the practice of irrational and indiscriminate use of HCQ for COVID-19 should be restrained with better pharmacovigilance. | PMC9825075 |
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Introduction | thrombotic eventsMany | MAY, VIRUS, SARS-COV-2 INFECTION, SECONDARY INFECTION | The novel corona virus (SARS-CoV-2) pandemic affected more than 575 million people worldwide with more than 6.3 million loss of life, as of 2nd August 2022When the study was carried out, there were no definitive therapeutic drugs available for the treatment of COVID-19. COVID-19 patients used to be managed with symptomatic and supportive care only, which includes mechanical ventilation, antibiotics for secondary infection, anti-inflammatory or immune-modulators for the hyperimmune response, and blood thinner to combat thrombotic eventsMany drugs, Ribavirin, Lopinavir, Remdesivir, Molnupiravir, ChloroquineHydroxychloroquine sulfate (HCQ), a chloroquine analog, was explored both for treatment as well as prevention of COVID-19 because of its potential anti-viral propertiesInitially, in March 2020 and subsequent revision with supporting evidence in May 2020, the Indian Council of Medical Research (ICMR) advisory endorsed HCQ prophylaxis for the individuals at risk for SARS-CoV-2 infection, which included all asymptomatic health care workers (HCW) involved in suspected or confirmed COVID-19 patient-care and all asymptomatic household contacts of laboratory-confirmed COVID-19 casesBut there were contradictory scientific evidence to prove or disprove the efficacy of HCQ as post-exposure chemo-prophylaxis for the prevention of COVID-19 in individuals at risk for SARS-CoV-2 infectionHousehold individuals in direct contact with COVID-19 patients are at extreme risk for SARS-CoV-2 infection. HCW represented a large part of the sample in the majority of the concluded studies and there were still limited clinical trials regarding the HCQ prophylaxis for the prevention of COVID-19 in non-HCW individuals who were at risk of SARS-CoV-2 infection. Through this RCT we made an effort to evaluate the efficacy of HCQ as PEP for the prevention of COVID-19 in asymptomatic household individuals in direct contact with laboratory-confirmed COVID-19 cases, who were not HCW. As a research institute of national interest, it brought us enormous scope to generate such strong evidence which could be utilized in reforming nationwide and global guidelines for the battle against COVID-19 pandemic. | PMC9825075 |
Methods | The methodology followed in this study was similar to our previously published institutional study, regarding HCQ prophylaxis for the prevention of COVID-19 | PMC9825075 |
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Aims of the study | To evaluate the efficacy of Hydroxychloroquine (HCQ) as post exposure prophylaxis (PEP) for the prevention of COVID-19 in asymptomatic high-risk household individuals in direct contact with the laboratory-confirmed COVID-19 cases. | PMC9825075 |
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Site of study | Communicable disease | COMMUNICABLE DISEASE, EMERGENCY | It was a single center study. The individuals with history of high-risk direct contacts with COVID-19 case were screened and enrolled for the study in the COVID-19 screening clinic at Emergency medical outpatient department (EMOPD) and Communicable disease ward of the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. The study was executed under cooperation between the Department of Internal Medicine, Virology, Pharmacology, and Community Medicine & School of Public Health of the institution. | PMC9825075 |
Study design | BLIND | In this randomized control double blind clinical trial, asymptomatic individuals with direct contact with laboratory-confirmed COVID-19 cases were screened for enrolment according to the inclusion and exclusion criteria and randomized into PEP/HCQ and control/placebo group after getting written informed consent. The participants were family members, relatives, friends or colleagues who were living with or spent hours/days with COVID-19 patients without following any personal protective measures | PMC9825075 |
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Study duration | The clinical trial was executed from the month of March to July 2021 during the second wave of the COVID-19 pandemic. The enrollment period was from 22nd march 2021 to 17th June 2021. The Delta variant of COVID-19 was an emerging predominant variant during that time. | PMC9825075 |
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Inclusion and exclusion criteria | Regardless of gender with age ≥ 18 years, all asymptomatic individuals with direct contact with laboratory-confirmed COVID-19 cases were included in the study | PMC9825075 |
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Method and intervention | followsThe | DISEASE PROGRESSION, BLIND | In this randomized control double blind clinical trial, the participants were randomly assigned into either PEP/HCQ group or control/placebo group, after getting written informed consent. The PEP/HCQ group received tablet HCQ 400 mg q 12 hourly on day one, followed by 400 mg once weekly for 3 weeks (total 5 tablets and collective dose of 2000 mg). The control/Placebo group received matching Placebo, 1 tablet q 12 hourly on day one, followed by one tablet once weekly for 3 weeks (total 5 tablets) instead of HCQ. Both groups were advised with standard care in the form of home quarantine for 2 weeks along with social distancing, and personal hygiene. The dose of HCQ for the study intervention was reached according to the ICMR recommendation for PEP with HCQThe COVID-19 cases were defined and categorized as followsThe participants, who were diagnosed to be COVID-19 cases, were instructed for continuing home quarantine along with symptomatic medications. They were followed up telephonically for any disease progression and offered admission at the COVID-19 center of the institution, PGIMER, Chandigarh, for further treatment according to the institutional COVID-19 management protocol. | PMC9825075 |
Outcome | ADVERSE DRUG REACTION | Primary outcome was the incidence of COVID-19 cases, definite COVID-19 cases & probable COVID-19 cases. Secondary outcomes were 1.new onset symptoms of COVID-19, 2. Compliance to the advised therapy, 3. Incidence of adverse drug reaction (ADR). | PMC9825075 |
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Sample size and statistical analysis | As per our institutional pilot study during the first wave of the COVID-19, the incidence of COVID-19 was considerably (P = 0.033) lower in the PEP group (10.6%) that received HCQ prophylaxis compared to the control group (19.5%) with absolute risk reduction of –8.9% pointsStudy design, screening and enrollment. | PMC9825075 |
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Results | PMC9825075 |
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Study population’s baseline characteristics | Diabetes mellitus, co-morbidity, bronchial asthma, hypothyroidism, hypertension | DIABETES MELLITUS, BRONCHIAL ASTHMA, HYPOTHYROIDISM, HYPERTENSION, CORONARY ARTERY DISEASE | Out of 1168 participants, majority of the participants were male 865 (74.1%) than female 303 (25.9%). Study population’s mean age was 35.0 (± 10.4) years, with majority of the participants were from 18 to 45 years age group (84.4%), followed by > 45–65 years age group (14.2%), and > 65 years of age group (1.4%). None of the participants had previous history of COVID-19. Out of 1168 participants, 234 (20.0%) individuals were alcohol consumers and 101 (8.6%) individuals were smokers. Diabetes mellitus (N = 43, 3.7%) was the most common co-morbidity, followed by hypertension (N = 41, 3.5%), hypothyroidism (N = 11, 0.9%), coronary artery disease (N = 3, 0.2%) and bronchial asthma (N = 1, 0.08%).The study groups were comparable for the age, age-groups, gender, risk factors and co-morbidity (Table Baseline demographic and clinical parameters of the study population. | PMC9825075 |
Symptomatic COVID-19 | Out of 51 COVID-19 cases majority of them were symptomatic 41 (80.4%) and only 10 (19.6%) participants were asymptomatic. The incidence of symptoms were comparable (p = 0.317) between the control group [N = 24 out of 594, 4.0%] and PEP [17 out of 574, 3.0%] groups (Table | PMC9825075 |
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Secondary outcome | gastritis-related symptoms, nausea, anxiety, vomiting, palpitation, skin rash | ADVERSE EVENTS, RECURRENCE, SIDE EFFECT | Overall compliance to the therapy was very good. The compliance to therapy was inadequate in 4 (0.3%) participants (1 in control group and 3 in PEP group) who stopped taking medication after day one either due to side effect or the anxiety related to the possible side effect. The drug was well tolerated and no serious adverse events were observed during the study period. Overall, 7 (0.6%) participants reported ADR, which was similar (P = 0.739) in the control (4, 0.7%) and PEP (3, 0.5%) groups. Most common ADR was gastritis-related symptoms in the form of epigastric abdominal discomfort with burning sensation, nausea and vomiting reported after loading dose by 4 participants (2 each from control and PEP group) which resolved with antacid without recurrence thereafter. Itching with skin rash over the foot was noticed in 2 participants (1 each from either group), which resolved spontaneously within few days after discontinuation of the study drug. Episode of palpitation was reported by one participant from PEP group during the follow-up. It was a single episode, self-limiting and lasted for less than a minute, for which no specific treatment was required, and there was no recurrence of episodes of palpitation thereafter. | PMC9825075 |
Discussion | retinopathy, G6PD-deficient, rheumatoid arthritis, systemic lupus erythematosusHCQ, SARS-CoV-2 infection, illness, palpitation, haemolysis | RETINOPATHY, RHEUMATOID ARTHRITIS, VIRUS, CARDIAC ARRHYTHMIAS, SARS-COV-2 INFECTION, RECURRENCE, DISEASE, EVENT, CARDIAC EVENTS, LOSS OF VISION, HYPOGLYCAEMIA | In this randomized, double-blind placebo-controlled clinical trial, 1168 asymptomatic individuals of high risk household direct contact with the laboratory-proven COVID-19 cases received PEP with either HCQ or Placebo and followed up for 4 weeks for the detection of new onset COVID-19. We found that PEP with HCQ was not associated with significant reduction in incidence of new onset COVID-19 as compared to the Placebo. Vaccines against COVID-19 came with great hope for the prevention of COVID-19 as well as reduction of the severity of illness and subsequent decrease in mortality. Even after more than a year of vaccine roll-out, many countries are going through multiple waves of the pandemic adding further assault to already traumatised human lives. Despite covering more than 66% of the population with full 2-dose vaccination, countries like the USA, UK and India have no respite from the surge of new COVID-19 casesHCQ generated sense of belief for the treatment and prevention of COVID-19 due to its in vitro virucidal action against SARS-CoV-2Presently evidence emerged against the therapeutic benefit of HCQ in hospitalised COVID-19 patients in term of recovery and prevention of mortalityBoulware et al. defined COVID-19 cases as symptomatic illness supported by a positive molecular assay or COVID-19-related symptoms, but asymptomatic presentation of COVID-19 is also very frequentIn Boulware et al. the majority (66.4%) of participants were HCW. There is still scarcity of RCT, exploring PEP with HCQ for the prevention of SARS-CoV-2 infection in high-risk household direct contacts of COVID-19 cases. The present study aimed to evaluate the efficacy of HCQ as PEP for prevention of COVID-19, particularly in asymptomatic household direct contacts of the laboratory-confirmed COVID-19 cases. Though, the HCW related to COVID-19 patient care and the household direct contacts of COVID-19 cases are at risk for SARS-CoV-2 infection, they have a comparatively different risk category. HCWs are expected to participate in COVID-19 patient care after wearing personal protective equipments, usually for a fixed duty hours, and can retain a safe distance from the patients as per feasibility. The household contacts get exposure to COVID-19 unknowingly without any precautions or personal protective equipment, as the patients are either family members or friends or relatives, and they live with COVID-19 patients for days to weeks without retaining a safe distance. Therefore, household direct contact possesses a greater risk for COVID-19 compared to HCW and incidence of COVID-19 after exposure may differ in HCW and household direct contact. So the HCW were excluded from the present study.In a household RCT, Barnabas et al. concluded that PEP with HCQ was not efficacious for the prevention of COVID-19Additionally, a Cluster-Randomized Trial concluded that PEP with HCQ did not prevent SARS-CoV-2 infection in asymptomatic direct contact of COVID-19 casesSafety has always been a concern against the use of HCQ as it can cause life-threatening cardiac arrhythmias, QT prolongation, retinopathy causing loss of vision, hypoglycaemia, and haemolysis in G6PD-deficient patients. However, these side effects are not common in conventional practice and HCQ has been found to be safe with prolonged lifelong use in rheumatoid arthritis and systemic lupus erythematosusHCQ was also tried unsuccessfully against the previous corona virus pandemic (MARS) and perhaps COVID-19 is not the last corona virus pandemic either. Despite the unfavorable results of HCQ for the treatment and prevention of COVID-19, the practice of irrational use of HCQ for the prevention of COVID-19 still continues in many countriesHCQ remains a myth only as it couldn’t produce sufficient in vivo evidence in favor of its benefit against COVID-19. But, at the same time it opens the gate for further research in search of newer and efficacious anti-viral drugs or repurposing of the established drugs against SARS-CoV-2 making us more efficient in defeating this ongoing pandemic. Till then, vaccination, increasing social awareness about the disease and better adherence to the use of face mask, maintaining adequate social distancing and hand hygiene are the best way for the prevention of COVID-19, breaking the chain of transmission of COVID-19 in communityLimitation of the study was, being a single center clinical trial raised doubt regarding the representation of large diverse Indian population. However, being a tertiary care center, the PGIMER caters to multiple states which include Punjab, Haryana, Himachal Pradesh, Uttarakhand, Uttar Pradesh, Jammu & Kashmir, Rajasthan and Bihar, representing large and diverse parts of India.The event number (primary end point) was lower than expected. The sample size may have been inadequate to exclude small but clinically meaningful decreases in the incidence of SARS-CoV-2 infection in high risk individuals.Follow-up ECG could not be done to detect new onset QT prolongation. Only one patient had a self-limiting episode of palpitation without recurrence, and none of the participants reported any symptoms related to any acute cardiac events.Majority of the participants represented a younger (18–45 years) age group (84.4%) with less representation for older age groups who may have contrasting risk factors for COVID-19 than younger population, and only 3 participants from > 45 years age group had COVID-19 (Table In conclusion, PEP with HCQ is not advantageous for the prevention of COVID-19 in asymptomatic household direct contact of the laboratory-confirmed COVID-19 cases. Though HCQ is a safer drug, the practice of irrational and indiscriminate use of HCQ for COVID-19 should be restrained with better pharmacovigilance till further supportive evidence emerges. Till then, mass vaccination, increasing social awareness and use of face masks, social distancing and personal hygiene are the best ways for the prevention of COVID-19. | PMC9825075 |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-022-26053-w. | PMC9825075 |
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Acknowledgements | We thank and acknowledge AKUMS Drugs & Pharmaceuticals LTD. Research & Development center Haridwar, Uttarakhand, for providing GMP-certified matching placebo tablets of Hydroxychloroquine (400 mg) free of cost. We are also grateful to all the participants for their voluntary participation in this clinical trial to create a better understanding about HCQ for the prevention of COVID-19. | PMC9825075 |
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Author contributions | RECRUITMENT | D.P.D.: Concept, design, contact tracing, recruitment, data analysis, data interpretation, protocol & manuscript writing. N.A.: Plan Execution, screening, contact tracing, follow up, data collection, Case record form. D.C.: Plan Execution, screening, contact tracing, recruitment, data collection, Case record form. A.P.: Data analysis, statistical analysis, interpretation, A.D.R. monitoring. B.M.: Expert guidance and ADR monitoring. N.S.: Screening data collection. R.M.: Participant management, isolation and diagnosis. V.S.: Participant management, isolation and diagnosis. A.B.: Participant management, isolation and diagnosis, expert guidance. N.S.: Expert guidance and resource facility availability. M.P.S.: SARS-CoV-2 RTPCR processing, interpretation, reporting. P.V.M.L.: Epidemiological analysis and interpretation. K.G.: SARS-CoV-2 RTPCR processing, interpretation, reporting. A.G.: SARS-CoV-2 RTPCR processing, interpretation, reporting. | PMC9825075 |
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Data availability | All reasonable data requests should be submitted to the corresponding author (DPD) for consideration. | PMC9825075 |
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Competing interests | The authors declare no competing interests. | PMC9825075 |
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References | PMC9825075 |
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Aim and background | autoimmune mucocutaneous disorder, OLP | ORAL LICHEN PLANUS | Oral lichen planus (OLP) is a chronic autoimmune mucocutaneous disorder of unknown etiology and treatment is targeted at alleviating symptoms. At present, corticosteroids are the mainstay treatment, and their side effects hamper their long-term use, demanding alternative therapy. This study intended to assess the efficacy of topical purslane | PMC10507837 |
Materials and methods | thirty-four, OLP | After sample size determination, thirty-four subjects confirmed histopathologically with OLP were included in the study. They were divided into 3 groups, Group 1(Control) was treated with 0.1% triamcinolone acetonide, and Group 2(Case) and 3 (Case) were treated with topical purslane 5% and 10%, respectively. They were examined at baseline, 14 days, 30 days, 60 days, and 90 days. Clinical improvement was then analyzed at the end of 90 days using a visual analog scale (VAS) and Thongprasom’s criteria. | PMC10507837 |
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Results | The study was analyzed statistically and a | PMC10507837 |
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Conclusion | Purslane, OLP | Purslane is a magical herb with a plethora of rich nutrients, ease in accessibility and devoid of side effects. It was concluded that its preparation is beneficial and can be a safer alternative long-term drug for the management of OLP. | PMC10507837 |
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Clinical significance | With available literature evidence, our present study is the first of its kind to formulate a topical gel with purslane to treat symptomatic OLP. Our study had a longer follow-up of 3 months compared to other studies in the literature. | PMC10507837 |
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Keywords | PMC10507837 |
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Introduction | ulcerative, OLP [, chronic inflammatory disorder, OLP, plaque-type, malignant disorder, cardiac glycoside | DISORDER, REMISSIONS, ULCERATIVE, DISORDERS, AUTOIMMUNITY, PATHOGENESIS, ORAL CANCER, PLAQUE, ORAL LICHEN PLANUS, OXIDATIVE STRESS, CHRONIC INFLAMMATORY DISORDER, ATROPHIC, DESQUAMATIVE GINGIVITIS | The World Health Organization Collaborating Centre for Oral Cancer Workshop held in the United Kingdom (2020) confirmed oral lichen planus (OLP) as a potentially malignant disorder. OLP is defined as a “chronic inflammatory disorder of unknown etiology with characteristic relapses and remissions, displaying white reticular lesions, accompanied or not by atrophic, erosive, and ulcerative and/or plaque-type areas’. Lesions are frequently bilaterally symmetrical. Desquamative gingivitis may be a feature” [To date, the etiology remains ambiguous, and multifactorial facets have been attributed, including genetic background, infectious agents, autoimmunity, psychological stress, and deleterious habits such as cigarette smoking and betelnut chewing. Various systemic disorders have also been hypothesized to contribute to etiology [OLP has six clinical subtypes: reticular, papular, plaque - like, bullous, erythematous, and ulcerative [Considering the autoimmune nature of the disorder, OLP is recalcitrant, and its management is oriented toward symptom alleviationPhytomedicine is rich in antioxidant and anti-inflammatory characteristics, making it an excellent alternative for safer, affordable, and efficient medication [Purslane is an edible herb with medicinal properties. It boasts phytochemical richness, namely, flavonoids, alkaloids, coumarins, anthraquinone glycoside, cardiac glycoside, fatty acids, terpenoids, polysaccharides, vitamins, sterols, proteins, and minerals. Additionally, it has higher β-carotene, ascorbic acid, and alpha-linolenic acid levels. The pharmacological actions are myriad actions ranging from antibacterial, antiulcerogenic, anti-inflammatory, antioxidant, wound healing and purgative to emollient, muscle relaxant, and diuretic properties [Studies by Bao and Chen et al. report that oxidative stress is one of the causative factors in the pathogenesis of OLP [ | PMC10507837 |
Aims and objectives | This study aims to assess and compare the therapeutic efficacy of topical purslane gel at two concentrations (5% and 10%) against topical triamcinolone acetonide 0.1% OLP management. | PMC10507837 |
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Materials used | PMC10507837 |
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Study design | Proper ethical clearance was obtained from the Institutional Review Board (SRMDC/IRB/2020/MDS/No.901), and the study was registered in the Clinical trial registry of India (CTRI/2021/09/036647) on 20/09/2021. A double blinded randomized controlled clinical trial was proposed and conducted in the Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Chennai, for a duration of 16 months (March 2021 - July 2022). Randomization of participants into each group was carried out using computer generated sequence numbers and allocation of participants to each group was performed using the Excel RAND function.As our study is a double blinded study, the primary researcher is blinded to the allocation of participants into the treatment group as they carry out the treatment and evaluate the outcome. The participants are blinded to the type of gel they are provided with. The allocation of the patients will be performed by a researcher who is not involved in patient evaluation. | PMC10507837 |
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Study samples | Based on the Agha Hosseini et al. (2010) study [ | PMC10507837 |
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Inclusion criteria |
Patients clinically diagnosed with symptomatic OLP were further confirmed by histopathology.Patients who had not used systemic or topical glucocorticosteroids for at least the past 2 weeks.Patients who agreed not to use any other medication such as analgesics and anesthetics in either topical form or systemic form during the study. | PMC10507837 |
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Exclusion criteria | lichenoid lesions, allergic, ulcerative | HYPERSENSITIVITY REACTIONS, ULCERATIVE |
Patients who are not willing to be a part of the study.Patients with lichenoid lesions are thought to develop hypersensitivity reactions to drugs and dental materials.Patients on long-term glucocorticosteroid therapy.Pregnant and lactating mothers.Patients who are allergic to purslane.Participants had a clinical appearance of an erythematous, ulcerative, and bullous type of OLP. | PMC10507837 |
Methodology | PMC10507837 |
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Preparation of purslane gel | Fresh leaves from Portulaca oleracea were collected from the local market in Tondiarpet, Chennai, Tamil Nadu washed with running water, shade dried, and powdered to granules. It was processed to obtain the ethanolic extract, which was formulated with the ora-base gel at 5% and 10% concentrations. The composition of the gel formulation is given in Table Formulation of the gelIn vitro analysis was performed for the prepared gel to evaluate antimicrobial, antioxidant and cytoprotective effects. For antimicrobial properties, a 10% concentration of purslane gel showed complete inhibition of both gram positive and gram negative bacteria. A 5% concentration of purslane gel showed no inhibitory concentration against | PMC10507837 |
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Double-blinded randomized controlled trial | chief complaints of burning sensation, pain | ORAL LICHEN PLANUS, ATROPHIC | Participants with chief complaints of burning sensation or pain were selected for the study. Thirty-four participants with clinically diagnosed and histopathologically confirmed oral lichen planus were categorized into 3 groups by randomization. Participants were evaluated at baseline, 14 days, 30 days, 60 days, and 90 days for characteristics of burning sensation and pain scored using the Visual Analog Scale (VAS) - subjective scoring scale which has gradings from 0 - 10 where 0 is no pain, 1-3 is mild, 4–6 is moderate and 7 -10 is severe. The lesion size was scored using Thongprasom’s criteria - 0: No lesion, normal mucosa, 1: Mild white striae, no erythematous area, 2: White striae with atrophic area less than 1 cmBrief protocol of the study | PMC10507837 |
Statistical analysis | pain | The SPSS program (IBM SPSS Statistics, Version 20.0, Armonk, NY: IBM Corp.), the statistical analysis was carried out. “Shapiro Wilks test” was used to evaluate the normality of the data distribution of the study variables. Nonparametric tests were used to determine differences in significance between the comparison groups. Intergroup comparison for the study evaluated variables (burning sensation, pain, lesion score, symptomatic response of burning sensation, symptomatic response of pain, clinical response) and the age difference between the three groups was performed using the “Kruskal-Wallis test”. Intergroup comparison for nominal categorical variables (gender and site) were performed using “chi square test”. Using the “Friedman test” at various time points, an intragroup comparison was made for the research variables that were analyzed. For all comparisons, P 0.05 was considered statistically significant. | PMC10507837 |
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Results | pain | REMISSION | The descriptive statistics pertaining to “demographic data” (mean age group, gender, and site) for both intervention groups showed that the mean age of the 3 groups was 45.60(Group 1), 42.17(Group 2), and 40.25(Group 3). The results on mean age in our study are in accordance with the literature. The male: female ratio of each group was 3 males and 7 females in the control group, and 4 males and 8 females each in study groups 2 and 3. The overall gender distribution showed a female predilection of 23 (67.6%). The buccal mucosa was the most affected region, followed by the buccal mucosa along with the dorsum of the tongue, and the buccal mucosa along with the gingiva. There was no significant difference in the demographic data [mean age group (When the research variables were compared between the groups at each of the five time points, the intergroup comparison showed that there was no statistically significant difference between the compared groups (baseline, 14 days, 30 days, 60 days, and 90 days). An intergroup comparison of the study variables (symptomatic reaction of burning sensation (Intergroup comparison of symptomatic response - burning sensation & painIntergroup comparison of clinical response - Lesion scoreThe intragroup comparison of study variables showed a statistically significant difference between the five time periods (baseline, 14 days, 30 days, 60 days, and 90 days) according to the intragroup comparison (More cases in the “no burning sensation” category were reported at the end of three months for all three groups with percentage distribution of 50%, 33.3%, and 33.3% for groups 1, 2, and 3, respectively (Table Intragroup comparison of burning sensation at five different time periods** A greater number of cases in the “no pain” category was reported at the end of three months for all three groups with percentage distribution of 90%, 66.7%, and 75% for groups 1, 2, and 3, respectively (Table Intragroup comparison of pain at five different time periods** A greater percentage of the absence of lesions was observed at the end of three months for all three groups with percentage distribution of 50%, 41.7%, and 50%, respectively for the compared groups (Table Intragroup comparison of lesion scores at five different time periods** All the participants were followed up for a period of 3 months and there were no dropouts during the study. All the participants in the purslane study group showed partial to complete relief of burning sensation and pain along with partial to complete remission of at the end of three months. No side effects were reported in any of the groups. | PMC10507837 |
Discussion | pain, OLP [, OLP | ORAL LICHEN PLANUS, RECURRENCE, RECURRENT APHTHOUS STOMATITIS | PK Mankapure et al., undertook a study to better understand the demographics and clinical characteristics of OLP in 108 patients. The findings revealed that 87.9% of cases involved the buccal mucosa, with females making up 70.4% of those affected [Kia et al., assessed the comparative efficacy of triamcinolone and curcumin in OLP patients where the use of curcumin showed a significant response. However, few patients had a burning sensation, and few reported the undesirable yellow color of the drug [Najafi et al., in a placebo-controlled clinical trial, systemically treated recurrent aphthous stomatitis with 235 mg purslane, yielding favorable pain control outcomes and reduced recurrence. These results tout the antioxidant and anti-inflammatory efficacy of purslane [In a placebo-controlled study by Agha Hosseini et al., in 2010, oral lichen planus patients were treated with 235 mg capsules prepared from the ethanolic extract of purslane leaves, and the results showed better clinical improvement with no reported side effects making purslane a favorable, safer alternative for treating OLP [ | PMC10507837 |
Clinical significance | With available literature evidence, our present study is the first of its kind to formulate a topical gel with purslane to treat symptomatic OLP. Our study had a longer follow-up of 3 months compared to other studies in the literature. Additionally, the results were compared as intergroup and intragroup comparisons at all five time periods. Intragroup comparison of all the groups at five different periods showed that both 5% and 10% topical purslane gel showed significant efficacy compared to the gold standard, making it a reliable treatment option. | PMC10507837 |
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Conclusion | OLP | RECURRENCES | Over the period, corticosteroids have been the mainstay treatment for OLP. Undesirable effects of steroids have made it possible for more herbal therapies to be used, and many studies are being focused on in search of safer alternatives. Purslane, a magical herb with a plethora of rich nutrients, easy availability, and a lack of side effects, is beneficial and can be a safer alternative drug in OLP treatment. Future research with larger sample sizes, and longer follow-ups to check recurrences should also be included. | PMC10507837 |
Acknowledgements | We are thankful for Dr. Dhamodaran Umapathy, Academic Co- Ordinator (Tamil Nadu Chapter, Educational Multimedia Research Centre (EMMRC), Anna University Campus, Guindy for helping out in the gel preparation. | PMC10507837 |
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Clinical trial registry | The study was registered in Clinical trial registry of India (CTRI/2021/09/036647) registered on 20/09/2021. | PMC10507837 |
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Authors’ contributions | Arul Jothi Murugan - is the primary investigator of the study, conceptualized, collected the sample and the data, interpreted, and worked on the manuscript. Anuradha Ganesan- helped in framing the concept and study design. Guided throughout the study and helped in drafting the manuscript. Yesoda K. Aniyan - helped in framing the concept, study design and drafting the manuscript. Helped in recruiting the samples. Krithika Chandrasekar Lakshmi- Helped in recruiting the sample and corrections in the manuscript. Kannan A- Helped in recruiting the sample and corrections in the manuscript. | PMC10507837 |
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Funding | This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. It is a self-funded study. | PMC10507837 |
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Availability of data and materials | The datasets generated and/or analyzed during the current study are not publicly available as permission has to be obtained from the institution but are available from the corresponding author on reasonable request. | PMC10507837 |
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Declarations | PMC10507837 |
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Ethics approval and consent to participate | Proper ethical clearance obtained from Institutional Review Board (IRB) of SRM Dental College, Ramapuram, Chennai – 600089 (SRMDC/IRB/2020/MDS/No.901) and registered in Clinical trial registry of India (CTRI/2021/09/036647). Following the guidelines of the Helsinki declaration, participants who volunteered for the study and met the inclusion criteria were chosen. Informed consent was obtained from the participants of the study. | PMC10507837 |
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Consent for publication | Proper consent is obtained from the participants for the publication of study results without revealing personal information. | PMC10507837 |
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Competing interests | The authors declare no competing interests. | PMC10507837 |
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References | PMC10507837 |
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Background | malignancy, Neuroblastoma, NB | NEUROBLASTOMA | Neuroblastoma (NB) is a childhood malignancy with marked heterogeneity, resulting in highly variable outcomes among patients. This study aims to establish a novel nomogram and risk stratification system to predict the overall survival (OS) for patients with NB. | PMC10465685 |
Methods | neuroblastoma | REGRESSION, NEUROBLASTOMA | We analyzed neuroblastoma patients from the Surveillance, Epidemiology, and End Results (SEER) database between 2004 and 2015. The nomogram was constructed using independent risk factors for OS, identified through univariate and multivariate Cox regression analyses. The accuracy of this nomogram was evaluated with the concordance index, receiver operating characteristic curve, calibration curve, and decision curve analysis. In addition, we developed a risk stratification system based on the total score of each patient in the nomogram. | PMC10465685 |
Results | tumor, NB | BRAIN METASTASES, TUMOR | A total of 2185 patients were randomly assigned to the training group and the testing group. Six risk factors, including age, chemotherapy, brain metastases, primary site, tumor stage, and tumor size, were identified in the training group. Using these factors, a nomogram was constructed to predict 1-, 3-, and 5-year OS of NB patients. This model exhibited superior accuracy in the training and testing groups, exceeding traditional tumor stage prediction. Subgroup analysis suggested worse prognosis for retroperitoneal origin in the intermediate-risk group and adrenal gland origin in the high-risk group compared to other sites. Additionally, the prognosis for high-risk patients significantly improved after surgery. We also developed a web application to make the nomogram more user-friendly in clinical practices. | PMC10465685 |
Conclusion | This nomogram demonstrates excellent accuracy and reliability, offering more precise personalized prognostic predictions to clinical patients. | PMC10465685 |
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Keywords | PMC10465685 |
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Introduction | neuroblastoma, tumor, Neuroblastoma, malignancy, NB, intermediate-risk neuroblastoma | MALIGNANCIES, NEUROBLASTOMA, NEUROBLASTOMA, TUMOR | Neuroblastoma (NB) is a childhood malignancy that originates from the developing sympathetic nervous system (Maris Despite these advancements, the prognosis for patients with neuroblastoma still demonstrates substantial variability due to the considerable tumor heterogeneity. Patients with low- and intermediate-risk neuroblastoma exhibit an overall survival (OS) rate exceeding 90%, while those with high-risk neuroblastoma face a dismal prognosis, with survival rates as low as 50% (Baker et al. In recent years, nomograms have demonstrated superiority over traditional TNM staging system and have been extensively used for individualized estimation of prognosis in various malignancies (Liang et al. | PMC10465685 |
Methods | PMC10465685 |
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Patients and methods | PMC10465685 |
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Data source | cancer, Cancer | CANCER, CANCER | The patient data were extracted from the SEER database of the National Cancer Institute (NCI). The SEER database, administered by the NCI, serves as the authoritative source of information that provides updated data on cancer incidence and patient survival rates from population-based cancer registries, covering approximately 48.0% of the U.S. population. | PMC10465685 |
Patients selection | neuroblastoma, death, neuroblastoma or, deaths, ganglioneuroblastoma | ONCOLOGY, DISEASES, NEUROBLASTOMA, GANGLIONEUROBLASTOMA | Patients with neuroblastoma between 2004 and 2015 were selected from the SEER database according to the International Classification of Diseases for Oncology 3rd Edition (ICD-O-3). Inclusion criteria were: (1) age equal to or below 18 years, and (2) diagnosed with neuroblastoma or ganglioneuroblastoma (GNB). Exclusion criteria included: (1) survival time less than 1 month or unknown, (2) deaths attributed to causes other than neuroblastoma or ganglioneuroblastoma or unknown cause of death, (3) uncertainty surrounding whether cancer-directed surgery was performed, and (4) uncertainty regarding whether a surgical procedure other than at the primary site was performed. The selection criteria and screening process are depicted in Fig. Flowchart illustrating the inclusion and exclusion of patients | PMC10465685 |
Clinical variables and outcomes | tumor, death, Tumor | TUMOR, METASTASES, TUMOR | The collected patient information included age, race, sex, histology, primary site, tumor number, tumor size, first malignant primary indicator, tumor grade, distant metastases, tumor stage, surgery, scope of regional lymph node surgery, regional nodes, surgical procedure of other sites, chemotherapy, and radiotherapy. Racial categories were classified as White and others (including Asian or Pacific Islander, American Indian/Alaska Native, Black, or Unknown). The primary site was determined in several locations including the adrenal gland, retroperitoneum, and others. The tumor stage was classified into four types based on SEER Combined Summary Stage: localized, regional, distant, and unknown/unstaged. Distant metastases occurred in organs such as the bone, brain, liver, and lung. The optimal cutoff value for tumor size was determined by the X-Tile software, and then categories as 0–62 mm, 63–87 mm, 88–989 mm, and unknown. Tumor grade was stratified as Grade I (well-differentiated), Grade II (moderately differentiated), Grade III (poorly differentiated), Grade IV (undifferentiated), or unknown. OS served as the primary endpoint, defined as the duration (in months) from the date of diagnosis to death or the last follow-up. | PMC10465685 |
Statistical analysis | Analyses were performed using SPSS 26.0 (IBM, Chicago, IL, USA) and R software (version 4.2.2). Statistical significance was defined as | PMC10465685 |
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Prognostic nomogram construction | REGRESSION | Univariate and multivariate Cox regression analyses were carried out to identify independent prognostic factors. Significant factors ( | PMC10465685 |
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Prognostic nomogram validation | The concordance index (C-index) was used to measure the accuracy of model predictions. A value above 0.7 indicates that the predictive model has excellent discriminative ability. The receiver operating characteristic (ROC) curve was employed to evaluate the performance of classification models. An area under the ROC curve (AUC) above 0.7 signifies that the model possesses excellent discriminative ability. The calibration curve was used to verify the accuracy of probability predictions. A curve close to the 45-degree diagonal line indicates that the predicted probabilities are consistent with the actual observed probabilities. Finally, decision curve analysis (DCA) was utilized to appraise the clinical utility of a predictive model at different thresholds. | PMC10465685 |
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Risk stratification based on nomogram | Patients were categorized into three groups according to their total scores on the nomogram using X-tile software: the low-risk group (total score ≤ 140), the intermediate-risk group (140 < total score < 223), and the high-risk group (total score ≥ 223). The differences in survival among these risk categories were compared using Kaplan–Meier curves and log-rank tests. | PMC10465685 |
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Dynamic nomogram construction | A web-based dynamic nomogram was constructed using the open source R Shiny Server, which allows clinicians to conveniently assess patient prognosis using the nomogram. | PMC10465685 |
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Results | PMC10465685 |
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Patient characteristics | neuroblastoma, ganglioneuroblastoma | NEUROBLASTOMA, GANGLIONEUROBLASTOMA | A total of 2,185 patients were diagnosed with neuroblastoma or ganglioneuroblastoma between 2004 and 2015. Of these, 1529 were assigned to the training group and 656 to the testing group. The demographic and clinical features of the patients are outlined in Table Demographics and clinical characteristics of patients with neuroblastoma in the training and testing groups | PMC10465685 |
Nomograms validation | tumor | TUMOR | The accuracy and applicability of the nomogram were assessed using both the training and testing groups for internal and external validation. The C-index was first used for estimation, resulting in values of 0.790 (95% CI 0.768–0.812) and 0.781 (95% CI 0.750–0.812) for the training and testing groups, respectively. In contrast, the C-index values for the conventional tumor stage were 0.718 (95% CI 0.698–0.738) and 0.724 (95% CI 0.695–0.754) in the training and testing groups, respectively. In the ROC curve analysis, the AUC values for predicting 1-, 3-, and 5-year OS were 0.764 (95% CI 0.724–0.804), 0.812 (95% CI 0.784–0.840), and 0.829 (95% CI 0.803–0.855) in the training group, and 0.730 (95% CI 0.670—0.791), 0.783 (95% CI 0.743–0.823), and 0.810 (95% CI 0.773–0.848) in the testing group, respectively (Fig. Receiver operating characteristic (ROC) curves of the nomogram and combined summary stage. Calibration plots of the nomogram. Decision curve analysis (DCA) of the nomogram. | PMC10465685 |
Nomogram-Based risk stratification system | The overall prognostic score for each patient was calculated based on variables within the nomogram. Two optimal cutoff values were identified at 140 and 223 scores using X-tile software. Utilizing these thresholds, patients were stratified into low, intermediate, and high-risk groups, consisting of 1100 patients (50.3%, total score ≤ 140), 831 patients (38.0%, 140 < total score < 223), and 254 patients (11.6%, total score ≥ 223), respectively. The OS rates for the low-risk group were 98.7%, 97.4%, and 97.0% at 1, 3, and 5 years, respectively. In the intermediate-risk group, the OS rates were marginally lower at 90.0%, 77.1%, and 70.4% at 1, 3, and 5 years, respectively. However, patients in the high-risk group exhibited a substantially worse prognosis, with OS rates of merely 86.7%, 61.6%, and 46.9% at 1, 3, and 5 years, respectively (Fig. Establishment of a risk stratification system through the optimal cut-off value of the risk score. | PMC10465685 |
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Subgroup analysis based on the new risk stratification | PRIMARY TUMOR | To underscore the benefits of risk stratification, we conducted an analysis of primary tumor sites and surgical outcomes across the different risk groups. Intriguingly, we observed a poorer prognosis in the retroperitoneum for the intermediate-risk group, whereas a worse prognosis was noted in the adrenal gland for the high-risk group (Fig. | PMC10465685 |
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Web-based nomogram | NEUROBLASTOMA | We developed a web-based nomogram to predict patient outcomes (≤ 18 years) diagnosed with neuroblastoma. This accessible tool empowers physicians and patients alike to individually and visually appraise survival probability of each patient by selecting common clinical variables ( | PMC10465685 |
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Author contributions | XZ: Writing-Original draft preparation, Methodology, Software. LX: Data curation, Visualization, Investigation. WT: Conceptualization, Supervision. WH: Conceptualization, Writing-Reviewing and Editing. | PMC10465685 |
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Data availability | The data supporting the findings of this study are sourced from the publicly available Surveillance, Epidemiology, and End Results (SEER) Program ( | PMC10465685 |
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Declarations | PMC10465685 |
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Conflict of interest | On behalf of all authors, the corresponding author states that there is no conflict of interest. | PMC10465685 |
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References: | PMC10465685 |
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Background | anxiety | Test anxiety is a prevalent issue among students, including those in the medical field. The present study aims to examine the impact of auricular acupressure on reducing test anxiety specifically among medical students. | PMC10629063 |
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Methods | Anxiety | In this single-blind randomized parallel-group trial, a total of 114 medical students from Kermanshah, Iran, were allocated into two groups: intervention and control. Each group consisted of 57 students. The data collection instruments included a demographic information form and the Sarason Anxiety Inventory. In the intervention group, bilateral auricular acupressure was administered on the Shen Men point for a duration of 10 min. On the other hand, the control group received bilateral auricular acupressure on the Sham point, located in the earlobe, as a placebo, also for 10 min. | PMC10629063 |
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Results | anxiety | The mean test anxiety scores in the Shen Men acupressure group exhibited a significant reduction from 18.4 ± 5.3 before the intervention to 13.3 ± 4.8 after the intervention (P = 0.001). Conversely, in the Sham acupressure group, the mean test anxiety scores showed no significant change, with values of 16.36 ± 6.4 before the intervention and 16.4 ± 6.1 after the intervention (P = 0.963). Prior to the intervention, the majority of participants in both the intervention group (87.7%) and control group (86.0%) exhibited moderate to severe levels of test anxiety. Following acupressure, a significant improvement was observed in the intervention group, with 52.6% of participants experiencing a reduction to mild anxiety levels (P = 0.001); however, no notable change in anxiety levels was observed in the control group. Furthermore, a statistically significant difference in anxiety intensity after the intervention was found between the two groups (P = 0.001). | PMC10629063 |
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Conclusion | anxiety | Shen Men auricular acupressure demonstrates efficacy in reducing test anxiety among medical students. However, to validate its effectiveness, further research using objective measures is warranted. | PMC10629063 |
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Keywords | PMC10629063 |
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Introduction | anxiety | One common source of anxiety among students is examinations [Severe cases of test anxiety may necessitate therapeutic interventions [The Shen Men point, located in the triangular fossa of the ear, is an acupressure point known for its relaxing and analgesic effects [Test anxiety is a widespread issue among students, known to have detrimental effects on their physical, psychological, and academic well-being [
What is the prevalence of test anxiety among medical students?What is the effect of auricular acupressure at the Shen Men point on test anxiety?What is the effect of auricular acupressure at the Sham point (placebo) on test anxiety in the control group?Is there a significant difference in test anxiety levels between the intervention and control groups after the acupressure intervention? | PMC10629063 |
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Methods | PMC10629063 |
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Study design | The current study employed a randomized, single-blind, parallel-group trial design, adhering to the guidelines outlined in the Consolidated Standards of Reporting Trials (CONSORT) criteria [ | PMC10629063 |
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Sample and sampling method | anxiety | The study population consisted of medical students from Kermanshah University of Medical Sciences (KUMS), Iran. A total of 114 medical students were included in the study. Sample size estimation was conducted using the formula for comparing means between two independent groups. The sample size calculation was based on data from a study by Cho et al. (2021), where the mean anxiety scores in the intervention and control groups were reported as 41.1 ± 8.9 and 46.1 ± 9.9, respectively. Considering a test power of 80% and a confidence level of 95%, a total of 57 students were estimated for each group [The samples were selected for the study using convenience sampling and were then allocated to either the intervention or control group through block randomization. To carry out the randomization, an online tool ( | PMC10629063 |
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Study setting | The intervention was carried out in the examination hall of the Kermanshah School of Medicine, which serves as the venue for all medical students’ exams. The examination hall has a capacity to accommodate 200 students, providing a suitable environment for conducting the intervention in this study. | PMC10629063 |
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