High-quality Clinical Trials Research Articles

Clinical Trial of Herbal Medicine in Children

Herbal medicines have been used for decades to care for children's health. However, well-controlled clinical studies with herbal medicines in children are rare. Therefore, the authors' aim was to evaluate clinical trials with herbal medicines in children, based on literature searches in PubMed and the Web of Science. A total of 133 trials were identified. 90 studies were randomized, 32.2% were randomized and double-blind. Most of the studies were done in China, in the 6-12 age group and in children with respiratory diseases, most of the herbal medicines with Hedera helix were tested. Analysis shows that studies on herbal medicine are feasible in children. Although clinical trials were found, this literature search was limited and did not include all studies performed. However, only a few high-quality clinical trials have been identified. Therefore, further studies are needed to support good experimental results. A total of 133 trials were identified. 90 studies were randomized, 32.2% were randomized and double-blind. Most of the studies were done in China, in the 6-12 age group and in children with respiratory diseases, most of the herbal medicines with Hedera helix were tested. The review found that studies of herbal medicines are feasible in children and also highlights some significant challenges associated with effective monitoring of their safety.

The efficacy and safety of sodium nitroprusside in the treatment of schizophrenia: Protocol for an updated systematic review and meta-analysis.

Schizophrenia is a chronic persistent disease with high recurrence rate and high disability rate in the field of psychiatry. Sodium nitroprusside is a nitric oxide (NO) donor and considered a promising new compound for the treatment of schizophrenia. New high-quality clinical trials of sodium nitroprusside in the treatment of schizophrenia have been published in recent years. It is necessary to re-conduct the meta-analysis after the inclusion of these new clinical trials. Our study will conduct a systematic review and meta-analysis of the relevant literature in this field, so as to lay an evidence-based medicine foundation for the efficacy of sodium nitroprusside in the treatment of schizophrenia. Randomized controlled trials (RCTs) of sodium nitroprusside in the treatment of schizophrenia were searched through English databases (PubMed, Web of Science, Embase, and Cochrane Library) and Chinese databases (China Biology Medicine disc, VIP, WanFang Data, and CNKI). The extracted data will be inputted into Review Manager 5.3 for Meta-analysis. The included literature will be assessed for bias risk according to the bias risk assessment tools in the Cochrane Handbook for Systematic Reviews of Interventions. Funnel plots will be used to assess possible publication bias. Heterogeneity is tested by I2 and χ2 tests, and the existence of heterogeneity is defined as I2 ≥50% and P ≤0.1. If heterogeneity exists, the random-effect model will be used, and sensitivity analysis or subgroup analysis will be performed to further determine the source of heterogeneity. CRD42022341681.

Optimizing Adjuvant Therapy after Surgery for Colorectal Cancer Liver Metastases: A Systematic Review

The liver is the most common site of colorectal cancer metastatic spread. Although metastasectomy is the gold standard for fit patients with resectable colorectal cancer liver metastases (CRLMs), their management after surgical treatment remains controversial. The objective of this systematic review was to collate the currently available data of the agents used in the adjuvant setting in order to define the most optimal therapeutic strategy. A systematic review of the literature was conducted by searching PubMed/Medline and Cochrane library databases. We included studies that evaluated the efficacy, the tolerability and the safety profile of various chemotherapeutic agents that are used as adjuvant treatment after surgical resection of CRLMs. The outcomes of interest were regression-free survival (RFS), disease-free survival (DFS), overall survival (OS) and severe toxicities. From 543 initial articles, 29 publications with 7028 patients were finally included. In general, the results of the eligible studies indicated that adjuvant therapy after resection of CRLMs led to improved RFS/DFS rates, but this benefit did not contribute to a statistically significant prolongation of OS. Moreover, the choice of the therapeutic strategy, namely systematic or regional chemotherapy or the combination of both, did not seem to have a differential impact on patient outcomes. However, these results should be interpreted with caution since the majority of the chosen studies are of low or moderate quality. In this context, further high-quality clinical trials conducted on patient sub-populations with modern therapies are required in order to reduce in-study and between-study heterogeneity and determine which patients are expected to derive the maximum benefit from adjuvant therapy after surgery for CRLMs.

Trends in clinical trials for olfactory dysfunction in the COVID-19 era.

Nearly half of all olfactory dysfunction (OD) clinical trials since 2010 are COVID-19-related. COVID-19-related OD trials are published significantly faster than COVID-19-unrelated trials. High-quality clinical trials and publications are crucial to discovering effective treatments.

A CASE SERIES on the Convalescent Plasma use in SARSCOV2 PCR Positive Filipino Patients in Makati Medical Center

The COVID-19 pandemic has caused tremendous stress in the healthcare system worldwide with millions of death and morbidities. Convalescent plasma therapy has given hope for cure at this time of great uncertainty. Multiple studies and literature review attempted to understand the efficacy of the therapy but unable to provide definite and clear answers. This case series presents data on 55 Filipino patients who were given convalescent plasma therapy. In this observation, mean age of patients is 63 ± 13 years old, predominantly male (67.27%, N=37), all Filipinos, with 2 or more co-morbidities, with severe and critical case (92.73%, N=51), with symptoms of fever, difficulty of breathing and body malaise. Majority of the plasma were collected in -house, given after 2 weeks of illness but within 7 days of hospital admission. More patients were discharged at 60%(N=33). No improvement in Vital signs, Laboratory results and Chest X-ray was noted after Convalescent plasma therapy. The lack of high quality studies on plasma therapy and definitive cure in COVID-19 infection maintains convalescent plasma therapy as a possible cure, mostly at times of infection in a pandemic scale. High quality clinical trials in the use of Convalescent plasma therapy is encouraged to provide high quality data as basis of treatment recommendation.

Research Trends of Acupuncture Therapy on Myofascial Pain Syndrome from 2000 to 2022: A Bibliometric Analysis.

Acupuncture has been widely used to relieve myofascial pain syndromes (MPS) in many countries. However, the bibliometric analysis of the global application of acupuncture for MPS remains unknown. The present study aims to evaluate the research trends and hot spots of acupuncture for MPS. Literatures about acupuncture for MPS from 2000 to 2022 were obtained from the Web of Science. CiteSpace (6.1.R3) was used to analyze the number of publications, countries, institutions, authors, cited journals, cited authors, cited references and keywords. A total of 403 records were included in the final analysis. The total number of publications increased but with some fluctuations. The Pain was the most cited journals. The most productive country and institution were USA, and China Medicine University, respectively. Liwei Chou was the most prolific author, and Simons DG ranked first in the cited author. In the ranking of frequency and centrality in cited references, the first article was published by Tough EA and Simons DG, respectively. The keyword of "acupuncture" ranked first in frequency, "double blind" ranked first in centrality. "Meta-analysis" was the keyword with the strongest citation burst. There were three hot topics in this field, including "the clinical feature of MPS", "measure of intervention" and "research method". The mechanism of acupuncture on MPS was one of the main research directions. This study reveals that acupuncture was more and more acceptable, while the cooperation between different countries, institutions and authors should be strengthened. The researches of therapeutic effect and mechanism were the main research directions. More high-quality clinical trials are needed to confirm the therapeutic effect of acupuncture for MPS, and more studies to unify the acupuncture parameters such as frequency, duration, and intensity. More basic studies are needed to elucidate the precise mechanism of acupuncture for MPS.

General Anesthesia Versus Regional Anesthesia in the Elderly Patients Undergoing Hip Fracture Surgeries: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Surgery is the preferred treatment option for the elderly patients with hip fractures. However, the choice of general anesthesia (GA) or regional anesthesia (RA) remains controversial. The quality of evidence has further improved with the advent of several high-quality randomized clinical trials (RCTs) in the last two years. The purpose of this study was to compare the clinical outcomes of two anesthetic techniques in elderly patients undergoing hip fracture surgeries. Eligible studies were identified from PubMed/MEDLINE, Web of Science, Scopus, EMBASE and reference lists from January 2000 to June 2022 in this current systematic review and meta-analysis. The outcomes included the surgery-related outcomes (duration of surgery, duration of anesthesia, intraoperative blood loss and number of transfusions) and postoperative outcomes (30-day mortality, postoperative delirium,cardiovascular events and other complications). A total of 10 RCTs were included, and a total of 3594 patients were analyzed. RA was associated with shorter duration of surgery, shorter length of hospital stays and less intraoperative blood loss compared to GA. There were no significant differences between the two groups in the number of blood transfusions, duration of anesthesia, 30-day mortality or postoperative delirium. Our pooled analysis identified no significant differences in terms of the safety between RA and GA, while RA reduces intraoperative blood loss, length of hospital stays and duration of surgery. These results suggest that RA appears to be preferable for the elderly patients with hip fractures.

Effects of traditional Chinese exercises on the rehabilitation of patients with chronic heart failure: A meta-analysis.

With the development of rehabilitation medicine, exercise therapy has gradually become one of the methods to prevent and treat cardiovascular diseases. It is widely used in clinic because it can further reduce the mortality rate, improve clinical symptoms, restore the activity ability of the body, improve the quality of life of patients and reduce the hospitalization rate. Traditional Chinese exercises have developed rapidly in recent years, which mainly include Baduanjin, Tai Ji, etc. However, meta-analyses of all types of exercises are not well characterized. To evaluate the effect of traditional Chinese exercises (TCEs) on the rehabilitation of patients with chronic heart failure (CHF) using a meta-analysis. A systematic search of randomized controlled trials (RCTs) on TCEs for patients with CHF in 13 databases (PubMed, China National Knowledge Infrastructure, etc.). Meta-analysis was performed using Review Manager software (version 5.3) after two investigators independently screened the studies, assessed the quality of the studies, and extracted the data. Meta-analysis of 21 randomized controlled trials which involved 1,665 patients with chronic heart failure showed that practicing TCEs was effective in improving patients' physiological outcomes such as VO2max [MD = 2.14, 95% CI (1.02, 3.26), P < 0.001], AT [MD = 1.61, 95% CI (1.06, 2.16), P < 0.001], and left ventricular ejection fraction [MD = 2.60, 95% CI (1.17, 4.02), P < 0.001]. Non-physiological outcomes benefited from the application of TCEs: 6-min walking distance [MD = 38.55, 95% CI (36.67, 40.42), P < 0.001], quality of life [MD = 5.52, 95% CI (3.17, 7.88), P < 0.001], and single-item TCM symptom scores in CHF patients: tiredness and fatigue [MD = 0.78, 95% CI (0.03, 1.53), P = 0.04], shortness of breath [MD = 0.44,95% CI (0.26, 0.62), P < 0.0001], facial puffiness and limb swelling [MD = 0.44,95% CI (0.12, 0.76), P = 0.007], palpitations [MD = 0.68,95% CI (0.14, 1.21), P = 0.01] were improved. TCEs improved several recovery indicators, heart failure-related clinical symptoms, quality of life, and physiological indicators in patients with CHF. It is worthwhile to expand the participants for practical application in clinical practice, but the existing evidence is insufficient and the heterogeneity of outcome is large. Therefore, more high-quality clinical trials are needed to support these results. PROSPERO, identifier [CRD42022383246].

Three-Dimensional Evaluation Effects of Microimplant-Assisted Rapid Palatal Expansion on the Upper Airway Volume: A Systematic Review and Meta-Analysis

Microimplant-assisted rapid palatal expansion is increasingly used clinically; however, the effect on the upper airway volume in patients with maxillary transverse deficiency has not been thoroughly evaluated yet. The following electronic databases were searched up to August 2022: Medline via Ovid, Scopus, Embase, Web of Science, Cochrane Library, Google Scholar, and ProQuest. The reference lists of related articles were also reviewed by manual search. The Revised Cochrane Risk of Bias Tool for randomized trials (ROB2) and the Risk of Bias in non-randomized Studies of Interventions (ROBINS-I) tool were used to evaluate the risks of bias of the included studies. The mean differences (MD) and 95% confidence intervals (CI) of changes in nasal cavity and upper airway volume were analyzed using a random-effects model, and subgroup and sensitivity analyses were also performed. Two reviewers independently completed the process of screening studies, extracting data, and assessing the quality of studies. In total, twenty-one studies met the inclusion criteria. After assessing the full texts, only thirteen studies were included, with nine studies selected for quantitative synthesis. Oropharynx volume increased significantly after immediate expansion (WMD: 3156.84; 95% CI: 83.63, 6230.06); however, there was no significant change in nasal volume (WMD: 2527.23; 95% CI: -92.53, 5147.00) and nasopharynx volume (WMD: 1138.29; 95% CI: -52.04, 2328.61). After retention a period, significant increases were found in nasal volume (WMD: 3646.27; 95% CI: 1082.77, 6209.77) and nasopharynx volume (WMD: 1021.10; 95% CI: 597.11, 1445.08). However, there was no significant change after retention in oropharynx volume (WMD: 789.26; 95% CI: -171.25, 1749.76), palatopharynx volume (WMD: 795.13; 95% CI: -583.97, 2174.22), glossopharynx volume (WMD: 184.50; 95% CI: -1745.97, 2114.96), and hypopharynx volume (WMD: 39.85; 95% CI: -809.77, 889.46). MARPE appears to be linked with long-term increases in nasal and nasopharyngeal volume. However, high-quality clinical trials are required to further verify the effects of MARPE treatment on the upper airway.

Protocol for a systematic review of reporting standards of lower limb endovascular interventions in peripheral arterial disease

IntroductionTechniques and devices for the endovascular treatment of peripheral arterial disease (PAD) are continuously evolving. High-quality clinical trials limit the variation in how endovascular interventions are described, performed and reported.The aim of this systematic review is to assess the quality of reporting standards in randomised controlled trials (RCTs) of endovascular lower limb interventions against the Consolidated Standards of Reporting Trials for Non-Pharmacologic Treatments (CONSORT-NPT) and template for intervention description and replication (TIDieR) framework.MethodsRandomised trials including participants with peripheral arterial disease undergoing any infra-inguinal lower limb endovascular arterial intervention, searched from Medline, Embase and Cochrane Library databases from inception to December 2021, will be included. All study data, including details of the procedure investigated, will be extracted in keeping with the CONSORT-NPT and TIDieR checklist. Descriptive statistics will be used to summarise general study details and reporting standards of the trials.DiscussionThe results will be used to inform the design of future RCTs in this area by optimising the way the interventions are described, standardised, and monitored. The systematic review will be disseminated via peer-reviewed manuscripts and presentations at relevant conferences.Systematic review registrationPROSPERO CRD42022288214

No Association between Gastrointestinal Rebleeding and DOAC Therapy Resumption: A Systematic Review and Meta-Analysis.

There are recommendations for anticoagulation resumption after gastrointestinal bleeding (GIB), although data addressing this topic by direct oral anticoagulants (DOACs)-treated patients is lacking. We aim to determine the safety and efficacy of restarting DOACs after GIB. Studies that reported rebleeding, thromboembolic events, and mortality after restarting or withholding DOACs were selected. The systematic research was conducted in five databases (MEDLINE, EMBASE, CENTRAL, Web of Science, and Scopus). The random effect model was implemented to calculate the pooled odds ratio (OR). The ROBINS-I tool was used for risk of bias assessment, and the certainty of the evidence was evaluated with the GRADE approach. Four retrospective cohort studies (1722 patients) were included in the meta-analysis. We did not find a significant increase in the risk of rebleeding in patients restarting DOACs after index GIB (OR = 1.12; 95% CI: 0.74-1.68). The outcomes of thromboembolic events and mortality data were not suitable for meta-analytic calculations. Single studies did not show statistically significant differences. Data quality assessment showed a serious overall risk of bias and very low quality of evidence (GRADE D). DOAC resumption after a GIB episode may not elevate the risk of rebleeding. However, the need for high-quality randomized clinical trials is crucial.

Hepatic arterial infusion chemotherapy for advanced hepatocellular carcinoma in the era of chemo-diversity.

Recently, treatments for unresectable hepatocellular carcinoma (HCC) have undergone remarkable development. Various systemic chemotherapy drugs have been approved and are recommended by clinical guidelines worldwide. Although systemic treatments are effective and contribute to prolonged patient survival, their effects are unsatisfactory for some specific tumor conditions, such as macrovascular invasion. Hepatic arterial infusion chemotherapy (HAIC) is a traditional treatment for advanced HCC. As yet, there is no worldwide consensus recommending HAIC because no high-quality clinical trials have demonstrated its survival benefit. However, clinical evidence is gradually accumulating that shows its survival benefit, and it is recognized as an effective locoregional treatment for advanced HCC. Several HAIC regimens have been reported, including cisplatin monotherapy, cisplatin plus 5-fluorouracil (low-dose FP), lipiodol-suspended FP, and an oxaliplatin-based regimen. We have entered an era of chemo-diversity in the treatment of advanced HCC. This review aimed to clarify the relevance of HAIC in the era of chemo-diversity. We propose a multidisciplinary therapeutic strategy combining locoregional HAIC treatment with sequential drug therapy, with the aim of becoming cancer-free through conversion therapy.

Therapeutic Effect of Curcumin on Metabolic Diseases: Evidence from Clinical Studies

Metabolic diseases have become a serious threat to human health worldwide. It is crucial to look for effective drugs from natural products to treat metabolic diseases. Curcumin, a natural polyphenolic compound, is mainly obtained from the rhizomes of the genus Curcuma. In recent years, clinical trials using curcumin for the treatment of metabolic diseases have been increasing. In this review, we provide a timely and comprehensive summary of the clinical progress of curcumin in the treatment of three metabolic diseases, namely type 2 diabetes mellitus (T2DM), obesity and non-alcoholic fatty liver disease (NAFLD). The therapeutic effects and underlying mechanisms of curcumin on these three diseases are presented categorically. Accumulating clinical evidence demonstrates that curcumin has good therapeutic potential and a low number of side effects for the three metabolic diseases. It can lower blood glucose and lipid levels, improve insulin resistance and reduce inflammation and oxidative stress. Overall, curcumin may be an effective drug for the treatment of T2DM, obesity and NAFLD. However, more high-quality clinical trials are still required in the future to verify its efficacy and determine its molecular mechanisms and targets.

A review of evidence-based management of infectious ocular surface disease in shelter-housed domestic cats.

Infectious ocular surface disease (IOSD) is a common problem in shelter-housed domestic cats and has a widespread negative impact on animal welfare. While the common etiological agents are well-described, addressing IOSD in large groups of animals presents a management challenge to the clinician and logistical challenges to shelter employees. Treatments, diagnostics, and prevention strategies that are effective in privately owned or experimental animals may be impractical or ineffective in the shelter environment. This review article focuses on the relative prevalence of etiological agents in feline IOSD, practical diagnostic testing protocols, prevention strategies, and treatment of IOSD in shelter-housed cats. Discrepancies between experimental laboratory-based studies and clinical trials assessing therapeutics for treatment of feline herpes virus are highlighted. Further high-quality clinical trials are necessary to determine optimal preventative and therapeutic protocols for IOSD in shelter-housed cats.

Women’s experiences with using domperidone as a galactagogue to increase breast milk supply: an Australian cross-sectional survey

BackgroundDomperidone is one of the most commonly utilised pharmacological galactagogues, with evidence of increasing use in clinical practice. However, the use of domperidone as a galactagogue remains controversial, with mixed evidence on safety and efficacy, leading to variable clinical practice recommendations. We sought to evaluate contemporary patterns of domperidone use and examine maternal experiences related to perceived safety and effectiveness.MethodsIn 2019, we conducted an online, cross-sectional survey of Australian breastfeeding women to examine individual experiences related to domperidone use, in addition to perceptions of safety and effectiveness.ResultsAmong 1876 survey responses, 19% (n = 355) reported using domperidone. Domperidone use was significantly higher in women who were primiparous, gave birth preterm, delivered by caesarean section, had self-perceived low milk supply, and saw a lactation consultant. Nearly 20% of women commenced domperidone use in the first week postpartum (19%, n = 67). The median duration of use was six weeks (interquartile range 3–16 weeks). Maximum reported doses of domperidone used ranged from 20 mg/day to 160 mg/day. Half (n = 178, 50%) of women reported using a dose of 30 mg/day or less, 44% (n = 155) reported using a dose between 31 and 60 mg/day, and 6% (n = 22) reported using a dose greater than 61 mg/day. Nearly half of the respondents reported domperidone as ‘very’ or ‘extremely effective’ (45%, n = 161), with only 8% (n = 27) reporting it was ‘not at all effective’. Almost half (n = 172, 48%) of all women using domperidone reported side effects, including weight gain (25%), headaches (17%) and dry mouth (13%). Higher doses were associated with an increased likelihood of any side effects (≤ 30 mg/day, 38%; >31-≤60 mg/day, 48%, > 61 mg/day 73%; P < 0.004), with 31 (9%) stopping domperidone because of side effects.ConclusionWe identified widespread variation in domperidone utilisation patterns, with domperidone broadly perceived to be effective in increasing breast milk supply. Side effects associated with domperidone treatment were common, appeared to be dose-related, and were frequently associated with treatment cessation. These findings highlight the importance of improved clinical practice recommendations and generation of evidence from additional high-quality clinical trials evaluating the efficacy and safety of domperidone. More conclusive clinical trials are needed to determine the efficacy, as well as optimal dose and duration, of domperidone use.

The management of developmental dysplasia of the hip in children aged under three months : a consensus study from the British Society for Children's Orthopaedic Surgery.

A national screening programme has existed in the UK for the diagnosis of developmental dysplasia of the hip (DDH) since 1969. However, every aspect of screening and treatment remains controversial. Screening programmes throughout the world vary enormously, and in the UK there is significant variation in screening practice and treatment pathways. We report the results of an attempt by the British Society for Children's Orthopaedic Surgery (BSCOS) to identify a nationwide consensus for the management of DDH in order to unify treatment and suggest an approach for screening. A Delphi consensus study was performed among the membership of BSCOS. Statements were generated by a steering group regarding aspects of the management of DDH in children aged under three months, namely screening and surveillance (15 questions), the technique of ultrasound scanning (eight questions), the initiation of treatment (19 questions), care during treatment with a splint (ten questions), and on quality, governance, and research (eight questions). A two-round Delphi process was used and a consensus document was produced at the final meeting of the steering group. A total of 60 statements were graded by 128 clinicians in the first round and 132 in the second round. Consensus was reached on 30 out of 60 statements in the first round and an additional 12 in the seond. This was summarized in a consensus statement and distilled into a flowchart to guide clinical practice. We identified agreement in an area of medicine that has a long history of controversy and varied practice. None of the areas of consensus are based on high-quality evidence. This document is thus a framework to guide clinical practice and on which high-quality clinical trials can be developed.Cite this article: Bone Joint J2023;105-B(2):209-214.

EFFICACY AND SAFETY OF DIFFERENT TRAPEZIUM IMPLANTS FOR TRAPEZIOMETACARPAL JOINT OSTEOARTHRITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS

The trapeziometacarpal joint (TMCJ) is the most common hand joint affected by osteoarthritis (OA), and trapezium implant arthroplasty is a potential treatment for recalcitrant OA. This meta-analysis aimed to investigate the efficacy and safety of various trapezium implants as an interventional option for TMCJ OA. Web of Science, PubMed, Scopus, Google Scholar, and Cochrane library databases were searched for relevant studies up to May 2022. Preferred Reported Items for Systematic Review and Meta-Analysis guidelines were adhered to and registered on PROSPERO. The methodological quality was assessed by National Heart, Lung, and Blood Institute tools for observational studies and the Cochrane risk of bias tool. Subgroup analyses were performed on different replacement implants, the analysis was done via Open Meta-Analyst software and P values &lt; 0.05 were considered statistically significant.A total of 123 studies comprising 5752 patients were included. Total joint replacement (TJR) implants demonstrate greater significant improvements in visual analogue scale pain scores postoperatively. Interposition with partial trapezial resection implants was associated with the highest grip strength and highest reduction in the Disabilities of the Arm, Shoulder, and Hand score. Revision rates were highest in TJR (12.3%), and lowest in interposition with partial trapezial resection (6.2%).Total joint replacement and interposition with partial trapezial resection implants improve pain, grip strength, and DASH scores more than other implant options. Future studies should focus on high-quality randomized clinical trials comparing different implants to accumulate higher quality evidence and more reliable conclusions.

Curcumin-piperine co-supplementation and human health: A comprehensive review of preclinical and clinical studies.

Curcumin is extracted from the rhizomes Curcuma longa L. It is known for its anti-inflammatory and anti-oxidant activities. Despite its safety and potential for use against various diseases, curcumin's utility is restricted due to its low oral bioavailability. Co-administration of curcumin along with piperine could potentially improve the bioavailability of curcumin. The present review aimed to provide an overview of the efficacy and safety of curcumin-piperine co-supplementation in human health. The findings of this comprehensive review show the beneficial effects of curcumin-piperine in improving glycemic indices, lipid profile and antioxidant status in diabetes, improving the inflammatory status caused by obesity and metabolic syndrome, reducing oxidative stress and depression in chronic stress and neurological disorders, also improving chronic respiratory diseases, asthma and COVID-19. Further high-quality clinical trial studies are needed to firmly establish the clinical efficacy of the curcumin-piperine supplement.

Efficacy and Safety of a Persian Medicine Formula on Functional Dyspepsia Symptoms: A Randomized Double-Blind Active-Control Clinical Trial

Introduction: Functional dyspepsia (FD) is one of the most frequent gastrointestinal disorders with a high burden. Although FD is a heterogeneous disorder without any standard therapy (treatment/treatment – repetition), there is a wide history of using herbal remedies for its treatment. Two of these herbal remedies quoted in various Persian medicine resources are celery and ajwain. Their effects have been investigated in recent clinical trials in FD patients. We aimed to compare the effect of celery and ajwain to that of domperidone in patients with postprandial distress syndrome. Methods: This is a randomized double-blind active-control clinical trial, conducted at Kerman, Iran in 2020. Participants of this study were 100 patients suffering from FD (postprandial distress syndrome subtype). The intervention group received 1 g of the combination of celery and ajwain (Apium graveolens L. and Trachyspermum copticum [L.] Link), while the control group received 30 mg of domperidone per day for 4 consecutive weeks. Primary outcomes were symptom severity and frequency, and secondary outcomes were quality of life (QoL) and safety. All outcomes were assessed at the end of the trial and also 4 weeks after the trial was finished. Results: No significant differences in symptom frequency were found between groups. However, differences in symptom severity were found at the end of the follow-up (week 8) (p = 0.001). The intragroup analysis showed a significant decrease in the symptoms severity and frequency at the end of week 4 in both groups (p < 0.001). QoL in the intervention group was higher compared to the control group at the end of the study (p < 0.001) and at the point of the follow-up (week 8; p < 0.001). No serious adverse events occurred in either group. Conclusion: The herbal mixture of celery and ajwain could be considered a safe and effective remedy, decreasing the severity of symptoms and increasing QoL in patients with postprandial distress syndrome. It is further suggested to confirm these findings in high-quality multi-center clinical trials.

Medicines for Obesity: Appraisal of Clinical Studies with Grading of Recommendations, Assessment, Development, and Evaluation Tool

We evaluated the quality of evidence from phase III/IV clinical trials of drugs against obesity using the principles of Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. Our systematic review evaluates the quality of clinical evidence from existing clinical trials and not the pharmacological efficacy of anti-obesity therapies. A literature search using select keywords in separate was performed in PubMed and ClinicalTrials.gov databases for phase III/IV clinical trials during the last ten years. Our findings indicate that the quality of existing clinical evidence from anti-obesity trials generally ranges from low to moderate. Most trials suffered from publication bias. Less frequently, trials suffered from the risk of bias mainly due to lack of blindness in the treatment. Our work indicates that additional higher-quality clinical trials are needed to gain more confidence in the estimate of the effect of currently used anti-obesity medicines, to allow more informed clinical decisions, thus reducing the risk of implementing potentially ineffective or even harmful therapeutic strategies.