Reviews on Recent Clinical Trials - Current Issue

Gallstone Disease (GSD) is a multifactorial risk factor for various complications.

This study aimed to examine the relationship between GSD and Cardiovascular Disease (CVD) through a systematic review and meta-analysis approach.

A thorough search was conducted across Web of Science, Scopus, MEDLINE/PubMed, Cochrane Library, and Embase databases. Only studies published between 1980 and December 2023 were included. Chi-square, I², and forest plots were used to assess heterogeneity. Begg's and Egger's tests were used to evaluate publication bias. Statistical significance was considered at p <0.05, and all analyses were performed using Stata 17.

This meta-analysis involved 21 studies and comprised 2,138,282 participants; there has been a significant association found between GSD and an increased risk of CVD (with a relative risk of 1.46, 95% confidence interval: 1.32-1.63, p <0.001). The analysis found no evidence of publication bias based on Begg's test (p =0.085) and Egger's test (p =0.231). Subgroup analysis of the studies showed a higher risk of CVD in studies with a sample size of less than 10,000 participants, conducted in 2016 or later, utilizing a cross-sectional design, in Asian countries; the analysis had a moderate quality score, with a follow-up period of equal to or less than ten years.

There has been a significant association found between GSD and CVD and their incidence is related to each other. Taking proactive steps to implement targeted interventions for individuals with gallstone disease could potentially reduce the risk of cardiovascular disease within this population.

The HSP90 marker is believed to play a constructive role in facilitating neoplastic transformation mainly via interaction with multiple pro-survival proteins. Well-designed studies are needed to elucidate the role of HSP90 as a diagnostic marker and therapeutic target in testicular tumors.

The current study aimed to investigate the expression of HSP90 in various types of testicular cancer and highlight its expression in embryonal testicular cancer.

Immunohistochemical staining for HSP90 in 84 male patients, with non-metastatic testicular cancer, who underwent orchiectomy from 2000 to 2023, was retrospectively performed at the Laboratory Department of General Hospital of Nikaia in Greece.

A total of 84 males, with a mean age of 36.2 years, who have undergone high-cord radical orchiectomy, were included in this study. Out of the included males, 28.57% had embryonal carcinoma, 23.81% had seminoma, 19.05% had yolk sac tumor, 11.9% had mature teratoma, 9.52% had immature teratoma, and 7.14% had choriocarcinoma. HSP90b was positive in all embryonal carcinoma, seminoma, and choriocarcinoma cases, while it was positive in 75% of the yolk sac tumor, 75% of mature teratoma, and 75% of immature teratoma specimens. HSP90 was found negative in all choriocarcinoma, mature teratoma, and immature teratoma specimens, while it was positive in 25% of yolk sac tumor, 8.33% of embryonal carcinoma, and 10% of seminoma cases. Concerning the expression of HSP90b, a statistically significant relationship was found between excised tumor specimens and normal parenchyma specimens, especially in sac cases (p <0.001). Regarding HSP90a expression, a statistically significant relationship (OR=21.5, p =0.021) was found between excised tumor specimens and normal parenchyma specimens, especially in embryonal carcinoma cases (p <0.001).

HSP90b is highly expressed in the majority of the types of testicular tumors, both in tumor and normal parenchyma specimens, while HSP90a staining is negative in resected specimens. Further well-designed studies are needed to elucidate the role of HSP90 as a diagnostic marker and therapeutic target in testicular tumors.

Helicobacter pylori (H. pylori) infection is the main cause of most PUD; therefore, the eradication of H. pylori is extremely important in the treatment of PUD. There are several recommended treatment regimens suggested to eradicate this organism.

This study compared the efficacy of three anti-Helicobacter pylori regimens in patients with dyspepsia or peptic ulcer disease (PUD).

The objective of this study was to assess the efficacy of three anti-H pylori treatments in patients based on C14 urease breath test (C-UBT) results, drug compliance, and adverse effects.

This randomized, open-label clinical trial included 136 H. pylori-infected patients without prior treatment. Patients were randomly divided into three groups. The OAC group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and 500 mg Clarithromycin capsules twice a day for 14 days. The OAL group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and Levofloxacin 500 mg capsules twice a day for 14 days. The OAMB group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, Metronidazole 500 mg three times a day, and Bismuth 240 mg twice a day for 14 days. Evaluation for compliance and drug-related adverse effects were assessed at the end of two weeks. H. pylori eradication was evaluated eight weeks after treatment using the C-UBT.

A total of 136 patients participated in this study, and their groups were matched based on age and sex. The results of the C-UBT test showed that the eradication rate of H. pylori was 82.2%, 91.3%, and 97.3% for the three-drug OAC, OAMB, and OAL treatment regimens, respectively. Moreover, all the regimens showed high compliance among the patients. Only OAC and OAL showed a significant difference in the H. pylori eradication rate, and no superiority was found between OAMB and OAL or OAC therapies.

The regime of OAL achieved a satisfactory rate of H. pylori infection eradication with good tolerance in patients with PUD, without any acute side effects.

IRCT201605189014N100.

In the present study, we evaluated the impact of empagliflozin on serum levels of oxidative stress parameters in individuals with type 2 diabetes (T2DM) who also suffer from heart failure with Reduced Ejection Fraction (HFrEF).

In this prospective, single-center clinical trial, 80 patients with T2DM and HFrEF, stabilized on guideline-directed heart failure therapy and classified as New York Heart Association functional (NYHA) functional classes II or III, were randomized to receive either empagliflozin (10 mg/daily) or a matching placebo for a duration of 12 weeks. Serum levels of malondialdehyde (MDA), along with the activity of superoxide dismutase (SOD) and glutathione peroxidase (GPx), were measured at baseline and after the 12-week treatment period.

The baseline demographic and clinical characteristics of the randomized patients were comparable across the study groups. As anticipated, empagliflozin demonstrated a significant reduction in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) compared to the placebo after 12 weeks of treatment. Additionally, in comparison to the placebo, empagliflozin significantly increased the antioxidant capacity by elevating serum activity of SOD and GPx, while reducing oxidative damage, as evidenced by diminished MDA levels. Empagliflozin-treated patients also experienced greater improvement in their NYHA functional classes by week 12, though no significant changes in Left Ventricular Ejection Fraction (LVEF) were observed.

The findings of this study shed light on the potential mechanisms through which SGLT2 inhibitors exert their beneficial effects on clinical outcomes in diabetic patients with HFrEF. This provides compelling evidence supporting the cardio-protective of SGLT2 inhibitors in this patient population.

The trial was registered at the Iranian Registry of Clinical Trials (https://irct.behdasht.gov.ir/trial/72825, identifier code: IRCT20120215009014N484). Registration date: 2022-09-30.

Wernicke Encephalopathy (W.E.) is an acute neurological disorder induced by thiamine deficiency. Alcohol abuse is considered to be the leading cause of the disease; however, numerous other conditions, such as malnutrition or cancer, have been identified as potential risk factors.

Clinical manifestations include a typical triad of mental status alteration, nystagmus, and ataxia and are attributed to damage in brain regions of high thiamine demand. The diagnosis is mainly clinical and further supported by the immediate response of neurological signs to parenteral thiamine administration. Among paraclinical examinations, brain MRI is considered substantial for diagnosis and is supported by the determination of thiamine blood levels.

Non-alcoholic W.E. is trickier to diagnose due to its atypical clinical course and risk factors. We herein describe a case of non-alcoholic W.E. in a woman with colon cancer who gradually developed the classic symptoms of thiamine deficiency.