Evaluation of the effectiveness of Berberis integerrima Bunge root extract combined with spearmint essential oil in the treatment of acne vulgaris: A randomized controlled clinical trial.

BACKGROUND: Acne vulgaris is one of the most common dermatological disorders. Berberis integerrima Bunge belongs to the Berberidaceae family. Several studies on different Berberis species in addition to B. integerrima have shown antimicrobial, antioxidant, and anti-inflammatory effects. Spearmint essential oil also has antioxidant, antibacterial, and anti-inflammatory activities. This study aimed to evaluate the clinical effectiveness of the topical combination of B. integerrima root extract and spearmint essential oil in the treatment of acne vulgaris. METHODS: Patients with mild to moderate facial acne who met the inclusion criteria were randomly assigned to either drug (B. integerrima extract/spearmint essential oil topical solution) or control (clindamycin 1% topical solution) groups. Each group applied the solution twice a day for 4 weeks. Before and at the end of the intervention, the number of lesions and mGAGS (Modified Global Acne Grading Scale) score were recorded. RESULTS: Thirty patients in each group of drug and control completed the study. Topical B.integerrima root extract/spearmint essential oil significantly reduced the number of lesions (27.33 ± 26.17 vs. 21.58 ± 21.10; p < 0.001) and mGAGS (18.76 ± 8.61 vs. 13.87 ± 8.14; p < 0.001) at the end of the intervention. However, there was no significant difference between the two groups regarding the number of lesions (p = 0.906) and mGAGS (p = 0.882). CONCLUSIONS: B. integerrima root extract combined with spearmint essential oil has significant anti-acne effects, comparable to topical antibiotic clindamycin. It could be considered as a potential treatment for acne vulgaris. However, more studies with larger sample sizes and longer durations are required to confirm this effect.

Invasive fungal infections in hematologic malignancies: Incidence, management, and antifungal therapy.

The incidence of invasive fungal infections (IFIs) has increased in recent years as a result of increasing the incidence of hematologic malignancies (HMs). IFIs, as the opportunistic diseases, are the most important concern in these patients with a high mortality rate. These infections are one of the leading causes of morbidity and mortality in HM patients and an important factor in increasing the costs of patients' management because of the prolonged hospitalization and the inevitable need to use antifungal agents. Due to the changes in the pattern of organisms causing IFIs, unavailability of effective and safe antifungal drugs, and high rate of drug resistance as well as lack of fast and accurate diagnostic methods, these infections have become a serious and life-threatening problem necessitating effective prevention and treatment strategies using suitable antifungal agents, especially in high-risk patients. The aim of the present study was to review the pathogens causing various types of IFIs, diagnostic methods, and novel prophylactic and therapeutic antifungal regimens in HM patients according to the new published studies and clinical trials.

Probiotic Lactobacillus and the potential risk of spreading antibiotic resistance: a systematic review.

Background and purpose: Lactobacillus, the most popular probiotic, has recently gained more attention because it is a potential reservoir of antibiotic resistance. This review summarized and discussed the phenotypic-genotypic characteristics of antibiotic resistance. Experimental approach: Google Scholar, PubMed, Web of Science, and Scopus were searched up to February 2022. The inclusion criteria were all studies testing antibiotic resistance of probiotic Lactobacillus strains present in human food supplementation and all human/animal model studies in which transferring antibiotic-resistant genes from Lactobacillus strains to another bacterium were investigated. Findings/Results: Phenotypic and genotypic characterization of Lactobacillus probiotics showed that the most antibiotic resistance was against protein synthesis inhibitors (fourteen studies, 87.5%) and cell wall synthesis inhibitors (ten studies, 62.5%). Nine of these studies reported the transfer of antibiotic resistance from Lactobacillus probiotic as donor species to pathogenic bacteria and mostly used in vitro methods for resistance gene transfer. Conclusion and implications: The transferability of resistance genes such as tet and erm in Lactobacillus increases the risk of spreading antibiotic resistance. Further studies need to be conducted to evaluate the potential spread of antibiotic resistance traits via probiotics, especially in elderly people and newborns.

The Effectiveness of Silymarin in the Prevention of Anti-tuberculosis Drug-induced Hepatotoxicity: A Randomized Controlled Clinical Trial.

Background: Several animal studies have shown the protective effect of silymarin (the extract of Silybum marianum seeds) against anti-tuberculosis drug-induced hepatotoxicity (ATDH). However, the knowledge of ATDH of silymarin in humans is scarce. In this study, we aimed to clinically evaluate it. Methods: During this randomized controlled clinical trial, 36 new cases of tuberculosis (TB) were enrolled to receive either silymarin 150 mg twice daily for two weeks along with a standard anti-TB therapeutic regimen (experimental group; n = 16) or standard anti-TB therapeutic regimen alone (control group; n = 21). Liver function tests (serum AST, ALT, ALP, and total bilirubin) at the end of weeks 1 and 2 as well as the rate of ATDH during the study were determined and compared between the groups. Results: No significant differences between the experimental and control groups were observed at the end of the first week regarding liver function tests; However, at the end of the second week, the mean serum levels of AST (P = 0.03) and ALP (P = 0.04) were significantly lower in the experimental group. ALT (P = 0.016) and ALP (P = 0.027) levels in the experimental group significantly decreased during the study, while the changes in the control group were not significant. Two patients in the control group (9.5%) developed ATDH, while no one in the experimental group manifested this adverse effect. Conclusions: Our study suggests that silymarin use has the potential for the reduction of anti-TB drug-induced hepatotoxicity.

Evaluation of the effectiveness of topical oily solution containing frankincense extract in the treatment of knee osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: Pharmacological treatments of osteoarthritis (OA) have several side effects. Boswellia serrata resin (frankincense) is rich in boswellic acids that have antioxidant and anti-inflammatory effects; though, their oral bioavailability is low. The aim of this study was evaluation of the clinical effectiveness of frankincense extract in the treatment of knee OA. In a randomized double-blind placebo-controlled clinical trial, eligible patients with knee OA were randomly divided into two groups of drug (33 patients) and control (37 patients), to use oily solution of frankincense extract or placebo, respectively, on the involved knee three times daily for four weeks. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), VAS (visual analogue scale; for pain severity), and PGA (patient global assessment) scores were determined before and after intervention. RESULTS: For all evaluated outcome variables, there was a significant decrease from baseline in both groups (P < 0.001 for all). Furthermore, the end-of-intervention values for all parameters were significantly lower in drug group than placebo group (P < 0.001 for all), showing more effectiveness of drug compared to placebo. CONCLUSION: Topical oily solution containing enriched extract of boswellic acids could decrease pain severity and improve the function in patients with knee OA. Trial Registration Trial registration number: IRCT20150721023282N14. Trial registration date: September 20, 2020. The study was retrospectively registered in Iranian Registry of Clinical Trials (IRCT).

The effectiveness of colistin/levofloxacin compared to colistin/meropenem in the treatment of ventilator-associated pneumonia (VAP) caused by carbapenem-resistant Acinetobacter baumannii: a randomized controlled clinical trial.

Background and purpose: The treatment of ventilator-associated pneumonia (VAP) caused by carbapenem-resistant Acinetobacter baumannii (CRAB) is still a great challenge. This study evaluated the effectiveness of the colistin/levofloxacin regimen compared to the usual colistin/meropenem regimen in the treatment of patients with VAP caused by CRAB. Experimental approach: The patients with VAP were randomly assigned to experimental (n = 26) and control (n = 29) groups. The first group received IV colistin 4.5 MIU every 12 h + levofloxacin 750 mg IV daily, and the second group received IV colistin with the same dose + meropenem 1 g IV every 8 h for 10 days. The clinical (complete response, partial response, or treatment failure) and microbiological responses at the end of the intervention were recorded and compared between the two groups. Findings/Results: The complete response rate was higher (n = 7; 35%) and the failure rate was lower (n = 4; 20%) in the experimental group than in the control group (n = 2; 8%, and n = 11; 44%, respectively), but the differences were not statistically significant. Even though the microbiological response rate was higher in the experimental group (n = 14; 70%) than in the control group (n = 12; 48%), the difference was not statistically significant. The mortality rate was 6 (23.10%) and 4 patients (13.8%) in the experimental and control groups, respectively (P = 0.490). Conclusion and implication: The levofloxacin/colistin combination can be considered an alternative regimen to meropenem/colistin in the treatment of VAP caused by CRAB.

Evaluation of Synbiotics in the Prevention of Ventilator-Associated Pneumonia: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

Background: Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections. The role of probiotics in preventing VAP is still questionable. This study aimed at evaluating the effect of synbiotic FamiLact 2plus on the prevention of VAP in patients admitted to the intensive care unit (ICU). Methods: A total of 80 mechanically ventilated patients were included and divided into two groups of 40. Group 1 received FamiLact 2plus, and group 2 received placebo. The outcome variables were compared, including the incidence of VAP, the time interval between the onset of ventilation and VAP, the duration of mechanical ventilation, and the length of stay in the ICU. Results: VAP is documented in four patients (10%) in group 1 and 11 patients (27.5%) in group 2 (P = 0.045). The length of stay in the ICU in group 1 was significantly shorter than in group 2, and the time interval between the start of intubation and the onset of VAP in group 1 was longer than in the placebo group. During the intervention, 15 patients in group 1 (37.5%) and 26 patients in group 2 (65%) developed diarrhea, which was a significant difference (P = 0.02). Conclusions: Synbiotic is associated with a reduction in the incidence of VAP as well as a reduction in ICU stay and delayed VAP.

The Effectiveness of Perovskia abrotanoides Extract Topical Formulation on the Cutaneous Leishmaniasis: A Randomized Controlled Clinical Trial.

Objective: Despite many attempts to treat leishmaniasis, new approaches are necessary to reduce the burden of disease. Perovskia abrotanoides (Brazambel) has shown significant effects against Leishmania parasites in some studies. This study aimed to investigate the effects of P. abrotanoides extract topical formulation on cutaneous leishmaniasis. Methods: In this randomized controlled clinical trial, patients with cutaneous leishmaniasis were assigned to experimental (n = 18) and control (n = 18) groups. Both groups received intralesional meglumine antimoniate (Glucantime®). The experimental group also received 5% Brazambel extract ointment once a day. The interventions continued until the complete healing of the lesions (reepithelialization) for a maximum of 8 weeks. The clinical response, defined as complete response (reepithelialization >75%), partial response (reepithelialization 50%-75%), or treatment failure (reepithelialization <50%), was compared between the groups. Findings: The percentage of reepithelialization in the experimental group (4th week: 64.44 ± 25.13; 8th week: 83.85 ± 11.54) was higher than the control group (4th week: 53.97 ± 25.88; 8th week: 76.27 ± 21.67); however, the differences were not statistically significant (P = 0.252 and 0.494, respectively). Moreover, there was no significant difference between the experimental and control groups regarding the rate of complete healing (88.9% vs. 72.2%, respectively). Conclusion: The use of P. abrotanoides extract 5% topical formulation does not affect the healing of cutaneous leishmaniasis.

Efficacy of an Oral Solution Containing Five Herbal Extracts in the Treatment of Urolithiasis: A Randomized, Single-blind, Placebo-controlled Clinical Trial.

Objective: The high prevalence of urolithiasis and its recurrence entail the preparation of an efficient drug with the least side effects. Tribulus terrestris, Urtica dioica, Adiantum capillus-veneris, Stigma maydis (corn silk), and Cucumis melo are herbal remedies utilized in traditional medicine for urolithiasis. This study aimed to assess the efficiency of these plants' extracts in treating urolithiasis. Methods: In a randomized, single-blind, placebo-controlled clinical trial, participants meeting inclusion criteria were randomly allocated to the drug (n = 27) and placebo (n = 27) groups to take herbal or placebo solutions, respectively, at a dose of 60 drops 3 times daily for 4 weeks with standard treatment. Before and after the intervention, 24-h urine volume and the quantities of calcium, sodium, citrate, oxalate, urea, creatinine, and uric acid in 24-h urine, and urinary pH were measured. The number and size (diameter in mm) of stones were determined by ultrasonography and recorded for each patient. Findings: Except for 24 h urine volume, other urinary parameters did not alter significantly at the end of the intervention compared to baseline. Furthermore, the two groups had no significant difference regarding these indices. Regarding stone parameters, the stone size decreased significantly in the drug group compared to the placebo group (P = 0.049). The number of cases with complete stone expulsion in the drug group was significantly higher than in the placebo group (12 cases vs. 4 cases, respectively, P = 0.017). Conclusion: Oral consumption of the herbal solution causes stone size reduction and stone expulsion in patients with urolithiasis.

The Effect of Vitamin B6 in the Prevention of Hematological Adverse Effects of Linezolid in Patients with Chronic Osteomyelitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

Background: Due to the contradictory results of the effects of Vitamin B6 in reducing the hematotoxic effects of linezolid, the present study aimed to investigate the possible role of Vitamin B6 administration in reducing linezolid-related hematological toxicities in patients with chronic osteomyelitis. Materials and Methods: In a randomized double-blind placebo-controlled clinical trial, patients with chronic osteomyelitis were randomly divided into two groups (n = 40 each): the intervention group received Vitamin B640 mg twice daily from the beginning of treatment with linezolid and the control group received placebo with linezolid, both for 21 days. Blood variables including hemoglobin (Hb), white blood cells (WBC), and platelets (PLT) were measured at baseline and at the end of the 1st, 2nd, and 3rd weeks (days 7, 14, and 21) of the intervention. Results: There was no significant difference between the groups regarding the count of WBC and PLT and level of Hb at evaluated time points. Furthermore, there was a significant decreasing trend in all parameters within both groups; however, the decreasing trend of both PLT and WBC was slower in the intervention (Vitamin B6) group compared to the placebo group. Conclusion: Vitamin B6 has no significant effect in the reduction of hematological adverse effects of linezolid in chronic osteomyelitis patients. However, it could retard the decreasing trend of WBC and PLT counts.

The effect of Allium hirtifolium bulb on serum lipid profile in adult patients with hyperlipidemia: A randomized double-blind placebo-controlled clinical trial.

BACKGROUND: One of the first goals of reducing the risk of cardiovascular disease (CVD) is to achieve effective therapies for hyperlipidemia. This study aimed to investigate the effect of Allium hirtifolium bulbs on serum lipid profile in patients with hyperlipidemia. METHODS: This clinical trial was conducted on hyperlipidemic patients in two drug (Allium; n = 25) and placebo (n = 24) groups. The first group received 500 mg of A. hirtifolium bulbs twice daily for 6 weeks, while the second group received placebo for the same frequency and duration. Cholesterol, triglycerides (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), fasting blood sugar (FBS), creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were measured at the beginning and the end of study and were compared between the groups. RESULTS: A. hirtifolium reduced total cholesterol and LDL significantly compared to the placebo (P < 0.05). However, no significant effects on other parameters were observed. Furthermore, the use of A. hirtifolium had no effects on renal and liver function tests. CONCLUSION: The use of A. hirtifolium bulbs can decrease serum total cholesterol and LDL in hyperlipidemic adult patients.

Antibiotic use during the first 6 months of COVID-19 pandemic in Iran: A large-scale multi-centre study.

WHAT IS KNOWN AND OBJECTIVE: Although antibiotics are ineffective against viral infections, epidemiological studies have revealed that the COVID-19 pandemic resulted in the overuse of antibiotics and disruption of antimicrobial stewardship programmes. We investigated the pattern of antibiotic use during the first 6 months of the COVID-19 pandemic in Iran. METHODS: A multi-centre retrospective study was designed to investigate the use of 16 broad-spectrum antibiotics in 12 medical centres. The rate of antibiotic use was calculated and reported based on the Defined Daily Dose (DDD) per 100 hospital bed-days. The bacterial co-infection rate was also reported. RESULTS AND DISCUSSION: Totally, 43,791 hospitalized COVID-19 patients were recruited in this study. It was found that 121.6 DDD of antibiotics were used per 100 hospital bed-days, which estimated that each patient received approximately 1.21 DDDs of antibiotics every day. However, the bacterial co-infections were detected only in 14.4% of the cases. A direct correlation was observed between the rate of antibiotic use and mortality (r[142] = 0.237, p = 0.004). The rate of antibiotic consumption was not significantly different between the ICU and non-ICU settings (p = 0.15). WHAT IS NEW AND CONCLUSION: In this study, widespread antibiotic use was detected in the absence of the confirmed bacterial coinfection in COVID-19 patients. This over-consumption of broad-spectrum antibiotics may be associated with increased mortality in hospitalized COVID-19 patients, which can be an alarming finding.

Antibiotic resistance pattern of Helicobacter pylori strains isolated from patients in Isfahan, Iran.

Background: The objective of this study was to evaluate the antibiotic resistance pattern of Helicobacter pylori strains isolated from patients in Isfahan province. Materials and Methods: Gastric antrum biopsy specimens of patients undergoing endoscopy were cultured. The samples with the growth of H. pylori underwent antibiotic susceptibility test by disk diffusion method. Reaults: Of 96 samples, 50 samples (53%) were positive for H. pylori. The rates of antibiotic resistance were as follows: amoxicillin, 6%; azithromycin, 20%; furazolidone, 22%; levofloxacin, 16%; metronidazole, 20%; rifampin, 12%; and tetracycline, 22%. Conclusion: H. pylori strains in our area have high rates of resistance to azithromycin, levofloxacin, metronidazole, tetracycline, and furazolidone.

The effectiveness of gabapentin and gabapentin/montelukast combination compared with dextromethorphan in the improvement of COVID-19- related cough: A randomized, controlled clinical trial.

INTRODUCTION: Cough is one of the most common presenting symptoms of COVID-19, which can persist for weeks or months. OBJECTIVE: The goal of this study was to evaluate the effectiveness of gabapentin (GBT) alone and in combination with montelukast (MTL) for improving cough. METHODS: In this open-label randomized controlled clinical trial, eligible cases were patients hospitalized with moderate to severe COVID-19 who had cough with a Breathlessness, Cough, and Sputum Scale (BCSS) score of at least 2 based on its cough subscale. The participants were randomly assigned to three groups including two experimental groups and one control group. The first and second experimental groups received GBT and GBT/MTL, respectively, whereas the control group received dextromethorphan (DXM). Treatment duration was 5 days in all groups. Before and after the interventions, the severity of cough was evaluated using BCSS scale and Visual Analog Scale (VAS). RESULTS: A total of 180 patients were included; GPT, GPT/MTL, and DXM consisted of 76, 51, and 53 patients, respectively. There was no significant difference between the three groups in terms of age, gender, and comorbidities (P > 0.05). Regarding BCSS and VAS scores, there was significant reduction from the baseline values in all groups (P < 0.0001), with the change rate being significantly higher in DXM group. The amount of reduction of BCSS in the GPT/MTL group was significantly more than the GPT group, whereas there was no significant difference between the two groups regarding VAS score. Although the duration of hospitalization differed between the groups with the GPT/MTL group having the shortest duration, the difference was statistically significant only between the GPT and GPT/MTL groups (P < 0.0001). CONCLUSION: GPT, both alone and in combination with MTL, improves cough frequency and severity in hospitalized patients with COVID-19, with the combination being more efficacious. This regimen may be useful in patients who cannot tolerate opioids.

The effectiveness of olibanum orally disintegrating tablet in the treatment of oral aphthous ulcers: A randomized, double-blind, placebo-controlled clinical trial.

Background: Boswellia serrata oleo-gum-resin (frankincense; olibanum) has anti-inflammatory, analgesic, and antimicrobial effects. This study aimed to evaluate the clinical effectiveness of frankincense extract in the treatment of oral aphthous ulcers. Materials and Methods: In a randomized, double-blind, placebo-controlled clinical trial, patients with aphthous ulcers were randomly assigned to either experimental (Frankincense extract) or placebo groups to use orally disintegrating tablets (ODT) of frankincense and placebo, respectively, four times a day for 3 days. The size of aphthous ulcers and the pain severity by visual analogue scale were recorded at days 0, 2, and 4 and compared between the groups. Results: Twenty-five patients in each group completed the study. Olibanum extract ODT significantly reduced the ulcer size on the second (P < 0.001) and fourth (P < 0.001) days as well as the pain score on the second (P = 0.002) and fourth (P < 0.001) days of the intervention compared to placebo. Furthermore, at the end of the intervention, the number of patients with complete ulcer healing and pain relief in the experimental group was significantly more than the placebo group (5 vs. 0, P = 0.02; and 11 vs. 0, P < 0.001, respectively). Conclusion: Taking olibanum extract ODTs reduces the ulcer size and pain severity and accelerates the healing process in the oral aphthous lesions.

The Effect of Topical Cow's Milk on the Healing of Diabetic Foot Ulcers: A Randomized Controlled Pilot Clinical Trial.

Diabetic foot ulcer (DFU) is a very serious side effect among the diabetic patients with substantial clinical and economic consequences. The aim of this study was to investigate the efficacy of cows' milk topical ointment, as an available and cost-effective natural product, on accelerating the healing of DFU. In this randomized controlled clinical trial, patients with grade 1 or 2 DFU were randomly divided into two groups of intervention (n = 50) and control (n = 49). For patients of intervention group, cows' milk 20% topical ointment was applied on the ulcer once daily for two weeks, while a type of novel dressing was used for control group with the same frequency and duration. Both groups received usual standard wound care measures. The percentage of change in the ulcer size and the number of cases with complete wound healing (>90% reduction in the ulcer size) were recorded in the both groups. The ulcer size significantly reduced in both groups on the seventh and 14th days of intervention; however, the percentage of reduction was significantly higher in the intervention (milk) group compared to control at both time points (44.64 ± 15.98 vs. 24.95 ± 12.78, P < .001; 67.67 ± 22.15 vs. 42.87 ± 19.74, P < .001). Furthermore, although more patients in the intervention group (n = 4, 8%) showed complete healing of the ulcer compared to control (n = 0), the difference was not statistically significant (P = .117). Cow's milk 20% topical ointment improves and accelerates the healing of diabetic foot ulcers. However, more clinical studies are required to confirm these effects.

The Effect of Plantago major Hydroalcoholic Extract on the Healing of Diabetic Foot and Pressure Ulcers: A Randomized Open-Label Controlled Clinical Trial.

Aims: Diabetic foot ulcer (DFU) and pressure ulcer (PU) both are common types of ulcers worldwide. The wound healing effect of Plantago major leaves has been shown in a few animal studies. This study aimed to evaluate the clinical efficacy of P. major hydroalcoholic extract on DFU and PU healing. Methods: In this clinical trial, patients with DFU or PU who met the inclusion criteria were randomly assigned to drug (P. major) or control groups. For patients in the drug group, Plantago extract 10% topical gel was applied on the wound once daily concurrent with dressing and routine wound care for two weeks, while for the control group, an appropriate novel dressing was used along with routine wound care for the same duration. The percentage of wound size reduction at the end of the seventh and 14th days of intervention was recorded and compared between the groups. Results: Fifty and 44 patients in drug and control groups, respectively, completed the interventions. Plantago extract gel significantly resulted in more reduction in the wound size compared to control at the end of the first (64.90 ± 29.75% vs. 33.11 ± 26.55%; P < 0.001) and second week (86.85 ± 24.34% vs. 52.87 ± 32.41%; P < 0.001). Furthermore, the number of patients with complete wound healing in the drug group (n = 32, 64%) was significantly more than the control group (n = 9, 20.45%; OR: 3.129, 95% CI: 1.685-5.809, P < 0.001). Conclusion: The use of 10% topical gel of P. major leaf extract results in the acceleration of DFU and PU healing. Key points: Application of P. major topical gel results in the acceleration of diabetic foot ulcer and pressure ulcer healing. - P. major extract helps reducing the wound's erythema.- P. major leaf extract assists decreasing the wound size.- The number of patients completing wound healing process is higher among whom undergoing P. major dressing.

The Effect of acetyl-L-carnitine, Alpha-lipoic Acid, and Coenzyme Q10 Combination in Preventing Anti-tuberculosis Drug-induced Hepatotoxicity: A Randomized, Double-blind, Placebo-controlled Clinical Trial.

Drug-induced liver injury (DILI) is one of the most serious adverse effects of anti-tuberculosis (TB) drugs. A suggested mechanism of this adverse effect is mitochondrial dysfunction (MDF). The purpose of this study was an evaluation of the possible preventive effects of the combination of acetyl-L-carnitine (ALCAR), alpha-lipoic acid (ALA), and coenzyme Q10 (CoQ10), as mitochondrial nutrients (MNs), against anti-TB DILI. In this clinical trial, patients who met the inclusion criteria were randomly assigned to either experimental (n = 44) or placebo (n = 43) groups. The experimental group received capsules containing CoQ10 (200 mg) + ALA (250 mg) + ALCAR (250 mg) orally twice daily for two weeks, and the placebo group received oral placebo capsules with the same interval and duration. The mean serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin (TBil) at the end of the first and second weeks as well as the incidence of DILI during the intervention were recorded and compared between the two groups. At the end of the study, the mean serum levels of AST and ALT in the experimental group were significantly lower than the placebo group (36.27 ± 36.43 vs. 86.02 ± 97.23 and 28.41 ± 27.41 vs. 78.80 ± 118.28, respectively, P = 0.003 for both). Also, the incidence of anti-TB DILI was significantly lower in the experimental group than the placebo group (6.8% vs. 25.6%, P = 0.017). In conclusion, using the combination of ALCAR, ALA, and CoQ10 may provide an effective strategy in preventing anti-TB DILI.

The effect of lycopene on serum level of cardiac biomarkers in patients undergoing elective percutaneous coronary intervention: A randomized controlled clinical trial.

BACKGROUND: Myocardial ischemia may recur in a significant subset of patients following percutaneous coronary intervention (PCI). Lycopene, a carotenoid with antioxidant activity, has evidence for beneficial effects on cardiovascular system. In the present study, we aimed to evaluate the possible preventive effect of lycopene against post-PCI myocardial damage by detection of cardiac biomarkers of ischemia. METHODS: A total of 45 patients who planned to undergo elective PCI were randomly assigned to two groups to receive either lycopene (30 mg 12 hours before PCI as well as 15 mg just before and 8 hours after PCI) along with standard treatment (n = 23) or only standard treatment (n = 22). Standard treatment included aspirin, a statin, and a beta-blocker. The serum levels of creatine kinase-MB (CK-MB), troponin I, and high sensitivity C-reactive protein (hs-CRP) were measured 12 hours before and 12 hours after the procedure and were compared between the two groups. RESULTS: The use of lycopene significantly prevented the increase of CK-MB following PCI compared to control (P = 0.048). However, it had not any significant effect on serum levels of troponin I (TnI) (P = 0.176) and hs-CRP (P = 0.186) compared to control. CONCLUSION: Lycopene can prevent the increase of CK-MB following PCI. Therefore, it has the potential for prevention of post-PCI cardiovascular events. However, more studies are needed to confirm such an effect.