The efficacy and safety of oral low dose naltrexone versus placebo in the patients with lichen planopilaris: a randomized controlled clinical trial.

BACKGROUND AND OBJECTIVES: Lichen planopilaris (LPP) is one of the important causes of cicatricial alopecia. We aimed to evaluate the efficacy and safety of low-dose naltrexone (LDN) in the setting of a clinical trial in patients with LPP. METHODS: We included patients with LPP between 2018 and 2020. Patients were allocated to two groups. The first group received topical clobetasol plus oral low dose naltrexone (3 mg) while the second received topical clobetasol plus placebo. The assessment was made for the disease severity by lichen planopilaris activity index (LPPAI) instrument and the safety of the drug in 2-month intervals up to 6 months. To compare both groups, we used the ANOVA test for repeated measures. Clinical trials registry code: IRCT20180809040747N1. RESULTS: Thirty-four patients were analyzed in an intention-to-treat fashion. There was a decrescendo pattern on LPPAI scores that was statistically significant within the LDN (p = .001) but almost significant within the placebo group (p = .060) and non-significant between the groups (p = .813). The side effects attributable to the low dose naltrexone was not statistically different between studied groups. CONCLUSION: Low-dose naltrexone (3 mg) failed to improve the severity of the LPP more than what is achievable with topical clobetasol.

Oral simvastatin combined with narrowband UVB for the treatment of psoriasis: A randomized controlled trial.

Psoriasis is a common chronic skin condition, which is an immune-related hyperproliferative disorder. Among the different treatments for psoriasis, statins have been found to reduce the severity of the disease. Accordingly, fluvastatin and simvastatin are known to have anti-inflammatory effects by inhibiting inflammatory cytokines and lymphocyte function. Narrowband ultraviolet B (NB-UVB) is known as an effective and safe modality for psoriasis treatment. In this double blind, randomized controlled trial, we investigated the efficacy and safety of adding simvastatin to NB-UVB phototherapy in patients with psoriasis. Forty-eight patients with psoriasis undergoing NB-UVB phototherapy were randomly divided into placebo groups; one received oral simvastatin, and the other received a placebo for 12 weeks. Psoriasis severity was assessed with the Psoriasis Area and Severity Index (PASI) and Dermatology Life and Quality Index (DLQI). Both groups showed a significant decline in PASI score after 6 and 12 weeks compared to the baseline. The differences in reducing PASI score and DLQI between the two groups were not significant neither at week sixth nor 12th. In addition, DLQI decreased significantly in the placebo group at week 12th. In contrast with previous studies, we did not find any additional effects for oral simvastatin5 in treating psoriasis with NB-UVB. Also, an insignificant difference in the improvement of quality of life between both groups was ascertained.

Efficacy and safety of pioglitazone plus phototherapy versus phototherapy in patients with plaque type psoriasis: a Double Blinded Randomized Controlled Trial.

Introduction: Thiazolidinediones have shown a good therapeutic effect in psoriasis treatment with no major adverse effects. The purpose of this study was to evaluate and compare the therapeutic effects of the combination of phototherapy and Pioglitazone with the phototherapy alone on plaque psoriasis patients. Methods and Materials: About 60 adults with plaque type psoriasis entered the study. They were randomly divided into two groups; one with pioglitazone and one with placebo and both underwent 30 sessions of phototherapy during 10 weeks. Before and after the treatment Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were assessed. Side effects of the treatment were also investigated. Results: The average PASI of the pioglitazone group was reduced from 20.9 ± 9.8 to 1.8 ± 1.4 (p < .001) versus the placebo group in which the PASI was reduced from 22 ± 8.5 to 4.4 ± 4. In other words, PASI was reduced in the pioglitazone and placebo group by 83.5% and 56.7% respectively (p < .05). The two groups didn't have a significant difference in reducing the DLQI (p = .315). Conclusion: Pioglitazone can vastly enhance the effectiveness of phototherapy in plaque psoriasis patients without causing any important adverse effect and with no success in improving the score of DLQI.

Tranexamic acid in treatment of melasma: A comprehensive review of clinical studies.

Melasma is a human melanogenesis dysfunction that results in localized, chronic acquired hyperpigmentation of the skin. It has a significant impact on appearance, causing psychosocial and emotional distress, and reducing the quality of life of the affected patients. Tranexamic acid (TA) is a plasmin inhibitor used to prevent abnormal fibrinolysis to reduce blood loss and exerts its effect by reversibly blocking lysine binding sites on plasminogen molecules, thus inhibiting plasminogen activator (PA) from converting plasminogen to plasmin. As plasminogen also exists in human epidermal basal cells and cultured human keratinocyte are known to produce PA, there is basic rationale that TA will affect keratinocyte function and interaction. A thorough literature review indicates that while TA is used through various route of administration including oral, topical, and intradermal injection and as adjutant therapy with laser to treat melasma, its efficacy is not established adequately. Further studies are needed to clarify the role of TA in treatment of melasma.

A randomized crossover clinical trial of sertraline for intradialytic hypotension.

INTRODUCTION: Intradialytic hypotension (IDH) has been reported in 15% to 50% of hemodialysis patients and increases patients morbidity and mortality. Some small noncontrolled studies evaluated the effect of sertraline on IDH with conflicting results. This study is a randomized crossover controlled trial on the effectiveness of sertraline to reduce IDH. MATERIALS AND METHODS: Patients on hemodialysis who suffered IDH in at least 50% of their dialysis sessions were enrolled. Each patient received either sertraline or placebo for 4 weeks and after a 4-week washout period, was switched to the other arm of the trial. All patients started sertraline at a daily dose of 50 mg that increased to 100 mg after 1 week. RESULTS: Twelve patients completed all phases of the study. Sertraline therapy increased nadir intradialysis diastolic and systolic blood pressure by 3.8 mm Hg and 4.9 mm Hg at the end of the intervention, respectively. Sertraline therapy also significantly increased postdialysis diastolic and systolic blood pressure by 6.0 mm Hg and 8.7 mm Hg. Sertraline therapy significantly reduced the risk of hypotension episodes by 43%. The improvement of intradialysis and postdialysis diastolic and systolic blood pressure were only significant in nondiabetic patients. CONCLUSIONS: Sertraline therapy significantly increases intradialysis and postdialysis blood pressure. These effects of sertraline can result in significant decrease in hypotension episodes during dialysis treatment and the number of interventions required to manage IDH. However, not all patients may benefit from sertraline depending on comorbidities such as diabetes mellitus.

Association between depression and inflammatory/anti-inflammatory cytokines in chronic kidney disease and end-stage renal disease patients: a review of literature.

Depression is a common psychiatric disorder in patients with advanced chronic kidney diseases (CKDs). Strong correlation has been reported between depression and patients' morbidity and mortality among dialysis patients. On the contrary, chronic inflammation may be a major contributor to morbidity and mortality in these patients. Elevated plasma levels of proinflammatory cytokines, especially C-reactive protein and interleukin (IL)-6, have been correlated with cardiovascular events, hospitalization, and all-cause and cardiovascular-associated mortality in dialysis patients. Studies suggested that inflammation-mediated atherosclerotic cardiovascular diseases are the possible reasons for depression-induced mortality among patients without renal diseases. Several studies found significant elevations in circulating levels of proinflammatory cytokines, particularly IL-6 and tumor necrosis factor-α, in patients with major depression. Furthermore, depressive mood and behaviors, including sadness and suicidal ideation, were observed in patients who received repeated injections of recombinant cytokines. A thorough literature review indicates that while depressive symptoms and elevated inflammatory cytokine levels coexist in CKD and dialysis patients, their association is uncertain. Depression seems to be more associated with elevated serum levels of IL-6 than other cytokines in these patients. Further studies are needed to clarify the possibility of a causal relationship between inflammation and depressive symptoms in CKD and dialysis patients.

A two-year utilization of the pharmacist-operated drug information center in Iran.

OBJECTIVE: To assess and describe the call services delivered by drug and poison information call center (DPIC) of 13-Aban pharmacy, which is closely operated by the Department of Clinical Pharmacy, College of Pharmacy affiliated to Tehran University of Medical Sciences. METHODS: All calls services including counseled and follow-up calls provided by 13-Aban DPIC to health care professionals and public were collected, documented, and evaluated in a 2 years period from July 2010 to June 2012 using the designed software. Data analysis was done by SPSS version 16.0. FINDINGS: Totally 110,310 calls services delivered during a 2 years period. Among healthcare professionals, pharmacists, general physicians, and nurses requested more call services respectively (P = 0.001). DPIC could detect 585 potential cases of adverse drug reactions (ADRs) and 420 cases of major drug-drug interactions (DDIs). CONCLUSION: This study by analyzing and reporting the two-years activities of one of the major DPICs in Iran, showed that DPICs can offer drug consultation for healthcare professional and public as well as detect and prevent ADRs and DDIs, and therefore can promote patients' health regarding drug therapy.

Sertraline decreases serum level of interleukin-6 (IL-6) in hemodialysis patients with depression: results of a randomized double-blind, placebo-controlled clinical trial.

BACKGROUND: This study was designed to assess the effect of sertraline on serum concentrations of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), IL-10 and high-sensitivity C-reactive protein (hs-CRP) of depressed hemodialysis (HD) patients. METHODS: During a randomized, double-blind, placebo-controlled trial, fifty depressed HD patients were allocated to receive sertraline or placebo for 12 weeks. Patients' depression was assessed using Beck Depression Inventory-second edition (BDI-II). Biochemical parameters (hemoglobin, serum albumin, iron stores, etc.) and serum IL-6, IL-10, TNF-α, and hs-CRP levels were measured at baseline and at weeks 6 and 12 of the study. RESULTS: Sertraline significantly improved depression symptoms in 47.5% of the patients. Compared with placebo, serum levels of IL-6 significantly decreased (P<0.01) in the sertraline group at week 12 of the study. Although serum level of TNF-α decreased and serum level of IL-10 increased in sertraline group at week 12 versus initiation of the study, no significant differences were found between sertraline and placebo groups. Serum hs-CRP did not display differences neither for inter- nor intra-group comparisons. Hemoglobin and serum albumin concentrations were significantly lower at week 12 in the placebo versus sertraline group (P=0.012 and P=0.006, respectively). No significant differences were observed in the inflammatory mediators between responders and non-responders to sertraline. CONCLUSIONS: Compared with placebo, sertraline significantly decreased serum level of IL-6. The anti-inflammatory effect of sertraline was independent to its efficacy for depression treatment. Sertraline could be a promising strategy to reduce the systemic inflammation and to treat depression in HD patients.

Association between antiinflammatory cytokine, IL-10, and sleep quality in patients on maintenance hemodialysis.

Elevated proinflammatory cytokines have been attributed to poor sleep quality in patients receiving hemodialysis. This is the first investigation about the relationship between sleep quality and circulating levels of antiinflammatory markers in these patients. A total of 72 patients who were receiving maintenance hemodialysis were enrolled in this cross-sectional study. The Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality. Patients were divided into two groups: good sleepers (PSQI score < 5) and poor sleepers (PSQI score ≥ 5). Assessments were made for serum biochemical parameters (albumin, parathyroid hormone), inflammatory (interleukin [IL]-6, tumor necrosis factor-alpha [TNF-α], and high-sensitivity c-reactive protein [hs-CRP] ) and antiinflammatory (IL-10) markers. Fifty-four patients (75%) were classified as poor sleepers. Poor sleepers showed significantly lower levels of serum IL-10 and higher serum triglyceride and parathyroid hormone concentrations. These patients were more likely to have more comorbidities. The global PSQI score was significantly correlated with serum IL-10 (p = 0.03) and triglyceride levels (p = 0.01). Multivariate logistic regression analysis showed a direct correlation between PSQI and having comorbidities (p = 0.011, odds ratio [OR] = 3.918; confidence interval 95% [CI] = 2.742-19.031), between PSQI and serum triglyceride (p = 0.027, OR = 1.027 [95% CI = 1.007-1.048] ), and an inverse correlation between PSQI and serum IL-10 level (p = 0.021, OR = 0.424 [95% CI = 0.195-0.922]). Reduced circulating levels of the antiinflammatory cytokine IL-10 were significantly associated with poor sleep quality in hemodialysis patients. Factors including serum IL-10 and triglyceride concentrations and having comorbidities may predict patients prone to poor sleep quality.

Relationship between a pro- and anti-inflammatory cytokine imbalance and depression in haemodialysis patients.

AIM: Depression represents the most frequent psychiatric disorder in patients on maintenance haemodialysis (HD), and it might be associated with secretion of inflammatory cytokines. In this study, we explore the possible correlations between depression and pro-inflammatory (IL-1ß, IL-6, and TNF-α), anti-inflammatory (IL-10) cytokines, as well as high-sensitivity C-reactive protein (hs-CRP) serum levels. METHODS: Eighty three HD patients were enrolled in this cross-sectional study. Depressive symptoms were measured with the Beck Depression Inventory (BDI), and 'elevated symptoms of depression' were defined as a BDI score of ≥16. Biochemical parameters (serum albumin, haemoglobin, ferritin, etc.) and dialysis dosage delivery (kt/v) were assessed. Serum IL-1ß, IL-6, IL-10, TNF-α, and hs-CRP levels were measured using an ELISA method. Thirty two, healthy, age- and sex-matched individuals were included as the control group. RESULTS: The prevalence of depression in HD patients was 61.4%. HD Patients with symptoms of depression had lower educational levels compared to non-depressed ones (P = 0.02), but did not differ with respect to age, gender, time on dialysis program, marital status, or smoking habits. Depressed patients also had significantly higher serum levels of IL-6, the IL-6-to-IL-10 ratio, as well as lower haemoglobin levels (P = 0.003, P = 0.002, and P = 0.02 respectively). No differences in mean serum IL-1ß, IL-10, TNF-α, or hs-CRP concentrations were noted between the two groups. The BDI scores showed a significant, positive correlation with serum levels of IL-1ß (P = 0.03), IL-6 (P = 0.001), TNF-α (P = 0.02), the IL-6-to-IL-10 ratio (P = 0.001), and a negative correlation with haemoglobin levels (P = 0.02). CONCLUSIONS: Maintenance HD patients with symptoms of depression may have higher serum levels of IL-6, a IL-6-to-IL-10 ratio, and lower haemoglobin concentrations. An imbalance between pro- and anti-inflammatory cytokines may play an important role in the pathogenesis of depression in HD patients.

Serum TNF-α levels reflect the clinical severity of envenomation following a Hemiscorpius lepturus sting.

Hemiscorpius lepturus (H. lepturus), found in south-western areas of Iran and south of Iraq, is considered to be the most dangerous scorpion in the region, and poses a significant risk to the health of the indigenous population due to the unique, clinical manifestations associated with its sting.. In the present study, 36 patients from the Khuzestan province in the southwest of Iran, displaying varying degrees of envenomation following an H. lepturus scorpion sting, were admitted to hospital. Serum levels of interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-8 (IL-8) and tumour necrosis factor-α (TNF-α) were measured using double-ligand, enzyme-linked, immunosorbent assay (ELISA) kits, and were compared with 30 healthy controls and ten age-matched patients stung by the Mesobuthus eupeus (M. eupeus) scorpion, a less dangerous species that produces primarily neurotoxic manifestations. Blood samples from M. eupeus and H. lepturus victims were taken on admission, and from H. lepturus-stung patients six hours after serotherapy with multivalent anti-venom. When compared to healthy volunteers, with the exception of TNF-α, significantly higher serum cytokine levels were measured in patients following M. eupeus envenomation. However, all three groups of H. lepturus-stung patients showed significantly, and in a severity-related manner, higher mean values for all the interleukins that were measured, including TNF-α, when compared with M. eupeus-stung cases. Six hours after serotherapy, there was a greater reduction in cytokine and TNF-α levels in patients classed as having mild symptoms, in comparison with patients classed as having moderate to severe symptoms. The results of the present study suggest that, unlike M. eupeus, the toxic manifestations observed following being stung by H. lepturus are associated with increased serum TNF-α levels and correlate positively with the clinical severity of the symptoms. Furthermore, serotherapy is only effective when administered to mild cases of H. lepturus scorpion envenomation.

An epidemiological and a clinical study on scorpionism by the Iranian scorpion Hemiscorpius lepturus.

The aim of this retrospective descriptive study was to describe the epidemiological and some common clinical symptoms and signs among humans stung by Hemiscorpius lepturus (H. lepturus) in the southwest province of Iran, Khuzestan. Cases were collected from hospital patients' files referred to two major Khuzestan hospitals over 5 years. Only definite stings of this species, identified by trained health-caring personnel, were included in this study. Epidemiological and clinical signs and symptoms were recorded. There were 354 scorpion victims, 43% of whom were from rural areas. Stings mainly occurred at night between 7p.m. and 5a.m. (56.1%), or from early morning 5a.m. to 12a.m. (38.6%), 41% of which occurred in the lower extremities. Eighty three percent of accidents occurred in mild/hot months of this area between April and October. The age most inflicted was between 1 month to 10 years and 11-20 years old, observed in 39.6% and 26.8% of victims, respectively. Among all the 26,397 scorpion stung files studied over the period of the study, while only 10-15% of stung cases occurred due to this not highly prevalent scorpion of Iran, it was responsible for 89% of the deaths and 92% of hospitalized scorpion-stung patients. The majority of cases were children aged less than 12 years old. Clinical signs and symptoms were both local and systemic. The local symptoms ranged from erythema to severe necrosis with no immediate sensation of pain. Renal toxicity is one of the serious systemic effects, which, if not treated early by administration of the polyvalent antivenom, can progress to severe renal and cardio-respiratory failure. Overall, the findings demonstrate that the characteristic clinical features of envenomation produced by this scorpion differ significantly from those reported for other scorpions in the world.