Lichtiger Colitis Activity Index Research Articles

Clinical Background Factors as Predictors of the Efficacy of 5-Aminosalicylic Acid Suppositories in Patients with Ulcerative Colitis

Introduction: Although the efficacy of 5-aminosalicylic acid (ASA) suppositories for ulcerative colitis (UC) has been reported in many studies, many studies have also described poor adherence to 5-ASA suppository regimens. We aimed to identify the clinical background factors that influence adherence to 5-ASA suppositories to improve adherence and efficacy of the treatment. Methods: We conducted a retrospective cohort study of 61 patients with active UC who were using 5-ASA suppositories. All patients underwent endoscopy and rectal biopsy for histological diagnosis prior to 5-ASA suppository treatment. The efficacy of 5-ASA suppository treatment was compared in relation to clinical background factors (sex, age, disease duration, disease type, clinical activity, Ulcerative Colitis Endoscopic Index of Severity, histological activity, serum C-reactive protein level, concomitant use of immunomodulators, history of steroid use, and dose of oral 5-ASA). Results: The efficacy of 5-ASA suppositories was significantly related to low Lichtiger Colitis Activity Index (LCAI) scores and proctitis type prior to its use. In terms of sex, females tended to show higher efficacy. Multivariate logistic regression analysis using these three factors showed high predictive value for the efficacy of 5-ASA suppositories (AUC, 0.788; sensitivity, 87.2%; and specificity, 63.7%). Conclusion: This study is the first to extract clinical background factors for predicting the efficacy of 5-ASA suppositories. The use of 5-ASA suppositories in patients who are expected to show efficacy will be effective in improving patient co-operation.

Efficacy of Plantago major seed in management of ulcerative colitis symptoms: A randomized, placebo controlled, clinical trial

ObjectiveEvaluation of the effect of Plantago major (P. major) seed on ulcerative colitis (UC) symptoms. MethodsIn this randomized double-blind clinical trial, 61 subjects received 3600 mg/day roasted P. major seed in intervention group (n = 31) and roasted wheat flour in control group (n = 30), for 8 weeks, as a complementary to standard medications. Variables were assessed using the Lichtiger Colitis Activity Index (LCAI) at baseline, week 4, and week 8. Results51 patients completed the trial (n = 28 in Plantago and n = 23 in placebo groups). Abdominal tenderness (p = 0.011), gastroesophageal reflux and gastric pain (p = 0.049 for both), were significantly less severe in P. major group. Visible blood in stool (p = 0.001), distension (p = 0.001), and anal pain (p = 0.051), decreased significantly in P. major group, although no significant difference was observed between the two groups: (p = 0.224), (p = 0.283), and (p = 0.455) respectively. ConclusionP. major seems to be effective in complementary management of UC.

The Role of Syndrome Differentiation in the Clinical Efficacy of Punica granatum on Patients with Ulcerative Colitis

Background: Tendency of patients toward diseases and their therapeutic responses are different based on their own temperament according to traditional Persian medicine. Objectives: The aim of this study is to investigate the difference between therapeutic responses of hot and cold temperament patients (based on traditional Persian medicine) with ulcerative colitis to pomegranate peel extract. Methods: Seventy-eight patients with moderate ulcerative colitis based on the Lichtiger colitis activity index (LCAI) criteria were randomized to receive an aqueous extract of the Punica granatum peel (6 grams per day) or placebo for four weeks. They were assessed before and after the intervention, in terms of symptoms, by the LCAI scoring system. The results were compared in two therapeutic groups based on the patients’ temperament (cold and hot), which were diagnosed based on a previous validated questionnaire. Results: Therapeutic response was significantly higher in patients with hot temperament compared to patients with cold temperament in the P. granatum group (1.916 ± 0.492 versus -0.500 ± 0.500, P = 0.029). Conclusions: This study showed the importance of considering syndrome differentiation and temperaments in interpreting the effect of P. granatum peels extract on ulcerative colitis.

Adiposity is associated with early reduction in bone mass in pediatric inflammatory bowel disease

ObjectivesThe effect of adiposity on bone mass in the early phases of inflammatory bowel disease (IBD) in children and adolescents is unclear. The aim of this study was to determine the role of adiposity on bone mass in the first 3 y of diagnosis of IBD. The expected result is that increased adiposity will be associated with increased bone mass in both the controls and IBD subjects. MethodsHeight-adjusted bone mineral density (BMD) z-scores of 25 subjects, age 13.97 ± 2.70 y, diagnosed with IBD for <4 y were compared to 24 controls, age 13.65 ± 2.60 y. Overweight was defined as BMI of ≥85th but <95th percentile, and obesity as BMI ≥95th percentile. Severity of IBD was determined by the Pediatric Crohn's Disease Activity Index and Lichtiger Colitis Activity Index. ResultsBefore stratification by BMI criterion, height-adjusted BMD z-scores were not significantly lower in IBD subjects versus controls for both the femoral neck (−0.8 ± 1.1 versus −0.06 ± 1.1, P = 0.070) and lumbar vertebrae (−0.4 ± 1.2 versus 0.2 ± 1.2, P = 0.086). Following stratification, height-adjusted BMD z-scores were significantly lower in the overweight/obese IBD subjects versus overweight/obese controls for femoral neck (−0.9 ± 0.9 versus 0.3 ± 1.3, P = 0.032); and non-significantly lower for the lumbar spine z-score (−0.4 ± 1.6 versus 0.5 ± 1.3, P = 0.197). BMD z-score had no relationship with the duration of disease, steroid therapy, and the severity of disease. ConclusionAdiposity was associated with reduced bone mass in the early phases of IBD, but with increased bone mass in the controls.

Efficacy of the Punica granatum peels aqueous extract for symptom management in ulcerative colitis patients. A randomized, placebo-controlled, clinical trial

ObjectiveTo investigate the effects of the Punica granatum peel extract on symptoms of patients with ulcerative colitis (UC). MethodPatients with UC were randomized to receive an aqueous extract of the P. granatum peel (6 g of dry peel/day) or placebo for four weeks complementary to standard medications. Symptoms were assessed using the Lichtiger Colitis Activity Index (LCAI) at baseline, week 4, and week 10 (follow-up). Clinical response was defined by ≥ 3 point decrease in LCAI. ResultsThe LCAI score was similarly reduced in both the P. granatum (−1.68 ± 3.85, P = 0.019) and placebo groups (−1.39 ± 2.41, P = 0.002). Clinical response was higher with P. granatum compared with placebo at week 4 (41.4% vs. 18.2%, P = 0.055), but not at week 10 (48.3% vs. 36.4%, P = 0.441). ConclusionsThe P. granatum peel extract seems effective in complementary management of UC. Further studies in a larger sample of patients are warranted. IRCT2014040617156N1.

Psychological status in Iranian patients with ulcerative colitis and its relation to disease activity and quality of life.

Background:Psychological profile of inflammatory bowel disease patients is not well studied in Iran. We investigated the psychological status of Iranian patients with ulcerative colitis (UC) and its relationship with disease activity and quality of life (QOL).Materials and Methods:A cross-sectional study was conducted on adult UC patients. The Lichtiger Colitis Activity Index, Hospital Anxiety and Depression Scale, General Health Questionnaire-12, and WHOQOL-BREF, were completed by the patients.Results:From 120 studied patients, 35 (29.2%), 48 (40.0%), and 46 (38.3%) had significant anxiety, depression, and psychological distress, respectively. Anxiety, depression, and psychological distress were strongly correlated with disease activity (r = 0.357 to 0.439, P < 0.01). Disease activity was negatively correlated with all QOL dimensions (r = −0.245 to −0.550, P < 0.01). Anxiety, depression, and psychological distress were also negatively correlated with all QOL domains (r = −0.356 to −0.789, P < 0.01). In the regression models, anxiety was independently associated with active disease (β = 4.150, P = 0.049). Furthermore, disease activity was associated with the physical health (β = −0.371, P < 0.001). For almost all of the QOL domains, depression and psychological distress were independent predictors (β = −0.296 to −0.453, P < 0.001).Conclusion:Anxiety, depression, and psychological distress are highly frequent in UC patients of our society and are strongly associated with disease activity. Depression and psychological distress are important predictors of poor QOL in these patients. Further prospective studies, as well as clinical trials, are warranted in this regard.

Efficacy of duloxetine add on in treatment of inflammatory bowel disease patients: A double-blind controlled study

Background:Treating inflammatory bowel disease (IBD) with antidepressants might be of utility to improve patient's condition. The aim of this study was to assess the efficacy of Duloxetine on depression, anxiety, severity of symptoms, and quality of life (QOL) in IBD patients.Materials and Methods:In a randomized, double-blind, controlled clinical trial on 2013-2014, in Alzahra Hospital (Isfahan, Iran), 44 IBD patients were chosen to receive either duloxetine (60 mg/day) or placebo. They were treated in a 12 weeks program, and all of the participants also received mesalazine, 2-4 g daily. We assessed anxiety and depression with Hospital Anxiety and Depression Scale, the severity of symptoms with Lichtiger Colitis Activity Index and QOL with World Health Organization Quality of Life Instruments, before and just after the treatment. The data were analyzed using Paired sample t-test and ANCOVA.Results:In 35 subjects who completed the study, the mean (standard error [SE]) scores of depression and anxiety were reduced in duloxetine more than placebo group, significantly (P = 0.041 and P = 0.049, respectively). The mean (SE) scores of severity of symptom were also reduced in duloxetine more than the placebo group, significantly (P = 0.02). The mean (SE) scores of physical, psychological, and social dimensions of QOL were increased after treatment with duloxetine more than placebo group, significantly (P = 0.001, P = 0.038, and P = 0.015, respectively). The environmental QOL was not increased significantly (P = 0.260).Conclusion:Duloxetine is probably effective and safe for reducing depression, anxiety and severity of physical symptoms. It also could increase physical, psychological, and social QOL in patients.

Effect of a Probiotic Preparation (VSL#3) on Induction and Maintenance of Remission in Children With Ulcerative Colitis

Several probiotic compounds have shown promise in the therapy of ulcerative colitis (UC). However, a strong sustained benefit remains to be seen. Uncontrolled pilot studies suggest that a probiotic preparation (VSL#3) maintains remission in mild to moderate UC and reduces active inflammation in adult patients. Aims of our prospective, 1-year, placebo-controlled, double-blind study were to assess the efficacy of VSL#3 on induction and maintenance of remission and to evaluate the safety and tolerability of the probiotic preparation therapy in children with active UC. A total of 29 consecutive patients (mean age: 9.8 years; range: 1.7-16.1 years; female/male: 13/16) with newly diagnosed UC were randomized to receive either VSL#3 (weight-based dose, range: 450-1,800 billion bacteria/day; n=14) or an identical placebo (n=15) in conjunction with concomitant steroid induction and mesalamine maintenance treatment. Children were prospectively evaluated at four time points: within 1 month, 2 months, 6 months, and 1 year after diagnosis or at the time of relapse. Lichtiger colitis activity index and a physician's global assessment were used to measure disease activity. At baseline, within 6 months and 12 months or at the time of relapse, all patients were assessed endoscopically and histologically. All 29 patients responded to the inflammatory bowel disease (IBD) induction therapy. Remission was achieved in 13 patients (92.8%) treated with VSL#3 and IBD therapy and in 4 patients (36.4%) treated with placebo and IBD therapy (P<0.001). Overall, 3 of 14 (21.4%) patients treated with VSL#3 and IBD therapy and 11 of 15 (73.3%) patients treated with placebo and IBD therapy relapsed within 1 year of follow-up (P=0.014; RR=0.32; CI=0.025-0.773; NNT=2). All 3 patients treated with VSL#3 and 6 of 11 (54.5%) patients treated with placebo relapsed within 6 months of diagnosis. At 6 months, 12 months, or at time of relapse, endoscopic and histological scores were significantly lower in the VSL#3 group than in the placebo group (P<0.05). There were no biochemical or clinical adverse events related to VSL#3. This is the first pediatric, randomized, placebo-controlled trial that suggests the efficacy and safety of a highly concentrated mixture of probiotic bacterial strains (VSL#3) in active UC and demonstrates its role in maintenance of remission.

Short-term response to adalimumab in childhood inflammatory bowel disease

Adalimumab is effective for adults with moderate to severe Crohn's disease (CD). Data in children with inflammatory bowel disease (IBD) is sparse. We aim to evaluate pediatric IBD response to adalimumab. We conducted a retrospective chart review of pediatric IBD patients treated with adalimumab. We defined response as either a decrease in the disease activity index severity or remission after 3-6 months of treatment. Ten patients were identified. Seven had CD, three had ulcerative colitis (UC). All had colonic disease and disease in either the esophagus, stomach, or duodenum. Eight patients initially responded to infliximab, 5 with CD and 3 with UC; 2 CD patients had incomplete data for evaluation. The mean and median times between initial infliximab and initial adalimumab were 29.5 and 24 months, respectively. Eight patients responded to adalimumab 40 mg or 80 mg biweekly, or 80 mg initial dose followed by 40 mg biweekly. The mean Pediatric Crohn's Disease Activity Index (PCDAI) in CD patients before and after adalimumab were 12 and 4.2, respectively (normal <or=10). The mean Lichtiger Colitis Activity Index (LCAI) in UC patients before and after adalimumab were 9 and 5.1, respectively (normal <10). Corticosteroids were weaned off in 4/7 patients at 1 to 10 months after initiation of adalimumab. One patient with CD and 1 patient with UC failed adalimumab, required surgery, and remained on corticosteroids. Adalimumab is useful in pediatric IBD patients who become intolerant of infliximab.

Infliximab for pediatric ulcerative colitis: a retrospective Italian multicenter study

Infliximab (IFX), the chimeric anti TNFalpha antibody, an established treatment for Crohn's disease in adults and in children, is used less frequently in ulcerative colitis (UC). To report the clinical course of pediatric patients with active UC receiving IFX. Charts of 22 patients were reviewed (13 male, 9 female): 4 with a severe UC attack refractory to systemic corticosteroids (CS); 18 with a protracted course, of which 16 CS-dependent and 2 CS-resistant. The baseline therapeutic program consisted of 3 consecutive intravenous infusions (0, 2, 6 weeks) of IFX (5 mg/kg), followed by a retreatment schedule (infusion every 8 weeks); azathioprine (AZA) was administered chronically in all. Clinical evaluation was done with the Lichtiger Colitis Activity Index (LCAI). Follow-up was performed until week 54. LCAI >/= 9 was considered treatment failure; a LCAI </= 2 was consistent with remission. All 22 patients began the study with a LCAI > 9: 12 had a full response and were on remission at week 54 and did not receive CS (8 on IFX re-treatment and AZA, 4 on AZA alone); 6 had a partial response; 4 were non responders. Colectomy was performed in 7 patients, beyond the period of the acute attack in all but one. In children with severe ulcerative colitis IFX is a valuable treatment for inducing remission, avoiding emergency colectomy; retreatment may be offered to maintain remission.

Immune Response to Influenza Vaccine in Pediatric Patients With Inflammatory Bowel Disease

The aim of this study was to compare response to inactivated influenza vaccine in healthy children and pediatric patients with inflammatory bowel disease (IBD). A prospective, open-label, controlled clinical trial during influenza seasons of 2002-2004 was performed. Single-dose inactive trivalent influenza vaccine was administered. Immune response to vaccination was measured by pre-immunization and postimmunization hemagglutinin inhibition titers. A postimmunization hemagglutinin inhibition titer of 40 or higher was considered protective against influenza. IBD activity and adverse events were recorded. Eighty subjects were enrolled (29 healthy controls, 51 IBD patients). One patient did not complete the study. Patients were divided into 3 subgroups: infliximab and immunomodulatory (16), immunomodulatory (20), and anti-inflammatory therapy (14). Immunomodulatory therapy included corticosteroids, 6-mercaptopurine, or methotrexate. Overall, there was a statistically significant decrease in immune response in patients compared with healthy controls who received 1 influenza vaccine antigen (B/Hong Kong, P = .0125). Patients receiving infliximab and immunomodulatory therapy were less likely to respond to 2 influenza vaccine antigens (A/New Caledonia/20/99 and B/Hong Kong/330/2001, P = .018 and .0002, respectively). Fifteen subjects (19%) reported 19 mild adverse events: 11 (14%) reported soreness at the site, 4 (5%) reported having a cold, 3 (4%) reported flu-like symptoms, and 1 (1%) reported a headache. The clinical activity of IBD was not affected by vaccination. The serologic conversion rate to influenza vaccine in patients with IBD ranged from 33% to 85%. Patients on concomitant infliximab and immunomodulatory therapy are at risk of inadequate response to vaccination. The vaccine was safe and did not affect IBD activity.

Short‐ and Long‐term Response to and Weaning from Infliximab Therapy in Pediatric Ulcerative Colitis

We evaluated the response to infliximab in pediatric patients with ulcerative colitis (UC) and their long-term follow-up. We expanded our previous study of 14 patients and furthermore evaluated the success of weaning patients from infliximab. We reviewed the charts of 27 pediatric patients with UC who were treated with infliximab instead of undergoing a colectomy. Patients with new-onset UC refractory to intravenous steroids for 5 to 10 days and patients with non-steroid-dependent UC with an acute exacerbation were classified as acutely ill (n = 16); patients with chronic steroid-dependent UC were classified as chronically ill (n = 11). The Lichtiger Colitis Activity Index (LCAI) was measured for all patients at baseline and at 1 and 2 months after treatment with infliximab was initiated. Patients were regarded as successfully treated if they remained off steroids and avoided colectomy. The acutely ill group had a mean LCAI score of 11.4 at induction and 0.3 after 2 months. The chronically ill group had a mean LCAI score of 11.2 at induction and 5.5 after 2 months. Treatment with infliximab was successful in 75% of acutely ill patients and in 27% of chronically ill patients. Infliximab was discontinued in 80% of successfully treated patients (83% of acutely ill, 67% of chronically ill). These patients had an average of 10 infusions and a mean follow-up time of 10 months from their last infliximab infusion. Our results suggest that infliximab is more effective in acutely ill UC patients than in patients with chronic steroid-dependent UC. In addition, some patients treated with infliximab can be weaned from infliximab and maintain remission.

The Treatment of Pediatric Ulcerative Colitis with Infliximab, a Long-Term Evaluation

Purpose: We evaluate the indications for infliximab to treat pediatric ulcerative colitis (UC) and report long-term follow-up. Methods: The charts of 27 pediatric patients with UC who were treated with infliximab were reviewed. All patients would have otherwise been candidates for colectomy. The acute group included patients with new onset UC refractory to IV steroids for 5–7 days and patients with non-steroid dependent UC with a fulminant exacerbation; the chronic group included patients with chronic steroid dependent UC. Lichtiger colitis activity index (LCAI) was measured for all patients at 0, 1, and 2 months after infliximab. Patients were regarded as successfully treated if they remained off steroids and avoided colectomy. Results: The acute and chronic groups included 16 and 11 patients respectively. The acute group had a mean LCAI score of 11.4 at induction and a mean net change of 11.1 after 2 months. The chronic group had a mean LCAI score of 11.2 and a mean change of 5.7. The acute group had a significantly greater net LCAI change than the chronic, p = 0.001. The net LCAI change in the patients treated successfully was not significantly different than those who failed, p = 0.43. The mean follow-up time from last infliximab was 13 months. Infliximab was successful in 75% of patients in the acute group and 27% in the chronic. Infliximab is no longer required in 80% of patients (83% of acute; 67% of chronic) who were successfully treated. These patients had a mean of 10 infusions and a mean follow-up of 10 months from last infliximab. Conclusions: (1) Infliximab appears to be effective for patients with acute UC refractory to IV steroids and non-steroid dependent UC with fulminant exacerbation. (2) Patients with steroid dependent UC respond poorly to infliximab. (3) Infliximab could be first line therapy for severe UC although further study is needed. 4) Patients successfully treated with infliximab can discontinue therapy and maintain their remission, possibly only needing the induction phase of infliximab therapy.

Infliximab Is Effective in Acute but not Chronic Childhood Ulcerative Colitis

ABSTRACTPurpose:The authors report their experience with infliximab in pediatric patients with ulcerative colitis (UC).Methods:Fourteen patients were reviewed. Group 1 included five patients with newly diagnosed, fulminant colitis refractory to 7 to 10 days of intravenous steroids. Group 2 included four patients with ulcerative colitis in remission off steroid therapy who experienced relapse and were hospitalized with fulminant colitis refractory to intravenous steroids for 7 to 10 days. Group 3 included five patients chronically dependent on steroids with colitis refractory to medical management. All patients were treated on an open‐label basis with infliximab infusions of 5 mg/kg/dose at 0, 2, and 6 weeks and every 6 to 8 weeks thereafter. Follow‐up was maintained for at least 6 weeks. Clinical status was scored with the Lichtiger Colitis Activity Index (LCAI) at each visit. LCAI ≥10 was considered treatment failure. We defined success as LCAI ≤2, a score consistent with UC remission. Response was categorized for each group.Results:All patients began the study with LCAI ≥11 before infliximab treatment. All group 1 patients experienced response to infliximab. All but one (75%) patient in group 2 had a response. Only one (20%) group 3 patient had a response to infliximab.Conclusion:Infliximab was an effective agent in the treatment of acute UC in our patients. Long‐term steroid use and emergency colectomy were avoided. Infliximab was less effective in patients who were dependent on steroids.

Infliximab as a Novel Therapy for Pediatric Ulcerative Colitis

ABSTRACTObjectivesThe role of infliximab (anti–tumor necrosis factor α antibody) therapy in ulcerative colitis (UC) is not well defined. There are only two reports published describing its use in UC. The authors describe their experience with open‐label use of infliximab in children with moderate to severe UC.MethodsThe authors collected data on all consecutive pediatric patients with UC who received infliximab at The Children's Hospital of Philadelphia until July 2001. The primary measured outcome was clinical response at 2 days and 2 weeks after infliximab infusion, as measured by the Lichtiger colitis activity index (LCAI) score and the Physician Global Assessment (PGA). Tolerance of the infusions and adverse events were recorded.ResultsNine patients qualified for clinical response analysis. The median Lichtiger colitis activity index score decreased from 11 before the infusion to 1 at 2 days and 2 weeks after the infusion, respectively (P = 0.01 for 2 days and 2 weeks). Seven of nine (77%) patients had decreased activity of their disease measured by the Physician Global Assessment. Corticosteroid therapy was discontinued in six (66%) patients. An infusion reaction developed (generalized pruritus and facial flushing) in two patients and an elevated anti‐nuclear antibody (ANA) titer of 1:1280 developed in one patient.ConclusionInfliximab is associated with short‐term clinical improvement in children and adolescents with moderate to severe UC.

Infliximab as a novel therapy for pediatric ulcerative colitis.

The role of infliximab (anti-tumor necrosis factor alpha antibody) therapy in ulcerative colitis (UC) is not well defined. There are only two reports published describing its use in UC. The authors describe their experience with open-label use of infliximab in children with moderate to severe UC. The authors collected data on all consecutive pediatric patients with UC who received infliximab at The Children's Hospital of Philadelphia until July 2001. The primary measured outcome was clinical response at 2 days and 2 weeks after infliximab infusion, as measured by the Lichtiger colitis activity index (LCAI) score and the Physician Global Assessment (PGA). Tolerance of the infusions and adverse events were recorded. Nine patients qualified for clinical response analysis. The median Lichtiger colitis activity index score decreased from 11 before the infusion to 1 at 2 days and 2 weeks after the infusion, respectively (P = 0.01 for 2 days and 2 weeks). Seven of nine (77%) patients had decreased activity of their disease measured by the Physician Global Assessment. Corticosteroid therapy was discontinued in six (66%) patients. An infusion reaction developed (generalized pruritus and facial flushing) in two patients and an elevated anti-nuclear antibody (ANA) titer of 1:1280 developed in one patient. Infliximab is associated with short-term clinical improvement in children and adolescents with moderate to severe UC.