-
Oxidative Medicine and Cellular... 2022To systematically assess effectiveness and safety of Bifidobacterium quadruple viable bacteria combined with mesalamine against ulcerative colitis (UC) in the Asian... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To systematically assess effectiveness and safety of Bifidobacterium quadruple viable bacteria combined with mesalamine against ulcerative colitis (UC) in the Asian population.
METHODS
An electronic search was conducted in PubMed, Embase, Cochrane Library, CNKI, VIP, and Wanfang databases for a random collection of controlled trials of Bifidobacterium quadruple viable bacteria combined with mesalamine against UC. Following data screening and extraction, a Cochrane risk assessment tool was adopted to evaluate the quality of the included studies, and RevMan 5.3 and Stata/SE 15.1 software were used for meta-analysis.
RESULTS
Nineteen articles which enrolled 1,707 subjects were included ultimately in this study. The experimental group performed better than the control group in improving the Mayo score (MD = -1.94, 95% CI = (-2.69, -1.19), < 0.00001), increasing the total clinical efficiency (OR = 5.10, 95% CI (3.53, 7.38), < 0.00001), reducing the levels of IL-8 (SMD = -1.79, 95% CI (-2.36, -1.12), < 0.00001), increasing the levels of IL-4 (SMD = 1.00, 95% CI (0.60, 1.41), < 0.00001), and reducing the levels of hsCRP (MD = -3.26, 95% CI (-4.28, -2.25), < 0.00001), TNF- (MD = -7.11, 95% CI (-9.23, -5.00), < 0.00001), ox-LDL (MD = -14.46, 95% CI (-17.20, -11.72), < 0.00001), and LPO (MD = -3.55, 95% CI (-4.70, -2.39), < 0.0001) as well as increasing SOD level (SMD = 1.68, 95% CI (1.02, 2.35), < 0.00001), and adverse reactions were substantially less than that of control (OR = 0.43, 95% CI = (0.28, 0.66), = 0.0001).
CONCLUSION
In conclusion, the current meta-analysis shows that Bifidobacterium quadruple viable bacterium combined with mesalamine has a satisfactory effect in the treatment of UC in China, and its safety is better than that of mesalamine or Bifidobacterium quadruple viable bacteria alone. However, randomized controlled trials with standardized designs and large sample sizes are still needed for further validation.
Topics: Bifidobacterium; C-Reactive Protein; Colitis, Ulcerative; Humans; Interleukin-4; Interleukin-8; Mesalamine; Superoxide Dismutase; Tumor Necrosis Factor-alpha
PubMed: 36238645
DOI: 10.1155/2022/8272371 -
United European Gastroenterology Journal Oct 2022We performed a systematic review to investigate the definition of mild to moderate active ulcerative colitis (UC), and to describe predictors of good response to... (Review)
Review
We performed a systematic review to investigate the definition of mild to moderate active ulcerative colitis (UC), and to describe predictors of good response to treatment in clinical trials assessing 5-ASA and/or budesonide. Thirty-nine randomized controlled trials were included. The UC Disease Activity Index (UCDAI) was the most frequent score used for defining mild to moderate active UC (16 studies, 41%), followed by Clinical Activity Index in 11 studies (28.2%). Four different cut-offs were used to define mild to moderate active UC using the UCDAI. The most frequently reported predictors of good response to treatment was a mild and moderate disease activity. There is heterogeneity in the definition of mild to moderate active UC in randomized clinical trials. A standardized definition of mild to moderate active UC used for inclusion of patients in clinical trials is needed.
Topics: Budesonide; Colitis, Ulcerative; Humans; Mesalamine
PubMed: 36029157
DOI: 10.1002/ueg2.12283 -
Pharmaceutics Jun 2022Due to ethical and practical reasons, a knowledge gap exists on the pharmacokinetics (PK) of inflammatory bowel disease (IBD)-related drugs in pregnant women with IBD.... (Review)
Review
Due to ethical and practical reasons, a knowledge gap exists on the pharmacokinetics (PK) of inflammatory bowel disease (IBD)-related drugs in pregnant women with IBD. Before evidence-based dosing can be proposed, insight into the PK has to be gained to optimize drug therapy for both mother and fetus. This systematic review aimed to describe the effect of pregnancy and IBD on the PK of drugs used for IBD. One aminosalicylate study, two thiopurine studies and twelve studies with biologicals were included. Most drugs within these groups presented data over multiple moments before, during and after pregnancy, except for mesalazine, ustekinumab and golimumab. The studies for mesalazine, ustekinumab and golimumab did not provide enough data to demonstrate an effect of pregnancy on concentration and PK parameters. Therefore, no evidence-based dosing advice was given. The 6-thioguanine nucleotide levels decreased during pregnancy to 61% compared to pre-pregnancy levels. The potentially toxic metabolite 6-methylmercaptopurine (6-MMP) increased to maximal 209% of the pre-pregnancy levels. Although the PK of the thiopurines changed throughout pregnancy, no evidence-based dosing advice was provided. One study suggested that caution should be exercised when the thiopurine dose is adjusted, due to shunting 6-MMP levels. For the biologicals, infliximab levels increased, adalimumab stayed relatively stable and vedolizumab levels tended to decrease during pregnancy. Although the PK of the biologicals changed throughout pregnancy, no evidence-based dosing advice for biologicals was provided. Other drugs retrieved from the literature search were mesalazine, ustekinumab and golimumab. We conclude that limited studies have been performed on PK parameters during pregnancy for drugs used in IBD. Therefore, more extensive research to determine the values of PK parameters is warranted. After gathering the PK data, evidence-based dosing regimens can be developed.
PubMed: 35745812
DOI: 10.3390/pharmaceutics14061241 -
The Cochrane Database of Systematic... May 2022Antibiotics have been considered to treat ulcerative colitis (UC) due to their antimicrobial properties against intestinal bacteria linked to inflammation. However,... (Review)
Review
BACKGROUND
Antibiotics have been considered to treat ulcerative colitis (UC) due to their antimicrobial properties against intestinal bacteria linked to inflammation. However, there are concerns about their efficacy and safety.
OBJECTIVES
To determine whether antibiotic therapy is safe and effective for the induction and maintenance of remission in people with UC.
SEARCH METHODS
We searched five electronic databases on 10 December 2021 for randomised controlled trials (RCTs) comparing antibiotic therapy to placebo or an active comparator.
SELECTION CRITERIA
We considered people with UC of all ages, treated with antibiotics of any type, dose, and route of administration for inclusion. Induction studies required a minimum duration of two weeks for inclusion. Maintenance studies required a minimum duration of three months to be considered for inclusion.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Our primary outcome for induction studies was failure to achieve remission and for maintenance studies was relapse, as defined by the primary studies.
MAIN RESULTS
We included 12 RCTs (847 participants). One maintenance of remission study used sole antibiotic therapy compared with 5-aminosalicylic acid (5-ASA). All other trials used concurrent medications or standard care regimens and antibiotics as an adjunct therapy or compared antibiotics with other adjunct therapies to examine the effect on induction of remission. There is high certainty evidence that antibiotics (154/304 participants) compared to placebo (175/304 participants) result in no difference in failure to achieve clinical remission (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.74 to 1.06). A subgroup analysis found no differences when steroids, steroids plus 5-ASA, or steroids plus 5-ASA plus probiotics were used as additional therapies to antibiotics and placebo. There is low certainty evidence that antibiotics (102/168 participants) compared to placebo (121/175 participants) may result in no difference in failure to achieve clinical response (RR 0.75, 95% CI 0.47 to 1.22). A subgroup analysis found no differences when steroids or steroids plus 5-ASA were used as additional therapies to antibiotics and placebo. There is low certainty evidence that antibiotics (6/342 participants) compared to placebo (5/349 participants) may result in no difference in serious adverse events (RR 1.19, 95% CI 0.38 to 3.71). A subgroup analysis found no differences when steroids were additional therapies to antibiotics and placebo. There is low certainty evidence that antibiotics (3/342 participants) compared to placebo (1/349 participants) may result in no difference in withdrawals due to adverse events (RR 2.06, 95% CI 0.27 to 15.72). A subgroup analysis found no differences when steroids or steroids plus 5-ASA were additional therapies to antibiotics and placebo. It is unclear if there is any difference between antibiotics in combination with probiotics compared to no treatment or placebo for failure to achieve clinical remission (RR 0.68, 95% CI 0.39 to 1.19), serious adverse events (RR 1.00, 95% CI 0.07 to 15.08), or withdrawals due to adverse events (RR 1.00, 95% CI 0.07 to 15.08). The certainty of the evidence is very low. It is unclear if there is any difference between antibiotics compared to 5-ASA for failure to achieve clinical remission (RR 2.20, 95% CI 1.17 to 4.14). The certainty of the evidence is very low. It is unclear if there is any difference between antibiotics compared to probiotics for failure to achieve clinical remission (RR 0.47, 95% CI 0.23 to 0.94). The certainty of the evidence is very low. It is unclear if there is any difference between antibiotics compared to 5-ASA for failure to maintain clinical remission (RR 0.71, 95% CI 0.47 to 1.06). The certainty of the evidence is very low. It is unclear if there is any difference between antibiotics compared to no treatment for failure to achieve clinical remission in a mixed population of people with active and inactive disease (RR 0.56, 95% CI 0.29 to 1.07). The certainty of the evidence is very low. For all other outcomes, no effects could be estimated due to a lack of data.
AUTHORS' CONCLUSIONS
There is high certainty evidence that there is no difference between antibiotics and placebo in the proportion of people who achieve clinical remission at the end of the intervention period. However, there is evidence that there may be a greater proportion of people who achieve clinical remission and probably a greater proportion who achieve clinical response with antibiotics when compared with placebo at 12 months. There may be no difference in serious adverse events or withdrawals due to adverse events between antibiotics and placebo. No clear conclusions can be drawn for any other comparisons. A clear direction for future research appears to be comparisons of antibiotics and placebo (in addition to standard therapies) with longer-term measurement of outcomes. Additionally. As there were single studies of other head-to-head comparisons, there may be scope for future studies in this area.
Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Humans; Mesalamine; Remission Induction
PubMed: 35583095
DOI: 10.1002/14651858.CD013743.pub2 -
European Journal of Medical Research Apr 2022Acute interstitial nephritis (AIN) is an important cause of kidney injury accounting for up to 27% of unexplained renal impairment. In up to 70% of cases, drugs,... (Review)
Review
BACKGROUND
Acute interstitial nephritis (AIN) is an important cause of kidney injury accounting for up to 27% of unexplained renal impairment. In up to 70% of cases, drugs, including aminosalicylates, are reported as the underlying cause. Following two recent paediatric cases of suspected mesalazine induced AIN within our own department, we performed a systematic review of the literature to address the following question: In patients with inflammatory bowel disease (IBD), is interstitial nephritis associated with 5-aminosalicylate (5-ASA) treatment? Our primary objective was to identify the number of cases reported in the literature of biopsy-proven 5-ASA induced interstitial nephritis, in children and adults with IBD. We also aimed to identify which variables influence the onset, severity and recovery of 5-ASA interstitial nephritis.
METHODS
Embase and PubMed databases were searched from inception to 07/10/20. Search terms had three main themes: "inflammatory bowel disease", "interstitial nephritis" and "aminosalicylates". Studies were included if they reported an outcome of AIN, confirmed on biopsy, suspected to be secondary to a 5-ASA drug in those with IBD. A narrative synthesis was performed.
RESULTS
Forty-one case reports were identified. Mesalazine was the most frequently reported aminosalicylate associated with AIN (95%). The median duration of treatment before AIN was diagnosed was 2.3 years (Interquartile Range (IQR) 12-48 months). The median rise in creatinine was 3.3 times the baseline measurement (IQR 2.5-5.5). Aminosalicylate withdrawal and steroids were the most frequently used treatments. Despite treatment, 15% of patients developed end-stage renal failure.
CONCLUSIONS
AIN is a serious adverse drug reaction associated with aminosalicylates, with mesalazine accounting for most reports. The current guidance of annual monitoring of renal function may not be sufficient to identify cases early. Given the severity of AIN and reports in the literature that early treatment with steroids may be beneficial, we would recommend at least 6 monthly monitoring of renal function. PROSPERO registration number CRD42020205387.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Child; Chronic Disease; Female; Humans; Inflammatory Bowel Diseases; Male; Mesalamine; Nephritis, Interstitial
PubMed: 35488310
DOI: 10.1186/s40001-022-00687-y -
Evidence-based Complementary and... 2022Ulcerative colitis (UC), a chronic inflammatory bowel disease, is characterized by abdominal pain, diarrhea, and mucopurulent bloody stool. In recent years, the...
BACKGROUND
Ulcerative colitis (UC), a chronic inflammatory bowel disease, is characterized by abdominal pain, diarrhea, and mucopurulent bloody stool. In recent years, the incidence and prevalence of UC have been increasing consistently. Five-flavor enteric-coated capsule (FSEC), a licensed Chinese patent medicine, was specifically used to treat UC. This review was aimed to assess the effectiveness and safety of FSEC for the treatment of UC.
METHODS
Six electronic databases were searched from inception to March 2021. Randomized clinical trials (RCTs) comparing FSEC or FSEC plus conventional Western medicine with conventional Western medicine in participants with UC were included. Two authors screened all references, assessed the risk of bias, and extracted data independently. Binary data were presented as risk ratios (RRs) with 95% confidence intervals (CIs) and metric data as mean difference (MD) with 95% CI. The overall certainty of the evidence was assessed by GRADE.
RESULTS
We included 15 RCTs (1194 participants, 763 in the FSEC group and 431 in the control group). The treatment duration ranged from 42 to 64 days. Twelve trials compared FSEC with conventional Western medicine, and two trials compared FSEC plus conventional medicine with conventional medicine. Another trial compared FSEC plus mesalazine with compound glutamine enteric capsules plus mesalazine. FSEC showed a higher clinical effective rate (improved clinical symptoms, colonoscopy results, and stools) (RR 1.12, 95% CI 1.05 to 1.20; 729 participants; 8 trials; low-quality evidence) as well as the effective rate of traditional Chinese medicine (TCM) syndromes (RR 1.10, 95% CI 1.01 to 1.20; 452 participants; 5 trials; low-quality evidence) compared to mesalazine. There was no significant difference in the adverse events between FSEC and control groups.
CONCLUSIONS
FSEC may show effectiveness in UC treatment compared to conventional medicine, and the use of FSEC may not increase the risk of adverse events. Due to the limited number of clinical trials and low methodological quality of the included trials, our findings must be interpreted with discretion.
PubMed: 35069773
DOI: 10.1155/2022/9633048 -
Annals of Internal Medicine Mar 2022The American College of Physicians (ACP) developed this guideline to provide clinical recommendations on the role of colonoscopy for diagnostic evaluation of colorectal...
Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis: A Clinical Guideline From the American College of Physicians.
DESCRIPTION
The American College of Physicians (ACP) developed this guideline to provide clinical recommendations on the role of colonoscopy for diagnostic evaluation of colorectal cancer (CRC) after a presumed diagnosis of acute left-sided colonic diverticulitis and on the role of pharmacologic, nonpharmacologic, and elective surgical interventions to prevent recurrence after initial treatment of acute complicated and uncomplicated left-sided colonic diverticulitis. This guideline is based on the current best available evidence about benefits and harms, taken in the context of costs and patient values and preferences.
METHODS
The ACP Clinical Guidelines Committee (CGC) based these recommendations on a systematic review on the role of colonoscopy after acute left-sided colonic diverticulitis and pharmacologic, nonpharmacologic, and elective surgical interventions after initial treatment. The systematic review evaluated outcomes rated by the CGC as critical or important. This guideline was developed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method.
TARGET AUDIENCE AND PATIENT POPULATION
The target audience is all clinicians, and the target patient population is adults with recent episodes of acute left-sided colonic diverticulitis.
RECOMMENDATION 1
RECOMMENDATION 2
RECOMMENDATION 3
Topics: Adult; Colonoscopy; Diverticulitis, Colonic; Humans; Physicians; United States
PubMed: 35038270
DOI: 10.7326/M21-2711 -
Annals of Internal Medicine Mar 2022The value of interventions used after acute colonic diverticulitis is unclear.
BACKGROUND
The value of interventions used after acute colonic diverticulitis is unclear.
PURPOSE
To evaluate postdiverticulitis colonoscopy and interventions to prevent recurrent diverticulitis.
DATA SOURCES
MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, CINAHL, and ClinicalTrials.gov from 1 January 1990 through 16 November 2020.
STUDY SELECTION
Comparative studies of interventions of interest reporting critical or important outcomes, and larger single-group studies to evaluate prevalence of colonoscopy findings and harms.
DATA EXTRACTION
6 researchers extracted study data and risk of bias. The team assessed strength of evidence.
DATA SYNTHESIS
19 studies evaluated colonoscopy. Risk for prevalent colorectal cancer (CRC) compared with the general population is unclear. Based on low-strength evidence, long-term CRC diagnosis is similar with or without colonoscopy. High-strength evidence indicates that risk for prevalent CRC is higher among patients with complicated diverticulitis and colonoscopy complications are rare. Based on high-strength evidence, mesalamine does not reduce recurrence risk (6 randomized controlled trials [RCTs]). Evidence on other nonsurgical interventions is insufficient. For patients with prior complicated or smoldering or frequently recurrent diverticulitis, elective surgery is associated with reduced recurrence (3 studies; high strength). In 19 studies, serious surgical complications were uncommon.
LIMITATIONS
Few RCTs provided evidence. Heterogeneity of treatment effect was not adequately assessed.
CONCLUSION
It is unclear whether patients with recent acute diverticulitis are at increased risk for prevalent CRC, but those with complicated diverticulitis are at increased risk. Mesalamine is ineffective in preventing recurrence; other nonsurgical treatments have inadequate evidence. Elective surgery reduces recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.
PRIMARY FUNDING SOURCE
Agency for Healthcare Research and Quality and American College of Physicians. (PROSPERO: CRD42020151246).
Topics: Colonoscopy; Diverticulitis; Diverticulitis, Colonic; Humans; Mesalamine; United States
PubMed: 35038269
DOI: 10.7326/M21-1646 -
Journal of Crohn's & Colitis Jul 2022Ulcerative proctitis is a common and often highly symptomatic form of inflammatory bowel disease. We performed a systematic review to assess the efficacy of different...
BACKGROUND
Ulcerative proctitis is a common and often highly symptomatic form of inflammatory bowel disease. We performed a systematic review to assess the efficacy of different therapies in the management of patients with ulcerative proctitis.
METHODS
We identified randomized controlled trials in adults with ulcerative proctitis treated with oral or topical therapies for induction of response or remission, or prevention of relapse.
RESULTS
A total of 32 randomized controlled trials were included [27 induction/2839 participants, five maintenance/334 participants]. Follow-up varied from 3 to 8 weeks for induction, and from 6 to 24 months for maintenance of remission. 5-Aminosalicylic acid [5-ASA] suppository was the most frequently evaluated treatment [14/32, 43.7%], followed by steroid enema [7/32, 21.9%]. Topical 5-ASA demonstrated effectiveness for induction of clinical response or remission and prevention of relapse in several studies. Combined topical steroids and 5-ASA was more effective than topical 5-ASA or topical steroids alone to induce response [100% of patients for combination vs 70% for beclomethasone alone and 76% for 5-ASA alone]. One observational study suggested azathioprine may be effective in patients with ulcerative proctitis. Only two cohort studies evaluated the efficacy of tumour necrosis factor inhibitors in ulcerative proctitis. Small molecules, anti-integrins and anti-interleukin therapies have not been evaluated in isolated ulcerative proctitis.
CONCLUSION
The role of topical 5-ASA as a treatment for ulcerative proctitis has been confirmed in this systematic literature review, for induction and maintenance of remission. Future trials are needed to investigate the efficacy of more recent and upcoming drug classes in patients with ulcerative proctitis.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Humans; Mesalamine; Observational Studies as Topic; Proctitis; Recurrence
PubMed: 34850857
DOI: 10.1093/ecco-jcc/jjab218 -
United European Gastroenterology Journal Dec 2021Diversion proctocolitis (DP) is a non-specific mucosal inflammation arising in the defunctionalized colon and/or rectum following faecal diversion (colostomy,...
BACKGROUND AND AIMS
Diversion proctocolitis (DP) is a non-specific mucosal inflammation arising in the defunctionalized colon and/or rectum following faecal diversion (colostomy, ileostomy). Differential diagnosis of DP from the underlying disease in patients with inflammatory bowel diseases (IBD) is often unclear. As a result, it might be difficult to undertake any specific treatment. We aimed to systematically review the literature evidence on DP in IBD patients.
METHODS
For this qualitative systematic review, we searched PubMed, EMBASE and Scopus to identify all studies published until July 2021 including IBD patients affected by DP.
RESULTS
Overall, 37 papers published between 1982 and 2021 were included. A total of 1.211 IBD patients were included: 613 UC (50.6%), 524 CD (43.3%), 66 IBD-unclassified (IBD-U) (5.4%), 8 unspecified patients (0.7%). Most patients with DP are asymptomatic, although inflammation is detectable in almost all patients with a rectal stump. Reduced short-chain fatty acids and an altered microbiome, may trigger mucosal inflammation and have been proposed as causing factors. An increased risk of developing cancer on DP has been reported in patients with a history of previous dysplasia/cancer.
CONCLUSIONS
The etiopathogenesis of DP is still unknown. The efficacy of mesalamine, corticosteroids or short-chain fatty acids has not been proven by randomized trials yet. Since the incidence of cancer of the rectal stump can reach 4.5 per 1.000 diverted patients-year, IBD patients undergoing subtotal colectomy with end-ileostomy should undergo close endoscopic surveillance, being eventually counseled for surgery with or without the restoration of the intestinal continuity.
Topics: Colectomy; Humans; Ileostomy; Inflammatory Bowel Diseases; Proctocolitis; Rectal Neoplasms
PubMed: 34845854
DOI: 10.1002/ueg2.12175