Effects of mesalamine rectal: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Main Research Findings

Mesalamine rectal formulations, including suppositories, enemas, and foams, have been studied for their efficacy in treating various forms of ulcerative colitis, particularly proctitis, which is the mildest form of the disease. 19 23 18 These formulations aim to deliver mesalamine directly to the inflamed areas of the rectum and colon, providing targeted treatment and potentially reducing systemic side effects.

Research has explored various approaches to enhance the efficacy of mesalamine rectal formulations. This includes optimizing drug release profiles by incorporating sustained-release technologies like chitosan microparticles. 13 Additionally, researchers have investigated the combination of mesalamine with other medications like corticosteroids, 21 and probiotics. 11

Studies have also shown that mesalamine rectal formulations can be beneficial for maintaining remission in ulcerative colitis. 26 However, some patients may experience side effects such as diarrhea, abdominal pain, and nausea. 3

Benefits and Risks

Benefit Summary

Mesalamine rectal formulations offer the following potential benefits:

  • Targeted delivery of mesalamine to the inflamed areas of the rectum and colon
  • Improved efficacy in treating ulcerative colitis, particularly proctitis
  • Potential reduction in systemic side effects
  • Potential for maintaining remission in ulcerative colitis

Risk Summary

Potential risks associated with mesalamine rectal formulations include:

  • Diarrhea
  • Abdominal pain
  • Nausea

Comparison Across Studies

Commonalities

Studies consistently demonstrate the effectiveness of mesalamine rectal formulations in treating ulcerative colitis, particularly proctitis. Researchers have explored various delivery methods and strategies for optimizing drug release and targeting the inflamed areas.

Differences

The specific formulations, dosages, delivery methods, and treatment durations vary across studies. Additionally, the efficacy and safety of mesalamine rectal formulations may depend on individual patient characteristics and disease severity.

Consistency and Contradictions in Results

While research consistently supports the effectiveness of mesalamine rectal formulations, there is variability in results depending on the specific formulation, patient factors, and disease stage. Further research is needed to identify the most effective and safe treatment strategies for individual patients.

Implications for Real-World Applications

Mesalamine rectal formulations can be a valuable treatment option for patients with ulcerative colitis, particularly those with proctitis. However, it is essential to consult a healthcare professional to determine the appropriate formulation, dosage, and treatment plan for individual needs.

Limitations of Current Research

More research is needed to fully understand the optimal use of mesalamine rectal formulations. This includes investigating the long-term effects of these formulations, identifying the most effective strategies for individual patients, and further exploring the potential for combination therapies.

Future Research Directions

Future research should focus on:

  • Investigating the long-term efficacy and safety of mesalamine rectal formulations
  • Developing personalized treatment plans based on patient characteristics and disease severity
  • Exploring the potential for combination therapies with other medications or therapies
  • Evaluating the efficacy of mesalamine rectal formulations in different forms of ulcerative colitis

Conclusion

Mesalamine rectal formulations, such as suppositories, enemas, and foams, have shown promise in treating ulcerative colitis, particularly proctitis. These formulations offer targeted delivery, improved efficacy, and potentially reduced systemic side effects. However, it's crucial to consult a healthcare professional for personalized treatment plans and to monitor for any side effects. Continued research is needed to further optimize these formulations and understand their long-term effects.

Literature analysis of 26 papers
Positive Content
23
Neutral Content
1
Negative Content
2
Article Type
4
4
4
2
26
1.

Survival of the probiotic Escherichia coli Nissle 1917 (EcN) in the gastrointestinal tract given in combination with oral mesalamine to healthy volunteers.

Author: Joeres-Nguyen-XuanThai Hoa, BoehmStephan Karl, JoeresLars, SchulzeJuergen, KruisWolfgang

Ulcerative colitis treatment
None mentioned

The combination of E. coli Nissle 1917 (EcN) and mesalamine had no significant effect on the survival of EcN in healthy volunteers.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Mesalamine, but Not Sulfasalazine, Reduces the Risk of Colorectal Neoplasia in Patients with Inflammatory Bowel Disease: An Agent-specific Systematic Review and Meta-analysis.

Author: OʼConnorAnthony, PackeyChristopher D, AkbariMona, MossAlan C

Colorectal cancer prevention
Not specified

Mesalamine at doses greater than 1.2 g per day has not been previously studied for its specific impact on colorectal cancer in inflammatory bowel disease.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

3.

Iatrogenic rectal perforation due to application of topical treatment in a patient with ulcerative colitis: a rare complication.

Author: Barajas PérezJorge, Moralejo LozanoÓscar, Arietti LópezNatalia María, López TorresLaura Monserrat, Lomas PérezRaquel Olvido, Muñoz RosasConcepción, Gómez RodríguezRafael Ángel

Ulcerative colitis treatment
Rectal perforation

This study reports a case of a patient with ulcerative colitis who suffered a rectal perforation after applying topical mesalazine foam.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Refractory fulminant colitis following ocrelizumab therapy requiring colectomy in a patient with multiple sclerosis.

Author: MalloyReuben, FernandesRichard, BegunJakob, AnYoon-Kyo

Clinical remission
Ocrelizumab-induced colitis

This case report describes a woman with relapsing-remitting multiple sclerosis treated with ocrelizumab who developed severe ocrelizumab-induced colitis. This highlights the potential for serious gastrointestinal complications associated with this treatment.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

6.

Randomised clinical trial and meta-analysis: mesalazine treatment in irritable bowel syndrome-effects on gastrointestinal symptoms and rectal biomarkers of immune activity.

Author: Castro TejeraValeria, ÖhmanLena, AabakkenLars, FellströmBengt, HauskenTrygve, HovdeØistein, HreinssonJohann P, LindbergGreger, VengePer, SimrénMagnus, TörnblomHans

Ineffective treatment

Mesalazine was ineffective in reducing irritable bowel syndrome (IBS) symptoms in a randomized, double-blind, placebo-controlled trial. Rectal measures of immune activity by mucosal patch technology could not predict response to mesalazine.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis.

Author: LouisEdouard, ParidaensKristine, Al AwadhiSameer, BegunJakob, CheonJae Hee, DignassAxel U, MagroFernando, MárquezJuan Ricardo, MoschenAlexander R, NarulaNeeraj, RydzewskaGrazyna, FreddiMatthew J, TravisSimon Pl

Increased remission rate
Reduced relapse rate
Reduced steroid and biologic use

Optimising 5-aminosalicylate (5-ASA) therapy for ulcerative colitis (UC) resulted in a 39% increase in patients achieving remission without needing steroids or biologics during induction. In maintenance, optimised treatment reduced relapses by 21%, leading to fewer patients needing steroids and biologics. This approach also resulted in a net saving of £272 per patient.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

pH-dependent vs. constant release of mesalazine in the treatment of ulcerative colitis: Do drug delivery concepts determine therapeutic efficacy? (Review).

Author: DeisslerHelmut, KrammerHeinrich, GillessenAnton

Ulcerative colitis treatment

This overview summarizes the evidence for preferential use of one type of mesalazine formulation over the other in patients with ulcerative colitis (UC). The review suggests that pH-dependent release formulations may be superior for certain subgroups of patients, such as those with proctitis-type UC or sites of inflammation in the proximal colon.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1).

Author: FellermannKlaus, SchiefkeIngolf, RáczIstván, DerovaJelena, JonaitisLaimas, WehrumSarah, NacakTanju, GreinwaldRoland

Safety (budesonide)
UC remission (budesonide)

Prolonged release budesonide granules were effective for inducing remission in patients with mesalazine-refractory ulcerative colitis. Clinical remission was achieved in 47.5% of patients by Week 8. Budesonide granules were well-tolerated with a favorable safety profile.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Development of an Indigo Naturalis Suppository for Topical Induction Therapy in Patients with Ulcerative Colitis.

Author: YoshimatsuYusuke, NaganumaMakoto, SugimotoShinya, TanemotoShun, UmedaSatoko, FukudaTomohiro, NomuraEna, YoshidaKosuke, OnoKeiko, MutaguchiMakoto, NankiKosaku, MizunoShinta, MikamiYohei, FukuharaKayoko, SujinoTomohisa, TakabayashiKaoru, OgataHaruhiko, IwaoYasushi, KanaiTakanori

Clinical response in UC patients
Indigo naturalis anti-inflammatory effects
Ulcerative colitis

Indigo naturalis (IN) has anti-inflammatory properties and can be used to treat ulcerative colitis (UC). This study explores the potential of IN as a topical treatment for UC proctitis, which is often resistant to standard therapies.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Improvement of the therapeutic treatment of inflammatory bowel diseases following rectal administration of mesalazine-loaded chitosan microparticles vs Asamax<sup>&#174;</sup>.

Author: PalmaErnesto, CostaNicola, MolinaroRoberto, FrancardiMarco, PaolinoDonatella, CoscoDonato, FrestaMassimo

IBD treatment

Chitosan microparticles containing mesalazine were more effective than a commercial formulation at treating inflammatory bowel disease in an in vivo model.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

The role of topical therapy for perianal fistulizing Crohn's disease: are we forgetting something?

Author: RibaldoneDavide G, ResegottiAndrea, PellicanoRinaldo, AstegianoMarco, SaraccoGiorgio M, MorinoMario

Rectal inflammation treatment

This systematic review evaluates the role of topical therapy in healing rectal inflammation in patients with Crohn's disease. It highlights the lack of discussion on topical therapy for rectal healing in European guidelines.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

15.

Comparison of the efficiency of different enemas on patients with distal ulcerative colitis.

Author: ZhangYujie, ChenDi, WangFang, LiXiaowei, XueXianmin, JiangMingzuo, XuBing, ChuYi, WangWeijie, WuKaichun, MaoRen, ShenJun, YangShaoqi, LiangJie

Few side effects
Treats left-sided colitis

This abstract discusses the efficacy of rectal steroid and 5-aminosalicylic acid (5-ASA) enemas in treating distal ulcerative colitis (UC). Previous studies have shown that the combination is superior to using a single agent, but more research is needed to confirm this.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

17.

Comparative efficacy and tolerability of pharmacological agents for management of mild to moderate ulcerative colitis: a systematic review and network meta-analyses.

Author: NguyenNghia H, FumeryMathurin, DulaiParambir S, ProkopLarry J, SandbornWilliam J, MuradMohammad Hassan, SinghSiddharth

Remission induction

Combined oral and topical mesalazine therapy and high-dose mesalazine are superior to standard-dose mesalazine for induction of remission in patients with mildly to moderately active left-sided or extensive ulcerative colitis, but not maintenance of remission.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

18.

Effects of mesalazine enemas on lymphoid follicular proctitis.

Author: LiuZhipeng, HuangSilin, ChenZhengyu, WangXinying

Resolution of LFP

Mesalazine enemas may be a promising and effective therapeutic option for lymphoid follicular proctitis (LFP). A 35-year-old male with LFP experienced complete resolution of symptoms and lesions within three days of receiving mesalazine enemas.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

19.

Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis.

Author: KruisWolfgang, NeshtaViacheslav, PesegovaMarina, AlekseevaOlga, AndreevPavel, DatsenkoOleksii, LevchenkoOlena, AbdulkhakovSayar, LozynskyyYuriy, MostovoyYuriy, SolovievKonstantin, DorofeyevAndrey E, ViethMichael, StiessMichael, GreinwaldRoland, MohrbacherRalf, SiegmundBritta

Proctitis treatment

This study compared the efficacy and safety of budesonide and mesalamine suppositories for treating proctitis.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Silk Fibroin-Based Fibrous Anal Fistula Plug with Drug Delivery Function.

Author: XieXusheng, LiuLei, ZhengZhaozhu, HanZhifen, ZhiMin, KaplanDavid L, LiGang, WangXiaoqin

Crohn's treatment

Drug-loaded silk fibroin fibrous membranes (DSFM) were developed for the treatment of Crohn's disease (CD). The membranes, which contained curcumin (CUR) and 5-aminosalicylic acid (5-ASA), exhibited no cytotoxicity and released the drugs in a steady and sustainable manner.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

21.

Efficacy and safety of rectal 5-aminosalicylic acid versus corticosteroids in active distal ulcerative colitis: a systematic review and network meta-analysis.

Author: ZhaoXiaojing, ZhouChangcheng, MaJingjing, ZhuYunjuan, SunMin, WangPeixue, ZhangYi, MaHaiqin, ZhangHongjie

Endoscopic remission
Ulcerative colitis remission

This study compared the efficacy and safety of different topical medications for active distal ulcerative colitis (UC), including 5-aminosalicylic acid (5-ASA) and corticosteroids. The combination of topical 5-ASA and Beclomethasone dipropionate (BDP) showed the highest probability of achieving clinical and endoscopic remission, suggesting it is a potential treatment option for active distal UC.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

23.

Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies.

Author: BosworthBrian P, SandbornWilliam J, RubinDavid T, HarperJoseph R

Ulcerative proctitis treatment

Rectal budesonide foam is effective for mild to moderate ulcerative proctitis and proctosigmoiditis. This subgroup analysis found that baseline oral 5-aminosalicylic acid (5-ASA) did not significantly impact the efficacy or safety of budesonide foam, suggesting its potential as a treatment option even in patients already on 5-ASA.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

25.

Use of Proktis-M suppositories in patients undergoing neoadjuvant radiochemotherapy for adenocarcinoma of the rectum.

Author: MontroneS, GonnelliA, CantarellaM, SainatoA

Proctitis treatment

Hyaluronic acid may be a viable option for treating actinic proctitis, a common side effect of radiation therapy for locally advanced rectal cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

26.

Once-daily Mesalamine Formulation for Maintenance of Remission in Ulcerative Colitis: A Randomized, Placebo-controlled Clinical Trial.

Author: GordonGlenn L, ZakkoSalam, MurthyUma, SedghiShahriar, PruittRonald, BarrettAndrew C, BorteyEnoch, PatersonCraig, ForbesWilliam P, LichtensteinGary R

Reduced relapse risk
UC remission maintenance
Well tolerated
Hepatic
renal
pancreatic concerns

Mesalamine granules 1.5 g once daily were efficacious and safe for the maintenance of ulcerative colitis remission.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

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