Oral Curcumin No More Effective Than Placebo in Preventing Recurrence of Crohn's Disease After Surgery in a Randomized Controlled Trial

Bommelaer, Gilles; Laharie, David; Nancey, Stéphane; Hébuterne, Xavier; Roblin, Xavier; Nachury, Maria; Peyrin–Biroulet, Laurent; Fuméry, Mathurin; Richard, Damien; Pereira, Bruno; Goutte, Marion; Buisson, Anthony; Çoban, Dilek; Dodel, Marie; Goutorbe, Félix; Allimant, Christophe; Reymond, Maud; Dapoigny, Michel; Rouquette, Olivier; Vazeille, Emilie; Poullenot, Florian; Rivière, Pauline; Boschetti, Gilles; Filippi, Jérôme; Tedesco, Émilie Del; Veyrard, Pauline; Pariente, Benjamin; Wils, Pauline; Zallot, Camille; Yzet, Clara; Brazier, Franck

doi:10.1016/j.cgh.2019.08.041

Cited by 40 publications

(47 citation statements)

References 30 publications

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“…Overall, 31 patients with CD receiving azathioprine were included in the control group 9 . Their characteristics are mentioned in Table 1.…”

Section: Resultsmentioning

confidence: 99%

“…From a randomized controlled trial where patients were recruited between October 2014 and January 2018, we included all the patients who were randomized in the control group to receive oral azathioprine 2.5 mg/kg/day with a concomitant placebo for 6 months 9 . Enrollment and treatment initiation had to occur within 15 days following bowel resection or following stoma closure when a diverting ostomy had been necessary 9 . Adherence to medications was evaluated, either by pill counts when patients brought back unused medications at each visit or by patient's interview.…”

Section: Methodsmentioning

confidence: 99%

“…We asked the centers who were involved in the randomized controlled trial 9 for screening their database to identify all CD patients who have been treated with ustekinumab to prevent endoscopic POR. Patients with prior exposure to ustekinumab before surgery were also included.…”

Section: Methodsmentioning

confidence: 99%

“…However, the magnitude of thiopurines efficacy remains limited in this situation 7,8 . In a recent randomized controlled trial, the rate of endoscopic POR was close to 60% in patients treated with azathioprine 9 . Anti‐TNF agents are probably the most effective drugs in this indication, 10–12 even though data comparing anti‐TNF to thiopurines are conflicting, 6,13–15 and frequent exposure to one or more anti‐TNF agents before surgery is a challenge in routine practice 16 …”

Section: Introductionmentioning

confidence: 99%

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Ustekinumab is more effective than azathioprine to prevent endoscopic postoperative recurrence in Crohn's disease

et al. 2021

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Background Preventing postoperative recurrence (POR) is a major concern in Crohn's disease (CD). While azathioprine is an option, no data is available on ustekinumab efficacy in this situation. Aims We compared the effectiveness of ustekinumab versus azathioprine in preventing endoscopic POR in CD. Methods We retrospectively collected data from all consecutive CD patients treated with ustekinumab after intestinal resection in 9 centers. The control group (azathioprine alone) was composed of patients who participated in a randomized controlled trial conducted in the same centers comparing azathioprine alone or in combination with curcumin. Propensity score analyses (inversed probability of treatment weighting = IPTW) were applied to compare the two groups. The primary endpoint was endoscopic POR (Rutgeerts' index ≥ i2) at 6 months. Results Overall, 32 patients were included in the ustekinumab group and 31 in the azathioprine group. The propensity score analysis was adjusted on the main risk factors (smoking, fistulizing phenotype, prior bowel resection, resection length >30 cm and ≥2 biologics before surgery) and thiopurines or ustekinumab exposure prior to surgery making the two arms comparable (∣d∣ < 0.2). After IPTW, the rate of endoscopic POR at 6 months was lower in patients treated with ustekinumab compared to azathioprine (28.0% vs. 54.5%, p = 0.029). After IPTW, the rates of i2b‐endoscopic POR (Rutgeerts' index ≥ i2b) and severe endoscopic POR (Rutgeerts' index ≥ i3) were 20.8% versus 42.5% (p = 0.066) and 16.9% versus 27.9% (p = 0.24), in the ustekinumab and azathioprine groups, respectively. Conclusion Ustekinumab seemed to be more effective than azathioprine in preventing POR in this cohort of CD patients.

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“…Overall, 31 patients with CD receiving azathioprine were included in the control group 9 . Their characteristics are mentioned in Table 1.…”

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Ustekinumab is more effective than azathioprine to prevent endoscopic postoperative recurrence in Crohn's disease

et al. 2021

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“…[ 16 – 18 ] Curcumin as a complementary therapy in ulcerative colitis has become quite common, two randomized, controlled trials investigated the efficacy and safety of curcumin in patients with crohn's disease recently. [ 19 – 27 ] The mechanism of its anti-inflammatory action deemed to be the most relevant is the inhibition of NF-κB, by blocking IκB kinase, thereby inhibiting the expression of pro-inflammatory cytokines (IL-1, IL-6, and TNF-α. [ 28 ] Therefore, it is necessary to conduct a meta-analysis of curcumin for IBD.…”

Section: Introductionmentioning

confidence: 99%

The effectiveness and safety of curcumin as a complementary therapy in inflammatory bowel disease

et al. 2020

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Background: Inflammatory bowel diseases (IBD), which include Crohn disease and ulcerative colitis, affect several million individuals worldwide. Curcumin as a complementary therapy has been used to cure the IBD, yet the efficacy and safety of curcumin remains to be assessed. In this study, we aim to draw up a protocol for systematic review to evaluate the efficacy and safety of curcumin for IBD. Methods: We will search the following electronic databases from inception to September 31, 2020: PubMed, Cochrane Library, EMBASE, Web of Science, Medline, the China National Knowledge Infrastructure Database, Wan Fang Database, the Chinese Scientific Journal Database, and Chinese Biomedical Literature Database. Clinical trial registrations, potential gray literatures, relevant conference abstracts and reference list of identified studies will also be searched. Relevant randomized controlled clinical trials were enrolled and analyzed. The literature selection, data extraction, and quality assessment will be completed by 2 independent authors. Either the fixed-effects or random-effects model will be used for data synthesis based on the heterogeneity test. Clinical remission will be evaluated as the primary outcome. Clinical response, endoscopic remission, inflammatory markers and adverse events will be assessed as the secondary outcomes. The RevManV.5.3.5 will be used for Meta-analysis. Subgroup analyses of doses, delivery way, frequency of treatment and the degree of IBD severity or different forms of IBD were also conducted. Results: This study will provide a synthesis of current evidence of curcumin for IBD from several aspects, such as clinical remission, clinical response, endoscopic remission, inflammatory markers, and adverse events. Conclusion: The conclusion of our study will provide updated evidence to judge whether curcumin is an effective solution to IBD patients. INPLASY registration number: INPLASY202090065.

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Curcumin's effect in advanced and metastatic breast cancer patients treated with first or second‐line docetaxel: A randomized trial

Judith,

Maureen,

Mélanie

et al. 2024

Health Science Reports

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BackgroundIn this study, we investigated whether the association of curcumin and docetaxel among advanced and metastatic breast cancer patients in first or second‐line treatment potentiated the objective response rate.Patients/MethodsA multicentre, randomized, open label, phase‐II study was conducted and included 42 patients from July 2009 to January 2017. The primary endpoint was the objective response rate of the docetaxel‐curcumin combination in comparison with docetaxel alone. The secondary endpoints were the assessment of clinical benefit, overall survival, time‐to‐progression, progression‐free survival, compliance, and safety. An interim analysis was planned to evaluate safety and efficacy.ResultsIn this interim analysis conducted on 37 patients (19 in the control group vs. 18 in the experimental group), no difference was observed for the objective response rate (p = 0.25, control 73.7% vs. experimental 55.6%). Concerning clinical benefit, overall survival and time‐to‐progression, we also failed to show any difference between the two arms. A slight tendency towards longer progression‐free survival at 12 months after randomization was observed in the curcumin group (65.5% vs. 41.4%) but this difference did not reach significance (p = 0.14).ConclusionIn this study, we showed for the first time that adding oral curcumin for advanced and metastatic breast cancer patients treated with first or second‐line docetaxel was not efficacious, although safe. Consequently, this study was stopped for reasons of futility. Further studies with a larger number of patients, a different curcumin preparation, a longer treatment period and a pharmacokinetic evaluation of curcumin are needed to explore the real efficacy of this compound.

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Oral Curcumin No More Effective Than Placebo in Preventing Recurrence of Crohn's Disease After Surgery in a Randomized Controlled Trial

Cited by 40 publications

References 30 publications

Ustekinumab is more effective than azathioprine to prevent endoscopic postoperative recurrence in Crohn's disease

Ustekinumab is more effective than azathioprine to prevent endoscopic postoperative recurrence in Crohn's disease

The effectiveness and safety of curcumin as a complementary therapy in inflammatory bowel disease

Curcumin's effect in advanced and metastatic breast cancer patients treated with first or second‐line docetaxel: A randomized trial

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