scholarly journals The efficacy of aspirin and metformin combination therapy in patients with rectal aberrant crypt foci: a double-blinded randomized controlled trial

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Takuma Higurashi ◽  
Jun Arimoto ◽  
Keiichi Ashikari ◽  
Tomohiro Takatsu ◽  
Noboru Misawa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Controlled Trial ◽  
Colorectal Polyps ◽  
Aberrant Crypt Foci ◽  
Randomized Controlled ◽  
Metformin Group ◽  
Incidence And Mortality ◽  
Chemopreventive Effect ◽  
Oral Aspirin

Abstract Background The incidence and mortality rates of colorectal cancer (CRC) continue to increase worldwide. Therefore, new preventive strategies are needed to lower the burden of this disease. Previous studies reported that aspirin could suppress the development of sporadic colorectal adenoma. In addition, metformin is a biguanide derivative that is long widely used for the treatment of diabetes mellitus and has recently been suggested to have a suppressive effect on carcinogenesis and cancer cell growth. Both drugs exhibit a chemopreventive effect, but their efficacy is limited. Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and stain more darkly with methylene blue than normal crypts, are more prevalent in patients with cancer and adenomas, and considered a reliable surrogate biomarker of CRC. Thus, we designed a prospective trial as a preliminary study prior to a CRC chemoprevention trial to evaluate the chemopreventive effect of aspirin combined with metformin on colorectal ACF formation in patients scheduled for polypectomy. Methods This study is a double-blind randomized controlled trial that will be conducted in patients with both colorectal ACF and colorectal polyps scheduled for polypectomy. Eligible patients will be recruited for the study and the number of ACF in the rectum will be counted at the baseline colonoscopy. Then, the participants will be allocated to one of the following two groups; the aspirin plus placebo group or the aspirin plus metformin group. Patients in the aspirin plus placebo group will receive oral aspirin (100 mg) and placebo for 8 weeks, and those in the aspirin plus metformin group will receive oral aspirin (100 mg) and metformin (250 mg) for 8 weeks. After 8 weeks of administration, polypectomy will be performed to evaluate changes in the number of ACF, and the cell-proliferative activity in the normal colorectal mucosa and colorectal polyps. Discussion This is the first study proposed that will explore the effect of aspirin combined with metformin on the formation of colorectal ACF in humans. Trial registration This trial has been registered in the University Hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000028259. Registered 17 July 2017.

Neonatal outcomes in case of euglycemic control in gestational diabetes using insulin versus metformin. Randomized controlled trial

2021 ◽  
Vol 04 (01) ◽  
pp. 01-08
Author(s):  
Ahmed Mansour
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Gestational Diabetes ◽  
Controlled Trial ◽  
Insulin Injection ◽  
Neonatal Outcomes ◽  
Insulin Group ◽  
Randomized Controlled ◽  
Metformin Group ◽  
Significant Difference

Background: Gestational diabetes mellitus (GDM) is a major global public health issue, with prevalence increasing in recent years due to the epidemic of obesity and type 2 diabetes. Aim of the Work: to compare different neonatal outcomes according to the different treatment modalities used in the management of GDM. Our hypothesis was that Metformin is as effective and safe as insulin in patients with gestational diabetes. Patients and Methods: The current non inferiority-Randomized controlled trial was conducted at Ain Shams Maternity hospital between June 2020 to February 2021. The study included 140 outpatient cases or admitted patients for antenatal care: Group A: women were given Metformin (Total 70) and Group B: Women were given insulin. (Total 70). Results: there was no significant difference between Metformin and Insulin groups regarding age, enrollment BMI, parity and family history of DM. There was no significant difference between Metformin and Insulin groups regarding gestational age at enrollment and delivery as well as pregnancy duration after intervention. BMI at delivery, BMI increase as well as BMI increase rate were significantly lower in Metformin group. There were no significant differences between Metformin and Insulin groups regarding fasting, two-hour postprandial and HbA1c blood glucose at enrollment and throughout treatment as well as their reduction after intervention. Maternal complications as hypoglycemia, hyperglycemia and preeclampsia were non-significantly less frequent among Metformin group than among Insulin group. Compliance to treatment was significantly more frequent among Metformin group than among Insulin group. Cesarean delivery was non­significantly less frequent among Metformin group than among Insulin group. There was no significant difference between Metformin and Insulin regarding birth weight APGAR-1, but APGAR-5 was significantly higher in Metformin group. Neonatal complications as IUFD, IUGR, macrosomia, congenital anomalies, neonatal hypoglycemia, respiratory distress and NICU admission were non-significantly less frequent among Metformin group. Conclusions: From the results of current study we can conclude that: Oral metformin was effective as insulin injection in control and management of GDM. BMI was controlled with oral metformin better than insulin injection. Maternal and neonatal complications specially birth weight were the same with both types of treatment. Women had better compliance to metformin treatment. Type of delivery wasn’t affected by type of treatment.

Fluoride varnish for white spot lesion prevention during orthodontic treatment: results of a randomized controlled trial 1 year after debonding

2020 ◽  
Author(s):  
Mikael Sonesson ◽  
Anna Brechter ◽  
Rolf Lindman ◽  
Salem Abdulraheem ◽  
Svante Twetman
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Orthodontic Treatment ◽  
Controlled Trial ◽  
White Spot ◽  
Fluoride Varnish ◽  
White Spot Lesion ◽  
Randomized Controlled

Summary Background Topical fluorides are commonly recommended to prevent the development of white spot lesion (WSL) during treatment with fixed orthodontic appliances (FOAs), but the certainty of evidence is low, and long-term effects of fluoride preventive methods to reduce lesions seem to be rare. Objective To evaluate the long-term effectiveness of professional applications of a fluoride varnish containing 1.5% ammonium fluoride in preventing WSL development in adolescents undergoing multi-bracket orthodontic treatment. Subjects and methods We performed a randomized controlled trial in which 166 healthy adolescents (12–18 years) from three different clinics were enrolled and randomly allocated to a test or a placebo group. The randomization was performed by a computer program, generating sequence numbers in blocks of 15. The fluoride varnish or the non-fluoride placebo varnish was applied in a thin layer around the bracket base every sixth week during the course of the orthodontic treatment (mean duration 1.7 years). We scored the prevalence of WSL on the labial surfaces of the maxillary incisors, canines and premolars immediately after debonding (baseline) and approximately 1 year after debonding, from digital photos with aid of a four-step score. The examiners were not involved in the treatment of the patients and blinded for the group assignment. Results One hundred and forty-eight patients were available at debonding and 142 of them could be re-examined after 1 year (71 in the test and 71 in the placebo group). The 1-year attrition rate was 4.0%. On patient level, the prevalence of post-orthodontic WSLs (score ≥ 2) dropped by over 50% during the follow-up with no significant difference between the groups. On surface level, there were significantly fewer remaining WSLs in the test group compared with the placebo group (4.5% versus 10.4%; relative risk 0.44, 95% confidence interval 0.28–0.68). Limitations The compliance with fluoride toothpaste was not checked, and the patients’ general dentists may have instigated additional risk-based preventive measures. No cost–benefit analysis was carried out. Conclusions This follow-up study displayed a small beneficial long-term effect of fluoride varnish in reducing WSL development during treatment with FOA. Registration NCT03725020. Protocol The protocol was not published before trial commencement.

scholarly journals Eicosapentaenoic acid (EPA) efficacy for colorectal aberrant crypt foci (ACF): a double-blind randomized controlled trial

BMC Cancer ◽  
2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Takuma Higurashi ◽  
Kunihiro Hosono ◽  
Hiroki Endo ◽  
Hirokazu Takahashi ◽  
Hiroshi Iida ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Eicosapentaenoic Acid ◽  
Controlled Trial ◽  
Aberrant Crypt Foci ◽  
Double Blind ◽  
Randomized Controlled

scholarly journals Efficacy of Intrauterine Perfusion of Cyclosporin A for Intractable Recurrent Spontaneous Abortion Patients With Endometrial Alloimmune Disorders: A Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Long Zhao ◽  
Lijuan Qi ◽  
Jinhua Fu ◽  
Shuqin Bi ◽  
Lin Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Cyclosporin A ◽  
Spontaneous Abortion ◽  
Luteal Phase ◽  
Controlled Trial ◽  
Recurrent Spontaneous Abortion ◽  
Main Study ◽  
Menstrual Cycles ◽  
Randomized Controlled

ObjectiveTo explore the therapeutic efficacy of intrauterine perfusion of cyclosporin A (CsA) in intractable recurrent spontaneous abortion (RSA) patients with endometrial alloimmune dysfunction.MethodsThis is a randomized controlled trial (RCT) of patients with intractable RSA with endometrial alloimmune disorders. A total of 201 women were enrolled, all of whom had at least 3 serial abortions and endometrial alloimmune dysfunction. Participants were randomly assigned to two groups. The CsA group (n = 101) received intrauterine infusion of 250 mg CsA on the 3rd and 7th days after menstruation for 2 menstrual cycles, while the placebo group (n = 100) received placebo. The birth of healthy, deformity-free babies was the main study outcome.ResultsIn total, 75 (74.26%) women in the CsA group and 59 (59.00%) women in the placebo group gave birth to healthy babies [P = 0.01, OR = 2.01; 95% CI (1.10∼3.65)]. Compared to the placebo group, the CsA group had dramatically lower endometrial CD56+ cell and CD57+ cell concentrations at the luteal phase of the second menstrual cycle (P < 0.05).ConclusionIntrauterine perfusion of CsA was confirmed to be a promising approach for the treatment of intractable alloimmune RSA.

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