Effect of oral contraceptive with and without associated estriol on ultrasound measurements of breast fibroadenoma: randomized clinical trial

CONTEXT AND OBJECTIVE: Fibroadenomas are the most common benign tumors of the female breast. The aim of this study was to evaluate the proliferative activity of breast fibroadenoma as shown by ultrasound measurements, following administration of oral contraceptives with and without associated estriol. DESIGN AND SETTING: This was a randomized, double-blind, placebo-controlled clinical trial carried out in the Mastology Sector, Department of Gynecology, Universidade Federal de São Paulo. METHODS: We studied 33 women with fibroadenomas. Ten were placed in group 1 and took an oral contraceptive consisting of levonorgestrel and ethinyl estradiol together with placebo material in the same capsule, for four consecutive cycles with a seven-day interval between them. The other 23 patients constituted group 2 and took the oral contraceptive as above together with estriol in the same capsule, in the same way as done by the group 1 patients. We took ultrasound measurements of their tumors (in three dimensions) before and after the intake of medication. At the end of the study, all the patients had their tumors removed by surgery. RESULTS: We observed decreased fibroadenoma width among the users of oral contraceptives with placebo, and this decrease was statistically significant. In the other group, we did not observe any changes (in width, length or height). CONCLUSION: The results confirm that estriol may block the protective effect of oral contraceptives on fibroadenomas, since we observed decreased fibroadenoma width among the group 1 patients but not the group 2 patients.

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Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combining Celecoxib with Pregabalin and Repetition Dose Combining Celecoxib with Pregabalin: Double-Blind Controlled Clinical Trial

Pain Research and Treatment ◽

10.1155/2018/3807217 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Andri M. T. Lubis ◽

Rangga B. V. Rawung ◽

Aida R. Tantri

Keyword(s):

Clinical Trial ◽

Total Knee Arthroplasty ◽

Knee Arthroplasty ◽

Preemptive Analgesia ◽

Controlled Clinical Trial ◽

Double Blind ◽

Significant Difference ◽

Total Knee ◽

Group 2 ◽

Group 1

Acute pain is the most common early complication after total knee arthroplasty causing delayed mobilization and increased demands of morphine, leading to higher operative cost. Several studies have assessed the effectiveness, side-effects, and ease of use of various analgesics. Preemptive analgesia with combined celecoxib and pregabalin has been reported to yield positive outcomes. In this randomized, double-blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. Group 1 was given celecoxib 400mg and pregabalin 150mg 1 hour before the operation, Group 2 was given celecoxib 200mg and pregabalin 75mg twice daily starting from 3 days before the operation, and Group 3 was given a placebo. The outcome was measured with Visual Analog Scale, knee range of motion, and postoperative mobilization. There was a significant difference in postoperative morphine usage between the groups that were administered with preemptive analgesia and the placebo group, but no significant difference was found between Group 1 and Group 2 that were given preemptive analgesia at different doses. ROM and postoperative mobilization were not significantly different among the three groups. Two patients in the first group, one patient in the second group, and one patient in the third group developed nausea. Preemptive analgesia is proven to reduce postoperative usage of morphine independent of the dosage. We recommend the use of combined celecoxib and pregabalin as preemptive analgesia after the total knee arthroplasty procedure. This trial is registered with NCT03523832 (ClinicalTrials.gov).

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Evaluation of the clinical efficacy of 1.2% atorvastatin by CBCT in the treatment of periodontal intrabony defects: A randomized controlled clinical trial

Journal of Dental Research Dental Clinics Dental Prospects ◽

10.15171/joddd.2019.029 ◽

2019 ◽

Vol 13 (3) ◽

pp. 183-191

Author(s):

Prerna Y. Shirke ◽

Abhay P. Kolte ◽

Rajashri A. Kolte ◽

Pranjali V. Bawanakar

Keyword(s):

Clinical Trial ◽

Statistical Significance ◽

Periodontal Regeneration ◽

Controlled Clinical Trial ◽

Pocket Depth ◽

Probing Pocket Depth ◽

Treat Ment ◽

Group 2 ◽

Attachment Level ◽

Group 1

Background. Atorvastatin (ATV), which belongs to the statin class of drugs, is the formidable inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. This clinical trial evaluated and compared the clinical and radiographic changes in chronic periodontitis (CP) patients, obtained through 1.2% ATV as an adjunct to scaling and root planing (SRP) in the treat-ment of intraosseous defects. Methods. Twenty CP patients, with a minimum of one pair of bilateral intraosseous, were randomly selected for this split-mouth study. Group 1 included 20 sites treated with SRP and subgingival delivery of a placebo gel, whereas an equal number of sites in group 2 were treated by SRP along with subgingival delivery of 1.2% ATV gel. The plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD) and clinical attachment level (CAL) were evaluated at baseline and 3- and 6-month intervals, while the intraosseous defect was assessed at baseline and 6-month interval using cone-beam computed tomography (CBCT). Paired t-test was used to determine statistical significance. Results. A greater reduction in the mean PPD and gain in CAL was found in group 2 compared to group 1 at 3- and 6-month intervals. Furthermore, a significantly greater bone fill was obtained in group 2 (1.70±0.54 mm) compared to group 1 (0.22±0.43 mm) after six months.Conclusion. ATV, as an adjunct to SRP, enhanced periodontal regeneration, as a noninvasive way to treat periodontal in-traosseous defects.

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Efficacy of estriol in inhibiting epithelial proliferation in mammary fibroadenoma: randomized clinical trial

Sao Paulo Medical Journal ◽

10.1590/s1516-31802007000600008 ◽

2007 ◽

Vol 125 (6) ◽

pp. 343-350 ◽

Cited By ~ 3

Author(s):

Rodrigo Augusto Fernandes Estevão ◽

Edmund Chada Baracat ◽

Ângela Flávia Logullo ◽

Celina Tizuko Fujiyama Oshima ◽

Afonso Celso Pinto Nazário

Keyword(s):

Clinical Trial ◽

Oral Contraceptive ◽

Randomized Clinical Trial ◽

Ethinyl Estradiol ◽

Study Groups ◽

Reproductive Age ◽

Double Blind ◽

Ki 67 ◽

Group 2 ◽

Group 1

CONTEXT AND OBJECTIVE: Mammary fibroadenoma is a disease that affects a large number of women of reproductive age. The aim of this study was to evaluate the proliferative activity of mammary fibroadenoma through expression of Ki-67 and c-myc antigens, following administration of oral contraceptive with or without estriol. DESIGN AND SETTING: Placebo-controlled double-blind randomized clinical trial in the Mastology Sector of the Department of Gynecology, Universidade Federal de São Paulo. METHODS: Thirty-three fibroadenoma patients were studied. Ten women (group 1) took an oral contraceptive constituted by levonorgestrel and ethinyl estradiol together with placebo manufactured in the same capsule for four consecutive cycles with a seven-day interval between them. The other 23 patients (group 2) took the same oral contraceptive together with estriol, which was put into the same capsule and used in the same way as among the group 1 patients. After four cycles, the nodules were surgically removed and sent for immunohistochemical analysis of Ki-67 and c-myc expression. RESULTS: The Ki-67 and c-myc analysis did not reveal any significant differences between the study groups. The values were 9.16 and 10.54 for group 1 and 10.86 and 17.03 for group 2, respectively. There was a tendency towards higher expression of antigens in group 2. CONCLUSION: Our results showed that there was no significant statistical difference in Ki-67 and c-myc expression between our study groups, but only a tendency towards higher expression among users of oral contraceptives containing estriol.

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Association between Rapid Maxillary Expansion and Nocturnal Enuresis in Children: A Pilot Study for a Randomized Controlled Clinical Trial

Applied Sciences ◽

10.3390/app10249025 ◽

2020 ◽

Vol 10 (24) ◽

pp. 9025

Author(s):

Xiaowen Niu ◽

Marie A. Cornelis ◽

Konstantinos Kamperis ◽

Paolo M. Cattaneo

Keyword(s):

Clinical Trial ◽

Pilot Study ◽

Nocturnal Enuresis ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Maxillary Expansion ◽

Randomized Controlled ◽

Urine Production ◽

Group 2 ◽

Group 1

Objectives: This pilot study was conducted to test the protocol of a randomized controlled trial evaluating whether rapid maxillary expansion (RME) can relieve nocturnal enuresis (NE) and improve breathing in children, after ruling out a placebo effect, and investigating whether the effects of RME and NE are related to the morphology of the upper airway. Methods: Seventy 6–15-year-old patients with NE were assessed for eligibility (e.g., constricted maxilla). Enrolled subjects were randomized to immediate treatment with RME (Group 1) or to have the same treatment (RME) delayed for at least six weeks (Group 2). Outcomes comprised the number of wet nights per week, the nocturnal urine production, and the scores of a pediatric sleep questionnaire at baseline, after active treatment (Group 1) or delayed treatment (Group 2), and after 3 months’ retention. Cone beam computed tomographies were taken at baseline and after retention. Results: Six patients were randomized: three in each group. In four of six patients, the number of wet nights per week decreased. Moreover, in responders, nocturnal urine production was reduced following RME. Conclusions: This pilot study suggested that RME might reduce the severity of NE and showed that the protocol of this randomized controlled clinical trial was appropriate.

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Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy: a randomized clinical trial

Trials ◽

10.1186/s13063-021-05527-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xiaotian Sun ◽

Yang Xu ◽

Xueting Zhang ◽

Cuiyun Ma ◽

Aitong Li ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Clinical Trial ◽

Diagnostic Efficiency ◽

Examination Time ◽

Significant Difference ◽

Group 3 ◽

Group 2 ◽

Solution Intake ◽

Upper Gastrointestinal ◽

Group 1

Abstract Background Esophagogastroduodenoscopy is very useful in diagnosing and treating upper gastrointestinal mucosal disorders, but too much foam and water in stomach decrease its diagnostic efficiency. Simethicone administration can help remove excessive foam. Aims To determine the optimal simethicone administration strategies in a comparative randomized controlled clinical trial. Methods Adult outpatients with indications for esophagogastroduodenoscopy were enrolled and randomly divided into group 1 (simethicone solution intake 20–30 min before procedure, n = 110), group 2 (simethicone solution intake 31–60 min before procedure, n = 92), and group 3 (simethicone solution intake > 60 min before procedure). Primary and secondary outcomes were procedure time and the patients’ satisfaction after the examination. All symptoms like abdominal pain and distension were recorded. Results No statistically significant differences were found on the patients’ demographic and clinical features and mean examination time (all P values > 0.05). The distribution of patients with different endoscopic and pathological diagnosis was comparable among three groups, respectively (P = 0.607; P = 0.289). However, the proportion of patients with Gastric Cleanness Grade A was most in group 2 (n = 73, 79.3%), and patient proportion with Gastric Cleanness Grade C was most found in group 1 (n = 72, 65.5%), which was greatly different (P < 0.001). There was no statistically significant difference on the satisfaction scores [immediately 6 (3–8) vs. 6 (1–10) vs. 6 (1-9), P = 0.533; 2 h after 10 (8–10) vs. 10 (10–10) vs. 10 (8-10), P = 0.463]. Conclusion Simethicone solution intake 31–60 min before esophagogastroduodenoscopy can help obtain the best gastric cleanness, which is recommended in clinical practice (registered at ClinicalTrials.gov, NCT03776916 on December 13, 2018).

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The effectiveness of waist-shaped and straight-shaped interdental brushes in cleaning implant overdenture attachments: a self-controlled clinical trial

Journal of Oral Implantology ◽

10.1563/aaid-joi-d-19-00149 ◽

2020 ◽

Author(s):

Qiuwen Chen ◽

Yanjun Ge ◽

Jinyou Chai ◽

Hailan Feng ◽

Jianzhang Liu ◽

...

Keyword(s):

Clinical Trial ◽

Oral Hygiene ◽

Respiratory Diseases ◽

The Other ◽

Controlled Clinical Trial ◽

Cleaning Procedure ◽

Plaque Removal ◽

Line Angle ◽

Implant Overdenture ◽

Interdental Brush

Elderly patients often find it challenging to remove plaque accumulated on the attachments of implant overdentures (IOD) using conventional cleaning instruments. Further, excessive plaque accumulation can lead to peri-implant diseases and occasionally to respiratory diseases. Therefore, here, we aimed to compare the effectiveness of waist-shaped interdental brushes (WIB) with that of straight-shaped ones (SIB) in plaque removal from the locator attachments of IOD. Twenty participants with two locator attachments retaining mandibular IOD participated in this study. After the baseline cleaning, the participants refrained from oral hygiene maintenance for 3 days. A dentist cleaned one of the attachments using the WIB and the other attachment using the SIB. The pre- and post-cleaning modified plaque index (mPLI) scores were recorded. Following another 3 days free from oral hygiene maintenance, the trained participants repeated the same cleaning procedure using the WIB and SIB. Pre- and post-cleaning mPLI scores were recorded. Regardless of the type of brush used, the post-cleaning mPLI scores were lower than the pre-cleaning ones. After the cleaning procedure, the overall mean mPLI score was lower in the WIB group than in the SIB group. The post-cleaning mPLI scores at the line-angles and on the axial surfaces of the attachments were also lower in the WIB group than in the SIB group. There was no difference in the cleaning effectiveness between the dentist and participants when they used the same type of interdental brush. The WIB was significantly more efficient in plaque removal than the SIB, especially at the line-angle sites.

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Myeloid neoplasms in the setting of chronic lymphocytic leukaemia/chronic lymphocytic leukaemia-like disease: a clinicopathological study of 66 cases comparing cases with prior history of treatment to those without

Journal of Clinical Pathology ◽

10.1136/jclinpath-2020-207334 ◽

2021 ◽

pp. jclinpath-2020-207334

Author(s):

Catherine Luedke ◽

Yue Zhao ◽

Jenna McCracken ◽

Jake Maule ◽

Lian-He Yang ◽

...

Keyword(s):

Chronic Lymphocytic Leukaemia ◽

Lymphocytic Leukaemia ◽

The Other ◽

Prior History ◽

Myeloid Neoplasm ◽

Myeloid Neoplasms ◽

History Of ◽

Cytogenetic Profile ◽

Group 2 ◽

Group 1

AimsMyeloid neoplasms occur in the setting of chronic lymphocytic leukaemia (CLL)/CLL-like disease. The underlying pathogenesis has not been elucidated.MethodsRetrospectively analysed 66 cases of myeloid neoplasms in patients with CLL/CLL-like disease.ResultsOf these, 33 patients (group 1) had received treatment for CLL/CLL-like disease, while the other 33 patients (group 2) had either concurrent diagnoses or untreated CLL/CLL-like disease before identifying myeloid neoplasms. The two categories had distinct features in clinical presentation, spectrum of myeloid neoplasm, morphology, cytogenetic profile and clinical outcome. Compared with group 2, group 1 demonstrated a younger age at the diagnosis of myeloid neoplasm (median, 65 vs 71 years), a higher fraction of myelodysplastic syndrome (64% vs 36%; OR: 3.1; p<0.05), a higher rate of adverse unbalanced cytogenetic abnormalities, including complex changes, −5/5q- and/or −7/7q- (83% vs 28%; OR: 13.1; p<0.001) and a shorter overall survival (median, 12 vs 44 months; p<0.05).ConclusionsMyeloid neoplasm in the setting of CLL/CLL-like disease can be divided into two categories, one with prior treatment for CLL/CLL-like disease and the other without. CLL-type treatment may accelerate myeloid leukaemogenesis. The risk is estimated to be 13-fold higher in patients with treatment than those without. The causative agent could be attributed to fludarabine in combination with alkylators, based on the latency of myeloid leukaemogenesis and the cytogenetic profile.

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Urinary melatonin, LH, oestradiol, progesterone excretion during the menstrual cycle or in women taking oral contraceptives

Acta Endocrinologica ◽

10.1530/acta.0.1160145 ◽

1987 ◽

Vol 116 (1) ◽

pp. 145-149 ◽

Cited By ~ 34

Author(s):

Jocelyne Brun ◽

Bruno Claustrat ◽

Michel David

Keyword(s):

Oral Contraceptive ◽

Menstrual Cycle ◽

Urinary Excretion ◽

Oral Contraceptives ◽

Coefficient Of Variation ◽

Luteal Phase ◽

Positive Relationship ◽

Follicular Phase ◽

The Other ◽

Normal Women

Abstract. Nocturnal urinary excretion of melatonin, LH, progesterone and oestradiol was measured by radioimmunoassay in nine normal women during a complete cycle. In addition, these hormonal excretions were studied in two women taking an oral contraceptive. A high within-subject coefficient of variation was observed for melatonin excretion in the two groups. In the nine normal cycling women, melatonin excretion was not decreased at the time of ovulation, but was significantly increased during the luteal phase compared with that of the follicular phase (P < 0.01). These data are consistent with a positive relationship between melatonin and progesterone during the luteal phase. In the two women under an oral contraceptive, melatonin excretion was found within the same range as for the other nine. The results are discussed in terms of pineal investigation in human.

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Comparison of peribulbar anesthesia and topical anesthesia on outcome of phacoemulsification

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20172456 ◽

2017 ◽

Vol 5 (6) ◽

pp. 2608 ◽

Cited By ~ 2

Author(s):

Rishi Mehta ◽

Sharda Punjabi ◽

Nutan Bedi ◽

Chandra Kant Nagar

Keyword(s):

Intraoperative Complications ◽

Visual Outcome ◽

Topical Anesthesia ◽

Satisfaction Score ◽

The Other ◽

Patients Satisfaction ◽

Peribulbar Anesthesia ◽

Group 2 ◽

A Prospective Study ◽

Group 1

Background: Due to advancement in phacoemulsification techniques, there has been growing shift from peribulbar anesthesia (PA) to topical anesthesia (TA). But dilemma exists regarding the supremacy of one over the other as both types have certain advantages and disadvantages.Methods: A prospective study was conducted. Patients were divided into two groups. Group-1 underwent PA while group-2 underwent TA. Satisfaction score of patients and surgeons and incidence of complications were noted. The data was analyzed.Results: Lowest patients’ satisfaction score among group-1 vs. group-2 was 160 (87.9%) vs.82 (45.81%). Highest surgeons satisfaction score among group-1 and group-2 was 74(40.65%) vs. 2(1.1%). Intraoperative complications among the group-1 and group-2 were 35 (19.2%) vs. 86(48.0%).Conclusions: While TA provides initial painless phase of surgical procedure, PA results in lesser intraoperative complications resulting in better visual outcome.

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Can pharmacokinetic dosing decrease nephrotoxicity associated with aminoglycoside therapy.

Journal of the American Society of Nephrology ◽

10.1681/asn.v4181 ◽

1993 ◽

Vol 4 (1) ◽

pp. 81-90

Author(s):

D J Leehey ◽

B I Braun ◽

D A Tholl ◽

L S Chung ◽

C A Gross ◽

...

Keyword(s):

Peak Level ◽

Serum Levels ◽

Control Group ◽

Controlled Clinical Trial ◽

Aminoglycoside Therapy ◽

Concentration Peak ◽

Trough Serum ◽

Individualized Dosing ◽

Group 2 ◽

Group 1

A randomized, controlled clinical trial was performed to determine whether individualized dosing by use of Bayesian pharmacokinetic modeling could decrease nephrotoxicity accosted with aminoglycoside therapy. Two hundred forty-three patients receiving aminoglycosides for suspected or proven infection were randomly assigned to one of three groups: usual physician-directed dosing (Group 1), pharmacist-assisted dosing (Group 2), or pharmacist-directed dosing (Group 3). Dosing in Groups 2 and 3 was based on a Bayesian pharmacokinetic dosing program, whereas Group 1 served as the control group. Individualized dosing resulted in higher mean postinfusion (peak) serum aminoglycoside levels, higher ratios of mean peak level to minimum inhibitory concentration (peak/MIC ratios), and a trend toward lower trough serum levels. Milligrams per dose were higher and number of doses per day was lower in the pharmacist-dosed groups. However, the incidence of nephrotoxicity (> or = 100% increase in serum creatinine) was not different among the three groups (16, 27, and 16% in Groups 1, 2, and 3, respectively). Similarly, severity of toxicity was not affected by the dosing intervention. Risk factors for toxicity included duration of therapy, shock, treatment with furosemide, older age, and liver disease. After controlling for these factors, the dosing intervention still had no effect on nephrotoxicity. It was concluded that Bayesian pharmacokinetic dosing did not decrease the risk of nephrotoxicity associated with aminoglycoside therapy.

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