scholarly journals A Comparative Efficacy of Low-Dose Combined Oral Contraceptives Containing Desogestrel and Drospirenone in Premenstrual Symptoms

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Jirath Wichianpitaya ◽  
Surasak Taneepanichskul
Keyword(s):  
Low Dose ◽  
Ethinyl Estradiol ◽  
Controlled Trial ◽  
Health Assessment ◽  
Analysis Of Covariance ◽  
Open Label ◽  
Premenstrual Symptoms ◽  
Repeated Analysis ◽  
The Difference ◽  
To Receive

Objective. To compare the efficacy of low-dose COC containing desogestrel (DSG) with drospirenone (DRSP) in the changes of premenstrual symptoms.Methods. In an open-label randomized controlled trial, 90 women with premenstrual syndrome who required COC were randomly recruited and allocated equally to receive either 6 cycles of 20 micrograms ethinyl estradiol (EE)/150 micrograms DSG (DSG group) or 20 micrograms EE/3 mg DRSP (DRSP group) in 24/4 extended regimen. Analysis of covariance and repeated analysis of variance were used to determine the difference of mean Women's Health Assessment Questionnaire (WHAQ) scores changes between groups, within group, and in premenstrual, menstrual, and postmenstrual phases.Results. Baseline characteristics and WHAQ scores were comparable. At the ends of the 3rd and the 6th cycles, mean WHAQ scores of all the 3 phases in DRSP group showed significant reduction and were significantly lower than those in DSG group. DSG group showed significant reduction in both premenstrual and menstrual phases after the 6th cycle. Adverse effects were comparable in both groups. In conclusion, low-dose COC containing either DSG or DRSP reduced premenstrual symptoms, but the latter showed greater efficacy and earlier reduction.

scholarly journals Comparison of Low-Dose Rosuvastatin with Atorvastatin in Lipid-Lowering Efficacy and Safety in a High-Risk Pakistani Cohort: An Open-Label Randomized Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Abdul Rehman Arshad
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
Lipid Lowering ◽  
Lipid Levels ◽  
Primary And Secondary Prevention ◽  
Percent Reduction ◽  
Open Label ◽  
Randomized Controlled ◽  
To Receive

Background. Treatment of hyperlipidemia is helpful in both primary and secondary prevention of coronary heart disease and stroke.Aim. To compare lipid-lowering efficacy of rosuvastatin with atorvastatin.Methodology. This open-label randomized controlled trial was carried out at 1 Mountain Medical Battalion from September 2012 to August 2013 on patients with type 2 diabetes, hypertension, myocardial infarction, or stroke, meriting treatment with a statin. Those with secondary causes of dyslipidemia were excluded. Blood samples for estimation of serum total cholesterol, triglycerides, HDL-C, and LDL-C were collected after a 12-hour fast. Patients were randomly allocated to receive either atorvastatin 10 mg HS or rosuvastatin 5 mg HS daily. Lipid levels were rechecked after six weeks.Results. Atorvastatin was used in 63 patients and rosuvastatin in 66. There was a greater absolute and percent reduction in serum LDL-C levels with rosuvastatin as compared to atorvastatin (0.96 versus 0.54 mg/dL;P=0.011and 24.34 versus 13.66%;P=0.045), whereas reduction in all other fractions was equal. Myalgias were seen in 5 (7.94%) patients treated with atorvastatin and 8 (12.12%) patients treated with rosuvastatin (P: 0.432).Conclusion. Rosuvastatin produces a greater reduction in serum LDL-C levels and should therefore be preferred over atorvastatin.

Impact of Temperature on Injection-Related Pain Caused by Subcutaneous Administration of Ustekinumab: A Three-arm Crossover Open-label Randomized Controlled Trial

2017 ◽  
Vol 1 (3) ◽  
pp. 117-127
Author(s):  
Yasaman Mansouri ◽  
Yasmin Amir ◽  
Michelle Min ◽  
Raveena Khanna ◽  
Ruiqi Huang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Subcutaneous Administration ◽  
Open Label ◽  
Post Dose ◽  
Subcutaneous Injections ◽  
Pain Scores ◽  
Observational Cohort ◽  
Vas Scores ◽  
Pre Treatment ◽  
To Receive

Background: Adherence to subcutaneous biologic agents for the treatment of psoriasis can be negatively influenced by injection pain.Objective: To explore the differences in injection site pain when patients are pre-treated with heat or cold, versus no pre-treatment prior to administration of a subcutaneous biologic agent.Methods: In an observational cohort study, patients receiving subcutaneous injections of ustekinumab were randomly assigned to receive pretreatment with ice, heat, or no intervention over three visits. Post-dose, patients rated pain on a 100 mm visual analogue scale (VAS).Results: There was an increase in the VAS score for both heat (2.51, P=0.30) and ice (3.33, P=0.16), compared to no intervention. No differences were found between the two intervention groups (-0.83, P=0.73). On average, females had the same VAS scores with ice compared to that of no intervention (-0.12, P=0.97) and a non–significant decrease of 3.29 points (P=0.38) with heat. Males had increased pain scores by 5.65 points (P=0.07) with ice and by 6.39 points (P=0.04) with heat.Limitations: Pain is a subjective measurement and objective quantification is difficult.Conclusions: On average, neither heat nor cold application reliably reduced pain. Our results do not support the application of heat or cold prior to ustekinumab injection.

scholarly journals Effects of the Progesterone Receptor Modulator VA2914 in a Continuous Low Dose on the Hypothalamic-Pituitary-Ovarian Axis and Endometrium in Normal Women: A Prospective, Randomized, Placebo-Controlled Trial

2007 ◽  
Vol 92 (9) ◽  
pp. 3582-3589 ◽  
Author(s):  
Nathalie Chabbert-Buffet ◽  
Axelle Pintiaux-Kairis ◽  
Philippe Bouchard
Keyword(s):  
Progesterone Receptor ◽  
Endometrial Hyperplasia ◽  
Low Dose ◽  
Ethinyl Estradiol ◽  
Controlled Trial ◽  
Endometrial Biopsy ◽  
Receptor Modulator ◽  
Phase Range ◽  
Normal Women ◽  
Estradiol Levels

Abstract Context: Progestin-only pills, the main hormonal alternative to ethinyl estradiol-containing pills in women bearing vascular risk factors, are poorly tolerated due to irregular bleeding. In contrast, progesterone receptor modulators can inhibit ovulation, alter endometrial receptivity, and improve cycle control. Objective: We evaluated the effects of a new progesterone receptor modulator, VA2914, administered continuously for 3 months, on ovulation and endometrial maturation. Design, Settings, and Patients: Forty-six normal women were included in a prospective, placebo-controlled, randomized trial, conducted in four referral centers. Intervention: VA2914 (2.5, 5, or 10 mg/d) was administered continuously for 84 d. Pelvic ultrasound (treatment d 67 and 77), hormonal monitoring (FSH, LH, estradiol, and progesterone on treatment d 59, 63, 67, 70, 74, 77, 80, and 84), and endometrial biopsy (treatment d 77) were performed. Main Outcome Measure: Ovulation inhibition was assessed by the absence of progesterone values above 3 ng/ml at any time during treatment month 3. Results: Anovulation was observed in 81.8% women in the 5-mg group and 80% in the 10-mg group, and amenorrhea occurred in 81.2 and 90% of cases in the 5- and 10-mg groups. We did not detect any cases of endometrial hyperplasia despite estradiol levels that remained in the physiological follicular phase range throughout treatment cycle 3. Conclusions: Continuous low-dose VA2914 can induce amenorrhea and inhibit ovulation without down-regulating estradiol levels or inducing endometrial hyperplasia in normal women. Long-term studies with a larger population are required to confirm the contraceptive efficacy of this regimen.

scholarly journals Effectiveness of Measures to Eradicate Staphylococcus aureus Carriage in Patients with Community-Associated Skin and Soft-Tissue Infections: A Randomized Trial

2011 ◽  
Vol 32 (9) ◽  
pp. 872-880 ◽  
Author(s):  
Stephanie A. Fritz ◽  
Bernard C. Camins ◽  
Kimberly A. Eisenstein ◽  
Joseph M. Fritz ◽  
Emma K. Epplin ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Soft Tissue ◽  
Controlled Trial ◽  
Control Group ◽  
Open Label ◽  
Intention To Treat ◽  
Intranasal Mupirocin ◽  
Mupirocin Ointment ◽  
Hygiene Education ◽  
To Receive

Background.Despite a paucity of evidence, decolonization measures are prescribed for outpatients with recurrent Staphylococcus aureus skin and soft-tissue infection (SSTI).Objective.Compare the effectiveness of 4 regimens for eradicating S. aureus carriage.Design.Open-label, randomized controlled trial. Colonization status and recurrent SSTI were ascertained at 1 and 4 months.Setting.Barnes-Jewish and St. Louis Children's Hospitals, St. Louis, Missouri, 2007–2009.Participants.Three hundred patients with community-onset SSTI and S. aureus colonization in the nares, axilla, or inguinal folds.Interventions.Participants were randomized to receive no therapeutic intervention (control subjects) or one of three 5-day regimens: 2% mupirocin ointment applied to the nares twice daily, intranasal mupirocin plus daily 4% chlorhexidine body washes, or intranasal mupirocin plus daily dilute bleach water baths.Results.Among 244 participants with 1-month colonization data, modified intention-to-treat analysis revealed S. aureus eradication in 38% of participants in the education only (control) group, 56% of those in the mupirocin group (P = .03 vs controls), 55% of those in the mupirocin and chlorhexidine group (P = .05), and 63% off those in the mupirocin and bleach group (P = .006). Of 229 participants with 4-month colonization data, eradication rates were 48% in the control group, 56% in the mupirocin only group (P = .40 vs controls), 54% in the mupirocin and chlorhexidine group (P = .51), and 71% in the mupirocin and bleach group (P = .02). At 1 and 4 months, recurrent SSTIs were reported by 20% and 36% of participants, respectively.Conclusions.An inexpensive regimen of dilute bleach baths, intranasal mupirocin, and hygiene education effectively eradicated S. aureus over a 4-month period. High rates of recurrent SSTI suggest that factors other than endogenous colonization are important determinants of infection.Trial Registration.ClinicalTrials.gov identifier: NCT00513799.

Adding a Low Dose of Fentanyl to Propofol in Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Trial

2021 ◽  
Vol 104 (10) ◽  
pp. 1692-1697
Keyword(s):  
Blood Pressure ◽  
Electroconvulsive Therapy ◽  
Low Dose ◽  
Controlled Trial ◽  
Optimal Dose ◽  
Hemodynamic Response ◽  
Mean Difference ◽  
Seizure Duration ◽  
American Society ◽  
To Receive

Objective: To evaluate the effects of low-dose fentanyl combined with a reduced dose of propofol on seizure duration and hemodynamic response during electroconvulsive therapy (ECT). Materials and Methods: Twenty-two patients with the American Society of Anesthesiologist Physical Status II to III undergoing ECT were enrolled in the present study. One hundred and five bilateral ECT sessions randomized to receive thiopental 2 mg/kg, propofol 1 mg/kg, and fentanyl 0.3 mcg/kg, followed by propofol 0.5 mg/kg. Succinylcholine 0.5 mg/kg was used for muscle paralysis. Seizure duration, awakening time and hemodynamic changes were compared between groups. Results: One hundred and five bilateral ECT treatments were randomized into thiopental group (n=35), propofol group (n=35), and fentanyl plus propofol group (n=35). The thiopental and fentanyl plus propofol groups had longer EEG and motor seizure durations than the propofol group, but the differences were not statistically significant. There was no difference in stimulus intensity across groups. However, fentanyl plus propofol group had statistically significant prolonged awakening time compare with thiopental group [mean difference 2.71, (95% CI 0.37 to 5.06, p=0.019)] and propofol group (mean difference 2.77, 95% CI 0.42 to 5.12, p=0.016). Only systolic blood pressure in propofol group was significantly lower than thiopental group [mean difference –10.4, (95% CI –19.4 to –1.38, p=0.018)]. There were no significant differences in diastolic blood pressure (df=2, F=2.546, p=0.083), heart rate (df=2, F=0.596, p=0.553), or oxygen saturation across group (df=2, F=2.914, p=0.059). Conclusion: Using a combination of low-dose fentanyl and low-dose propofol during ECT could be beneficial. Further investigation is needed to establish the optimal dose of propofol and fentanyl. Keywords: Electroconvulsive therapy; Fentanyl, Hemodynamic response; Propofol; Thiopental; Seizure duration

scholarly journals Impact of valganciclovir therapy on severe IRIS-Kaposi Sarcoma mortality: an open-label, parallel, randomized controlled trial.

2021 ◽  
Author(s):  
Patricia Volkow ◽  
Leslie Chavez-Galan ◽  
Lucero Ramon-Luing ◽  
Judith Cruz-Velazquez ◽  
Patricia Cornejo-Juarez ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Kaposi Sarcoma ◽  
Pulmonary Involvement ◽  
Skin Lesions ◽  
Attributable Mortality ◽  
Control Group ◽  
Open Label ◽  
Parallel Group ◽  
Pulmonary Lymph Node ◽  
The Difference

High HHV-8 viral load (VL) in Kaposi Sarcoma (KS) has been associated with severe Immune reconstitution inflammatory syndrome (S-IRIS-KS), which can occur after initiating cART, and is linked with high mortality particularly in patients with pulmonary involvement. We investigate if valganciclovir initiated before cART decreases HHV-8 VL and assess if it reduces the incidence of S-IRIS-KS and its attributable mortality. Methods: Open-label parallel-group randomized clinical trial in AIDS cART naive patients with disseminated KS (DKS) as defined by at least two of the following: pulmonary, lymph-node or gastrointestinal involvement, lymphedema, or equal or more 30 skin lesions. In the experimental group (EG), patients were randomized to valganciclovir 900 mg BID four weeks before cART and continued until week-48; in the control group (CG), cART was initiated on week-0. Non-severe-IRIS-KS was defined as: increase in the number of lesions plus equal or more than one log10 HIV-VL decrease or equal or more than 50 cells/mm3 increase or equal or more than 2-fold rise in baseline CD4+ cells. S-IRIS-KS was defined as abrupt clinical worsening of KS lesions and/or fever after ruling out another infection following cART initiation, and at least three of the following: thrombocytopenia, anemia, hyponatremia, or hypoalbuminemia. Results: 40 patients were randomized and 37 completed the study. In the ITT analysis, the overall mortality did not differ between groups. In the per-protocol analyses, the difference showed a trend for higher S-IRIS-KS mortality in the CG 3/19 (15.7%), compared to EG 0/18 (p=0.07). The incidence of S-IRIS KS was significantly lower in the EG; two patients, one each had S-IRIS-KS episode (0.038 per 100 patient-days) compared to CG group, four patients developed 12 S-IRIS-KS episodes (0.21 per 100 patient-days); incidence rate of 0.09 (95% CI 0.02-0.5 p=0.006). Mortality in patients with pulmonary KS was significantly lower in EG, 3/4 in CG vs 0/5 in EG. S-IRIS-KS was associated with higher HHV-8-VL; IL6 and CRP; valganciclovir was protective. Of survivors at week 48, 82% achieved more than 80% remission. No difference was found between groups in the number of non-S-IRIS-KS events. Conclusions: Valganciclovir significantly reduced the episodes of S-IRIS-KS although attributable KS mortality was lower in the EG the difference was not significant (p=0.07). Mortality was significantly lower in EG patients with pulmonary KS.

Green tea might be effective in alleviating COVID-19 associated psychiatric complications: preliminary results from a pilot randomized controlled trial

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Marjan Mahdavi-Roshan ◽  
Arsalan Salari ◽  
Eshagh Mohammadyari ◽  
Tofigh Yaghubi Kalurazi ◽  
Aydin Pourkazemi ◽  
...  
Keyword(s):  
Green Tea ◽  
Trait Anxiety ◽  
Controlled Trial ◽  
Black Tea ◽  
Analysis Of Covariance ◽  
Depression And Anxiety ◽  
Open Label ◽  
Content Type ◽  
Neuropsychiatric Complications ◽  
Psychiatric Complications

Purpose It is argued that COVID-19 patients show various neuropsychiatric symptoms, including fatigue, depression and anxiety. On the other hand, epidemiological and experimental evidence indicated that green tea could potentially have antiviral effects and ameliorate psychiatric disorders. However, there is a lack of clinical evidence. The purpose of this study was to investigate whether drinking green tea can clinically improve psychiatric complications of COVID-19 infection. Design/methodology/approach This study included 40 patients with laboratory confirmed mild-to-moderate COVID-19 disorder in the current randomized open-label controlled trial. Patients were instructed to include three cups/day of green tea (intervention) or black tea (control) to their usual diet for four weeks immediately after diagnosis of the disease. At the study baseline and after the intervention, the enrolled patients’ fatigue, depression and anxiety were assessed by the Chalder Fatigue Scale, Beck Depression Inventory-Fast Screen and State-Trait Anxiety Inventory questionnaires. Findings A total of 19 COVID-19 cases in the intervention group (mean age = 52 years) and 14 cases (mean age = 50 years) in the control group completed the study. Analysis of covariance adjusted for baseline levels, and confounders revealed that those who consumed three cups/day of green tea compared to the patients who received black tea experienced significantly lower fatigue, depression and state and trait anxiety levels (adjusted means for fatigue = 12.3 vs 16.2 (P = 0.03), depression = 0.53 vs 1.8 (P = 0.01), 37.4 vs 45.5 (P < 0.01) and 37.9 vs 45.2 (P < 0.01)). Research limitations/implications The open-label design may bias the evaluation of the self-reported status of fatigue, depression or anxiety as the main outcomes assessed. Moreover, as this study did not include patients with severe COVID-19, this might affect the generalizability of the present results. Thus, the recommendation of daily drinking green tea may be limited to the subjects diagnosed with mild-to-moderate type of infection or those with long-term neuropsychiatric complications owing to COVID-19. Besides, considering the ethical issues, this study could not exclude the drug therapy’s confounding effects; thereby, this point should be considered when interpreting the current results. Besides, it is worth noting that Guilan province in the north of Iran is recognized as a tea (and particularly green tea) producing region; thereby, it is an available and relatively inexpensive product. Considering this issue, the recommendation to consume this medicinal plant in adjunct to the routine treatment approach among patients with mild-to-moderate COVID-19 based on its beneficial effects may be widely accepted. Practical implications Green tea consumption could be considered an option to combat COVID-19 associated psychological complications, including fatigue, depression and anxiety among patients suffering from mild-to-moderate type of this viral infection. Originality/value To the best of the authors’ knowledge, in this study, for the first time, the effects of green tea compared to black tea on COVID-19 associated fatigue, depression and anxiety status within an open-label controlled trial have been investigated.

Low-Dose Aspirin for the Prevention and Treatment of Preeclampsia

2021 ◽  
pp. 7-12
Author(s):  
Danielle M. Panelli ◽  
Deirdre J. Lyell
Keyword(s):  
Lower Risk ◽  
Low Dose ◽  
Controlled Trial ◽  
Entire Cohort ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Prevention And Treatment ◽  
Double Blinded ◽  
The Impact ◽  
To Receive

“CLASP: A Randomized Trial of Low-Dose Aspirin for the Prevention and Treatment of Preeclampsia Among 9364 Pregnant Women” was a double-blinded, placebo-controlled trial that evaluated the impact of antenatal aspirin administration on development of preeclampsia and intrauterine growth restriction (IUGR). A total of 9364 women either at risk for preeclampsia or currently experiencing preeclampsia or IUGR were enrolled between 12 and 32 weeks and randomized to receive 60mg aspirin daily or placebo. While a nonsignificant 12% reduction in the odds of preeclampsia was found among the entire cohort, the reduction in preeclampsia with aspirin use was more pronounced for those who began prophylaxis prior to 20 weeks (22% reduction, p = 0.06). There was also a lower risk of preterm birth before 37 weeks in those who received aspirin at any time (19.7% vs. 22.2%, p = 0.003) but no difference in IUGR infants. In conclusion, 60mg aspirin daily did not significantly reduce the risk of preeclampsia or IUGR among the women included in this study.

Effect of Cotherapy Reduction on Tolerability of Epilepsy Add-On Therapy: A Randomized Controlled Trial

2005 ◽  
Vol 39 (3) ◽  
pp. 418-423 ◽  
Author(s):  
Dean K Naritoku ◽  
Joseph F Hulihan ◽  
Lesley Kraut Schwarzman ◽  
Marc Kamin ◽  
William H Olson
Keyword(s):  
Adverse Events ◽  
Dose Group ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Primary Study ◽  
Open Label ◽  
Open Label Study ◽  
Effective Doses ◽  
Receive Treatment ◽  
To Receive

BACKGROUND: Adverse effects are the most common cause for failure of an antiepileptic drug (AED), especially when an AED is added to existing therapy. With the increased drug load, it may not be possible to titrate the newly added AED to effective doses. Reducing the dosage of AED cotherapy as the new drug is introduced may improve tolerability. OBJECTIVE: To evaluate reduction of AED cotherapy as a strategy to improve tolerability and patient retention when a new AED is added to existing therapy. METHODS: In a 20-week, randomized, open-label study, topiramate was initiated as add-on therapy in adults and adolescents (⩾12 y of age) with inadequately controlled partial-onset seizures. Patients were randomized to receive treatment in which adverse events could be managed by adjustments in AED cotherapy (flex-dose group) or treatment in which AED cotherapy dosages remained fixed (fixed-dose group). Topiramate could be adjusted as needed in both groups. In the flex-dose group, patients exited randomized treatment when topiramate was discontinued. In the fixed-dose group, patients exited when AED cotherapy was reduced due to adverse events or when topiramate was discontinued. The primary study outcome was the percentage of patients exiting randomized treatment due to adverse events. RESULTS: The flex-dose group comprised 297 patients; 302 patients were in the fixed-dose group. Significantly fewer patients in the flex-dose group exited the study due to adverse events (16% vs 23% in the fixed-dose group; p = 0.02). In the flex-dose group, 10% (17 of 168) of patients discontinued topiramate due to adverse events after AED cotherapy was reduced versus 22% (29 of 129) when AED cotherapy was not reduced. CONCLUSIONS: Reduction of AED cotherapy is a useful strategy to improve tolerability and retention when topiramate is initiated as adjunctive therapy.

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