scholarly journals Centchroman versus Tamoxifen in the management of mastalgia: a randomized controlled clinical trial

2016 ◽  
Vol 18 (3) ◽  
pp. 60
Author(s):  
S Khadka ◽  
S Rajbanshi ◽  
S Khaniya ◽  
CS Agrawal ◽  
S Adhikary
Keyword(s):  
Cost Effective ◽  
Controlled Clinical Trial ◽  
Ongoing Debate ◽  
Randomized Controlled ◽  
Vas Score ◽  
Drug Of Choice ◽  
Tamoxifen Group ◽  
End Of Treatment ◽  
Number Of Patients

Introduction and Objective: Mastalgia is defined as painful nodularity for more than 1 week of menstrual cycle. The long list of drugs highlights the ongoing debate about the drug of choice for the management of mastalgia. So in this study, we compared the effectiveness and cost of Centchroman and Tamoxifen in the management of mastalgia.Materials and methods: A total of 106 female patients with the clinical diagnosis of mastalgia were enrolled in the study and randomized to 1:1 ratio into Centchroman and Tamoxifen group for a period of 1 year. The duration of therapy was 3 months. All patients completed the study and follow up. The response of therapy was assessed on 1, 2, 3 and 6 months by using a Visual Analogue Scale (VAS).Results: Baseline mean VAS score was 6.25 in Tamoxifen and 6.49 in Centchroman group.There was marked improvement in VAS score after the treatment in both the groups, which was statistically significant with greater reduction in Centchroman group(p= 0.001).The number of patients who achieved VAS less than 3 were 51(96.2%) in Centchroman and 49(92.5%) in Tamoxifen group at the end of treatment. Tamoxifen was found to be statistically significant and cost-effective (p <0.001) in comparison to Centchroman.Conclusion: We conclude that Centchroman is not inferior to Tamoxifen and both the drugs effectively reduced pain, however Centchroman reduced the pain more than Tamoxifen.

scholarly journals Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

2020 ◽  
Author(s):  
Fatemeh Roozbeh ◽  
Majid Saeedi ◽  
Reza Alizadeh-Navaei ◽  
Akbar Hedayatizadeh-Omran ◽  
Shahin Merat ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Difference ◽  
Novel Coronavirus ◽  
Loss Of Appetite

Abstract Introduction Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection. Methods This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1. Results Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P &lt; 0.001. Conclusions In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.

Documenting Patients’ and Providers’ Preferences When Proposing a Randomized Controlled Trial: A Qualitative Exploration

2021 ◽  
Author(s):  
Devesh Oberoi ◽  
Cynthia Kwok ◽  
Yong Li ◽  
Cindy Railton ◽  
Susan Horsman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Design ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
Referral Letter ◽  
Care Providers ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Follow Up Care

Abstract Background With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we sought to explore patients’ and OPs’ reactions to our proposed recruitment methods. Methods We used a qualitative study design with content analysis, and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial. Results OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers. Conclusion OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials.

Controlled Evaluation of Intravenous Drugs in the Specific Desensitization of Phobias

1973 ◽  
Vol 18 (1) ◽  
pp. 47-53 ◽  
Author(s):  
J. Trevor Silverstone ◽  
M.R. Salkind
Keyword(s):  
Normal Saline ◽  
Rating Scales ◽  
Behaviour Therapy ◽  
Social Phobias ◽  
General Anxiety ◽  
Drug Of Choice ◽  
End Of Treatment ◽  
Specific Phobias ◽  
Controlled Evaluation

The present study was undertaken to compare intravenous methohexitone, given as an adjunct to the behaviour therapy of phobias, with another centrally-acting, rapidly metabolised intravenous agent, propanidid, and also with normal saline. Thirty-five patients were included in the trial, all of whom had had phobic symptoms of at least one year's duration which were seriously interfering with their lives — 15 had specific phobias, 9 had social phobias and 11 had agoraphobia. Treatment consisted of twelve weekly drug-assisted desensitization treatments, using either 1 per cent methohexitone, 2.5 per cent propanidid or normal saline. Within each diagnostic group the drugs were randomly allocated. All treatments were conducted by one of the authors and all assessments by the other (who did not know which of the three preparations the patient had received). In addition to monthly ratings of the phobic symptoms, assessments of anxiety and depression were made, using self-rating scales. Patients were followed up six months after the end of treatment. Patients with specific phobias fared best, 9 out of the 13 who completed being considered to be markedly improved. Although the numbers are small there was a suggestion that patients receiving the two active drugs did better than those on the placebo. While methohexitone and propanidid were similarly effective, recovery time was much more rapid with propanidid. No patient in the specific phobia group relapsed significantly during the six months follow-up period. Furthermore, as the phobia improved the general anxiety level fell. Few depressive symptoms arose during successful desensitization, and there was no evidence of symptom substitution. Patients with social phobias and agoraphobia did far less well. In neither case did the active drugs appear to possess any advantage over placebo. Furthermore, of the 7 patients with agoraphobia who had improved, 4 relapsed within six months. It was concluded that drug-assisted desensitization is likely to be of greatest benefit in the management of specific phobias, with propanidid being the drug of choice.

scholarly journals Interruzione del trattamento nei pazienti con schizofrenia che ricevono olanzapina o aripiprazolo: metanalisi degli studi clinici controllati

2005 ◽  
Vol 6 (1) ◽  
pp. 69-76
Author(s):  
Benedetta Santarlasci ◽  
Giovanni Biricolti ◽  
Cecilia Orsi
Keyword(s):  
Treatment Group ◽  
Literature Search ◽  
Drop Out ◽  
Inclusion Criteria ◽  
Antipsychotic Therapy ◽  
Therapy Discontinuation ◽  
Randomized Controlled ◽  
Drop Out Rate ◽  
Number Of Patients

BACKGROUND: In schizophrenia the drop-out rate can be used as proxy of effectiveness. The drop-out evaluation is also important considering the relevant economic impact for NHS of an antipsychotic therapy discontinuation in terms of patient hospitalization and other related healthcare resources consumption. OBJECTIVE: To analyze the differences in the rates of drop-out from clinical trials between olanzapine and aripiprazole. METHODS: Literature search was based on MEDLINE, on Iowa-IDIS and Drugdex databases (1966-Dec 2004). Analysis included 12 randomized controlled trials (3.778 patients), 8 for olanzapine (2.559 patients) and 4 for aripiprazole (1.219 patients). RCT inclusion criteria were: a) Patients affected by schizophrenia; b) Randomized assignment to olanzapine or aripiprazole treatment group; c) Number of patients included in the treatment group higher than 100; d) Drop-out frequency evaluation between 4th and 26th weeks of follow-up. RESULTS: The rate of treatment discontinuation was greater for aripiprazole than for olanzapine (42,2% vs. 31,6% respectively). The comparison between drop-out percentages is statistically significant (p

Su1345 Long Term Increases in Adenoma Detection At Colonoscopy. Follow up of a Randomized Controlled Clinical Trial

2012 ◽  
Vol 75 (4) ◽  
pp. AB300 ◽  
Author(s):  
Vivian Ussui ◽  
Susan G. Coe ◽  
Saowanee Ngamruengphong ◽  
Cynthia Rizk ◽  
Michael B. Wallace
Keyword(s):  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Adenoma Detection
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