scholarly journals Letrozole vs. Placebo Pretreatment in the Medical Management of First Trimester Missed Miscarriage: a Randomized Controlled Trial

2018 ◽  
Vol 78 (01) ◽  
pp. 63-69 ◽  
Author(s):  
Haitham Torky ◽  
Heba Marie ◽  
ElSayed ElDesouky ◽  
Samy Gebreel ◽  
Osama Raslan ◽  
...  
Keyword(s):  
Side Effects ◽  
Medical Management ◽  
Severe Pain ◽  
Controlled Trial ◽  
First Trimester ◽  
Nausea And Vomiting ◽  
Severe Bleeding ◽  
Randomized Controlled ◽  
Estrogen Effect ◽  
Control Study

Abstract Introduction Misoprostol is used for the medical management of miscarriage as it is more effective in the early stages of pregnancy. Letrozole has an anti-estrogen effect and is used for the pretreatment of miscarriage with misoprostol. Aim The aim of this study was compare the efficacy and safety of letrozole with placebo pretreatment in the medical management of first trimester missed miscarriage. Design This was a prospective randomized case-control study. Patients and Methods Four hundred and thirty-eight women were randomly divided into two groups of 219; the placebo group received placebo tablets twice daily for 3 days, followed by 800 micrograms of misoprostol vaginally on the fourth day of enrolment, while the letrozole group received letrozole 10 mg twice daily for three days followed by 800 micrograms misoprostol administered vaginally. Symptoms and side effects were recorded, and the women advised to return to hospital if they experienced severe pain or bleeding or intolerable side effects and to report to hospital for a check-up one week after misoprostol administration. Ultrasound was done seven days after misoprostol administration to monitor outcomes. Surgical evacuation was carried out if medical management failed. Results There were significant differences between the two groups, with better outcomes found for the letrozole group in terms of rates of complete miscarriage, onset of vaginal bleeding, and interval between induction and onset of expulsion (p < 0.001). A higher rate of nausea and vomiting was reported for the letrozole group (p = 0.002). Differences between groups with regard to pre- and post-termination hemoglobin levels, fever, severe pain and severe bleeding needing evacuation were not statistically significant. Conclusion Adding letrozole to misoprostol improves the success rate and decreases the interval between induction and expulsion in cases of first trimester miscarriage; however, nausea and vomiting is higher with letrozole.

scholarly journals The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Audrey Murat-Ringot ◽  
Pierre Jean Souquet ◽  
Marion Chauvenet ◽  
Charlotte Rentler ◽  
Fabien Subtil ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Digestive System ◽  
Controlled Trial ◽  
Conventional Care ◽  
Nausea And Vomiting ◽  
Digestive System Cancer ◽  
Randomized Controlled ◽  
Antiemetic Drugs

BACKGROUND The side effects of chemotherapy, specifically chemotherapy-induced nausea and vomiting, are a concern for patients. To relieve these side effects, antiemetic drugs are recommended. However, some patients report that these drugs are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in complementary and alternative medicines, and express the desire for nonpharmacological treatments to be used in hospitals. Foot reflexology is a holistic approach that is reported to significantly reduce the severity of chemotherapy-induced nausea and vomiting in patients with breast cancer. Some of the chemotherapy treatments for patients with lung and digestive system cancer are moderately or highly emetic. OBJECTIVE The primary objective of this study is to assess the benefits of foot reflexology, together with conventional treatments, on the severity and frequency of chemotherapy-induced nausea and vomiting in patients with lung or digestive system cancer. The secondary objectives to be assessed are quality of life, anxiety, and self-esteem. METHODS This study is an open-label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive system cancer with an indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient basis. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogue scale, and the frequency of these side effects between the two groups. The secondary objectives will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Hospital and Anxiety Depression Scale; and Body Image Questionnaire. RESULTS This study was approved by the regional ethics committee (Île de France X CPP) on April 3, 2018 (No. ID RCB 2018-A00571-54). Enrollment started in June 2018. Data analysis will be performed during the second quarter of 2020 and results will be published in the last quarter of 2020. CONCLUSIONS The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend it for this use. This study will provide evidence of the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs. CLINICALTRIAL Clinicaltrials.gov NCT03508180; https://www.clinicaltrials.gov/ct2/show/NCT03508180. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17232

scholarly journals The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial

10.2196/17232 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e17232
Author(s):  
Audrey Murat-Ringot ◽  
Pierre Jean Souquet ◽  
Marion Chauvenet ◽  
Charlotte Rentler ◽  
Fabien Subtil ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Digestive System ◽  
Controlled Trial ◽  
Conventional Care ◽  
Nausea And Vomiting ◽  
Digestive System Cancer ◽  
Randomized Controlled ◽  
Antiemetic Drugs

Background The side effects of chemotherapy, specifically chemotherapy-induced nausea and vomiting, are a concern for patients. To relieve these side effects, antiemetic drugs are recommended. However, some patients report that these drugs are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in complementary and alternative medicines, and express the desire for nonpharmacological treatments to be used in hospitals. Foot reflexology is a holistic approach that is reported to significantly reduce the severity of chemotherapy-induced nausea and vomiting in patients with breast cancer. Some of the chemotherapy treatments for patients with lung and digestive system cancer are moderately or highly emetic. Objective The primary objective of this study is to assess the benefits of foot reflexology, together with conventional treatments, on the severity and frequency of chemotherapy-induced nausea and vomiting in patients with lung or digestive system cancer. The secondary objectives to be assessed are quality of life, anxiety, and self-esteem. Methods This study is an open-label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive system cancer with an indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient basis. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogue scale, and the frequency of these side effects between the two groups. The secondary objectives will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Hospital and Anxiety Depression Scale; and Body Image Questionnaire. Results This study was approved by the regional ethics committee (Île de France X CPP) on April 3, 2018 (No. ID RCB 2018-A00571-54). Enrollment started in June 2018. Data analysis will be performed during the second quarter of 2020 and results will be published in the last quarter of 2020. Conclusions The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend it for this use. This study will provide evidence of the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs. Trial Registration Clinicaltrials.gov NCT03508180; https://www.clinicaltrials.gov/ct2/show/NCT03508180. International Registered Report Identifier (IRRID) DERR1-10.2196/17232

Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial

2001 ◽  
Vol 26 (1) ◽  
pp. 67-71 ◽  
Author(s):  
S. A. Ahmadi-Abhari ◽  
S. Akhondzadeh ◽  
S. M. Assadi ◽  
O. L. Shabestari ◽  
Z. M. Farzanehgan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Controlled Trial ◽  
Double Blind ◽  
Randomized Controlled
Sign in / Sign up

Export Citation Format

Share Document