scholarly journals Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jumara Martins ◽  
Ana Francisca Vaz ◽  
Regina Celia Grion ◽  
Lúcia Costa-Paiva ◽  
Luiz Francisco Baccaro
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Randomized Clinical Trial ◽  
Open Label ◽  
Treatment Groups ◽  
Vaginal Stenosis ◽  
Significant Difference ◽  
Vaginal Dilators ◽  
The Mean ◽  
Topical Estrogen

Abstract Background We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. Methods open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18–75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. Results the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). Conclusions there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. Trial registration Brazilian Registry of Clinical Trials, RBR-23w5fv. Registered 10 January 2017 - Retrospectively registered.

scholarly journals Topical Estrogen, Testosterone, and Vaginal Dilator in the Prevention of Vaginal Stenosis after Radiotherapy in Women with Cervical Cancer

2021 ◽  
Author(s):  
Jumara Martins ◽  
Ana Francisca Vaz ◽  
Regina Celia Grion ◽  
Lúcia Costa-Paiva ◽  
Luiz Baccaro
Keyword(s):  
Cervical Cancer ◽  
Open Label ◽  
Treatment Groups ◽  
Symmetry Test ◽  
Vaginal Stenosis ◽  
Significant Difference ◽  
Vaginal Dilators ◽  
The Mean ◽  
One Year ◽  
Topical Estrogen

Abstract Background: we aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. Methods: open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18-75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. Results: the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p<0.01), except for the users of vaginal dilator (p=0.37). Conclusions: there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment.Trial registration: Brazilian Registry of Clinical Trials, RBR-23w5fv. Registered 10 January 2017 - Retrospectively registered, https://ensaiosclinicos.gov.br/rg/RBR-23w5fv

scholarly journals Effect of Acupressure on Stress and Anxiety of Patients with Multiple Sclerosis: A Sham-controlled Randomized Clinical Trial

2020 ◽  
Vol 10 (3) ◽  
pp. 270-283
Author(s):  
Mohammad Ali Nahayati ◽  
◽  
Seyed Abolfazl Vaghar Seyyedin ◽  
Hamid Reza Bahrami-Taghanki ◽  
Zahra Rezaee ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Test Scores ◽  
Sham Group ◽  
Applied Pressure ◽  
Intervention Group ◽  
T Test ◽  
Significant Difference ◽  
The Mean

Objective: Stress and anxiety are common in patients with Multiple Sclerosis (MS). These complications exacerbate the symptoms of MS. This study aims to evaluate the effect of acupressure on stress and anxiety of MS patients. Methods: In this randomized clinical trial, participants were 106 MS Patients referred to Multiple Sclerosis Society in Mashhad, Iran. After signing an informed consent form, they completed a demographic form and stress, and the Depression Anxiety Stress Scale - 42 items (DASS-42). Then, they were randomly assigned into intervention and sham groups by tossing a coin. Participants in the intervention group were asked apply a pressure on the Shenmen and Yin Tang acupoints for one month (once per day for 15 minutes), while the sham group applied pressure 2.5 cm below the Shenmen acupoint and 3 cm above the Yin Tang acupoint. Participants in each group were then completed the DASS-42 again one hour after the final session. Data were analyzed using chi-square test, Kolmogorov-Smirnov test, independent t-test, and Paired t-test. Results: In the intervention and sham groups, there was no statistically significant difference between the mean pre-test scores of stress (34.73±5.80 vs. 33.06±6.42) and anxiety (27.09±6.99 vs. 25.31±6.88), and neither between the mean post-test scores of stress (29.20±6.21 vs. 33.73±9.44) and anxiety (22.79±5.68 vs. 25.21±6.72) (P>0.05). However, comparison of DASS-42 scores between groups showed that the mean scores of stress and anxiety in the intervention group were significantly lower than in the sham group (P< 0.05). Conclusion: It seems that acupressure can be used along with other therapeutic and pharmacological interventions to reduce stress and anxiety in patients with MS.

scholarly journals A randomized clinical trial of chlorambucil versus COP in stage B chronic lymphocytic leukemia. The French Cooperative Group on Chronic Lymphocytic Leukemia

Blood ◽  
1990 ◽  
Vol 75 (7) ◽  
pp. 1422-1425 ◽  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Chronic Lymphocytic Leukemia ◽  
Randomized Clinical Trial ◽  
Survival Rates ◽  
Lymphocytic Leukemia ◽  
Cooperative Group ◽  
Survival Times ◽  
Treatment Groups ◽  
Significant Difference

Abstract In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia started a randomized clinical trial in which intermediate prognosis patients (stage B) received either an indefinite course of chlorambucil (0.1 mg/kg/d) or 12 cycles of the COP regimen (vincristine, cyclophosphamide, and prednisone). We present the results of the third interim analysis based on 291 patients (151 in the chlorambucil group and 140 in the COP group) with a mean follow-up of 53 months at the reference date of June 1, 1987. At this date, 129 deaths were observed, 65 in the chlorambucil group and 64 in the COP group; there was no improvement in overall survival with the COP regimen (P = .44) even after adjusting for both prognostic and imbalanced factors (P = .24). The 3-year and 5-year overall survival rates were, respectively, 69% and 44% in the chlorambucil group as compared with 73% and 43% in the COP group. The median survival times were 58 months in the chlorambucil group and 57 months in the COP group. Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.

Compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section: A double-blinded randomized clinical trial

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Ali Abbasijahromi ◽  
Hamed Hojati ◽  
Saeid Nikooei ◽  
Hossein Kargar Jahromi ◽  
Hamid Reza Dowlatkhah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Essential Oil ◽  
Essential Oils ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Content Type ◽  
Gate Control Theory ◽  
Significant Difference ◽  
The Mean ◽  
Damask Rose

AbstractBackgroundAnxiety is the most common psychological reaction in women during labor. Similar to numerous other surgeries, postoperative pain is also reported following cesarean section (C-section). According to the (Gate) Control Theory, there is a relationship between pain and psychological problems such as anxiety. Accordingly, the present study aimed to compare the effect of aromatherapy using lavender and Damask rose essential oils on the level of anxiety and severity of pain following C-section.MethodsThis triple-group randomized clinical trial was performed on 90 mothers who visited Motahari Hospital of Jahrom, Iran, for C-section in 2017. The incidence and severity of pain and anxiety were measured and recorded for all three groups prior to intervention. The intervention groups underwent aromatherapy with lavender and Damask rose essential oils. Patients were asked to inhale cotton balls, separately stained with three drops of each essential oil at a distance of 10 cm for 30 mins. The severity of pain and anxiety was measured using the visual analogue scale (VAS) and the Spielberger State-Trait Anxiety Inventory (STAI) 5 min after the specified process, respectively. The control group underwent aromatherapy in a similar fashion with normal saline. Finally, data were analyzed using descriptive statistical indices and ANOVA and Kruskal–Wallis tests in SPSS 21.ResultsThere was no significant difference between the three groups in the mean severity of pain and anxiety before the intervention (p>0.05). The mean severity of pain and overt anxiety in the lavender and Damask rose aromatherapy groups was significantly different than the control group after the intervention (p<0.001). In addition, no significant difference was observed between the overt and overall anxiety levels of the two intervention groups after the intervention (p>0.05).ConclusionsThe findings suggested that inhalation aromatherapy can reduce the severity of overt anxiety and pain after C-section, with Damask rose essential oil showing a larger effect than lavender.

scholarly journals The Comparison of the Effect of Repetitive Doses of Succinylcholine and Thiopental Sodium on the Duration and Severity of Seizure in Electro Convulsive Therapy: Randomized Clinical Trial

2019 ◽  
pp. 1-8
Author(s):  
Farhad Nanaei ◽  
Hadi Bahrami ◽  
Aziz Kasani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Initial Dose ◽  
Psychiatric Ward ◽  
Convulsive Therapy ◽  
Treatment Groups ◽  
Significant Difference ◽  
Thiopental Sodium ◽  
Hypnotic Drugs

Background and Aim: Regarding the controversial results on the effects of anesthetics, especially thiopental sodium, on the duration and severity of seizure and the lack of adequate information on the use of doses of anesthetic and paralysing drugs during ECT, this study was designed to determine the effect of repetitive doses of succinylcholine and Thiopental sodium was administered on the duration and severity of seizure during ECT. Materials and Methods: The present study was a one-blind randomized clinical trial on patients admitted to the psychiatric ward of Dezful Ganjavian Hospital. The research samples were selected after informed consent and entry criteria. Then, the samples were randomly assigned to two groups. In one group, succinylcholine dose was repeated (one third of the initial dose), and in the other group, the dose of thiopental sodium was repeated (one third of the initial dose). In all patients, seizure duration based on EEG monitoring and severity of seizure was determined by the psychiatrist based on the symptoms of the patient during seizure. Results: There was a significant difference between the quality of seizure in the two treatment groups after the intervention. There was a strong and good seizure in the thiopental sodium group (p <0.0001). There was a significant difference between the variables of seizure status in comparison with the previous shock in the two treatment groups after the intervention (p <0.0001). The duration of seizure was higher in thiopental sodium treatment group, but no significant difference was observed (p = 0.82). Conclusion: The results of this study showed that the duration and quality of seizure was better in patients requiring repetitive doses of hypnotic drugs (Thiopental Sodium), which was used to repeat the dose of muscle relaxant (succinylcholine).

scholarly journals Efficacy of rescue blanket versus conventional blanket in terms of preventing accidental hypothermia during patient transfer by emergency medical service: a randomized clinical trial

2019 ◽  
Vol 6 (1) ◽  
pp. 38-42
Author(s):  
Peyman Saberian ◽  
Mostafa Sadeghi ◽  
Parisa Hasani-Sharamin ◽  
Maryam Modaber ◽  
Amirreza Farhoud ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Medical Service ◽  
Randomized Clinical Trial ◽  
Medical Service ◽  
Hospital Setting ◽  
Tympanic Temperature ◽  
Time Of Arrival ◽  
Emergency Medical ◽  
Significant Difference ◽  
The Mean

Objective: This study aimed to compare the efficacy of rescue blankets with conventional blankets in terms of preventing hypothermia in the pre-hospital setting. Methods: In this randomized clinical trial, patients older than 18 years old with Cold Discomfort Scale (CDS) > 2, and those who were transferred to the emergency department (ED) by emergency medical service entered the study. Patients were randomly divided into two groups based on the type of transfer. In this regard, one group was transferred with rescue blankets and the other group was transferred with conventional blankets. The tympanic temperature in patients and CDS were recorded before the use of blanket (primary) and at the time of arrival in the ED (secondary). Results: Finally, 161 patients with the mean age of 45.31±19.8 years were included (63.4% were male). Totally, 88 cases (54.7%) were transferred with rescue blankets and 73 cases (45.3%) with conventional blankets. The mean of the primary tympanic temperatures in the rescue and conventional blanket groups were 36.20±0.84°C and 36.34±0.65°C, respectively (P=0.23). The mean of the primary CDS in rescue and conventional blanket groups were 6.55±1.95 and 5.89±2.29, respectively (P=0.05). Also, the mean of the secondary tympanic temperatures in the rescue and conventional blanket groups were 36.59±0.47°C and 36.76±0.48 °C, respectively (P=0.03). Besides, the mean of the secondary CDS in the rescue and conventional blanket groups were 2.64±2.80 and 2.41±1.29, respectively (P=0.48). Conclusion: According to the results, there is no significant difference in the tympanic temperature and CDS of the patients transferred with the rescue blanket compared with the conventional blanket.

scholarly journals Subjects living in an onchocerciasis focus and treated 3-monthly with ivermectin develop fewer new onchocercal nodules than subjects treated annually

2020 ◽  
Author(s):  
Jérémy Campillo ◽  
Cédric B. CHESNAIS ◽  
Sébastien D. Pion ◽  
Jacques Gardon ◽  
Joseph Kamgno ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Poisson Regression ◽  
Prophylactic Effect ◽  
Poisson Regression Model ◽  
Initial Number ◽  
Treatment Groups ◽  
The Third ◽  
Significant Difference ◽  
The Mean ◽  
First Time

Abstract Background Little information is available on the effect of ivermectin on the third and fourth stage larvae of Onchocerca volvulus . To assess a possible prophylactic effect of ivermectin on this parasite, we compared the effects of different ivermectin regimens on the acquisition of onchocercal nodules. Methods We analyzed data from a controlled randomized clinical trial of ivermectin conducted in the Mbam valley (Cameroon) between 1994 and 1998 in a cohort of onchocerciasis infected individuals. The number of nodules that appeared between the start and the end of the clinical trial was analyzed, using ANOVA and multivariable Poisson regressions, between four treatment arms: 150 µg/kg annually, 800 µg/kg annually, 150 µg/kg 3-monthly, and 800 µg/kg annually. Results The mean number of nodules that appeared during the trial was reduced by 17.7% in subjects treated 3-monthly compared to those treated annually (regardless of the dose). Poisson regression model, adjusting on subject’s age and weight, initial number of nodules and intensity of O. volvulus infection in his village of residence, confirmed that the incidence of new nodules was reduced in 3-monthly treatment arms compared to annually treatment arms, and that the dosage of ivermectin does not seem to influence this effect. Besides, the number of newly acquired nodules was positively associated with the initial number of nodules. Analysis of disappearance of nodules did not show any significant difference between the treatment groups. Conclusions Our result suggest, for the first time in humans, that ivermectin has a prophylactic effect on O. volvulus . Three-monthly treatment seems more effective than annual treatment to prevent the appearance of nodules.

scholarly journals Slanted versus Augmented Recession for Horizontal Strabismus

2019 ◽  
Author(s):  
Zhale Rajavi ◽  
Mohadeseh Feizi ◽  
Sayed Aliasghar Nabavi ◽  
Hamideh Sabbaghi ◽  
Narges Behradfar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Surgical Outcomes ◽  
Significant Difference ◽  
The Mean ◽  
Distance Deviation ◽  
Convergence Excess

Purpose: To compare the surgical outcomes of slanted versus augmented recession in patients with horizontal strabismus. Methods: In this randomized clinical trial, a total of 100 esotropic (ET) and exotropic (XT) patients with a high AC/A ratio which was defined as a difference of ≥ 10 prism diopters (pd) between the distance and near deviations were included if the patients had a distance deviation ≥ 15 pd. Patients were randomly assigned into the slanted (n = 26 in ET and n = 24 in XT group) and augmented recession groups (n = 25 in ET and n = 25 in XT group). In the slanted group, recession was performed on the superior and inferior poles of the muscle based on the distance and near deviations, respectively, while in the augmented recession group, the muscles were recessed 1.00 or 1.50 mm more than the standard amount according to the distance and near difference between 10 and 20 pd or > 20 pd, respectively. Results: The mean age was 9.8 ± 9.6 years and 63% were female. There was a significant postoperative reduction of difference in convergence excess in ET cases compared to patients who underwent the augmented recession procedure (12.65 ± 6.16 vs 8.64 ± 6.1 pd, P = 0.014). Among our XT groups, there was no significant difference in postoperative reduction in the XT angle in the slanted group compared with the augmented group (P > 0.05). Conclusion: Slanted recession is recommended in convergence excess ET patients. In XT patients, either slanted or augmented recession may be chosen according to the priority and experience of the surgeon.

scholarly journals A randomized clinical trial of chlorambucil versus COP in stage B chronic lymphocytic leukemia. The French Cooperative Group on Chronic Lymphocytic Leukemia

Blood ◽  
1990 ◽  
Vol 75 (7) ◽  
pp. 1422-1425 ◽  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Chronic Lymphocytic Leukemia ◽  
Randomized Clinical Trial ◽  
Survival Rates ◽  
Lymphocytic Leukemia ◽  
Cooperative Group ◽  
Survival Times ◽  
Treatment Groups ◽  
Significant Difference

In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia started a randomized clinical trial in which intermediate prognosis patients (stage B) received either an indefinite course of chlorambucil (0.1 mg/kg/d) or 12 cycles of the COP regimen (vincristine, cyclophosphamide, and prednisone). We present the results of the third interim analysis based on 291 patients (151 in the chlorambucil group and 140 in the COP group) with a mean follow-up of 53 months at the reference date of June 1, 1987. At this date, 129 deaths were observed, 65 in the chlorambucil group and 64 in the COP group; there was no improvement in overall survival with the COP regimen (P = .44) even after adjusting for both prognostic and imbalanced factors (P = .24). The 3-year and 5-year overall survival rates were, respectively, 69% and 44% in the chlorambucil group as compared with 73% and 43% in the COP group. The median survival times were 58 months in the chlorambucil group and 57 months in the COP group. Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.

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