Does Combination Therapy with Desmopressin and Tolterodine Improve the Treatment Outcomes of Patients with Monosymptomatic Nocturnal Enuresis? A Randomized Clinical Controlled Trial

Several therapeutic options have been described for children with nocturnal enuresis, but still their efficacy and outcomes are controversial. This study compares the combined Desmopressin and Tolterodine efficacy versus Desmopressin alone efficacy in the treatment of nocturnal enuresis. One hundred children 5–16 years old with nocturnal enuresis were enrolled in a randomized trial study and were assigned to two equal groups. In a double-blind manner, we used 2 mg of Tolterodine tablet plus 20 μg of nasal Desmopressin in group A and 20 μg of nasal Desmopressin plus placebo in group B. The two groups were matched for age and sex (P = 0.547, P = 0.414). The mean number of the wet nights was reduced in both groups (P < 0.001, P < 0.001). Upon ICCS scoring in the Tolterodine + Desmopressin group, 27 (54%) had full response, 17 (34%) had partial response, and 5 (10%) had an unsuccessful outcome. In the Desmopressin + placebo group, 17 (34%) had full response, 23 (46%) had partial response, and 10 (20%) had an unsuccessful outcome. The response in the Tolterodine + Desmopressin group was significantly higher (P = 0.049). Regarding the results, combined Tolterodine plus Desmopressin is slightly more effective than monotherapy.

Download Full-text

Ormeloxifene versus Medroxyprogesterone Acetate (MPA) in the Treatment of Dysfunctional Uterine Bleeding: A Double-Blind Randomized Controlled Trial

Journal of SAFOG with DVD ◽

10.5005/jp-journals-10006-1116 ◽

2011 ◽

Vol 3 (1) ◽

pp. 21-24 ◽

Cited By ~ 5

Author(s):

MB Bellad ◽

D Mekhala ◽

Jyotsna Shravage ◽

MS Ganachari ◽

HA Dhumale

Keyword(s):

Blood Loss ◽

Medroxyprogesterone Acetate ◽

Endometrial Thickness ◽

Controlled Trial ◽

Dysfunctional Uterine Bleeding ◽

Double Blind ◽

Randomized Controlled ◽

Group A ◽

The Mean ◽

Group B

ABSTRACT Objective To find the effectiveness of ormeloxifene vs medroxyprogesterone acetate (MPA) to reduce blood loss in dysfunctional uterine bleeding (DUB). Materials and methods: Design—A double blind randomized controlled trial. Data source—The women attending gynecology OPD in teaching hospital attached to Jawaharlal Nehru Medical College, Belgaum, India for menorrhagia, meeting the selection criteria were enrolled into the study. Randomization—Computer-generated randomization, with block size of two, was done into two groups. Intervention—One group (group A) received capsule ormeloxifene 60 mg to be taken two days a week at an interval of 3 days, and a placebo form of medroxyprogesterone acetate for 21 days starting from day 2 to 5 of the menstrual cycle for three consecutive cycles. Other group (group B) received medroxyprogesterone acetate (MPA) 10 mg for 21 days starting from day 2 to 5 of the menstrual cycle, and a placebo form of ormeloxifene for 2 days a week with an interval of 3 days for three consecutive cycles. The drug and its placebo were in similar capsular form. All the participants were ensured to use the similar type of sanitary napkins, and transvaginal ultrasonography was done to note the endometrial thickness (ET) before and after the drug therapy. Blinding—The department of clinical pharmacy prepared the drug packets and kept the randomization code till the data was analyzed, thus ensuring the double blinding. Outcome Participants were interviewed during subsequent cycle. Pictorial blood assessment chart (PBAC) score was used to calculate blood loss during menses at the first and subsequent three months. Data analysis The mean PBAC scores and endometrial thickness were compared in two groups. Results The mean pretreatment PBAC scores in group A and group B were 262.26 and 238.71 ml respectively. The mean PBAC scores at the end of the study period were 73 and 108 in group A and B respectively, reporting an overall reduction in mean blood loss by 85.7 and 54.76% (p = 0.0205) in group A and B respectively. Thus, there was a significant reduction in blood loss in the group receiving ormeloxifene. The reduction in the mean endometrial thickness was more in ormeloxifene group. However, this was not statistically significant (p = 0.0942). Conclusion Ormeloxifene is more effective as compared to MPA in reducing the blood loss in the treatment of DUB.

Download Full-text

The Effect of Ginger-chamomile Sachet with Honey on Primary Dysmenorrhea and Associated Symptoms: A Randomized, Double-Blind, Controlled Trial

Current Women s Health Reviews ◽

10.2174/1573404816999200505105057 ◽

2020 ◽

Vol 16 (4) ◽

pp. 348-358

Author(s):

Fatemeh Shabani ◽

Aroona Chabra ◽

Katayon Vakilian ◽

Soodabeh Bioos ◽

Mahbubeh Bozorgi ◽

...

Keyword(s):

Mefenamic Acid ◽

Statistical Tests ◽

Controlled Trial ◽

Primary Dysmenorrhea ◽

Double Blind ◽

Verbal Scale ◽

Associated Symptoms ◽

Group A ◽

The Mean ◽

Group B

Background: Dysmenorrhea is one of the most frequent pelvic pains among young women, impairing their quality of life. Objective: This research aims to investigate the effect of ginger-chamomile herbs with honey in reducing dysmenorrhea pain, associated symptoms, and the extent of bleeding. Methods: In this randomized clinical trial (IRCT No.: 2016100825031N5), 200 female students with primary dysmenorrhea, from Arak universities, were included and randomly divided into two groups. All the students were evaluated for one cycle without intervention, then group (A) received mefenamic acid (250 mg) and group (B) received ginger (1000 mg), chamomile (5000 mg), and one teaspoonful of honey for two days before and for the first three days of menstruation, three times a day, in two consecutive cycles. Pain severity, associated symptoms of dysmenorrhea, and bleeding were assessed using a visual analogue scale, Andersch-Milsom Verbal Scale, and Higham chart. Data were analyzed by descriptive and inferential statistical tests through SPSS21. Results: The pain intensity in group B diminished significantly after the intervention in comparison to group A (p <0.05). The mean severity of dysmenorrhea accompanying symptoms decreased significantly in group B compared to group A (P=0.009). However, the mean quantity of bleeding significantly decreased in group A (P = 0.004), with no increase in the extent of bleeding in group B. Conclusion: The present study indicated that the combination of the ginger-chamomile sachet with honey has the same effect as nonsteroidal anti-inflammatory drugs for pain mitigation, and the associated symptoms reduced better than mefenamic acid.

Download Full-text

The effect of external ventricular drain tunneling length on CSF infection rate in pediatric patients: a randomized, double-blind, 3-arm controlled trial

Journal of Neurosurgery Pediatrics ◽

10.3171/2020.9.peds20748 ◽

2021 ◽

pp. 1-8

Author(s):

Esmaeil Mohammadi ◽

Sara Hanaei ◽

Sina Azadnajafabad ◽

Keyvan Tayebi Meybodi ◽

Zohreh Habibi ◽

...

Keyword(s):

Infection Rate ◽

Pediatric Patients ◽

Controlled Trial ◽

External Ventricular Drain ◽

Hazard Ratio ◽

Spontaneous Discharge ◽

Standard Group ◽

Double Blind ◽

Group A ◽

Group B

OBJECTIVE The role of tunneling an external ventricular drain (EVD) more than the standard 5 cm for controlling device-related infections remains controversial. METHODS This is a randomized, double-blind, 3-arm controlled trial done in the Children’s Medical Center in Tehran, Iran. Pediatric patients (< 18 years old) with temporary hydrocephalus requiring an EVD and no evidence of CSF infection or prior EVD insertion were enrolled. Patients were randomly assigned (1:1:1) into the following arms: 5-cm (standard; group A); 10-cm (group B); or 15-cm (group C) EVD tunnel lengths. The investigators, parents, and person performing the analysis were masked. The surgeon was informed of the length of the EVD by the monitoring board just before operation. Patients were followed until the EVD’s fate was established. Infection rate and other complications related to EVDs were assessed. RESULTS A total of 105 patients were enrolled in three random groups (group A = 36, group B = 35, and group C = 34). The EVD was removed because there was no further need in most cases (67.6%), followed by conversion to a new EVD or ventriculoperitoneal shunt (15.2%), infection (11.4%), and spontaneous discharge without further CSF diversion requirement (5.7%). No statistical difference was found in infection rate (p = 0.47) or EVD duration (p = 0.81) between the three groups. No group reached the efficacy point sooner than the standard group (group B: hazard ratio 1.21, 95% CI 0.75–1.94, p = 0.429; group C: hazard ratio 1.03, 95% CI 0.64–1.65, p = 0.91). CONCLUSIONS EVD tunnel lengths of 5 cm and longer did not show a difference in the infection rate in pediatric patients. Indeed, tunneling lengths of 5 cm and greater seem to be equally effective in preventing EVD infection. Clinical trial registration no.: IRCT20160430027680N2 (IRCT.ir)

Download Full-text

Clinical Efficacy Of Ceftriaxone Versus Ciprofloxacin In Paediatric Enteric Fever

Journal of Bahria University Medical and Dental College ◽

10.51985/jbumdc2018031 ◽

2018 ◽

Vol 08 (02) ◽

pp. 67-71

Author(s):

Anila Farhat ◽

Asma Shaukat ◽

Tariq Mahmood Khan

Keyword(s):

Enteric Fever ◽

Research Study ◽

Controlled Trial ◽

Clinical Effectiveness ◽

Randomized Controlled ◽

Group A ◽

The Mean ◽

Group B ◽

Objective Determination

Objective: Determination of the clinical effectiveness of ciprofloxacin versus ceftriaxone in children with enteric fever on the basis of defervescence within 72 hours of commencement of treatment. Duration and Place of Study: This randomized controlled trial was carried out from 15th May to 15th November 2017 in pediatrics units of Benazir Bhutto Shaheed Teaching Hospital Abbottabad and Jinnah International Hospital Abbottabad. Methodology: 90 children with uncomplicated enteric fever were admitted and divided randomly into two groups, Group A was administered I/V Ceftriaxone 75mg/kg OD and Group B was given I/V Ciprofloxacin 10mg/kg BD for seven days. Response to drug was taken as defervescence within 72 hours while continued fever after 72 hours was taken as no response. The data was analyzed by using SPSS Version 21.00. Results: In our research study 53(58.9%) children were male and 37(41.1%) patients were female. The mean age was 8.43±3.17 years encompassing 4 to 14 years, mean weight of the patients in kg was 29.54±10.8 kg. Efficacy of ceftriaxone group was 93.3% while in ciprofloxacin group 62.2% patients became afebrile in 72 hours. The proportion of achieving defervescence within 72 hours was higher with ceftriaxone than with ciprofloxacin Conclusion: Ceftriaxone is more efficacious in terms of achieving defervescence than ciprofloxacin in children having enteric fever.

Download Full-text

Comparison of letrozole and clomiphene citrate efficacy in terms of ovulation induction and pregnancy rate.

The Professional Medical Journal ◽

10.29309/tpmj/2021.28.05.6497 ◽

2021 ◽

Vol 28 (05) ◽

pp. 749-754

Author(s):

Nadia Sharif ◽

Uzma Manzoor ◽

Saadia Bano ◽

Uzma Shahzaad

Keyword(s):

Pregnancy Rate ◽

Ovulation Induction ◽

Endometrial Thickness ◽

Controlled Trial ◽

Clomiphene Citrate ◽

Epidemiological Data ◽

P Value ◽

Group A ◽

The Mean ◽

Group B

Objective: To compare the efficacy of Letrozole and clomiphene citrate in Patients of Anovulation polycystic ovarian syndrome with Infertility. Study Design: Randomized Controlled Trial Setting: Department of Obstetrics and Gynecology Independent Medical College Faisalabad. Period: 30-09-2019 to 29-6-2020. Material & Methods: This study included 100 patients with 50 patients in each group. Group A received 2.5 to 5mg letrozole in each cycle from day 3 to 7. Group B received clomiphene citrate 50 to 100 mg incremental dose depending on ovarian response. Both Drugs were given for consecutive 3 to 6 cycles to see response. Main outcome Measure included optimal follicle size (> 18mm), endometrial thickness, and pregnancy rate. Epidemiological data and efficacy outcome measures were recorded on a Performa. Statistical analysis was done using SPSS version 13. Chi-square test applied and p-value <o.o5 was considered significant. Both group included primary infertility patients. Results: The mean age of patients was 28.03+ 3.02 years. Mean age of group A patients was 29.04+3.44 and 28.47+3.90 group B patients. Mono ovulation in group A patients (88.9%) and 27 in group b patients (60.0%). The mean endometrial thickness was 9.6mm + 1.6 in letrozole group and 6.9mm + 1.2 in clomiphene citrate group A. In group A 18% got pregnant from Letrozole group and 1.1% from the group B. Conclusion: Efficacy was significantly higher in group A Patients received letrozole as compared to patients echo received clomiphene citrate. The effects of Letrozole showed better outcome in terms of Ovulation Induction Endometrial Thickness and Pregnancy rate.

Download Full-text

The role of tolvaptan in prevention of hyponatremia in patients undergoing transurethral resection of prostate surgery- A randomized double blind study

Indian Journal of Clinical Anaesthesia ◽

10.18231/j.ijca.2021.059 ◽

2021 ◽

Vol 8 (2) ◽

pp. 321-325

Author(s):

Dinesh Kumar Singh ◽

B B Baj ◽

Vipin Goyal

Keyword(s):

Transurethral Resection ◽

Blind Study ◽

Transurethral Resection Of Prostate ◽

Double Blind Study ◽

Double Blind ◽

Significant Difference ◽

Group A ◽

The Mean ◽

Group B

The aim of our study to determine the role of tolvaptan in prevention of hyponatremia in transurethral resection of prostate surgery. This is randomized double-blind study conducted in 60 ASA grade status 1 and 2 patients age group between 45-80 yrs undergoing TURP under spinal anaesthesia in urology operation theatre in Mahatma Gandhi hospital Jaipur after receiving permission from hospital ethical committee. A detailed history, complete physical examination and routine investigation were done for all patients followed by informed written consent was obtained. Patients are randomly divided into 2 groups. In group A -30 patients who received orally tab tolvaptan 15 mg and group B-30 patients who received orally tab multivitamin 2 hrs before surgery after doing electrolytes of the patients in the morning. In both groups age (in yrs), wt (in kg), ASA grade, volume of irrigating fluid (in litres), volume of prostate resected (in gm) and duration of surgery (in minutes) all demographic and surgical details data were compared. Electrolytes were compared in both groups pre and post-operatively and statistical analysis was done.There was significant difference in post-operative sodium level between the two groups (A and B). The mean level of sodium significantly reduced post-operatively in group –B (control grp). The mean level of sodium significantly increased post-operatively in group –A (tolvaptan grp). We conclude single dose of tolvaptan -15 mg found to effective in prevention of hyponatremia in patients undergoing TURP.

Download Full-text

Comparison of harmonic scalpel versus Milligan Morgan technique in haemorrhoidectomy patients

Journal of the Pakistan Medical Association ◽

10.47391/jpma.03-1303 ◽

2021 ◽

Author(s):

Muhammad Ahmad ◽

Syed Tatheer Abbas ◽

Amna Javaid ◽

Naveed Arshad ◽

Falak Shair

Keyword(s):

Wound Healing ◽

Operative Time ◽

Harmonic Scalpel ◽

Controlled Trial ◽

P Value ◽

Randomized Controlled ◽

Group A ◽

The Mean ◽

Complete Wound Healing ◽

Group B

Objectives: To assess the comparison of harmonic scalpel versus Milligan Morgan technique in patients undergoing haemorrhoidectomy. Methodology: This randomized controlled trial study was conducted at General Hospital, Lahore, from March 2019 to September 2019. Informed consent was obtained from eligible 60 patients. Patients were randomly divided into two equal groups. In group-A, haemorrhoidectomy was conducted according to the harmonic scalpel method. In group-B, open haemorrhoidectomy was performed by the Milligan Morgan procedure. Data was assembled through a designed questionnaire and investigated via SPSS version 25. Data were stratified for descriptive statistics, level of haemorrhoids and period of haemorrhoids. Post-stratification, independent sample t-test was used. Results: Mean age of both groups patients were 44.6±7.6 and 43.8±8.2 years, respectively. In group-A, mean operative time was 20.8±2.8 minutes, while 26.5±2.8 minutes in group-B, which was statistically significant with p-value of 0.001. In group-A, mean convalescence period was 9.7±2.9 days, while 13.4±3.7 days in group-B, which was statistically significant with p-value of 0.001. The mean convalescence period with harmonic scalpel method was 7.4 days (range 5–14, SD 3.6) versus 18.6 days (range 7–30, SD 5.4) with Milligan Morgan technique (P?0.001). This research observed that harmonic scalpel method required almost six weeks for complete wound healing, whereas in Milligan Morgan technique, complete wound healing was achieved after three months (P<0.05). Conclusion: Harmonic scalpel haemorrhoidectomy found an advantageous method when assessing the operative time and convalescence period. Hence, Harmonic scalpel haemorrhoidectomy can be adapted as a safe and effective alternative method for treating symptomatic haemorrhoids. Continuous...

Download Full-text

A Double-Blind Randomized Prospective Study Comparing Ondansetron with Droperidol in the Prevention of Emesis following Strabismus Surgery

Anaesthesia and Intensive Care ◽

10.1177/0310057x9502300404 ◽

1995 ◽

Vol 23 (4) ◽

pp. 438-443 ◽

Cited By ~ 25

Author(s):

A. Davis ◽

S. Krige ◽

D. Moyes

Keyword(s):

Recovery Time ◽

Strabismus Surgery ◽

Double Blind Study ◽

Double Blind ◽

Oral Fluids ◽

Group A ◽

The Mean ◽

Group B ◽

To Receive ◽

Mean Time

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 μg/kg (Group A), ondansetron 75 μg/kg (Group B), or droperidol 75 fig/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 μg/kg was as effective as 150 μg/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.

Download Full-text

Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial

Pharmacy Practice ◽

10.18549/pharmpract.2020.3.2025 ◽

2020 ◽

Vol 18 (3) ◽

pp. 2025

Author(s):

Mariam A. Alameri ◽

Syed A. Syed Sulaiman ◽

Abdullah M. Ashour ◽

Ma’ad F. Al-Saati

Keyword(s):

Randomized Controlled Trial ◽

Patient Education ◽

Risk Stratification ◽

Controlled Trial ◽

Education Programs ◽

Randomized Controlled ◽

Group A ◽

Total Knee ◽

The Mean ◽

Group B

Background: Total knee replacement (TKR) is a major orthopedic surgery that is considered high risk for the development of venous thromboembolism (VTE). Objective: The aim of this study is to evaluate the clinical outcomes that resulted from the use of a new proposed VTE risk stratification protocol for selecting a suitable extended VTE prophylaxis for post TKR surgery patients administered in conjunction with patient education programs. Method: A randomized controlled trial was conducted in two medical centers in Saudi Arabia. A total of 242 patients were enrolled in the study, 121 patients in each group. The experimental group (A) was assessed by using the proposed VTE risk stratification protocol and also took part in patient education programs about TKR and its complications. The control group (B) was assessed by using the 2005 Caprini risk assessment tool and no education programs were given to this group. Both groups were followed for 35 days post operation. Results: The mean age of the participants was 65.86 (SD 8.67) and the majority of them were female 137 (56.6%). The mean body mass index of the study sample was 32.46 (SD 5.51). There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p˂0.05). There were no confirmed pulmonary embolism cases in the study sample and diagnosis of deep-vein thrombosis was confirmed in 12/242 (5.0%) of patients: 1/121 (0.8%) in group A and 11/121 (9.1%) in group B (p˂0.05). The readmission rate for all patients was 2.5% (6/242), all of whom were in group B (p˂0.05). Conclusion: The proposed VTE risk stratification protocol that was applied in conjunction with patient education programs reduced VTE complications and readmission events, post TKR surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04031859.

Download Full-text