scholarly journals Oral diclofenac potassium versus hyoscine-N-butyl bromide for pain relief during copper intrauterine device insertion: randomized clinical trial

2018 ◽  
Vol 7 (3) ◽  
pp. 783
Author(s):  
Ahmed M. Abbas ◽  
Mohammed F. Abdel-Ghany ◽  
Nadia Abdullah Mohammed ◽  
Mostafa Khodry ◽  
Armia Michael ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Relief ◽  
Randomized Clinical Trial ◽  
Pain Perception ◽  
Intrauterine Device ◽  
Study Groups ◽  
University Hospital ◽  
Butyl Bromide ◽  
Copper Iud ◽  
Copper Intrauterine Device

Background: Present study was carried out to compare the analgesic effect of oral diclofenac potassium versus hyoscine-N-butyl bromide (HBB) for pain relief during copper intrauterine device (IUD) insertion.Methods: It was a a randomized clinical trial carried out at Assiut University Hospital, Assiut, Egypt. Parous women eligible for Copper IUD insertion were recruited and randomized in a 1:1 ratio to diclofenac potassium or HBB. The participants were asked to take 2 tablets of the study medications 30 minutes before IUD insertion. The primary outcome was the participant's self-rated pain perception using a 10-cm Visual Analogue Scale (VAS) during IUD insertion. We considered a 1.5 cm difference in VAS scores between study groups as clinically significant.Results: One hundred eight women were enrolled (n=54 in each group). Diclofenac significantly has lower mean pain score during speculum placement (1.73 vs. 2.13) and tenaculum placement (1.85 vs. 2.3) than HBB with p<0.001. No statistical significant differences between both groups in other steps of IUD insertion. Additionally, the duration of IUD insertion was significantly lower in the diclofenac group (5.34±0.76 vs. 5.74±1.23 minutes, p=0.045). No women reported side effects in both groups.Conclusions: The use of oral diclofenac potassium 30 minutes prior to copper IUD insertion slightly reduce the insertional pain and duration than oral HBB with no adverse effects.

scholarly journals Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

2020 ◽  
Author(s):  
Pedro Acién ◽  
Irene Velasco ◽  
Maribel Acién
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Transvaginal Ultrasound ◽  
Intrauterine Device ◽  
Conservative Surgery ◽  
University Hospital ◽  
Ca 125 ◽  
Fertility Sparing ◽  
Ultrasound Guided Puncture ◽  
Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

scholarly journals Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

2020 ◽  
Author(s):  
Pedro Acién ◽  
Irene Velasco ◽  
Maribel Acién
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Transvaginal Ultrasound ◽  
Intrauterine Device ◽  
Conservative Surgery ◽  
University Hospital ◽  
Ca 125 ◽  
European Medicines Agency ◽  
Fertility Sparing ◽  
Ultrasound Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019).Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.Details of trial registration: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

scholarly journals A randomized clinical trial between ultrasound-guided and uterine sound-sparing approach for copper intrauterine device insertion

2019 ◽  
Vol 112 (3) ◽  
pp. e9
Author(s):  
Mohammed Khairy Ali ◽  
Ahmed M. Abbas ◽  
Asmaa Ramadan ◽  
Ahmed M. Abdelmagied ◽  
Mostafa Nasr Ibrahim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intrauterine Device ◽  
Ultrasound Guided ◽  
Copper Intrauterine Device

scholarly journals Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

2020 ◽  
Author(s):  
Pedro Acién ◽  
Irene Velasco ◽  
Maribel Acién
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Transvaginal Ultrasound ◽  
Intrauterine Device ◽  
Conservative Surgery ◽  
University Hospital ◽  
Ca 125 ◽  
Fertility Sparing ◽  
Ultrasound Guided Puncture ◽  
Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

scholarly journals Anastrozole and levonorgrestrel-releasing intrauterine device in the treatment of endometriosis: a randomized clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pedro Acién ◽  
Irene Velasco ◽  
Maribel Acién
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Transvaginal Ultrasound ◽  
Intrauterine Device ◽  
Conservative Surgery ◽  
University Hospital ◽  
Ca 125 ◽  
European Medicines Agency ◽  
Fertility Sparing ◽  
Ultrasound Findings

Abstract Background To study the effectiveness of an aromatase inhibitor (Anastrozole) associated with levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis. Methods Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas > 3 × 4 cm, CA-125 > 35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole + Mirena® + Conservative Surgery(CS) (n = 8), anastrozole + Mirena® + transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n = 7), Mirena® + CS (n = 9), or Mirena® + TUGPA (n = 7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9–56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients including anastrozole in their treatment (51%, 95% CI 33.3–68.7). For CA-125, the most significant decrease was observed in patients not taking anastrozole (73.8%, 95% CI 64.2–83.4 vs. 53.8%, 95% CI 25.7–81.6 under Mirena® + anastrozole). After CS for endometriosis, a reduction of ultrasound findings of endometriomas and long-term recurrence occurred, with or without anastrozole. At 4.2 ± 1.7 years (95% CI 3.57–4.85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p = 0.019). Conclusions Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces significantly the painful symptoms and delays recurrence, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective. Trial registration Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

scholarly journals Isometric exercise, acupuncture, and magnet therapy for knee osteoarthritis: randomized clinical trial

2019 ◽  
Vol 23 (3) ◽  
pp. 12-20
Author(s):  
Faezeh Hakimi ◽  
Mahsa Asheghan ◽  
Seyed Ebrahim Hashemi
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Randomized Clinical Trial ◽  
Isometric Exercise ◽  
Exercise Program ◽  
The Elderly ◽  
Study Groups ◽  
University Hospital ◽  
Common Disease ◽  
P Values

Introduction: Knee osteoarthritis is a common disease, particularly in the elderly population. Degenerative disorders of the cartilage cause pain and stiffness in the knee joint. As a result, patients frequently experience limitation in their daily activities. Purpose: To compare the effects of exercise, acupuncture, and magnet therapy on symptoms and physical function among middle-aged and elderly people with knee osteoarthritis. Materials and methods: We carried out a parallel three-arm randomized clinical trial in an outpatient clinic of the Department of Physical Medicine and Rehabilitation at a University Hospital. In total, 60 female patients of age ≥ 40 years with chronic knee osteoarthritis were randomly allocated to one of three groups of isometric exercise, acupuncture, and magnet therapy. The primary outcome measure was subjective pain rated according to the Visual Analog Scale. We also used the Western Ontario McMaster Universities Osteoarthritis Index for assessing and monitoring the symptoms of knee osteoarthritis in order to evaluate the efficacy of the interventions. An isometric exercise program was prescribed, consisting of three sessions per week for six weeks. Participants in the acupuncture group received three treatment sessions per week for six weeks, each lasting for 30 minutes. For pulsed electro-magnetic field therapy, a total of three 30-minute sessions per week for a period of 6 weeks were administered to each patient. Results: There were no statistically significant differences between the study groups in terms of the outcome measures (all p values > 0.05). However, within-group analyses showed that there were significant differences regarding the clinical outcomes in each group (all p values < 0.05). Conclusion: All three therapeutic modalities are effective and could be used as the first line of treatment for knee osteoarthritis. Moreover, it should be noted that the favorable outcomes remained at least two months after treatment concluded.

scholarly journals Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

2020 ◽  
Author(s):  
Pedro Acién ◽  
Irene Velasco ◽  
Maribel Acién
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Transvaginal Ultrasound ◽  
Intrauterine Device ◽  
Conservative Surgery ◽  
University Hospital ◽  
Ca 125 ◽  
European Medicines Agency ◽  
Fertility Sparing ◽  
Ultrasound Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019).Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time.Details of trial registration: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

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