scholarly journals Comparison of effect of auriculotherapy and mefenamic acid on the severity and systemic symptoms of primary dysmenorrhea: a randomized clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Masoomeh Vahedi ◽  
Seyedeh Batool Hasanpoor-Azghady ◽  
Leila Amiri-Farahani ◽  
Imaneh Khaki
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Mefenamic Acid ◽  
Acid Group ◽  
Primary Dysmenorrhea ◽  
Link Type ◽  
Significant Difference ◽  
Grade 3 ◽  
Systemic Symptoms

Abstract Background Primary dysmenorrhea (PD) is the most common complaint in young women and adolescents. Side effects of non-steroidal anti-inflammatory drugs can limit their use. Therefore, non-pharmacological pain relief methods such as auriculotherapy may play an important role in PD management. This study was conducted to compare the effect of auriculotherapy and mefenamic acid on the severity and systemic symptoms of PD. Methods In a randomized clinical trial, 83 students were randomized into two groups. In the auriculotherapy group, electrical stimulation of the ear was conducted once a week for two menstrual cycles. In each cycle close to menstruation, ear seeds were inserted on pressure points to be pressed in times of pain. In the mefenamic acid group, subjects took mefenamic acid capsules upon seeing the initial symptoms of menstruation until the pain reduces. The primary outcomes were mean pain intensity and systemic symptoms associated with it. Pain intensity was measured through the visual analog scale (VAS) and the verbal multidimensional scoring system (VMS). Systemic symptoms were assessed using VMS, as well as the yes/no question form. Results Mean pain intensity with the VAS was significantly lower in the auriculotherapy group than the mefenamic acid group in the first and second cycles of intervention. There was a significant difference in VMS grade between both groups during the second cycle of intervention. In terms of the systemic symptoms in the second cycle of intervention, no subjects had dysmenorrhea grade 3 (common systemic symptoms) in the auriculotherapy group. Whereas in the mefenamic acid group, 16.7% of the subjects still had dysmenorrhea grade 3. There was no significant difference between the two groups in the frequency of systemic symptoms of PD. There was a significant decrease in the frequency of fatigue and diarrhea in both groups. However, there was a significant reduction in the frequency of nausea, headache, and anger in the auriculotherapy group. Conclusion Mean pain intensity with the VAS was lower with the auriculotherapy. Also, 65.9% of auriculotherapy group subjects were in the dysmenorrhea grades 0 and 1. Therefore, auriculotherapy is recommended because of its fewer complications and more effect on PD. Trial registration ClinicalTrials.gov IRCT20181207041873N1. Registered on February 24, 2019. https://en.irct.ir/user/trial/35967/view

Comparative Study on Vit. E & Mefenamic acid vs Mefenamic acid alone on mean reduction in pain in Primary Dysmenorrhea

2021 ◽  
Vol 15 (12) ◽  
pp. 3195-3197
Author(s):  
Fariha Sadiqa ◽  
Mufakhara Fatimah ◽  
Abdul Mudabbir Rehan ◽  
Sidra Mushtaq ◽  
Asia Firdous ◽  
...  
Keyword(s):  
Vitamin E ◽  
Mefenamic Acid ◽  
Controlled Trial ◽  
Acid Group ◽  
P Value ◽  
Primary Dysmenorrhea ◽  
High Concentration ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Menstrual Fluid

Background: Pelvic pain around the time of mensturation without any identifiable pathologic lesion present from menarche is called primary dysmenorrhea. The pain is believed to be related to prostaglandin (PG). Women with dysmenorrhoea have a relatively high concentration of PGF 2 alpha in menstrual fluid and suppression of PG synthesis has become the main treatment. Aim: To compare mean reduction in pain in patients presenting with primary dysmenorrhea given vitamin E & Mefenamic acid versus Mefenamic acid alone. Results: It was a randomized controlled trial which was conducted in Department of Obstetrics & Gynecology, THQ Raiwind Hospital, Lahore for 6 months duration w.e.f 01/02/2017 to 31/07/2017. In this study, 18(36%) in Vitamin-E group and 21(42%) in Mefenamic acid group were between 15-20 years while 32(64%) in Vitamin-E group and 29(58%) in Mefenamic acid group were between 21-25 years, mean±sd was calculated as 20.86±2.92 and 20.66±2.86 years respectively, mean dysmenorrheal pain at baseline was recorded as 50.06±10.27 in Vitamin-E group and 50.14±10.28 in Mefenamic acid group, p value < 0.754, showing that both groups are insignificant, mean dysmenorrheal pain after treatment was recorded as 20.50±10.04 in Vitamin-E group and 30.22±10.28 in Mefenamic acid group, p value was < 0.002 showing significant difference between the two group, comparison of mean reduction in dysmenorrheal pain after treatment was recorded as 20.56±0.91 in Vitamin-E group and 10.92±0.75 in Mefenamic acid group, p value was < 0.000, showing significant difference. Conclusion: We concluded that there is a significant mean reduction in dysmenorrhic pain in patients given Mefenamic Acid + Vitamen E as compared to patients given Mefenamic Acid alone. Keywords: Dysmenorrhic pain, Mefenamic Acid + Vitamen E, mean reduction in dysmenorrhic pain

scholarly journals The Effect of Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial

2015 ◽  
Vol 4 (1) ◽  
pp. 26-32
Author(s):  
Sara Azima ◽  
Hajar Rajaei Bakhshayesh ◽  
Keramatollah Abbasnia ◽  
Maasumeh Kaviani ◽  
Mehrab Sayadi
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pharmacological Method

Background: Primary dysmenorrhea is the most common cyclic pelvic pain and is also the most common gynecological problem worldwide and affects quality of life. The present study aimed to investigate the effect of isometric exercises on intensity and duration of pain and level of anxiety in the students with primary dysmenorrhea.Materials and Methods: In this randomized controlled clinical trial, 68 students living in dormitories of Shiraz University with primary dysmenorrhea  were randomly assigned to isometric exercises and control groups. The intervention group performed isometric exercises since the third day of the menstrual cycle for 8 weeks. Pain intensity was measured using Visual Analog Scale (VAS). In addition, the anxiety level was assessed using Spielberger questionnaire. The data were analyzed using independent t-test, repeated measures ANOVA, and Bonferroni Post hoc test at the end of the second and third months of the study. Besides, P<0.05 was considered as statistically significant.Results: Pain intensity and duration of pain was significantly reduced in exercises group (p<0.001). However, no significant difference was found between the two groups concerning the mean anxiety levels.Conclusion: Primary dysmenorrhea is a common complaint among young women. Isometric exercises seem to be an easy, non-pharmacological method for reducing primary dysmenorrheal.

scholarly journals Comparison of the effect of Chamomile and Mefenamic Acid on primary dysmenorrhea, associated symptoms and menstrual bleeding – A randomized clinical trial study

2020 ◽  
Author(s):  
Fatemeh Shabani ◽  
Katayon Vakilian ◽  
Fereshteh Narenji ◽  
Mahbubeh Bozorgi ◽  
Soodabeh Bioos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Mefenamic Acid ◽  
Statistical Tests ◽  
Primary Dysmenorrhea ◽  
Verbal Scale ◽  
Associated Symptoms ◽  
Ethics Code ◽  
Group A ◽  
Group B

Abstract Background Dysmenorrhea is one of the most common pelvic pains in women, impairing their quality of life.This study investigated the effects of chamomile sachet and mefenamic acid on primary dysmenorrhea, associated symptoms and bleeding. Methods In this randomized clinical trial, 200 female students with primary dysmenorrhea from Arak universities were randomly assigned to two groups. The group (A) received mefenamic acid (250 mg) and group (B) received chamomile (5000 mg) plus one teaspoonful of honey )as a flavoring( for two days before up to the first three days of menstruation, three times a day in two consecutive cycles. Pain severity, associated symptoms and bleeding were assessed using visual analog scale, Andersch-Milsom Verbal Scale and Higham chart, respectively. Data were analyzed by descriptive and inferential statistical tests by SPSS 21. Results Severe pain during two months after intervention was in 6 (6.3%) of group (B) and 6 (6.3%) in group (A) (p = 0.351, p = 0.332). Mean severity of associated symptoms two months after the treatment was( 4.93 ± 3.54) in group (B) and (5.62 ± 3.54 ) in group (A), indicating further reduction in group (B) but not significant (p = 0.278). Mean of bleeding was (88.71 ± 66.4 vs. 70.54 ± 53. 34) in group (B) and (A) respectively, in two months later. therefore decrease in the two groups but was not significant between groups(p = 0.567). Conclusions It seems chamomile sachet can reduce the severity of pain and bleeding similar to mefenamic acid and even further mitigate the symptoms associated with dysmenorrhea. Trial registration: This study was performed with the proposal approval code of 2611, ethics code of (ARAKMU.REC.1395.164) at Arak University of medical sciences and code of IRCT 2016100825031N5 on 2016.11.08.

scholarly journals Rapid initiation of nasal saline irrigation to reduce morbidity and mortality in COVID+ outpatients: a randomized clinical trial compared to a national dataset

2021 ◽  
Author(s):  
Amy L. Baxter ◽  
Kyle R. Schwartz ◽  
Ryan W. Johnson ◽  
Ann-Marie Kuchinski ◽  
Kevin M. Swartout ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Conflict Of Interest ◽  
Povidone Iodine ◽  
Morbidity And Mortality ◽  
Saline Irrigation ◽  
Nasal Irrigation ◽  
Link Type ◽  
Phone Calls ◽  
Significant Difference

AbstractImportanceSARS-CoV-2 enters the nasopharynx to replicate; mechanical debridement with nasal irrigation soon after diagnosis could reduce morbidity and mortality.ObjectiveTo determine whether initiating nasal irrigation after COVID-19 diagnosis reduces hospitalizations and death, and whether irrigant composition impacts severity.DesignUnblinded randomized clinical trial of two nasal irrigation protocols in outpatients PCR positive for SARS-CoV-2, nested in a prospective case:cohort using laboratory-confirmed cases in the CDC COVID-19 Case Surveillance dataset.SettingSingle-lab community testing facility associated with the emergency department (ED) in Augusta, GA.ParticipantsA consecutive sample of outpatients 55 years and older were contacted from daily COVID-19+ lab reports between September 24 and December 21 of 2020. Patients without supplemental oxygen use or cognitive barriers agreeing to same-day irrigation initiation were remotely consented. Among 826 screened, 321 were unable to be reached, 132 were ineligible, 294 refused participation, and 79 participants were enrolled.InterventionsParticipants were randomly assigned adding 2.5 mL povidone-iodine 10% or 2.5 mL sodium bicarbonate to 240ml of isotonic nasal irrigation twice daily for 14 days.Main Outcomes and MeasuresThe primary outcome was hospitalization or death from COVID-19 within 28 days of enrollment by daily self-report confirmed with phone calls and hospital records, compared to the CDC Surveillance Dataset covering the same time. Secondary outcomes compared symptom resolution by irrigant additive.ResultsSeventy-nine participants were enrolled (mean [SD] age, 64 [8] years; 36 [46%] women; 71% Non-Hispanic White). Analyzed by intention-to-treat, by day 28, COVID-19 symptoms resulted in 1/42 hospitalizations in those irrigating with alkalinization, 0/37 in the povidone-iodine group, (1.27%) and no deaths. Of nearly three million CDC cases, 9.14% were known to be hospitalized, with an additional 1.5% mortality in those without hospitalization data. The total risk of hospitalization or death (10.6%) was 8.4 times that of enrolled patients (SE=2.74; P=.006). 62 completed daily surveys (78%), averaging 1.8 irrigations/day. Eleven had irrigation complaints, and four discontinued. There were no significant differences by additive.ConclusionSARS-CoV-2+ participants initiating nasal irrigation were over 8 times less likely to be hospitalized than the national rate.Trial RegistrationClinicalTrial.gov Identifier: NCT04559035Author ApprovalAll authors have filled out ICMJE and approved submission.Conflict of Interest StatementMaterials were provided by Neilmed Inc. and Rhinosystems Inc. The study was supported by funding from the Bernard and Anne Gray Donor Advised Fund Community Foundation for Greater Atlanta, Neilmed Inc., and Rhinosystems. No authors have conflict of interest.Key PointsQuestionAfter testing positive for COVID-19, will rapidly initiating nasal irrigation with alkaline or povidone-iodine isotonic solution reduce the risk of morbidity and mortality compared to a national dataset?FindingsIn this randomized trial of 79 older adults nested in a case:control with the CDC COVID-19 National Dataset, 1.27% of participants initiating nasal irrigation were hospitalized or died, compared to 10.6%, a significant difference.MeaningIn older outpatients testing positive for SARS-CoV-2 who initiated nasal irrigation rapidly after diagnosis, risk of hospitalization or death was eight times lower than national rates reported by the CDC.

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.

Complications and surgical results of stone-directed antegrade pyelography compared to the retrograde pyelographic access method in percutaneous nephrolithotomy using ‘bull’s eye’ technique: A randomized clinical trial

2021 ◽  
pp. 205141582199372
Author(s):  
Dariush Irani ◽  
Abdolreza Haghpanah ◽  
Mohammad Mehdi Hosseini ◽  
Leila Malekmakan ◽  
Mohammad Ali Ashraf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Percutaneous Nephrolithotomy ◽  
Renal Stones ◽  
Surgical Results ◽  
Retrograde Pyelography ◽  
Antegrade Approach ◽  
Antegrade Pyelography ◽  
Significant Difference ◽  
Bull's Eye

Objectives: This study aimed to evaluate the differences in outcomes and complications in stone-directed antegrade pyelography using the ‘bull’s eye’ technique in patients with renal stones versus the conventional method of percutaneous nephrolithotomy (PCNL). Although conventional PCNL access using retrograde pyelography is useful, it is time-consuming and may cause postoperative discomfort. Herein, we report our experience in the application of this new technique. Methods: Between January 2017 and June 2018, 100 patients participated in this randomized clinical trial. Stone-directed antegrade pyelography using the ‘bull’s eye’ technique under fluoroscopic guidance was used for percutaneous access in the intervention group. The second group, consisting of those who had undergone conventional PCNL using retrograde pyelography and ‘bull’s eye’ technique in the same period, were considered as the controls. Pre- and postoperative laboratory examinations, surgical results and complications were recorded and compared between the two groups. Results: A single calyceal puncture in partial staghorn and staghorn stone patients was sufficient in 72.2% of the antegrade group and in 78.9% of the retrograde group ( p=0.69). The double-puncture technique was necessary for 71.9% of renal pelvis stones in the antegrade group and for 9.4% in the retrograde group ( p<0.001). The antegrade approach reduced the mean operative time and analgesic requirement significantly ( p<0.001). No statistically significant difference, however, was found between the two groups regarding stone migration to the ureter, radiation time and postoperative complications. Conclusions: The stone-directed antegrade approach using the ‘bull’s eye’ technique is a safe and accurate method in PCNL access in patients with radiopaque and semi-opaque renal stones.

scholarly journals A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Christine Elizabeth Jones ◽  
Anna Calvert ◽  
Jo Southern ◽  
Mary Matheson ◽  
Nick Andrews ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Pertussis Toxin ◽  
Geometric Mean ◽  
Control Group ◽  
Primary Immunization ◽  
Link Type ◽  
In Pregnancy ◽  
Pertussis Antigens ◽  
Phase Iv

Abstract Background Pertussis vaccines containing three or five pertussis antigens are recommended in pregnancy in many countries, but no studies have compared the effect on infants’ antigen-specific immunoglobulin G (IgG) concentrations. The aim of this study was to compare anti-pertussis IgG responses following primary immunization in infants of mothers vaccinated with TdaP5-IPV (low dose diphtheria toxoid, tetanus toxoid, acellular pertussis [five antigens] and inactivated polio) or TdaP3-IPV in pregnancy (three pertussis antigens). Methods This multi-centre phase IV randomized clinical trial was conducted in a tertiary referral centre and primary care sites in England. Women were randomized to receive TdaP5-IPV (n = 77) or TdaP3-IPV (n = 77) at 28–32 gestational weeks. A non-randomized control group of 44 women who had not received a pertussis-containing vaccine in pregnancy and their 47 infants were enrolled post-partum. Results Following infant primary immunization, there was no difference in the geometric mean concentrations (GMCs) of anti-pertussis toxin, filamentous haemagglutinin or pertactin IgG between infants born to women vaccinated with TdaP5-IPV (n = 67) or TdaP3-IPV (n = 63). However, the GMC of anti-pertussis toxin IgG was lower in infants born to TdaP5-IPV- and TdaP3-IPV-vaccinated mothers compared to infants born to unvaccinated mothers (n = 45) (geometric mean ratio 0.71 [0.56–0.90] and 0.78 [0.61–0.98], respectively); by 13 months of age, this difference was no longer observed. Conclusion Blunting of anti-pertussis toxin IgG response following primary immunization occurs in infants born to women vaccinated with TdaP5-IPV and TdaP3-IPV, with no difference between maternal vaccines. The blunting effect had resolved by 13 months of age. These results may be helpful for countries considering which pertussis-containing vaccine to recommend for use in pregnancy. Trial registration ClinicalTrials.gov, NCT02145624, registered 23 May 2014

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

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