scholarly journals Randomized Controlled Trial of Etodolac versus Combination of Etodolac and Eperisone in Patients of Knee Osteoarthritis

2013 ◽  
Vol 2013 ◽  
pp. 1-5
Author(s):  
Navjot Kaur ◽  
Harinder Singh ◽  
Avinash Chander Gupta
Keyword(s):  
Adverse Events ◽  
Controlled Trial ◽  
Spontaneous Pain ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Chi Square ◽  
Once Daily ◽  
Knee Oa ◽  
Treatment Regimens ◽  
Significant Difference

Objective. To compare the efficacy and tolerability of etodolac versus etodolac in combination with eperisone in patients of Osteoarthritis knee. Patients and Methods. A prospective, randomized, open label, parallel group, comparative study was conducted in 60 patients of knee OA over a period of 2 months. Thirty patients received etodolac 600 mg once daily and 30 patients received eperisone 50 mg thrice daily in addition to etodolac 600 mg once daily for 8 weeks. Efficacy assessment was done on the basis of improvement in mean scores of spontaneous pain on Visual analog scale (VAS), pain on movement, functional capacity, joint tenderness, swelling, erythema on Likert scale, and patient's overall arthritic condition on a five-point investigator scale at the end of study period as compared with the baseline scores. Assessment of tolerability was done by recording the occurrence of adverse events. Data was analyzed using Chi square test and students t-test. Results. All the enrolled patients completed the study and were compliant to the treatment regimens that they were allocated to. Both the treatment groups showed a statistically significant improvement in all the efficacy parameters at the end of 8 weeks as compared to baseline (P<0.05) with no statistically significant difference between the groups. Adverse events were few and mild in nature. Conclusion. Combination of etodolac and eperisone is as effective as etodolac alone in patients of OA knee. Thus, it is concluded that additional use of muscle relaxant has no adjuvant value in patients of OA knee and is not recommended. The study is registered with the Clinical Trial Registry of India vide registration number CTRI/2013/03/003442.

scholarly journals Efficacy and safety of a centrally acting analgesic flupirtine in primary knee osteoarthritis in comparison to tramadol: a randomized controlled trial

2018 ◽  
Vol 7 (3) ◽  
pp. 381
Author(s):  
Tanmoy Kanti Goswami ◽  
Pradip Kumar Ghoshal ◽  
Avijit Hazra ◽  
Asish Biswas
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Opioid Analgesics ◽  
Womac Score ◽  
Open Label ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Considerable Morbidity

Background: Osteoarthritis (OA) is a chronic, degenerative joint disorder responsible for considerable morbidity, particularly in old age. Flupirtine, a new centrally acting analgesic, is devoid of the adverse effects of NSAIDs and opioid analgesics. In this study author compared the effectiveness and safety of flupirtine with tramadol in knee OA.Methods: An open label, randomized, controlled trial was done with patients of primary knee OA of both sexes, age >50 years. Patients were recruited from Rheumatology OPD of SSKM Hospital. A minimum WOMAC score of 35 was essential for recruitment. Patients with serious comorbidities were excluded. They were treated orally with either flupirtine (100mg thrice daily) or tramadol (50mg thrice daily) for 12 weeks.Results: Ninety patients were recruited and data of 42 on flupirtine and 41 on tramadol were analysed. There was significant improvement in pain, stiffness and physical function compared to baseline in both the groups. However, there was no significant difference between groups at 4, 8 and 12 weeks. Responder rate (50% reduction in pain score from baseline) was 66.67% with flupirtine and 48.78% with tramadol (p = 0.122). Flupirtine caused 4 adverse events compared to 16 with tramadol. However, both the drugs were well-tolerated.Conclusions: The effectiveness of flupirtine in knee OA is comparable to tramadol, while causing minimal adverse effects. Long-term benefits need to be explored.

A Moxifloxacin-based Regimen for the Treatment of Recurrent, Drug-sensitive Pulmonary Tuberculosis: An Open-label, Randomized, Controlled Trial

2019 ◽  
Vol 70 (1) ◽  
pp. 90-98 ◽  
Author(s):  
Rubeshan Perumal ◽  
Nesri Padayatchi ◽  
Nonhlanhla Yende-Zuma ◽  
Anushka Naidoo ◽  
Dhineshree Govender ◽  
...  
Keyword(s):  
Adverse Events ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Treatment Success ◽  
Control Group ◽  
Open Label ◽  
Serious Adverse Events ◽  
Conversion Rates ◽  
Significant Difference ◽  
Culture Conversion

Abstract Background The substitution of moxifloxacin for ethambutol produced promising results for improved tuberculosis treatment outcomes. Methods We conducted an open-label, randomized trial to test whether a moxifloxacin-containing treatment regimen was superior to the standard regimen for the treatment of recurrent tuberculosis. The primary and secondary outcomes were the sputum culture conversion rate at the end of 8 weeks and the proportion of participants with a favorable outcome, respectively. Results We enrolled 196 participants; 69.9% were male and 70.4% were co-infected with human immunodeficiency virus (HIV). There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks (83.0% [moxifloxacin] vs 78.5% [control]; P = .463); however, the median time to culture conversion was significantly shorter (6.0 weeks, interquartile range [IQR] 4.0–8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0– 11.4; P = .018). A favorable end-of-treatment outcome was reported in 86 participants (87.8%) in the moxifloxacin group and 93 participants (94.9%) in the control group, for an adjusted absolute risk difference of −5.5 (95% confidence interval −13.8 to 2.8; P = .193) percentage points. There were significantly higher proportions of participants with Grade 3 or 4 adverse events (43.9% [43/98] vs 25.5% [25/98]; P = .01) and serious adverse events (27.6% [27/98] vs 12.2% [12/98]; P = .012) in the moxifloxacin group. Conclusions The replacement of ethambutol with moxifloxacin did not significantly improve either culture conversion rates at the end of 8 weeks or treatment success, and was associated with a higher incidence of adverse events. Clinical Trials Registration NCT02114684.

scholarly journals FRI0228 TOFACITINIB IN THE TREATMENT OF SKIN AND MUSCULOSKELETAL INVOLVEMENT IN ADULT PATIENTS WITH EARLY SYSTEMIC SCLEROSIS, EVALUATED BY ULTRASOUND

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 697-697
Author(s):  
R. Karalilova ◽  
T. Sapundzhieva ◽  
Z. Batalov ◽  
M. Matucci-Cerinic ◽  
A. Batalov
Keyword(s):  
Systemic Sclerosis ◽  
Adverse Events ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Skin Thickness ◽  
Open Label ◽  
Safety And Efficacy ◽  
Significant Difference ◽  
Musculoskeletal Involvement

Background:The whole management of systemic sclerosis (SSc) remains to be defined while trials mainly focus on the treatment of different organ involvement and disease-modifying treatments are still not available.Objectives:To assess the safety and efficacy of tofacitinib (TOF) treatment on skin and musculoskeletal involvement as compared to methotrexate (MTX) treatment in patients with early SSc.Methods:In this 52-week, prospective, investigator-initiated, open-label, single-centre study, 66 patients with SSc were enrolled. Thirty-three patients received 5mg of oral TOF twice a day; and thirty-three received 7.5-10 mg of MTX weekly. The primary outcome measures were: skin fibrosis improvement at week 26, assessed by the reduction in skin thickness - evaluated by the modified Rodnan skin score (mRSS) and the ultrasound (US) measured skin thickness; improvement in the musculoskeletal involvement, assessed by the reduction in the joint and tendon score (US10SSc score); and adverse events from baseline to week 26. The dynamics in the outcome measures within each group were examined through Wilcoxon tests and between-group comparisons were performed through Mann-Whitney U and Chi-square tests.Results:At baseline, both groups of patients had similar median scores with no significant differences on all measures: mRSS (p = 0.589), US measured skin thickness (p = 0.822), and US10SSc score (p = 0.918). At week 26, significant differences were observed between the two treatment groups as the TOF treated patients showed a greater reduction in mRSS and musculoskeletal manifestations. In the TOF group, the median mRSS score decreased by 50% from 24 to 12 (IQR = 7.50) versus a smaller decrease of 8.70% in the MTX group, from 23 to 21 (IQR = 8.00), p < 0.001. The median US measured skin thickness in the TOF treated patients decreased by 12.87% from 1.71 to 1.49 (IQR =0.31) versus a decrease of 4.73%, from 1.69 to 1.61 (IQR =0.52) in the MTX group, p = 0.040. The US10SSc median score in the TOF group decreased by 56.25% from 16 to 7 (IQR = 6.50) versus a decrease of 12.5% in MTX group from 16 to 14 (IQR =10.50), p < 0.001. There was no significant difference between the groups in the number of adverse events from baseline to week 26. No cases of herpes zoster and deep vein thrombosis were observed in the TOF group.Conclusion:The data show that in early SSc TOF may lead to a significant improvement of skin thickness, measured with the mRSS and US, and of the musculoskeletal involvement, measured by the US10SSc score. TOF has also shown a satisfactory safety profile.References:[1]Elhai M, Boubaya M, Distler O, et al. Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study. Ann Rheum Dis. 2019 Jul;78(7):979-987.[2]Khanna D, Denton CP, Lin CJF, et al. Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). Ann Rheum Dis. 2018;77:212-220.[3]Gordon JK, Martyanov V, Franks JM, et al. Belimumab for the Treatment of Early Diffuse Systemic Sclerosis: Results of a Randomized, Double-Blind, Placebo-Controlled, Pilot Trial. Arthritis Rheumatol. 2018 Feb;70(2):308-316.Figure 1.Panel A - Dynamics in mRSS between baseline and week 26 in the MTX group;Panel B- Dynamics in mRSS between baseline and week 26 in the TOF group.Figure 2.Panel A - Dynamics in skin thickness between baseline and week 26 in the MTX group; Panel B - Dynamics in skin thickness between baseline and week 26 in the TOF group.Disclosure of Interests:Rositsa Karalilova: None declared, Tanya Sapundzhieva: None declared, Zguro Batalov: None declared, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Bristol-Myers Squibb, Speakers bureau: Acetelion, Lilly, Boehringer Ingelheim, Anastas Batalov: None declared

scholarly journals TO EVALUATE EFFICACY AND SAFETY OF RUPATADINE, BILASTINE, AND LEVOCETRIZINE IN ALLERGIC RHINITIS AT TERITARY CARE HOSPITAL, TELANGANA

2021 ◽  
pp. 140-143
Author(s):  
NAGUR SHARONE GRACE ◽  
SYED ARSHADDUDDIN AHMED ◽  
BHUVANESWARI E ◽  
SYED HAMZA QUADRI ◽  
VEENA B ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Nasal Congestion ◽  
Care Hospital ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Significant Difference ◽  
The Mean ◽  
The Government

Objective: Allergic rhinitis (AR) is a heterogeneous disorder characterized by symptoms – sneezing, itching, nasal congestion, and rhinorrhea. The aim of the study is to evaluate the efficacy and safety of rupatadine, bilastine, and levocetirizine in AR. Methods: A prospective, open-label, comparative study was conducted at the Government ENT Hospital, Hyderabad, Telangana. Ninety patients diagnosed with AR were randomized, of whom Group 1 received oral tab. bilastine 20 mg once daily, Group 2 received oral tab. levocetirizine 5 mg once daily, and Group 3 received oral tab. rupatadine with a dose of 10 mg once daily for 2 weeks. The reduction in total nasal symptom score (TNSS) and absolute eosinophil counts (AECs) was compared with baseline and at 2 weeks. Safety was assessed according to adverse events reported during the study period. An analysis of variance was used as a test of significance for the three groups. Results: Overall, 90 cases were included in the study, with 48% of males and 52% of females. All three drugs significantly reduced the TNSS and AEC after treatment compared to before treatment (p<0.05). The mean difference in TNSS and AEC showed no statistically significant difference among the three groups (TNSS: p>0.908 and AEC: p>0.967). In terms of safety, all three drugs showed nearly similar adverse events. Conclusion: In this study, after 2 weeks of follow-up, the three drugs (bilastine, levocetirizine, and rupatadine) showed significant improvement clinically, but the mean reduction in the score of symptoms and AEC was not statistically significant in the treatment of AR.

scholarly journals The effects of a limited infusion rate of fluid in the early resuscitation of sepsis on glycocalyx shedding measured by plasma syndecan-1: a randomized controlled trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Jutamas Saoraya ◽  
Lipda Wongsamita ◽  
Nattachai Srisawat ◽  
Khrongwong Musikatavorn
Keyword(s):  
Adverse Events ◽  
Organ Failure ◽  
Fluid Resuscitation ◽  
Infusion Rate ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Endothelial Glycocalyx ◽  
Open Label ◽  
Randomized Controlled ◽  
Standard Rate

Abstract Background Aggressive fluid administration is recommended in the resuscitation of septic patients. However, the delivery of a rapid fluid bolus might cause harm by inducing degradation of the endothelial glycocalyx. This research aimed to examine the effects of the limited infusion rate of fluid on glycocalyx shedding as measured by syndecan-1 in patients with sepsis-induced hypoperfusion. Methods A prospective, randomized, controlled, open-label trial was conducted between November 2018 and February 2020 in an urban academic emergency department. Patients with sepsis-induced hypoperfusion, defined as hypotension or hyperlactatemia, were randomized to receive either the standard rate (30 ml/kg/h) or limited rate (10 ml/kg/h) of fluid for the first 30 ml/kg fluid resuscitation. Subsequently, the fluid rate was adjusted according to the physician’s discretion but not more than that of the designated fluid rate for the total of 6 h. The primary outcome was differences in change of syndecan-1 levels at 6 h compared to baseline between standard and limited rate groups. Secondary outcomes included adverse events, organ failure, and 90-day mortality. Results We included 96 patients in the intention-to-treat analysis, with 48 assigned to the standard-rate strategy and 48 to the limited-rate strategy. The median fluid volume in 6 h in the limited-rate group was 39 ml/kg (interquartile range [IQR] 35–52 ml/kg) vs. 53 ml/kg (IQR 46–64 ml/kg) in the standard-rate group (p < 0.001). Patients in the limited-rate group were less likely to received vasopressors (17% vs 42%; p = 0.007) and mechanical ventilation (20% vs 41%; p = 0.049) during the first 6 h. There were no significantly different changes in syndecan-1 levels at 6 h between the two groups (geometric mean ratio [GMR] in the limited-rate group, 0.82; 95% confidence interval [CI], 0.66–1.02; p = 0.07). There were no significant differences in adverse events, organ failure outcomes, or mortality between the two groups. Conclusions In sepsis resuscitation, the limited rate of fluid resuscitation compared to the standard rate did not significantly reduce changes in syndecan-1 at 6 h. Trial registration Thai Clinical Trials Registry number: TCTR20181010001. Registered 8 October 2018, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=4064

scholarly journals Levetiracetam versus fosphenytoin as a second-line treatment after diazepam for status epilepticus: study protocol for a multicenter non-inferiority designed randomized control trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kensuke Nakamura ◽  
◽  
Aiki Marushima ◽  
Yuji Takahashi ◽  
Akio Kimura ◽  
...  
Keyword(s):  
Status Epilepticus ◽  
Adverse Events ◽  
Controlled Trial ◽  
Insurance Coverage ◽  
Line Treatment ◽  
Second Line ◽  
Open Label ◽  
Consciousness Disturbance ◽  
Multicenter Randomized Controlled Trial ◽  
Severe Adverse Events

Abstract Background Status epilepticus (SE) is an emergency condition for which rapid and secured cessation is important. Phenytoin and fosphenytoin, the prodrug of phenytoin with less severe adverse effects, have been recommended as second-line treatments. However, fosphenytoin causes severe adverse events, such as hypotension and arrhythmia. Levetiracetam reportedly has similar efficacy and higher safety for SE; however, evidence to support its use for adult SE is lacking. In the present study, a non-inferiority designed multicenter randomized controlled trial (RCT) is being conducted to compare levetiracetam with fosphenytoin after diazepam as a second-line treatment for SE. Methods This multicenter, prospective, and open-label RCT is conducted in emergency departments. Between December 23, 2019, and March 31, 2023, 176 patients with convulsive SE transported to an emergency room will be randomized into a fosphenytoin group and levetiracetam group at a ratio of 1:1. The definition of SE is “continuous seizures longer than 5 min or discrete seizures longer than 2 min with intervening consciousness disturbance.” In both groups, diazepam is initially administered at 1–20 mg, followed by intravenous fosphenytoin at 22.5 mg/kg or intravenous levetiracetam at 1000–3000 mg. The primary outcome is the seizure cessation rate within 30 min. Seizure recurrence within 24 h, severe adverse events, and intubation rate within 24 h are secondary outcomes. Discussion The present study was approved and conducted as an initiative study of the Japanese Association for Acute Medicine. If non-inferiority is identified, the society will pursue an application for the national health insurance coverage of levetiracetam for SE via a public knowledge-based application. Trial registration Japan Registry of Clinical Trials jRCTs031190160. Registered on December 13, 2019

TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽  
2021 ◽  
pp. 033310242110474
Author(s):  
Debashish Chowdhury ◽  
Luv Bansal ◽  
Ashish Duggal ◽  
Debabrata Datta ◽  
Ankit Mundra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Virus Disease ◽  
Controlled Trial ◽  
Preventive Treatment ◽  
Point Estimate ◽  
Tolerability Profile ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

Allopurinol dose escalation to achieve serum urate below 6 mg/dL: an open-label extension study

2017 ◽  
Vol 76 (12) ◽  
pp. 2065-2070 ◽  
Author(s):  
Lisa K Stamp ◽  
Peter T Chapman ◽  
Murray Barclay ◽  
Anne Horne ◽  
Christopher Frampton ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Escalation ◽  
Controlled Trial ◽  
Serum Urate ◽  
Extension Study ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Extension ◽  
Randomised Controlled ◽  
Kidney Impairment

ObjectivesTo determine the long-term safety and efficacy of allopurinol dose escalation (DE) to achieve target serum urate (SU) in gout.MethodsPeople, including those with chronic kidney disease, who completed the first 12 months of a randomised controlled trial continued into a 12-month extension study. Participants randomised to continue current dose for the first 12 months began allopurinol DE at month 12 if SU was ≥6 mg/dL (control/DE). Immediate DE participants who achieved target SU maintained allopurinol dose (DE/DE). The primary endpoints were reduction in SU and adverse events (AEs) at month 24.ResultsThe mean (SE) change in SU from month 12 to 24 was −1.1 (0.2) mg/dL in control/DE and 0.1 (0.2) mg/dL in DE/DE group (p<0.001). There was a significant reduction in the percentage of individuals having a gout flare in the month prior to months 12 and 24 compared with baseline in both groups and in mean tophus size over 24 months, but no difference between randomised groups. There were similar numbers of AEs and serious adverse events between groups.ConclusionsThe majority of people with gout tolerate higher than creatinine clearance-based allopurinol dose and achieve and maintain target SU. Slow allopurinol DE may be appropriate in clinical practice even in those with kidney impairment.Trial registration numberACTRN12611000845932

scholarly journals COMPARISON OF EFFICACY AND SAFETY SILODOSIN 8 MG ONCE DAILY AND SILODOSIN 4 MG TWICE DAILY IN BPH PATIENTS WITH LUTS

2019 ◽  
Vol 26 (1) ◽  
Author(s):  
Ramzie Nendra Diansyah ◽  
Johan Renaldo ◽  
Wahjoe Djatisoesanto ◽  
Lukman Hakim
Keyword(s):  
Adverse Events ◽  
Side Effect ◽  
Similar Efficacy ◽  
Common Adverse Event ◽  
Common Side Effect ◽  
Urinary Flow ◽  
Once Daily ◽  
Significant Difference ◽  
Male Patients ◽  
Maximum Urinary Flow

Objective: This study was aimed to compare the efficacy and side effect of silodosin 8mg once daily and silodosin 4mg twice daily in BPH-LUTS patients after 4 and 12 weeks. Material & Methods: Single blind randomized controlled trials in 60 male patients aged ≥45 years with BPH-LUTS from July 2017 to October 2017 was divided into groups who received 8mg of silodosin once daily and those who received 4mg of silodosin twice daily. Efficacy and adverse events were evaluated after 4 and 12 weeks of treatment. Results:  There was no significant difference of mean age of the two groups was 67.93 ± 6.49 years and 69.07 ± 6.28 years respectively (p 0.49). Both doses of this drug decreased the International Prostate Symptom Score (IPSS) and significantly increased the maximum urinary flow (Qmax) (p<0.05) but there was no significant differences between the two groups (p>0.05). Ejaculation disorder was the most common side effect in all groups (6.7% and 5%) and there was no significant difference between the two groups (p>0.05). Conclusion: The administration of 8mg of once daily silodosin has similar efficacy as 4mg twice daily silodosin. There were no adverse events differences in the two groups. Ejaculation disorder is the most common adverse event of silodosin administration.

scholarly journals The Use of Milrinone Versus Conventional Treatment for the Management of Life-Threatening Bronchial Asthma

2019 ◽  
Vol 13 (1) ◽  
pp. 12-17 ◽  
Author(s):  
Amr Sobhy ◽  
Doaa M. K. Eldin ◽  
Hany V. Zaki
Keyword(s):  
Bronchial Asthma ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Blood Gases ◽  
Categorical Variables ◽  
Chi Square ◽  
Arterial Blood ◽  
Number Of Patients ◽  
Significant Difference ◽  
Life Threatening

Background and Aims: In our study, we investigated the effectiveness of intravenous milrinone in life-threatening bronchial asthma as compared to conventional treatment. Methods: Fifty patients aged 18-50 years, presenting with life-threatening asthma were enrolled in a Randomised Controlled Trial (RCT). They were randomly allocated into Group C (25 patients): who received the standard pharmacotherapy and placebo, and Group M (25 patients): who in addition to the standard therapy, received 25 μg milrinone as an initial slow IV bolus diluted in 10 ml of normal saline. The following data were recorded: PEFR (Peak Expiratory Flow Rate) expressed as a percentage of the patient’s previous value, Respiratory Rate (RR), MABP (Mean Arterial Blood Pressure), arterial blood gases, and the number of patients requiring mechanical ventilation. Differences between groups were tested using Analysis of Variance (ANOVA) for quantitative variables with post hoc using the Least Significant Difference (LSD) test, and Chi square test for categorical variables. Results: Group M showed marked improvement in PEFR that was highly significant (P < 0.001) 10 min after injection and significant after one hour from the start of treatment in comparison to Group C. There was also an improvement in RR and PO2 that was significant in group M. Milrinone was associated with a reduction in MABP only after 10 min from injection, and showed a statistically significant decrease in the number of patients requiring mechanical ventilator support (P ˂ 0.05). Conclusion: Milronine is a promising agent as a rescue drug in the treatment of life-threatening bronchial asthma.

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