Blind Comparative Trial Research Articles

51745 Aesthetic outcome of running subcuticular suture versus running horizontal mattress suture closure of linear wounds on the trunk and extremities: a randomized evaluator blinded split wound comparative effectiveness trial

51745 Aesthetic outcome of running subcuticular suture versus running horizontal mattress suture closure of linear wounds on the trunk and extremities: a randomized evaluator blinded split wound comparative effectiveness trial

Randomized controlled trial of enteral vitamin D supplementation (ViDES) in infants

BackgroundVitamin D is necessary to develop healthy lungs and other organs early in life. Most infants born before 28 weeks’ gestation have low vitamin D levels at birth and a limited intake during the first month. Enteral vitamin D supplementation is inexpensive and widely used. The appropriate supplementation regimen for extremely preterm infants is controversial, and the effect of different regimens on their blood levels and outcomes is unclear.MethodsRandomized, blinded comparative effectiveness trial to compare two vitamin D supplementation regimens for inborn infants <28 weeks gestation or <1000 g birth weight at a large academic center in the United States. Infants are stratified by birth weight and randomized within 96 h after birth to either routine supplementation (400 IU/day with established feedings) or increased supplementation (800 IU/day with any feedings) during the first 28 days after birth. We hypothesize that the higher and early vitamin D dose (800 IU/day with early feeding) compared to placebo plus routine dose (400 IU/day with established feeding) will substantially increase total 25-hydroxyvitamin D3 levels measured as state-of-art at 1 month, reduce respiratory support at 36 weeks’ postmenstrual age (on an ordinal scale predictive of later adverse outcomes), and improve or at least not worsen other important secondary outcomes. The infants in the study will follow up at 22–26 months’ corrected age (~2 years) with blinded certified examiners to evaluate neurodevelopmental outcomes. The sample size of a minimum of 180 infants provides >90% power to detect a >95% posterior probability of a 33% increase in serum 25-hydroxy vitamin D3 and >80% power to detect a >80% posterior probability of a relative risk decrease of 20% of reducing respiratory support by intention-to-treat Bayesian analyses using a neutral prior probability.DiscussionOur study will help clarify the uncertain relationship of vitamin D supplementation and its associated serum metabolites to clinical outcomes of extremely preterm infants. Confirmation of our hypotheses would prompt reconsideration of the supplementation regimens used in extremely preterm infants and justify a large multicenter study to verify the generalizability of the results.Trial registrationClinicalTrials.gov NCT05459298. Registered on July 14, 2022.

A Randomized Trial of Intravenous Labetalol Versus Oral Nifedipine in Acute Blood Pressure Control in Hypertensive Emergencies of Pregnancy

Background: Hypertension in pregnancy, called a disease of degree is more of a sign than a disease by itself. Hypertensive disorders of pregnancy, including chronic hypertension, with or without superimposed pre-eclampsia/eclampsia, gestational hypertension, HELLP syndrome, pre-eclampsia with or without severe features or eclampsia present a significant risk of morbidity to both mother and fetus. Effective pharmacologic therapy modifies the course of the disease. The effective use of anti-hypertensive therapy should be based on well designed controlled clinical trials and the experience of the clinician with the drugs. Hypertensive disorders complicate 5-10% of all pregnancies worldwide. 1 Dangerous hypertension is a harbinger of cerebrovascular accidents, eclampsia, hypertensive encephalopathy and other end organ damage with a poor perinatal outcome. 2 Methods: This prospective randomized double blind comparative clinical trial with randomization done using computer generated numbers study was carried out in 100 cases being brought in OBG department of AL Ameen Medical College, Bijapur, from July 2023 to December 2023. A detailed data of sociodemographic profile, general examination and obstetric examination were carried out. The pregnant women were randomized with computer generated numbers into two groups to receive either oral nifedipine or intermittent intravenous labetalol injections. Results: There is no significant difference in the parity of both the groups. Majority of the patients constituting 80% of group A and 58% of group B were primigravida. 69% enrolled in the study were primigravida. There is a higher incidence of pre-eclampsia in the first pregnancy. The majority of the patients had gestational age of 34 to 36 weeks constituting 48% on the whole with 50% and 46% respectively in group A and B. The recruited patients did not significantly differ in gestational age

Comparison between Diclofenac Sodium and Ketorolac in the Management of Post-Appendectomy Pain

Aim: To compare the Diclofenac Sodium and ketorolac in the management of post-appendectomy pain. Study design: Single blinded analytical comparative trial Place and duration of study: Tertiary Care Hospital, Lahore from 01-03-2022 to 30-11-2022. Methodology: One hundred and twenty three patients within 8-48 years who were suffering from acute appendicitis and required appendectomy were randomly selected. They were randomly divided into two groups. One was Diclofenac sodium group which had 61 cases in it and was selected to receive Diclofenac Sodium post-surgery. The other group having 62 patients was ketorolac group receiving ketorolac for pain relief. The patients received the pain killer post 30 and then 60 minutes after their surgery. The comparative results and efficacy of each pain killer was analyzed and assessed through faces pain scale. Results: The mean age of the patients was 20.5±5.5 in diclofenac sodium and 21.3±6.1 in Ketorolac group. There were 75.4% males in former group while 62.9% in later group. The mean value of BMI was within normal range in both groups. The pain score recorded highest number of cases in Diclofenac Sodium and ketorolac group at score 02 within 30 minutes after surgery while the pain score significantly dropped in ketorolac group in 60 minutes to score 00 while it persisted highest in score 02 among patients given Diclofenac Sodium. Conclusion: Intravenous ketorolac has advanced analgesic effect than Diclofenac Sodium with a substantial low risk involved in cases of appendectomy. Key Words: Appendicitis, NSAIDS, Ketorolac, Diclofenac, Management.

Efficacy of Brahmi vati in generalised anxiety disorder – Randomized double blind comparative clinical trial

BackgroundGeneralized Anxiety Disorder (GAD) is the most common anxiety disorder. GAD has high comorbidities and it can affect social, professional and personal life. Ayurvedic medicine, Brahmi vati is explored for the possible role in management of GAD and is compared to Manasmitra vataka. AimTo evaluate the efficacy of B. vati on Generalized Anxiety Disorder. MethodsA randomized double blind controlled trial, with total 56 patients meeting the DSM V criteria of GAD between 20–60 years of age and either sex participated in the study. Participants were randomly divided into two groups, Brahmi group received capsule B. vati 500 mg and Manasmitra group received capsule M. vataka 500 mg thrice a day with water for 45 days. Assessments were conducted through various clinical parameters such as Hamilton Anxiety Rating Scale (HARS), GAD 7 scale (GAD 7), Beck Depression Inventory scale (BDI), Epworth sleepiness scale (ESS), Pittsburgh Sleep Quality Index (PSQI), WHO Quality of Life- BREF (WHOQOL-BREF), Clinical Global Improvement scale (CGI). Blood variables including Haemoglobin, Erythrocyte Sedimentation Rate (ESR), Liver Function Test (LFT) and serum creatinine were assessed before and after the study. Assessments during intervention were conducted on every 15th day. ResultsStudy results indicate that both B. vati and M. vataka were comparable and each produced significant improvement (p < 0.001) in HARS, GAD-7, BDI, ESS, PSQI, WHOQOL-BREF and CGI. Brahmi vati also produced significant decrease in systolic (p = 0.002) and diastolic (p < 0.001) blood pressure. Both groups showed good safety profile evaluated through the assessment of serum creatinine levels and LFT. ConclusionB. vati and M. vataka were effective, safe and comparable in the management of GAD. Warrants further studies.

A novel treatment protocol in severe acute pancreatitis: the first double blinded comparative trial to assess efficiency of omega 3 fatty acid infusion

Background: For decades, the treatment of acute pancreatitis (AP) has been largely supportive. However, a therapeutic window for intervention using immune modulators exists between the onset of clinical symptoms and peak pro-inflammatory cytokine expression. Soybean oil derived ω-3 PUFA is shown to inhibit the formation of ω-6 PUFA derived pro-inflammatory eicosanoids and suppresses pro-inflammatory activity of nuclear transcription factors (NF-κβ); thus, bringing about a much-needed immune regulation, both locally and systemically. Our aim was to study the efficacy of ω-3 PUFA infusion in severe AP (SAP) and set a new treatment protocol.Methods: This, first of its kind, doubled blinded randomised control trial was undertaken to assess the efficacy of early ω-3 PUFA supplementation in patients with predicted SAP by using serum amylase, serum lipase and C-reactive protein (CRP) with BISAP and Marshal scoring systems as markers for clinical outcome. 60 such patients were randomised into two groups: 30 were given ω-3 PUFA infusion and 30 were given a placebo. Chi square test and unpaired t test were used for comparison.Results: ω-3 PUFA infusion was found to be highly significant (p&lt;0.05) in bringing about clinical improvement, reduced progression of SAP, reduced hospital stay and prompt reversal of organ dysfunction and SIRS.Conclusions: ω-3 PUFA infusion is the future for the treatment of patients with SAP. This drug is cheap and easily available, has no known side effects, reduces the morbidity and mortality, reduces the duration of hospital stay; thus, resulting in overall reduced medical expenditure.

Safety and immunological effectiveness of the domestic combined trivaccine for the prevention of measles, rubella and mumps Vaktrivir&lt;sup&gt;®&lt;/sup&gt; in children 12 months and 6 years of age (results of a simple blind multicenter comparative randomized clinical trial)

Relevanc. Measles, mumps and rubella, despite many years of vaccination, retain their epidemiological and social significance at the present time. The aim of the work is to study the safety and immunogenicity. Of the vaccine for the prevention of measles, rubella and mumps Vactrivir® in children's immunization. Materials and methods. The safety and immunogenicity of the vaccine was studied in a simple multicenter blind comparative randomized clinical trial involving children aged 12 months and 6 years. Results. The Vactrivir® vaccine is characterized by low reactogenicity, a high safety and immunogenicity profile and is comparable in terms of indicators to the foreign Priorix® vaccine, which has been used in the Russian Federation for specific prevention of measles, rubella and mumps since 2018.

A double blinded comparative study between omega 3 fatty acid infusion versus octreotide infusion in acute pancreatitis

Background: Over decades the treatment of acute pancreatitis remains debatable with no common consensus on treatment guidelines, with some workers using octreotide infusion and some workers only relying on fluid therapy and symptomatic management. This double blinded comparative trial between omega 3 fatty acid infusion versus octreotide infusion and its response in cases of acute pancreatitis. Methods: This is a study where a double blinded randomised control trial was undertaken in proven cases of acute pancreatitis and patients were given omega 3 fatty acid infusion and octreotide infusion and the observations were documented and followed upon. 50 cases were given omega 3 fatty acid infusion and other 50 were given octreotide infusion and the clinical response, symptomatic improvement was assessed and compared using BISAP and Marshal scoring systems and lipase levels.Results: Omega 3 fatty acid infusion was found to be highly significant as compared to octreotide in cases of acute pancreatitis in terms of clinical improvement, reduced hospital stay, and SIRS.Conclusions: Omega 3 fatty acid infusion is the future in cases of acute pancreatitis which is cheap and easily available with no side effects and reduces the morbidity and mortality in acute pancreatitis with reduced hospital stay in turn resulting in overall reduced medical expenditure.

A novel treatment protocol in acute pancreatitis: the first double blinded comparative trial of omega 3 fatty acid infusion versus octreotide

Background: Over decades the treatment of acute pancreatitis remains debatable with no common consensus on treatment guidelines, with some workers using octreotide infusion and some workers only relying on fluid therapy and symptomatic management. This is the first of its kind double blinded comparative trial between omega 3 fatty acid infusion versus octreotide infusion and its response in cases of acute pancreatitis.: Our aim is to study the efficacy of omega 3 fatty acid infusion and set a new treatment protocol in cases of acute pancreatitis with the use of omega 3 fatty acid infusion in all admitted cases of acute pancreatitis unless otherwise contraindicated.Methods: This is the first study where a doubled blinded randomised control trial was undertaken in proven cases of acute pancreatitis and patients were given omega 3 fatty acid infusion and octreotide infusion and the observations were documented and followed upon.100 cases of proven acute pancreatitis were randomised with double blinded closed envelop method. 50 cases were given omega 3 fatty acid infusion and other 50 were given octreotide infusion and the clinical response, symptomatic improvement was assessed and compared using BISAP and Marshal scoring systems and lipase levels. Chi Square test was used along with unpaired t test and p value was obtained in both groups.Results: Omega 3 fatty acid infusion was found to be highly significant as compared to octreotide in cases of acute pancreatitis in terms of clinical improvement, reduced hospital stay, reversal of organ dysfunction and SIRS.Conclusions: Omega 3 fatty acid infusion is the future in cases of acute pancreatitis which is cheap and easily available with no side effects and reduces the morbidity and mortality in acute pancreatits with reduced hospital stay in turn resulting in overall reduced medical expenditure.

Double blinded clinical comparative trial of intrathecal dexmedetomidine and fentanyl as an adjuvant to isobaric levobupivacaine

Aim: To compare a combination of isobaric Levobupivacaine with fentanyl and dexmedetomidine. Material and methods: This was a prospective, randomized, and double blinded clinical comparative study conducted in the Department of Anaesthesiology Metro Hospital and Cancer Research Center, Jabalpur, Madhya Pradesh, India. The study population consisted of 180 adult patients who were classified as American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective lower limb orthopaedic surgery under spinal anesthesia. The study participants were randomly divided into three groups. Group A: 0.5% Levobupivacaine Isobaric 2.5ml+ 0.5ml normal saline (total volume is upto 3.0 ml). Group F: 0.5% Levobupivacaine Isobaric 2.5ml + 25mug fentanyl (test solution will diluted with normal saline to total volume of 3.0ml). Group D: 0.5% Levobupivacaine isobaric 2.5ml +5 mcg dexmedetomidine (test solution will diluted with normal saline to total volume of 3.0 ml. Result: The mean time for onset of sensory block was 10.74 ±4.11 min in the saline group and 8.56±2.89 min in the dexmedetomidine group and 2.18±1.32 min in the fentanyl group. The mean time taken to achieve maximum sensory block in group A was 15.78±4.93 min, in group D was 13.36±3.62 min and in group F it was 5.42±1.87 min so maximum sensory block was achieved earlier in group. Peak level of sensory block attained in the fentanyl group was T4 and the peak level of sensory block in dexmedetomidine group was T6 and in the saline group peak level was T8. So the highest sensory block was attained in the fentanyl group. Conclusion: Dexmedetomidine group has longer onset of and duration of sensory block and effective postoperative analgesia and fewer side effects as compared to fentanyl group.

Use of 2-octylcyanoacrylate versus 5-0 fast absorbing gut during cutaneous wound closure: A randomized evaluator blinded split wound comparative effectiveness trial

Use of 2-octylcyanoacrylate versus 5-0 fast absorbing gut during cutaneous wound closure: A randomized evaluator blinded split wound comparative effectiveness trial

Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope

Passive video capsule endoscopy is the criterion standard for small-bowel exploration but cannot be used for the large gastric cavity. We report the first blinded comparative clinical trial in humans comparing a magnetically guided capsule endoscope (MGCE) and a conventional high-definition gastroscope. To assess the potential of gastric examination with a guided capsule. Blinded, nonrandomized comparative study. Single endoscopy center. The trial involved 61 patients included in a blinded capsule and gastroscopy comparative study. MGCE examination was performed 24 hours after patients had undergone gastroscopy. To remove food residue or mucus, patients drank 900 mL of water in 2 portions. Then to provide the air-water interface required by the guidance system, they drank 400 mL of water at 35°C. Visualization of the gastric pylorus, antrum, body, fundus, and cardia was evaluated as complete in 88.5%, 86.9%, 93.4%, 85.2%, and 88.5% of patients, respectively. Of gastric lesions, 58.3% were detected by both gastroscopy and MGCE at immediate assessment and review of recorded data. Capsule examination missed 14 findings and gastroscopy missed 31 findings seen with MGCE. Overall diagnostic yield was similar for both modalities. Pilot study. Diagnostic results were similar for the 2 methods. After some technical difficulties related to gastric expansion or presence of mucus had been overcome, this study opened a new field for noninvasive gastric examination in countries where high gastric cancer incidence demands a screening tool.

A randomized, comparative trial: does pillow type alter cervico-thoracic spinal posture when side lying?

BackgroundMany patients ask for advice about choosing a pillow. This research was undertaken to determine if pillow type alters cervico-thoracic spine position when resting in the side-lying position.AimTo investigate the effect of different pillow shape and content on the slope of cervico-thoracic spine segments when side lying.Materials and methodsThe study was a randomized blinded comparative trial set in a laboratory that replicated a bedroom. The subjects were side sleepers aged over 18 years. Exclusion criteria were history of surgery to the cervico-thoracic spine, an injury or accident to the cervico-thoracic spine in the preceding year, or currently receiving treatment for neck symptoms. Each participant rested in a standardized side-lying position for 10 minutes on each of the trial pillows: regular shaped polyester, foam, feather, and latex pillows, and a contour shaped foam pillow. Reflective markers were placed on external occipital protuberance (EOP), C2, C4, C7, and T3, and digital images were recorded of subjects at 0 and 10 minutes on each pillow. Images were digitized using each reflective marker and the slope of each spinal segment calculated. Univariate analysis of variance models were used to investigate slope differences between pillows at 0 and 10 minutes. Significance was established at P < 0.01 to take account of chance effects from repeated measures and multiple comparisons.ResultsAt 0 and 10 minutes, the EOP-C2, C2-C4, and C4-C7 segmental slopes were significantly different across all pillows. Significant differences were identified when comparing the feather pillow with the latex, regular and contour foam pillows, and when comparing the polyester and foam contour pillows. The regular and contour foam pillows produced similar slopes at all spinal segments.ConclusionCervico-thoracic spinal segment slope alters significantly when people change from a foam, latex, or polyester pillow to a feather pillow and vice versa. The shape of a foam pillow (contour versus regular shape) does not significantly alter cervico-thoracic spinal segment slope.

Randomized, Double Blinded Comparative Trial of Intradermal Injections of Lignocaine Versus N-Saline Around the Knee to Relieve Pain in Patients Awaiting Total Knee Replacement

We report a randomized, double-blinded comparative study assessing the efficacy of local anesthetic with N-saline intradermal blocks around the knee to reduce pain and improve patient satisfaction while waiting for a total knee joint replacement. Patients were offered involvement in this study while on the hospital waiting list for a knee replacement. Eligible patients, after completing a prestudy assessment, received an average of 6.3 (range: 1 to 10) intradermal injections of 0.5 mL either saline or 1% lignocaine injections into tender points around the knee. Patients were assessed at 2 hours and 1 week after the injections. Pain was assessed using 0 to 100 visual analog pain scale. Global perceived effect (satisfaction) was measured on a 7-point Likert scale. Thirty-two of 34 patients attended at 1-week assessment, 24 (75%) felt that they were improved, and 8 (25%) considered they were unchanged or worse. In both the saline and lignocaine groups, 12 of 16 patients felt that they had improved. N-saline proved as effective as lignocaine in reducing knee pain when injected intradermally. Seventy-five percent of patients were improved at 1 week.

Assessing the Impact of Ureteral Stent Design on Patient Comfort

We assessed the near term comfort of newly designed ureteral study stents or marketed control stents, including Polaris and Percuflex stents. Study stents had distal 6Fr pigtail ends with 3Fr or less loops. Decreased material in situ was hypothesized to enhance comfort. Usefulness of the patient self-administered Ureteral Stent Symptoms Questionnaire (Stone Management Unit, Southmead Hospital, United Kingdom) was assessed. This 4-arm multicenter study enrolled adults requiring retrograde unilateral ureteral stent placement for 4 to 28 days. Ureteral Stent Symptoms Questionnaire administration was done before placement (baseline), on day 4 after placement and on day 30 after removal. A total of 236 patients were randomized in a 1:1:1:1 ratio to the short loop tail stent (60), the long loop tail stent (59), the Percuflex Plus stent (64) and the Polaris stent (53). Overall pain worsened from baseline to day 4 and improved from days 4 to 30. Mean pain medication use peaked for all stents on day 1 after placement. Common device related symptoms were mild or moderate in severity, including flank pain in 47 patients, hematuria in 39, dysuria in 34, frequent urination in 30 and urinary urgency in 27. Six patients experienced a total of 9 device related adverse events requiring hospitalization. All adverse events resolved, including most within 3 days of inpatient treatment. Although it was not statistically significant, patients stented with the short loop tail had lower questionnaire pain scores on day 4 after placement and lower pain medication use on day 1 after placement when pain peaked in all stent groups, suggesting that ureteral stent comfort, especially pain, may be improved by less material in situ. The Ureteral Stent Symptoms Questionnaire may be better suited for longer term comparisons in stented vs nonstented patients, rather than in this short-term ureteral stent trial.

A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

BackgroundInfestation with the human head louse (Pediculus humanus capitis) occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92%) concentration of the silicone oil dimeticone (identical in composition to NYDA®), as compared to a 1% permethrin lotion.MethodsRandomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations) were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice) after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology.ResultsOverall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5%) and permethrin 66.7% (95% CI: 54.6% – 77.3%; p < 0.0001); day 7 – dimeticone 64.4% (95% CI: 53.3% – 75.3%) and permethrin 59.7% (95% CI: 47.5% – 71.1%; p = 0.5); day 9 – dimeticone 97.2% (95% CI: 90.3% – 99.7%) and permethrin 67.6% (95% CI: 55.4%-78.2%); p < 0.0001). Itching was reduced similarly in both groups. Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group (p = 0.01). Two mild product-related incidents occurred in the dimeticone group.ConclusionThe dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system), development of resistance is unlikely.Trial registrationCurrent Controlled Trials ISRCTN15117709.

A PROSPECTIVE RANDOMIZED SINGLE-BLIND COMPARISON OF URETERAL STENTS COMPOSED OF FIRM AND SOFT POLYMER

Ureteral stents are composed of different polymers and it is unclear if stent composition influences patient comfort. We compared the impact of stents composed of firm and soft polymer on patient health related quality of life. A total of 130 patients requiring insertion of ureteral stents during the treatment of urinary calculi were randomized to receive a stent composed of firm (Percuflex, group 1) or soft (Contour, group 2) polymer. Patients were asked to complete the Ureteric Stent Symptoms Questionnaire, a validated instrument, at weeks 1 and 4 with the stent in situ and 4 weeks after its removal, this served as the main outcome measure. Additional assessments included difficulty in stent insertion and the need for early stent removal. There were 78 men and 38 women in total (61 in group 1 and 55 in group 2) with a mean age of 51 years (range 22 to 79) and no difference in age between the 2 groups (p = 0.9). Comparison of the results of the Ureteric Stent Symptoms Questionnaire survey at weeks 1 and 4 with stent in situ revealed no significant differences in the domain scores of urinary symptoms (p = 0.9 and p = 0.8), pain (p = 0.8 and p = 0.6) and general health (p = 0.6 and p = 0.4). Similarly, there were no differences in the number of days with reduced activities, work performance (p = 0.7) and sexual dysfunction between the 2 groups. A similar number of patients (8 and 7 in groups 1 and 2, respectively) required stent removal earlier than planned due to stent related symptoms. This randomized study showed no difference in the impact on patient quality of life between ureteral stents composed of firm or soft polymer.

The Efficacy and Safety of Meropenem and Tobramycin vs Ceftazidime and Tobramycin in the Treatment of Acute Pulmonary Exacerbations in Patients With Cystic Fibrosis

Cystic fibrosis (CF) is characterized by chronic pulmonary infection with acute pulmonary exacerbations (APEs) requiring IV antibiotic treatment. We report on a blinded comparative trial of IV meropenem (40 mg/kg to 2 g q8h) or ceftazidime (5 mg/kg to 2 g q8h), each of which was administered with IV tobramycin (at a serum peak of > or = 8 microg/mL and a trough of < 2 microg/mL), as treatment for CF patients with APEs. Patients who were > or = 5 years of age who were infected with ceftazidime-susceptible Pseudomonas aeruginosa were stratified by lung function and randomized to treatment with meropenem/tobramycin or ceftazidime/tobramycin. Patients infected with Burkholderia cepacia complex or ceftazidime-resistant P aeruginosa were assigned to receive open-label meropenem/tobramycin. Clinical response was assessed by spirometry to determine the change in percent predicted FEV1 and by a clinical acute change score (ACS). One hundred two patients were randomized to meropenem/tobramycin (n = 50) or ceftazidime/tobramycin (n = 52). Nineteen patients received open-label meropenem/tobramycin. FEV1 was improved at the end of treatment (EOT) with meropenem/tobramycin (mean [+/- SD] increase, 38.8 +/- 52.3%) and with ceftazidime/tobramycin (mean increase, 29.4 +/- 35.1%; p < 0.0001 vs baseline values). The proportion of patients with > or = 15% relative increase from baseline FEV1 (satisfactory response) at day 7 was 62% for the meropenem/tobramycin group and 44% for the ceftazidime/tobramycin group (p = 0.04). The median time to FEV1 response was 4 days for meropenem/tobramycin therapy vs 6 days for ceftazidime/tobramycin therapy. Similarly, FEV1 improved in the open-label group (mean increase, 12.5 +/- 25.7%; p = 0.05). ACS improved in all three groups at EOT (p < 0.0001 vs baseline values). Therapy with both meropenem/tobramycin and ceftazidime/tobramycin improved pulmonary and clinical status and reduced sputum bacterial burden in CF patients with APEs. A larger proportion of patients receiving meropenem/tobramycin therapy demonstrated a satisfactory FEV1 response at day 7. Resistant P aeruginosa emerged infrequently during treatment with both regimens.

Crotaline snake bite in the Ecuadorian Amazon: randomised double blind comparative trial of three South American polyspecific antivenoms

Objective To compare the efficacy and safety of three polyspecific antivenoms for bites by pit vipers.Design Randomised double blind comparative trial of three antivenoms.Setting Shell, Pastaza, southeastern Ecuador.Participants 210 patients...

A Randomized Outcomes Trial of Ureteral Stents for Extracorporeal Shock Wave Lithotripsy of Solitary Kidney or Proximal Ureteral Stones

Routine use of ureteral stents before extracorporeal shock wave lithotripsy of kidney stones between 10 and 20 mm. is controversial. We conducted a prospective randomized clinical trial to evaluate the outcome of ureteral stents for treating solitary kidney stones between 10 and 20 mm. or solitary proximal ureteral stones less than 20 mm. with shock wave lithotripsy. A total of 97 patients who met the aforementioned criteria were randomized between March 1994 to July 1997 into group 1-no stent, group 2-a 4.7Fr multi-length stent and group 3-a 7Fr multi-length stent. The patients were treated with the Dornier HM3 lithotriptor (Dornier Medical Systems, Inc., Marietta, Georgia) and monitored for stone-free rate, number of days lost from work, number of patients requiring rehospitalization, emergency room visits, irritative voiding symptom score and pain symptom score. Objective outcome was obtained from 91 patients based on a followup of at least 3 months. The overall stone-free rate was 80%, with a re-treatment rate of 7%. The number of days lost from work was approximately 2, with no significant differences among individual groups or subgroups. The hospitalization rate and number of emergency room visits in group 1 (22%) were statistically higher compared to groups 2 (7%) and 3 (7%). The irritative voiding symptom score was statistically higher in the stented groups 2 and 3 compared to the nonstented group 1. Although ureteral stents are associated with more irritative symptoms, their use resulted in fewer hospital readmissions and emergency room visits compared to when no stent was used to treat solitary kidney stones of 10 to 20 mm. or solitary proximal ureteral stones less than 20 mm. Size 4.7Fr stents may be preferable over 7Fr stents when used in conjunction with shock wave lithotripsy.