A randomized,double-blind clinical trial comparing the effects of continuous and pulsed ultrasound in patients with chronic rhinosinusitis

The objective of the present study was to compare the effects of continuous ultrasound (CUS) with pulsed ultrasound (PUS) in patients with chronic rhinosinusitis (CRS). In this prospective, randomized, double-blind, parallel group study, 40 patients (10 losses) with CRS participated. Patients received either continuous or pulsed (1:9) 1 MHz ultrasound (US) using a US head of 1?cm² at 1 W/cm² and 0.5 W/cm² for the maxillary and frontal sinuses, respectively. Treatment was performed in 10 sessions, 3 days per week, with US given every other day. The primary outcome measure was percent improvement in the Sinusitis Symptom Score. Measurements were taken before and after 10 treatment sessions. The patients were followed up monthly for 2 months. After treatment, both groups improved significantly on the Sinusitis Symptoms Score. Patients who received PUS had significantly decreased total symptom scores compared with patients receiving CUS (mean change 9.8 vs. 5.6, p?=?0.049). The percent improvement in the Sinusitis Symptom Score between the PUS group (65.2 SD 23.1) and the CUS group (43.9 SD 40.7) was not statistically significant (p?=?0.09). The effect size for each treatment was large; PUS: d?=?3.92 and CUS: d?=?1.93. Symptom improvement in both groups was similar at the 2-month follow-up. These results support the use of therapeutic US for CRS. This pilot study gives only marginal evidence to favor PUS over CUS.     

A randomized clinical trial comparing pulsed ultrasound and erythromycin phonophoresis in the treatment of patients with chronic rhinosinusitis

Abstract

Therapeutic ultrasound, an important physiotherapy modality, has been used successfully in the treatment of patients with chronic rhinosinusitis (CRS). No study has compared pulsed ultrasound (PUS) with erythromycin phonophoresis (EP). The aim of this randomized, double-blind, parallel group study with concealed allocation was to compare PUS with EP. Sixty CRS patients were randomly allocated into two groups. Group 1 had PUS and Group 2 had EP. Patients were treated 3 days a week for 10 sessions over 4 weeks. The severity of nine CRS symptoms was self-rated by patients on an ordinal scale of 0–3 (absent, mild, moderate or severe) at baseline and after the 10th treatment session. Individual symptom scores were summed to obtain a “Total Symptom Score” (TSS). The outcome measure included percentage improvement in the TSS. A statistically significant improvement in TSS occurred with both PUS and EP therapy groups (p?<?0.05). The percentage improvement in the EP group was statistically greater than in the PUS group (67.2 versus 49.3%) (p?=?0.03). The effect sizes in both therapy groups were large; PUS: d?=?1.36 and EP: d?=?2.15. EP was found to be superior over PUS therapy.     

A double-blind trial of clinical effects of therapeutic ultrasound in knee osteoarthritis

A randomized double blind clinical trial was conducted to determine the effectiveness of ultrasound (US) therapy in knee osteoarthritis (OA). Sixty-seven patients (mean age 54.8 +/-7) were randomized to receive either 1 MHz frequency or 1 watt/cm(2) power continuous ultrasound for 5 min (n = 34) or sham US (n = 33) as a placebo. Ten sessions of treatment were applied to the target knee of the patient. A blinded evaluation at baseline and after treatment was made. Primary outcome was pain on movement assessed by visual analog scale (VAS). Secondary outcomes consisted of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and 50 meters walking time. Both groups showed significant improvements in knee pain on movement. In the treatment group, the improvement in VAS score was statistically and significantly higher (p < 0.001) and more pronounced than in the placebo group. Pain reduction averaged 47.76% in the treatment group (p = 0.013). Secondary outcomes improved in both groups but reached statistical significance only in the treatment group: p = 0.006 for the mean change in total WOMAC scores and p = 0.041 for 50 meters walking time. Results suggest that therapeutic US is safe and effective treatment modality in pain relief and improvement of functions in patients with knee OA.     

A randomized clinical trial comparing ranitidine and antacids in critically ill patients

In a randomized trial of gastric pH control for stress ulcer prophylaxis, 200 mg/day ranitidine iv was compared to antacids in 86 patients admitted to an ICU. Six (15%) patients receiving ranitidine and six (13%) given antacids failed to maintain greater than 50% of the hourly gastric pH measurements at or above 4. Increasing the ranitidine dosage to 300 mg/day did not provide additional control. One patient in the antacid group developed an overt upper GI bleed secondary to endoscopically proven erosive disease. We conclude that iv ranitidine in a dosage of 200 mg/day is as effective as antacids in reducing gastric acidity and preventing stress ulcer disease in critically ill patients.     

A double-blind, randomized, controlled trial comparing pinacidil to hydralazine in essential hypertension

Pinacidil is a direct vasodilator with good absorption, a half-life of 2 to 4 hours, and side effects similar to those of other vasodilators. We hypothesized that controlled-release pinacidil would be comparable to or better than hydralazine for blood pressure control and side effects. A double-blind, randomized trial comparing pinacidil with hydralazine when combined with hydrochlorothiazide or propranolol to control side effects or the diastolic blood pressure was performed. Pinacidil decreased systolic and diastolic blood pressure from 156/100 mm Hg to 132/81 mm Hg. The increase in heart rate and weight with both drugs was controlled with the additional drugs. There was 1/17 successes on monotherapy with both drugs. When combined with other drugs there were 15/18 successes with hydralazine and 16/20 successes with pinacidil. Side effects were typical of vasodilators. Both drugs acutely increased plasma norepinephrine and epinephrine during chronic therapy.     

Effect of pulsed ultrasound on chronic rhinosinusitis: A case report

This case report demonstrates that pulsed ultrasound (US), when used for a total of 20 treatment sessions, provided symptom relief to a patient with chronic rhinosinusitis (CRS). A 16-year-old boy with a 12-month history of rhinosinusitis and candidate for sinus surgery was referred for ultrasound therapy. He presented with facial pain/pressure, nasal obstruction, and postnasal drip (total sinusitis score=7). On computed tomographic (CT) scanning, the total opacification of the right maxillary sinus was observed. The ostiomeatal complex was occluded (total CT score=6). Pulsed ultrasound was administered three times a week, every other day. After 10 treatment sessions, his symptoms were resolved with exception of nasal obstruction being mild (total sinusitis score=2). On CT scan, right maxillary sinus showed partial improvement (total CT score=2). After additional 10 treatments, the nasal obstruction was resolved, and follow-up CT scan of his sinuses showed that right maxillary sinus was clear and normal. At 6-month follow-up, the positive effects were maintained and the patient reported no recurrence of symptoms. Twenty sessions of pulsed ultrasound therapy eradicated the CRS and resolved the symptoms.     

A double-blind one year clinical trial comparing alclofenac with gold in rheumatoid arthritis

Twenty-seven patients with rheumatoid arthritis entered and 20 completed a one year double blind trial in which the effects of alclofenac 1 g 3 or 4 times daily were compared with gold injections 50 mg weekly intramuscularly to 1 g then 50 mg monthly. Previous anti-inflammatory medication was continued. Assessments were done every 3 months. On both drugs there was a delayed continued improvement over at least the first 6 months in mean pain scores, morning stiffness, grip strength, articular index and an overall grading system. The mean ESR fell markedly in patients on gold, but in those on alclofenac it showed no consistent change. Several measurements showed improvements statistically compared with initial values in both groups after 6 months. Rheumatoid factor, and hand and feet X-rays, were not influenced by either treatment. Side effects were rather similar on both drugs, and 4 patients in each group developed a rash.     

A prospective,randomized, double-blind,multicenter study comparing remifentanil with fentanyl in mechanically ventilated patients

Purpose  

To compare the quality of analgesia provided by a remifentanil-based analgesia regime with that provided by a fentanyl-based regime in critically ill patients.     

A randomized, blinded trial comparing the hemostatic effects of pentastarch versus hetastarch

BACKGROUND: HES solutions provide a sterile, alternative colloidal fluid to albumin solutions and/or plasma in the management of patients who need plasma volume expansion. Solutions of HES are widely accepted internationally but are used only modestly in the United States, largely because of concerns over hemostasis. STUDY DESIGN AND METHODS: A randomized, blinded, two-arm trial comparing the hemostatic effects of pentastarch versus hetastarch when infused in the clinically relevant dose of 90 g of HES dissolved in 1.5 L of saline was conducted. Multiple studies of fibrin clot formation, fibrinogen/fibrinolysis, and platelet (PLT) functions were performed before and on multiple occasions for 70 days following HES infusion. RESULTS: Several significant abnormalities of hemostasis assay results occurred following HES infusions, with hetastarch causing significantly greater abnormalities than pentastarch. Individual clotting proteins and blood PLTs fell modestly because of plasma volume expansion and hemodilution. A fall in excess of that caused by hemodilution was demonstrated for von Willebrand factor antigen plus its associated FVIII and ristocetin cofactor activities. The partial thromboplastin time was prolonged, whereas the thrombin time was shortened. Plt function abnormalities were seen in most subjects to a modest degree. Studies of fibrinolysis were normal. CONCLUSIONS: Solutions of hetastarch produce significant abnormalities of some hemostasis laboratory results when infused at clinically relevant doses, but it is unlikely that the modest hemostatic abnormalities produced at these doses per se would lead to clinical bleeding. Hetastarch causes greater hemostatic abnormalities than pentastarch, and because both HES solutions have comparable plasma volume-expanding effects, it is reasonable to prefer pentastarch as a plasma volume expander.     

A prospective,randomized trial comparing endoscopic and surgical therapy for chronic pancreatitis

BACKGROUND AND STUDY AIMS: Invasive treatment for abdominal pain due to chronic pancreatitis may be either surgical or endoscopic, particularly in cases of ductal obstruction. To date, the data published on the effectiveness of these two forms of therapy have been mostly retrospective, and there have been no randomized studies. A prospective, randomized study comparing surgery with endoscopy in patients with painful obstructive chronic pancreatitis was therefore conducted. PATIENTS AND METHODS: Consecutive patients with pancreatic duct obstruction and pain were invited to participate in a randomized trial comparing endotherapy and surgery, the latter consisting of resection and drainage procedures, depending on the patient's individual situation. Patients who did not agree to participation and randomization were also further assessed using the same follow-up protocol. RESULTS: Of 140 eligible patients, only 72 agreed to be randomized. Surgery consisted of resection (80 %) and drainage (20 %) procedures, while endotherapy included sphincterotomy and stenting (52 %) and/or stone removal (23 %). In the entire group, the initial success rates were similar for both groups, but at the 5-year follow-up, complete absence of pain was more frequent after surgery (37 % vs. 14 %), with the rate of partial relief being similar (49 % vs. 51 %). In the randomized subgroup, results were similar (pain absence 34 % after surgery vs. 15 % after endotherapy, relief 52 % after surgery vs. 46 % after endotherapy). The increase in body weight was also greater by 20 - 25 % in the surgical group, while new-onset diabetes developed with similar frequency in both groups (34 - 43 %), again with no differences between the results for the whole group and the randomized subgroup. CONCLUSIONS: Surgery is superior to endotherapy for long-term pain reduction in patients with painful obstructive chronic pancreatitis. Better selection of patients for endotherapy may be helpful in order to maximize results. Due to its low degree of invasiveness, however, endotherapy can be offered as a first-line treatment, with surgery being performed in case of failure and/or recurrence.     

A randomized, double-blind study comparing morphine with fentanyl in prehospital analgesia

STUDY OBJECTIVE: The aim of this study was to compare, by a randomized double-blind method, morphine (M) and fentanyl (F) in a prehospital setting. METHODS: Consecutive patients with severe, acute pain defined as a visual analog scale score (VASS) of 60/100 or higher were included. The M group received an initial intravenous M injection of 0.1 mg/kg then of 3 mg every 5 minutes. The F group received an initial intravenous F injection of 1 microg/kg then of 30 microg every 5 minutes. The goal of analgesia was a VASS of 30/100 or lower. The end point was the VASS measured 30 minutes after initial administration (VAS [T30]). RESULTS: There were 26 patients included in the M group and 28 in the F group. Initial VASS(T0) and VASS(T30), mean (95% CI), were 83 (78-88) and 40 (28-52) in the M group and 77 (72-82) and 35 (27-43) in the F group (P=NS). Sixty-two percent of patients in the M group described analgesia as excellent or good vs 76% of those in the F group who did (P=NS). There were no differences in the incidence of side effects in the 2 groups. CONCLUSION: This study demonstrates that M and F were comparable in treating severe, acute pain in a prehospital setting during the first 30 minutes in spontaneous breathing patients.     

A randomized,double-blind,multicenter trial of nimesulide-beta-cyclodextrin versus naproxen in patients with osteoarthritis

BACKGROUND: Nonsteroidal anti-inflammatory drugs are the most widely used agents in the symptomatic treatment of osteoarthritis (OA). No data are presently available on the medium-term management of this disease with an on-demand treatment regimen, which nevertheless reflects medical practice. OBJECTIVES: The aim of this study was to compare nimesulide-beta-cyclodextrin and naproxen in terms of short-term (2 weeks) pain control with scheduled dosing and medium-term (5.5 months) pain control with on-demand dosing in patients with OA. METHODS: In this multicenter, randomized, double-blind, controlled study, we compared 2 weeks of scheduled treatment plus 5.5 months of on-demand treatment in patients with OA of the hip and/or knee and moderate to severe pain, with no important concomitant disorders. Treatment consisted of nimesulide-beta-cyclodextrin (400 mg BID, orally = 100 mg nimesulide BID) or naproxen (500 mg BID). The primary outcome measures for scheduled dosing were pain on movement (measured by visual analog scale), morning stiffness score, Lequesne index, and adverse events. For on-demand dosing, the measures were the same as for scheduled dosing, plus duration of treatment and global assessment of efficacy and tolerability by patient and physician. RESULTS: After 2 weeks, there was equivalent reduction from baseline in pain on movement in the 2 treatment groups (nimesulide-beta-cyclodextrin, -41.5%; naproxen, -40.5%); the reduction was significant after 1 week (P < 0.001). The findings were also similar for the morning stiffness score and Lequesne index. There were no significant differences in mean duration of on-demand treatment (nimesulide-beta-cyclodextrin, 163.03 days; naproxen, 166.3 days) or in mean consumption of study drug (nimesulide-beta-cyclodextrin, 0.85 +/- 0.61 sachets/d; naproxen, 0.74 +/- 0.42 sachets/d). Withdrawal due to intolerance occurred in 8 patients given nimesulide-beta-cyclodextrin and 13 patients given naproxen, with no significant difference between groups; 3 and 12 patients, respectively, withdrew due to gastrointestinal intolerance, a finding that was significantly different between groups (P < 0.01). Global assessment of efficacy by patient and physician was similar for both drugs. Assessment of tolerability significantly favored nimesulide-beta-cyclodextrin on the physician assessments (P < 0.05) but was similar for the 2 drugs on the patient assessments (physicians, 46.9% vs 30.9%; patients, 43.5% vs 33.3%). CONCLUSIONS: The results suggest that nimesulide-beta-cyclodextrin provides similar pain relief to naproxen in the management of OA of the hip and/or knee and is associated with fewer gastrointestinal adverse reactions. On-demand dosing may be an effective and well-tolerated low-dose regimen of nonsteroidal anti-inflammatory drugs for the maintenance of pain control in OA in the medium term.     

A randomized clinical trial of TENS and exercise for patients with chronic neck pain

OBJECTIVE: To investigate the effect of transcutaneous electrical nerve stimulation (TENS) on acupuncture points and neck exercise in chronic neck pain patients. DESIGN: A randomized clinical trial. SETTING: Hospital-based practice. SUBJECTS: Two hundred and eighteen patients with chronic neck pain. INTERVENTIONS: Subjects were randomized into three groups, receiving either (1) TENS over the acupuncture points plus infrared irradiation (TENS group); (2) exercise training plus infrared irradiation (exercise group); or (3) infrared irradiation alone (control); twice a week for six weeks. OUTCOME MEASURES: The values of verbal numeric pain scale, Northwick Park Neck Pain Questionnaire, and isometric neck muscle strength were assessed before, at the end of the six-week treatment, and at the six-month follow-up. RESULTS: Results demonstrated that after the six-week treatment, significant improvement in the verbal numerical pain scale was found only in the TENS group (0.60+/-2.54, p = 0.027) and the exercise group (1.57+/-2.67, p < 0.001). Though significant reduction in Northwick Park Neck Pain Questionnaire score was found in all three groups, post-hoc tests showed that both the TENS and the exercise group produced better improvement (0.38+/-0.60% and 0.39+/-0.62% respectively) than the control group (0.23+/-0.63%). Significant improvement (p = < 0.001 to 0.03) in neck muscle strength was observed in all three groups, however, the improvement in the control group was not clinically significant and it could not be maintained at the six-month follow-up. CONCLUSIONS: After the six-week treatment, patients in the TENS and exercise group had a better and clinically relevant improvement in disability, isometric neck muscle strength, and pain. All the improvements in the intervention groups were maintained at the six-month follow-up.     

Memantine for prophylaxis of chronic tension-type headache—a double-blind, randomized, crossover clinical trial

Treatment for chronic tension-type headache (CTTH) is unsatisfactory. Our aim was to investigate the efficacy of the N-methyl D-aspartate (NMDA) antagonist memantine in the prophylactic treatment of CTTH. We included 40 patients in a randomized, double-blind, placebo-controlled, crossover trial. Memantine 20–40 mg/day or placebo was each given for 10 weeks separated by a 2-week wash-out period; 29 patients completed the study. The primary efficacy variable, area-under-the-headache curve (duration × intensity), did not differ between memantine (1352 ± 927) and placebo (1449 ± 976; P  = 0.10). Headache intensity in both sexes was significantly lower on a 0–10 verbal rating scale with memantine (3.8) than with placebo (4.1; P  = 0.03). In women, area-under-the-headache curve was significantly lower with memantine (1343 ± 919) than with placebo (1555 ± 1019; P  = 0.01). The most common side-effects were dizziness and nausea. In conclusion, although no statistically significant effect was seen in the primary end-point, some beneficial effects of memantine were observed in women. Memantine was shown to reduce pain intensity in CTTH patients, albeit to a limited extent. Future NMDA antagonists with higher efficacy could be of major interest as regards the pathophysiology and future treatment of CTTH and other chronic pain disorders.     

A randomized clinical trial comparing breakfast,dinner, or bedtime administration of insulin glargine in patients with type 1 diabetes

OBJECTIVE: Insulin glargine (Lantus), a long-acting human insulin analog, provides effective glycemic control when administered at bedtime. This open-label, randomized, parallel group, multicenter study investigated whether insulin glargine is equally effective if administered before breakfast, before dinner, or at bedtime. RESEARCH DESIGN AND METHODS: Patients with type 1 diabetes on basal-bolus therapy (n = 378, 18-68 years, HbA(1c) 5.5-9.8%) were treated with once-daily individually titrated insulin glargine in combination with prandial insulin lispro for 24 weeks. RESULTS: Baseline characteristics were similar in the three groups (overall age 40.9 +/- 11.9 years, diabetes duration 17.3 +/- 11.5 years). Median total daily insulin dose was similar at baseline (0.65, 0.65, and 0.66 IU/kg for breakfast, dinner, and bedtime, respectively) and remained relatively constant over the study period; however, the insulin glargine-to-total insulin dose ratio increased more in the breakfast group than in the dinner and bedtime groups. A similar reduction of adjusted mean HbA(1c) from baseline to end point occurred in all patients (7.6-7.4, 7.6-7.5, and 7.6-7.5% for breakfast, dinner, and bedtime, respectively), and a similar percentage achieved HbA(1c) <7.0% at end point in all groups (29.5, 29.8, and 25.8%, respectively). The 24-h blood glucose profiles in relation to injection time were similar in all groups. The incidences of total symptomatic and severe hypoglycemia did not differ between the three treatment groups; however, nocturnal hypoglycemia occurred in significantly fewer patients in the breakfast group (59.5%) compared with the dinner (71.9%) and bedtime (77.5%) groups (P = 0.005). CONCLUSIONS: These data suggest that insulin glargine, in combination with insulin lispro, is safe and effective when administered before breakfast, before dinner, or at bedtime.     

A randomized,double-blind,placebo-controlled,clinical trial of the effects of pioglitazone on glycemic control and dyslipidemia in oral antihyperglycemic medication-naive patients with type 2 diabetes mellitus

OBJECTIVE: The goal of this study was to compare the effects of 2 doses of pioglitazone hydrochloride (a thiazolidinedione insulin sensitizer) with placebo on glycated hemoglobin (HbA(1c)), insulin sensitivity, and lipid profiles in patients with type 2 diabetes mellitus who had suboptimal glycemic control and mild dyslipidemia. METHODS: Patients with type 2 diabetes mellitus (HbA(1c) >/=6.5% and /=7% to <8%) or high (>/=8% to 相似文献