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PubMed1990

Erythromycin for persistent or recurrent nongonococcal urethritis. A randomized, placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy of a 3-week regimen of erythromycin for treatment of persistent or recurrent nongonococcal urethritis in men. DESIGN: A prospective, randomized, double-blind trial with follow-up at 2, 4, and 8 weeks after enrollment. PATIENTS: Seventy-seven evaluable men with objective evidence of nongonococcal urethritis (36 in the erythromycin group and 41 in the placebo group) with a mean age of 28 years, a median duration of urethritis of 3 months, and a median number of three previous antimicrobial regimens. INTERVENTION: Erythromycin, 500 mg, or placebo four times daily for 3 weeks. RESULTS: After 2 weeks of treatment, urethral symptoms resolved in 13 of 25 erythromycin-treated patients compared with 8 of 34 placebo-treated patients (P = 0.03). Erythromycin also resulted in more frequent resolution of urethral discharge and leukocytosis at all visits compared with placebo but these differences were not statistically significant. First-voided urine leukocyte counts decreased, however, by a median of 89% (95% CI, -96% to -67%) in the erythromycin group compared with 23% (CI, -73% to 83%) in the placebo group after treatment (P = 0.02 for the difference in changes). Further, in men with prostatic inflammation, urinary leukocyte counts decreased by a median of 94% (CI, -99% to -83%) after treatment in erythromycin-treated patients compared with a 46% increase (CI, -57% to 290%) in placebo-treated patients (P = 0.0003 for the difference in changes). CONCLUSION: A 3-week regimen of erythromycin was more effective than placebo in improving symptoms and in reducing pyuria in men with persistent or recurrent nongonococcal urethritis, especially among men with prostatic inflammation.

Adult↗
PubMed1991

Response to treatment with the leukocyte-derived immunomodulator IMREG-1 in immunocompromised patients with AIDS-related complex. A multicenter, double-blind, placebo-controlled trial.

OBJECTIVE: To determine if a 6-month course of therapy with IMREG-1, a leukocyte-derived immunomodulator, slows disease progression in patients with AIDS-related complex. DESIGN: Randomized, double-blind trial. SETTING: Five academic- and three community-based clinics. PATIENTS: Immunocompromised patients (143) with HIV. INTERVENTIONS: IMREG-1 or placebo every 2 weeks (13 doses). MAIN RESULTS: Twelve of forty-eight patients on placebo and 5 of 95 patients on IMREG-1 experienced adverse events (AIDS-defining opportunistic infection or neoplasm, wasting syndrome, HIV-associated encephalopathy, or peripheral sensory neuropathy). Based on an intention-to-treat analysis, Kaplan-Meier event probabilities were 26% for the placebo group and 6% for the IMREG-1 group (P less than 0.001); based on the Cox proportional hazards model, the relative risk for patients on placebo compared with patients on IMREG-1 was 5.1 (95% CI, 1.8 to 14.8). The frequency of symptoms significantly increased from baseline in patients receiving placebo. The mean decrease in CD4+ cells from baseline was 80 x 10(6) cells/L in the placebo group and 29 x 10(6) cells/L in patients on IMREG-1, with 20% (8) and 38% (32) of patients, respectively, showing a trend toward an increase (P = 0.04). In patients receiving IMREG-1, the size and rate of delayed hypersensitivity responses were larger than in the placebo group. CONCLUSIONS: Patients with AIDS-related complex experienced fewer adverse events and constitutional symptoms after IMREG-1 treatment. The slower loss of CD4+ cells and increased size and rate of delayed hypersensitivity responses most likely reflect the effect of IMREG-1 on the immune system. No toxicity related to IMREG-1 administration was observed.

AIDS-Related Complex↗
PubMed1993

Oral acyclovir to suppress frequently recurrent herpes labialis. A double-blind, placebo-controlled trial.

OBJECTIVE: To determine whether oral acyclovir reduces the incidence of recurrent herpes labialis in otherwise healthy patients with proven frequently recurrent disease. DESIGN: Randomized, double-blind, placebo-controlled, crossover trial. SETTING: Outpatient facility of the Clinical Center, National Institutes of Health, Bethesda, Maryland. PATIENTS: Fifty-six otherwise healthy adults who reported frequently recurrent herpes labialis (> or = 6 episodes/y) were enrolled into the study. During a 4-month observation period, 22 patients had herpes labialis two or more times and were eligible for study treatment. INTERVENTIONS: Twenty-two patients were randomized to receive either acyclovir, 400 mg twice daily, or matched placebo for 4 months. After the first treatment period, patients were given the alternate treatment for another 4 months and were then taken off study medication to observe the first post-treatment recurrence. Recurrent outbreaks were determined by examination and by viral culture. RESULTS: Twenty patients completed blind treatment with both acyclovir and placebo. The median time to first clinically documented recurrence was 46 days for placebo courses and 118 days for acyclovir courses (P = 0.05). The mean number of recurrences per 4-month treatment period was 1.80 episodes per patient during placebo treatment and 0.85 episodes per patient during acyclovir treatment (P = 0.009). The mean number of virologically confirmed recurrences per patient was 1.40 with placebo therapy compared with 0.40 with acyclovir (P = 0.003). CONCLUSIONS: Oral acyclovir, 400 mg twice daily, is effective in suppressing herpes labialis in immunocompetent adults confirmed to have frequently recurrent infection. Treatment with acyclovir in this study resulted in a 53% reduction in the number of clinical recurrences and a 71% reduction in virus culture-positive recurrences compared with placebo therapy.

Acyclovir↗
PubMed2001

Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial.

BACKGROUND: Although observational studies suggest that estrogen replacement therapy (ERT) reduces cardiovascular morbidity and mortality in postmenopausal women, use of unopposed ERT for prevention of coronary heart disease in healthy postmenopausal women remains untested. OBJECTIVE: To determine the effects of unopposed ERT on the progression of subclinical atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: University-based clinic. PATIENTS: 222 postmenopausal women 45 years of age or older without preexisting cardiovascular disease and with low-density lipoprotein cholesterol levels of 3.37 mmol/L or greater (>/=130 mg/dL). INTERVENTION: Unopposed micronized 17beta-estradiol (1 mg/d) or placebo. All women received dietary counseling. Women received lipid-lowering medication if their low-density lipoprotein cholesterol level exceeded 4.15 mmol/L (160 mg/dL). MEASUREMENTS: The rate of change in intima-media thickness of the right distal common carotid artery far wall in computer image processed B-mode ultrasonograms obtained at baseline and every 6 months during the 2-year trial. RESULTS: In a multivariable mixed-effects model, among women who had at least one follow-up measurement of carotid intima-media thickness (n = 199), the average rate of progression of subclinical atherosclerosis was lower in those taking unopposed estradiol than in those taking placebo (-0.0017 mm/y vs. 0.0036 mm/y); the placebo-estradiol difference between average progression rates was 0.0053 mm/y (95% CI, 0.0001 to 0.0105 mm/y) (P = 0.046). Among women who did not receive lipid-lowering medication (n = 77), the placebo-estradiol difference between average rates of progression was 0.0147 mm/y (CI, 0.0055 to 0.0240) (P = 0.002). Average rates of progression did not differ between estradiol and placebo recipients who took lipid-lowering medication (n = 122) (P > 0.2). CONCLUSIONS: Overall, the average rate of progression of subclinical atherosclerosis was slower in healthy postmenopausal women taking unopposed ERT with 17beta-estradiol than in women taking placebo. Reduction in the progression of subclinical atherosclerosis was seen in women who did not take lipid-lowering medication but not in those who took these medications.

Aged↗
PubMed2005

Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Lateral epicondylitis is a common condition for which botulinum toxin has been reported to have a therapeutic role in uncontrolled studies. OBJECTIVE: To determine if an injection of botulinum toxin is more effective than placebo for reducing pain in adults with lateral epicondylitis. DESIGN: Randomized, double-blind, placebo-controlled trial conducted from September 2002 to December 2004. SETTING: Outpatient clinics at a university hospital and a district hospital in Hong Kong. PARTICIPANTS: 60 patients with lateral epicondylitis. MEASUREMENTS: The primary outcome was change in subjective pain as measured by a 100-mm visual analogue scale (VAS) ranging from 0 (no pain) to 10 (worst pain ever) at 4 weeks and 12 weeks. All patients completed post-treatment follow-up. INTERVENTIONS: A single injection of 60 units of botulinum toxin type A or normal saline placebo. RESULTS: Mean VAS scores for the botulinum group at baseline and at 4 weeks were 65.5 mm and 25.3 mm, respectively; respective scores for the placebo group were 66.2 mm and 50.5 mm (between-group difference of changes, 24.4 mm [95% CI, 13.0 to 35.8 mm]; P < 0.001). At week 12, mean VAS scores were 23.5 mm for the botulinum group and 43.5 mm for the placebo group (between-group difference of changes, 19.3 mm [CI, 5.6 to 32.9 mm]; P = 0.006). Grip strength was not statistically significantly different between groups at any time. Mild paresis of the fingers occurred in 4 patients in the botulinum group at 4 weeks. One patient's symptoms persisted until week 12, whereas none of the patients receiving placebo had the same complaint. At 4 weeks, 10 patients in the botulinum group and 6 patients in the placebo group experienced weak finger extension on the same side as the injection site. LIMITATIONS: The trial was small, and most participants were women. The blinding protocol may have been ineffective because the 4 participants who experienced paresis of the fingers could have correctly assumed that they received an active treatment. CONCLUSIONS: Botulinum toxin injection may improve pain over a 3-month period in some patients with lateral epicondylitis, but injections may be associated with digit paresis and weakness of finger extension.

Adult↗
PubMedDate not supplied

Does nimesulide induce gastric mucosal damage? "A double-blind randomized placebo-controlled trial".

BACKGROUND/AIMS: In this study, it was aimed to examine the effect of nimesulide, a selective inhibitor of cox-2 enzyme, to the gastric mucosa and to correlate its effect with aspirin. METHODOLOGY: This study was planned as double-blind, randomized and placebo-controlled. Mean age of voluntary persons (n = 32) was 42.3 +/- 2.7. Divided into 3 groups of volunteers were given randomized placebo (n = 10), aspirin (n = 10) (500 mg aspirin, Bayer) and nimesulide (n = 12) (100 mg mesulid, Pfizer) with 50 mL of water after 12 hours fasting period at 08.00 am. Gastroduodenoscopy was performed to the volunteers 3 hours after each therapy. RESULTS: Endoscopic scores of groups were; placebo: 0.20 +/- 0.13, aspirin: 2.8 +/- 0.46, nimesulide: 1.41 +/- 0.51. Lesion scores both in the aspirin group when compared with nimesulide and placebo groups (P < 0.00002, < 0.03), and in the nimesulide group when compared with the placebo group (P < 0.01) were significantly high. The positivity of Helicobacter pylori of groups was found; 67% in placebo, 72% in aspirin, 71% in nimesulide and there was no statistically significant difference in the groups. CONCLUSIONS: It was shown that nimesulide causes significantly serious gastric mucosal lesion when compared with placebo. The lesion score of nimesulide was found less than aspirin. According to the findings, nimesulide should be given carefully just as other analgesics due to the probability of causing gastric lesion.

Adult↗
PubMed2000

[Penicillin treatment of acute maxillary sinusitis in adults. A randomized, double-blind, placebo-controlled trial from general practice].

INTRODUCTION: The aim of the study was to compare the effectiveness of penicillin V with placebo in the treatment of adult patients with acute maxillary sinusitis (in general practice). MATERIAL AND METHODS: The study was designed as a randomised, double-blind, placebo-controlled trial in 26 Danish general practices. The participants were 133 adult patients with acute maxillary sinusitis clinically diagnosed on maxillary pain and raised values of either C-reactive protein (CRP) or the erythrocyte sedimentation (ESR) rate. Main outcome measures were pain score and illness score, and CRP and ESR values after initiation of treatment. RESULTS: Penicillin V led to a better recovery than placebo. The difference in pain reduction was statistically significant three days after initiation of treatment, whereas no significant difference was found in the reduction in the sense of illness. At the end of the study, significantly more patients in the penicillin group were completely free of pain than in the placebo group. This difference was found only in patients with an initial pain score of more than three. The cure rate was 71% in the penicillin group and 37% in the placebo group. Significantly more patients treated with penicillin achieved normal CRP values than those receiving placebo, respectively 88% and 75%. CONCLUSION: Penicillin V is more effective than placebo in the treatment of acute maxillary sinusitis in adults in general practice, but only in patients with pronounced pain.

Adolescent↗
PubMed2000

Propinox in intestinal colic: multicenter randomized prospective double-blind study of three doses of propinox vs. placebo in acute intestinal colic pain.

The aim of this double-blind study was to assess the efficacy and tolerability of propinox administered i.v. and to establish a dose-response relationship according to three dose levels (10 mg, 20 mg and 30 mg), vs. placebo in patients with moderate-to-severe acute intestinal colic pain. Four hundred patients (100 per treatment group) were included and allocated to the following treatment groups: propinox 10 mg, 20 mg, 30 mg and placebo. All treatments induced significant and progressive pain reduction as from the 20 min evaluation of 20.3% in the placebo group, 45% in the group treated with propinox 10 mg; 52% in the group receiving propinox 20 mg and 56% in the propinox 30 mg group. Statistical comparison showed differences between placebo and the three active doses as well as between propinox 10 mg and the 20 mg and 30 mg doses. The 20 min evaluation revealed that 40% of patients receiving placebo had to be excluded from the study due to lack of efficacy; the percentage of which was significantly higher compared with those observed with the three doses of propinox ranging between 10% and 13%. The 120 min evaluation revealed that 47.7% of patients treated with propinox 10 mg were free from pain vs. 68.8% and 73.5% of those receiving 20 mg and 30 mg, respectively. These percentages were considerably higher than the 15% found with placebo. Statistical analysis revealed significant differences between the 10 mg vs. the 20 mg and 30 mg groups with not differences between the latter doses. No differences in blood pressure or heart rate were found among treatments. The incidence of mouth dryness was significantly more frequent with the 20 mg and 30 mg doses of propinox than with the placebo or the 10 mg dose.

Adolescent↗
PubMed2001

Chondroitin sulfate in osteoarthritis of the knee: a prospective, double blind, placebo controlled multicenter clinical study.

OBJECTIVE: To assess the efficacy and safety of chondroitin sulfate (CS) 1 g/day per os compared to placebo, in a double blind, randomized, parallel group study, with 3 months treatment followed by a 3 month posttreatment period, in patients with femorotibial osteoarthritis (OA). METHODS: The main criterion was the functional handicap assessed by Lequesne's algofunctional index (AFI). Secondary efficacy criteria were: self-assessed pain with activity and at rest, self-assessed impact of OA on daily living, patient and physician assessed overall change in patient state since the previous visit, and daily NSAID and analgesic consumption, all evaluated monthly. The main analysis was performed on the intent-to-treat (ITT) population at treatment endpoint compared to baseline (Day 0). RESULTS: The ITT efficacy data set comprised 130 patients (63 in CS group and 67 in placebo group). At treatment endpoint, the AFI showed greater but nonsignificant improvement in the CS than in the placebo group. Improvement became significant (p = 0.02) in the completer population (n = 114). In the ITT population, all variables tended towards greater improvement in the CS than the placebo group. In the completer population, pain at rest also significantly decreased in the CS group compared to the placebo group (p = 0.03), and, one month after treatment, CS had a significantly higher persistent effect than placebo on the AFI (p = 0.01), pain with activity (p = 0.001), physician assessed patient state (p = 0.05), and most other efficacy criteria. Adverse event rates did not differ significantly. CONCLUSION: We observed a trend towards efficacy of CS 1 g/day compared to placebo with good tolerability after 3 month treatment, and persistent efficacy one month posttreatment. Further investigations are required to confirm this trend.

Administration, Oral↗
PubMed1999

Quality of life of patients with mild hypertension treated with captopril: a randomized double-blind placebo-controlled clinical trial.

OBJECTIVE: To determine the quality of life (QOL) of mild hypertensive patients treated with captopril as compared to placebo. METHODS: This is a randomized, double-blind, placebo-controlled clinical trial held in the out-patient clinic of Zhong Shan Hospital. Adult patients aged from 28 to 75 years with mild hypertension defined as diastolic blood pressure from 90 to 105 mm Hg were the inclusion criteria of the study. There were 278 patients who were eligible to enter the study. They were randomized to receive captopril or placebo 25 to 50 mg bid for 12 weeks. Change of QOL was compared both quantitatively and qualitatively between captopril and placebo groups. Change of blood pressure and side effects were also compared. RESULTS: With intention-to-treat analysis, significantly more improved QOL patients could be found qualitatively in patients with captopril treatment (45.3% vs 23.7%, P = 0.0002 for physical health domain; 48.9% vs 26.6%, P = 0.0002 for mental health domain; 33.8% vs 11.5%, P = 0.0001 for general function domain). Quantitatively, the change of score of mental health, general function and total QOL of captopril (3.18 +/- 5.90; 1.65 +/- 4.43; 7.84 +/- 11.03) were significantly higher than those of placebo (1.32 +/- 5.13, P = 0.00004; 0.64 +/- 3.45, P = 0.0008; 4.19 +/- 10.33, P = 0.0025 respectively), and the change of score of physical health domain (3.01 +/- 5.26 vs 2.23 +/- 4.79, P = 0.044) was of borderline statistical significant difference. Blood pressure was significantly lowered by captopril than by placebo (P = 0.000). CONCLUSION: Compared with the placebo, captopril is not only effective in lowering blood pressure, as has been established, but also effective in improving QOL in mild hypertensives.

Adult↗
PubMed2002

Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis.

OBJECTIVE: We compared the efficacy and upper gastrointestinal safety of the cyclooxygenase-2-specific inhibitor valdecoxib with naproxen and placebo in treating moderate to severe osteoarthritis of the knee. STUDY DESIGN: This multicenter, randomized, double-blind, placebo-controlled study compared the efficacy and upper gastrointestinal tract safety of valdecoxib at dosages of 5, 10, and 20 mg once daily with placebo and naproxen at the dosage of 500 mg twice daily. POPULATION: We included patients who had been diagnosed with moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology. OUTCOMES MEASURED: The Patient's and Physician's Global Assessment of Arthritis (PaGAA, PhGAA), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), and Western Ontario and McMaster's Universities (WOMAC) Osteoarthritis indices were assessed at baseline and at weeks 2, 6, and 12. Upper gastrointestinal ulceration was assessed by pre- and posttreatment endoscopies. RESULTS: Valdecoxib 10 and 20 mg once daily (but not 5 mg once daily) demonstrated similar efficacy to naproxen at 500 mg twice daily, and all 3 dosages were superior to placebo for the PaGAA, PhGAA, PAAP-VAS, and WOMAC Osteoarthritis indices at most assessments throughout the 12-week study (P <.05). The incidence of endoscopically proven ulcers was significantly higher in the naproxen group than in the 5- and 10-mg valdecoxib groups, but not in the 20-mg valdecoxib group. All 3 valdecoxib doses were comparable to placebo in ulcer incidence. CONCLUSIONS: Valdecoxib (10 and 20 mg once daily) is significantly superior to placebo and as effective as naproxen (500 mg twice daily) in improving moderate to severe osteoarthritis of the knee. Upper gastrointestinal tract safety of valdecoxib (5 and 10 mg) was comparable to that of placebo and significantly better than that of naproxen.

Aged↗
PubMed2003

No effect of highly dosed nitric oxide donor molsidomine on the angiographic restenosis rate after percutaneous coronary angioplasty: a randomized, placebo controlled, double-blind trial.

BACKGROUND: Nitric oxide (NO) counteracts several mechanisms involved in the restenotic process after coronary angioplasty. NO mediates an antiproliferative effect on smooth muscle cells, inhibition of leukocyte-vessel wall interactions, and platelet aggregation and adhesion. Because these effects are mainly dose dependent, NO-releasing drugs have to be applied at a high dose to have an effect on restenotic mechanisms. OBJECTIVES: To study the effect of the NO donor molsidomine at a high dose of 8 mg tid on angiographic restenosis rate in a randomized, placebo controlled, double-blind trial. PATIENTS AND METHODS: One hundred and sixty-six patients with de novo stenosis were randomly assigned to molsidomine or placebo treatment for six months (83 patients each). The primary end point was the angiographic restenosis rate at six months. The secondary end points were major adverse cardiac events (MACE) including death, myocardial infarction and revascularization. Analyses were performed by intention to treat. RESULTS: There were no differences in clinical, procedural and angiographic data, including minimum lumen diameter and reference diameter. Provisional stenting was performed in 28% of patients receiving molsidomine and 25% of patients treated with placebo. All other patients were treated with standard balloon angioplasty. Reangiography rate was 89.3% (molsidomine 90 lesions, placebo 97 lesions). Restenosis rate (greater than 50% diameter stenosis) was not significantly different (molsidomine 25.6% and placebo 29.9%). Patients receiving molsidomine improved significantly more in their anginal class than patients receiving placebo (P<0.026). Occurrence of MACE did not significantly differ between both groups (molsidomine 26.8% and placebo 34.9%, P=0.26). CONCLUSION: Treatment with the NO donor molsidomine at a high dose of 8 mg tid for six months after coronary angioplasty has no effect on the angiographic restenosis rate. Due to the vasodilating effect of NO, the anginal status improves slightly more in patients receiving molsidomine.

Administration, Oral↗
PubMed1992

[Anti-emetic effect and safety of ondansetron tablet in double-blind comparison with placebo].

Ondansetron, a selective 5-HT3 receptor antagonist, has already been reported to have a marked effect to alleviate or prevent nausea and vomiting associated with cancer chemotherapy, after its intravenous administration. The present study was planned to examine the usefulness of its tablet form, which was prepared for the convenient use in outpatients receiving chemotherapy. In order to make an objective evaluation of anti-emetic effect and safety of ondansetron 4 mg tablet, this study was conducted in double-blind comparison versus placebo in patients receiving cisplatin at a single dose of 50mg/m2 or higher. Either 4 mg of ondansetron or placebo (lactose tablet) was administered orally once at 2 hrs prior to administration of cisplatin. If any satisfactory anti-emetic effects were not obtained, 4 mg of ondansetron injection was given once intravenously as a rescue medication. The inhibitory effect on nausea and vomiting was assessed in 4 grades as "excellent", "good", "fair" and "poor" based on severity of nausea and number of vomiting that occurred during the first 24hrs after administration of cisplatin. When rescue medication was conducted, the case was assessed as "poor". Ondansetron was significantly superior to placebo in inhibition of nausea and vomiting, in which efficacy rates (excellent+good) of ondansetron and placebo groups were 58.1% (25/43 cases) and 16.7% (7/42 cases), respectively. Number of cases requiring rescue medication with ondansetron injection was obviously greater in placebo group (31 cases) than that in ondansetron group (12 cases). In those patients given ondansetron injection as the rescue medication, satisfactory effects were obtained in 5 cases in ondansetron group and in 18 cases in placebo group. Although side effects including chest itching (ondansetron group), headache and dull headache (placebo group) were observed after the rescue medication with ondansetron injection, these symptoms were not severe and disappeared after 1-2 days. As mentioned above, ondansetron tablet was shown to possess excellent anti-emetic effect on nausea and emesis induced by high dose of cisplatin and to have no problem in safety. Hence ondansetron was proven to be clinically very useful anti-emetic.

Administration, Oral↗
PubMed2003

Analgesic efficacy of low-dose diclofenac versus paracetamol and placebo in postoperative dental pain.

AIMS: To compare the efficacy and safety of diclofenac-K (12.5 mg) vs paracetamol (500 mg) and placebo given in a flexible dosage regimen to treat pain resulting from extraction of impacted third molar teeth. METHODS: This was a 2-day, double-blind, double-dummy, randomized, parallel-group, placebo-controlled study of diclofenac-K (12.5 mg) tablets vs paracetamol (500 mg) tablets and placebo in patients with moderate or severe pain within 8 hours of extraction of impacted third molars. RESULTS: After the first 2-tablet dose, patients took on average 2.5 additional tablets of diclofenac-K or 2.4 tablets of paracetamol, almost all as 1-tablet doses. Most placebo patients discontinued by taking rescue medication (ibuprofen 200 mg) on the first day. Pain relief after the initial dose of diclofenac-K (2 x 12.5 mg) was superior to placebo (P < .01 for all efficacy outcomes) and comparable to paracetamol (2 x 500 mg). About 30% of patients in each active treatment group took rescue medication during the study, compared to 78% on placebo. About 70% in each active treatment group considered the overall pain relief to be "some," "a lot," or "complete" compared to only 15% on placebo. The incidence of adverse events in each active treatment group was low and comparable between the treatments. CONCLUSION: An initial double-dose of diclofenac-K (2 x 12.5 mg) or paracetamol (2 x 500 mg) adequately relieved the most intense postoperative pain, and the flexible multiple dose regimen (1 or 2 tablets) maintained adequate pain relief thereafter. Most patients needed only 1-tablet doses following the initial 2-tablet dose.

Acetaminophen↗
PubMed2004

Concomitant medication use in a large, international, multicenter, placebo controlled trial of anakinra, a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis.

OBJECTIVE: To examine the safety of anakinra when added to a background of standard rheumatoid arthritis (RA) medications in patients with RA with active disease. METHODS: This analysis further evaluates data from the first 6 months of a blinded, placebo controlled safety trial that had a subsequent 30 month, open label portion (not reported here). Patients with RA with a wide range of comorbid conditions, disease activity, and background medications were randomly assigned in a 4:1 allocation ratio to treatment with anakinra 100 mg or placebo administered daily by injection. Safety was assessed by comparing adverse event profiles between anakinra and placebo patients according to concomitant medications received. RESULTS: Anakinra patients (n = 1116) showed no difference in the incidence of upper respiratory infections or overall serious adverse events compared with placebo patients (n = 283). The anakinra group had more injection site reactions (72.6% vs 32.9% in placebo) and a small increase in serious infections (2.1% vs 0.4% in placebo). Anakinra's safety profile did not differ in patients receiving antihypertensive, antidiabetic, or statin drugs. CONCLUSION: This study indicates that anakinra has a good safety profile in patients typically seen in a rheumatology practice who are considered candidates for therapy with agents that are immunomodulatory and disease modifying. Except for injection site reactions and a nonstatistically although potentially clinically significant increase in serious infections in the anakinra versus the placebo groups, the addition of anakinra to a stable background regimen of RA medications introduced no other important safety risk in patients with RA.

Antirheumatic Agents↗
PubMedDate not supplied

Evaluating the efficiency of a combination of Pygeum africanum and stinging nettle (Urtica dioica) extracts in treating benign prostatic hyperplasia (BPH): double-blind, randomized, placebo controlled trial.

OBJECTIVES: In spite of its historical use, published data about phytotherapic products is characterized by the absence of well conducted studies, leading to conflictive and indefinite results about efficiency and safety of theses drugs. In that sense, we have analyzed the results of a combination of Pygeum africanum and stinging nettle (Urtica dioica) extracts in patients with benign prostatic hyperplasia (BPH), based in a double-blind, randomized, placebo-controlled protocol. MATERIALS AND METHODS: We have selected, according to inclusion and exclusion criteria, only patients with >or=50 years, presenting urinary symptoms assessed by the International Prostatic Symptoms Score (IPSS), with minimum score of 12, and Quality of Life (QoL) index of at least 3 points, rectal examination consistent with BPH, and maximum urinary flow rate (Q(max)) between 5 and 15 mL/s. Phytotherapic and placebo groups were formed by 27 and 22 patients, respectively. The major variables analyzed during the study were IPSS variation, Q(max), and side effects. Reduction of >or=30% and >or=50% in IPSS were the parameters used to define a clinically significant response (CSR). We have also analyzed >or=30% and >or=50% Q(max) increases. RESULTS: After six months of treatment we did not observe significant differences in clinical improvement potential between the phytotherapic combination and placebo groups. Percent IPSS drop of 21.6% in the phytotherapic group was similar to 19.7% obtained in the placebo group (p=0.928). Neither we observed any difference (p=0.530) for QoL improvement between phytotherapic (9.26%) and placebo (5.98%) groups. The alterations of Q(max) followed the trend line observed in clinical data, with no significant difference (p=0.463) in Q(max) increasing percent between phytotherapic (17.2%) and placebo (13.3%) groups. The CSR evaluation of clinical and urodynamic data was also similar between the groups. CONCLUSION: The combination of 25mg Pygeum africanum and 300mg stinging nettle extracts produced clinical and urodynamic effects similar to placebo in a group of HBP patients.

Journal Article↗
PubMedDate not supplied

[Double-blind placebo-controlled trial of terazosine efficacy in patients with chronic abacterial prostatitis].

A double-blind placebo-controlled trial of teraosin efficacy (Kornam, Lek, Slovenia) was made in 51 patients with chronic abacterial prostatitis/chronic pelvic pain syndrome (CAP/CPPS) of category IIla according to NIH. All the patients were given a 2-week induction course of placebo followed by teraosin treatment (5 mg/day, n = 29) or placebo (n = 22) for 8 weeks. The participants of the study were followed up for 12 months. Pretreatment differences between the groups by NIH-CPSI system, symptoms frequency scale, leukocyte count of the prostate and uroflowmetry were insignificant. Teraosin and placebo patients showed a noticeable improvement (39.7 and 9.9% by symptoms frequency scale, respectively; by 36.4 and 6.6% by the linear scale, respectively). The drug reduced pain and dysuria, improved quality of life considerably (by 36.2%). Maximal urine flow accelerated by 22.96 and 10.01% in teraosin and placebo groups, respectively. Leukocyte count fell two-fold in the study group and lowered insignificantly in the placebo group. The recurrence-free interval was 25 and 9 weeks, respectively. Thus, teraosin monotherapy improves quality of life in CAP/CPPS patients, significantly relieves symptoms and prolongs recurrence-free interval vs placebo.

Adrenergic alpha-Antagonists↗
PubMed2005

Clinical effects of specific immunotherapy: a two-year double-blind, placebo-controlled study with a one year follow-up.

BACKGROUND: A new depot allergoid of house dust mite (Dermatophagoides pteronyssinus - D.pt) has been created in line with the principles and methodology established in the successful development of pollen allergoids. A two-year double-blind placebo-controlled clinical trial, with one further follow-up year of active treatment, has been conducted to assess clinical efficacy and tolerance. METHODS: 40 patients (20 verum and 20 placebo) with IgE-mediated mite allergy and a history of moderate to severe perennial symptoms of rhinoconjunctivitis with or without asthma participated in a 2-year randomized, double-blind, placebo-controlled trial. Actively treated patients were included in a follow-up year. Active treatment was performed with an aluminium hydroxide adsorbed house dust mite allergoid. Parameters for baseline data and clinical efficacy: nasal challenge, quantitative skin prick testing, Visual Analog Scale (VAS), patients' diaries, physician's assessment of patients? health condition, symptoms and use of anti-allergic medication as well as adverse reactions and changes in specific IgG4 and IgE antibodies. RESULTS: The trial detected superiority (p < 0.05) of mite depot allergoid versus placebo with regard to VAS and symptom intensity sum score in patients who needed anti-allergic medication in the baseline period. Significant differences (p < 0.05) between verum and placebo groups were also seen for patients' reactivities to nasal challenges and prick tests with allergen. The blinded assessment by the physician documented a significant difference (p < 0.05) between the groups in favour of active treatment. After reaching the maximum dose as well as after 12 and 24 months, specific IgG4 antibody concentrations were significantly elevated in the verum group (p < 0.05) by comparison with placebo. Local reactions were less frequent in the verum group and no systemic adverse reactions occurred. A third year of active treatment resulted in further improvement and documented the advantage of booster therapy to stabilize the clinical success. CONCLUSION: Specific immunotherapy with a mite depot allergoid induced significant clinical improvements versus placebo. Safety was assessed as excellent, and no systemic adverse reactions occurred.

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