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PubMedDate not supplied

Weight reduction and ursodeoxycholic acid in subjects with nonalcoholic fatty liver disease. A double-blind, placebo-controlled trial.

OBJECTIVE: Nonalcoholic fatty liver disease is an increasingly recognized condition that may progress to end-stage liver disease. We investigated the effects of weight reduction and ursodeoxycholic acid administration in patients with this disease. RESEARCH METHODS AND PROCEDURES: A double-blind, placebo-controlled trial. Twenty-seven women with a body mass index of >30 kg/m2 and willing to participate in the diet plan for six weeks were studied were assigned to one of two treatment groups (ursodeoxycholic acid, n = 14: placebo n = 13). Both groups received a normal diet (1,200 kcal/d) plus 1200 mg/d of ursodeoxycholic acid or placebo. Hepatic steatosis, was assessed by abdominal ultrasound. Fasting glucose, cholesterol, triglycerides, and aminotransferases levels were determined before and after treatment. RESULTS: Body mass index decreases significantly from 34.2 +/- 4.2 kg/m2 and 33.3 +/- 1.6 kg/m2 to 31.8 +/- 4.5 kg/m2 and 30.6 +/- 2.6 kg/m2 in the ursodeoxycholic acid and placebo groups, p < 0.001. The hepatic steatosis index decreased from 2.3 +/- 0.7 to 1.0 +/- 0.6 and 2.2 +/- 0.7 to 1.1 +/- 0.7 in the ursodeoxycholic acid and placebo groups, p<0.003. Serum AST decreased significantly from 41.2 +/- 5.6 to 34.5 +/- 3.4 in the ursodeoxycholic acid group, p <0.001, and from 43.6 +/- 4.2 to 35.3 +/- 2.9 in the placebo group, p <0.001. Serum ALT decreased from 62.9 +/- 6.5 to 44.0 +/- 3.5 in the ursodeoxycholic acid group, p <0.001, and from 63.5 +/- 4.5 to 44.0 +/- 3.5 in the placebo group. We did not find any differences in all variables studied between groups. CONCLUSIONS: The present study shows beneficial effect of weight reduction, producing improvements in biochemical and imaging markers of liver disease.

Adult↗
PubMedDate not supplied

Quality of life is improved in breast cancer patients by Standardised Mistletoe Extract PS76A2 during chemotherapy and follow-up: a randomised, placebo-controlled, double-blind, multicentre clinical trial.

The objective of this randomised, multicentre, double-blind clinical trial was to investigate the impact of PS76A2, an aqueous mistletoe extract standardised to mistletoe lectins, on quality of life (QoL) in breast cancer patients. A total of 352 patients were randomly allocated to 2 groups receiving PS76A2 (15 ng mistletoe lectin/0.5 ml) or matching placebo twice weekly for 4 to 6 cycles of CMF (cyclophosphamide, methotrexate, fluorouracil) chemotherapy followed by 2 months follow-up. The primary efficacy end-point was the change from baseline of 3 FACT-G subscales (physical, emotional and functional well-being) during the fourth CMF cycle. Secondary measures included GLQ-8 (8 linear analogue self-assessment scales), Spitzer's uniscale and haematological variables. The main variables of safety analysis were adverse events, including injection site reactions and clinical laboratory tests. The results showed that physical, emotional and functional well-being improved upon PS76A2, but deteriorated following placebo. The treatment differences were statistically significant for the 3 subscales as well as for the summary score FACT-G, which was analysed as O'Brien's rank sum of its 3 subscales: The total score increased by 4.40 +/- 11.28, indicating a higher QoL after PS76A2, but decreased by 5.11 +/- 11.77 with placebo (p<0.0001). The GLQ-8 sum of 8 LASA scales was analysed as a summary score of GLQ-5 (sum of item nos. 1, 5, 6, 7, 8) and GLQ-3 (sum of item nos. 2, 3, 4). GLQ-5 characterises typical aspects of QoL, while GLQ-3 consists of 3 side-effects of CMF (feeling sick, numbness or pins and needles, loss of hair). GLQ-5 decreased by 42.9 +/- 125.0 upon PS76A2, indicating an improvement in QoL, but increased by 60.3 +/- 94.0 upon placebo (p<0.0001). GLQ-3 deteriorated in both groups (PS76A2: 13.9 +/- 52.4; placebo: 34.5 +/- 57.0), but the differences in favour of PS76A2 were, nevertheless, statistically significant (p=0.0007). The total score GLQ-8 improved by 28.9 +/- 154.6 after PS76A2 and deteriorated by 94.8 +/- 141.1 after placebo (p<0.0001). Spitzer's uniscale improved by 12.2 +/- 30.7 upon PS76A2 and deteriorated by 10.8 +/- 26.1 with placebo (p<0.0001). After follow-up without chemotherapy, a significant treatment difference in favour of PS76A2 was determined by means of FACT-G, GLQ-8 and Spitzer's uniscale. PS76A2 was well tolerated in this trial, with the exception of slight local reactions in 17.6% of the PS76A2 group. In conclusion, PS76A2 (15 ng mistletoe lectin/0.5 ml twice weekly) was shown to be safe and effective in improving QoL in breast cancer patients during chemotherapy and follow-up.

Adult↗
PubMed2006

[Placebo surgery: surprises and ethical questions].

Placebo has a well-known therapeutic potential and this explains why placebo-controlled trials are considered necessary for showing the efficacy (and to a lesser extent the safety) of a new drug treatment. However, there are clear examples of a potent surgical placebo-effect in several pathological fields (cardiology, osteoarthropathy, slipped disk, post-traumatic lesions, abdominal adhesions, Parkinson's disease). The efficacy of the placebo surgery would suggest the advisability of placebo-controlled studies also for some surgical treatments. This type of trials, however, raises a number of reservations and ethical questions. In particular, it is necessary to consider the possible unethical nature of placebo surgery as against the unethical nature of surgical operations lacking any evidence of "specific" efficacy (i.e. being better than placebo).

Angina Pectoris↗
PubMed2006

The ethics of placebo-controlled studies on perinatal HIV transmission and its treatment in the developing world.

Perinatal HIV transmission in the United States has been greatly reduced since the 1993 discovery of zidovudine, known as protocol 076. However, a feasible treatment in developing countries has not yet been found due to the high cost and medical standards needed to implement protocol 076. This presents an ethical question: whether placebo or active control should be used in testing new treatments. Proponents of a placebo control argue that a placebo control is the only method that provides definitive evidence of efficacy and side-effects, especially important given the scarce financial resources present in developing countries. Critics, however, argue that the use of a placebo controlled study when an effective treatment exists would be jeopardizing the health of individuals in developing countries. The key to resolving this debate is realizing that protocol 076 would not necessarily be effective when transplanted to developing countries due to the lack of adequate medical infrastructure, malnutrition, prevalence of disease, and low standard of living--it is not certain protocol 076 would be better than placebo at all. Following this line of reasoning, quite a few placebo-controlled studies on perinatal HIV treatment have already been performed. Upon examination of this accumulated evidence, one finds that protocol 076, and shortened courses of it, are indeed effective in non-breastfeeding participants in developing countries; however, no treatment has been proven effective for breastfeeding populations. Therefore, it would be ethical to conduct placebo-controlled studies on breastfeeding populations, but not on non-breastfeeding populations.

Anti-HIV Agents↗
PubMed1991

Placebo-controlled trial to evaluate zidovudine in treatment of human immunodeficiency virus infection in asymptomatic patients with hemophilia. NHF-ACTG 036 Study Group.

One hundred ninety-three asymptomatic patients with hereditary coagulation disorders and human immunodeficiency virus (HIV) infection were studied in a controlled trial of zidovudine (ZDV) versus a placebo (with an average of 9.7 months on study). Pretreatment characteristics were well balanced between the placebo and drug-treated groups, including CD4 distributions, types of clotting disorders, transaminase abnormalities, and use of various hemostatic agents. At the time of analysis, 161 patients either were still receiving treatment or had previously reached an endpoint of disease progression while receiving treatment. Twenty-five patients withdrew voluntarily. The toxic effects noted included granulocytopenia and anemia, especially in older patients, and subjective symptoms of asthenia, malaise, and nausea, consistent with the known consequences of treatment with 300 mg ZDV five times daily. There was a trend toward more diagnoses of acquired immunodeficiency syndrome (AIDS), advanced or early AIDS-related complex (ARC), single ARC symptoms, or death in placebo recipients as compared with those receiving ZDV (22 v 13). Because older patients with hemophilia have more rapid disease progression, the same efficacy analysis was performed in the 89 patients aged more than 30 years who were receiving treatment. In this subgroup, there was a similar trend (11 v 6). With regard to the most advanced problems of the infection among the older patients, there were five patients who were newly diagnosed with AIDS or died in the placebo group versus none in the ZDV group (P = .02) among the older patients. The pretreatment distribution of CD4 counts for the placebo and ZDV groups were similar, but patients aged more than 30 years had significantly (P less than .049) fewer CD4 cells than patients aged less than 30 years. A beneficial ZDV effect is also supported by a trend toward higher CD4 counts (a 48-cell increase in the ZDV group at 24 weeks as compared with a four-cell increase in the placebo group) and a significant (P = .03) difference in weight gain in the ZDV patients aged more than 30 years (8 pounds) as compared with the older placebo patients (aged more than 30 years) (2 pounds) at week 24. The findings in the asymptomatic hemophilic patients aged more than 30 years support a useful effect of ZDV, which is similar to observations in the larger study of its use in asymptomatic, nonhemophilic patients.

AIDS-Related Complex↗
PubMed1989

A comparison of amlodipine, verapamil and placebo in the treatment of mild to moderate hypertension. Amlodipine Study Group.

This is a double blind parallel group comparison in patients with mild-moderate hypertension, of amlodipine, verapamil and placebo. One hundred and sixty patients entered the double blind phase. In the amlodipine group the mean supine and standing systolic pressures at week 12 were respectively lowered from baseline by 11.9 mmHg and 11.3 mmHg more than for the placebo group (P = 0.0001). Diastolic blood pressures were also significantly reduced. With verapamil the mean supine and standing systolic blood pressure at week 12 were reduced by 7.7 mmHg and 8.3 mmHg more on verapamil than on placebo (P = 0.0083). Blood pressures of the amlodipine group were lower 24 hour post-dose than verapamil 12 hours post dose. The responder rates after eight weeks of double blind therapy were amlodipine 72.3%, verapamil 47.8% and placebo 32.6%. Body weight after verapamil increased by mean 0.9 kg, after amlodipine by 0.2 kg and after placebo decreased by 0.2 kg. Six patients were withdrawn because of adverse effects (3 amlodipine, 2 verapamil, 1 placebo). The number of patients with adverse effects possibly related to therapy were 22/53 for amlodipine, 19/54 for verapamil and 14/53 for placebo. Both drugs were, overall, well tolerated, effective and had no unexpected adverse effects.

Adult↗
PubMed1989

Placebos in clinical trials of peptic ulcer. ACG Committee on FDA-Related Matters.

Placebo use in controlled clinical trials is often challenged as being unethical, as though the investigator in a clinical trial and the clinician are in conflict, one interested primarily in scientific validity, the other in patient care. This paper will review the specific issues in trials for short term (4-8 wk) peptic ulcer disease, demonstrating that controlled trials utilizing placebo are worthwhile, are safe, offer distinct advantages over alternative trials, and impose no real ethical conflict. The ethics regarding the use of a placebo for a controlled trial have been reviewed previously in this column (1). Placebo controls are appropriate in therapeutic trials when 1) standard therapy is either unavailable, of unproven efficacy, or possesses unacceptable side effects, 2) placebo itself is an effective therapy, or 3) the ongoing disease has little adverse effect on the patient. Furthermore, the use of placebo is considered advisable (2), "when the disease process is characterized by frequent spontaneous exacerbations and remissions." Certainly, peptic ulcer is such a disease. It has been argued that the decision to utilize placebo might be between only two individuals, the physician and his patient (3), but realistically, many more must approve the trial, through multi-center participation, involvement by the pharmaceutical industry, and peer review (including human research committee approvals).

Clinical Trials as Topic↗
PubMed1978

Placebo effect in the treatment of angina pectoris.

The interference of placebo effect in the treatment of angina pectoris has been studied in a group of patients with stable angina pectoris, selected on the basis of normal electrocardiogram at rest and a pathologic ergometric electrocardiographic test. It was found that the patients could be divided, according to the results of the exercise test, into two groups: placebo responders and place-bo-non-responders. The anti-anginal effect of beta-blocking agents has been clearly demonstrated only in the placebo-non-responders group. No statistically significant effect of beta-blocking agents was observed in the placebo-responders group. This result shows that it is necessary, in double blind trials, at first to separate placebo-responders from placebo-non responders. Otherwise the correct evaluation of a drug can be modified by the placebo-responders group.

Adult↗
PubMed1987

Comparative efficacy of propranolol, chlordiazepoxide, and placebo in the treatment of anxiety: a double-blind trial.

The efficacy and safety of propranolol in the treatment of anxiety was compared with those of chlordiazepoxide and placebo in a 3-week, double-blind study of 212 patients. After a 1-week, single-blind placebo-washout period, patients were randomized to receive either propranolol (80, 160, or 320 mg/day), chlordiazepoxide (30, 45, or 75 mg/day), or placebo. Patients were evaluated by three physician-rated scales--Hamilton Rating Scale for Anxiety (HAM-A), Covi Anxiety Scale (CAS), and Clinical Global Impressions scale--and two patient-rated scales--Symptoms Checklist 90 and Profile of Mood States. Patients in all groups demonstrated significant improvement in their level of anxiety at all time points compared with their baseline level. At Week 1 propranolol and chlordiazepoxide patients were significantly better than placebo patients, as measured by the HAM-A and CAS. At Week 2 only propranolol was superior to placebo, based on HAM-A and CAS scores. Fifteen patients prematurely terminated because of adverse reactions (4 taking propranolol, 4 taking placebo, and 7 taking chlordiazepoxide). The incidence of side effects was similar for the two active drugs; fatigue, drowsiness, and change in libido were significantly more frequent with chlordiazepoxide and drowsiness and indigestion were more frequent with propranolol compared with placebo.

Adolescent↗
PubMed1986

Nifedipine as an adjunct to St. Thomas' Hospital cardioplegia. A double-blind, placebo-controlled, randomized clinical trial.

The cardioprotective effect of the addition of the slow calcium-channel blocker nifedipine to cardioplegic solution was tested in two double-blind placebo controlled randomized studies. The first study included 24 patients undergoing aortic-coronary bypass grafting, and the second included 24 patients undergoing aortic valve replacement. Nifedipine at a dose of 200 micrograms/L or placebo was added to St. Thomas' Hospital cardioplegic solution. The following markers of ischemia were used: adenosine triphosphate and its catabolites, creatine phosphate and inorganic phosphate, determined in transmural left ventricular biopsy specimens taken before, at the end of, and after aortic cross-clamping; hemodynamic recovery 15 minutes after cessation of cardiopulmonary bypass; clinical outcome in terms of the incidence of arrhythmias, low cardiac output, positive inotropic support immediately after operation, and follow-up at 15 months. The main difference between the two studies was that myocardial temperature during cross-clamping remained constant at 14 degrees C in coronary bypass grafting but increased to 25 degrees C in valve operations despite the application of the same amounts of cardioplegic solutions. This lower temperature resulted in better preservation of high-energy phosphates in coronary bypass operations as compared to the placebo group having valve replacement operations. According to analysis of variance, a drug effect could be demonstrated only in the aortic valve replacement study: Accumulation of breakdown products of the adenine nucleotide pool was less in the nifedipine group than in the placebo group (p less than 0.05). Adenosine triphosphate decreased only to 84% in the nifedipine group and to 72% in the placebo group. Despite this adenosine triphosphate-sparing effect, weaning from cardiopulmonary bypass was more difficult in the nifedipine group. Left ventricular stroke work index 15 minutes after bypass was decreased to 72% of the prebypass value in the nifedipine group (t test, p less than 0.01) and only to 86% in the placebo group (p = NS). In contrast, after the patients were admitted to the intensive care unit, the incidence of low cardiac output tended to be lower in the nifedipine group than in the placebo group: 33% versus 58% (p = NS). In conclusion, ischemia-induced degradation of nucleotides as it occurs when myocardial cooling is inadequate can be prevented by the addition of nifedipine to the St. Thomas' Hospital cardioplegic solution. This effect, however, is not associated with an improved clinical outcome.

Adult↗
PubMed1980

The German-Austrian aspirin trial: a comparison of acetylsalicylic acid, placebo and phenprocoumon in secondary prevention of myocardial infarction. On behalf of the German-Austrian Study Group.

In a multicenter clinical trial on the prevention of recurrent myocardial infarction, 946 patients who had survived a myocardial infarction for 30-42 days were randomly allocated to acetylsalicylic acid (ASA, 1.5 g/day) (317 patients), placebo (309 patients) or phenprocoumon treatment (320 patients) and were followed to determine the incidence of total mortality, coronary death and nonfatal recurrent myocardial infarction. The ASA and placebo groups were treated in double-blind fashion. The observation period for each patient was 2 years. Total mortality was lower in the ASA group (27 patients) than in the placebo (32 patients) and phenprocoumon groups (39 patients). There were 13 coronary deaths (fatal myocardial infarction and sudden death) in the ASA group, 22 in the placebo group and 26 in the phenprocoumon group. This represents a reduction rate of 42.3% in the ASA group compared with placebo (p less than 0.1) and of 46.3% in the ASA group with phenprocoumon (p approximately 0.07). Considering male patients alone, the difference regarding coronary death is significant between ASA vs placebo (p less than 0.05, reduction rate 56.4%) and ASA vs phenprocoumon (p less than 0.05, reduction rate 55.6%). Coronary events (coronary death and nonfatal recurrent myocardial infarctions) were lower in the ASA group (24 events) than in the placebo (37 events) (p less than 0.07) or phenprocoumon group (32 events).

4-Hydroxycoumarins↗
PubMed1980

Cimetidine vs placebo: complete gastric ulcer pain relief. Six week controlled double blind study without any antacid therapy.

We studied the efficacy of cimetidine or placebo in relieving ulcer pain on 27 endoscopically-proven gastric ulcer outpatients in a randomized controlled prospective double blind trial. There were 12 patients in the cimetidine (1,200 mg daily) treated group and 15 patients in the placebo treated group. No antacid was allowed, but a placebo antacid with no neutralizing capacity was given as needed for pain. The incidence of complete pain relief at 2 and 4 weeks was 58% and 67% in the cimetidine treated patients, and 60% and 80% in the placebo treated patients. At 6 weeks of treatment there was no increase in the number of patients with complete pain relief in either group. There was no significant difference between the 2 groups in the incidence of ulcer pain relief at any of the 3 observation periods. Gastric ulcer healing rates and gastric ulcer pain relief were compared at 2 and 4 weeks. The cimetidine treated group healed 17% with 58% pain relief, and the placebo treated group had no ulcers healed at 2 weeks with 60% complete pain relief. There was no statistical association between ulcer healing and pain relief in both treatment groups at the 2 week evaluation period, but there was statistical association (P less than .05) at 4 weeks. The results of this study demonstrated that in gastric ulcer outpatients treated for 6 weeks: 1) the complete relief of gastric ulcer pain is not influenced by treatment with cimetidine when compared to placebo, and 2) there is no association between complete pain relief and the presence of an endoscopically proven gastric ulcer during the first 2 weeks of treatment with either cimetidine or placebo.

Aged↗
PubMed1995

Pattern of placebo response in panic disorder.

This study characterizes the pattern of placebo response in depressed panic disorder patients who participated in a randomized clinical trial. We compared placebo-treated subjects whose panic attacks remitted, with those whose attacks did not remit, and with remitting and nonremitting subjects treated with active medication. Seventy-one subjects who met criteria for panic disorder and for a concurrent depressive diagnosis (major depression, dysthymia, or depressive disorder not otherwise specified [NOS]) were treated with either imipramine (n = 36) or alprazolam (n = 35), and 28 patients were treated with placebo. Sixteen placebo-treated and 40 medication-treated patients were panic free at Week 8. Placebo panic remitters were significantly more ill than active-medication remitters on all measures. In contrast, subjects who achieved panic remission on placebo showed no difference on other clinical measures from active medication nonremitters, and little difference from placebo nonremitters. Results support the need for assessment of all core panic disorder symptoms in determining treatment efficacy and in considerations of response and remission.

Alprazolam↗
PubMed1995

Medroxyprogesterone increases basal temperature: a placebo-controlled crossover trial in postmenopausal women.

OBJECTIVE: To assess whether temperature is increased by medroxyprogesterone (MPA) and thus whether basal temperature records could be used to determine ovulation during cyclic MPA therapy. DESIGN: A 2-month double-blind placebo-controlled crossover trial in which oral basal temperature was measured daily. SETTING: Normal human volunteers in an academic medical environment. SUBJECTS: Eleven postmenopausal women not taking gonadal hormones. INTERVENTION: Medroxyprogesterone acetate (10 mg/d) or placebo, calendar days 16 to 25, with crossover. MAIN OUTCOME MEASURES: Comparison of mean temperature days 17 to 26 during MPA versus placebo; comparison of differences between temperatures days 7 to 16 and 17 to 26 in MPA versus placebo months; and analysis for a significant monthly thermal shift. RESULTS: The mean temperatures during MPA treatment averaged 0.27 degrees C higher than during the placebo phase and showed a significant change from pretreatment to "treatment" phases during MPA but not during placebo cycles. Eight of the MPA and one of the placebo cycles showed a shift from lower to higher temperatures days 16 to 25. CONCLUSIONS: Medroxyprogesterone acetate has a physiological progesterone-like thermal effect. Therefore basal temperature data cannot reliably indicate ovulation during cyclic MPA administration.

Adult↗
PubMed1994

Ambulatory pressure decreases on long-term placebo treatment in older patients with isolated systolic hypertension. Syst-Eur Investigators.

OBJECTIVE: This long-term study investigated the widely accepted hypothesis that ambulatory pressure does not decrease in patients given placebo. METHODS: One hundred and twelve older (> or = 60 years) outpatients with isolated systolic hypertension were recruited. Treatment consisted of a placebo during a 3-month baseline period and long-term follow-up. RESULTS: At baseline, on placebo treatment, clinic systolic/diastolic (SBP/DBP) blood pressure (+/- SD) averaged 176 +/- 12/86 +/- 7 mmHg and 24-h SBP/DBP 151 +/- 15/81 +/- 10 mmHg. These pressures were unaltered in 51 patients in whom the baseline measurements were repeated after a further month on placebo. After the 112 patients had received placebo for 1 year (median), clinic SBP/DBP fell by 6.6 +/- 15.9 (P < 0.001)/1.4 +/- 7.4 (P = 0.06)mmHg and 24-h SBP by 2.4 +/- 10.7 mmHg (P < 0.05), whereas 24-h DBP did not change significantly. The 24-h SBP decreased more with higher baseline level and longer follow-up (5-21 months). CONCLUSIONS: These findings in older patients with isolated systolic hypertension suggest that in long-term studies the ambulatory pressure may slightly but significantly decrease on a placebo. Like those using conventional sphygmomanometry, long-term studies using non-invasive ambulatory monitoring require a placebo-controlled design.

Aged↗
PubMedDate not supplied

Efficacy of divalproex vs lithium and placebo in the treatment of mania. The Depakote Mania Study Group.

OBJECTIVE: To compare the effectiveness of divalproex sodium with that of lithium and placebo in patients with acute mania. DESIGN: Randomized, double-blind, parallel-group study of treatment outcomes in patients with manic-depressive illness. PATIENTS: A total of 179 hospitalized, acutely manic patients meeting the Research Diagnostic Criteria for manic disorder, approximately half of whom had been nonresponsive to lithium previously, were studied at nine university-affiliated hospitals. INTERVENTIONS: After a minimum 3-day washout period, random assignment for 21 days to divalproex, lithium, or placebo in a 2:1:2 ratio. Dosage of divalproex and lithium was increased if tolerated to a target concentration of 1041 mumol/L (150 micrograms/mL) or 1.5 mmol/L (conventionally expressed as milliequivalents per liter), respectively. MAIN OUTCOME MEASURES: Primary outcome measures were changes in the Mania Rating scale derived from the Schedule for Affective Disorders and Schizophrenia. RESULTS: Intent-to-treat analysis for efficacy was based on data from 68, 35, and 73 patients in the divalproex, lithium, and placebo groups, respectively. Groups were initially comparable except that all eight patients with four or more manic episodes in the previous year were in the divalproex group. In 30%, 33%, and 51% of the above groups, treatment was prematurely terminated due to lack of efficacy, with fewer premature terminations from divalproex than placebo (P = .017). The proportions of patients improving at least 50% were higher for divalproex and lithium groups than for the placebo group: 48% for divalproex (P = .004) and 49% for lithium (P = .025) vs 25% for placebo. Divalproex was as effective in rapid-cycling manic patients as in other patients. CONCLUSIONS: Both divalproex and lithium were significantly more effective than placebo in reducing the symptoms of acute mania. The efficacy of divalproex appears to be independent of prior responsiveness to lithium.

Acute Disease↗
PubMed1993

Antihypertensive effect and tolerability of felodipine extended release (ER) tablets in comparison with felodipine plain tablets (PT) and placebo in hypertensives on a diuretic. Canadian Study Group.

Antihypertensive efficacy and tolerability of felodipine extended release (ER) (o.d.), felodipine plain tablet (PT) (b.i.d.), and placebo were compared in mild to moderate hypertensives whose seated diastolic blood pressure (DBP) was > or = 95 mm Hg while on hydrochlorothiazide 25 mg od. In addition to the diuretic, patients were randomised to felodipine ER 5 mg od (n = 50), PT 2.5 mg bid (n = 50), or placebo (n = 48) for 6 weeks, with clinic visits every 2 weeks. If seated DBP was > or = 90 mm Hg at any visit, daily dosage of felodipine was doubled to a maximum of 20 mg. The mean difference between ER and placebo was 5.1 mm Hg (p = 0.003); for PT vs. placebo the difference was 5.3 mm Hg (p = 0.002). Seated systolic blood pressure (SBP) was reduced by a mean difference of 6.8 mm Hg in the felodipine PT group compared with placebo (p = 0.03). Fourteen patients were withdrawn: 4 from the placebo group, 4 from the felodipine ER group, and 6 from the felodipine PT group. The most commonly reported adverse event was peripheral edema. In patients not adequately controlled on diuretic alone, felodipine ER o.d. and felodipine PT b.i.d. were superior to placebo in reducing seated DBP.

Adult↗
PubMed1996

Comparison of once-daily doses of omeprazole (40 and 20 mg) and placebo in the treatment of benign gastric ulcer: a multicenter, randomized, double-blind study.

OBJECTIVE: The purpose of this multicenter, randomized, double-blind study, conducted in 520 patients, was to compare the efficacy and safety of omeprazole (40 and 20 mg once daily) with placebo in the treatment of benign gastric ulcer. METHODS: Treatment with omeprazole or placebo lasted 4 wk; those whose ulcers remained unhealed continued the same treatment regimen for an additional 4 wk. The effects of therapy were determined by endoscopy and assessment of GI symptoms. Safety and tolerability were evaluated through reported adverse events, physical examinations, and laboratory tests. RESULTS: At weeks 4 and 8, the proportion of patients with healed ulcers was significantly greater in the omeprazole 40- and 20-mg groups than in the placebo group (p < 0.01). At week 8, the healing rate was significantly greater in the 40-mg group than in the 20-mg group (82.7 vs 74.8%, p < 0.05). In patients with large ulcers (>1 cm), the 40-mg regimen was associated with a significantly higher healing rate (78.9%) than both the 20-mg regimen (61.4%) and placebo (34.6%) at week 8 (p < 0.05 vs omeprazole 20 mg; p < 0.01 vs placebo). Healing rates in patients with small ulcers were similar for the 40- and 20-mg groups. Omeprazole was well tolerated, with no significant differences versus placebo in the overall incidence of clinical or laboratory adverse events. CONCLUSIONS: Omeprazole 40 and 20 mg, administered once daily, healed a significantly greater proportion of patients than did placebo. The 40-mg regimen offered significant advantages over the 20-mg regimen in patients with large ulcers.

Double-Blind Method↗