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PubMed1998

Brompheniramine, loratadine, and placebo in allergic rhinitis: a placebo-controlled comparative clinical trial.

A double-blind, randomized, placebo-controlled, parallel-group, multicenter study was conducted to compare the effectiveness of an extended-release formulation of a classical antihistamine, brompheniramine, and a second-generation compound, loratadine, in the treatment of allergic rhinitis. Subjects with symptoms of allergic rhinitis received brompheniramine 12 mg twice daily (n = 112), loratadine 10 mg once daily (n = 112), or placebo twice daily (n = 114) for 7 days. Study medications were blinded using a double-dummy technique. Subjects completed an overall evaluation of symptom relief on a daily basis and returned on treatment days 3 and 7, at which times the investigator assessed symptom severity. The investigator and subject each completed a global efficacy evaluation, and subjects were interviewed regarding adverse experiences. The primary efficacy variable was the physicians' global efficacy evaluation on day 3. Symptoms also were analyzed as summed severity scores for all symptoms and for the nasal symptom cluster of rhinorrhea, sneezing, and nasal blockage. At all post-baseline evaluations (days 3, 7, and averaged over the two days), brompheniramine was significantly better than loratadine and placebo for both sets of summed symptom scores and all three global assessments. Loratadine was significantly better than placebo for physician ratings of total symptom severity averaged over the two days and for the physician and subject ratings of the nasal cluster on day 3. Central nervous system-related symptoms were the most frequently reported adverse experiences; somnolence was reported most frequently by patients taking brompheniramine, and its occurrence was less frequent as treatment continued. A nonprescription, extended-release formulation of brompheniramine 12 mg twice daily provided significantly better relief of symptomatic allergic rhinitis than loratadine 10 mg once daily.

Adolescent↗

PubMed1988

Double-blind placebo-controlled study of loratadine, mequitazine, and placebo in the symptomatic treatment of seasonal allergic rhinitis.

Loratadine is a long-acting H1 antagonist devoid of anticholinergic and sedative effects. A double-blind, placebo-controlled, parallel-group study was performed in 69 patients to compare efficacy and safety of loratadine and mequitazine. Patients allergic to grass pollens were randomly assigned to one of the three treatment groups and followed up to 2 weeks during the peak of the pollen season. Symptoms of allergic rhinitis were evaluated at baseline and after 3, 7, and 14 days of treatment by the physician with patients rating their response daily on diary cards. Both loratadine and mequitazine induced a significant relief of nasal symptoms when these were compared to placebo. Loratadine was found to be significantly superior to placebo after 3 days of treatment, whereas a significant improvement was only observed after 7 days in patients treated with mequitazine. For nonnasal symptoms, none of the two anti-H1 antagonist induced a significant improvement, and this lack of effect may be related to low symptoms at baseline. Loratadine did not induce more side effects than placebo. Loratadine can be considered to be an effective and safe anti H1 histamine with a rapid onset of action.

Adolescent↗

PubMed2004

Homeopathic proving symptoms: result of a local, non-local, or placebo process? A blinded, placebo-controlled pilot study.

BACKGROUND: Homeopathic pathogenetic trials (HPTs) (provings) are the pillar of homeopathy. Symptoms experienced by healthy volunteers are used to find the correct medicine for therapy. It is unclear whether these symptoms are specific or due to placebo noise. Furthermore, it is uncertain whether proving effects, if present at all, are due to a local or non-local process OBJECTIVES: To develop a test model which allows for testing if homeopathic proving symptoms are caused by placebo or causative mechanisms, and if these symptoms are due to local or non-local processes. DESIGN: Randomised, blinded, placebo-controlled, parallel-group study, with 1-week baseline and 2-weeks proving period. SUBJECTS: 11 healthy volunteers from two different homeopathic schools. PROVING SUBSTANCE: An homeopathic medicine (Cantharis 30c), blindly chosen from 12 potential medicines, compared to placebo. OUTCOME MEASURE: Number of symptoms typical for the medicine in the experimental and control group during baseline and proving period. RESULTS: During baseline there was no difference in the number of typical or atypical symptoms in either group. During the proving period, both more typical symptoms for Cantharis (P= 0.03) and more atypical symptoms (P= 0.02) were observed compared to baseline. Between-group differences were not significant. Effect sizes for the difference between the proving and control group for typical symptoms was d=0.4, and for atypical symptoms d=0.6. DISCUSSION: This proving model could be valuable in studying the validity of proving symptoms of homeopathic substances in healthy volunteers. CONCLUSION: Homeopathic proving symptoms appear to be specific to the medicine and do not seem to be due to a local process. Since this was a pilot study using a small number of provers, rival hypotheses cannot be ruled out and the study needs replication.

Adult↗

PubMed2003

Placebo adverse events in headache trials: headache as an adverse event of placebo.

We analysed the adverse events of placebo in acute and preventive randomized, double-blind, placebo-controlled studies for migraine treatment. Fifty-seven trials (oral triptans, non-steroidal anti-inflammatory drugs, nasal ergot alkaloids and preventive agents) were included. From 10 to 30% of subjects reported adverse events after placebo. Most common were features associated with a migraine attack, such as nausea, phono- and photophobia. Other frequent complaints resembled those of the active drug (e.g. chest pressure in triptan trials). A third group of adverse events appeared to be coincidental (e.g. sleep disturbance). Adverse events following placebo are probably related to the drug under study and the symptomatology of migraine; some have no obvious explanation.

Administration, Intranasal↗

PubMed2002

[Placebo and placebo effects--a review].

Placebo controls in clinical trials are usually employed to filter out undesired, psychological or non-specific effects from "true" therapeutic effects. Although this is useful in the context of clinical trials for the purpose of proving pharmacological efficacy, it is misleading to generalize this strategy to therapy as a whole. This would imply that placebo effects are irrelevant. Precisely this opinion is criticized in this paper. After some consideration about an appropriate notion of placebo, some empirical evidence is reviewed which underlines the importance of placebo effects. It is likely that the unspecific effects due to the individual meaning of an intervention are an important factor of any therapeutic approach. It would be therapeutically desirable to maximize these factors. This point of view would also have consequences on how interventions have to be evaluated.

Humans↗

PubMedDate not supplied

The safety and efficacy of topical norfloxacin compared with placebo in the treatment of acute, bacterial conjunctivitis. The Norfloxacin-Placebo Ocular Study Group.

Two hundred and eighty-four patients with acute conjunctivitis were enrolled in a double-masked study comparing norfloxacin ophthalmic solution with placebo. The proportion of patients who were clinically improved after 5 days treatment was 88.1% in the norfloxacin group and 71.6% in the placebo group (p less than 0.01). The proportion of patients who had all organisms eradicated, including the coagulase-negative staphylococci, after two to three days treatment was 52.7% for norfloxacin and 23.9% for placebo (p less than 0.01) and 64.7% and 26.3% (p less than 0.01) respectively when the coagulase-negative staphylococci were not included. Adverse experiences occurred in 4.2% of the patients receiving norfloxacin compared to 7.1% of the placebo patients. None of the adverse experiences was serious.

Acute Disease↗

PubMed1998

Antithrombin III in patients with severe sepsis. A randomized, placebo-controlled, double-blind multicenter trial plus a meta-analysis on all randomized, placebo-controlled, double-blind trials with antithrombin III in severe sepsis.

OBJECTIVES: To evaluate the safety and potential efficacy of antithrombin III (AT III) in reducing mortality in patients with severe sepsis. DESIGN: Prospective, randomized, placebo-controlled, double-blind, phase II, multicenter, multinational clinical trial. SETTING: Seven academic medical center intensive care units (ICU) in Belgium, Denmark, the Netherlands, Norway and Sweden. PATIENTS: 42 patients with severe sepsis who received standard supportive care and antimicrobial therapy, in addition to the administration of AT III or placebo. INTERVENTIONS: Patients received either an intravenous loading dose of 3000 IU AT III followed by a maintenance dose of 1500 IU every 12 h for 5 days or equivalent amounts of placebo. MEASUREMENTS AND RESULTS: All patients were evaluated for safety and for 30-day all-cause mortality. CONCLUSIONS: The administration of AT III was safe and well-tolerated. It was followed by a 39 % reduction in 30-day all-cause mortality (NS). The reduction in mortality was accompanied by a considerably shorter stay in the ICU. Patients treated with AT III exhibited a better performance in overall severity of illness and organ failure scores (Acute Physiology and Chronic Health Evaluation II, multiple organ failure, organ system failure), which was noticeable soon after initiation of treatment. Patients treated with AT III demonstrated a better resolution of pre-existing organ failures and a lower incidence of new organ failures during the observation period. A meta-analysis comprising this and two other double-blind, placebo-controlled trials with AT III with a total of 122 patients suffering from severe sepsis confirms the positive trend. The results of the meta-analysis demonstrate a 22.9 % reduction in 30-day all-cause mortality in patients treated with AT III. Although still too small to be confirmative, the meta-analysis clearly points to the fact that a sufficiently powered phase III trial is warranted to prove whether AT III has a beneficial role in the treatment of severe sepsis.

APACHE↗

PubMed1995

Double-blind, randomized, placebo-controlled Canadian multicenter trial of two doses of synthetic surfactant or air placebo in 224 infants weighing 500 to 749 grams with respiratory distress syndrome. Canadian Exosurf Neonatal Study Group.

In a multicenter, double-masked, placebo-controlled rescue trial conducted at 12 Canadian hospitals, two 5 ml/kg doses of a synthetic surfactant or air placebo were administered to 224 infants with birth weights of 500 to 749 gm who had established respiratory distress syndrome and an arterial/alveolar oxygen tension ratio of less than 0.22. The first dose was given between 2 and 24 hours of age; the second dose was given 12 hours later to the infants continuing to receive mechanical ventilation. Infants were stratified at study entry by birth weight and gender. Infants receiving synthetic surfactant showed significant improvements in alveolar-arterial oxygen tension gradient, arterial/alveolar oxygen tension ratio, and oxygen and ventilator requirements through day 7. In the group randomized to synthetic surfactant, significant improvements were seen in oxygen requirements at the first time point measured (2 hours; p = 0.02), in the alveolar-arterial oxygen tension gradient by the second time point measured (6 hours; p = 0.03), and in mean airway pressure after 6 hours. Overall mortality at 28 days was not significantly different in the two groups (50% vs 46%, air placebo group vs synthetic surfactant group; p = 0.586). Similarly, neither the incidence of bronchopulmonary dysplasia (37% vs 30%, air placebo group vs synthetic surfactant group; p = 0.089) nor the incidence of survival without BPD through 28 days (17% vs 26%, respectively; p = 0.070) was significantly different in the two groups. No significant differences in the incidence of safety-related outcomes or in adverse effects such as apnea or pulmonary hemorrhage were noted. These findings indicate that rescue therapy with synthetic surfactant results in physiologic improvements in very tiny premature infants, but improvements in overall mortality or other complications of respiratory distress syndrome were not documented in the sample evaluated.

Air↗

PubMed2002

A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy.

STUDY OBJECTIVES: To evaluate and compare the efficacy and safety of three doses of sodium oxybate and placebo for the treatment of narcolepsy symptoms. DESIGN: A multicenter, double blind, placebo-controlled trial. SETTING: N/A. PARTICIPANTS: Study subjects were 136 narcolepsy patients with 3 to 249 (median 21) cataplexy attacks weekly. INTERVENTIONS: Prior to baseline measures, subjects discontinued anticataplectic medications. Stable doses of stimulants were permitted. Subjects were randomized in blinded fashion to receive 3, 6, or 9 g doses of sodium oxybate or placebo taken in equally divided doses upon retiring to bed and 2.5-4 hours later for 4 weeks. MEASUREMENTS AND RESULTS: Disease symptoms and adverse events were recorded in daily diaries. The primary measure of efficacy was the change from baseline in weekly cataplexy attacks. Secondary measures included daytime sleepiness using the Epworth Sleepiness Scale (ESS), inadvertent daytime naps/sleep attacks and nighttime awakenings. Investigators assessed changes in disease severity using Clinical Global Impression of Change (CGI-c). Compared to placebo, weekly cataplexy attacks were decreased by sodium oxybate at the 6 g dose (p=0.0529) and significantly at the 9 g dose (p=0.0008). The ESS was reduced at all doses, becoming significant at the 9 g dose (p=0.0001). The CGI-c demonstrated a dose-related improvement, significant at the 9 g dose (p=0.0002). The frequency of inadvertent naps/sleep attacks and the nighttime awakenings showed similar dose-response trends, becoming significant at the 9 g dose (p=0.0122 and p=0.0035, respectively). Sodium oxybate was generally well-tolerated at all three doses. Nausea, headache, dizziness and enuresis were the most commonly reported adverse events. CONCLUSIONS: Sodium oxybate significantly improved symptoms in patients with narcolepsy and was well tolerated.

Adjuvants, Anesthesia↗

PubMed1997

Treatment of early rheumatoid arthritis with minocycline or placebo: results of a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To determine if minocycline is an effective therapy for seropositive rheumatoid arthritis (RA) when used within the first year of disease. METHODS: The Rheumatoid Arthritis Investigational Network enrolled 46 patients with RA of <1 year duration into a 6-month study of minocycline (100 mg twice daily) versus placebo. All patients were rheumatoid factor positive. The primary end point of the study was successful completion of 6 months of treatment with no drug toxicity while maintaining 50% improvement in composite symptoms of arthritis. RESULTS: Eighteen of the 46 patients who were enrolled met 50% improvement criteria at 3 months, and maintained at least a 50% improvement for 6 months with no significant drug toxicity. Among them were 15 of the 23 patients (65%) treated with minocycline and 3 of 23 patients (13%) treated with placebo (P < 0.001). CONCLUSION: In patients with early seropositive RA, therapy with minocycline is superior to placebo.

Adult↗

PubMedDate not supplied

Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.

BACKGROUND: Homoeopathy is widely used, but specific effects of homoeopathic remedies seem implausible. Bias in the conduct and reporting of trials is a possible explanation for positive findings of trials of both homoeopathy and conventional medicine. We analysed trials of homoeopathy and conventional medicine and estimated treatment effects in trials least likely to be affected by bias. METHODS: Placebo-controlled trials of homoeopathy were identified by a comprehensive literature search, which covered 19 electronic databases, reference lists of relevant papers, and contacts with experts. Trials in conventional medicine matched to homoeopathy trials for disorder and type of outcome were randomly selected from the Cochrane Controlled Trials Register (issue 1, 2003). Data were extracted in duplicate and outcomes coded so that odds ratios below 1 indicated benefit. Trials described as double-blind, with adequate randomisation, were assumed to be of higher methodological quality. Bias effects were examined in funnel plots and meta-regression models. FINDINGS: 110 homoeopathy trials and 110 matched conventional-medicine trials were analysed. The median study size was 65 participants (range ten to 1573). 21 homoeopathy trials (19%) and nine (8%) conventional-medicine trials were of higher quality. In both groups, smaller trials and those of lower quality showed more beneficial treatment effects than larger and higher-quality trials. When the analysis was restricted to large trials of higher quality, the odds ratio was 0.88 (95% CI 0.65-1.19) for homoeopathy (eight trials) and 0.58 (0.39-0.85) for conventional medicine (six trials). INTERPRETATION: Biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.

Bias↗

PubMed1997

Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials.

BACKGROUND: Homeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homeopathic remedies is equivalent to that reported for placebo. METHODS: We sought studies from computerised bibliographies and contracts with researchers, institutions, manufacturers, individual collectors, homeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 185 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homeopathy type, dilution, "remedy", population, and outcomes. FINDINGS: The combined odds ratio for the 89 studies entered into the main meta-analysis was 2.45 (95% CI 2.05, 2.93) in favour of homeopathy. The odds ratio for the 26 good-quality studies was 1.66 (1.33, 2.08), and that corrected for publication bias was 1.78 (1.03, 3.10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2.03 (1.51, 2.74). Five studies on postoperative ileus had a pooled mean effect-size-difference of -0.22 standard deviations (95% CI -0.36, -0.09) for flatus, and -0.18 SDs (-0.33, -0.03) for stool (both p < 0.05). INTERPRETATION: The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.

Double-Blind Method↗

PubMed2006

Levetiracetam versus placebo in childhood and adolescent autism: a double-blind placebo-controlled study.

The purpose of this study was to determine the safety and efficacy of the anticonvulsant levetiracetam in the treatment of children with autism. A previous open-label study in autistic children treated with levetiracetam demonstrated effectiveness in hyperactivity, impulsivity/aggression, and mood lability. Twenty patients with autism ranging from 5 to 17 years of age were entered into a 10-week, placebo-controlled, double-blind trial of levetiracetam versus placebo. The mean maximum dosage for levetiracetam was 862.50+/-279.19 mg/day. We evaluated global improvement of autism with the Clinical Global Impression-Improvement (CGI-I) Scale and aggression and affective instability with the Aberrant Behavior Checklist (ABC) parent and teacher ratings. We measured repetitive behaviors using the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score and impulsivity and hyperactivity with the Conners' Rating Scale-Revised: Long Version for parent and teacher. No significant difference was found between levetiracetam and placebo groups comparing the change in CGI-I (t=0.350, d.f.=13.621, P=0.765), nor on change in ABC, CY-BOCS or Conners' scales. These findings suggest that levetiracetam does not improve behavioral disturbances of autism, but are limited by the small sample size and lack of stratification of the autistic sample at baseline.

Adolescent↗

PubMed1987

[Placebo-controlled studies with mianserin. Discussion from the viewpoint of a re-evaluated placebo concept].

In this paper the literature on placebo-controlled studies with Mianserin is being commented in view of the enclosed discourse "Placebo: Beyond pretense and nuisance variable." This paper's purpose is to enrich the understanding of the effect of a drug under everyday therapeutic conditions, an understanding, that derives from the physicians synthesis of personal uncontrolled observations of a drug's profile and the reported "mean-effect" in placebo-controlled studies.

Clinical Trials as Topic↗

PubMed1984

Placebo effect in surgery for Meniere's disease: a three-year follow-up study of patients in a double blind placebo controlled study on endolymphatic sac shunt surgery.

In a previously published double blind, placebo controlled study, the efficacy of an endolymphatic sac-mastoid shunt was compared with a purely placebo operation (mastoidectomy) in controlling the symptoms in 30 patients with typical Meniere's disease. Minor differences could be demonstrated after one year between patients with the shunt versus the sham operation, but the greatest difference was between the pre- and postoperative scores, and both groups improved significantly. It was concluded that the impact of the various endolymphatic sac shunts upon the symptoms in patients with Meniere's disease is highly unspecific, and that the 70% improvement in both our groups was most likely caused by a placebo effect. The patients have now been regularly followed for a minimum of 3 years and the symptoms registered whenever present. The results of hearing tests, the patients' own evaluation, and the investigator's evaluation (while still unaware of the type of operation in each patient) show that the 3-year results are the same as our results from the first year: no significant difference could be found between the two groups.

Adult↗

PubMed2003

Cognitive and motor function after administration of hydrocodone bitartrate plus ibuprofen, ibuprofen alone, or placebo in healthy subjects with exercise-induced muscle damage: a randomized, repeated-dose, placebo-controlled study.

RATIONALE: Medications combining hydrocodone bitartrate and non-steroidal anti-inflammatory agents appear more beneficial than anti-inflammatory medications alone in treating pain and inflammation from acute soft tissue trauma, but opiate side effects may include sedation and impaired cognitive and motor performance. OBJECTIVE: Performance on complex cognitive and motor tasks was evaluated in healthy subjects with exercise-induced muscle damage who were treated with a hydrocodone-ibuprofen combination, ibuprofen alone, or placebo. METHODS: This double-blind, randomized, placebo-controlled, repeated-dose clinical trial compared the effects of hydrocodone bitartrate (7.5 mg) plus ibuprofen (200 mg), ibuprofen alone, and placebo on cognitive and motor function in 72 healthy college men. Muscle damage in the quadriceps of each subject's dominant leg was induced by an eccentric exercise protocol. Subjects took the study medication four times daily (every 4-6 h) for 5 days. Forty minutes after medication ingestion at the same time each day, subjects underwent tests of attention/concentration, motor performance, and reaction time. Four trained assessors rotated among subjects so that none tested the same participant on more than three occasions. RESULTS: Repeated measures analyses of covariance revealed no between-group differences on a complex memory and cognition task or complex reaction time. Subjects using hydrocodone bitartrate plus ibuprofen performed significantly less well on a simple tracking task and made significantly more errors on a simple reaction-time task than the other two groups. These deficits were found to be highly transitory and not related to confusion or fatigue. CONCLUSION: Hydrocodone plus ibuprofen was not associated with deterioration in complex cognition but was related to very transitory decrements in tasks involving simple hand-eye coordination.

Adolescent↗

PubMed2003

A double-blind, placebo-controlled trial of fluvoxamine in binge eating disorder: a high placebo response.

Twenty subjects with binge eating disorder were randomly assigned to flexible-dose fluvoxamine or placebo for 12 weeks. A significant reduction in binge frequency, Beck Depression Inventory scores and the eating concern, shape concern and weight concern subscales of the Eating Disorder Examination were noted for both fluvoxamine (n = 9) and placebo (n = 11) groups. There were no significant differences between fluvoxamine and placebo for any treatment outcome variables. The findings from this small trial contribute to the inconsistent results of antidepressant studies in binge eating disorder.

Adult↗

PubMed1994

Response patterns of depressed outpatients with and without melancholia: a double-blind, placebo-controlled trial of fluoxetine versus placebo.

Fluoxetine (20 mg/day) and placebo were compared in 89 outpatient men and women with major depression with (n = 52) or without (n = 37) DSM-III-R melancholia in an 8-week double-blind study to determine predictors of treatment response. Fluoxetine was statistically superior to placebo both within the melancholic subtype and in the total patient group (all measures). Response rate and mean decrease in 17-item Hamilton Depression Rating Scale total score approached statistical significance in favor of fluoxetine-treated melancholic patients compared with fluoxetine-treated non-melancholic patients. There were no statistically significant differences between fluoxetine-treated and placebo-treated non-melancholic patients. Results support DSM-III-R melancholia as a predictor of antidepressant response.

Adolescent↗