Results for “PLACEBOS” — Page 9

Albuterol aerosol was an effective bronchodilator as reflected by indices of pulmonary function obtained from spirometry and flow volume curves; Compared with isoproterenol, there were minimal side effects even at the highest doses, and bronchodilation lasted significantly longer. In addition albuterol was successfully used by a patient with idiopathic hypertrophic subaortic stenosis who was unable to tolerate isoproterenol, as well as by some patients with idiosyncratic responses to isoproterenol; A few patients appeared to derive little benefit from either albuterol or isoproterenol.

Adolescent↗

PubMed2004

A response to 'Acupuncture compared to placebo-acupuncture for postoperative nausea and vomiting prophylaxis: A randomised placebo-controlled patient and observer blind trial', Streitberger K, Diefenbacher M, Bauer A et al. Anaesthesia 2004; 59: 142-9.

Explore the source record for details and available documents.

Acupuncture Points↗

PubMed1998

Schizophrenia: do we really need placebo-controlled studies?

OBJECTIVE: To investigate whether placebo control is necessary to prove efficacy in short-term studies in schizophrenia. DESIGN: This study compares the efficacy results of placebo-controlled studies versus positive controlled studies, that is controlled studies without a placebo control, in the short-term treatment of chronic schizophrenia. RESULTS: Concerning mean improvement on the BPRS, the placebo arms showed in two cases a worsening, in one case almost no change, and in the remaining studies (6) the improvement was between 1 and 5%. The percentage mean improvement in the haloperidol arms of the placebo-controlled studies was comparable to the percentage mean improvement in the corresponding arms of the non-placebo-controlled studies. The highest percentage responders in the placebo-groups was 43% and the lowest was 6%. Moreover the responder rates in the atypical antipsychotic and haloperidol arms of the non-placebo-controlled studies were, in two of the three studies, in the same order of magnitude as the responder rates of the placebo arms in the placebo-controlled studies. The overall dropout rates in the placebo arms was between 48% and 80% and were higher than the drop out rates in the atypical neuroleptic arms and haloperidol arms of the placebo-controlled studies. The dropout rates due to an insufficient response in the atypical neuroleptic arms and haloperidol arms of the non-placebo-controlled studies were lower when compared to corresponding treatment arms of the placebo-controlled studies. CONCLUSION: In contrast to the mean improvement on the BPRS, responder rates in the placebo arms varied considerably from study to study. Responder rates in the atypical antipsychotic and haloperidol arms of the non-placebo-controlled studies were, in two of the three studies, of the same order of magnitude as the responder rates of the placebo arms in the placebo-controlled studies. These results indicate that placebo control is necessary. Moreover as responders are a more clinically relevant outcome measure when compared to mean improvement on a rating scale, placebo-controlled studies are still needed. However, consensus on responder definition should be agreed upon. For the moment, alternatives to placebo-controlled studies are inadequate in demonstrating efficacy in studies with schizophrenic patients.

Antipsychotic Agents↗

PubMed1999

Placebo--efficacy and adverse effects in controlled clinical trials.

UNLABELLED: The therapeutic efficacy of placebo in a series of diseases has long been known. It is less well known, however, that treatment with placebo can also produce significant adverse drug reactions. Therefore, the placebo drug reactions from controlled trials were studied for the first time systematically. METHOD: The efficacy and the safety of placebos were investigated using patient and drug data pooled from randomized, placebo-controlled, multicentre studies in five different groups of indications covering the therapeutic areas of cardiology (nisoldipine), neurology/psychiatry (nimodipine/ipsapirone), metabolism (acarbose) and gastroenterology (hydrotalcite). RESULTS: The efficacy of placebo was clear, and varied not only between the five indication groups but also within them. Whereas placebo, unlike active treatment, produced hardly any improvement in symptoms in patients with severe stroke, it was as effective as active treatment in patients with mild neurological deficits, producing an improvement of about 50%. In patients with angina pectoris, placebo produced an increase in exercise tolerance (treadmill walking time to onset of ST-segment depression and angina attacks) of about 10% on average, compared with about 22% under active treatment (nisoldipine). In diabetes therapy, placebo produced no improvement in fasting and postprandial blood glucose levels compared with active treatment (acarbose), and also had no effect on HbA1C values. ADVERSE EFFECTS OF PLACEBO: Adverse drug reactions were observed under treatment with placebo. The frequency and type of placebo-induced adverse reactions also varied between indication groups. For example, typical cardiovascular effects such as tachycardia were observed in the control group. The placebo side effect profile was largely similar to the side effect profile of the active treatment. Some adverse drug reactions (such as "dry mouth" in patients with generalized anxiety syndromes) were observed more frequently under placebo than under active treatment. CONCLUSIONS: Treatment with placebo is frequently effective and cannot therefore be considered as "non-treatment". Placebo effects can only be quantified by direct comparison with "non-treatment". Like active treatment, treatment with placebo is frequently accompanied by adverse drug reactions. Placebo adverse effects are often disease- and active treatment-specific. The effects and adverse effects of a placebo need to be known before the effects of active treatment in controlled clinical trials can be assessed. The mechanisms of placebo effects are many and varied (e.g. endorphin release, conditioning). Since the use of drugs without regard to evidence-based medicine (prescription of drugs without proven efficacy = pseudoplacebos) may clearly also result in serious adverse effects, such practice may not only be non-beneficial but may even be harmful.

Controlled Clinical Trials as Topic↗

PubMed1999

[Placebo effect in clinical trials].

BACKGROUND: It is well known that placebos evoke a variety of effects in the human body. It is less known that placebo medication can produce adverse drug reactions (ADRs). METHOD: The efficacy and, as the main topic, the tolerability were investigated from an international clinical data pool on placebo-controlled randomized multicenter studies of 5 different groups of indications. The therapeutic areas analyzed were neuropsychiatry (nimodipine, ipsapirone), cardiology (nisoldipine), metabolism (acarbose) and gastroenterology (hydrotalcit). RESULTS: The placebo efficacy was evident and varied not only in comparison to 5 indication groups analyzed, but also within them. Placebo showed for example hardly an effect on the symptomatology of stroke patients with a severe neurological deficit in comparison to verum while there was a 50% improvement in symptoms following placebo application in patients with a mild stroke. In angina patients exercise tolerance increased under placebo by 10% (time to onset of ST segment depression and symptoms of angina) while verum showed a 22% improvement. In diabetes placebo had no effect as compared to baseline and to a verum on blood glucose and HbA1C. ADRs could be observed under placebo treatment. The frequency and kind of placebo-induced ADRs varied also between the indication groups, i.e. typical CV side-effects were observed in CV controls. The placebo ADR profile was similar to the reference drug also. Some ADRs were reported even more frequently under placebo than under verum, like "dry mouth" in patients with general anxiety status. CONCLUSIONS: Placebo therapy is frequently effective and is not a "non-therapy". Placebo effects can be shown only by direct comparison with a "non-therapy". A placebo therapy is frequently accompanied by adverse drug reactions (ADRs) just as a verum therapy. Placebo ADRs are frequently illness- and verum-specific. Effects and ADRs of placebo therapy must be known, to judge the effect of verum medication in controlled clinical trials. The mechanisms of placebo effects are manifold (e.g. endorphine release, conditioned learning). Since placebo therapy outside of evidence-based medicine (use of drugs without proven efficacy = pseudoplacebos) may potentially also cause serious side effects, the use may not only be useless but also harmful.

Clinical Trials as Topic↗

PubMed2001

The double-blind variable placebo lead-in period: results from two antidepressant clinical trials.

The 1-week single-blind placebo lead-in has long been a standard in double-blind psychopharmacology clinical trials. Although a lead-in period is often necessary (e.g., to receive laboratory results before randomization), some authors have demonstrated that the standard single-blind placebo lead-in's performance was similar to having a lead-in in which placebo was not administered. The single-blind placebo lead-in did not decrease postrandomization placebo response, nor did it increase drug-placebo differences. To eliminate a higher percentage of placebo responders before randomization and to reduce potential biases in baseline ratings, the authors designed and implemented two depression studies with a double-blind variable placebo lead-in period. In these designs, both the patients and personnel at the investigative sites were blinded to the length of the placebo lead-in period and the start of the active treatment period. Approximately 28% of the patients in the double-blind placebo lead-in studies met criteria to be placebo lead-in responders, as compared with fewer than 10% from two single-blind placebo lead-in studies conducted in a similar time frame. Although all patients continued in the study (including placebo lead-in responders), the primary efficacy analysis prospectively excluded double-blind placebo lead-in responders. Analysis of postrandomization changes revealed that double-blind placebo lead-in responders, even when continuing to receive placebo treatment, maintained their response. At the study endpoint, these placebo lead-in responders had significantly lower severity scores than their counterparts who were not lead-in responders. The prospective removal of lead-in responders thus resulted in an increase in mean endpoint placebo group severity scores. This resulted in an increased drug-placebo treatment difference in one of the two studies but had no effect on the treatment difference in the other study.

Antidepressive Agents↗

PubMed2000

[Placebo effects and adverse effects in clinical trials].

BACKGROUND: It is well known that placebos evoke a variety of effects in the human body. It is less known that placebo medication can produce adverse drug reactions (ADRs). METHOD: The efficacy and, as the main topic, the tolerability were investigated from an international clinical data pool on placebo-controlled randomized multicenter studies of 5 different groups of indications. The therapeutic areas analyzed were neuropsychiatry (nimodipine, ipsapirone), cardiology (nisoldipine), metabolism (acarbose) and gastroenterology (hydrotalcit). RESULTS: The placebo efficacy was evident and varied not only in comparison to 5 indication groups analyzed, but also within them. Placebo showed for example hardly an effect on the symptomatology of stroke patients with a severe neurological deficit in comparison to verum while there was a 50% improvement in symptoms following placebo application in patients with a mild stroke. In angina patients exercise tolerance increased under placebo by 10% (time to onset of ST segment depression and symptoms of angina) while verum showed a 22% improvement. In diabetes placebo had no effect as compared to baseline and to a verum on blood glucose and HbA1C. ADRs could be observed under placebo treatment. The frequency and kind of placebo-induced ADRs varied also between the indication groups, i.e. typical CV side-effects were observed in CV controls. The placebo ADR profile was similar to the reference drug also. Some ADRs were reported even more frequently under placebo than under verum, like "dry mouth" in patients with general anxiety status. CONCLUSIONS: Placebo therapy is frequently effective and is not a "non-therapy". Placebo effects can be shown only by direct comparison with a "non-therapy". A placebo therapy is frequently accompanied by adverse drug reactions (ADRs) just as a verum therapy. Placebo ADRs are frequently illness- and verum-specific. Effects and ADRs of placebo therapy must be known, to judge the effect of verum medication in controlled clinical trials. The mechanisms of placebo effects are manifold (e.g. endorphine release, conditioned learning). Since placebo therapy outside of evidence-based medicine (use of drugs without proven efficacy = pseudoplacebos) may potentially also cause serious side effects, the use may not only be useless but also harmful.

Adverse Drug Reaction Reporting Systems↗