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At least 19 recordsLinked to original sources
PubMed2004

[Nocebo effect: the other side of placebo].

Administration of drugs is often followed by beneficial (placebo effects) and harmful (nocebo effects) effects that are not always related to their mechanism of action. Nocebo effects are rather unknown even when may be the source of many adverse reactions which could be erroneously attributed to drug therapy. Some mechanisms have been postulated which might be associated with the development of nocebo effects. Expectancy, learning and classical conditioning are probably important in the psychological domain. The neuropharmacological substrate is much less known yet an opioid peptide-cholecystokinin interaction has been suggested. At the clinical setting, a nocebo effect should be suspected in those patients who present common unspecific symptoms after drug administration and have a tendency to somatize. An early detection of these patients may contribute to the prevention of the nocebo effect.

Clinical Trials as Topic↗
PubMed1999

The nocebo effect: do no harm.

The nocebo effect creates negative expectations about symptoms and can have devastating influence on patient recovery. Just as the placebo effect works by making patients believe they will get better, the nocebo effect can serve to make patients worse. Two case histories are presented in which patients were assigned diagnoses without objective physical findings. This resulted in poor outcomes. Physicians should avoid assigning a diagnosis without objective physical evidence and thus avoid creating the nocebo effect in patients.

Adult↗
PubMed2004

Evaluation of the nocebo effect during oral challenge in patients with adverse drug reactions.

The nocebo effect is the onset of untoward reactions following the administration of an indifferent substance. The oral challenge with alternative drugs plays a central role in the management of drug allergy and the use of inert substances is part of this procedure. We evaluated the occurrence and clinical characteristics of nocebo effect in patients with adverse drug reactions. Six hundred patients, seen in three different centres (Genoa, Naples and Verona) with a history of reactions to drugs, underwent a blind oral challenge with the administration of an indifferent substance and active drugs. The administration of an inert substance provoked untoward reactions in 54 patients (27%) in Verona, 60 (30%) in Naples and 48 (24%) in Genoa. The overall occurrence of nocebo effect was 27%. The majority of reactions were subjective symptoms (itching, malaise, headache etc), perceived as troublesome by all subjects. The occurrence was significantly higher in women than in men. Our data, collected in a large population, confirm that the nocebo effect occurs frequently in clinical practice. In managing adverse drug reactions through oral challenge the nocebo effect is mandatory to recognize false positive responses.

Adolescent↗
PubMed2005

The role of placebo and nocebo effects of perioperative administration of sedatives and opioids in interventional pain management.

BACKGROUND: The role of nonspecific treatment effects in the outcomes of patients receiving interventions for pain has been the subject of controversy and interest. While the administration of placebo and its effects have been widely studied, the role of placebo and nocebo effects of active agents administered prior to or during interventional techniques has not been explored. OBJECTIVES: The evaluation of placebo and nocebo effects of sodium chloride solution and active agents (midazolam and fentanyl) administered during interventional techniques. STUDY DESIGN: Randomized, placebo-controlled, evaluation. METHODS: A total of 360 patients were divided into three groups, with Group I receiving placebo, Group II receiving midazolam, and Group III receiving fentanyl. At 3 months, information was obtained with regards to their impressions or the experience of the study, compared to their previous experiences with the treatment and sedation. They were asked to rate their experience as better, worse, or no change compared to their previous experience. RESULTS: Between 13% to 30% of patients across all three groups of the study, rated their pain relief following injection as better than their previous experience. A smaller proportion, 3% to 8%, of patients in all three groups rated their experience following injection as worse than their previous experience. The majority of patients, 67% to 79%, regardless of group, described no significant differences as compared to their previous experiences with sedation and treatment for cervical or lumbar facet joint pain. CONCLUSION: In patients undergoing interventional procedures, sodium chloride solution, midazolam, and fentanyl produced placebo effects in 13% to 15%, 15% to 20%, and 18% to 30% of the patients respectively. Similarly, a nocebo effect was seen in 5% to 8% of the patients in the sodium chloride group, 8% of the patients in the midazolam group, and 3% to 8% of the patients in the fentanyl group. It is concluded that positive and negative effects may be seen either with placebo or active agents in 13% to 30% of the patients.

Journal Article↗
PubMed2006

The biochemical and neuroendocrine bases of the hyperalgesic nocebo effect.

Despite the increasing research on placebos in recent times, little is known about the nocebo effect, a phenomenon that is opposite to the placebo effect and whereby expectations of symptom worsening play a crucial role. By studying experimental ischemic arm pain in healthy volunteers and by using a neuropharmacological approach, we found that verbally induced nocebo hyperalgesia was associated to hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis, as assessed by means of adrenocorticotropic hormone and cortisol plasma concentrations. Both nocebo hyperalgesia and HPA hyperactivity were antagonized by the benzodiazepine diazepam, suggesting that anxiety played a major role in these effects. The administration of the mixed cholecystokinin (CCK) type-A/B receptor antagonist proglumide blocked nocebo hyperalgesia completely but had no effect on HPA hyperactivity, which suggests a specific involvement of CCK in the hyperalgesic but not in the anxiety component of the nocebo effect. Importantly, both diazepam and proglumide did not show analgesic properties on basal pain, because they acted only on the nocebo-induced pain increase. These data indicate a close relationship between anxiety and nocebo hyperalgesia, in which the CCKergic systems play a key role in anxiety-induced hyperalgesia. These results, together with previous findings showing that placebo analgesia is mediated by endogenous opioids, suggest that the analgesic placebo/hyperalgesic nocebo phenomenon may involve the opposite activation of endogenous opioidergic and CCKergic systems.

Adrenocorticotropic Hormone↗
PubMedDate not supplied

[The nocebo effect].

Explore the source record for details and available documents.

1-Propanol↗
PubMed1984

[Pain diagnosis and pain measurement. II. Clinical aspects].

Experimental methods differ from clinical methods for the measurement of pain. Some developments in both areas, clinical and experimental pain investigation, are presented. The measurement of pain, i.e. its quantification, should not be confused with pain diagnosis. Some advantages of visual analogue scales in the measurement of clinical pain, especially for intraindividual short-time issues, are presented. Nevertheless, we are still far away from "ideal" methods. If subjective phenomena such as pain are studied, especially in the field of pain therapy, then nonspecific factors like suggestion, intentional or not, must be taken into consideration: Placebo effect and Nocebo effect.

Humans↗
PubMed2001

Interindividual variations in beliefs about the placebo effect: a study in 300 rheumatology inpatients and 100 nurses.

PATIENTS AND METHODS: Three hundred patients admitted to a rheumatology department (mean age, 49.2+/-15.5 years) and 100 nurses working in the same teaching hospital (mean age, 36+/-8.6 years) completed a questionnaire on the placebo effect in the treatment of pain. RESULTS: The patients believed that the percentages of subjects who responded occasionally or consistently to a placebo were 32% (+/- 22%) and 21% (+/- 17%), respectively. The figures given by the nurses were only slightly higher: 42% (+/- 23%) and 23% (+/- 17%), respectively. Only 27% of the patients and 58% of the nurses knew that pain could resolve completely under placebo therapy. The mean percentage improvement induced by placebo therapy as compared to the study analgesic was estimated at 21% (+/- 17%) by the patients and 30% (+/- 18%) by the nurses. Only 23% of patients and 24% of nurses knew about nocebo effects. CONCLUSION: These data suggest that during double-blind placebo-controlled trials three-quarters of the placebo arm patients who experience a marked improvement or a nocebo effect may believe they received the active drug. This is likely to reduce the difference between the placebo and active drug groups. Furthermore, most patients and nurses have a negative perception of placebo therapy. It may be useful to include a brief description of placebo and nocebo effects into the patient's information and informed consent documents used in double-blind placebo-controlled trials.

Adult↗
PubMed2000

Cultural differences: implications on drug therapy and global drug development.

INTRODUCTORY REMARKS: Discussing the "inter-ethnicity" of kinetics and actions of drugs is fraught with terminology problems. It is, however, generally accepted that "ethnicity" covers the influences of factors genetically and culturally transmitted. The study of inter-ethnic variability in drug response addresses the problem of distinguishing variability factors that are common to one particular group of individuals from those which are not specifically shared. DIFFERENCES IN DAILY DOSES BETWEEN DIFFERENT GEOGRAPHIC REGIONS: It is well known that for a number of drugs, the daily dose prescribed in Japan is lower than in the US and Europe. Presently, independent surveys strongly indicate that for a majority of drugs dose differences are not the result of pharmacokinetic differences. In addition, they indicate that inter-ethnic differences do not seem to be larger than intra-ethnic variations. The differences observed for daily doses must thus be found elsewhere than in pharmacogenetic traits. DIFFERENCES IN DIAGNOSES: The most important impediments encountered in the evaluation of minority patients include differences with respect to language, communication style, cultural belief. The same problems arise if studies performed in different geographic areas are compared, socio-economic aspects play then an even greater role. Language problems arise differently if minorities are evaluated and compared to a majority of patients living in the same country or if clinical studies are performed in different regions. Communication styles also differ markedly between cultures. As an example, certain gestures may be considered as disrespectful or insulting by some ethnic groups and constitute normal behavior in others. RATING SCALES: Ethnicity clearly plays a role on the cross-cultural use of rating scales. Sophisticated rating scales established and validated in Western culture must undergo culturally sensitive revision and rigorous evaluation before their use in non-Western culture. EFFICACY-SAFETY ASSESSMENT: As an example, the assessment of risk and benefit is different in Japan, Europe and the United States. In Japan, safety is given a greater weighting relative to efficacy than in the two other regions. PLACEBO/NOCEBO EFFECTS: Placebo and nocebo effects are difficult to study, even in the absence of any cultural difference. They are even more so if ethnicity is concerned. PATIENT COMPLIANCE: Clinicians treating cross-cultural patients must carefully explore the beliefs held by their patient regarding illness causality and treatment expectations. CONCLUDING REMARKS: There are many unanswered questions in the field of inter-ethnic variability in drug response. The present overview will not pretend to have given specific answers, but it is hoped that it will point to some areas where more research is needed, in particular in the area of methodologies to take inter-ethnicity into account during drug development.

Cross-Cultural Comparison↗
PubMed1995

Influence of the behaviour pattern on the nocebo response of healthy volunteers.

The occurrence of a nocebo effect after placebo administration to healthy volunteers in a Phase I trial was analysed according to their type of personality (Bortner Rating Scale). More subjects with a behaviour pattern A (competitive and aggressive) (50%) described subjective side effects of the placebo than type B subjects (17%, P = 0.03). The volunteers who had nocebo effect had a higher Bortner score (BS) than did placebo non-responsive subjects (P = 0.05). The BS was 205 for paramedical staff, 189 for medical and dentistry students, 173 for non-science students and 161 for science students (P < 0.04). The nocebo response was not statistically correlated with professional status. These results suggest that volunteer's type of personality might influence the reporting of subjective symptoms after placebo, and therefore impair the evaluation of new drugs in Phase I clinical trials.

Adult↗
PubMed1997

Blockade of nocebo hyperalgesia by the cholecystokinin antagonist proglumide.

In patients who reported mild postoperative pain, we evoked a nocebo response, a phenomenon equal but opposite to placebo. Patients who gave informed consent to increase their pain for 30 min received a substance known to be non-hyperalgesic (saline solution) and were told that it produced a pain increase. A nocebo effect was observed when saline was administered. However, if a dose of 0.5 or 5 mg of the cholecystokinin antagonist proglumide was added to the saline solution, the nocebo effect was abolished. A dose of 0.05 mg of proglumide was ineffective. The blockade of the nocebo hyperalgesic response was not reversed by 10 mg of naloxone. These results suggest that cholecystokinin mediates pain increase in the nocebo response and that proglumide blocks nocebo through mechanisms not involving opioids. Since the nocebo procedure represents an anxiogenic stimulus and previous studies showed a role for cholecystokinin in anxiety, we suggest that nocebo hyperalgesia may be due to a cholecystokinin-dependent increase of anxiety.

Analgesics, Non-Narcotic↗
PubMed2001

No gender differences in placebo responses of patients with major depressive disorder.

BACKGROUND: This study was designed to compare placebo responses in men and women. METHODS: Data for 501 women and 375 men with major depressive disorder treated with placebo from seven investigational randomized double-blind trials comparing fluoxetine with placebo were analyzed. Changes in major depressive disorder symptoms with placebo administration were measured as changes in total Hamilton Depression Rating Scale scores and adverse (nocebo) effects were measured by comparing treatment-emergent signs and symptoms. RESULTS: Both women and men with major depressive disorder showed significant symptomatic improvement following placebo administration, similar in magnitude and time course of response. Women on placebo reported slightly more nocebo effects than men. CONCLUSIONS: The finding that women and men with major depressive disorder demonstrated a similar therapeutic outcome after placebo administration suggests that gender is not a predictor of placebo response.

Adult↗
PubMed1999

[Allergology: quo vadis?].

The discovery of the immunoglobulin E 30 years ago, and the subsequent availability of serological techniques for in vitro allergy tests, have given fresh impetus to allergy diagnosis in clinical practice. Independently of the more refined allergy diagnosis, there has been a continuous increase in allergic diseases in recent decades. Various factors, summed by the term "Western lifestyle", have produced this increase. As well as individual measures (primary, secondary and tertiary allergy prevention), intensive interdisciplinary cooperation is necessary to arrive at a broad and successful prevention concept. Governments and the political community should accord higher priority than hitherto to fighting allergies, which are now the primary environmental diseases. Parallel to progress in fundamental immunology and the introduction of effective drugs for symptomatic treatment of the various atopic manifestations, a problem facing us today is the growing popularity among the public of "alternative medicine" for the treatment of allergies, even though many of these unconventional diagnostic and therapeutic methods are judged pseudoscientific and their efficacy is unproven. The allergy patient is increasingly caught in the tug-of-war between allopathic and "alternative" medicine, pharmacists, so-called "natural healers", patient and consumer organisations and the mass media. Expectations of successful results from "natural", "soft", "Chinese" or "Tibetan" medicine are high, along with the corresponding marked placebo effect and scepticism about allopathic medicine. This "nocebo" effect thrives on psychosocial territory and is fostered by public opinion. Evidence of this is the rise of new environment-related forms of disease for which there is no proof of a toxic or immunologic origin ("idiopathic environment-related intolerances", according to the new WHO terminology). Allopathic and complementary medicine are often consumed together, thus increasing treatment costs. At the same time, fewer and fewer allergy patients are treated by allergen immunotherapy, the only treatment which can affect the natural course of allergic disease and which may also prevent the development of asthma in patients which allergic rhinitis.

Complementary Therapies↗