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P C Gøtzsche

Publications and source records attributed to P C Gøtzsche.

At least 19 recordsLinked to original sources
PubMed2006

Screening for breast cancer with mammography.

BACKGROUND: A variety of estimates of the benefits and harms of mammographic screening for breast cancer have been published and national policies vary. OBJECTIVES: To assess the effect of screening for breast cancer with mammography on mortality and morbidity. SEARCH STRATEGY: We searched PubMed (June 2005). SELECTION CRITERIA: Randomised trials comparing mammographic screening with no mammographic screening. DATA COLLECTION AND ANALYSIS: Both authors independently extracted data. Study authors were contacted for additional information. MAIN RESULTS: Seven completed and eligible trials involving half a million women were identified. We excluded a biased trial from analysis. Two trials with adequate randomisation did not show a significant reduction in breast cancer mortality, relative risk (RR) 0.93 (95% confidence interval 0.80 to 1.09) at 13 years; four trials with suboptimal randomisation showed a significant reduction in breast cancer mortality, RR 0.75 (0.67 to 0.83) (P = 0.02 for difference between the two estimates). RR for all six trials combined was 0.80 (0.73 to 0.88). The two trials with adequate randomisation did not find an effect of screening on cancer mortality, including breast cancer, RR 1.02 (0.95 to 1.10) after 10 years, or on all-cause mortality, RR 1.00 (0.96 to 1.04) after 13 years. We found that breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly because of differential misclassification of cause of death. Numbers of lumpectomies and mastectomies were significantly larger in the screened groups, RR 1.31 (1.22 to 1.42) for the two adequately randomised trials; the use of radiotherapy was similarly increased. AUTHORS' CONCLUSIONS: Screening likely reduces breast cancer mortality. Based on all trials, the reduction is 20%, but as the effect is lower in the highest quality trials, a more reasonable estimate is a 15% relative risk reduction. Based on the risk level of women in these trials, the absolute risk reduction was 0.05%. Screening also leads to overdiagnosis and overtreatment, with an estimated 30% increase, or an absolute risk increase of 0.5%. This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily. It is thus not clear whether screening does more good than harm. Women invited to screening should be fully informed of both benefits and harms.

Breast Neoplasms↗
PubMed2006

Laser and photoepilation for unwanted hair growth.

BACKGROUND: Unwanted hair growth is a therapeutic challenge and considerable resources are spent to achieve a hair-free appearance. Epilation with laser devices (alexandrite, diode, neodymium:YAG, and ruby lasers) and intense pulsed light are commonly used although the long-term effect is uncertain. OBJECTIVES: To assess the effects of epilation with lasers and light sources. SEARCH STRATEGY: We searched the Cochrane Skin Group's Specialised Register in February 2004; MEDLINE (from 1966) and EMBASE (from 1980) in April 2005. We searched reference lists of collected trials and contacted trial authors. SELECTION CRITERIA: Randomised controlled trials of laser or photoepilation. DATA COLLECTION AND ANALYSIS: Primary outcomes were objective reduction in hair counts, adverse effects and subjective reduction in hairiness. Secondary outcomes were participants satisfaction and personal observations such as softer, finer, or paler hairs. Two authors independently extracted data and assessed trial quality. MAIN RESULTS: We included eleven randomised controlled trials involving 444 people, none of which were of high methodological quality. A large number of trials were excluded, mainly because of their non-randomised design. The randomisation procedures were either unclear or inadequate, using coin tossing, alternation, drawing lots or cards, or open tables of random numbers. The interventions and outcomes were too heterogeneous to be entered in a meta-analysis. Most trials examined a short-term effect up to six months after final treatment. There appeared to be a short-term effect of approximately 50% hair reduction with alexandrite and diode lasers up to six months after treatment, whereas little evidence was obtained for an effect of intense pulsed light, neodymium:YAG or ruby lasers. Long-term hair removal was not documented with any treatment. Pain, skin redness, swelling, burned hairs and pigmentary changes were infrequently reported adverse effects. AUTHORS' CONCLUSIONS: Some treatments lead to temporary short-term hair removal. High quality research is needed on the effect of laser and photoepilation.

Hair Removal↗
PubMed2006

Voriconazole versus amphotericin B in cancer patients with neutropenia.

BACKGROUND: Opportunistic fungal infections are a major cause of morbidity and mortality in neutropenic cancer patients and antifungal therapy are used both empirically and therapeutically in these patients. OBJECTIVES: To compare the benefits and harms of voriconazole with those of amphotericin B and fluconazole when used for prevention or treatment of invasive fungal infections in cancer patients with neutropenia. SEARCH STRATEGY: MEDLINE and the Cochrane Library (May 2005). Letters, abstracts and unpublished trials were accepted. Contact to authors and industry. SELECTION CRITERIA: Randomised trials comparing voriconazole with amphotericin B or fluconazole. DATA COLLECTION AND ANALYSIS: Data on mortality, invasive fungal infection, colonisation, use of additional (escape) antifungal therapy and adverse effects leading to discontinuation of therapy were extracted by two authors independently. MAIN RESULTS: Two trials were included. One trial compared voriconazole to liposomal amphotericin B as empirical treatment of fever of unknown origin (suspected fungal infections) in neutropenic cancer patients (849 patients, 58 deaths). The other trial compared voriconazole to amphotericin B deoxycholate in the treatment of confirmed and presumed invasive Aspergillus infections (391 patients, 98 deaths). In the first trial, voriconazole was significantly inferior to liposomal amphotericin B according to the authors' prespecified criteria. More patients died in the voriconazole group and a claimed significant reduction in the number of breakthrough fungal infections disappeared when patients arbitrarily excluded from analysis by the authors were included. In the second trial, the deoxycholate preparation of amphotericin B was used without any indication of the use of premedication and substitution with electrolytes and salt water to avoid handicapping this drug. This choice of comparator resulted in a marked difference in the duration of treatment on trial drugs (77 days with voriconazole versus 10 days with amphotericin B), and precludes meaningful comparisons of the benefits and harms of the two drugs. AUTHORS' CONCLUSIONS: Liposomal amphotericin B is significantly more effective than voriconazole for empirical therapy of neutropenic cancer patients and should be preferred. For treatment of aspergillosis, there are no trials that have compared voriconazole with amphotericin B given under optimal conditions.

Amphotericin B↗
PubMed2005

Somatostatin analogues for acute bleeding oesophageal varices.

BACKGROUND: Somatostatin and its derivatives are often used for emergency treatment of bleeding oesophageal varices in patients with cirrhosis of the liver. OBJECTIVES: To study whether somatostatin or analogues improve survival or reduce the need for blood transfusions in patients with bleeding oesophageal varices. SEARCH STRATEGY: MEDLINE and The Cochrane Library were searched; last search in Febr 2004. Reference lists of articles, contacted authors. SELECTION CRITERIA: All randomised trials comparing somatostatin or analogues with placebo or no treatment in patients suspected of acute or recent bleeding from oesophageal varices. DATA COLLECTION AND ANALYSIS: The effect variables extracted were: mortality, blood transfusions, use of balloon tamponade, initial haemostasis and rebleeding. Intention-to-treat analyses including all randomised patients were conducted; a random effects analysis was preferred if there was significant heterogeneity between the trials (P < 0.10). The trials were divided in two quality groups; the better trials had concealed allocation of patients and were double-blind. MAIN RESULTS: We included 20 trials (2518 patients). The drugs did not reduce mortality significantly (relative risk 0.96, 95% confidence interval 0.74 to 1.24, for the high-quality trials, and 0.79 for low-quality trials). Units of blood transfused were 0.7 (0.3 to 1.2) less with drugs in the high-quality trials and 1.5 (0.9 to 2.0) less in the low-quality trials. Number of patients failing initial haemostasis was reduced, relative risk 0.67 (0.53 to 0.86). Number of patients with rebleeding was not significantly reduced for the high-quality trials, relative risk 0.82 (0.45 to 1.49) while it was substantially reduced in the low-quality trials, relative risk 0.35 (0.18 to 0.67). Use of balloon tamponade was rarely reported. AUTHORS' CONCLUSIONS: The effect corresponded to one half unit of blood saved per patient. It is doubtful whether this effect is worthwhile. The findings do not suggest a need for further placebo-controlled studies of the type reviewed here. A large placebo controlled trial enrolling thousands of patients is needed if one wishes to rule out the possibility that a worthwhile effect on mortality may have been overlooked.

Acute Disease↗
PubMed2004

House dust mite control measures for asthma.

BACKGROUND: The major allergen in house dust comes from mites. Chemical, physical and combined methods of reducing mite allergen levels are intended to reduce asthma symptoms in people who are sensitive to house dust mites. OBJECTIVES: To assess the effects of reducing exposure to house dust mite antigens in the homes of people with mite-sensitive asthma. SEARCH STRATEGY: Cochrane Airways Group trials register, and PubMed and The Cochrane Library (last searches June 2004), reference lists. SELECTION CRITERIA: Randomised trials of mite control measures vs placebo or no treatment in asthmatic people known to be sensitive to house dust mites. DATA COLLECTION AND ANALYSIS: Two reviewers applied the trial inclusion criteria, assessed their quality and extracted the data independently. Study authors were contacted to clarify information. MAIN RESULTS: Forty-nine trials (2733 patients) were included; the number of patients has more than doubled since the last version of this review. Thirty-one trials assessed physical methods, ten assessed chemical methods, and eight a combination of chemical and physical methods. Despite the fact that many trials were of poor quality and would be expected to exaggerate the reported effect, we did not find an effect of the interventions. For the most frequently reported outcome, peak flow in the morning (1339 patients), the standardised mean difference was -0.02 (95% confidence interval (CI) -0.13 to 0.08). There were no statistically significant differences either in number of patients improved (relative risk 1.01, 95% CI 0.80 to 1.27), asthma symptom scores (standardised mean difference -0.01, 95% CI -0.10 to 0.13), or in medication usage (standardised mean difference -0.05, 95% CI -0.18 to 0.09). REVIEWERS' CONCLUSIONS: Chemical and physical methods aimed at reducing exposure to house dust mite allergens cannot be recommended. It is doubtful whether further studies, similar to the ones in our meta-analysis, are worthwhile. If other types of studies are considered, they should be methodologically rigorous and use other methods than those used so far, with careful monitoring of mite exposure and relevant clinical outcomes.

Allergens↗
PubMed2004

Paracetamol versus nonsteroidal anti-inflammatory drugs for rheumatoid arthritis.

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) are usually preferred for simple analgesics such as paracetamol for rheumatoid arthritis. It is not clear, however, whether the trade-offs between benefits and harms of NSAIDs are preferable to those of paracetamol (paracetamol is also called acetaminophen). OBJECTIVES: To compare the benefits and harms of paracetamol with NSAIDs in patients with rheumatoid arthritis. SEARCH STRATEGY: Medline Silverplatter, Embase databases were searched up until Sept 2002. Reference lists of identified articles were also searched. SELECTION CRITERIA: Randomised double-blind studies comparing paracetamol with an NSAID. DATA COLLECTION AND ANALYSIS: Decisions on inclusion of trials and data extraction were performed by the two authors independently. MAIN RESULTS: Four cross-over studies, published between 1968 and 1982, involving 121 patients, and four different NSAIDs were included. The generation of the allocation sequence and the use of methods to conceal the allocation were not described in any of the studies. The studies were double-blind but it was not clear whether the blinding was effective. Methods for collecting adverse effects were not described. The NSAIDs were preferred more often than paracetamol by the patients or the investigator. In the largest trial, 20 out of 54 patients (37%) preferred ibuprofen and 7 out of 54 (13%) paracetamol. Investigators preference (as established by joint tenderness, grip strength and joint circumference) was 17 out of 35 for diclofenac versus 5 out of 35 for paracetamol in another trial. However, because of the weaknessess in the trials, no firm conclusion can be drawn. REVIEWER'S CONCLUSIONS: When considering the trade off between the benefits and harms of non-steroidal anti-inflammatory drugs and paracetamol/acetaminophen, it is not known whether one is better than the other for rheumatoid arthritis. But people with rheumatoid arthritis and the researchers in the study did prefer non-steroidal anti-inflammatory drugs more than acetaminophen/paracetamol. There is a need for a large trial, with appropriate randomisation, double-blinding, test of the success of the blinding, and with explicit methods to measure and analyse pain and adverse effects.

Acetaminophen↗
PubMed2004

Placebo interventions for all clinical conditions.

BACKGROUND: Placebo interventions are often claimed to improve patient-reported and observer-reported outcomes, but this belief is not based on evidence from randomised trials that compare placebo with no treatment. OBJECTIVES: To assess the effect of placebo interventions. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2002), MEDLINE (1966 to 2002), EMBASE (1980 to 2002), Biological Abstracts (1986 to 2002), and PsycLIT (1887 to 2002). We contacted experts on placebo research, and read references in the included trials. SELECTION CRITERIA: We included randomised placebo trials with a no-treatment control group investigating any health problem. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. We contacted study authors for additional information. MAIN RESULTS: Outcome data were available in 156 out of 182 included trials, investigating 46 clinical conditions. We found no statistically significant pooled effect of placebo in 38 studies with binary outcomes (4284 patients), relative risk 0.95 (95% confidence interval (CI) 0.89 to 1.01). The pooled relative risk for patient-reported outcomes was 0.95 (95% CI 0.88 to 1.03) and for observer-reported outcomes 0.91 (95% CI 0.81 to 1.03). There was heterogeneity (P=0.01) but the funnel plot was symmetrical. There was no statistically significant effect of placebo interventions in the four clinical conditions investigated in three trials or more: pain, nausea, smoking, and depression, but confidence intervals were wide. We found an overall effect of placebo treatments in 118 trials with continuous outcomes (7453 patients), standardised mean difference (SMD) -0.24 (95% CI -0.31 to -0.17). The SMD for patient-reported outcomes was -0.30 (95% CI -0.38 to -0.21), whereas no statistically significant effect was found for observer-reported outcomes, SMD -0.10 (95% CI -0.20 to -0.01). There was heterogeneity (P<0.001) and large variability in funnel plot results even for big trials. There was an apparent effect of placebo interventions on pain (SMD -0.25 (95% CI -0.35 to-0.16)), and phobia (SMD -0.63 (95% CI -1.17 to -0.08)); but also a substantial risk of bias. There was no statistically significant effect of placebo interventions in eight other clinical conditions investigated in three trials or more: nausea, smoking, depression, overweight, asthma, hypertension, insomnia and anxiety, but confidence intervals were wide. REVIEWERS' CONCLUSIONS: There was no evidence that placebo interventions in general have clinically important effects. A possible small effect on continuous patient-reported outcomes, especially pain, could not be clearly distinguished from bias.

Humans↗
PubMed2004

Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment.

BACKGROUND: It is widely believed that placebo interventions induce powerful effects. We could not confirm this in a systematic review of 114 randomized trials that compared placebo-treated with untreated patients. AIM: To study whether a new sample of trials would reproduce our earlier findings, and to update the review. METHODS: Systematic review of trials that were published since our last search (or not previously identified), and of all available trials. RESULTS: Data was available in 42 out of 52 new trials (3212 patients). The results were similar to our previous findings. The updated review summarizes data from 156 trials (11 737 patients). We found no statistically significant pooled effect in 38 trials with binary outcomes, relative risk 0.95 (95% confidence interval 0.89-1.01). The effect on continuous outcomes decreased with increasing sample size, and there was considerable variation in effect also between large trials; the effect estimates should therefore be interpreted cautiously. If this bias is disregarded, the pooled standardized mean difference in 118 trials with continuous outcomes was -0.24 (-0.31 to -0.17). For trials with patient-reported outcomes the effect was -0.30 (-0.38 to -0.21), but only -0.10 (-0.20 to 0.01) for trials with observer-reported outcomes. Of 10 clinical conditions investigated in three trials or more, placebo had a statistically significant pooled effect only on pain or phobia on continuous scales. CONCLUSION: We found no evidence of a generally large effect of placebo interventions. A possible small effect on patient-reported continuous outcomes, especially pain, could not be clearly distinguished from bias.

Humans↗
PubMed2003

Regular self-examination or clinical examination for early detection of breast cancer.

BACKGROUND: Breast self-examination and clinical breast examination have been promoted for many years as general screening methods to diagnose breast cancer at an earlier stage in order to decrease morbidity and or mortality. The possible benefits and harms remain unclear. OBJECTIVES: To determine whether screening for breast cancer by regular self-examination or clinical breast examination reduces breast cancer mortality and morbidity. SEARCH STRATEGY: The Cochrane Library and Medline were searched for randomised trials; date of last search October 2002. The specialised register maintained by the Cochrane Breast Cancer Group was searched. SELECTION CRITERIA: Randomised clinical trials, including cluster randomised trials. DATA COLLECTION AND ANALYSIS: Decisions on which trials to include were taken independently by the reviewers based on the methods of trial. Disagreements were resolved by discussion. Intention to treat analyses were conducted using a fixed effect model with 95% confidence intervals. MAIN RESULTS: Two large population-based studies (388,535 women) from Russia and Shanghai that compared breast self-examination with no intervention were included. There was no statistically significant difference in breast cancer mortality, relative risk 1.05 (95% confidence interval (CI) 0.90 to 1.24) (587 deaths in total). In Russia, more cancers were found in the breast self-examination group than in the control group (relative risk 1.24, 95% CI 1.09 to 1.41), while this was not the case in Shanghai (relative risk 0.97, 95% CI 0.88 to 1.06). Almost twice as many biopsies (3406) with benign results were performed in the screening group compared to the control group (1856), relative risk 1.89, 95% CI 1.79 to 2.00. REVIEWER'S CONCLUSIONS: Data from two large trials do not suggest a beneficial effect of screening by breast self-examination whereas there is evidence for harms. There were no randomised trials of clinical breast examination. At present, breast self-examination cannot be recommended.

Breast Neoplasms↗
PubMed2003

Placebo treatment versus no treatment.

BACKGROUND: Placebo interventions are often believed to improve patient reported and observer reported outcomes, but this belief is not based on evidence from randomised trials that compare placebo with no treatment. OBJECTIVES: To assess the effect of placebo interventions. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (The Cochrane Library, issue 3, 1998), MEDLINE (Jan 1966 to Dec 1998), EMBASE (Jan 1980 to Dec 1998), Biological Abstracts (Jan 1986 to Dec 1998), PsycLIT (Jan 1887 to Dec 1998). Experts on placebo research were contacted and references in the included trials were read. SELECTION CRITERIA: Randomised placebo trials with a no-treatment control group investigating any health problem were included. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: Outcome data were available in 114 out of 130 included trials, investigating 40 clinical conditions. Outcomes were binary in 32 trials (3795 patients) and continuous in 82 (4730 patients). We found no statistically significant pooled effect of placebo in studies with binary outcomes, relative risk 0.95 (95 per cent confidence interval 0.88 to 1.02). The pooled relative risk for subjective (patient reported) outcomes was 0.95 (0.86 to 1.05) and for objective (observer reported) outcomes 0.91 (0.80 to 1.04). There was statistically significant heterogeneity (P < 0.03), but no evidence of sample size bias (P = 0.56). We found an overall positive effect of placebo treatments in trials with continuous outcomes, standardised mean difference -0.28 (95 per cent confidence interval -0.38 to -0.19). The standardised mean difference for subjective outcomes was -0.36 (-0.47 to -0.25), whereas no statistically significant effect was found for objective outcomes, standardised mean difference -0.12 (-0.27 to 0.03). There was statistically significant heterogeneity (P < 0.001), and evidence of sample size bias (P = 0.05). There was no statistically significant effect of placebo interventions in eight out of nine clinical conditions investigated in three trials or more (nausea, relapse in prevention of smoking and depression, overweight, asthma, hypertension, insomnia and anxiety), but confidence intervals were wide. There was a modest apparent analgesic effect of placebo interventions, standardised mean difference -0.27 (-0.40 to -0.15), but also a substantial risk of bias. REVIEWER'S CONCLUSIONS: There was no evidence that placebo interventions in general have clinically important effects. A possible moderate effect on subjective continuous outcomes, especially pain, could not be clearly distinguished from bias.

Humans↗
PubMed2001

Cochrane review on screening for breast cancer with mammography.

In 2000, we reported that there is no reliable evidence that screening for breast cancer reduces mortality. As we discuss here, a Cochrane review has now confirmed and strengthened our previous findings. The review also shows that breast-cancer mortality is a misleading outcome measure. Finally, we use data supplemental to those in the Cochrane review to show that screening leads to more aggressive treatment.

Breast Neoplasms↗
PubMed2001

Quality of Cochrane reviews: assessment of sample from 1998.

OBJECTIVE: To assess the quality of Cochrane reviews. DESIGN: Ten methodologists affiliated with the Cochrane Collaboration independently examined, in a semistructured way, the quality of reviews first published in 1998. Each review was assessed by two people; if one of them noted any major problems, they agreed on a common assessment. Predominant types of problem were categorised. SETTING: Cyberspace collaboration coordinated from the Nordic Cochrane Centre. STUDIES: All 53 reviews first published in issue 4 of the Cochrane Library in 1998. MAIN OUTCOME MEASURE: Proportion of reviews with various types of major problem. RESULTS: No problems or only minor ones were found in most reviews. Major problems were identified in 15 reviews (29%). The evidence did not fully support the conclusion in nine reviews (17%), the conduct or reporting was unsatisfactory in 12 reviews (23%), and stylistic problems were identified in 12 reviews (23%). The problematic conclusions all gave too favourable a picture of the experimental intervention. CONCLUSIONS: Cochrane reviews have previously been shown to be of higher quality and less biased on average than other systematic reviews, but improvement is always possible. The Cochrane Collaboration has taken steps to improve editorial processes and the quality of its reviews. Meanwhile, the Cochrane Library remains a key source of evidence about the effects of healthcare interventions. Its users should interpret reviews cautiously, particularly those with conclusions favouring experimental interventions and those with many typographical errors.

Bias↗
PubMed2001

[What is evidence-based medicine?].

Evidence-based medicine is based on the best results from clinical and epidemiological research, which is combined with clinical experience and patient preferences. Questions of prognosis and harm are often best elucidated in large cohort studies. For other clinical questions the best evidence is usually found by systematic review of randomised trials, if possible in the form of meta-analyses. To make a diagnosis is, for example, not an aim in itself but a way to arrive at a prognosis and to suggest a treatment, provided this leads to a better prognosis. The most relevant, albeit rarely seen, test of a diagnostic method is a randomised trial. Evidence-based medicine will provide the best basis for evaluations of which interventions should be abandoned and which are effective and economically feasible. The use of evidence-based clinical guidelines will lead to more cost-effective treatments. It should be a national strategy that health care should be evidence-based.

Cost-Benefit Analysis↗
PubMed2001

Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment.

BACKGROUND: Placebo treatments have been reported to help patients with many diseases, but the quality of the evidence supporting this finding has not been rigorously evaluated. METHODS: We conducted a systematic review of clinical trials in which patients were randomly assigned to either placebo or no treatment. A placebo could be pharmacologic (e.g., a tablet), physical (e.g., a manipulation), or psychological (e.g., a conversation). RESULTS: We identified 130 trials that met our inclusion criteria. After the exclusion of 16 trials without relevant data on outcomes, there were 32 with binary outcomes (involving 3795 patients, with a median of 51 patients per trial) and 82 with continuous outcomes (involving 4730 patients, with a median of 27 patients per trial). As compared with no treatment, placebo had no significant effect on binary outcomes (pooled relative risk of an unwanted outcome with placebo, 0.95; 95 percent confidence interval, 0.88 to 1.02), regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effect (pooled standardized mean difference in the value for an unwanted outcome between the placebo and untreated groups, -0.28; 95 percent confidence interval, -0.38 to -0.19), but the effect decreased with increasing sample size, indicating a possible bias related to the effects of small trials. The pooled standardized mean difference was significant for the trials with subjective outcomes (-0.36; 95 percent confidence interval, -0.47 to -0.25) but not for those with objective outcomes. In 27 trials involving the treatment of pain, placebo had a beneficial effect (-0.27; 95 percent confidence interval, -0.40 to -0.15). This corresponded to a reduction in the intensity of pain of 6.5 mm on a 100-mm visual-analogue scale. CONCLUSIONS: We found little evidence in general that placebos had powerful clinical effects. Although placebos had no significant effects on objective or binary outcomes, they had possible small benefits in studies with continuous subjective outcomes and for the treatment of pain. Outside the setting of clinical trials, there is no justification for the use of placebos.

Anxiety↗
PubMed2001

The revised CONSORT statement for reporting randomized trials: explanation and elaboration.

Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards. A group of scientists and editors developed the CONSORT (Con solidated S tandards o f R eporting T rials) statement to improve the quality of reporting of RCTs. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have adopted the CONSORT statement. The CONSORT statement facilitates critical appraisal and interpretation of RCTs by providing guidance to authors about how to improve the reporting of their trials. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the CONSORT statement. The meaning and rationale for each checklist item are presented. For most items, at least one published example of good reporting and, where possible, references to relevant empirical studies are provided. Several examples of flow diagrams are included. The CONSORT statement, this explanatory and elaboration document, and the associated Web site ( http://www.consort-statement.org ) should be helpful resources to improve reporting of randomized trials. Throughout the text, terms marked with an asterisk are defined at end of text.

Algorithms↗