SynthesisBMC medical research methodology2009
Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention.
Synthesis in BMC medical research methodology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
55 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- Differential power of placebo across major psychiatric disorders: a preliminary meta-analysis and machine learning study.Scientific reports · 2021Pooled it
- Placebo response rates and potential modifiers in double-blind randomized controlled trials of second and newer generation antidepressants for major depressive disorder in children and adolescents: a systematic review and meta-regression analysis.European child & adolescent psychiatry · 2020Pooled it
- Pooled it
- Risks and benefits of stress ulcer prophylaxis in adult neurocritical care patients: a systematic review and meta-analysis of randomized controlled trials.Critical care (London, England) · 2015Pooled it
- Placebo eff ects in psychiatry: mediators and moderators.The lancet. Psychiatry · 2015Pooled it
- Pooled it
- Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: network meta-analysis.BMJ (Clinical research ed.) · 2010Pooled it
- Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review.BMJ (Clinical research ed.) · 2010Pooled it
- Trial
- Probiotics as a treatment for prenatal maternal anxiety and depression: a double-blind randomized pilot trial.Scientific reports · 2021Trial
- Effectiveness of vergence/accommodative therapy for accommodative dysfunction in children with convergence insufficiency.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2021Trial
- Methylphenidate-Related Improvements in Math Performance Cannot Be Explained by Better Cognitive Functioning or Higher Academic Motivation: Evidence From a Randomized Controlled Trial.Journal of attention disorders · 2020Trial
- Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial.Pain medicine (Malden, Mass.) · 2019Trial
- Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial.BMJ (Clinical research ed.) · 2018Trial
- Mood Regulation Focused CBT Based on Memory Reconsolidation, Reduced Suicidal Ideation and Depression in Youth in a Randomised Controlled Study.International journal of environmental research and public health · 2018Trial
- Trial
- Does the placebo effect modulate drug bioavailability? Randomized cross-over studies of three drugs.Journal of negative results in biomedicine · 2017Trial
- Drug*placebo interaction effect may bias clinical trials interpretation: hybrid balanced placebo and randomized placebo-controlled design.BMC medical research methodology · 2016Trial
- Myofascial trigger point-focused head and neck massage for recurrent tension-type headache: a randomized, placebo-controlled clinical trial.The Clinical journal of pain · 2015Trial
- Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study.BMJ (Clinical research ed.) · 2012Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIt can be challenging for patients and clinicians to properly interpret a change in the clinical condition after a treatment has been given. It is not known to which extent spontaneous improvement, effect of placebo and effect of active interventions contribute to the observed change from baseline, and we aimed at quantifying these contributions.
methodsSystematic review and meta-analysis, based on a Cochrane review of the effect of placebo interventions for all clinical conditions. We selected all trials that had randomised the patients to three arms: no treatment, placebo and active intervention, and that had used an outcome that was measured on a continuous scale or on a ranking scale. Clinical conditions that had been studied in less than three trials were excluded.
resultsWe analysed 37 trials (2900 patients) that covered 8 clinical conditions. The active interventions were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95% confidence interval -0.36 to -0.12) for no treatment, -0.44 (-0.61 to -0.28) for placebo, and -1.01 (-1.16 to -0.86) for active treatment. Thus, on average, the relative contributions of spontaneous improvement and of placebo to that of the active interventions were 24% and 20%, respectively, but with some uncertainty, as indicated by the confidence intervals for the three SMDs. The conditions that had the most pronounced spontaneous improvement were nausea (45%), smoking (40%), depression (35%), phobia (34%) and acute pain (25%).
conclusionSpontaneous improvement and effect of placebo contributed importantly to the observed treatment effect in actively treated patients, but the relative importance of these factors differed according to clinical condition and intervention.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.