Dataset Information

The paradox of sham therapy and placebo effect in osteopathy: A systematic review.

ABSTRACT:

Background

Placebo, defined as "false treatment," is a common gold-standard method to assess the validity of a therapy both in pharmacological trials and manual medicine research where placebo is also referred to as "sham therapy." In the medical literature, guidelines have been proposed on how to conduct robust placebo-controlled trials, but mainly in a drug-based scenario. In contrast, there are not precise guidelines on how to conduct a placebo-controlled in manual medicine trials (particularly osteopathy). The aim of the present systematic review was to report how and what type of sham methods, dosage, operator characteristics, and patient types were used in osteopathic clinical trials and, eventually, assess sham clinical effectiveness.

Methods

A systematic Cochrane-based review was conducted by analyzing the osteopathic trials that used both manual and nonmanual placebo control. Searches were conducted on 8 databases from journal inception to December 2015 using a pragmatic literature search approach. Two independent reviewers conducted the study selection and data extraction for each study. The risk of bias was evaluated according to the Cochrane methods.

Results

A total of 64 studies were eligible for analysis collecting a total of 5024 participants. More than half (43 studies) used a manual placebo; 9 studies used a nonmanual placebo; and 12 studies used both manual and nonmanual placebo. Data showed lack of reporting sham therapy information across studies. Risk of bias analysis demonstrated a high risk of bias for allocation, blinding of personnel and participants, selective, and other bias. To explore the clinical effects of sham therapies used, a quantitative analysis was planned. However, due to the high heterogeneity of sham approaches used no further analyses were performed.

Conclusion

High heterogeneity regarding placebo used between studies, lack of reporting information on placebo methods and within-study variability between sham and real treatment procedures suggest prudence in reading and interpreting study findings in manual osteopathic randomized controlled trials (RCTs). Efforts must be made to promote guidelines to design the most reliable placebo for manual RCTs as a means of increasing the internal validity and improve external validity of findings.

SUBMITTER: Cerritelli F

PROVIDER: S-EPMC5008597 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Publications

The paradox of sham therapy and placebo effect in osteopathy: A systematic review.

Cerritelli Francesco F Verzella Marco M Cicchitti Luca L D'Alessandro Giandomenico G Vanacore Nicola N

Medicine 20160801 35

<h4>Background</h4>Placebo, defined as "false treatment," is a common gold-standard method to assess the validity of a therapy both in pharmacological trials and manual medicine research where placebo is also referred to as "sham therapy." In the medical literature, guidelines have been proposed on how to conduct robust placebo-controlled trials, but mainly in a drug-based scenario. In contrast, there are not precise guidelines on how to conduct a placebo-controlled in manual medicine trials (pa ...[more]

PMID: 27583913

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Project description:BACKGROUND:Chronic inflammatory diseases (CID) are globally highly prevalent and characterized by severe pathological medical conditions. Several trials were conducted aiming at measuring the effects of manipulative therapies on patients affected by CID. The purpose of this review was to explore the extent to which osteopathic manipulative treatment (OMT) can be benefi-cial in medical conditions also classified as CID. METHODS:This review included any type of experimental study which enrolled sub-jects with CID comparing OMT with any type of control procedure. The search was conducted on eight databases in January 2014 using a pragmatic literature search approach. Two independent re-viewers conducted study selection and data extraction for each study. The risk of bias was evaluated according to the Cochrane methods. Heterogeneity was assessed and meta-analysis performed where possible. RESULTS:10 studies met the inclusion criteria for this review enrolling 386 subjects. The search identified six RCTs, one laboratory study, one cross-over pilot studies, one observation-al study and one case control pilot study. Results suggest a potential effect of osteopathic medicine on patients with medical pathologies associated with CID (in particular Chronic Obstructive Pul-monary Disease (COPD), Irritable Bowel Syndrome, Asthma and Peripheral Arterial Disease) com-pared to no treatment or sham therapy although data remain elusive. Moreover one study showed possible effects on arthritis rat model. Meta-analysis was performed for COPD studies only show-ing no effect of any type of OMT applied versus control. No major side effects were reported by those receiving OMT. CONCLUSION:The present systematic review showed inconsistent data on the effect of OMT in the treatment of medical conditions potentially associated with CID, however the OMT appears to be a safe approach. Further more robust trials are needed to determine the direction and magnitude of the effect of OMT and to generalize favorable results.

Project description:In 2010, the World Health Organization published benchmarks for training in osteopathy in which osteopathic visceral techniques are included. The purpose of this study was to identify and critically appraise the scientific literature concerning the reliability of diagnosis and the clinical efficacy of techniques used in visceral osteopathy.Databases MEDLINE, OSTMED.DR, the Cochrane Library, Osteopathic Research Web, Google Scholar, Journal of American Osteopathic Association (JAOA) website, International Journal of Osteopathic Medicine (IJOM) website, and the catalog of Académie d'ostéopathie de France website were searched through December 2017. Only inter-rater reliability studies including at least two raters or the intra-rater reliability studies including at least two assessments by the same rater were included. For efficacy studies, only randomized-controlled-trials (RCT) or crossover studies on unhealthy subjects (any condition, duration and outcome) were included. Risk of bias was determined using a modified version of the quality appraisal tool for studies of diagnostic reliability (QAREL) in reliability studies. For the efficacy studies, the Cochrane risk of bias tool was used to assess their methodological design. Two authors performed data extraction and analysis.Eight reliability studies and six efficacy studies were included. The analysis of reliability studies shows that the diagnostic techniques used in visceral osteopathy are unreliable. Regarding efficacy studies, the least biased study shows no significant difference for the main outcome. The main risks of bias found in the included studies were due to the absence of blinding of the examiners, an unsuitable statistical method or an absence of primary study outcome.The results of the systematic review lead us to conclude that well-conducted and sound evidence on the reliability and the efficacy of techniques in visceral osteopathy is absent.The review is registered PROSPERO 12th of December 2016. Registration number is CRD4201605286 .

Project description:Background: Recent research shows that placebo mechanisms can be utilized in ethical and legal ways such as in open-label conditions, when patients know that they receive placebos, and through psychological interventions aiming to optimize patients' expectations. Showing that placebo interventions are also cost-efficient could improve their acceptability. Objective: To review studies that performed health economic evaluations (HEEs) of intentional placebo interventions and to review studies that intentionally applied placebo interventions and reported outcomes eligible for HEEs. Methods: Two systematic reviews of the literature were performed. For the first review, we searched MEDLINE using "placebo" and Medical Subject Headings (MeSH) terms associated with HEEs such as "costs," "cost-benefit analyses," and "economics." Studies were eligible if they employed patients, applied placebo interventions, included an appropriate control group, and reported results of cost analyses. For the second review, we searched the Journal of Interdisciplinary Placebo Studies (JIPS) database and MEDLINE using search terms for outcomes eligible for cost-utility analyses, such as "quality of life" or "quality-adjusted life years" ("QALYs"). Risk of bias of all studies found was assessed according to the Cochrane Handbook, and a narrative synthesis of the results is provided. Results: The first search resulted in 1,853 articles, which were screened for eligibility. Two studies were found only in which costs or cost-effectiveness analysis were reported, but with medium to high risks of biases. The second search yielded 164 articles particularly from the JIPS database of which 11 studies met our search criteria: in six studies, patients received placebo pills in open-label conditions; three studies investigated effects of patient-physician relationships; and two studies used psychological interventions to optimize treatment expectations, in patients with various diseases and disorders. These studies report outcomes potentially eligible for HEEs when costs of interventions were known. Risks of biases were low to medium, but patients were not blinded to the conditions in most studies. Conclusions: The state of knowledge about HEEs of placebo interventions is scarce. To gain more visibility and acceptability for placebo interventions, future studies should measure outcomes usable for HEEs and costs of interventions, and HEEs should be performed for existing studies if data are available.

Project description:ObjectiveTo assess the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development.DesignSystematic review and meta-analysis.Methods and analysisDifferent databases were screened up to 20 August 2020. Randomised controlled trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included.Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology and reflexology) and to no treatment. Primary outcomes were BP improvement, success of blinding and adverse effect (AE). Secondary outcomes were number of drop-outs. Dichotomous outcomes were analysed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.Results24 trials were included involving 2019 participants. Very low evidence quality suggests clinically insignificant pain improvement in favour of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation being the most recognised technique.Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).ConclusionsMT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings.Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.Prospero registration numberCRD42020198301.

Dataset Information

The paradox of sham therapy and placebo effect in osteopathy: A systematic review.

Background

Methods

Results

Conclusion

Publications

The paradox of sham therapy and placebo effect in osteopathy: A systematic review.

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