Homeopathic Plumbum metallicum for lead poisoning: a randomized clinical trial

Padilha, Roberto Queiroz; Riera, Rachel; Atallah, Álvaro Nagib

doi:10.1016/j.homp.2010.11.007

Cited by 5 publications

(7 citation statements)

References 20 publications

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“…With only three studies that can be classified as reliable evidence, it is difficult to separate an effect of homeopathy from the effect of poor quality. The three studies comprising ‘reliable’ RCT evidence are clinically heterogeneous: Plumbum metallicum for lead poisoning ([23]; null effect); Acthéane for menopausal syndrome ([24]; significant treatment effect; evidence of vested interest); Traumeel S for post-operative pain ([25]; null effect). Since the completion of our defined literature search, we are aware of recently published and potentially eligible RCT papers, whose findings we have yet to explore [26–29].…”

Section: Discussionmentioning

confidence: 99%

“…We report separately our model validity assessments of these trials, evaluating consequently their overall quality based on a GRADE -like principle of ‘downgrading’ [14]: two trials [23, 25] rated here as reliable evidence were downgraded to ‘low quality’ overall due to the inadequacy of their model validity; the remaining trial with reliable evidence [24] was judged to have adequate model validity. The latter study [24] thus comprises the sole RCT that can be designated ‘high quality’ overall by our approach5, a stark finding that reveals further important aspects of the preponderantly low quality of the current body of evidence in non-individualised homeopathy.…”

Section: Discussionmentioning

confidence: 99%

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Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis

et al. 2017

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BackgroundA rigorous systematic review and meta-analysis focused on randomised controlled trials (RCTs) of non-individualised homeopathic treatment has not previously been reported. We tested the null hypothesis that the main outcome of treatment using a non-individualised (standardised) homeopathic medicine is indistinguishable from that of placebo. An additional aim was to quantify any condition-specific effects of non-individualised homeopathic treatment.MethodsLiterature search strategy, data extraction and statistical analysis all followed the methods described in a pre-published protocol. A trial comprised ‘reliable evidence’ if its risk of bias was low or it was unclear in one specified domain of assessment. ‘Effect size’ was reported as standardised mean difference (SMD), with arithmetic transformation for dichotomous data carried out as required; a negative SMD indicated an effect favouring homeopathy.ResultsForty-eight different clinical conditions were represented in 75 eligible RCTs. Forty-nine trials were classed as ‘high risk of bias’ and 23 as ‘uncertain risk of bias’; the remaining three, clinically heterogeneous, trials displayed sufficiently low risk of bias to be designated reliable evidence. Fifty-four trials had extractable data: pooled SMD was –0.33 (95% confidence interval (CI) –0.44, –0.21), which was attenuated to –0.16 (95% CI –0.31, –0.02) after adjustment for publication bias. The three trials with reliable evidence yielded a non-significant pooled SMD: –0.18 (95% CI –0.46, 0.09). There was no single clinical condition for which meta-analysis included reliable evidence.ConclusionsThe quality of the body of evidence is low. A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions. Better designed and more rigorous RCTs are needed in order to develop an evidence base that can decisively provide reliable effect estimates of non-individualised homeopathic treatment.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-017-0445-3) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis

et al. 2017

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“…The original meta-analysis by Mathie et al yielded a statistically significantly greater efficacy of homeopathy than placebo (SMD: −0.33, 95% CI −0.44 to -0.21). 13 For our example, we included the 19 RCTs, [41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58][59] which were published between 2002 and 2014. We chose 2002 as a threshold because ClinicalTrials.…”

Section: The Impact Of Missing Trial Registration and Selective Publi...mentioning

confidence: 99%

Assessing the magnitude of reporting bias in trials of homeopathy: a cross-sectional study and meta-analysis

Gartlehner

Emprechtinger

Hackl

et al. 2022

BMJ EBM

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ObjectivesTo assess the magnitude of reporting bias in trials assessing homeopathic treatments and its impact on evidence syntheses.DesignA cross-sectional study and meta-analysis. Two persons independently searched Clinicaltrials.gov, the EU Clinical Trials Register and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials. To determine whether registered trials were published and to detect published but unregistered trials, two persons independently searched PubMed, Allied and Complementary Medicine Database, Embase and Google Scholar up to April 2021. For meta-analyses, we used random effects models to determine the impact of unregistered studies on meta-analytic results.Main outcomes and measuresWe report the proportion of registered but unpublished trials and the proportion of published but unregistered trials. We also assessed whether primary outcomes were consistent between registration and publication. For meta-analyses, we used standardised mean differences (SMDs).ResultsSince 2002, almost 38% of registered homeopathy trials have remained unpublished, and 53% of published randomised controlled trials (RCTs) have not been registered. Retrospective registration was more common than prospective registration. Furthermore, 25% of primary outcomes were altered or changed compared with the registry. Although we could detect a statistically significant trend toward an increase of registrations of homeopathy trials (p=0.001), almost 30% of RCTs published during the past 5 years had not been registered.A meta-analysis stratified by registration status of RCTs revealed substantially larger treatment effects of unregistered RCTs (SMD: −0.53, 95% CI −0.87 to −0.20) than registered RCTs (SMD: −0.14, 95% CI −0.35 to 0.07).ConclusionsRegistration of published trials was infrequent, many registered trials were not published and primary outcomes were often altered or changed. This likely affects the validity of the body of evidence of homeopathic literature and may overestimate the true treatment effect of homeopathic remedies.

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“…'acceptable' or 'uncertain') in MVHT, just one of those (A272 Colau 12 ) has been identified 'reliable evidence' 9 and thus able to be designated 'high quality' overall. Two trials rated as 'reliable evidence' by risk-of-bias assessment 9 (A103 Padilha 25 ; A120 Singer 29 ) were downgraded to 'low quality' overall due to inadequate MVHT, showing that the best conventionally viewed evidence is not necessarily also the best evidence from a homeopathy perspective. The remaining 56 of the 75 trials that were eligible for the overarching systematic review (i.e.…”

Section: Discussionmentioning

confidence: 99%

“…Only one of the three trials previously rated as reliable evidence had acceptable MVHT (A272 Colau 12 ): this single trial was therefore designated 'high quality' overall; the other two trials regarded as reliable evidence (A103 Padilha 25 ; A120 Singer 29 ) had inadequate MVHT, and so were down-graded to 'low quality' overall (Table 4). Of the remaining 23 trials (i.e.…”

Section: Overall Quality Designationmentioning

confidence: 99%

Model validity of randomised placebo-controlled trials of non-individualised homeopathic treatment

Mathie

Wassenhoven²,

Jacobs

et al. 2017

Homeopathy

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Of the 26 RCTs of non-individualised homeopathy that were judged 'not at high risk of bias', nine have been rated 'acceptable MVHT'. One of those nine studies was designated 'high quality' overall ('acceptable MVHT' and 'reliable evidence'), and is thus currently the only reported RCT that represents best therapeutic practice as well as unbiased evidence in non-individualised homeopathy. As well as minimising risk of bias, new RCTs in this area must aim to maximise MVHT and clarity of reporting.

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Homeopathic Plumbum metallicum for lead poisoning: a randomized clinical trial

Abstract: The homeopathic preparation Plumbum metallicum had no effect, in this study, in terms of reducing serum lead in workers exposed to lead.

Cited by 5 publications

References 20 publications

Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis

Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis

Assessing the magnitude of reporting bias in trials of homeopathy: a cross-sectional study and meta-analysis

Model validity of randomised placebo-controlled trials of non-individualised homeopathic treatment

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