23 november 2023: Bron:  2023; 12: 191. Published online 2023 Oct 7

Uit een meta-analyse van placebo gecontroleerde gerandomiseerde studies blijkt homeopatische aanpak bij verschillende ziektes betere resultaten te geven in vergelijking met een placebo. Dat blijkt uit een meta-analyse van in eerste instantie honderden studies waar er uiteindelijk maar 6 van overbleven om het effect tussen homeopathie en placebo te kunnen evalueren.

Uit de introductie een kort stukje tekst vertaald om aan te geven waar het in deze meta-analyse om gaat:

Homeopathie is een therapiesysteem dat veel wordt gebruikt in Europa, India en andere landen []. Kern kenmerken van homeopathie zijn onder meer medicijntests (observatie van symptomen die voorkomen bij gezonde personen die worden blootgesteld aan stoffen van minerale, botanische of zoölogische oorsprong), het simile-principe (overeenstemming tussen symptoompatronen in medicijntests en de symptomen die met dezelfde stof moeten worden behandeld) en potentiëring. (opeenvolgende verdunning van de homeopathische stof, waarbij elke verdunningsstap het herhaaldelijk schudden van vloeistoffen of het vermalen van vaste stoffen tot lactose omvat) [].

De klinische effecten van homeopathische behandelingen zijn onderzocht in enkele honderden gerandomiseerde gecontroleerde onderzoeken [] en in systematische reviews (SR’s). Onder de SR’s kunnen twee contrasterende benaderingen worden onderscheiden.
Eén benadering is om zich te concentreren op een specifieke indicatie (bijvoorbeeld depressie [], acute luchtweginfecties bij kinderen [), terwijl er vaak sprake is van open-label onderzoeken en observationele onderzoeken. In deze aanpak wordt de datasynthese gegroepeerd op basis van hun ontwerp, waardoor informatie ontstaat over homeopathie in de patiëntenzorg.
De tegenovergestelde benadering is om alle indicaties op te nemen en tegelijkertijd de onderzoeksopzet te beperken tot placebogecontroleerde onderzoeken en de resultaten samen te voegen in een MA's, waardoor informatie wordt verkregen over de specifieke effecten van homeopathie die verder gaat dan die van placebo. Een belangrijke reden voor het gebruik van deze aanpak is de bewering dat ‘homeopathie de natuurwetten schendt en dat elk effect dus een placebo-effect moet zijn’ [].

Sinds 1997 zijn er ten minste zes MA’s van placebogecontroleerde homeopathieonderzoeken voor welke aandoening dan ook gepubliceerd [–]. Deze MA's verschilden in hun methoden voor de opname van onderzoeken, gegevenssynthese en beoordeling van het risico op vertekening; bovendien waren hun resultaten en conclusies inconsistent.
Gedurende deze periode zijn er substantiële vorderingen gemaakt in de methodologie en kwaliteitsnormen voor MA's en andere SR's [–], waaronder SR's van SR's (ook wel overzichten of overkoepelende beoordelingen genoemd) [–]. Voor zover wij weten is er voor geen enkele aandoening een formele SR van MA's van gerandomiseerde, placebogecontroleerde homeopathieonderzoeken uitgevoerd. Hierin rapporteren wij een dergelijke SR.

In het volledige studierapport worden met veel grafieken uitleg gegeven hoe de onderzoekers te werk zijn gegaan en bijbehorende resultaten. Klik op de titel van het abstract en indien geinteresseerd raadpleeg ook de referentielijst waarin aantal interessante studies staan vermeld.

 2023; 12: 191.
Published online 2023 Oct 7. doi: 10.1186/s13643-023-02313-2
PMCID: PMC10559431
PMID: 37805577

Efficacy of homoeopathic treatment: Systematic review of meta-analyses of randomised placebo-controlled homoeopathy trials for any indication

H. J. Hamre,corresponding author1,2 A. Glockmann,1 K. von Ammon,2 D. S. Riley,3,4 and H. Kiene1,2
Author information Article notes Copyright and License information PMC Disclaimer

Abstract

Background and objective

Since 1997, several meta-analyses (MAs) of placebo-controlled randomised efficacy trials of homoeopathy for any indication (PRETHAIs) have been published with different methods, results and conclusions. To date, a formal assessment of these MAs has not been performed. The main objective of this systematic review of MAs of PRETHAIs was to evaluate the efficacy of homoeopathic treatment.

Methods

The inclusion criteria were as follows: MAs of PRETHAIs in humans; all ages, countries, settings, publication languages; and MAs published from 1 Jan. 1990 to 30 Apr. 2023. The exclusion criteria were as follows: systematic reviews without MAs; MAs restricted to age or gender groups, specific indications, or specific homoeopathic treatments; and MAs that did not assess efficacy. We searched 8 electronic databases up to 14 Dec. 2020, with an update search in 6 databases up to 30 April 2023.

The primary outcome was the effect estimate for all included trials in each MA and after restricting the sample to trials with high methodological quality, according to predefined criteria. The risk of bias for each MA was assessed by the ROBIS (Risk Of Bias In Systematic reviews) tool. The quality of evidence was assessed by the GRADE framework. Statistical analyses were performed to determine the proportion of MAs showing a significant positive effect of homoeopathy vs. no significant difference.

Results

Six MAs were included, covering individualised homoeopathy (I-HOM, n = 2), nonindividualised homoeopathy (NI-HOM, n = 1) and all homoeopathy types (ALL-HOM = I-HOM + NI-HOM, n = 3). The MAs comprised between 16 and 110 trials, and the included trials were published from 1943–2014. The median trial sample size ranged from 45 to 97 patients. The risk of bias (low/unclear/high) was rated as low for three MAs and high for three MAs.

Effect estimates for all trials in each MA showed a significant positive effect of homoeopathy compared to placebo (5 of 5 MAs, no data in 1 MA). Sensitivity analyses with sample restriction to high-quality trials were available from 4 MAs; the effect remained significant in 3 of the MAs (2 MAs assessed ALL-HOM, 1 MA assessed I-HOM) and was no longer significant in 1 MA (which assessed NI-HOM).

Discussion

The quality of evidence for positive effects of homoeopathy beyond placebo (high/moderate/low/very low) was high for I-HOM and moderate for ALL-HOM and NI-HOM. There was no support for the alternative hypothesis of no outcome difference between homoeopathy and placebo.

The available MAs of PRETHAIs reveal significant positive effects of homoeopathy beyond placebo. This is in accordance with laboratory experiments showing partially replicable effects of homoeopathically potentised preparations in physico-chemical, in vitro, plant-based and animal-based test systems.

Systematic review registration

PROSPERO CRD42020209661. The protocol for this SR was finalised and submitted on 25 Nov. 2020 and registered on 26 Dec. 2020.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13643-023-02313-2.

Background and rationale

Homoeopathy is a therapy system widely used in Europe, India and other countries []. Core features of homoeopathy include drug provings (observation of symptoms occurring in healthy persons exposed to substances of mineral, botanical or zoological origin), simile principle (similarity between symptom patterns in drug provings and the symptoms to be treated with the same substance) and potentization (successive dilution of the homoeopathic substance, with each dilution step involving repeated shaking of liquids or grinding of solids into lactose) [].

The clinical effects of homoeopathic treatment have been investigated in several hundred randomised controlled trials [] and in systematic reviews (SRs). Among the SRs, two contrasting approaches can be discerned.

One approach is to focus on a specific indication (e.g., depression [], acute respiratory tract infections in children []) while often including open-label trials and observational studies. In this approach, data synthesis is grouped by design, thus yielding information about homoeopathy in patient care.

The opposite approach is to include all indications while restricting study designs to placebo-controlled trials and aggregating results in an MAs, thus yielding information about the specific effects of homoeopathy beyond those of placebo. A major reason for using this approach has been the claim that ‘homoeopathy violates natural laws and thus any effect must be a placebo effect’ [].

Since 1997, at least six MAs of placebo-controlled homoeopathy trials for any condition have been published [–]. These MAs have differed in their methods for trial inclusion, data synthesis and assessment of risk of bias; furthermore, their results and conclusions have been inconsistent. During this period, there have been substantial advancements in methodology and quality standards for MAs and other SRs [–], including SRs of SRs (also called overviews or umbrella reviews) [–]. To our knowledge, a formal SR of MAs of randomised placebo-controlled homoeopathy trials for any condition has not been performed. Herein, we report such an SR.

Interpretation of the results in the context of other evidence

According to this SR, homoeopathy can have positive effects beyond placebo on disease in humans. This is in accordance with laboratory experiments showing partially replicable effects of homoeopathically potentised preparations in physico-chemical [], in vitro [], plant-based [, ] and animal-based [–] test systems.

Implications of the results for practice and policy

In contrast to frequent claims, the available MAs of homoeopathy in placebo-controlled randomised trials for any indication show significant positive effects beyond placebo. Compared to other medical interventions, the quality of evidence for efficacy of homoeopathy was similar or higher than for 90% of interventions across medicine []. Accordingly, the efficacy evidence from placebo-controlled randomised trials provides no justification for regulatory or political actions against homoeopathy in health-care systems.

Recommendations for future research

For I-HOM, an update of the MA conducted by Mathie (2014 []) would be warranted to reassess efficacy evidence after inclusion of trials published after 2011. For NI-HOM, the results of the MA conducted by Mathie (2017 []) with 54 trials were heterogeneous. Accordingly, future research on the efficacy of NI-HOM should focus on specific nonindividualised forms of homoeopathic therapy or specific interventions therein for specific indications. Recommendations for comparative effectiveness research on homoeopathy are beyond the scope of this review.

Acknowledgements

We thank Gunver S. Kienle (GSK) for the assistance with data extraction and assessment of risk of bias of the MAs.

Authors’ contributions

HJH: Literature search and screening, assessment of literature records for inclusion, data collection, assessment of risk of bias of MA, manuscript drafting and revision. AG: Literature search and screening, assessment of literature records for inclusion, data collection, coding of indications, additional analyses, manuscript drafting and revision. KvA: Manuscript drafting and revision. DSR: Manuscript drafting and revision. HK: Data collection, manuscript drafting and revision. All authors of the manuscript have read and agreed to its content and are accountable for all aspects of the accuracy and integrity of the manuscript in accordance with ICMJE criteria. All authors have approved the manuscript for submission.

Funding

Open Access funding enabled and organized by Projekt DEAL. Funding specifically for this SR was provided by Christophorus-Stiftung (No. 393 CST), Stiftung Marion Meyenburg (Date 24.09.2020), Dr. Hauschka Stiftung (Date 16.11.2020) and Gesellschaft für Pluralität im Gesundheitswesen (Dates 11.06.2021, 22.06.2021). General funding for IFAEMM was provided by the Software-AG Stiftung (SE-P 13544). The funders had no influence on the writing of the protocol or on the planning, conduct and publication of this SR.

Availability of data and materials

The complete protocol is permanently available on the website of the institution of the corresponding author: https://www.ifaemm.de/Abstract/PDFs/SMAP-HOM_Protocol_2020_11_25.pdf. All data extracted from the MA publications as well as analyses performed by the authors of this SR are presented in Tables ​Tables1,1, ​,2,2, ​,3,3, ​,4,4, ​,5,5, ​,6,6, ​,7,7, ​,8,8, ​,9,9, ​,10,10, ​,11,11, ​,1212 and Additional files 1, 2, 3, 4, 5.

Amendments, additional analyses and data

Amendments to the protocol from 25 Nov. 2020 are listed and explained in Suppl. Table 39. Additional analyses and data, not described in the protocol, are listed and explained in Suppl. Table 40.

Duplicate publications

The content of the manuscript has not been published or submitted for publication elsewhere.

Declarations

Ethics approval and consent to participate

Not applicable, as this SR does not involve any original research on humans.

Competing interests

In the past 3 years, HJH has received research grants from two manufacturers of anthroposophic medicinal products (Wala Heilmittel GmbH, Bad Boll/Eckwälden, Germany; Weleda AG, Arlesheim Switzerland). Anthroposophic medicine is not based on the homoeopathic simile principle or on drug provings, but some anthroposophic medicinal products are potentized. The two manufacturers had no involvement with the present SR. Anthroposophic medicinal products were not part of the intervention in any of the trials evaluated in the MAs of this SR (Suppl. Table 15). DSR has received a development grant from Heel GmbH (manufacturer of homoeopathic products) for online training in case report writing. AG, KvA and HK declare that they have no competing interests.

Footnotes

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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