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Complement Ther Med. 2016 Jun;26:146-63. doi: 10.1016/j.ctim.2016.03.013. Epub 2016 Mar 26.

Adverse effects of homeopathy, what do we know? A systematic review and meta-analysis of randomized controlled trials.

Author information

1
The National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, Faculty of Health Science, UiT The Arctic University of Tromsø, 9037 Tromsø, Norway. Electronic address: trine.stub@uit.no.
2
The National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, Faculty of Health Science, UiT The Arctic University of Tromsø, 9037 Tromsø, Norway.
3
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.

Abstract

OBJECTIVES:

Homeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients' symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed.

DESIGN AND SETTING:

Sixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis.

RESULTS:

A total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86-1.14, I(2)=54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high.

CONCLUSION:

Adverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine.

KEYWORDS:

Adverse effects; Adverse events; Homeopathic aggravations; Meta-analysis; Patient safety; Risk assessment; Systematic review

PMID:
27261996
DOI:
10.1016/j.ctim.2016.03.013
[Indexed for MEDLINE]

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