Volume 26, June 2016, Pages 146–163
Highlights
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- This review address the naive assumption that because of the generally diluted doses used homeopathy must be safe.
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- This review touches the neglected issue of the distinction between homeopathic aggravation, adverse reactions and adverse effects.
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- We found a similar risk for homeopathic treatment compared to controls such as placebo and conventional medicine
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, I2 = 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;
- Patient safety;
- Systematic review;
- Meta-analysis;
- Risk assessment
© 2016 Elsevier Ltd. All rights reserved.
