The benefit/risk balance of subcutaneous injections as used in homeopathy and anthroposophic medicine: A narrative literature review

Abstract Introduction This review explores the benefit/risk balance of using subcutaneous injections. Overall, regulatory authorities regard that the use of injectables are only justified for acute cases and that oral products are better alternatives for both ethical and safety reasons. Conversely, Complementary & Alternative Medicine (CAM) pharmaceutical companies and doctors who prescribe injectables consider them to have additional clinical value compared with the oral route of administration (ROA), and consider the risk of the parenteral ROA as very low. Methods A narrative review was conducted. The favourable and unfavourable effects, the uncertainty of the effects and the possible mode of action of the subcutaneous ROA are described and an estimation of the benefit/risk balance is performed. Results The review demonstrates a high prescribers demand, and evidence on the existence of several favourable effects of the subcutaneous ROA (e.g., higher clinical efficacy, higher bio-availability, quicker onset of action), some unfavourable low risk effects of the subcutaneous ROA (e.g., risk related to exposure, substance and the needle) and overall a positive benefit/risk balance. Conclusion The results justify a more positive attitude from regulatory authorities towards the use of this ROA and towards ampoule prescribing doctors. However, given the small number of good studies on this topic, more research on the favourable and unfavourable effects, the uncertainties of these effects and the conceptualization of the working mechanism of the subcutaneous ROA is indicated.