Evidence Check 2: Homeopathy - Homeowatch

Evidence Check 2: Homeopathy 37137. Currently, under the Simplified Scheme, homeopathic product labels must include thephrase “Homeopathic medicinal product without approved therapeutic indications”. 162 Weasked Professor Woods about the labelling on Arnica Montana 30C, the only productcurrently granted a licence under the NRS. Professor Woods explained that:The descriptor on the packet says […]: ‘A homeopathic medicinal product usedwithin the homeopathic tradition for the symptomatic relief of sprains, muscularaches, bruising and swelling’. That is what we wish to confirm and this is used withinthe homeopathic tradition for that purpose. It is not the same as us accepting it asevidence. 163138. We have two concerns about this label. First, the mere use of a product in thehomeopathic tradition, without any actual evidence of efficacy, does not provide anyinformation as to whether a product actually works, and therefore is a poor basis forallowing medical indications on a product label. Second, we are concerned about how thepublic would interpret the label. We asked Professor Woods whether the average personwould conclude from the labelling that the product worked for symptomatic relief of thelisted minor conditions or whether they would realise there was no evidence of efficacy. Hereplied:[B]y law all packaging and patient information leaflets are subjected to user testing toensure that they are comprehensible to the man in the street, and indeed that seemsto be a very straightforward statement of the reality. This is a homeopathic medicinalproduct used within the homeopathic tradition for the symptomatic relief of sprains,muscular aches and bruising or swelling after contusions. That is what it says and theuser testing is part of the approval of that leaflet, has the labelling been tested on theaverage man in the street. 164139. We were not reassured by this answer and so we requested further information on theMHRA’s user testing of the Arnica Montana 30C product label. The MHRA explained in asupplementary memorandum that as part of the label testing on Arnica, they carried outthree rounds of user tests, in each round asking 10 participants a set of questions. 165 Thequestions included the following:a) What does the label say that this medicine is for?b) What does the label say is the active ingredient in this medicine?c) This medicine contains Arnica Montana 30C. What are the other ingredients in thismedicine?140. In our view, these questions are problematic. Question a) implies that the product canbe used to treat the ailment in question. Questions b) and c) imply to participants thatthere is an active ingredient. On the evidence of these questions it appears to us that the162 “UK Homeopathic Registration and National Rules Scheme Guidance Notes: note on labelling requirements forhomeopathic products”, Medicines and Healthcare products Regulatory Agency, 2009163 Q 227164 Q 229165 Ev 90