Montellier, Marion <br/><br/>
Efficacy of opioid analgesics (IzalgiŽ and LamalineŽ): A systematic review of randomized clinical trials 

 -  2025.<br/>							 
<br/><br/> 11 
<br/><br/> Background. Opium extract-based drugs (LamalineŽ and IzalgiŽ) are classified as level 2 opioid analgesics according to the World Health Organization (WHO) classification. In the context of the proper use of analgesic drugs, particularly opium derivatives, and given the issues raised worldwide, it is important to critically asses their use. Method. This is a systematic review of the literature aimed at assessing the efficacy of opium derivatives (LamalineŽ, IzalgiŽ) compared to placebo in the management of pain, regardless of its origin. Results. The literature search included only one multicenter, randomized, double-blind phase III non-inferiority trial comparing the drug to a placebo. Analysis of this trial using the RoB 2 tool identified a risk of bias. According to the REB method, there is insufficient evidence to support the effectiveness of opium derivatives in alleviating pain. There seems to be a lack of published data on their use. Thus, in the era of evidence-based medicine (EBM), it is legitimate to question the prescription of analgesics such as opium derivatives, in the light of the lack of robust data demonstrating their effectiveness. This study has not identified sufficient evidence (convincing or not) to recommend the prescription of IzalgiŽ or LamalineŽ, whatever the cause of the pain, especially given their side effects. Conclusion. These results support the need to carefully evaluate the prescription of opium derivatives in pain management. Quality clinical trials are necessary to obtain a solid level of evidence.