This medication, often taken as self-medication, only has a placebo effect.

Each year, the medical journal Prescrire draws up two lists: that of medications “more dangerous than useful” and that “medications to rule out for better treatment”. A new remedy appears on the latter in 2024, and it is Spasfon (or phloroglucinol). Its effectiveness had already been widely questioned in the book Pink pills, ignorance in doctore, by Juliette Ferry-Danini, researcher at the University of Namur (Belgium) and specialist in philosophy in medicine.

How effective is Spasfon?

As recalled PrescribeSpasfon is authorized in only two countries in Europe: France and Italy. It is commonly used for spasmodic pain of the intestine, bile ducts and bladder. Although not intended for this purpose, it is also often prescribed for gynecological pain. In 2024, “Health Insurance reimbursed around 26.5 million boxes of phloroglucinol tablets, for a total amount of around 14 million euros”. This drug can be purchased without a prescription, and it is widely used in self-medication, the review says. To study the need to place this drug on the list of those to avoid, she “identified seven methodical syntheses relating to various so-called antispasmodic drugs and around fifteen clinical trial reports, including a few additional trials” since a summary dating back to 2020.

The authors noted that the effectiveness of phloroglucinol had been rarely compared with that of reference analgesics, or in the context of research with very poor methodological qualities. “The rest of the evaluation of phloroglucinol in painful situations was carried out in trials versus placebo or no treatment, which does not make it possible to evaluate a possible benefit compared to standard analgesic treatments”they indicate. In addition, they believe that existing research does not demonstrate its effectiveness in cases of renal colic. They also identified “no randomized, double-blind trial has evaluated phloroglucinol in gynecological or period-related pain” fin 2024.

Regarding the potential risks of this drug, they cite a meta-analysis on the threat of miscarriages linked to its use. They conclude that it is “low methodological quality and high risk of bias”so that it does not allow us to conclude that there is a significant association. However, they indicate that the risks of anaphylactic shock, Lyell syndrome and malformations during pregnancy should not be neglected for people who are pregnant or planning to become pregnant.

Spasfon, no more effective than a placebo, should be avoided

Following their research, Prescrire specialists conclude that“There is nothing to expect from phoroglucinol beyond the effectiveness of a placebo, although there is uncertainty around a modest symptomatic effect on recurrent benign intestinal disorders.” But they believe that it is associated with various risks, mainly allergic reactions, with in rare cases Lyell syndrome, as well as a teratogenic risk for pregnant people. The journal therefore does not add it to the list of medications “more dangerous than useful”but advise against its use in self-medication for people who are pregnant or who could become pregnant.

Contacted by AFP, the Teva laboratory, which manufactures Spasfon, declares that “knowledge about the effectiveness of these drugs on spasms of various origins is based on use in clinical research for several decades.”