This drug widely prescribed for painful periods would be ineffective according to a researcher

This drug widely prescribed for painful periods would be ineffective

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    Dr Gérald Kierzek (Medical Director of Doctissimo)

    Medical validation:
    November 21, 2023

    It is one of the most prescribed medications in France for menstrual pain… and yet its effectiveness is disputed. Researcher Juliette Ferry-Danini, author of a survey on the subject, paints a black picture of this molecule.

    It’s a scandal in the land of pink pills. In a new survey published this Wednesday, October 25 by Stock editions, researcher Juliette Ferry-Danini explains that “the addition of the indication of menstrual pain to the marketing authorization for Spasfon was the result of particular nonchalance […]. The mention of 10 patients was enough.” According to her, Spasfon does not have recognized evidence of effectiveness.

    “No clinical trial has proven its effectiveness for this indication”

    According to Juliette Ferry-Danini, teacher-researcher at the University of Namur and specialist in the philosophy of medicine, interviewed by our colleagues at HuffPost, the data on the little pink pill is clear:

    In the case of gynecological or abdominal pain, there is not enough data to conclude that Spasfon is effective, and research does not allow us to attest that it is indicated to prescribe it. For certain indications – including painful periods, a frequent reason for prescription – there is no published clinical trial, period.“, she confides.

    She even states that the lack of effectiveness of Spasfon “is obvious to many doctors, but rarely explicitly announced to patients (…) It is a lie and does not respect the autonomy of patients.”

    Difficult to believe, when we know that this medicine has been authorized in France for more than 60 years and that, in 2021 alone, 25 million boxes of Spasfon or its generic have been sold.

    According to Dr Kierzek, interviewed on this subject, the comments made by Juliette Ferry-Danini are too categorical. Spasfon would indeed have effectiveness even if it is moderate.

    Certainly, Spasfon presents “moderate actual benefit”. But that’s not why it shouldn’t be prescribed! Its effect is modest, but it remains superior to the placebo. We cannot therefore say that its effectiveness is zero. says the medical director of Doctissimo. “Need we remind you? The effectiveness of a drug is never universal. It varies depending on many elements, such as the age of the patient, their metabolism, etc..”

    The use of this antispasmodic is therefore always useful, “to treat abdominal pain, digestive pain, urinary or gynecological diseases… to name but a few“.

    An additional treatment, to keep in your medicine cabinet

    As to “insufficient clinical data” mentioned by the researcher, there is in reality evidence on the effectiveness of Spasfon, relayed by the HAS.

    A double-blind controlled study, conducted by the Cephalon France Laboratory, compared a placebo to the dosage of 4 oral lyophilisates per day in 70 patients with pelvic pain linked to dysmenorrhea (20% of cases), at the start of place of an intrauterine device (54%) or uterine trenches (26%).

    The results showed a statistically significant difference in the main endpoint which was the disappearance of pain after 3 days of treatment in favor of the treatment group.“, can we read in this study broadcast on February 6, 2008.

    The High Authority of Health nevertheless specifies that the use of this medication must be considered as an additional treatment. “The actual benefit is low“, she concludes.