How often is oral contraception used for contraception? The need of benefit’s formalisation
Short Condensation: A recent post marketing study in Europe shows that in 40 to 60% of cases combined oral contraceptives are prescribed to treat gynecological disorders, without being licensed for this purpose. The formalization of their therapeutic properties is necessary.
Since its introduction in the early 1960s, the oral contraceptive pill has been taken by millions of women. The pill allows women to independently determine their reproductive lives, relieving them of the burden of unwanted pregnancies. The impact on society has been enormous, with women now achieving higher levels of education and being able to fulfill their career and social ambitions. Although other contraceptive methods have been developed, some have greater efficiency [Citation1]the pill remains one of the most used contraceptive methods worldwide and the most used in Europe [Citation2,Citation3]. Whenever our mind turns to contraception, the first method that comes to mind is the pill. However, there may be other reasons why it is commonly prescribed today.
As physicians, we all know that the hormones contained in the pill can help treat many ailments that women suffer from. These non-contraceptive benefits are outlined in scientific papers [Citation4,Citation5], but are not mentioned in the leaflets provided with the pill, nor are they adequately considered in scientific debates focused on the risks associated with the use of oral contraception. Non-contraceptive benefits are still displayed on public websites (eg https://www.webmd.com/sex/birth-control/other-benefits-birth-control o https://www.Healthline.com/health/birth-control-benefits), and is likely to be considered by the woman who chooses a contraceptive method [Citation6–8].
How much non-contraceptive benefits account for pill prescription rates is unclear, particularly in Europe. However, some insight into this issue was provided by a recent post-marketing study, designed to evaluate the efficacy and cardiovascular safety of micronized oestradiol 1.5 mg and nomegestrol acetate 2.5 mg compared to other oral contraceptive pills. [Citation9,Citation10]. The study was conducted between 2010 and 2021, among 91,313 women, recruited in Russia (n= 36,092; 39.5%) Italy (n= 19,683; 21.6%), Hungary (n= 9,407; 10.3%), Spain (n= 8,656; 9.5%), Poland (n= 6,263; 6.9%), Germany (n= 4,712; 5.2%), France (n= 580; 0.6%), Sweden (n= 517; 0.6%) and Austria (n= 462; 0.5%). In the registry, physicians recorded the reason why they prescribed the oral contraceptive pill, either: 1. only for contraception; 2. for contraception and therapeutic reasons; 3. for therapeutic reasons only. The Italian company marketing the pill under investigation (Theramex Italy SRL, Milan, Italy) provided the datasets for the entire study and for the Italian cohort, separately (data on file). Overall, the pill was prescribed for contraception only in 56.5% of cases, and for therapeutic reasons in 42.5%, either with (33.5%) or without additional contraceptive purposes (9.1%). In Italy, the pill was prescribed for contraception only in 38.8% of cases, and for therapeutic reasons in 61% of cases, either with (44.2%) or without additional contraceptive purposes (16.7% ). Reasons for non-contraceptive prescription were stated as: treatment of cycle irregularity (44.3%), menstrual pain (39.5%), heavy or prolonged menstrual bleeding (25.5%), acne (9.0%), ovarian cyst (8.2%), polycystic ovary syndrome (6.2%), premenstrual syndrome (5.3%), and endometriosis (5.0%). These results are similar to those obtained in the USA almost a decade ago [Citation11]and according to surveys, which show non-contraceptive benefits sought by approximately 50–60% of women [Citation6–8].
With very few exceptions, contraceptive pills are licensed for contraception only, but as these figures show, in almost half of the cases in Europe, and 61% of the cases in Italy, they are prescribed to treat symptoms of reproductive disorders. Ten to 20% of oral contraceptive prescriptions are given for therapeutic reasons only. This data shows a clear dichotomy between the indication for which an oral contraceptive pill is licensed and the way it is commonly used. It seems that physicians are more aware than regulatory agencies of the therapeutic potential of oral contraceptives. The same probably applies to other forms of combined hormonal contraceptives such as the vaginal ring or patch. [Citation12,Citation13].
The widespread use of the pill, for therapeutic reasons is a clear indication of its non-contraceptive effectiveness. However, it is unlikely that any pharmaceutical company will decide to set up the large, randomized, placebo-controlled studies that would be required to receive formal therapeutic indications. However, modern statistics, such as network metaanalyses, can be a way of obtaining solid data on the therapeutic potential of the pill. This can put the pill or other hormonal contraceptives in a different light. The therapeutic effects on disorders that sometimes destroy the quality of life of the woman, may provide a different balance to the side effects or the adverse events that may occur later during the administration of hormonal contraceptives. As the data shows, doctors take advantage of the “unofficial” therapeutic properties of the pill on a massive scale. Their decision to do so is balanced by the often dramatic effects on women’s quality of life. But what happens on the admittedly rare occasion that a harmful side effect appears? How can a doctor defend themselves in the courts if they are prescribing “off-label”? Modern medicine must be evidence-based, and therefore evidence of effectiveness must be formalized. Scientific societies must resolutely demand this formalization.
