Placebos reduce the intensity and interference of PMS symptoms: study

When prescribed with transparency and empathy, placebos can be effective in the management of premenstrual syndrome (PMS), concluded the researchers at the University of Basel in Switzerland. The administration of an “open-label placebo,” i.e., with the full knowledge of the patient, “can significantly reduce the intensity and interference of symptoms (of premenstrual syndrome) in the absence of significant side-effects,” they wrote in an article recently published in BMJ Evidence-Based Medicine.In their study, the Swiss scientists reported that PMS affects, to varying degrees, up to half of all women of childbearing age, having an impact on their social and professional lives. It generally occurs seven to 10 days before the onset of menstruation, and is characterized by as many as a hundred symptoms. Some are physical (abdominal pain, nausea, headaches, extreme fatigue, etc.), others psychiatric (mood swings, irritability, depressed mood, anxiety, loss of concentration, etc.). First-line treatments for PMS include non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, oral contraceptives and hormonal treatments such as danazol. Their efficacy is proven, but they often have undesirable side-effects (dizziness, weight gain, gastrointestinal problems, etc.), and treatment discontinuation is frequent.Conversely, placebos have no side-effects, stressed one of the study's authors, nephrologist Dr. Jens Gaab, adding that placebos are well-documented, as they are used in all clinical trials as a yardstick for measuring the efficacy of supposedly active drugs. "We shouldn't underestimate (their) effect. Our brains have learned that if we take a drug regularly, it's effective, even if it doesn't contain any of the active ingredients.”Promising precedentsPrevious studies have shown that open placebos can reduce the need for medication in children with ADHD. They can also alleviate symptoms of irritable bowel syndrome, certain chronic pains, allergic rhinitis and menopausal hot flushes.With this in mind, the Swiss researchers set out to find out to what extent a placebo treatment would be relevant in reducing PMS symptoms. To do so, they conducted a randomized controlled trial, between August 2018 and December 2020, including 150 women aged 18 to 45 suffering from PMS or premenstrual dysphoric disorder. Only women not taking psychotropic medication were eligible to take part. Participants were divided into three groups of equal size. The first (control group) was made up of women receiving conventional treatment. In the second (OLP- group), participants were given two placebo tablets a day for six weeks, with no special explanation. Finally, the 50 women in the OLP+ group received the same prescription as those in the OLP-group but were also given a 15-minute explanation of the placebo effect and why it could potentially relieve their symptoms.Primary endpoints were PMS symptom intensity and impact between groups over three menstrual cycles; adverse events were assessed three and six weeks after the start of the intervention. Secondary endpoints included psychological and somatic assessment of PMS symptom intensity, as well as compliance. Primary outcomesIn the OLP+ group: 79.3% reduction in overall symptom intensity, compared with 33.0% in the control group (effect size: 0.94; 95% confidence interval [CI]: 0.44 to 1.43); symptom interference with daily life dropped by 82.5%, compared with 45.7% in the control group (effect size: 0.90; 95% CI: 0.38 to 1.53).PLO- group: 50.4% reduction in symptom intensity (95% CI: 0.01 to 0.94) and 50.3% reduction in functional interference (95% CI: -0.08 to 1.12), compared with the control group.Control group: 33.0% improvement in symptom intensity and 45.7% improvement in interference, possibly due to a natural regression effect or minimal attention during follow-up.Women in both placebo groups experienced very few side-effects, which were not serious. Compliance was excellent (93.18%), with a low drop-out rate (3.4%).Secondary outcomesIn terms of secondary outcomes, women in the placebo-with-explanation group reported the greatest reduction (70.7%) in the intensity of psychological symptoms between menstrual cycles, followed by the placebo without explanation group, who reported a 42.6% reduction in symptom intensity, compared with a reduction of only 29.1% in women receiving the usual treatment. Women in the OLP+ group also reported the greatest reduction (82.5%) in physical symptom intensity between menstrual cycles, followed by women in the OLP- group (50.3%) and those in the conventional treatment group (45.7%).Comparing the OLP+ and OLP-groups, the researchers also observed that adding an explanation of placebo mechanisms markedly increased the therapeutic effect, with an effect size of 0.66 for symptom intensity (95% CI: 0.12 to 1.18), and 0.77 for symptom interference (95% CI: 0.22 to 1.30). In other words, the explanation virtually doubles the placebo effect.According to the study's lead author, Dr. Antje Frey Nascimento, “Explaining to participants how placebos work strengthened their sense of being taken seriously, which may have contributed to the observed efficacy.” A professor of psychology at the University of Basel, he added that this approach highlights the crucial role of the therapeutic relationship and communication in the healing process.Among the limitations of their research, the authors acknowledge that by presenting the trial as a study of a side-effect-free intervention for premenstrual syndrome, they may have attracted participants more open to unconventional treatments and/or dissatisfied with their current treatment, which could restrict the generalizability of the results. In addition, the results were based on self-reporting, which could distort them.A clinically adoptable approachNevertheless, the scientists claim their study is the first to demonstrate the efficacy of open placebos for premenstrual syndrome in a randomized, controlled setting. They believe this approach, “could be particularly useful for women who wish to avoid medication or for whom pharmacological treatments are contraindicated.”However, they emphasize a crucial point: The maximum therapeutic effect of a placebo appears to be highly dependent on the way in which it is presented. Thus, the researchers conclude that the communication surrounding the administration of an open placebo is as important as the placebo itself. In their view, this strategy could be integrated into clinical practice, provided certain criteria are met: transparency, validation of symptoms experienced by patients and a supportive care environment.Read the study Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trial.This article has been translated from its original French and first appeared on our sister site Profession Santé.

Placebos reduce the intensity and interference of PMS symptoms: study

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