Medicina basata sulle evidenze, farmaci e personalizzazione della cura: tra benefici, limiti e consenso informato
on June 18, 2026

Evidence-based medicine, medications and personalized care: benefits, limitations and informed consent

Caring is not just prescribing

Modern medicine has radically transformed expectations and quality of life thanks to the development of drugs, vaccines, diagnostics, and prevention. At the same time, in recent years, debate has grown over how scientific evidence is produced, the role of the pharmaceutical industry, data transparency, and the risk of a progressive standardization of care.

Between those who consider medication the primary solution to every problem and those who radically question its usefulness, there is a more realistic and clinically useful space: evidence-based medicine centered on the person.

What are randomized clinical trials (RCTs) really

Randomized controlled trials (RCTs) are one of the most widely used tools for evaluating the efficacy and safety of drugs and healthcare interventions.

In a randomized study, participants are randomly assigned to different groups to reduce bias and confounding factors.

RCTs are considered highly reliable for evaluating cause-effect relationships, but they are not without limitations.

Among the main recognized limitations are:

often limited duration

selected populations that do not reflect all real patients

reduced ability to detect rare adverse events

possible influence of industry funding

use of endpoints that do not always coincide with what matters to the patient

For this reason, today scientific evaluation is not based exclusively on RCTs but integrates:

systematic reviews

meta-analyses

observational studies

pharmacovigilance

real-world evidence

clinical experience

patient preferences

Pharmaceutical industry and conflicts of interest: a real but regulated issue

Collaboration between industry and research has enabled the development of essential therapies.

At the same time, numerous studies have documented that industry funding can be more frequently associated with results favorable to the studied product.

In recent decades, tools have been introduced to increase transparency and control:

pre-registration of trials

mandatory declaration of conflicts of interest

independent monitoring

regulated sharing of clinical data

public study registries

Regulatory agencies such as the EMA and FDA receive detailed data from registration dossiers and require thorough evaluations of efficacy and safety.

This does not eliminate all the limitations of the system but represents an important control mechanism.

Medication is a tool: benefits and side effects

Every medication works by altering biological processes.

For this reason, no medication is completely free of side effects.

Clinical evaluation is based on the benefit-risk ratio.

A treatment may be appropriate when the expected benefit outweighs the foreseeable risk for that specific patient.

This principle is particularly important in chronic therapies and treatments that affect the nervous system.

Psychotropic drugs: what we really know

Anxiety, depression, and other mental disorders are complex conditions that cannot be explained by a single neurotransmitter.

The “serotonin deficiency” hypothesis as the sole explanation for depression is now considered reductive.

Contemporary research involves:

neuroplasticity

inflammation

the gut–brain axis

chronic stress

genetic factors

psychological and social factors

This does not, however, mean that antidepressants are useless.

Meta-analyses show that antidepressants can have clinical efficacy, especially in moderate and severe cases, although the average benefit varies among individuals.

Benzodiazepines can rapidly reduce anxiety symptoms but carry known risks of tolerance and dependence if used beyond their indications.

The importance of informed consent and shared decision-making

One of the most important developments in modern medicine is the shift from a paternalistic model to shared decision-making.

Patients should be able to know:

expected benefits

uncertainties

therapeutic alternatives

side effects

reassessment times

Informed consent is not a signature but a communication process.

Pharmacovigilance: listening to what happens outside of studies

Many adverse effects emerge only after a drug is placed on the market.

For this reason, pharmacovigilance systems exist to collect:

spontaneous reports

clinical records

international databases

post-marketing studies

Patients' experiences do not replace scientific research but represent an important source for generating new hypotheses and improving safety.

Sexuality and quality of life: often underestimated effects

Sexual function is a relevant component of health.

Several medications can interfere with:

desire

arousal

erectile function

lubrication

orgasm

Among the most studied classes are:

some antidepressants

antihypertensives

hormone medications

antipsychotics

This topic deserves an explicit discussion between the doctor and the patient.

Towards more integrated medicine

The future challenge is not to choose between medication and a natural approach.

The challenge is to integrate:

lifestyle

nutrition

physical activity

psychological support

behavioral interventions

medication when indicated

personalized care

Caring means choosing together the most appropriate path for that person at that moment.

Bibliography

Ioannidis JPA. Why Most Published Research Findings Are False. PLoS Med. 2005.

Turner EH et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008.

Cipriani A et al. Comparative efficacy and acceptability of antidepressants. Lancet. 2018.

Moncrieff J et al. The serotonin theory of depression: a systematic umbrella review. Mol Psychiatry. 2022.

Cosgrove L et al. Financial ties between DSM panel members and industry. PLoS Med. 2006.

Guyatt GH et al. Users’ Guides to the Medical Literature. JAMA.

WHO Pharmacovigilance guidance documents.

EMA Clinical Data Publication Policy.

Edited by Nico Martini