What does DM stand for in medicine. How does dextromethorphan work as a cough suppressant. What are the approved and off-label uses of dextromethorphan. How is dextromethorphan metabolized in the body. What are the potential side effects of dextromethorphan.

Decoding DM: Dextromethorphan’s Role in Medicine

In the realm of medicine, “DM” typically stands for dextromethorphan, a widely used compound with a rich history and diverse applications. Approved by the FDA in 1958 as a cough suppressant, dextromethorphan has been a staple ingredient in over-the-counter antitussives for over half a century. Its versatility and effectiveness have led to ongoing research into its potential for treating various conditions beyond its primary use.

The Evolution of Dextromethorphan

Dextromethorphan’s journey began as an attempt to create a non-addictive alternative to morphine. Despite its structural similarity to opioids, it does not interact with mu receptors, setting it apart from its addictive counterparts. This unique characteristic has allowed DM to maintain its widespread availability and safety profile over the decades.

Mechanism of Action: How Does Dextromethorphan Work?

The precise mechanism by which dextromethorphan suppresses coughs is not fully understood, highlighting the complexity of this seemingly simple medication. However, researchers have proposed several theories to explain its effectiveness:

• Interaction with the nucleus tractus solitarius in the brainstem
• Modulation of the cough reflex gate
• Multiple receptor site interactions

One leading hypothesis suggests that dextromethorphan acts on the nucleus tractus solitarius, a critical area in the brainstem where pulmonary vagal afferent fibers synapse. This region is believed to function as a gatekeeper for the cough reflex, and DM’s interaction with it may explain its antitussive properties.

Beyond Cough Suppression: Dextromethorphan’s Multifaceted Nature

While primarily known for its cough-suppressing abilities, dextromethorphan’s interactions with various receptor sites in the body contribute to its potential for treating a wide range of conditions. This versatility has sparked interest in the medical community, leading to numerous studies exploring its off-label uses.

FDA-Approved Uses: From Coughs to Pseudobulbar Affect

Dextromethorphan’s FDA-approved uses have expanded since its initial approval as a cough suppressant. In 2010, the FDA granted approval for a combination of dextromethorphan and quinidine to treat pseudobulbar affect (PBA), a neurological condition characterized by involuntary and inappropriate emotional outbursts.

Understanding Pseudobulbar Affect

Pseudobulbar affect is a complex neurological dysfunction that affects emotional expression. Patients with PBA may experience sudden, uncontrollable bouts of crying or laughter that are disproportionate to their actual mood or the situation at hand. While the exact pathology of PBA remains unclear, the prevailing theory suggests it results from a loss of descending cortical control over brainstem motor nuclei and the cerebellum, disrupting the inhibitory mechanisms that typically regulate emotional expression.

Exploring Off-Label Uses: Dextromethorphan’s Potential

The neuroprotective properties of dextromethorphan have piqued the interest of researchers, leading to investigations into its potential for treating various neurological and psychiatric conditions. Some of the off-label uses currently under study include:

1. Depression
2. Stroke recovery
3. Traumatic brain injury
4. Refractory seizures
5. Pain management
6. Methotrexate neurotoxicity
7. Parkinson’s disease
8. Autism spectrum disorders

Dextromethorphan in Depression Treatment

One of the most promising off-label applications of dextromethorphan is in the treatment of depression. Research has shown that DM exhibits rapid-acting antidepressant activity, similar to ketamine. This finding is particularly significant given the urgent need for fast-acting antidepressants to address treatment-resistant depression and suicidal ideation.

The Pharmacokinetics of Dextromethorphan: A Complex Journey

Understanding how dextromethorphan is processed in the body is crucial for appreciating its effects and potential applications. The pharmacokinetics of DM are complex and involve several metabolic pathways:

• Rapid metabolism upon absorption
• Conversion to dextrorphan (DX) via CYP2D6
• Further glucuronidation of DX
• Alternative metabolism to 3-methoxymorphinan via CYP3A4

Metabolic Variability: The Role of CYP2D6

The primary metabolic pathway for dextromethorphan involves cytochrome P450 2D6 (CYP2D6), which converts DM to its active metabolite, dextrorphan (DX). However, genetic variations in CYP2D6 activity lead to significant differences in how individuals process the drug. These variations result in four distinct metabolizer groups:

1. Ultrarapid metabolizers
2. Extensive metabolizers
3. Intermediate metabolizers
4. Poor metabolizers

The majority of the population falls into the extensive metabolizer category. However, approximately 9% are poor metabolizers, which can significantly affect the drug’s efficacy and potential side effects.

Bioavailability and Half-Life: Factors Influencing Dextromethorphan’s Effects

Dextromethorphan’s oral bioavailability is relatively low due to extensive first-pass metabolism. In extensive metabolizers, a single 30mg oral dose of DM has a median half-life of 2.4 hours and an oral bioavailability of just 1 to 2%. This low bioavailability contributes to the drug’s safety profile but also necessitates careful dosing considerations for optimal therapeutic effect.

Implications for Dosing and Administration

The variability in metabolism and low bioavailability of dextromethorphan have important implications for its use in clinical settings. Healthcare providers must consider these factors when determining appropriate dosages and administration schedules, particularly when using DM for off-label applications or in combination with other medications.

Safety Profile and Adverse Effects: Balancing Benefits and Risks

While dextromethorphan is generally considered safe when used as directed, it is not without potential side effects. Common adverse reactions may include:

• Dizziness
• Nausea
• Drowsiness
• Mild gastrointestinal disturbances

In rare cases or with excessive use, more serious side effects can occur, such as:

• Confusion
• Respiratory depression
• Serotonin syndrome (when combined with certain medications)

Dextromethorphan Abuse: A Growing Concern

The widespread availability of dextromethorphan in over-the-counter medications has led to concerns about its potential for abuse, particularly among adolescents and young adults. At high doses, DM can produce dissociative effects similar to those of ketamine or PCP. This has prompted efforts to increase awareness and implement safeguards to prevent misuse while maintaining access for legitimate medical purposes.

Future Directions: The Evolving Role of Dextromethorphan in Medicine

As research into dextromethorphan’s mechanisms and potential applications continues, the medical community anticipates new insights and possible therapeutic uses. Areas of ongoing investigation include:

• Neuroprotective effects in neurodegenerative disorders
• Potential applications in addiction treatment
• Refinement of dosing strategies for off-label uses
• Development of new drug combinations to enhance efficacy and reduce side effects

Challenges and Opportunities in Dextromethorphan Research

The complex pharmacology of dextromethorphan presents both challenges and opportunities for researchers. While its multi-faceted mechanisms of action make it a promising candidate for treating various conditions, they also complicate efforts to fully understand and optimize its effects. Future studies will likely focus on elucidating these mechanisms and developing targeted approaches to harness DM’s therapeutic potential while minimizing adverse effects.

Interprofessional Collaboration: Optimizing Dextromethorphan Use in Clinical Practice

Effective use of dextromethorphan in clinical settings requires a coordinated effort among healthcare professionals. This interprofessional approach ensures optimal patient outcomes and minimizes the risk of adverse events. Key aspects of this collaboration include:

• Pharmacists providing guidance on drug interactions and proper dosing
• Physicians considering individual patient factors when prescribing DM
• Nurses monitoring patients for potential side effects and therapeutic response
• Researchers sharing new findings to inform clinical practice

The Role of Patient Education

Given the widespread availability of dextromethorphan in over-the-counter medications, patient education plays a crucial role in its safe and effective use. Healthcare providers should emphasize the importance of following dosing instructions, potential interactions with other medications, and signs of adverse reactions to watch for.

As our understanding of dextromethorphan continues to evolve, so too will its applications in medicine. From its humble beginnings as a cough suppressant to its potential as a neuroprotective agent and rapid-acting antidepressant, DM exemplifies the dynamic nature of pharmacological research and the ongoing quest to improve patient care through innovative approaches to existing medications.

Dextromethorphan – StatPearls – NCBI Bookshelf

Continuing Education Activity

Dextromethorphan received FDA approval in 1958 for its use as a cough suppressant. It is one of the most common compounds found in most over-the-counter antitussives for the past 50 years. In 2010, the FDA approved the use of dextromethorphan for pseudobulbar affect in combination with quinidine. This activity will highlight the mechanism of action, adverse event profile, approved and off-label uses, dosing, pharmacodynamics, pharmacokinetics, monitoring, relevant interactions of dextromethorphan, pertinent for members of the interprofessional team using dextromethorphan for any of its intended indications.

Objectives:

• Identify the mechanism of action of dextromethorphan.

• Outline the approved and other indications for therapy with dextromethorphan.

• Review the adverse event profile for dextromethorphan.

• Explain the importance of improving care coordination among the interprofessional team to enhance care delivery for patients when using dextromethorphan.

Access free multiple choice questions on this topic.

Indications

Dextromethorphan (DM) received FDA approval in 1958 for its use as a cough suppressant. It has been one of the most common compounds found in most over-the-counter antitussives for the past 50 years.[1]

In 2010, the FDA approved the use of DM for pseudobulbar affect (PBA) combined with quinidine. PBA is a neurologic dysfunction of emotional expression characterized by outbursts of crying or laughing inappropriately and disproportionately to the mood. The pathology of PBA is still incompletely understood. Still, the leading hypothesis suggests that it is due to a loss of descending cortical control of brainstem motor nuclei and the cerebellum. This loss of control disrupts inhibitory mechanisms for motor control of emotional expression.[2][3]

Many other potential therapeutic uses for DM are currently under investigation in clinical studies. Most of these use the property that DM has as a neuroprotective agent. These indications include[4]:

• Depression: DM has a fast-acting antidepressant activity for its similarity to ketamine.

• Stroke: Studies have shown that DM has a role in the improvement of some neurological and psychiatric complications, however, not the overall functional outcomes.

• Traumatic Brain Injury: Although the studies have shown limited effects, there are proposed mechanisms that confer the benefits of DM in TBI, including its activity at NMDA and sigma-1 receptors.

• Seizure: Some clinical studies have shown that DM has efficacy in refractory seizures.

• Pain: There are studies on the analgesic effects of DM for pain conditions such as cancer-related, post-operative, neuropathic, and gastrointestinal pain.

• Methotrexate Neurotoxicity: DM showed a complete resolution in neurologic deficits associated with MTX toxicity in 5 cases.

• Parkinson disease: DM meliorated primary Parkinson disease in 2 studies.

• Autism: Contradicting data regarding DM’s role in behavioral improvement.

Mechanism of Action

Dextromethorphan has multi-faceted pharmacodynamic and pharmacokinetic properties. The drug is a lipophilic molecule with an ionizable amine at one end. It is structurally related to alkaloid opioids such as morphine but does not interact with the mu receptor. It derives from levorphanol, first designed as a morphine alternative. The main mechanism of action for its use in the cough suppressant is not completely understood. One proposed mechanism is that DM works on the nucleus tractus solitarius, the estimated site where the pulmonary vagal afferent fibers synapse in the central nervous system. This site in the brainstem functions as a gate for the cough reflex. DM is known to have many interactions with several different receptor sites.[4][5]

DM is a synthetic analog of codeine and undergoes rapid metabolism upon initial absorption. Its metabolism is via cytochrome P450 2D6 (CYP2D6) into major O-demethylated metabolite, dextrorphan (DX). DX is further glucuronidated by uridine diphosphate-glucuronosyltransferase to form dextrorphan-o-glucuronide, the most prevalent form of DX present in the plasma (98%). Dextrorphan-o-glucuronide is permanently charged and has less permeability to the blood-brain barrier. DM also gets metabolized into 3-methoxymorphinan via cytochrome P450 3A4.[1][4]

DM has low oral bioavailability due to its extensive first-pass metabolism; however, this is also dependent on different metabolizers. People may fall under different metabolic groups: ultrarapid, extensive, intermediate, and poor metabolizers. Most of the population falls under the extensive metabolizer. A single oral dose of 30mg of DM showed a median half-life of 2.4 hours with an oral bioavailability of 1 to 2%. Approximately 9% of the population are poor metabolizers. After a single dose orally, the median half-life of DM is 19.1 hours, with an oral bioavailability of 80%. Poor metabolizers have approximately four-fold higher plasma levels of DM. [1][4]

Although structurally similar, DM does not have a direct action on the opioid receptors that produce classic CNS effects of opioid agonists. DM is known for its main site of action at N-methyl-D-aspartate (NMDA) receptors as a non-competitive antagonist. However, studies have found many sites of action with which DM and DX interact.[1][4][5]

Other sites of action include:

• Sigma-1 receptors agonist

• Nicotinic receptors (a3b4, a4b2, a7) antagonists

• Serotonin transporters inhibitor

• Norepinephrine transporters inhibitor

• Voltage-gated calcium channels inhibitor

Administration

Dosing and administration of dextromethorphan are mostly via the oral route. There are many formulations for administration:

• Combination liquid cough syrups; the common OTC formulation contains 15 mg/5mL of DM; recommended adult dosing is 2 tsp (10ml) every 4 hours.

• Sustained-release cough syrup suspensions; another OTC product contains 30 mg/5mL

• Liquid filled capsules containing 15 or 30 mg of DM

• Oral strips containing 7. 5 or 15mg of DM

• Lozenges containing 5, 7.5, 10 mg of DM

The recommended dosing for DM is 0.5 mg/kg up to 30 mg, administered three or four times a day.

Some animal studies have suggested that to reach the potential neuroprotective effects requires the ingestion of doses higher than typically used for antitussive effects (60 to 120 mg/d).[6]

For PBA, the FDA has approved the use of DM in combination with quinidine, a CYP2D6 inhibitor. The approved dose is 20 DM and 10mg quinidine in capsule form.[2]

Specific Patients Population 

• Patient with Hepatic Impairment: There is no dose adjustment guidance in the manufacturer label for patients with hepatic impairment. 

• Patient with Renal Impairment: There is no dose adjustment guidance in the manufacturer label for patients with renal impairment. 

• Pregnant Women: It is considered as pregnancy category C medicine. It is mainly metabolized in the liver via CYP2D6 and CYP3A enzymes. Activities of these enzymes increased in pregnant women.[7][8] Standard doses of dextromethorphan are generally considered acceptable during pregnancy. However, It is recommended to avoid alcohol-containing dextromethorphan products during pregnancy.

• Breastfeeding Women: There is a very low amount of dextromethorphan and its active metabolite excreted in breastmilk. It is not expected to have any adverse effect on the infant in this amount. However, it is recommended to avoid Dextromethorphan products that contain high alcohol levels.[9]

• Pediatric Patients: The safety and efficacy of dextromethorphan on infants and very young children (less than 4 years) are not established by any systemic clinical trials in pediatric patients. 

• Geriatric Patients: There is no specific dose adjustment needed for geriatric patients.

Adverse Effects

Adverse effects from cough suppressants are rare. The most common are nausea and gastrointestinal discomfort, while drowsiness and dizziness can also occur.

One study showed at high doses (greater than 4 mg/kg), up to 64% of patients felt euphoria, and some experienced various CNS effects such as visual hallucinations and persecutory delusions. In addition, these episodes were associated with agitation, leading to patient management difficulties.

The most common side effects in this study were the sensation of a drunk feeling or a “high” (20%), nausea and vomiting (17%), nystagmus (15%), and dizziness (15%). Most side effects resolved within a day after the final dose, and no cardio-respiratory compromises were noted. Serum levels of DM exceeding 400 ng/ml presented in 87.5% of patients with these side effects. More than 60% of the patients who experienced side effects with DM had serum levels exceeding 120ng/ml and brain levels of 700 ng/g.[10]

Contraindications

Dextromethorphan is contraindicated for patients with known or established hypersensitivity and those with an idiosyncratic reaction upon administration of the drug.

It is not recommended to coadminister dextromethorphan with monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drugs.[11]

Since DM comes in combination with different medicines, consider contraindications of each ingredient for safe prescribing of combination products.

Monitoring

Dextromethorphan is well tolerated and has a wide therapeutic window, making it an amenable drug for clinical use.

Toxicity

One concern regarding dextromethorphan toxicity is its OTC misuse that has been increasing since the 2000s. DM misuse is known as “going pharming,” “robotripping,” and “dexing.” In 2006, three different OTC product formulations accounted for 66% of reported instances of DM misuse in the USA. One life-threatening toxicity associated with DM abuse is serotonin syndrome. Due to its action on serotonin reuptake inhibition, if patients are already on common SSRI or MAOI antidepressants, DM toxicity potentiates excess serotonin in the body, potentially leading to serotonin syndrome. These include agitation, confusion, dilated pupils, headache, tachycardia, hypotension, high fevers, seizures, irregular heartbeat, and can lead to unconsciousness.[12]

Enhancing Healthcare Team Outcomes

Dextromethorphan (DM) misuse and overdose have increased significantly since its introduction to its over-the-counter market. Diagnosis and management of DM overdose require an interprofessional team of healthcare professionals, including clinicians, mid-level practitioners, nurses, pharmacists, and any witnesses or family members. Careful documentation of past medical history and current medications is crucial in diagnosing one of its major overdose complications. Treatment for serotonin syndrome includes hydration, withdrawing the drugs, managing body temperature, and seizures. Without proper management, serotonin syndrome and DM overdose may be fatal.[13]

The paramedics have a crucial role in identifying any witnesses or empty pill bottles at the scene. The triage nurse has an essential role in suspecting a possible drug overdose and must guide patient admission accordingly. A careful history is necessary to initially distinguish the time of onset as well as later on when more serious effects may occur or when the condition of the patient deteriorates. The emergency department physician is responsible for ordering appropriate lab work when suspecting a drug overdose, including drug levels in the blood and/or urine. When appropriate, consultation must occur with pharmacists, toxicologists, radiologists, and hospitalists.

There are two grades of recommendation. Grade D includes patients with suicidal ideation, intentional abuse, or malicious intent; all should obtain a referral to the nearest emergency department. Grade C includes patients who show more than mild effects of DM overdose or after acute drug ingestion. These patients should get referred to the nearest emergency room. Patients who have ingested 5 to 7.5 mg/kg should follow poison control center-initiated treatment and follow up every 2 hours up to 4 hours. If more than mild symptoms continue or develop, they should be immediately sent to the emergency room. Any amount of drug ingested more than 7.5mg/kg should be sent to the emergency room right away.[14]

Review Questions

• Access free multiple choice questions on this topic.

• Comment on this article.

References

1.

Taylor CP, Traynelis SF, Siffert J, Pope LE, Matsumoto RR. Pharmacology of dextromethorphan: Relevance to dextromethorphan/quinidine (Nuedexta®) clinical use. Pharmacol Ther. 2016 Aug;164:170-82. [PubMed: 27139517]

2.

Pioro EP. Review of Dextromethorphan 20 mg/Quinidine 10 mg (NUEDEXTA(®)) for Pseudobulbar Affect. Neurol Ther. 2014 Jun;3(1):15-28. [PMC free article: PMC4381919] [PubMed: 26000221]

3.

Patatanian E, Casselman J. Dextromethorphan/quinidine for the treatment of pseudobulbar affect. Consult Pharm. 2014 Apr;29(4):264-9. [PubMed: 24704895]

4.

Nguyen L, Thomas KL, Lucke-Wold BP, Cavendish JZ, Crowe MS, Matsumoto RR. Dextromethorphan: An update on its utility for neurological and neuropsychiatric disorders. Pharmacol Ther. 2016 Mar;159:1-22. [PubMed: 26826604]

5.

Corado CR, McKemie DS, Knych HK. Pharmacokinetics of dextromethorphan and its metabolites in horses following a single oral administration. Drug Test Anal. 2017 Jun;9(6):880-887. [PubMed: 27580591]

6.

Werling LL, Lauterbach EC, Calef U. Dextromethorphan as a potential neuroprotective agent with unique mechanisms of action. Neurologist. 2007 Sep;13(5):272-93. [PubMed: 17848867]

7.

Wadelius M, Darj E, Frenne G, Rane A. Induction of CYP2D6 in pregnancy. Clin Pharmacol Ther. 1997 Oct;62(4):400-7. [PubMed: 9357391]

8.

Tracy TS, Venkataramanan R, Glover DD, Caritis SN., National Institute for Child Health and Human Development Network of Maternal-Fetal-Medicine Units. Temporal changes in drug metabolism (CYP1A2, CYP2D6 and CYP3A Activity) during pregnancy. Am J Obstet Gynecol. 2005 Feb;192(2):633-9. [PubMed: 15696014]

9.

Drugs and Lactation Database (LactMed®) [Internet]. National Institute of Child Health and Human Development; Bethesda (MD): Jan 16, 2023. Dextromethorphan. [PubMed: 30000516]

10.

Lauterbach EC. An extension of hypotheses regarding rapid-acting, treatment-refractory, and conventional antidepressant activity of dextromethorphan and dextrorphan. Med Hypotheses. 2012 Jun;78(6):693-702. [PubMed: 22401777]

11.

Bem JL, Peck R. Dextromethorphan. An overview of safety issues. Drug Saf. 1992 May-Jun;7(3):190-9. [PubMed: 1503667]

12.

Ganetsky M, Babu KM, Boyer EW. Serotonin syndrome in dextromethorphan ingestion responsive to propofol therapy. Pediatr Emerg Care. 2007 Nov;23(11):829-31. [PubMed: 18007217]

13.

Prakash S, Rathore C, Rana K. The prevalence of serotonin syndrome in an intensive care unit: A prospective observational study. J Crit Care. 2021 Jun;63:92-97. [PubMed: 33621893]

14.

Chyka PA, Erdman AR, Manoguerra AS, Christianson G, Booze LL, Nelson LS, Woolf AD, Cobaugh DJ, Caravati EM, Scharman EJ, Troutman WG. , American Assiciation of Poison Control Centers. Dextromethorphan poisoning: an evidence-based consensus guideline for out-of-hospital management. Clin Toxicol (Phila). 2007 Sep;45(6):662-77. [PubMed: 17849242]

Disclosure: SaeRam Oh declares no relevant financial relationships with ineligible companies.

Disclosure: Suneil Agrawal declares no relevant financial relationships with ineligible companies.

Disclosure: Sarah Sabir declares no relevant financial relationships with ineligible companies.

Disclosure: Alan Taylor declares no relevant financial relationships with ineligible companies.

What is the dm+d? The NHS Dictionary of Medicines and Devices

Over the past year we have been increasingly using NHS Dictionary of Medicines and Devices (dm+d). This blog post sets out to describe dm+d for the benefit of the wider prescribing analytics community and others.

What is the NHS Dictionary of Medicines and Devices (dm+d)?

dm+d is the standard dictionary for the medicines and devices used across the NHS. It contains standardised codes, descriptions, and metadata (such as price and pack size) for every entry. At last count it contained over 150,000 packs of medicines and devices.

Why is it important to have a standard NHS Dictionary of Medicines and Devices?

These codes and descriptions are very important when dealing with large amounts of data, to allow computers to operate consistently. All computer systems in primary care now communicate by exchanging dm+d codes with each other. For example, when your doctor generates a prescription on their computer, they select the items you need from the dm+d. The dm+d code and quantity is transferred securely over the NHS “Spine”, which delivers it to your pharmacy computer for dispensing. Last month over 62 million prescriptions were sent through the Spine, all facilitated by dm+d.

By contrast, a large hospital may have anywhere between 50 and 100 clinical software systems, each using a different coding system, which means they cannot talk or transfer information easily between them. This is one reason why your GP can’t see what medicines you have been prescribed on a hospital ward. Fortunately, the NHS has now mandated the use of dm+d. All NHS systems will soon be using dm+d, facilitating the transfer of medicines data between software and computers across the entire NHS.

What are the uses of NHS dm+d?

The stated primary use of the NHS dm+d is to improve ‘Interoperability’, which means computers talking to each other in the manner described above — but there are lots of other uses. At OpenPrescribing, we have linked prescribing data to dm+d, which means we can make use of the richer data that it provides. We previously described a simple but really useful feature of the dm+d, allowing us to show user-friendly names of medicines on OpenPrescribing. The dm+d makes more advanced filtering possible, such as listing all medicines delivered by injection, or all drugs not allowed to be prescribed in primary care. We have already started to implement new analyses utilising this structured data, such as our recent herbal measure.

Summary level descriptions of most important concepts

There are a bewildering number of data fields in NHS dm+d; we describe the most important ones here.

Virtual v Actual

A description starting with “actual” is a real product description: it describes a medicine or device that has been made available by a specific manufacturer or supplier, much like when a doctor prescribes by brand.

A description starting with “virtual” is an abstract description: it describes a general class of medicine or device that may be available as an “actual” product, much like when a doctor prescribes generically.

Source: NHS Business Services Authority

Virtual Therapeutic Moiety (abstract) — VTM

Example: Amoxicillin

The VTM is a highest level within dm+d. It is an abstract representation of a medicine or device. It is just the chemical name without any mention of the strength or formulation.

Virtual Medicinal Product (abstract) — VMP

Example: amoxicillin 250mg capsules

The VMP is the first level within dm+d. It describes the abstract or generic medicinal product.

Virtual Medicinal Product Pack (abstract) — VMPP

Example: Amoxicillin 250mg capsules — 21 capsule

The VMPP is closely linked to VMP in the hierarchical model of dm+d and additionally it identifies the amount of a product that is available in a pack. This is expressed differently depending on the type of formulation (e.g. liquids, tablets, etc). for example ml in liquids, number of tablets etc.

Actual Medicinal Product (real product) — AMP

Example: Amoxicillin 250mg capsules — Actavis UK Ltd

The AMP provides a unique description of a medicine or device that has been made available by a manufacturer or supplier but does not describe the pack size or the quantity of the medicine or device.

Actual Medicinal Product Pack (real product) — AMPP

Example: Amoxicillin 250mg capsules — Actavis UK — 21capsule — 3×7 capsules

The AMPP is below AMP in the hierarchical model of dm+d and additionally it identifies the amount of a product that is available in a pack. This will be expressed differently depending on the type of formulation, for example ml in liquids, number of tablets etc.

Further reading

For more information on the NHS dm+d you can consult the full technical guidance made available by NHS Business Services Authority; in particular, the Primary Care Implementation Guidance and the dm+d Technical Specification.If you have any questions, more insight into dm+d that you can share or would like to request a topic for a future blog on the NHS dm+d please get in touch at [email protected].

Get in touch

At the Bennett Institute we pride ourselves on developing our tools swiftly and iterating them based on the needs of our users. We believe that the most useful tools are built by listening to our users and pooling them with the knowledge and skills of our small mixed team of clinicians, academics, and software engineers. As always please get in touch and tell us what you are using the dm+d browser for and what improvements you would like to see.

Against doctors, patients and big pharma: 6 myths about evidence-based medicine

Evidence-based medicine promises patients a scientific approach and the relevance of research that guides the doctor. We tell you what myths are associated with this area and how justified they are. reviews and meta-analysis. Thus, the phrase “evidence-based medicine” (EBM) turns into an advertising slogan that convinces the patient that he is dealing with high medical standards. At the same time, the patient does not always understand the essence of the opposition between traditional and scientifically oriented medicine. And then he is not able to distinguish when he is treated by a strong specialist, and when he is a competent PR specialist from medicine. RBC Trends has collected several popular myths that have developed around dokmed.

Traditional medicine includes practical experience in the ways and means of treatment, accumulated by society and passed down from generation to generation.

Evidence-based medicine is a modern approach to treatment. It is based on a critical approach to everything – to one’s own or someone else’s, albeit the most authoritative, opinion.

Myth 1. Dokmed denies traditional medicine

It is generally accepted that scientifically oriented medicine stands in some opposition to traditional medicine. Differences between them are indeed not uncommon. For example, evidence-based medicine cancels some diagnoses that old-school doctors are still actively treating. These include vegetative-vascular dystonia, osteochondrosis, chronic tonsillitis, leaky intestines or dysbacteriosis. This can also include treatment for beriberi with dozens of dietary supplements and antiviral drugs for colds.

The most striking example of recent confrontation can be considered the “covid dissidence” of doctors who oppose vaccinations with reference to their negative professional experience. The coronavirus situation illustrates well the gap between DM and conventional medicine. According to the director of the DocMed Medical Center Marina Demidova, the latter relies mainly on the experience of a particular doctor and the knowledge he gained at the university, while evidence-based medicine does not deny the basic principles of already available information, but requires constant updating of knowledge and the search for the best and latest scientific evidence.

“A doctor based on the principles of dokmed can be guided by his clinical thinking and professional experience. But he always takes into account that scientific evidence is dozens of times greater than the experience of one, even the most professional doctor, ”says the expert.

Myth 2. Everything published in a medical journal is the ultimate truth

Knowledge of the principles of dokmed increases the effectiveness and validity of treatment. In this sense, in an ideal world, medical experience is always “friends” with scientifically oriented thinking.

What, then, endows the methods of dokmed with high probative power? First of all, understanding that not all scientific research has equal value and legitimacy.

There are levels of evidence developed in 1989 by one of the founders of evidence-based medicine, Canadian physician David Sackett. In descending order of quality, they are:

• Level 1: Systematic reviews and meta-analysis of randomized double-blind controlled trials

Patients are divided into two groups. Some are offered an experimental treatment, while others are offered standard therapy or a placebo. At the same time, the process of selection into groups, as well as the choice of treatment, takes place randomly: neither the participants in the experiment nor the researchers know what the patients receive. Experimental authors then track results and draw conclusions using systematic reviews and meta-analysis of the data. A systematized (or systematic) review is a scientific study that interprets the results of several clinical studies on a given topic. A meta-analysis is most often used to assess the clinical efficacy of a test drug, for which the results of two or more randomized, controlled trials are combined. And if the experiments are performed correctly, then their results are published in a reputable medical journal, and ultimately get into medical protocols. And advanced specialists begin to treat patients in accordance with the data of these experiments. Such studies are the “gold standard” for obtaining data on new methods of diagnosis or treatment.

• Level 2: non-randomized controlled trials

In such studies, the selection process of participants and the choice of treatment for groups is not carried out randomly: the researcher knows what patients of different groups receive. Therefore, in such studies, the objectivity of the conclusions will be less.

• Level 3: cohort studies

In cohort studies, researchers recruit two groups, or cohorts, of patients, one of whom receives the intervention of interest and one who does not.

• Level 4: historical case-control studies

In this study, the two groups are compared retrospectively. Scientists analyze the difference between the past exposure to possible risk factors on the participants in the experiment. Here much attention is paid to the attempt to investigate the accompanying symptoms or consequences of the disease.

• Level 5: expert opinion, case series

This includes the physician’s professional opinion based on clinical experience. Such conclusions have the least probative force.

For analysis, researchers try to choose the highest level available. Ideally, these are well-conducted Level 1 studies.

Polina Shilo, program director of the Graduate School of Oncology, oncologist-chemotherapist:

“You need to understand that studies with high evidentiary power are such an average temperature in a hospital, and individual effects can vary greatly. And it is impossible to predict them with 100% certainty. If an investigational drug, according to the results of an experiment, helps 80% of patients, this does not mean that we can say for sure whether the drug will help or not a particular person. But doctors have the tools with which we learn to deal with this state of affairs. These are subgroup analyzes where we analyze treatments within a study based on certain characteristics. For example, depending on age. Let’s imagine that the average age of the participants in the study tends to 60 years. We want to understand the effectiveness of the drug for 30-year-olds and 80-year-olds. To do this, subgroups are created in which we look at the effect of experimental treatment in comparison with the control. And we conclude, for example, that the drug helps 30-year-olds better than 80-year-olds.”

This is how knowledge is built up brick by brick. A researcher can subdivide a scientific question an infinite number of times. “At every stage of gaining knowledge, we have a blind spot when we do not know the answer to some question. And this point must be discussed with the patient. He must understand the measure of our uncertainty in this or that method of treatment,” notes Shilo.

In Russia, clinical trials with a low level of evidence are still quite common. The main reason for this is the lack or insufficient funding of independent clinical experiments. From recent cases, one can recall the criticism of the Ministry of Health related to the inclusion of Arbidol (international non-proprietary name – umifenovir) in the protocol for the treatment of coronavirus infection. Some experts noted that “the evidence base for the clinical use of this substance is insufficient.”

In 2022, a group of scientists from the Ufa Institute of Chemistry, Russian Academy of Sciences, Medical University. THEM. Sechenov, the Sochi Sirius Center, the Institute of Organic Chemistry of the Russian Academy of Sciences and the Novosibirsk Center Vector published an article with the conclusion that Arbidol in vitro has activity at an early stage of virus replication.

You can find a list of drugs with unproven effectiveness on the net. Such lists are formed due to the lack of convincing data on the effectiveness of the drug, enshrined in international medical protocols. The latter include, for example, Kagocel, the Zifivax vaccine against COVID-19and other means. Analyzing the demand for such drugs, Russian doctor and science journalist Pyotr Talantov, together with colleagues, published an article “Unconfirmed Clinical Studies in Russia: Exception or Norm?” in the international medical database National Library of Medicine. In the article, a group of authors conclude that “a significant part of clinical trials conducted in Russia and published in Russian-language medical journals violate the mandatory authorization procedure and do not undergo independent scientific or ethical review before the start of the study.” This, the authors believe, leads to the fact that studies do not meet generally accepted international standards.

However, the use of drugs with low evidence-based efficacy is not a purely Russian medical practice. In April 2023, the Food and Drug Administration (FDA) ordered the withdrawal of Makena, a drug used to prevent preterm birth, from the market. This happened three years after LATimes published an investigation into Covis Pharma. It turned out that the organization ignored the FDA’s requests to withdraw the drug all this time. At the same time, the drug remained available for twelve years, despite studies by the FDA itself, confirming its ineffectiveness.

It is also the job of the experienced clinician to select a good article with high evidentiary value that specifically describes his or her case. A doctor without the skill of critical reading of scientific materials is forced to reduce all his evidence to a “case series”. And in a series of cases, that is, the clinical experience of a single doctor, the evidentiary power is one of the lowest.

Myth 3. Dokmed ignores the patient’s requests

The classical formula of evidence-based medicine consists of the patient’s wishes and values, the doctor’s experience and proven scientific data. Therefore, taking into account the interests of the patient in this method is one of the key components. Within evidence-based medicine, this approach is called patient-centered.

Marina Demidova, Director of the DocMed Medical Center:

“In the concept of “patient-centered medicine”, I mean focusing on the wishes of the patient, on what he wants in terms of treatment methods and in terms of the result he wants to achieve. But there are significant difficulties with the concept of “the client is always right” in the medical field: the patient does not always have sufficient medical outlook to determine exactly what he needs. Therefore, the partnership between the doctor and the patient is of particular importance, this is the best format of work to achieve a successful treatment result.”

Myth 4. Dokmed criticizes drugs that work

The pharmaceutical conspiracy is an umbrella term that describes the patient’s general distrust of the medical community, pharmaceutical corporations, and the state. First of all, large pharmaceutical companies are under the gun of criticism. Supporters of the pharmaceutical conspiracy theory insist that scientists and doctors help medical corporations: they hide drugs for cancer, AIDS, secretly develop biological weapons and artificially inflate pandemics. Not least, such concepts are supported by some doctors who, for example, deny the effectiveness of vaccination or prescribe drugs that the international medical community considers ineffective. The latter include, for example, some antiviral drugs, nootropics (drugs for influencing higher mental functions) and dietary supplements.

Marina Demidova:

“According to the research results, the effect of nootropics has either not been proven, or it has been proven that there is no effect. With antiviral drugs, things are not so clear. There are really effective antiviral drugs that are used in the treatment of HIV, hepatitis, influenza. But, unfortunately, there are no effective and safe preparations for other viruses that meet all the criteria of evidence-based medicine. In addition, antiviral drugs may have side effects. That is, they can be not only useless, but also harmful. With dietary supplements, the story is more complicated: some of them have been proven to work. For example, D-mannose for the prevention of recurrence of lower urinary tract infections. But in most cases, especially when it is a naturopathic prescription containing dozens of supplements per day, the same effect is easier and cheaper to achieve through nutritional optimization.”

It should also be taken into account that the quality control of dietary supplements is much weaker than that of medicines. Hence, the expert emphasizes, there may be discrepancies between what is indicated on the package and what is actually contained in the supplement. And if it is possible to buy, for example, vitamin D in the form of a dietary supplement or in the form of a medicine, then it is better to choose the latter.

This principle applies to all medicines – you should choose only those that have been reviewed by medical regulators such as the FDA (United States Food and Drug Administration), EMA (European Medicine Agency), etc. These organizations are responsible for ensuring that As a result, the consumer received an effective, safe and high-quality drug.

Myth 5. Dokmed opposes the doctor’s experience

Another popular misconception is that dokmed translates algorithms that are divorced from clinical practice and ignore the doctor’s experience and intuition. It is assumed that adherents of dokmed follow ready-made templates and protocols in their work and do not focus on a specific medical case.

Polina Shilo:

“The first thing to understand is that evidence-based medicine is based on the best available evidence and published research. And a good doctor must first be able to distinguish an excellent study from a bad one. No research by itself, apart from a specific clinical case, can be perceived as the ultimate truth. But at the same time, it is necessary to take into account the best evidence.

How do we define research quality? The doctor learns this throughout his practice. We pay attention to a large number of points. Was there a statistically significant difference between experimental and control treatment groups? In which journal is the article published, how trustworthy is the publication? How many patients are included in the study? What is the design of the study – was it properly planned? There are many such moments.”

Published studies, the expert emphasizes, are a tool by which a doctor critically evaluates the experience of colleagues and decides whether the researched method of treatment is suitable for his patient. And if so, he applies the treatment taking into account the preferences of his patient.

Myth 6. Dokmed is just a fashion trend

The definition of “evidence-based medicine” (or evidence-based medicine) is a little over 30 years old. It was proposed by Dr. Gordon Guyatt in 1990 in his policy paper “Evidence Based Medicine” published in the ACP Journal Club.

Although the term is relatively recent in medical use, the foundation for a new treatment strategy was laid half a century ago. In the United States, one of the pioneers of evidence-based medicine was Suzanne and Robert Fletcher, who studied at Harvard Medical School, Stanford Medical Center and Johns Hopkins University. At 19In 1982 they published the textbook Fundamentals of Clinical Epidemiology. Prior to the use of the principles of dokmed, the average doctor in his practice did not come into contact with scientific methodology and did not apply statistical analysis. It was the Fletchers who were among the first to talk about the fact that doctors can (and should) use these data collection and analysis tools.

The impetus for the development of dokmed eventually came from a growing awareness of the inadequacy of traditional clinical practice based on expert experience. And the introduction of a systematic approach into the daily work of doctors eventually improved the process of decision-making and patient care.

Why Evidence-Based Medicine Needs an Aesthetic Surgeon – Borovikov and Tamarov

A. M. Borovikov, Doctor of Medical Sciences, Professor, Chief Editor of the Journal of Plastic Surgery and Cosmetology
Moscow, Russia
e-mail: [email protected]

Evidence-based medicine or evidence-based medicine (EBM) is ranked among the 15 fundamental achievements of medicine in history [1]. For a couple of years now, on the title of each article, our main journal Plastic and Reconstructive Surgery has been giving a LOE (level of evidence) pyramid (Fig. 1). Looking at which of the 5 levels an article is on, the reader immediately gets an idea of ​​how its conclusions can be taken as a guide to action. Since 2012, the purely aesthetic American Aesthetic Surgery Journal has acquired “pyramids of trust”. Most aesthetic surgeons will ask why should I? This question is asked in the title of their article by Dr. F. Eaves and A. Pusic, notable persons
in aesthetic surgery [2].

According to D. Sackett, DM is “a conscientious, direct and reasonable use of currently available data to make a decision in a particular clinical case” [3]. Consider the definition of what DM is in terms of what it is NOT, which is more important, in our opinion.
The first – “conscientious” – means an orderly thoughtful effort to apply the information received, rejecting the usual attitudes, which requires a revision of the usual course of reasoning. The second – “direct” – means a targeted systematic search for information that best suits our task, its critical analysis and inclusion in the action plan. Fundamentally,

that we are looking for reliable data, and not what we would like, and only directly. Therefore, the source can only be clinical studies, and not someone’s expert opinions, no matter how authoritative for us. The third – “reasonable”, or legible – shows what the DM is definitely not. It does not create algorithms that require us to mindlessly follow them. She does not tolerate standards. It does not conflict with the notions of healing as an art, of the priority of common sense. Fourth – “a specific clinical case” – the individuality of the patient in DM is again elevated to the proper height, freed from under a pile of clichés, standards and algorithms.
DM requires that reliable information be attached not to nosology or procedure, but to the person with whom we are dealing, taking into account requests, fears, anatomy, status, as well as our own, also quite specific capabilities, skills and experience.

American Society of Plastic Surgeons Guidelines for Ranking the Reliability of Treatment Studies (there are also tables for the reliability of diagnosis, prognosis, and risk factors)

Level in the hierarchy – Characteristics of publications
1 – Randomized controlled trial with a sufficient sample from one or more centers, or a systematic review of similar studies
2 – Randomized controlled trial of lower quality; prospective cohort study or systematic review of similar studies
3 — Retrospective comparison or patient follow-up or systematic review of similar studies
4 – Description of the series of observations
5 – Expert opinion; clinical example; opinion based on the laws of biology, laboratory research or basic principles

The complex definition at the beginning of the paragraph can be rephrased as follows: DM is a bridge between reliable data and a specific patient (Fig. 2) [4].
Its core is the integration of research, clinical experience and patient needs. It in no way limits or imposes solutions, it expands their range and optimizes a specific choice [5].
The mentioned pyramid of LOE levels is intended not to bluntly say “this is reliable, but this is rubbish”, but to understand the hierarchy of reliability (table). At the top are randomized clinical trials, organized according to rules to avoid “systematic errors”. Only they answer questions like which method of treatment is better in this case. Tier 4 articles are clinical experience reports. This is certainly valuable information, but it must be understood,

that such studies inevitably contain “systematic errors”. Analyzing articles on the lower levels, the reader begins to understand what the essence of DM is, according to what criteria they “do not roll”, although the information itself can be terribly interesting. This category includes the majority of Western and without exception all domestic reports on favorite techniques, richly decorated with impressive “before-after” photos without any comparison with alternatives (below the top three levels) and without tracking a series of observations in a row (below level 4) . Such reports have their own useful function. Without them, we would not have known about the short-scar facelift, for example. But before changing your tactics, it is not harmful to wait for the analysis of the observational cohort (level 4), but rather comparative studies (level 3 and above). That is why the authors are required to describe the research method. This boring “materials and methods” section with a bunch of numbers and no pictures is not needed at all so that the reader can “reproduce the results of the study”, as we all thought before. It is necessary for the reader to understand what level of certainty the conclusions belong to5. Today, this function is taken over by the magazines mentioned above. Should we do it? No need. Not a single domestic magazine will be able to show a level higher than 5. And if it does, it will be a fraud. Agree, no one here will “steam” with blind control, it’s easier to “draw”, all the more so, anyway, the public does not know what it is.

Continuing, following doctors F. Eaves and A. Pusic, to persuade the reader that DM is not an enemy (as it may seem from the comments below), but a friend, let us quote their words that authenticity in itself is not a fetish. DM does not require you to replace your personal judgment with the conclusions of ponderous dissertations. Its purpose is only to supplement your judgment with the conclusions of conscientious research.
We are all students of experts, not proof, because in aesthetics, personal experience is everything. Publications of the 5th level are not slag, but a demonstration of the personal path of the augurs. And any conclusions of the 1st level are inevitably flavored with a human factor, this is a matter of honesty, although not only. Let’s delve a little deeper into this sensitive issue.

The main instrument of DM is a “reliable study” free from “systematic errors” due to the fact that its design is based on randomization (ideally blind), control (ideally triple blind) and a sufficient number of trials [7]. The second equally powerful tool is meta-analysis or systematic reviews, so called because they are built according to common requirements and are systematically updated. Thus, the validity of the conclusions increases. A necessary condition is the reliability of the studies analyzed by a particular review. And this is where surprises await us. A number of publications show that studies funded by the manufacturers of a particular medical device are not free from “systematic errors”, namely, in the direction of protrusion of effectiveness [8–10, 14]. The January issue of Plastic Reconstructive Surgery published an article by Kim et al., containing a meta-analysis of works on the use of ADM (acellular dermal matrix – a cell-free skin matrix, known under the trade names Alloderm, Strattis, etc.) in breast reconstruction using implants [11]. 19 people met the selection requirementspublications. Their complication data were compared with 35 studies where the expander was covered by muscle and where ADM was found to be associated with an increased incidence of seromas, infection, and complete reconstruction failure.

Of the ADM articles, 10 were published in Plastic Reconstructive Surgery, and 5 of them disclosed some kind of association with ADM manufacturers. G.W. Carlson (a plastic surgeon at the Emory University Hospital, Atlanta) analyzed separately the results of these five studies and those whose authors had no connection with the manufacturers (Fig. 3) [12].

This comparison can be objected to, saying that the authors associated with the manufacturer are better than others in handling ADM, better in selecting patients, and better in knowing how to avoid complications. To resolve this issue, we analyzed 6 articles from Plastic Reconstructive Surgery that retrospectively assessed comparable cohorts of ADM reconstructions and submuscular expander reconstructions. The authors of three out of five articles declared association with ADM manufacturers, and in these three studies no more complications were found in the ADM groups than in the submuscular groups [13-15]. There were much more complications compared to submuscular groups in three other studies, the authors of which made the same comparisons, but were not associated with ADM manufacturers in any way [16-18].

Manufacturer-sponsored studies are 3.6 times more likely to prove product efficacy than non-manufacturer-sponsored studies [19]. Meanwhile, as many as two-thirds of all biomedical research receive financial support from producers, not necessarily direct payments. We are familiar with the promotion of products, such as breast implants, by the hands of surgeons in the form of training seminars. A third of the authors of articles have a personal financial interest in what they write about [19]. This systematic error is indirectly reproduced by the editors. “Positive” is published more readily, regardless of the presence of a “conflict of interest” of the authors, because it captivates the reader.

As for the “negative”, then there is also direct opposition to the publication on the part of the manufacturer, and for sure, such a publication will be followed by a “showdown”7. A conflict of interest is “any influence on professional judgments about what is of primary interest (patient well-being, research validity) leading to the consideration of secondary interests, for example, monetary” [20]. Money is not the only or even obligatory “secondary interest”. The desire for recognition works no worse [21], surgical ambitions, only indirectly and always demagogically veiled associated with funding.

Dead end? Of course not. The connection between doctors and manufacturers is not only natural, but also necessary for moving forward. Although it is clear that conflicts of interest in manufacturer-sponsored surgical research are inevitable. This does not mean that the authors necessarily conduct paid campaigning.
It is the duty of speakers, whether surgeons or politicians, to declare a conflict of interest (otherwise we will find it ourselves, if there really is one), and then it is up to us to decide if there is a “systematic error” here and draw our own conclusions. Everything made by a person bears the imprint of his personality, which means passions and interests. However, it is important to understand that it is time to move from the patriarchal culture of experts into the world of evidence. To do this, each clinician must learn to recognize systematic errors in their own and others’ studies, learn to prioritize reliability. Why is it for an aesthetic surgeon?

The damage caused by the enemies of the DM, such as algorithms, standards of practice, hasty transitions to the “most modern methodology”, can only be assessed by the wiser by experience, and even that minority, since most augurs, understandably, do not want to break the patriarchal house, which they are built their own algorithms, standards and innovations. What everyone can easily appreciate are lasers that are sheathed and pushed into a corner, ultrasonic lipoaspirators, endoscopic stands and other “monuments to revolutions in aesthetic medicine”. Among the endoprostheses that I have extracted, which I use when trying on the volume before augmentation mammoplasty, there are almost no round ones, only anatomic ones – this is the proportion of their carriers among those who are dissatisfied with the results and need to be replaced. But 15 years ago, I only set anatomical ones – such was the strength of the logic of the experts who stood up for them. Expert opinion is, as you know, the lowest, 5th level. I have not seen any studies with conclusions in favor of anatomic endoprostheses of a higher level, although the objects of potential research are quite definite – complications and reoperations.

In other disciplines, there are a lot of studies of levels 1–2, comparing their frequency in order to compare certain methods with each other [23]. It is clear that these are the most expensive and time-consuming studies for any specialty [24]. In addition to cost, ethical issues arise: you perform a new good operation on the study group, and the old one on the control group.

How do I get patient consent?

Another problem. For example, you are told about the undoubted advantages of an innovation, say, ultrasonic or radiofrequency dissection, on a material of 500 operations. However, everyone knows the role of such an insidious beast as the learning curve (the curve for improving performance as experience is gained). This beast will make your initial results a pain in the ass, even though the research you trust says minimal complications. Does that mean it’s false? Yes and no. No, because everything is reported honestly. Yes, because you would have to be told about all the problems overcome on the long way to the radiant total of 500 observations. And this, you see, is beyond the limit requirements.

Returning to the presentation of DM as an integration of conscientious research, clinical experience and patient requests, we will see that an aesthetic surgeon in the fight for this nomination will immediately play a powerful trump card – “the patient is everything to me.” The second trump card – “my experience prescribes …, my capabilities allow …” – is also strong. But with the third – the “conscientiousness” of collecting, analyzing and issuing information is a complete failure. We all lie. Willingly or involuntarily is another, complex, unexplored issue of our professional psychology. Therefore, let’s leave professional ethics aside (whether business people care about it), let’s return to the evidentiary power of publications on aesthetic surgery. Having studied four dozen of the most notable facelift works, you will not find the answer to the question of which of the many techniques is optimal. There is no evidence, only exhortations. And this is for a hundred years, based on the results of millions of operations!

Cosmeceuticals is a multi-billion dollar business juggling with the slogans “diamond dust”, “crystal energy”, “stem cells”, etc. Their responsibility to the consumer, who hung his ears, is negligible, as is the effectiveness of their ointments. The same cannot be said about us surgeons. So how can we proclaim and promise the effectiveness of an innovation that has not even become the subject of research? Even if we sincerely believe in it? Faith is not evidence. In general surgery, about 24% of procedures are justified by randomized controlled clinical trials, in therapy – almost 48%. What about aesthetic surgery? Near zero [27].
The opponent of the DM will object that the aesthetic result cannot be objectively assessed. Not true. Tools for measuring the subjective perception of the results of operations by patients have appeared, and they already show many unexpected things, for example, that the method of breast reconstruction does not matter to a woman [22, 28].

In addition to the importance of DM for each clinician individually, there is also a corporate interest. In the fight for taxpayers’ money, plastic surgeons lose out to subcontractors in such important areas as hand surgery, maxillofacial surgery, etc., since our literature is poor in scientific content of sufficient reliability. The editors of Plastic and Reconstructive Surgery complain that its portfolio is represented almost exclusively by articles 5 (expert opinion) and 4 levels (retrospective analysis of a series of observations without comparison groups) [29], and encourages planning for future studies at least at level 3 (including control groups). Optimal for plastic surgery would be level 2 studies (long-term prospective studies of comparable cohorts of patients), and preferably randomized controlled trials that answer any questions with scientific certainty. Together with ASPS, the editors began a systematic campaign to improve the scientific quality of publications. It was then in April 2009 that the first pyramids began to appear under each title of clinical trials [30]. Note that the main American journal for orthopedists and traumatologists, The Journal of Bone and Joint Surgery, adopted this standard back in 2003 and after 5 years brought its specialty to the leaders of DM [31].

As for our area – aesthetic plastic surgery, things here, as already mentioned, are not very good. A study of 526 articles from Plastic and Reconstructive Surgery (35.9%), Aesthetic Plastic Surgery (24.7%), Aesthetic Surgery Journal (21.3%), Annals of Plastic Surgery (10.6%), and Journal of Plastic, Reconstructive & Aesthetic Surgery (7. 4%) for 2000, 2005, and 2010 showed no increase in confidence over this time period (Figure 4). The lag behind other specialties is growing (Fig. 5) [32].

We are all witnesses to the ongoing debate: open or closed nose, the best method of mastopexy, front lift fixation, the advantages of an endoscope, anatomical endoprostheses, lipo-abdominoplasty … You can continue the debate ad nauseum, ad nauseam, Or you can get answers based on evidence [33].

Do I need to keep asking why an aesthetic surgeon needs DM? All clear? Let’s start collecting truthful information together? Alas. Objectivity is the enemy of our national foundations. Take a look at the online polls “who did you vote for on March 4?”. Putin got 30% there with the inevitable second round, the consolidation of the opposition and… Objections, they say, polls involve only Internet users, will lead to even sadder conclusions: the president won on the downtrodden and unproductive part of the population (difficult question – is it the majority?). In medicine, these foundations are reproduced with the same aggressive mobilization of the administrative resource. Just imagine the penetration of a “foreign agent” (the vocabulary of the Duma of the Russian Federation) in the form of DM into a procurement auction. But what about Arbidol? What about buying CT scanners with “ups and downs” of everything imaginable, mostly kickbacks? What about our magazines, fattening on advertising? Or VAK RF? What will be left of the multi-million dollar dissertation business? And if this “foreign agent” reaches the minds of the surgical youth? It’s scary to think that the authorities of heads, leaders, professors and academicians (including mine) will evaporate. No, we have “our” way. Dead end? You decide.

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