In recent years there has been an exponential increase in the therapeutic use of platelet-rich plasma (PRP). The excessive use of PRP in various clinical situations has greatly exceeded the ability of the scientific community to generate evidence of its benefits.
Platelets not only participate in the early stages of hemostasis but also play a role in the repair and regeneration of different tissues through the secretion of growth factors and other cytokines. Hence, the administration of PRP has been considered by many practitioners as potentially useful in numerous degenerative pathologies. This, together with the harmlessness of the therapy (provided that the preparation of the PRP complies with adequate procedures), has led to an increase in its application before the medical efficacy of the technique has been scientifically proven.
Applications of platelet-rich plasma: when is it recommended?
There is currently no authorized indication for the clinical use of PRP in Spain by the Spanish Agency of Medicines and Health Products (AEMPS). However, this treatment has been applied in numerous fields: Dentistry and Maxillofacial Surgery, Traumatology, Rheumatology, Sports Medicine, Plastic Surgery, Ophthalmology, Aesthetic Medicine, Vascular Surgery, Otorhinolaryngology, Neurosurgery, Burn Unit, Urology, Thoracic Surgery and Dermatology. In few of these specialties are there clinical trials with sufficient methodological quality to be able to draw significant conclusions.
Although PRP does not have a technical data sheet authorized by the AEMPS, the patient should receive a minimum amount of information that guarantees compliance with quality requirements, explains the efficacy of PRP in the correct indication in which it will be used, the advantages of this therapy and the possible therapeutic alternatives, as well as the risks and possible adverse reactions. It is the prescribing physician’s responsibility to ensure that this information is received by the patient before undergoing PRP treatment.
The pathologies in which platelet-rich plasma has been applied and clinical information is available are:
- Knee osteoarthritis. To date, 14 randomized clinical trials (RCTs) have been published in knee osteoarthritis analyzing the clinical benefit of PRP in terms of pain relief and functional recovery. Most of them have serious shortcomings in the design that condition a high risk of bias in the results. When the study is restricted to the few RCTs of high methodological quality (including 2 trials carried out in Spain, the most recent in Malaga published 3 years ago, and an earlier one in Vitoria), the unanimous conclusion is that platelet-rich plasma is not superior to hyaluronic acid (reference treatment) in pain relief and functional improvement of the joint. The benefit is marginal when compared to placebo. More RCTs are needed to verify this conclusion, drawn from a limited number of trials. Nevertheless, specialists should consider individual patient conditions, benefits and adverse effects, cost-effectiveness and alternatives to PRP when adopting the most appropriate clinical-therapeutic strategy.
- Other osteoarticular pathologies. In osteoarthritis of the hip, three RCTs have been published with conflicting results, and no relevant conclusions can be drawn on the effects of PRP. The administration of PRP during rotator cuff repair surgery does not systematically improve either the tear recurrence rate or the pain and functionality scales. The same happens in lateral epicondylitis or tennis elbow, where PRP infiltration is not superior to corticosteroid infiltration or its benefit is marginal.
- Wound treatment. In the healing of chronic wounds (diabetic foot, vascular ulcers in lower limbs or pressure ulcers) and acute wounds (surgical wounds), there are very few RCTs which, moreover, do not have sufficient statistical power to demonstrate a therapeutic benefit of PRP. In general there is insufficient clinical evidence to recommend the systematic use of PRP in wound healing or venous ulcers.
- Periodontal regenerative therapy and endodontics. The heterogeneity of the published RCTs makes it impossible to obtain conclusive information on the usefulness of PRP in these pathologies and procedures.
Is there any risk in treatment with platelet-rich plasma?
The administration of PRP is safe. Although no major adverse effects have been published, there may be local complications similar to those of any infiltration. On the other hand, the risk of infection is minimal, but aseptic measures must be taken.
The minimum quality guarantees in the production of PRP established by the autonomous communities and the AEMPS must be observed by the prescribing physician, who will be responsible for ensuring compliance with them (even if the obtaining and processing are performed by a third party).
PRP can be obtained:
- Manually with “open technique”. The method used must be evaluated from the point of view of its quality. Thus, an inspection should be requested to the competent authority, which should verify if the facilities are adequate, as well as the production and quality control activities carried out, taking as a reference the EU Good Manufacturing Practice (GMP).
- With disposable kits with “closed technique”. These kits must have the CE marking granted for this use.
On the other hand, although PRP is an autologous blood-derived product, the prescribing physician should adopt control, surveillance and traceability measures to prevent the transmission of infectious diseases. In this regard, all PRP donor patients should undergo ABO and Rh blood grouping and tests for the detection of infectious agents: syphilis, hepatitis B (AgHBs), hepatitis C (anti-HCV and NAT) or HIV I/II (anti-HIV I/II).
The exclusion criteria for autologous blood donation apply to PRP: severe cardiac disease, positive markers for HCV, HIV-I/II and HTLV I/II, history of hepatitis B and active bacterial infection (temporary exclusion).
False myths of platelet-rich plasma
PRP is a treatment whose clinical effectiveness with respect to placebo and in particular with respect to reference therapies, is still far from having been able to demonstrate significant superiority in any of the areas where it has been used so far. More clinical trials with an optimal methodological design and high statistical power are needed to obtain conclusive results and to be able to establish whether PRP is indeed a beneficial therapy in surgery and medicine, a reality that cannot currently be supported by the clinical information available.
What are the alternatives to platelet-rich plasma?
The price of each PRP injection ranges from less than €150 to €1,200, depending on the pathology. Alternatives to this treatment, ranging from non-steroidal anti-inflammatory drugs and corticosteroids to hyaluronic acid (63€/dose) are for the moment probably more cost-effective than PRP.