Drugs or non-drug alternatives: how should we treat chronic primary pain in the UK?
The UK’s NICE recently condemned the use of many drugs for chronic primary pain due to their limited benefit and potential to cause very real harm. Instead, the regulator recommended pharmacological interventions such as acupuncture, psychological therapy and exercise programmes. Allie Nawrat analyses the NICE guidance and considers its impact on the care of people suffering with chronic primary pain.
Defined as pain that persists or recurs for more than three months, chronic pain poses a real challenge to healthcare professionals. Patients experiencing chronic pain often go through a diagnostic odyssey, where there is a focus on identifying and treating the underlying cause of the pain, rather than looking holistically at the multidimensional nature of their recurring pain.
To try and alter this paradigm, the World Health Organization (WHO) oversaw a revision of the International Classification of Disease (ICD), a diagnostic tool used by clinicians across the world to inform the management of diseases.
In the most recent version of the ICD, ICD-11, saw a differentiation between two types of chronic pain introduced for the first time: chronic primary pain and chronic secondary pain. The ICD-11, and this definition of chronic primary pain, was accepted by the WHO’s Assembly in 2019 and is expected to come into effect in 2022.
According to the ICD-11, chronic primary pain is recognised as a type of chronic pain in and of itself and should be diagnosed, managed and treated accordingly, whereas chronic secondary pain is classified as a symptom of an underlying condition.
Examples of chronic primary pain include fibromyalgia, irritable bowel syndrome, migraines and complex regional pain syndrome. Whereas chronic secondary pain includes chronic pain due to diseases, such as cancer and the nervous system, or as the result of surgical procedures.
New treatment guidelines needed for chronic primary pain: enter NICE
Because of this new definition of chronic primary pain, the UK’s National Institute of Health and Care Excellence (NICE) moved to produce new guidance about managing and treating these conditions.
In its draft guidance – which recently underwent a consultation period and will be finalised and published in January 2021 – NICE recommends that although some antidepressants could be used to treat chronic primary pain, other commonly prescribed drugs often cause more harm than good.
The drugs in question are paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, benzodiazepines and opioids. The same was said by NICE of cannabis-based medicines, anti-epileptic drugs, including gabapentin, ketamine, corticosteroids, local anaesthetics and antipsychotics.
The regulator also considered non-pharmacological management approaches, including laser therapy, biofeedback, interferential therapy, manual therapy and hypnosis. However many of these were not recommended due to a lack of benefit and potential to cause harm to patients.
This mismatch between patient expectations and treatment outcomes can affect the relationship between healthcare professionals and patients.
NICE did note that acupuncture demonstrated clinical benefits and cost-effectiveness as a treatment for chronic primary pain, but only for a five-hour course and if the patient discontinued after the first few sessions if they did not find it effective for them.
Other non-drug-based strategies recommended by NICE were certain types of psychological therapy – acceptance and commitment therapy (ACT) and cognitive behaviour therapy (CBT) - and group exercise programmes.
Chair of the guidance committee and consultant psychiatrist at Dorset HealthCare NHS University Foundation Trust Nick Kosky commented: “This mismatch between patient expectations and treatment outcomes can affect the relationship between healthcare professionals and patients, a possible consequence of which is the prescribing of ineffective but harmful drugs.
“This guideline, by fostering a clearer understanding of the evidence for the effectiveness of chronic pain treatments, will help to improve the confidence of healthcare professionals in their conversations with patients. In doing so, it will help them better manage both their own and their patient’s expectations.”
Concern about impact on patients
“The reaction within the community has been quite negative, as well as confused,” notes Des Quinn, chair of Fibromyalgia Action UK (FMA UK). Fibromyalgia is a type of chronic primary pain, which causes widespread pain across the entire body.
Quinn explains there are concerns that although “the guidance doesn’t necessarily say that they’re going to take medication away, it is quite hard to read the guidance without thinking that medication is not going to be as easy to get as it was before”. This is especially troubling given that fibromyalgia patients were already reporting difficulty in accessing some drugs to FMA UK.
This worry is applicable to wider chronic primary pain conditions as it is mentioned in a statement by Pain Concern board of trustees chairman Dr Marin Dunbar: “We are aware of the anxiety that the recommendations are likely to raise amongst people living with chronic pain who rely on these medicines to cope.”
When evaluating drugs being prescribed for chronic primary pain, NICE looks at both their cost and clinical effectiveness for patients. However, Quinn notes that in chronic primary pain generally, and fibromyalgia specifically, “everybody’s journey is different” and that “a lack of good evidence [for a therapy] does not mean it is not working for a lot of people.”
It is quite hard to read the guidance without thinking that medication is not going to be as easy to get as it was before.
He continues it is very disheartening for patients who have spent years trying to find a treatment that works to now be told “it is no longer useful for you because there is evidence that it doesn’t work”.
“If you had a room of ten people, three of those are going to find that one of the drugs works [for them], another three are going to find another drug works, and another three are going to find that another, third drugs works, while the tenth person is perhaps still waiting to find something that works for them,” adds Quinn.
Therefore, Quinn suggests maybe there is a need to find out why certain drugs work for some people with chronic primary pain, and why they don’t work for others, rather than just ruling them out entirely for all patients across this spectrum of diseases. For instance, the NHS website states that paracetamol is commonly used to treat fibromyalgia, but under the new guidance, this treatment would no longer be recommended for these patients, even if it has been effective for some previously.
NICE’s guidance does call for further research into some areas not recommended, this is more linked to other non-pharmacological interventions, such as manual therapy, relaxation therapy and mindfulness. There is no desire to re-evaluate drugs like opioids, NSAIDs and antipsychotics to find out why they work for some patients with fibromyalgia, for instance, but not others, and then determine the appropriate recommendation.
Access issues to non-drug alternatives
Quinn is pleased that the NICE guidance does highlight some of the good alternative techniques that are effective for chronic primary pain. He notes that acupuncture, CBT and particularly exercise do seem to be effective in fibromyalgia – however, he stresses that patients often need pharmaceutical treatments to get them to a place where they feel able to participate in CBT or exercise classes.
However, Quinn is concerned about issues with accessing the non-pharmacological interventions recommended. “If there isn’t availability, then you’ve not got alternatives [to drugs] to offer”, Quinn concludes.
Acupuncture, CBT and particularly exercise do seem to be effective in fibromyalgia.
NICE does acknowledge challenges in terms of implementing the guidance into clinical practice as these alternatives are not necessarily commonly used at the moment.
However, it does not provide advice on how increased demand should be managed by the NHS; that is outside of the regulator’s remit.
Despite the positives of promoting these alternative tools to treat chronic primary pain, Quinn concludes that this guidance is being too pejorative in its criticism about pharmacological options that are often life-changing for some patients.
He adds it is already difficult for innovative drugs to come through to patients in the UK, but he is concerned that this new NICE guidance on chronic primary pain that seems to present some therapies in a negative way may actually make it even more difficult for new, improved drugs to be available in the UK.