Introduction

 

Background

Fibromyalgia

According to NHS 111 Wales, Fibromyalgia, also called fibromyalgia syndrome (FMS), is a long-term condition that causes pain all over the body. As well as widespread pain, people with fibromyalgia may also have:

• increased sensitivity to pain;
• extreme tiredness (fatigue);
• muscle stiffness;
• difficulty sleeping;
• problems with mental processes, such as memory and concentration;
• headaches;
• irritable bowel syndrome, a digestive condition that causes stomach pain and bloating;

Individuals who think they may have fibromyalgia are advised to visit a GP, although  it can be a difficult condition to diagnose. There is no specific test for the condition, and the symptoms can be similar to a number of other conditions. The exact cause of fibromyalgia is unknown, but it is thought to be related to abnormal levels of certain chemicals in the brain and changes in the way the central nervous system processes pain messages carried around the body.

Treatment is available to ease some of its symptoms, although they are unlikely to disappear completely. Treatment tends to be a combination of:

• patient education;
• medicine, such as antidepressants and painkillers;
• talking therapies, such as cognitive behavioural therapy (CBT) and counselling;
• lifestyle changes, such as exercise programmes and relaxation techniques.

Fibromyalgia Action UK report that the condition is seen in about 2% of the population, affects men, women, and children of all ages, races and economic levels, and around 14,000 people are diagnosed annually in the UK. The onset of symptoms can be at any age, but mainly from 20-60 years of age, and affects women more than men in the ratio of 9 to 1.

Hyperbaric Oxygen Treatment (HBOT)

Hyperbaric Oxygen Treatment (HBOT) involves breathing pure oxygen at higher than atmospheric pressures in an enclosed chamber, for a prescribed duration of usually 60 to 90 minutes. This process causes oxygen to be absorbed by all body fluids and by all body cells and tissues, even those with blocked or reduced flow.

Published evidence

The original petition includes links to two studies:

• Hyperbaric Oxygen Therapy Can Diminish Fibromyalgia Syndrome – Prospective Clinical Trial, (Efrati et al, Plos One, 2015). The study of 60 female patients ‘provides evidence that HBOT can improve the symptoms and life quality of FMS patients’;
• THU0512 Hyperbaric oxygen therapy (HBOT) treatment in fibromyalgia, (Muratore et al, Annals of the Rheumatic Diseases, June 2018). This argued that their data from 33 female patients confirmed the efficacy of HBOT in treating fibromyalgia, but further studies were required ‘to understand the duration of the clinical effect’.

It is possible to identify other published research studies; some argue for HBOTs’ benefit in treating fibromyalgia, but others also note areas for further study:

• Hyperbaric oxygen treatment of fibromyalgia: a prospective observational clinical study, (Atzeni et al, in Clinical and Experimental Rheumatology, January-February 2019). This study of 32 patients evaluated the efficacy and safety of HBOT after fewer sessions than generally used. The findings supported the view that HBOT is an effective, rapid and safe means of treating various symptoms of fibromyalgia;
• Comparative study of the effectiveness of a low-pressure hyperbaric oxygen treatment and physical exercise in women with fibromyalgia: randomized clinical trial, (Izquierdo-Alventosa et al, Therapeutic Advances in Musculoskeletal Disease, June 2020). A study of 49 patients indicated that low-pressure HBOT and physical exercise improve pressure pain threshold, endurance and functional capacity, as well as physical performance;
• Ozone therapy in 65 patients with fibromyalgia: an effective therapy, (Tirelli et al, European Review for Medical and Pharmacological Sciences, 2019) states that it is possible to propose ozone therapy to patients with fibromyalgia that are not obtaining adequate results from other available treatment;
• Hyperbaric oxygen and aerobic exercise in the long-term treatment of fibromyalgia: A narrative review, (El-Shewy et al,  Biomedicine & Pharmacotherapy, January 2019,) reports that ‘it has been known that HOBT and aerobic exercise have a promising role in chronic pain management’ but notes there are safety concerns regarding the oxidative damage that may follow HBOT, and calls for further studies and clinical trials;
• Hyperbaric Oxygen Therapy for the Treatment of Chronic Pain: A Review of Clinical Effectiveness and Cost-Effectiveness, (Pejic and Frey, Canadian Agency for Drugs and Technologies in Health; September 2018). This argued that the research provided evidence to suggest that two months of HBOT increases pain thresholds, physical functionality, and health-related quality of life However, ‘no evidence was identified regarding the cost-effectiveness of HBOT for the treatment of chronic musculoskeletal pain.

This does not represent an exhaustive review of the published literature, which appears to have a limited but emerging evidence base. It has not been possible to identify any published evidence on fibromyalgia and HBOT by the All Wales Medicines Strategy Group (AWMSG),  the National Institute for Health and Care Excellence (NICE), nor is it included in the Cochrane Library.

Following a consultation in 2018 on Reviewing Hyperbaric Oxygen Services in July 2018 NHS England published several new Commissioning Policies for HBOT and has confirmed routine funding for only the following two emergency conditions:

·         Decompression Illness (DCI);

·         Air / Gas embolism.

Welsh Government response to the petition

The Welsh Government’s response highlights that they rely on the expert advice of NICE and the AWMSG, and state that:

NICE guidance does not recommend oxygen therapy as an effective use of NHS resources; nor are we aware of the evidence of the effectiveness of oxygen therapy for people living with fibromyalgia.

The response also includes guidance from the Welsh Health Specialised Services Committee outlining the conditions HBOT should be provided for, which include:

·         Emergency indications:

-          Decompression illness;

-          Carbon monoxide intoxication;

-          Life threatening anaerobic or mixed soft tissue infections;

-          Crush injuries and other traumatic ischaemia with comprised circulation.   

·         Elective indications:

-           Diabetic foot ulcers;

-           Osteoradionecrosis (ORN) of the head and neck;

-           Prevention of osteo-radionecrosis for head and neck surgery;

-           Soft tissue radiation tissue damage;

-           Chronic refractory osteomyelitis.

WHSSC have also published a more detailed version of the guidance for HBOT (July 2019). The Welsh Government response goes on to note that:

…the majority of resources across Welsh Government and the NHS in Wales are now directed to tackling Covid-19 and preventing a future second wave.  As such, I hope you understand that at this time we are unable to consider the further investigation of oxygen therapy for fibromyalgia.

The Welsh Government response does, however, note that where medicines are not routinely available within NHS Wales, a clinician may apply for the medicine on behalf of their patient through an Individual Patient Funding Request (IPFR).  The clinician would need to provide sufficient evidence to demonstrate the clinical and cost effectiveness of the proposed treatment

Earlier in 2020 Welsh Government issued a statementsetting out their intention to merge three existing advisory groups (Persistent Pain, Arthritis, and ME/Chronic Fatigue Syndrome and fibromyalgia) into one advisory group. This would to report to the Chief Medical Officer on issues the conditions share, as well as bespoke issues relating to specific conditions. It was hoped the new group would be established by April 2020, although coronavirus may have intervened in its’ work. However, the Welsh Government response to this petition sets out that:

When normal services are able to resume, we will work together to continue the consideration of the most appropriate treatment and support for fibromyalgia patients.