Evidence review
Introduction
This fact sheet aims to give the reader an understanding of what research tells us about the benefits of acupuncture for fibromyalgia symptoms. This page of the factsheet provides an overview of the current evidence base. Interpreting the results requires an understanding of the challenges involved in acupuncture research, such as placebo/sham acupuncture and external validity. To learn more about these issues please also read the Evidence analysis page.
When evaluating clinical research, we must assess the strength and quality of the evidence as well as the results. For many conditions there are few high-quality clinical trials that evaluate the benefits of acupuncture. Consequently, researchers are cautious about the results. However, it is important not to conclude acupuncture is not effective because the evidence is ‘weak’ (too few high-quality clinical trials). This issue is summarised by the famous phrase ‘absence of evidence is not evidence of absence’.
Research investigating the benefits of acupuncture is increasing. In 1998, a systematic review analysed the data from nine clinical trials which included 377 patients [1]. Twenty years later in 2018, a systematic review by Vickers et al analysed the results of over 20,000 patients [2]. The Vickers et al review is arguably the most important investigation into the benefits of acupuncture that has been conducted to date. It has shown that acupuncture is effective in reducing pain for those with chronic pain: back, neck, shoulder, osteoarthritis, tension headaches and migraines. Moreover, it also shows that the benefits of acupuncture are not purely due to the placebo effect. In addition, the study also demonstrates that the benefits last for at least one year.
At present, clinical research indicates that there are benefits of acupuncture for fibromyalgia symptoms. Acupuncture reduces pain and improves wellbeing for those with a diagnosis of fibromyalgia when compared to sham procedures. The quality and size of clinical trials conducted to investigate the benefits of acupuncture for fibromyalgia is not as good as for conditions such as osteoarthritis. Therefore, further research needs to be conducted to evaluate whether acupuncture can also improve other symptoms such as insomnia, brain fog, fatigue, and irritable bowel syndrome for those with fibromyalgia.
Fibromyalgia symptoms
Fibromyalgia, also called fibromyalgia syndrome (FMS), is a long-term condition that causes pain all over the body.
As well as widespread pain, other symptoms of fibromyalgia include:
- increased sensitivity to pain
- muscle stiffness
- difficulty getting to sleep or staying asleep, which can make you feel very tired (fatigue)
- problems with mental processes (known as “fibro-fog”), such as difficulty concentrating or remembering things
- headaches
- irritable bowel syndrome (IBS), a digestive condition that causes stomach pain and bloating
- feelings of frustration, worry or low mood
Fibromyalgia falls into the category of chronic primary pain. Chronic pain refers to pain that persists or recurs for more than three months. Chronic primary pain has no underlying condition to adequately account for the pain or its impact.
The definitions of fibromyalgia and chronic primary pain are both from a biomedical understanding of illness. Members of the British Acupuncture Council (BAcC) have trained in one or more traditionally-based systems of acupuncture (TBSA). This means they use the traditional theory to assess all signs and symptoms and develop a treatment strategy. Individuals with a diagnosis of fibromyalgia are likely to receive different treatments: in terms of the acupuncture points used and the auxiliary techniques such as moxibustion and cupping. However, tailoring treatments for individuals can be problematic when it comes to researching the benefits of acupuncture for fibromyalgia.
Clinical evidence: systematic reviews
Effect of Acupuncture on Pain, Fatigue, Sleep, Physical Function, Stiffness, Well-Being, and Safety in Fibromyalgia: A Systematic Review and Meta-Analysis (Zheng and Zhou 2022) [3]
This review analysed the data from 12 studies. All these studies, a total of 715 patients, measured the treatment effect on pain. Four studies, with 357 patients, examined wellbeing. In these studies, acupuncture was compared to sham acupuncture.
The authors concluded that ‘Moderate quality of evidence supports acupuncture in reducing pain in patients with fibromyalgia. Therefore, acupuncture is recommended as a treatment for fibromyalgia.’
When compared to sham:
- acupuncture alleviated pain SMD: -0.42, CI, -0.66, -0.17, P< 0.001
- improved well-being SMD: -0.86, CI, -1.49, -0.24, P< 0.007
Standardised Mean Difference (SMD) is a way of estimating the effect of a treatment compared to a control or comparison group. By convention, 0.2 is considered a small effect, 0.5 medium and 0.8 large. To give some perspective in the National Institute of Health Care Excellence (NICE) analysis of the evidence of pharmacological management for chronic primary pain (including fibromyalgia), when compared to placebo < 3 months the SMDs were as follows: anti-depressants -0.45; SSRI -0.41; tricyclic antidepressants -0.99, benzodiazepines -0.38 and NSAIDs -0.28 [2].
The Zheng and Zhou 2022 review also analysed the data measuring fatigue, sleep, physical function, and stiffness. Fewer studies measured these outcomes, in each comparison there were fewer than 300 patients. Although acupuncture was superior to sham in most of these comparisons the results were not statistically significant. This means the results could have been due to chance. More research will need to be done before definitive conclusions can be drawn.
Acupuncture therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials (Zhang et al 2019) [4]
Like the Zheng and Zhou 2022 study above this review also included 12 studies. There is considerable crossover in the clinical trials analysed in these reviews. Zhang et al also showed that acupuncture was better at relieving pain than sham acupuncture. Similarly, Zhang et al indicates the acupuncture improves the quality of life when compared to sham.
Two of the studies included within this review compared the benefits of acupuncture for fibromyalgia compared to commonly used medications: amitriptyline, which is a tricyclic anti-depressant. These studies reported data on pain changes using a visual analogue scale (VAS) 0-10cm. This means that participants mark their pain at a point on a 10-centimetre line, where zero is ‘no pain’ and the 10 centimetre mark is ‘pain as bad as it could possibly be’.
Acupuncture was superior to amitriptyline by a mean difference -1.81 (-2.43,-1.18). So, a person whose pain reduced by 2 in the amitriptyline group ‘on average’ would have their pain reduced by 3.81 if they were in the acupuncture group.
Comparing Verum and Sham Acupuncture in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis (Kim et al, 2019) [5]
This review analysed the data from eight randomised controlled trials. Many of the included studies are the same as those analysed in the systematic reviews described above. ‘Verum’ means real acupuncture (see Evidence analysis). In this review, as well as effects on pain and wellbeing, acupuncture was also shown to improve sleep quality.
The reviewers concluded: Verum acupuncture is more effective than sham acupuncture for pain relief, improving sleep quality, and reforming general status in FMS post treatment. However, evidence that it reduces fatigue was not found.
Clinical guidelines
NICE: National Institute for Health and Care Excellence, U.K.
Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain. NICE guideline [NG193], 2021 [6]: recommends acupuncture for chronic primary pain, this includes fibromyalgia.
EULAR European Alliance of Associations for Rheumatology
EULAR revised recommendations for the management of fibromyalgia [7]: recommends acupuncture for fibromyalgia.
Agency for Healthcare Research and Quality (US)
Non-invasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review Update 2020 [8]: recommends acupuncture for fibromyalgia.
TSPMR: The Turkish Society of Physical Medicine and Rehabilitation
The Turkish Society of Physical Medicine and Rehabilitation (TSPMR) guideline recommendations for the management of fibromyalgia syndrome [9]: recommends acupuncture for fibromyalgia.
Other evidence and reviews
- American College of Rheumatology (ACR) state that acupuncture may easy the symptoms of fibromyalgia.
- John Hopkins Medicine list fibromyalgia as one of the conditions for which studies have shown acupuncture is an effective treatment alone or in combination with conventional therapies to treat.
- An Egyptian Consensus evidence‑based clinical practice recommendations for the management of fibromyalgia includes acupuncture for fibromyalgia [10].
Acupuncture safety
Many healthcare treatments have side effects and associated risks. Therefore, the potential for adverse events should be considered alongside the benefits. Studies have been conducted into the safety of acupuncture [11, 12]. These have demonstrated acupuncture is safe when provided by a properly trained practitioner who adheres to professional codes of conduct and safety. The British Acupuncture Council is an Accredited Register of the Professional Standards Authority (PSA). The PSA protects the public by overseeing the regulation and registration of healthcare professionals. To find a BAcC member please use our Find an acupuncturist page.
Evidence analysis
Introduction
Clinical research helps healthcare providers understand which therapies are the most effective in treating particular conditions. Moreover, many patients wish to understand the evidence base before starting a course of acupuncture. The double-blinded randomised controlled trial (RCT) with a placebo control group has for many years been considered the gold standard. However, this method of investigation was developed primarily to study the effects of medications. There are numerous challenges in investigating acupuncture using double-blinded placebo-controlled RCTs. For example, it is not possible to blind the practitioner. In other words, the acupuncturists knows that they are giving someone acupuncture. Similarly, it is difficult to blind the patients. Patients generally know whether someone has inserted acupuncture needles into them or not. On this page we will examine some of the key issues as they relate to the clinical trials that have investigated the benefits of acupuncture for fibromyalgia symptoms.
Acupuncture clinical research can be split into efficacy trials and effectiveness trials. Efficacy trials have a sham/ placebo control group. It is assumed that patients will feel better by going through the process of having a consultation and the ‘ritual’ of acupuncture. This is often described as the placebo effect. The objective of efficacy trials is to understand the clinical benefits of acupuncture beyond these psychological (placebo) effects. Effectiveness trials compare acupuncture to another form of treatment, for example medication.
Real or verum acupuncture
In evaluating the evidence base for acupuncture, it is important to assess whether the acupuncture given within clinical trials is similar to that given in practice. If there are differences, this may impact on the conclusions that can be drawn. This is called external validity.
In clinical trials the ‘real’ acupuncture is often called verum. This is to differentiate it from sham or placebo acupuncture. Two important aspects can be different between acupuncture in practice and clinical trials. These are the points used (points prescription) and the number of treatments given.
Point prescriptions
In clinical research, the standard approach is to provide the same treatment for each patient in the treatment group. This often means that the same acupuncture points are used for all of those in the acupuncture treatment group. These are known as fixed point protocols. Some clinical trials allow the acupuncturist to choose from a pool of pre-selected acupuncture points. These are semi-fixed protocols. Finally, some clinical trials allow the acupuncturist to select points as they would in normal practice. This is known as ‘individualised’ acupuncture. Therefore, clinical trials that use fixed point protocols are less like practice than those that use ‘individualised’ acupuncture. Semi-fixed protocols are somewhere in the middle. This means, potentially, the acupuncture delivered in a clinical trial is not as effective as the acupuncture received in practice. Consequently, there may be an underestimation of the benefit of acupuncture.
Very little research has been done to examine whether using individualised acupuncture is more effective than fixed points protocols. The impact of not using individualised acupuncture might be greater when investigating some conditions compared to others. It is possible that clinical trials of acupuncture for fibromyalgia are especially affected by this problem because it is a complicated condition.
A traditional acupuncturist does not base the treatment on the diagnosis of ‘fibromyalgia’. They will take a full case history and arrive at a diagnosis using the traditional theory. This diagnosis is called 证 zhèng. Zhèng is usually translated as pattern. Even for conditions where the signs and symptoms are fairly consistent, such as osteoarthritis of the knee, patients can be diagnosed with different zhèng-patterns. This means that patients with osteoarthritis of the knee we will get slightly different treatments depending on their overall signs and symptoms.
Fibromyalgia is far more complicated, beside the widespread pain there maybe other significant symptoms such as headaches, tiredness, insomnia, IBS and brain fog. A standard Chinese medicine textbook lists 17 zhèng – patterns associated with headaches, 9 associated with insomnia, and 20 associated with tiredness [13]. Whilst there is some overlap, different acupuncture points will be selected depending on the pattern. In addition, some of these patterns may require the use of moxibustion not just needles. This is a complicated issue and probably can only be fully understood through studying the traditional theories. However, hopefully, the central point is clear:
A fixed-point protocol given to all patients in the acupuncture group of a clinical trial is different to the individualised treatments those patients would receive in practice from a traditional acupuncturist. Consequently, clinical trials may underestimate the clinical benefit of acupuncture.
Acupuncturists take a full case history to understand individual ‘pattern’ for those with a diagnosis of fibromyalgia
The systematic reviews of acupuncture for fibromyalgia include many of the same randomised controlled trials (See Evidence review). Of the 13 studies included in the Zheng and Zhou 2022 review, 7 used standardised acupuncture treatment protocols past 5 used individualised treatments.
Number of treatments
A more straightforward, but profoundly important, aspect of external validity is the number and frequency of treatments given. Clinical trials conducted in China often show acupuncture to be more effective. Some researchers feel that this may be attributed to differences in the cultural acceptance of acupuncture. In other words, Chinese people have a higher expectations, therefore there is a stronger ‘placebo effect’ [14]. However, the reason might be much more mundane. Clinical trials in China generally provide more treatments at a higher frequency. So rather than being due to ‘expectation’ the greater benefits are attributable to the higher number of treatments.
In the Zheng and Zhou 2022 review 3 of the clinical trials provided less than 10 treatments. A subgroup analysis was done to see if more treatments led to a greater reduction in pain. However, the result was not ‘robust’. In other words, more high-quality trials need to be conducted before we can be confident in the results.
High-quality large-scale clinical trials have been conducted into acupuncture for lower back pain, neck pain, shoulder pain and osteoarthritis. Therefore, in this area the results are more robust than for fibromyalgia. A high-quality systematic review of these four conditions has demonstrated that acupuncture is dose dependent: more treatments lead to a greater reduction in pain [2]. Similarly, a recent systematic review shows more treatments lead to a greater reduction in the severity of depression [15].
Surprisingly, little attention has been paid to the quality of acupuncture provided in clinical trials, even though poor-quality acupuncture may lead to misleading results. Fortunately, things are beginning to change. Relatively recently, a means to evaluate the quality of acupuncture has been developed: the NICMAN scale (National Institute for Complementary Medicine Acupuncture Network) [16]. Evaluating the quality of acupuncture is a complex problem and much more work will need to be done. Is acupuncture dose dependent? Ramifications of acupuncture treatment dose within clinical practice and trials by Bauer, McDonald and Saunders (2020) provides a good explanation to the issue of number of treatments required [17].
Sham/placebo acupuncture
Perhaps the most controversial part of acupuncture research is the interpretation of placebo-controlled trials. There is an underlying assumption that placebo sham procedures are inert. However, sham acupuncture procedures are most likely active. Please see Should systematic reviews assess the risk of bias from sham–placebo acupuncture control procedures? [18]. The active nature of sham procedures will reduce the estimated size of effect. In other words, clinical trials that use sham acupuncture will tend to underestimate the benefits of acupuncture.
Summary
In assessing the benefits of acupuncture for fibromyalgia symptoms Zheng and Zhou 2022 concluded:
Moderate quality of evidence supports acupuncture in reducing pain in patients with fibromyalgia. Therefore, acupuncture is recommended as a treatment for fibromyalgia. They also found that acupuncture improved wellbeing.
but they also stated:
No evidence that acupuncture works on fatigue, sleep quality, physical function, or stiffness was found.
In the first statement, ‘moderate’ refers to the quality of the evidence. If more high-quality large-scale clinical trials are conducted these conducted these could be included in a future systematic review. The evidence would then be stronger.
In the second statement, ‘no evidence’ does not mean: clinical trials demonstrate acupuncture is not beneficial for fatigue, sleep quality, physical function, or stiffness. It means that the clinical evidence did not produce a statistically significant result. It is harder to achieve a statistically significant result if there is less data available. The more trials and the larger these trials are the better. This is a bit like tossing a coin. If you toss a coin 10 times and it comes up heads seven times, this may be due to chance. However, if you toss a coin 100 times and it comes up head 70 times, we become suspicious that the coin is fixed in some way. If we toss the coin 1000 times and it comes up heads 700 times, we will be more confident that the coin is fixed.
In the Zheng and Zhou 2022 review data was available for more than 300 participants for two of the six outcome measures: pain and wellbeing. Both produced statistically significant results in favour of acupuncture. For the other four outcomes data was available for fewer than 300 participants. These did not produce statistically significant results (Table 1).
Table 1: Fibromyalgia outcomes
| Outcome | Studies | N - participants | Statistically significant result |
| Pain | 12 | 715 | Yes |
| Fatigue | 4 | 251 | No |
| Sleep | 2 | 151 | No |
| Physical function | 3 | 268 | No |
| Stiffness | 2 | 104 | No |
| Wellbeing | 4 | 357 | Yes |
There are several possible explanations:
- absence of evidence – simply not enough clinical trials
- standardised treatments reduce the effectiveness of the acupuncture
- an insufficient number of treatment were given
- active sham procedures underestimate the efficacy of acupuncture
- all, or any combination, of the above
- acupuncture doesn’t work for these outcomes
Therefore, it is important that more high-quality clinical trials are conducted to investigate the benefits of acupuncture for fibromyalgia symptoms.
References
References
1. Ernst, E. and A.R. White, Acupuncture for back pain: a meta-analysis of randomized controlled trials. Archives of Internal Medicine, 1998. 158(20): p. 2235-2241.
2. Vickers, A.J., et al., Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. The journal of pain : official journal of the American Pain Society, 2018. 19(5): p. 455-474.
3. Zheng, C. and T. Zhou, Effect of Acupuncture on Pain, Fatigue, Sleep, Physical Function, Stiffness, Well-Being, and Safety in Fibromyalgia: A Systematic Review and Meta-Analysis. Journal of pain research, 2022. 15: p. 315-329.
4. Zhang, X.-C., et al., Acupuncture therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials. Journal of pain research, 2019. 12: p. 527-542.
5. Kim, J., et al., Comparing Verum and Sham Acupuncture in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis. Evidence-based complementary and alternative medicine : eCAM, 2019. 2019: p. 8757685.
6. NICE, Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain, in NICE Guideline NG193. 2021, National Institute for Health and Care Excellence.
7. Macfarlane, G.J., et al., EULAR revised recommendations for the management of fibromyalgia. Annals of the Rheumatic Diseases, 2017. 76(2): p. 318.
8. Skelly, A.C., et al., Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review Update. 2020, Agency for Healthcare Research and Quality (US), Rockville (MD).
9. Evcik, D., A. Ketenci, and D. Sindel, The Turkish Society of Physical Medicine and Rehabilitation (TSPMR) guideline recommendations for the management of fibromyalgia syndrome. Turkish Journal of Physical Medicine & Rehabilitation (2587-1250), 2019. 65(2): p. 111-123.
10. El Miedany, Y., et al., Consensus evidence-based clinical practice recommendations for the management of fibromyalgia. Egyptian Rheumatology and Rehabilitation, 2022. 49(1): p. 30.
11. Bäumler, P., et al., Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. BMJ Open, 2021. 11(9): p. e045961.
12. Witt, C.M., et al., Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forschende Komplementärmedizin, 2009. 16(2): p. 91-97.
13. Maciocia, G., The practice of Chinese medicine: the treatment of diseases with acupuncture and Chinese herbs. 1994, Edinburgh: Churchill Livingstone. 924.
14. NICE, Depression in adults: treatment and management: History, in NICE Guidelines 2022, National Institute for Health and Care Excellence.
15. Armour, M.A.-O., et al., Acupuncture for Depression: A Systematic Review and Meta-Analysis. . Journal of Clinical Medicine, 2019. 8(2077-0383 (Print)).
16. Smith, C.A., et al., Reliability of the NICMAN Scale: An Instrument to Assess the Quality of Acupuncture Administered in Clinical Trials. Evidence-Based Complementary and Alternative Medicine, 2017. 2017: p. 5694083.
17. Bauer, M., J.L. McDonald, and N. Saunders, Is acupuncture dose dependent? Ramifications of acupuncture treatment dose within clinical practice and trials. Integrative Medicine Research, 2020. 9(1): p. 21-27.
18. Appleyard, I., T. Lundeberg, and N. Robinson, Should systematic reviews assess the risk of bias from sham–placebo acupuncture control procedures? European Journal of Integrative Medicine, 2014. 6(2): p. 234-243.
