A randomized controlled trial of acupuncture added to usual treatment for fibromyalgia

Targino et al. · J Rehabil Med · 2008

🎯Controlled RCT👥n=58 participantsModerate Evidence

Evidence Level

MODERATE
75/ 100
Quality
4/5
Sample
3/5
Replication
4/5
🎯

OBJECTIVE

To assess the efficacy of acupuncture as an adjunctive treatment to standard care for fibromyalgia

👥

WHO

58 women with fibromyalgia, ages 20-70, taking tricyclic antidepressants

⏱️

DURATION

20 acupuncture sessions over 10 weeks, 2-year follow-up

📍

POINTS

Ex-HN-3, LR-3, LI-4, PC-6, GB-34, and SP-6 bilateral - classical Chinese medicine points

🔬 Study Design

58participants
randomization

Acupuncture + standard treatment

n=34

20 acupuncture sessions + antidepressants + exercise

Standard treatment only

n=24

Tricyclic antidepressants + exercise + counseling

⏱️ Duration: Treatment for 10 weeks, follow-up of 24 months

📊 Results in numbers

5.0 vs 8.0

Pain reduction at 3 months (VAS)

12.5 vs 17.0

Tender points at 3 months

3.53 vs 2.84 kg/cm²

Pain threshold at 3 months

0%

Treatment adherence rate

0%

Adverse events

Percentage highlights

97.1%
Treatment adherence rate
5.8%
Adverse events

📊 Outcome Comparison

Pain intensity (VAS) at 3 months

Acupuncture
5
Control
8

Number of tender points at 3 months

Acupuncture
12.5
Control
17
💬 What does this mean for you?

This Brazilian study showed that adding acupuncture to conventional fibromyalgia treatment can significantly reduce pain and improve quality of life in the first 3-6 months after treatment. Benefits were most evident in the short term, with important improvement in pain intensity and reduction in tender points.

📝

Article summary

Plain-language narrative summary

Fibromyalgia is a complex condition affecting approximately 2.5% of the Brazilian population, characterized by widespread muscular pain, chronic fatigue, and specific tender points throughout the body. This syndrome significantly impacts patients' quality of life, frequently leading to limitations in daily activities, sleep disturbances, anxiety, and depression. Although conventional treatment primarily involves antidepressant medications and physical exercise, many patients continue to experience persistent symptoms, which has motivated the search for complementary therapies such as acupuncture.

The present Brazilian study aimed to investigate whether the addition of acupuncture to conventional fibromyalgia treatment could provide additional benefits to patients. Researchers from the University of São Paulo conducted a randomized controlled clinical trial involving 58 women diagnosed with fibromyalgia according to rigorous criteria. Participants were randomly divided into two groups: one received acupuncture along with standard treatment, while the other received standard treatment only. Standard treatment consisted of tricyclic antidepressant medications, regular walking, and relaxation exercises.

The acupuncture group received 20 treatment sessions, performed twice a week by an experienced clinician, using specific points from traditional Chinese medicine. Patient follow-up was exceptionally long, extending two years after treatment.

Results demonstrated significant benefits of acupuncture, especially in the first months after treatment. Three months after the end of acupuncture sessions, patients who received this additional therapy showed substantial pain reduction, going from a mean intensity of 8 to 5 on a 10-point scale. In addition, these patients showed decreased numbers of tender points throughout the body and increased pain threshold, indicating greater pressure tolerance at traditionally sensitive sites. Quality of life also improved in multiple aspects, including physical functioning, vitality, mental health, and limitations related to emotional problems.

At six months, some benefits still persisted, particularly regarding tender points and pain threshold, although the improvement in pain intensity had diminished. It is important to emphasize that patients who received acupuncture maintained improvements compared to their initial pain levels even after two years, demonstrating durable benefits relative to the pre-treatment state.

For patients with fibromyalgia and healthcare professionals, these findings suggest that acupuncture can be a valuable addition to the therapeutic arsenal, especially when integrated with conventional treatment. The therapy proved safe, with only two cases of temporary hand swelling, and was very well tolerated by patients, with 97% completing all scheduled sessions. The results indicate that acupuncture can provide significant pain relief and improvement in quality of life, particularly in the first months after treatment. For professionals, the study reinforces the importance of a multimodal approach in fibromyalgia treatment, where different therapies work synergistically to provide better outcomes than when used in isolation.

However, it is essential to recognize the limitations of this study. Patients knew which treatment they were receiving, which may have influenced their perceptions of improvement. In addition, those who received acupuncture had more contact with healthcare professionals, which by itself may have contributed to the observed benefits. The study used fixed acupuncture points in all patients, while in clinical practice treatment is often individualized.

Researchers also relied on patients' reports of adherence to exercise and medications, without objective verification. Despite being the first such study conducted in a developing country and with long-term follow-up, the significant benefits of acupuncture were observed primarily in the short term. This suggests that booster sessions may be necessary to maintain beneficial effects over time. The results encourage both patients and professionals to consider acupuncture as part of a comprehensive treatment plan for fibromyalgia, especially considering its favorable safety profile and demonstrated benefits for pain and quality of life.

Strengths

  • 1First controlled study of acupuncture for fibromyalgia in Brazil
  • 2Long 24-month follow-up to assess durability of effects
  • 3High treatment adherence rate (97.1%)
  • 4Low adverse event rate (5.8%)
  • 5Blinded outcome assessment by independent professionals
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Limitations

  • 1Relatively small sample size (58 participants)
  • 2Only women included in the study
  • 3Inability to blind patients to treatment
  • 4Benefits limited to the short term (3-6 months)
  • 5Lack of placebo group with sham acupuncture
Dr. Marcus Yu Bin Pai

Expert Commentary

Dr. Marcus Yu Bin Pai

MD, PhD · Pain Medicine · Physical Medicine and Rehabilitation · Medical Acupuncture

Clinical Relevance

Fibromyalgia remains one of the most challenging diagnoses in pain and rehabilitation services, precisely because of the heterogeneity of presentation and the partial response to conventional pharmacological interventions. This trial by Targino et al. documents that 20 sessions of acupuncture added to a regimen of tricyclic antidepressants and exercise produced a reduction in pain intensity from 8.0 to 5.0 on the VAS and a decrease in tender points from 17.0 to 12.5 at three months, with measurable gain in pressure threshold. For the physiatrist who has already established baseline treatment and still faces relevant residual pain, these numbers justify formal inclusion of acupuncture in the therapeutic plan, especially in women with established fibromyalgia. The safety profile — only 5.8% mild adverse events and 97.1% adherence — gives the intervention a favorable benefit-risk ratio within a structured multimodal protocol.

Notable Findings

The most noteworthy finding is not just the magnitude of response, but its selective persistence. At six months, when the difference in VAS between groups had already attenuated, the outcomes of tender points and pain threshold still remained favorable to the acupuncture group — suggesting that the effect on peripheral and central sensitization has different kinetics from immediate subjective relief. The maintenance of gains relative to the pre-treatment state after 24 months, even without documented booster sessions, is a finding that few interventions in fibromyalgia can demonstrate with such prolonged follow-up. The increase in pressure threshold from 2.84 to 3.53 kg/cm² represents a biologically plausible mechanism — descending pain modulation and reduction of central sensitization — and converges with what pain neurophysiology predicts for needling of specific somatic points.

From My Experience

In my practice in musculoskeletal pain service, fibromyalgia is the condition in which I most frequently combine acupuncture with the pharmacological regimen from the start, not as a rescue resource. I usually observe noticeable response in pain intensity and sleep quality around the fourth to sixth session, which coincides with the period when the patient begins to trust the process and reduces anticipatory hypervigilance. I usually work with cycles of 12 to 15 twice-weekly sessions, followed by monthly maintenance for six months. The profile that responds best, in my observation, is the patient with predominant mechanical allodynia and non-restorative sleep, precisely the profile in which central modulation translates into faster functional gain. I systematically combine this with a supervised aerobic exercise program — the synergy between the two reduces the need for analgesic escalation. I avoid initiating isolated acupuncture in patients with untreated psychiatric comorbidity, since the response tends to be erratic; I prefer to wait for minimum stabilization before including acupuncture as a structuring component of the plan.

PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture.

Full original article

Read the full scientific study

J Rehabil Med · 2008

DOI: 10.2340/16501977-0216

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Scientific Review

Marcus Yu Bin Pai, MD, PhD

Marcus Yu Bin Pai, MD, PhD

CRM-SP: 158074 | RQE: 65523 · 65524 · 655241

PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture. Scientific review and curation of every entry in this library.

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⚕️

Medical disclaimer: This content is for educational purposes only and does not replace consultation, diagnosis, or treatment by a qualified professional. Some information may be assisted by artificial intelligence and is subject to inaccuracies. Always consult a physician.

Content reviewed by the medical team at CEIMEC — Integrated Centre for Chinese Medicine Studies, a reference in Medical Acupuncture for over 30 years.