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Partially randomized patient preference trial: Comparative evaluation of fibromyalgia between acupuncture and cupping therapy (PRPP-FACT)

Cao et al. · Complementary Therapies in Clinical Practice · 2020

⚖️Partially Randomized Trial👥n=126 participants🧪Feasibility Study

Evidence Level

MODERATE
70/ 100
Quality
4/5
Sample
3/5
Replication
3/5
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OBJECTIVE

Evaluate the feasibility of the partially randomized patient preference (PRPP) trial model to compare acupuncture and cupping therapy in fibromyalgia

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WHO

126 patients with fibromyalgia, ages 20-60 years, VAS pain > 30 mm

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DURATION

5 weeks of treatment (15 sessions), 3 times per week

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POINTS

Ashi points (tender points), Bladder and Du Mai channels for cupping therapy

🔬 Study Design

126participants
randomization

Randomized acupuncture

n=30

Needling at Ashi points for 30 min

Randomized cupping

n=30

Retained cupping therapy at Ashi points for 10 min

Preferred acupuncture

n=39

Acupuncture by patient choice

Preferred cupping

n=27

Cupping therapy by patient choice

⏱️ Duration: 5 weeks

📊 Results in numbers

25 mm

Pain reduction (VAS) acupuncture

35 mm

Pain reduction (VAS) cupping

0%

Adjusted dropout rate

0%

Satisfaction 'very satisfied'

Percentage highlights

16.67%
Adjusted dropout rate
38%
Satisfaction 'very satisfied'

📊 Outcome Comparison

Pain reduction (VAS mm)

Acupuncture
25
Cupping
35

Patient satisfaction (very satisfied %)

Randomized group
38
Non-randomized group
38
💬 What does this mean for you?

This study tested a new way of conducting research that allows patients to choose their preferred treatment. Both acupuncture and cupping therapy proved effective in relieving fibromyalgia pain, with clinically significant reduction in pain intensity and no important differences between the two treatments.

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Article summary

Plain-language narrative summary

Treating fibromyalgia has been a constant challenge for patients and physicians around the world. This chronic condition causes widespread muscle pain and significantly affects quality of life. Although different therapeutic approaches are available, pharmacological options do not always provide adequate relief and may cause unwanted side effects. As a result, many patients seek alternatives such as acupuncture and cupping therapy, traditional Chinese treatments that have shown promising results for pain relief.

However, an important problem arises when researchers try to scientifically study these therapies: how can different treatments be compared when patients have specific preferences for one technique or another?

To address this question, Chinese researchers developed an innovative study using a method called "partially randomized patient preference trial." This design allows some participants to choose their preferred treatment, while others are randomly assigned to treatment groups. The main objective was to determine whether this method is suitable for evaluating non-pharmacological therapies of traditional Chinese medicine, specifically comparing acupuncture with cupping therapy for the treatment of fibromyalgia. The study was conducted over four years, from 2013 to 2017, in two hospitals in Beijing, recruiting 126 participants diagnosed with fibromyalgia according to established medical criteria.

The methodology divided participants into four distinct groups. Sixty individuals who did not show a specific preference for either treatment were randomly assigned to acupuncture or cupping therapy, with 30 in each group. The remaining 66 participants, who had clear preferences, were directed to the treatment of their choice: 39 preferred acupuncture and 27 chose cupping therapy. Both treatments used specific points called "Ashi," which are tender areas identified during physical examination.

In acupuncture, needles were inserted at these points and retained for 30 minutes. In cupping therapy, suction cups were applied to the same areas for 10 minutes, using different techniques such as fixed, moving, and flash cupping. Treatments occurred three times per week for five weeks, totaling 15 sessions for each participant.

The results revealed important aspects regarding both the efficacy of the treatments and the feasibility of the research method. Both therapies demonstrated significant benefits for patients with fibromyalgia. Pain intensity, measured by a visual analog scale from 0 to 100 points, decreased on average by 25 to 40 points in all groups, representing a clinically significant improvement. Other aspects also improved substantially, including quality of life, depressive symptoms, and patients' functional capacity.

Importantly, there were no statistically significant differences between acupuncture and cupping therapy, suggesting that both treatments are equally effective for fibromyalgia. As for the research method, the study showed that participants who chose their treatments did not present different dropout rates, expectations, or satisfaction compared to those who were randomly assigned.

For patients suffering from fibromyalgia, these results bring hope and valuable practical information. The finding that both acupuncture and cupping therapy provide significant pain relief offers complementary treatment options to conventional approaches. Since there were no significant differences between the two treatments, patients can choose based on personal preferences, local availability, or individual tolerability. For health professionals, the study scientifically validates these long-standing practices, providing evidence that may guide clinical recommendations.

The absence of serious adverse effects reported during treatment also reinforces the safety profile of these therapies when applied appropriately by qualified professionals.

The study also has important methodological implications for research in complementary medicine. The partially randomized trial method proved feasible, allowing patients with specific preferences to participate in research without compromising the scientific quality of the results. Interestingly, participants who were able to choose their treatments were recruited eight months faster than those randomly assigned, suggesting that this method may accelerate the conduct of future research. This is particularly relevant for studies of complementary therapies, where patient preferences are often an obstacle to recruitment.

However, some limitations should be considered. The study was conducted only in China, in a cultural context where these practices are widely accepted, which may limit the generalization of the results to other populations. Additionally, the evaluation focused only on the immediate effects of the treatments, without following participants long-term to verify the durability of the benefits. The inability to conduct a blinded study—where neither patients nor researchers know which treatment is being applied—also represents a limitation inherent to research with physical therapies such as acupuncture and cupping therapy.

In summary, this study offers encouraging evidence that both acupuncture and cupping therapy can be effective therapeutic options for people with fibromyalgia, providing pain relief and improvement in quality of life. The equivalence between treatments allows the choice to be based on individual preferences and availability. For the research field, it demonstrates that innovative methods can overcome traditional challenges in studying complementary therapies, paving the way for future investigations that are more inclusive and representative of patients' real preferences.

Strengths

  • 1Innovative model that considers patient preference
  • 2Faster recruitment than traditional studies
  • 3Both treatments demonstrated clinical efficacy
  • 4Good patient satisfaction independent of randomization
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Limitations

  • 1Inability to blind treatments
  • 2Differences in initial dropout rate
  • 3Change in billing policy during the study
  • 4Lack of 3-month follow-up as planned
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 represents one of the most frustrating scenarios in musculoskeletal pain practice: polymedicated patients with partial response to available drugs and high demand for non-pharmacological alternatives. This work provides empirical support for including acupuncture and cupping therapy in the multimodal plan, especially in patients who have already tried pregabalin, duloxetine, or cyclobenzaprine without satisfactory relief. The magnitude of VAS reduction—25 to 35 mm on average—is clinically relevant, surpassing the minimum clinically detectable difference threshold for chronic pain. The satisfaction data are also operationally useful: 38% reporting "very satisfied" in a population with fibromyalgia, notoriously difficult to treat, indicates therapeutic adherence above expected. Patients with marked central sensitization and no contraindication to needling constitute the population that may benefit most from this integration with the conventional protocol.

Notable Findings

The most noteworthy finding is not the isolated efficacy of each technique, but the equivalence between acupuncture and cupping therapy in a fibromyalgia population—a condition classically responsive to modulation of descending pain control systems. Both modalities acted on Ashi points, reinforcing the hypothesis that localized mechanical stimulation in areas of tissue hypersensitivity generates analgesic effects regardless of the specific technique used. The methodological aspect is also noteworthy: the preference arm recruited participants eight months faster than the randomized arm, which has concrete implications for the feasibility of future trials in physical therapies. The absence of a difference in expectations and satisfaction between patients who chose versus those who were randomized challenges the assumption that preference bias necessarily distorts outcomes—a relevant point for interpreting pragmatic trials in this area.

From My Experience

In my pain and rehabilitation outpatient practice, fibromyalgia is a diagnosis that demands therapeutic humility: rarely does a single intervention resolve it, and treatment adherence is variable. I usually see noticeable response to acupuncture within three to four sessions in cases predominated by localized pain and well-defined Ashi points on physical examination; when the pain distribution is very diffuse and the central component dominates, the response tends to be slower. My usual protocol combines acupuncture with a supervised aerobic exercise program—a combination that, in my experience, potentiates analgesia and reduces relapse rates. In general, I work with cycles of eight to ten sessions before formal reassessment. The data from this study on cupping therapy with efficacy equivalent to acupuncture leads me to consider offering it as an alternative for patients with needle aversion, a group for whom we historically had few options within physical medicine. I do not indicate needling in fibromyalgia patients with decompensated anxiety disorder or intense cutaneous allodynia—in those cases, the approach must begin with control of the central neurological component before any peripheral stimulation.

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

Complementary Therapies in Clinical Practice · 2020

DOI: 10.1016/j.ctcp.2020.101255

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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.