A Randomized Clinical Trial of Acupuncture Compared with Sham Acupuncture in Fibromyalgia

University of Washington Seattle, Seattle, Washington, United States
Annals of internal medicine (Impact Factor: 17.81). 08/2005; 143(1):10-9.
Source: PubMed


Fibromyalgia is a common chronic pain condition for which patients frequently use acupuncture.
To determine whether acupuncture relieves pain in fibromyalgia.
Randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group.
Private acupuncture offices in the greater Seattle, Washington, metropolitan area.
100 adults with fibromyalgia.
Twice-weekly treatment for 12 weeks with an acupuncture program that was specifically designed to treat fibromyalgia, or 1 of 3 sham acupuncture treatments: acupuncture for an unrelated condition, needle insertion at nonacupoint locations, or noninsertive simulated acupuncture.
The primary outcome was subjective pain as measured by a 10-cm visual analogue scale ranging from 0 (no pain) to 10 (worst pain ever). Measurements were obtained at baseline; 1, 4, 8, and 12 weeks of treatment; and 3 and 6 months after completion of treatment. Participant blinding and adverse effects were ascertained by self-report. The primary outcomes were evaluated by pooling the 3 sham-control groups and comparing them with the group that received acupuncture to treat fibromyalgia.
The mean subjective pain rating among patients who received acupuncture for fibromyalgia did not differ from that in the pooled sham acupuncture group (mean between-group difference, 0.5 cm [95% CI, -0.3 cm to 1.2 cm]). Participant blinding was adequate throughout the trial, and no serious adverse effects were noted.
A prescription of acupuncture at fixed points may differ from acupuncture administered in clinical settings, in which therapy is individualized and often combined with herbal supplementation and other adjunctive measures. A usual-care comparison group was not studied.
Acupuncture was no better than sham acupuncture at relieving pain in fibromyalgia.

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    • "Exercises was used in 43 studies (Matsutani et al., 2007;Hasson et al., 2004;Ang et al., 2011;Gusi and TomasCarus, 2008;Mannerkorpi et al., 2009;Redondo et al., 2004;Ramsay et al., 2000;King et al., 2002;Ide et al., 2008;Da Costa et al., 2005;Cedraschi et al., 2004;Fontaine et al., 2010Fontaine et al., & 2011Gavi et al., 2014;Gowans et al., 2001;ArcosCarmona et al., 2011;Assis et al., 2006;Bement et al., 2011;Bjersing et al., 2012;Bressan et al., 2008;Gusi et al., 2006;6 | P a g eHakkinen et al., 2001;Jentoft et al., 2001;Jones et al., 2002;Jones et al., 2008;Kaleth et al., 2013;Kingsley et al., 2005;Munguia-Izquierdo et al., 2008;Newcomb et al., 2011;Richards and Scott, 2002;Rooks et al., 2007;Sanudo et al., 2010;Schachter et al., 2003;Stephens et al., 2008;Tomas-Carus et al., 2007;2008;Valim et al., 2013;Valkeinen et al., 2004;2008;); Pharmacology was used in another 3 studies (Younger et al., 2009;Arnold et al., 2011;Chappell et al., 2008); cognitive behavioral therapy and other psychotherapy techniques were studied in 15 studies (Kashikar-Zuck et al., 2012;2013a, 2013bHamnes et al., 2012;Alda et al., 2011;Carleton and Richter, 2011;Koulil et al., 2010;Ang et al., 2013;Hsu et al., 2010;Luciano et al., 2014;Menga et al., 2014;Menzies et al., 2014;Sephton et al., 2007;Thieme et al., 2003); MFR techniques were reported in 2 studies (Castro-Sanchez et al., 2011a& 2011b; Multidisciplinary programme were reported in 5 studies (Castel et al., 2013;Clarke-Jenssen et al., 2014;Lemstra and Olszynski 2005;Martins et al., 2014;Bourgault et al., 2015), Acupuncture were studied in 7 studies (Itoh and Kitakoji, 2010;Hadianfard and Parizi, 2012;Harris et al., 2005;Harris et al., 2009;Martin et al., 2006;Stival et al., 2014;Targino et al., 2008) and the remaining 21 studies are reported on other treatment techniques like reiki, acupuncture, biofeedback, Qigong therapy, Soy supplement, Transcranial direct current stimulation, Craniosacral therapy, Guided imagery, Internet-enhanced management, whole-body vibration training, and laser (Assefi et al., 2005;Williams et al., 2010;Riberto et al., 2011;Wahner-Roedler et al., 2011;Lynch et al., 2012;Babu et al., 2007;Assefi et al., 2008;Gusi et al., 2010;Lofgren et al., 2009;Garza-Villarreal et al., 2014;Reis et al., 2014;Wang et al., 2010;Gamber et al., 2002;Letieri et al., 2013;Fioravanti et al., 2009;Almeida et al., 2003;Zijlstra et al., 2005). "

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    • "Study ID Diagnostic criteria Sample size (T/C, male/female) Age (yr, T/C) Duration of disease (month, T/C) Experimental intervention Control intervention Duration of treatment Outcomes Assefi et al. 2005 [14] ACR 1990 3/22 2/69 Unclear 144 ± 216 112.08 ± 120.48 Acupuncture on points chose to treat fibromyalgia according to TCM theory for 30 min, twice weekly One of three sham acupuncture (false points, not insertion, or unrelated points) for 30 min, twice weekly 12 weeks Visual Analogue Scores (VAS) for pain, fatigue, Sleep, and overall well-being; SF-36 for physical and mental function; adverse effects Cao and Li 2003 [15] ACR 1990 28 28 42.1 ± 14.5 19.3 ± 15.1 Acupuncture plus moving cupping therapy on bilateral Jiaji points, once every 3 days, plus seroxat 20 mg daily Seroxat 20 mg daily 4 weeks Hamilton Depression Scale (HAMD); VAS; number of tender points; effective rate Deluze et al. 1992 [16] ACR 1990 3/33 13/21 46.8 ± 2.3 49 ± 2 172.8 ± 40.8 82.8 ± 15.6 Electroacupuncture on 4–10 common points with electrostimulation 1–99 Hz, 10 mA, twice weekly for 6 sessions Sham electroacupuncture on false points (20 mm away from the point which has been chosen for real elec- troacupuncture) twice weekly for 6 sessions 3 weeks Pain threshold; number of analgesic tablets; regional pain score; VAS for pain; Sleep Quaty; morning stiffness; patients and evaluation physicians appreciation of the patients general status Gong and Wang 2010 [17] ACR 1990 9/21 11/19 35 ± 8 34 ± 6 15.0 ± 3.5 13.0 ± 2.5 Acupuncture at Ashi points and lower Dantian (CV4 and CV6) for 30 min, once daily to twice weekly Amitriptyline 25 mg twice daily added to 150–300 mg daily for 2 months, then 50–150 mg per month for another month 12 weeks VAS for pain; sleep quality; HAMD; effective rate Hadianfard and Parizi 2012 [18] ACR 1990 0/15 0/15 43.86 ± 7.9 44.2 ± 10.8 82.8 ± 68.4 79.6 ± 69.8 Acupuncture on ST36, GB34, RN6, SP6, LI4, ST44, BL40, HT7, and DU20 for 30 min, three sessions weekly Fluoxetine 20 mg every morning 8 weeks VAS; number of tender points; Fibromyalgia impact questionnaire (FIQ) Evidence-Based Complementary and Alternative Medicine Table 1: Continued. Study ID Diagnostic criteria Sample size (T/C, male/female) Age (yr, T/C) Duration of disease (month, T/C) Experimental intervention Control intervention Duration of treatment Outcomes Harris et al. 2005 [19] ACR 1990 0/29 3/27 4/24 1/26 46 ± 10.1 44.5 ± 10.9 51.3 ± 10.0 48.1 ± 10.9 66 ± 44.52 63 "
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    ABSTRACT: Background. Acupoint stimulation is popular for treatment of fibromyalgia though there is lack of comprehensive evaluation of current clinical evidence for its effect and safety. Objective. To systematically review the beneficial effects and safety of acupoint stimulation for fibromyalgia. Methods. We searched six electronic databases for randomized trials on acupoint stimulation for treatment of fibromyalgia. Two authors extracted data and assessed the trial quality independently. RevMan 5.2 software was used for data analyses with effect estimate presented as (standard) mean difference and a 95% confidence interval. We defined minimum, medium, and large SMD effect sizes as 0.3, 0.5, and 0.75. Results. 16 RCTs with 1081 participants were involved in this review. Only two trials were evaluated as low risk of bias. Meta-analysis showed that acupuncture alone or combined with cupping therapy was superior to conventional medications on reducing pain scores and/or the number of tender points. However, acupuncture showed no better than sham acupuncture on pain reduction. There was no serious adverse event reported to be related to acupoint stimulation. Conclusions. Acupoint stimulation appears to be effective in treating fibromyalgia compared with medications. However, further large, rigorously designed trials are warranted due to insufficient methodological rigor in the included trials.
    Full-text · Article · Dec 2013 · Evidence-based Complementary and Alternative Medicine
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    • "of acupuncture trials, a series of placebo control methods have been applied in acupuncture trials. For instance, sham needling invasive to subcutaneous or dermal tissues at nonacupoints [10] [11], noninvasive sham needle with a blunt tip, sham laser acupuncture [12], and sham electrode on acupoints without electricity [13]. The authors found that there is a trend that the newer the report is, the more confirmed that deqi will attribute to the active interventional effect. "
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    ABSTRACT: Objective. To evaluate the similarity of deqi sensation of real and noninvasive placebo acupuncture in healthy people with knowledge of Chinese medicine. Methods. In a crossover design, volunteers recruited from Chinese medicine college students were randomized to two groups to receive two phases of intervention with a one-week washout interval. In Group A, the participants were firstly treated by real acupuncture and then by sham needle, and the treatment sequence was reversed in Group B. VAS for pain intensity and deqi sensation was evaluated as outcomes. Results. Sixty-three volunteers were recruited and 60 were included and finished the study. In Group A, VAS was higher in Phase I than in Phase II (P = 0.017). Only treatment methods were selected as factor to VAS difference (P = 0.046) in ANOVA test. More positive deqi was reported in Group A in Phase I when treated by real acupuncture (P = 0.039), but the difference was not significant in Phase II (P = 0.301). Conclusion. The noninvasive placebo acupuncture device can effetely simulate the deqi sensation as real acupuncture, but it is less likely to evoke the active effect of deqi in real practice. This trial is registered with Chinese Clinical Trial Registry: ChiCTR-ORC-09000505.
    Full-text · Article · Jul 2013 · Evidence-based Complementary and Alternative Medicine
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