ACUPUNCTURE study for FIBRO shows it can HELPS

Discussion in 'Fibromyalgia Main Forum' started by victoria, Apr 29, 2007.

  1. victoria

    victoria New Member

    I and my husband have used acupuncture very successfully for shingles and other things... so I find this really interesting... even tho I have CFIDS.... it does say it can help fatigue as well, so am thinking it would be worth a try for me as well!

    Dr. David Cohen, in Oakwood GA (who does acupuncture) sent me this article.... he has helped both my husband and me using acupuncture, so we recommend him highly!

    ABSTRACT:

    IMPROVEMENT IN FIBROMYALGIA SYMPTOMS WITH ACUPUNCTURE: RESULTS OF A RANDOMIZED CONTROLLED TRIAL

    David P. Martin MD, PHD: Christopher D. sletten PHD: Brent A. Williams MS: Ines H. Berger MD.

    OBJECTIVE: To test the hypothesis that acupuncture improves symptoms of fibromyalgia.

    (FIQ=Fibromyalgia Impact Questionnaire; MPI=Multidimensional Pain Inventory )

    PATIENTS & METHODS:
    We conducted a prospective, partially blinded, controlled, randomized clinical trial of patients receiving true acupuncture compared with a control group of patients who received simulated acupuncture.

    All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture. We measured symptoms with the Fibromyalgia Impact Questionnaire (FIQ) and the Multidimensional Pain Inventory at baseline, immediately after treatment, and at 1 month and 7 months after treatment. The trial was conducted from May 28, 2002, to August 18, 2003.

    RESULTS:
    Fifty patients participated in the study: 25 in the acupuncture group and 25 in the control group. Total fibromyalgia symptoms, as measured by the FIQ, were significantly improved in the acupuncture group compared with the control group during the study period (P=.01).

    The largest difference in mean FIQ total scores was observed at 1 month (42.2 vs 34.8 in the control and acupuncture groups, respectively; P=.007). Fatigue and anxiety were the most significantly improved symptoms during the followup period. However, activity and physical function levels did not change. Acupuncture was well tolerated, with minimal adverse effects.

    CONCLUSION: This study paradigm allows for controlled and blinded clinical trials of acupuncture. We found that acupuncture significantly improved symptoms of fibromyalgia. Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety.

    Mayo Clin Proc. 2006;81(6):749-757

    ----------------

    I did not print the whole study here, but here is the Discussion, references and conclusion from it:

    ----------------


    DISCUSSION

    In this controlled, randomized, and blinded assessment of acupuncture, our study patients were unable to determine in which group they had participated. Such blinding is necessary for quality research in acupuncture because the control group displayed the expected placebo response that is typical of pain studies.11

    An alternative choice for control treatments in studying acupuncture is to place needles at incorrect or “sham” points. Although it would have been easier to use this as a control, we agree with others who have argued that needling at sham locations is also likely to provide neuromodulatory inputs to the sensory nervous system. Sham needling may in fact produce physiologic changes indistinguishable from “true” acupuncture points.

    We believe that the simulated acupuncture configuration described herein provides an inexpensive and effective method of providing realistic placebo acupuncture treatments to patients who have not previously experienced genuine acupuncture.

    Acupuncture treatments were well tolerated by our patients. Most patients found participation in the study to be pleasant and rewarding. Bruising and soreness were more common in the acupuncture group than in the control group, but these were mild and did not affect treatment.

    Acupuncture rarely causes adverse effects that might limit cognition or functional rehabilitation. Vasovagal symptoms (in both the acupuncture group and the control group) were the most troubling adverse effects for a few of our patients. Placing patients in the supine position would likely make them more comfortable.

    We found that acupuncture improved symptoms of fibromyalgia significantly more than placebo. All symptom subscales were improved with acupuncture, but only fatigue and anxiety were statistically significant on their own. Pain trended closely toward statistical significance in the FIQ (P=.07) and MPI
    (P=.05). However, fibromyalgia is a syndrome of symptoms not just pain.

    Our patients were homogenous in diagnosis and severity of symptoms. The Fibromyalgia Treatment Program has been shown to reduce the mean FIQ total score from 51.3 to 44.7.12 The average FIQ total score of our patients at baseline after the Fibromyalgia Treatment Program was 42.5, which is close to the expected value. The improvement observed in our study was additive to the benefits obtained with the Fibromyalgia Treatment Program (ie, educational and behavioral interventions).

    We saw maximum benefit at 1 month (among time points we considered), and that benefit was less significant at 7 months. Unfortunately, the design of this clinical trial does not allow a more precise determination of acupuncture’s duration. The time course of improvement after acupuncture should be better characterized in future studies.

    Although patients receiving acupuncture reported improved symptoms, they did not report significantly increased levels of activity or physical functioning. However, we neither set this as a goal for our patients nor encouraged any changes in behavior, even if they mentioned symptomatic improvement during the study. Also, the Fibromyalgia Treatment Program had already encouraged exercise and activity to these patients, so they may have previously adopted these suggestions. Regardless, the lack of functional improvement after reduction of chronic pain is not an observation unique to this study. Symptom reduction may be necessary, but not sufficient, for functional rehabilitation.

    Two other randomized controlled studies of acupuncture for fibromyalgia have been published.6,7 Deluze et al6 prospectively studied 70 patients with fibromyalgia who were randomized to receive either acupuncture or control acupuncture (35 patients in each group). The control acupuncture arm consisted of needle insertion at points 20 mm away from the experimental points, with decreased intensity of electrical stimulation. Patients received 6 treatment sessions and were assessed immediately after the course of acupuncture with no long-term follow-up. Intention-to-treat analysis showed that patients in the experimental group improved significantly in all parameters except morning stiffness, whereas the controls had no change.

    Pain threshold was improved by 70% in the experimental group and 4% in the control group. Unfortunately, this study did not use standardized or validated measures of fibromyalgia symptoms or quality of life. Furthermore, there were no long-term follow-up measurements to determine the duration of the effect.

    Assefi et al7 studied 25 patients in the acupuncture group compared with 3 separate control groups, each consisting of 25 patients. Their patients were drawn from “all comers” in the community who had fibromyalgia.

    Our patients were drawn from the Mayo Fibromyalgia Treatment Program, and thus they may have been more homogenous and possibly more severely affected. It has been suggested that patients at tertiary care centers have more severe disease. Our population may represent patients who have recalcitrant symptoms or are more severely affected than the general population. Many had already used most of the basic treatments for fibromyalgia. Although this may be the case, most of our patients were from the local community, so such a referral bias may be less significant.

    The study by Assefi et al was performed at several sites by 8 different acupuncturists. Our study was done at 1 site by 2 acupuncturists. This may have reduced the variability in our data.

    The study by Assefi et al looked primarily at pain. Their quality-of-life measurement, the Medical Outcomes Study 36-Item Short-Form Health Survey, is not designed specifically for patients with fibromyalgia. We looked at all symptoms of fibromyalgia with a disease-specific, validated measurement tool, the FIQ. In fact, the FIQ was more sensitive in detecting significant differences between groups in our study than the MPI.

    Our study showed that acupuncture reduced the FIQ score by 7 points. This benefit was additive to the beneficial effect produced by the Fibromyalgia Treatment Program, which also produced a mean benefit of 7 points.12 The magnitude of clinical benefit produced by acupuncture is similar to that reported with pharmacological interventions such as tricyclic antidepressants13 (7 points), fluoxetine14 (8 points), and tramadol and acetaminophen15 (6 points). Therefore, the effect of acupuncture is both clinically and statistically significant.

    Our study has certain limitations. Perhaps most significant is the relatively small size of the study population. Additionally, some will argue that the acupuncture therapy provided was not optimal with respect to point selection, elicitation of de Qi, and electrical stimulation. To preserve blinding, the design of the study did not allow customized point selection or specific elicitation of the de Qi sensation, sometimes referred to as “needle grab.” Some schools of acupuncture require this sensation as an indication of proper needle position. However, studies suggest that the sensation of de Qi occurs equally frequently at true and sham acupuncture points.16 Nevertheless, these deficiencies would tend to minimize the treatment effect observed. Hence, our results may represent a minimum effectiveness of acupuncture.

    Our patients were mostly women, which does not accurately reflect the male-female ratio of the incidence of fibromyalgia. This may represent scheduling difficulties on behalf of potential patients or other factors that limited enrollment by men. Our population was also predominantly white, which reflects the community population in Olmsted County, Minnesota, where this study was conducted. Future research should extend these observations to men and to other ethnic and racial groups.

    CONCLUSION

    This study represents a prospective, blinded, randomized trial of acupuncture for patients with fibromyalgia. Acupuncture was well tolerated with minimal adverse effects. Symptoms of fibromyalgia improved in the acupuncture group to a greater extent than in the control group. Specific symptoms that showed the most significant improvements included fatigue and anxiety. The improvement was both clinically and statistically significant. Therefore, acupuncture may have a role in the symptomatic treatment of patients with fibromyalgia.

    We thank Gregory A. Wilson for study coordination and patient recruitment; Heidi L. Schmitz, Carolyn J. Nereson, Victoria L. Rud, Donna J. Fritsch, and Evelyn K. Perry for help with patient scheduling and appointment flow; and Yuko F. Voss, BA, Megan M. O’Byrne, MA, and Cyndy O. Townsend, PhD, for help with data analysis.

    REFERENCES

    1. Buskila D. Fibromyalgia, chronic fatigue syndrome, and myofascial pain syndrome. Curr Opin Rheumatol. 2001;13:117-127.
    2. Wolfe F, Ross K, Anderson J, Russell IJ. Aspects of fibromyalgia in the general population: sex, pain threshold, and fibromyalgia symptoms. J. Rheumatol. 1995;22:151-156.
    3. Wahner-Roedler DL, Elkin PL, Vincent A, et al. Use of complementary and alternative medical therapies by patients referred to a fibromyalgia treatment program at a tertiary care center. Mayo Clin Proc. 2005;80:55-60.
    4. NIH Consensus Development Panel on Acupuncture. Acupuncture. JAMA.
    1998;280:1518-1524.
    5. Berman BM , Ezzo J, Hadhazy V, Swyers JP. Is acupuncture effective in the treatment of fibromyalgia? J Fam Pract. 1999;48:213-218.
    6. Deluze C, Bosia L, Zirbs A, Chantraine A, Vischer TL. Electroacupuncture in fibromyalgia: results of a controlled trial. BMJ.
    1992;305:1249-1252.
    7. Assefi N, Sherman K, Jacobsen C, Goldberg J, Smith W, Buchwald D. A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia. Ann Intern Med. 2005;143:10-19.
    8. Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991;18:728-733.
    9. Turk DC. Customizing treatment for chronic pain patients: who, what, and why. Clin J Pain. 1990;6:255-270.
    10. Turk DC, Okifuji A, Sinclair JD, Starz TW. Differential responses by psychosocial subgroups of fibromyalgia syndrome patients to an interdisciplinary treatment. Arthritis Care Res. 1998;11:397-404.
    11. Turner J, Deyo R, Loeser J, VonKorff M, Fordyce W. The importance of placebo effects in pain treatment and research. JAMA. 1994;271:1609-1614.
    12. Pfeiffer A, Thompson J, Nelson A, et al. Effects of a 1.5-day multidisciplinary outpatient treatment program for fibromyalgia: a pilot study. Am J Phys Med Rehabil. 2003;82:186-191.
    13. Heymann RE, Helfenstein M, Feldman D. A double-blind, randomized, controlled study of amitriptyline, nortriptyline and placebo in patients with fibromyalgia: an analysis of outcome measures. Clin Exp Rheumatol.
    2001;19:697-702.
    14. Goldenberg D, Mayskiy M, Mossey C, Ruthazer R, Schmid C. A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia. Arthritis Rheum. 1996;39:1852-1859.
    15. Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med. 2003;114:537-545.
    16. Vincent CA, Richardson PH, Black JJ, Pither CE. The significance of needle placement site in acupuncture. J Psychosom Res. 1989;33:489-496.

    (From the Department of Anesthesiology (D.P.M., I.H.B.) and Department of Health Sciences Research (B.A.W.), Mayo Clinic College of Medicine, Rochester, Minn; and Division of Psychology and Department of Pain Medicine, Mayo Clinic College of Medicine, Jacksonville, Fla (C.D.S.). Dr Berger is now with the Medical College of Georgia, Augusta.

    This work was supported by Mayo Foundation and the Mayo Anesthesia Clinical Research Unit. Dr Martin is supported in part by a Research Starter Grant from the Foundation for Anesthesia Education and Research.

    Address reprint requests and correspondence to David P. Martin, MD, PhD, Department of Anesthesiology, Mayo Clinic College of Medicine, 200 First St SW, Rochester, MN 55905 (e-mail: martin.david@mayo.edu).
  2. Suzan

    Suzan New Member

    Then accupuncture sounds like a good thing to try. But it did not seem to help with morning stiffness..a big one for me! ..and it didn't reduce pain markedly..although at one point it says it did for 70%..at another point it says
    "Although patients receiving acupuncture reported improved symptoms, they did not report significantly increased levels of activity or physical functioning". I'm am not sure that this is an option for many of us...
    Until it is a covered insurance expense...!
  3. victoria

    victoria New Member

    but it does state:
    Regardless, the lack of functional improvement after reduction of chronic pain is not an observation unique to this study. Symptom reduction may be necessary, but not sufficient, for functional rehabilitation.

    I AM wondering why that would not have an impact, if it also caused reduction in fatigue as well as pain...

    I tend to pick out the positive statements... as I'm the 'glass half-full' person... going to have my PhD hubby read this over... he's a 'glass half-empty' person lol.

    Thanks for pointing out the inconsistency.
    Victoria