Articles Effect of yearly mass drug administration with diethylcarbamazine and albendazole on bancroftian ﬁlariasis in Egypt: a comprehensive assessment Reda M R Ramzy, Maged El Setouhy, Hanan Helmy, Ehab S Ahmed, Khaled M Abd Elaziz, Hoda A Farid, William D Shannon, Gary J Weil Lancet 2006; 367: 992–99 Background Egypt was one of the ﬁrst countries to implement a national
Prescribing tai chi for fibromyalgia — are we there yet?Prescribing Tai Chi for Fibromyalgia — Are We There Yet?
Gloria Y. Yeh, M.D., M.P.H., Ted J. Kaptchuk, and Robert H. Shmerling, M.D.
Fibromyalgia is a common and poorly under- It is no wonder, then, that many people with stood pain disorder that afflicts an estimated fibromyalgia seek out less conventional (and less 200 million or more people worldwide.1 The lack evidence-based) treatments, such as tai chi, yoga, of objective abnormalities detected on physical massage, or acupuncture. The limited success of examination and standard blood and imaging conventional treatments and the efficacy and tests has led many physicians to question the safety reported in preliminary studies of tai chi6 existence of this disorder.2 However, for those make this practice an ideal intervention to study experiencing the pain and other associated symp- in patients with fibromyalgia. In this issue of the toms (including fatigue, stiffness, and nonrestor- Journal, Wang et al. report the results of a ran- ative sleep), there is little doubt that the condi- domized, controlled trial of tai chi as a treat- tion is real — and so is the need for relief. ment for fibromyalgia.7 Studies over the past decade suggest that fibro- Tai chi is a gentle, meditative exercise that myalgia may be due, at least in part, to an altera- consists of flowing, circular movements, balance tion in pain sensitivity in the central nervous and weight shifting, breathing techniques, and system.3 Other potential mechanistic contributors cognitive tools (e.g., imagery and focused inter- include a genetic predisposition, emotional or nal awareness). Researchers have investigated tai physical stress, disordered sleep, and neurohor- chi as an intervention for a variety of health is- sues, including balance impairments and cardio- What relief can we offer persons with fibro- vascular disease.8 Although data from other ran- myalgia? Once the diagnosis is established with domized, controlled trials specifically examining confidence (which is no small feat, since this is tai chi for fibromyalgia are not available, this a diagnosis of exclusion, with many mimics), practice has been studied as a treatment for other standard treatment recommendations include ex- rheumatologic conditions, such as rheumatoid ercise, sleep hygiene, and medications. The ideal arthritis, and other musculoskeletal conditions, exercise program is unclear, although a mix of such as osteoarthritis and low back pain.9 The aerobic and strengthening activities may be best.4 data suggest that tai chi may be effective, al- Other nonmedication approaches include cogni- though rigorous studies with adequate sample tive and behavioral therapies. Pharmacologic sizes have not been performed.
agents commonly recommended for fibromyal- In the study by Wang et al., aside from reduc- gia include amitriptyline, cyclobenzaprine, fluoxe- tions in pain, patients in the tai chi group re- tine, and several drugs now approved by the ported improvements in mood, quality of life, Food and Drug Administration (including dulox- sleep, self-efficacy, and exercise capacity. These etine, pregabalin, and milnacipran). Yet even with results parallel those of small studies of tai chi optimal use of standard measures, the clinical in other patient populations.8 Other meditative response is often disappointing. For example, in a therapies, such as mindfulness-based stress re- 12-week, placebo-controlled trial of duloxetine, duction, have been studied in patients with fibro- only 55% of the treated patients, as compared myalgia. In some cases, symptoms improved, al- with 33% of those given placebo, had improve- though in general, the results have been equivocal. ment of at least 30% in a standard pain score.5 For example, although an 8-week, randomized, Other limitations of standard treatment include controlled study of mindfulness meditation and significant side effects with pharmacologic ap- tai chi–like movements (qigong) in 128 patients proaches and variable compliance with lifestyle with fibromyalgia showed significant reductions changes (especially exercise). Finally, given the in pain, disability, and depression, these improve- chronicity of this disorder, long-term efficacy is ments were no better than those seen in the of paramount importance; unfortunately, most control group, which received educational sup- studies to date have been of short duration, so port.10 Given this background, the positive re- the durability of even modest improvement is sults across all outcome measures reported by n engl j med 363;8 nejm.org august 19, 2010 Downloaded from www.nejm.org at TEL AVIV UNIV on October 6, 2010. For personal use only. No other uses without permission. Copyright 2010 Massachusetts Medical Society. All rights reserved. With such provocative results, this study may double-blind pharmaceutical trials. It is also pos- have far-reaching implications. But several criti- sible that future studies will not replicate the cal questions remain. How much of the benefit dramatic findings of this small trial12 and that of tai chi is due to a placebo effect? What is an not all patients with fibromyalgia will find tai appropriate control for tai chi? And what do these chi acceptable or available. Even so, the potential efficacy and lack of adverse effects now make it The authors state that they tried to minimize reasonable for physicians to support patients’ any a priori differences between expectations for interest in exploring these types of exercises, tai chi and the control intervention, which con- even if it is too early to take out a prescription sisted of stretching and health education, and pad and write “tai chi.” they report that expectations in the two groups Disclosure forms provided by the authors are available with were similar at baseline. However, it seems likely the full text of this article at NEJM.org.
that when a persuasive and enthusiastic teacher From the Division for Research and Education in Complemen- of tai chi first explained its potential benefits to tary and Integrative Medical Therapies, Harvard Medical School the class, expectations in this group were height- (G.Y.Y., T.J.K.); and the Divisions of General Medicine and Pri- ened. The authors dutifully suggest that a sham mary Care (G.Y.Y., T.J.K.) and Rheumatology (R.H.S.), Beth Israel Deaconess Medical Center — all in Boston.
tai chi intervention would have been desirable as a control. Ideally, a placebo control matches all 1. Spaeth M. Epidemiology, costs, and the economic burden of
aspects of the therapeutic intervention except for fibromyalgia. Arthritis Res Ther 2009;11:117-8.
the “active” element of that intervention. But 2. Harris RE, Clauw DJ. How do we know that the pain in fibro-
myalgia is “real”? Curr Pain Headache Rep 2006;10:403-7.
what is the active element of a complex, multi- 3. Dadabhoy D, Crofford LJ, Spaeth M, Russell IJ, Clauw DJ.
component therapy such as tai chi?11 Is it rhyth- Biology and therapy of fibromyalgia: evidence-based biomarkers mic exercise, deliberate and deep breathing, con- for fibromyalgia syndrome. Arthritis Res Ther 2008;10:211-28.
4. Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA.
templative concentration, group support, relaxing Exercise for fibromyalgia: a systematic review. J Rheumatol imagery, a charismatic teacher, or some syner- 2008;35:1130-44.
gistic combination of these elements? If so, would 5. Arnold LM, Rosen A, Pritchett YL, et al. A randomized,
double-blind, placebo-controlled trial of duloxetine in the treat- the matched control include awkward move- ment of women with fibromyalgia with or without major depres- ments, halted breathing, participant isolation, sive disorder. Pain 2005;119:5-15.
unpleasant imagery, or a tepid teacher? Would 6. Taggart HM, Arslanian CL, Bae S, Singh K. Effects of T’ai
Chi exercise on fibromyalgia symptoms and health-related qual- the resulting sham intervention be credible, valid, ity of life. Orthop Nurs 2003;22:353-60.
7. Wang C, Schmid CH, Rones R, et al. A randomized trial of
Instead of embarking on a quixotic search tai chi for fibromyalgia. N Engl J Med 2010;363:743-54.
8. Wang C, Collet JP, Lau J. The effect of Tai Chi on health
for the ideal sham, what else needs to be done outcomes in patients with chronic conditions: a systematic re- and what is a reasonable course of action for the view. Arch Intern Med 2004;164:493-501.
physician who must counsel the patient with fi- 9. Hall A, Maher C, Latimer J, Ferreira M. The effectiveness of
Tai Chi for chronic musculoskeletal pain conditions: a system- bromyalgia? For next steps, we need replications atic review and meta-analysis. Arthritis Rheum 2009;61:717-24.
of this study on a larger scale over longer peri- 10. Astin JA, Berman BM, Bausell B, Lee WL, Hochberg M, Forys
ods of time, with different practitioners and dif- KL. The efficacy of mindfulness meditation plus Qigong move- ment therapy in the treatment of fibromyalgia: a randomized ferent styles at multiple sites; determination of controlled trial. J Rheumatol 2003;30:2257-62.
the optimal “dose”; comparisons with similar 11. Wayne PM, Kaptchuk TJ. Challenges inherent to t’ai chi re-
therapies such as yoga; and an assessment of search: part I — t’ai chi as a complex multicomponent interven- tion. J Altern Complement Med 2008;14:95-102.
cost-effectiveness. In the end, however, it may 12. Moore RA, Gavaghan D, Tramèr MR, Collins SL, McQuay HJ.
be that further evidence in support of tai chi for Size is everything — large amounts of information are needed fibromyalgia, even if consistently positive, will to overcome random effects in estimating direction and magni- tude of treatment effects. Pain 1998;78:209-16.
never be as fully convincing as the results of Copyright 2010 Massachusetts Medical Society. n engl j med 363;8 nejm.org august 19, 2010 Downloaded from www.nejm.org at TEL AVIV UNIV on October 6, 2010. For personal use only. No other uses without permission. Copyright 2010 Massachusetts Medical Society. All rights reserved.
A GYÓGYSZER MEGNEVEZÉSE Elidel 10 mg/g krém 2. MINİSÉGI ÉS MENNYISÉGI ÖSSZETÉTEL Egy gramm krém 10 mg pimekrolimusz hatóanyagot tartalmaz. A segédanyagok teljes listáját lásd a 6.1 pontban. 3. GYÓGYSZERFORMA Fehéres, homogén krém. 4. KLINIKAI JELLEMZİK Terápiás javallatok A 2 éves vagy ennél idısebb, enyhe vagy középsúl