Complementary and Alternative Medicine in the Treatment of Pain in Fibromyalgia: A Systematic Review of Randomized Controlled Trials

LITERATURE REVIEW COMPLEMENTARY AND ALTERNATIVE MEDICINE IN THE TREATMENT OF PAIN IN FIBROMYALGIA: A SYSTEMATIC REVIEW OF RANDOMIZED CONTROLLED TRIALS Lauren Terhorst, PhD, a Michael J. Schneider, DC, PhD, b Kevin H. Kim, PhD,c Lee M. Goozdich, DC,d and Carol S. Stilley, PhD, RNe

ABSTRACT Objective: The purpose of this study was to systematically review the literature for randomized trials of complementary and alternative medicine (CAM) interventions for fibromyalgia (FM). Methods: A comprehensive literature search was conducted. Databases included the Cochrane library, PubMed, PsycINFO, Cumulative Index to Nursing and Allied Health, Natural Medicines Comprehensive Database Manual, Alternative and Natural Therapy Index System (MANTIS), Index for Chiropractic Literature, and Allied and Complementary Medicine (AMED). Inclusion criteria were (a) subjects were diagnosed with fibromyalgia and (b) the study design was a randomized controlled trial that compared a CAM therapy vs a control group. Studies were subgrouped by CAM treatment into 11 categories. Evidence tables and forest plots were organized to display quality ratings and effect sizes of each study. Results: The literature search yielded 1722 results; 102 abstracts were selected as potential articles for inclusion. Sixty studies met criteria and were rated by 2 reviewers; 18 were rated as good quality; 20, moderate; 18, low; and 4, very low. Synthesis of information for CAM categories represented by more than 5 studies revealed that balneotherapy and mindbody therapies were effective in treating FM pain. This study analyzed recent studies and focused exclusively on randomized controlled trials. Despite common use of manual therapies such as massage and manipulation to treat patients with FM, there is a paucity of quality clinical trials investigating these particular CAM categories. Conclusion: Most of these studies identified were preliminary or pilot studies, thus had small sample sizes and were likely underpowered. Two CAM categories showed the most promising findings, balneotherapy and mind-body therapies. Most of the other CAM categories showed a trend favoring the treatment group. It appears that several CAM therapies show some preliminary treatment effect for FM pain, but larger trials that are more adequately powered are needed. (J Manipulative Physiol Ther 2011;34:483-496) Key Indexing Terms: Fibromyalgia; Complementary and Alternative Medicine; Randomized Controlled Trials; Systematic Review a

Assistant Professor, University of Pittsburgh School of Nursing, Pittsburgh, PA. b Assistant Professor, University of Pittsburgh School of Rehabilitation Sciences, Pittsburgh, PA. c Associate Professor, University of Pittsburgh School of Education, Pittsburgh, PA. d Chiropractor, Private Practice, National Pike Chiropractic, Brownsville, PA. e Associate Professor, University of Pittsburgh School of Nursing, Pittsburgh, PA. Submit requests for reprints to: Lauren Terhorst, PhD, 3500 Victoria St, Rm 360, Pittsburgh, PA 15261 (e-mail: [email protected]). Paper submitted April 21, 2011; in revised form May 9, 2011; accepted May 12, 2011. 0161-4754/$36.00 Copyright © 2011 by National University of Health Sciences. doi:10.1016/j.jmpt.2011.05.006

ibromyalgia (FM) is a clinical syndrome characterized primarily by chronic widespread pain and fatigue as well as a cluster of other symptoms including sleep disorders, cognitive dysfunction, irritable bowel and bladder, headache, and a variety of somatic complaints.1,2 This condition of unknown etiology affects approximately 2% to 7% of the population, with women 10 times more likely to develop FM than men; and the occurrence of the condition increases with age.3-6 The etiology of FM is still unknown; and therefore, the standard of medical care has been focused chiefly on pain management and modulation of fatigue. The public health, economic, and disability burdens of FM are substantial. United States patients with clinically diagnosed FM incur direct medical costs approximately twice that of matched controls.7 Workers with FM have been shown to have 2 to 3 times higher

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absenteeism rates and visits to hospital emergency departments compared with matched workers without FM.8 The lack of any known cure for FM—along with a poor prognosis and ongoing chronic symptoms—has led many patients to turn to complementary and alternative medicine (CAM) therapies in search of possible pain relief. Eisenberg et al8 performed a national survey of CAM use in the United States and found that a little over a third of Americans reported the use of a least 1 CAM therapy in the previous year.9 Many studies10-12 have documented even higher rates of CAM usage by patients with FM, including a study showing that 50% of patients attending the Mayo Clinic's FM treatment program reported using some type of CAM therapy.13 The National Center for Complementary and Alternative Medicine broadly categorizes the various types of CAM therapies into the following groups14: • Natural products, such as vitamins, minerals, probiotics, and other dietary supplements; • Mind-body medicine, including meditation, guided imagery, and hypnosis; • Manipulative practices such as chiropractic manipulation and massage; and • Other CAM practices, including movement therapies, energy fields, and whole medical systems such as homeopathy. There have been many previous review articles, clinical practice guidelines, and systematic reviews of the FM literature that have summarized the research on CAM and standard medical therapies.15-29 Many of these reviews were focused on a single CAM intervention such as acupuncture, massage, and other.16,18,22-24 Other review articles and guidelines were published more than 5 years ago and did not include the most current research evidence.20 The aims of this study were to perform an updated systematic review of randomized controlled trials (RCTs) that used a CAM therapy as treatment of pain in adults with FM, rate the methodological quality of the trials, and examine the magnitude of the difference in posttreatment pain between the treatment and control groups.

METHODS Search Strategy and Inclusion Criteria A comprehensive literature search of several databases was conducted using a combination of the keywords fibromyalgia, randomized controlled trials, complementary medicine, and alternative/complementary medicine. In addition to the aforementioned keywords, specific CAM therapies were also included in the search, including but not limited to balneotherapy, acupuncture, homeopathy, chiropractic, massage, electromagnetic fields, meditation, and

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hypnosis. The databases explored included the Cochrane library (Cochrane Central Register of Controlled Trials), PubMed, PsycINFO (from 1967 to 2010), Cumulative Index to Nursing and Allied Health, and Medline (from 1950 to 2010). Relevant alternative and complementary medicine databases such as the Natural Medicines Comprehensive Database, Manual, Alternative and Natural Therapy Index System (MANTIS), Index for Chiropractic Literature, and the Allied and Complementary Medicine Database (from 1985 to 2010) were also queried. Dissertation Abstracts Online was also searched in an attempt to include nonpublished studies in the review. In addition to individual RCTs, we also retrieved several systematic reviews and meta-analyses to find any potentially relevant studies that had not come up in the database search. We conducted the last search of the databases at the end of December 2010. To complement the database search, we combed through the reference sections of retrieved articles for relevant publications or articles that had not been previously identified. Peer-reviewed journals (eg, Journal of Manipulative and Physiological Therapeutics, Journal of Alternative and Complementary Medicine, Arthritis and Rheumatism, Rheumatology) were also reviewed for pertinent citations that included a combination of randomized controlled trials, fibromyalgia, and any of the keywords. Once potential studies had been identified, abstracts were inspected to determine article eligibility. Study inclusion criteria included (a) RCTs comparing a CAM therapy to a control group and (b) adult subjects diagnosed with FM using American College of Rheumatology, Yunus, or Smythe criteria.30-32 Inclusion status was determined after 2 authors independently reviewed the full-length manuscripts. There was no disagreement between the reviewers regarding the eligibility of studies for inclusion.

Rating Methodological Quality The system used to provide evidence of individual study quality was created after 2 authors participated in webinars pertaining to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) rating method from the Cochrane Website (http://ims.cochrane.org/revman/ other-resources/gradepro/resources). The GRADE system is typically used to rate the quality of a body of evidence for a particular outcome.33 We adapted ideas from the GRADE system and the Cochrane Handbook for Systematic Reviews of Interventions, Version 5.0.134 to assign a ranking of “good,” “moderate,” “low,” or “very low” to each study. A point system was implemented using the following criteria: • Randomization: To be awarded a point, the specific method of random assignment was mentioned, for example, a computer-generated randomization schedule with allocation concealment. If randomization was mentioned without specific details, then the study

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received no point; and if randomization was in the title but not addressed at all in the text, a point was subtracted. Blinding: We realize the difficulty associated with double blinding in CAM interventions; therefore, we applied a more relaxed approach. If blinding was not mentioned at all in the study, no points were assigned for this criterion. However, if the subjects, examiners, or practitioner(s) of the study were blinded, the study received a point (single-blinded study). Missing data/dropouts: The studies that we reviewed were longitudinal in nature, which presented the need to assess dropout rates for both treatment and control groups. If the study applied the intent-to-treat principle for missing data or if all subjects enrolled in the study at baseline had complete data for all time points, a point was allocated. No points were allocated if there was minimal dropout and the researchers reported reasons for dropouts but there was no further mention of handling the missingness in the data. If the study had a large number of dropouts in either group and the researchers did not address this issue in any way, then a point was subtracted. Outcomes: Many studies included both primary and secondary outcomes. The purpose of this category was to assess the completeness of the results section. If results were reported for all outcomes, with appropriate analyses and enough information, a point was assigned. If there were concerns with the thoroughness or adequacy of the results section, a point was subtracted. Other: If there were no other methodological concerns, the study received a point for the “other” criterion. If a minor flaw in methodology was uncovered, then the study received no points in this area; however, if a major flaw was detected, a point was subtracted. Examples of minor flaws included the inability to separate the CAM effect from a combination treatment group (eg, chiropractic and resistance training as the treatment group and resistance training as the control) or no attention given to the control group. A major flaw (in terms of CAM research) was the use of prescription medications in conjunction with the CAM therapy.

It should be noted that our rating method does not penalize studies for small sample size and/or lack of double blinding. Other rating scales used to assess RCTs, such as the Jadad scale,35 require studies to use double blinding to receive an adequate rating. A study could earn a maximum of 5 points and a minimum of 0 points. Two independent raters assessed each article, and the final ranking was determined by consensus using the following point system: • • • •

5 or 4 points indicates good; 3 points, moderate; 2 points, low; and 1 or 0 point, very low.

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Study Characteristics and Outcome The characteristics of each study, along with the quality ratings, were recorded into a data file in Predictive Analytics Software (PASW).36 Each study was assigned an identification number, and first author and year of publication were recorded. Next, the sample sizes of the treatment and control group were entered, along with a description of the CAM treatment and the mode of control. Complementary and alternative medicine treatments were then classified into 11 groups: (1) balneotherapy, (2) massage, (3) manipulative, (4) vibration, (5) magnetic, (6) homeopathic/nutritional supplements, (7) mind body, (8) movement therapies, (9) energy medicine, (10) acupuncture, and (11) miscellaneous. The principal outcome measure of interest in this study was sensory pain, measured on various scales such as a Visual Analog Scale, 37 the Fibromyalgia Impact Questionnaire,38 and the McGill Pain Questionnaire.39 Although studies varied on frequency and length of time between outcome assessments, all studies reported baseline and at least 1 after-treatment assessment of pain. If available, mean pain scores and SDs or SEs (converted into SDs) for the first assessment after intervention were recorded for both experimental and control groups; therefore, the pain score used as the outcome was from 1 time point (first time after intervention), not the difference between baseline and postintervention. The first point after intervention varied for all studies, ranging from no time lapse (with some of the mind-body interventions such as hypnosis) to 6 months posttreatment. Some articles represented the outcome data in graphs such that the mean pain scores and SDs would have to be estimated; the authors of those articles were contacted in attempt to acquire precise data points. Many authors were unable to be contacted or did not respond, in which case, test statistics (eg, t, F, or χ2 test) were recorded.

Computing Effect Sizes Once mean values and SDs or test statistics were recorded, the standardized mean difference (SMD) technique was implemented to compute effect sizes. This method is recommended when outcome measures are obtained using various assessment scales.40-42 The SMD is a scale-free measure of the ratio of the difference in mean outcomes between groups to the SD of the outcome among study subjects. The intervention effect, when expressed in SMD units, is a standardized value rather than the original unit of measure. As an example, a medium effect size value of −0.5 would indicate that pain for subjects in the treatment group was a half of a SD less than the pain for subjects in the control group. Sample sizes and effect sizes were then imported into the Comprehensive Meta-Analysis software package (Biostat, Englewood, NJ)43 for the purpose of generating forest plots,

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which graphically display the effect sizes for each study. Forest plots use a box-and-whiskers plot form to represent effect size, which is symbolized by the box, and the corresponding 95% confidence interval, which is denoted by whiskers. We created 11 forest plots to visually inspect the effect of CAM treatments across studies within each category. There was no forest plot generated for the miscellaneous group, but the homeopathic/nutritional supplements group was split for the purpose of visually inspecting the effect of each type of treatment separately.

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category. Mean values and SDs were available for 37 of the 60 studies—either through text or by communication with the author—and an additional 14 studies provided test statistics that were converted to effect sizes. The next sequential step to synthesize the results within each category would be to synthesize the data; however, we were not able to summarize within all categories. Of the 11 categories, 6 contained less than 5 studies, which would not provide trustworthy results. Therefore, summary effects were generated for 5 categories containing more than 5 studies: balneotherapy, massage, nutritional supplements, mind-body, and acupuncture.

RESULTS Search Results The initial search of the databases yielded 1722 hits for potential studies to include in the review. Of the 1722 records, we identified 970 as duplicates. The remaining 752 abstracts were then screened for inclusion criteria. The abstract review revealed 15 relevant systematic reviews and meta-analyses; the reference lists of these reviews were examined to find studies that did not appear in the database search. We then retrieved full-length manuscripts based on abstracts of studies most likely to meet our inclusion criteria. Once reference lists of the retrieved articles and relevant journals were reviewed, a total of 162 full-length studies remained as possibilities for the final subset. To select the most relevant studies that clearly fit our inclusion criteria, we eliminated studies that used mixed patient populations and studies that were not truly randomized. Although all 162 reviewed studies used some type of nonpharmacologic therapy for pain management, only studies that used CAM treatments represented in the National Center for Complementary and Alternative Medicine guidelines were considered for inclusion. This eliminated nonpharmacologic approaches such as aerobic exercise, cognitive behavioral therapy, and education from the final subset of articles. Figure 1 depicts the study selection process.

Rating Studies and Computing Effect Sizes The final subset of 60 full-length manuscripts was carefully selected based on inclusion criteria, and each study was rated based on our scale. Table 1 displays a list of the accepted studies, with explanations of treatment and control groups, sample sizes, and our quality rating scores. The overall number of subjects in the treatments groups was slightly higher (n = 1463) than the number of subjects in the control groups (n = 1434). Overall, the distribution was similar for the “good” (30%), “moderate” (33%), and “low” (30%) ratings, with only 7% of studies rated as “very low.” Of the 60 studies, 51 were included in the forest plots, although all 60 studies are listed in Table 1; specific details regarding reasoning for not including all studies in the forest plots are described within the results of each

Results Per CAM Group Figure 2 displays the forest plots for each CAM treatment group. The effect size, which can be interpreted as the magnitude of the difference between groups, is symbolized by a box for each study. The horizontal bars or whiskers, extending from the box, denote the 95% confidence interval for the effect size. A wide confidence band is indicative of a small sample size, whereas a narrow confidence band is associated with a study with a large sample size. The central vertical line corresponding to 0 within the plot represents the null hypothesis or the line of no difference. If a box falls to the right of the null line, then the effect is in the direction of the control group; and if the box is to the left of the null line, the effect is in the direction of the treatment group. If the study's box or whiskers cross the null line, then there was no significant effect in favor of the treatment or control group, that is, the treatment did not provide a greater reduction in pain than the control mechanism or vice versa. The manipulative, vibration, magnetic, homeopathic, movement, and energy therapy categories contained less than 5 studies; therefore, all boxes within the forest plot are weighted equally. The diamond symbol located at the bottom of the forest plots for the balneotherapy, massage, nutritional supplements, mind-body, and acupuncture categories is the overall combined effect size for all studies within the plot. When the overall effect is produced, the boxes in the forest plot become weighted and sized differently for each study within the category. The area of the box is proportional to the weight of the study, which is a function of sample size. This overall summary effect, along with several statistics, is used in meta-analyses to draw a conclusion from a group of studies. We caution that the location of the summary is only 1 piece of evidence and that much more is needed to make a conclusive decision about a treatment's effectiveness. Balneotherapy. The group of studies in the balneotherapy category was represented by various water-based treatments, such as therapeutic pools and whirlpools, mud packs, and phytothermotherapy, which is a bath infused with fermented hay. 4 4- 54 Some treatments were

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Records identified through database searching, reference lists and journals (n = 1,722)

Records after duplicates removed (n = 752)

Abstracts screened (n = 162)

Full-text articles assessed for eligibility (n = 60)

Records excluded due to title not matching inclusion criteria (n = 590)

Abstracts excluded (not randomized, not CAM, etc) (n = 101)

Full-text articles excluded from forest plots, with reasons (n = 9)

Studies included in forest plot (n = 51)

Fig 1. Study selection process. multicomponent therapies, including balneotherapy with massage47 and Stanger bath with amitripyline.48 Of the 11 studies, 8 were represented in the forest plot. The effect size of 1 balneotherapy study 51 was not considered for use in the forest plot because the author was already represented in this category. The study by Buskila et al46 was also eliminated; it shared the same methodology, sample size, and authors as the study by Neumann et al,53 and the study by Eksioglu et al48 was not represented because it did not include a specific pain outcome but rather assessed the change in the number of tender points. The effect sizes of the 8 of 11 studies were in the direction of the treatment group, and the overall effect signified that balneotherapy was more effective than the control methods for this set of studies. A previous metaanalysis found moderate evidence that spa therapy can improve pain of FM; however, there was no evidence that medical, Stanger, or mud baths improved pain.22 Massage. The 6 studies in the massage category used several muscular manipulation techniques such as Swedish massage, connective tissue massage, and tui na, which is a

hands-on body therapy that combines martial arts and Taoism principles to restore balance.55-60 Of the 6 studies' effect sizes, 5 were entered into the forest plot; the study by Sunshine et al60 could not be represented because only mean values were reported. Of the 5 studies, 4 showed no effect; and the composite effect indicated that massage was not effective in reducing FM pain in this set of studies. Manipulative. There were only 3 studies in the manipulative category, which included 2 chiropractic studies and 1 osteopathic study. One chiropractic study used a multimodal technique, with a combination of both manipulation and resistance training. All studies in this category were relatively small and pilot in nature; the total sample size for the treatment groups in the 3 studies was 27, and the total number of subjects in the control group was 25. The effect size for the osteopathic study of Gamber et al62 was not computed because we could not distinguish among the 3 treatment groups (to ascertain a mean) vs the control group; therefore, the 2 chiropractic studies61,63 make up the forest plot for the manipulative category. Both studies had effect sizes that were in the direction of the treatment group. No overall effect was produced for this

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Table 1. Characteristics of selected studies Author, year

Treatment group

Balneotherapy (n = 11) Altan et al, 200344 Brockow et al, 200745 Buskila et al, 200146, a Donmez et al, 200547 Eksioglu et al, 200748, b Evcik et al, 200249 Fioravanti et al, 200750 Fioravanti et al, 200951, c Gunther et al, 199452 Neumann et al, 200153 Zijlstra et al, 200554

Balneotherapy Balneotherapy Balneotherapy Balneotherapy + massage Stanger bath + amitripyline Balneotherapy Mud bath Phytothermotherapy Balneotherapy Balneotherapy Balneotherapy

n = 22 n = 69 n = 24 n = 16 n = 25 n = 22 n = 40 n = 30 n = 12 n = 24 n = 58

Pool-based exercise Multimodal rehabilitation Spa stay Treatment as usual Amitripyline Treatment as usual Treatment as usual Treatment as usual Jacobsen relaxation Spa stay Treatment as usual

n = 24 n = 70 n = 24 n = 13 n = 25 n = 20 n = 40 n = 26 n = 13 n = 24 n = 76

Good Good Low Good Moderate Low Moderate Moderate Low Low Moderate

Massage (n = 6) Alnigenis et al, 200155 Brattberg, 199956 da Silva et al, 200757 Ekici et al, 200958 Field et al, 200259 Sunshine et al, 199660, d

Swedish massage Connective tissue massage Tui na + yoga Connective tissue massage Massage Massage

n = 11 n = 23 n = 16 n = 25 n = 10 n = 10

Standard care Discussion groups Yoga Lymph drainage Relaxation Sham tens

n = 13 n = 25 n = 17 n = 25 n = 10 n = 10

Very low Low Low Low Very low Low

Manipulative (n = 3) Blunt et al, 199761 Gamber et al, 200262, d Panton et al, 200963

Chiropractic Osteopathic Chiropractic + resistance training

n = 10 n=6 n = 11

Wait list Treatment as usual Resistance training

n=9 n=6 n = 10

Moderate Low Low

Vibration (n = 2) Alentorn-Geli et al, 200864 Chesky et al, 199765

Vibration + exercise Music vibration

n = 11 n = 13

Exercise Sinusoidal vibration

n = 12 n = 13

Good Moderate

Magnetic (n = 3) Alfano et al, 200166 Colbert et al, 199967 Sutbeyaz et al, 200968

Magnetic sleep pads Magnetic sleep pads Pulsed electromagnetic field

n = 32 n = 13 n = 25

Sham sleep pads Sham sleep pads Sham therapy

n = 24 n = 12 n = 24

Good Moderate Good

Homeopathic/nutritional supplements (n = 9) Ali et al, 200969 Myer's cocktail Bell et al, 200470 Homeopathic remedy Homeopathic remedy Fisher et al, 198971, d Jacobsen et al, 199172 SAM-e Merchant et al, 200173 Chlorella pyrenoidosa Relton et al, 200974 Homeopath care SAM-e Tavoni et al, 198775, b Volkmann et al, 199776 SAM-e Wahner-Roedler et al, 200877 Soy

n = 15 n = 26 n = 15 n = 22 n = 37 n = 20 n = 17 n = 29 n = 12

Placebo Placebo Placebo Placebo Placebo Usual care Placebo Placebo Placebo

n = 16 n = 27 n = 27 n = 22 n = 34 n = 16 n = 17 n = 29 n = 16

Good Good Low Moderate Moderate Good Low Good Good

Mind body (n = 11) Babu et al, 200778 Buckelew et al, 199879 Castel et al, 200780 Ferraccioli et al, 198781 Fors et al, 200282 Hanaan et al, 199183 Hsu et al, 201084 Menzies et al, 200685 Sephton et al, 200786 van Santen et al, 200187 Weissbecker et al, 200288, a

n = 15 n = 27 n = 15 n=6 n = 17 n = 20 n = 24 n = 24 n = 51 n = 38 n = 51

Sham biofeedback Education Relaxation Sham biofeedback Treatment as usual Physical therapy Wait list Usual care Wait list Treatment as usual Wait list

n = 15 n = 27 n = 15 n=6 n = 17 n = 20 n = 21 n = 24 n = 40 n = 27 n = 40

Moderate Moderate Very low Very low Moderate Moderate Good Moderate Moderate Low Moderate

Biofeedback Biofeedback Hypnosis Biofeedback Guided imagery Hypnotherapy Affective self-awareness Guided imagery + usual care Meditation Biofeedback Meditation

Control group

Grade

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Table 1. (continued) Author, year

Treatment group

Movement therapies (n = 4) Astin et al, 200389 Haak and Scott, 200890 Mannerkorpi and Arndorw, 200491 Wang et al, 201092

Qigong + meditation Qigong Qigong + body awareness therapy Tai chi

n = 32 n = 29 n = 19 n = 30

Education Wait list Treatment as usual Education

n n n n

= 33 = 28 = 17 = 29

Good Low Moderate Good

Energy medicine (n = 2) Assefi et al, 200893 Stiller, 200794

Direct reiki Therapeutic touch

n = 23 n = 21

Sham reiki Placebo

n = 23 n = 21

Moderate Moderate

Acupuncture (n = 7) Assefi et al, 200595 Deluze et al, 199296 Harris et al, 200597 Itoh and Kitakoji, 201098 Jang et al, 201099 Martin et al, 2006100 Targino et al, 2002101, d

Acupuncture Acupuncture Acupuncture Acupuncture Acupuncture + cupping + med Acupuncture Acupuncture

n = 21 n = 36 n = 19 n=7 n = 60 n = 25 n = 12

Sham acupuncture Sham acupuncture Sham acupuncture Less acupuncture Western medicine Sham acupuncture Sham acupuncture

n n n n n n n

Good Good Good Low Moderate Good Low

Miscellaneous (n = 2) Kiyak, 2009102 Ko et al, 2006103

Wool clothing Essential oils

n = 25 n = 65

Nonwool clothing Placebo oils

n = 25 n = 68

a b c d

Control group

Grade

= 21 = 34 = 15 =6 = 56 = 24 = 13

Low Low

Not represented in forest plot because of possible subject/author dependence with another study in the same category. Not represented in forest plot because they did not include a specific pain outcome. Not represented in forest plot because it appears twice within 1 category. Not represented in forest plot because they did not provide enough information to compute an effect size for the pain outcome.

category because of the limited amount of studies with very small sample sizes. Vibration. The 2 studies64,65 in the vibration category used the very different treatment methods of music vibration and whole-body vibration. Although whole-body vibration had an effect size that favored the treatment group, the music vibration effect was clearly in the direction of the control group. Because there were only 2 studies in this category and the methods were so completely different, the overall effect was not provided within the plot. Magnetic. The 3 studies66-68 comprising the magnetic category used either magnetic sleep pads or a pulsed electromagnetic field as treatment. The examination of the forest plot indicated that the 2 studies that used sleep pads found no difference between the treatment and control groups; however, the study that used the pulsed magnetic field had an effect size that was in the direction of the treatment. The overall effect was not computed for this set of 3 studies. Homeopathic/Nutritional Supplements. There were 3 homeopathic studies70,71,74 in our review, 2 used a homoeopathic remedy and 1 used homeopathic care as treatment. The 6 studies69,72,73,75-77 in the nutritional supplement group used a wide variety of supplements, such as S-Adenosyl methionine (SAM-e), Chlorella, Myer's cocktail, and soy. Although these 2 methods were combined into 1 category for the summary table, we felt that they should be addressed separately in forest plots. Fisher et al71 did not provide

adequate information to compute an effect size for the pain outcome and are not represented in the homeopathic forest plot, whereas the study by Tavoni et al75 is not represented because it did not assess a specific pain outcome. One homeopathic study and 3 nutritional studies favored the treatment group. The overall effect for the 6 nutritional studies indicated that the treatment was not effective for this set of studies. Mind-Body. The mind-body category contained studies that used a wide range of treatment methods. The studies examined the effectiveness of biofeedback, hypnosis, guided imagery, meditation, and affective self-awareness. One study85 used a multicomponent approach of guided imagery plus usual care. Weissbecker et al88 shared the same methodology, sample sizes, and authors as the study of Sephton et al86 in the same mind-body category; therefore, an effect size was not computed. An inspection of the forest plot revealed that the overall effect of 10 studies could potentially favor the treatment group, that is, mind-body techniques were effective in treating pain. Previous research also suggested that mind-body techniques were effective for reducing FM pain.26 Movement Therapies. The 4 studies in the movement therapies category89-92 used techniques such as quigong and tai chi as treatment; all 4 studies were included in the forest plot. Two studies used a multicomponent approach (qigong + meditation; quigong + body awareness therapy).89,91 The 2 singlecomponent studies of quigong90 and tai chi92 had effects that clearly favored the treatment group. The overall effect for the

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studies23 reported no significant effect for the use of acupuncture in the treatment of pain for FM. Miscellaneous. Two studies were not able to be included in any of the other categories; therefore, a miscellaneous group was created. Wool clothing102 and topical oils103 were used as treatments. The methodology of the studies was rated as “low,” and the treatment methods were too dissimilar to examine the effects within a forest plot.

DISCUSSION

Fig 2. Forest plots by CAM treatment. Boxes within plots represent effect sizes; horizontal lines represent 95% confidence interval, and diamonds are the overall effect. See “Methods” section for more detail. movement therapies was not computed because there were only 4 studies within this category. Energy Therapy. Reiki93 and therapeutic touch94 were the treatment methods of choice for the 2 energy therapy studies. An examination of the forest plot revealed that therapeutic touch was in the direction of the treatment group. Because there are only 2 studies in this category, the overall effect was not produced. Acupuncture. There were 7 studies in the acupuncture category. Most studies used a form of acupuncture for the treatment and sham acupuncture as control95-97,100,101; however, 1 study98 used less acupuncture as the control, and 1 study used a multicomponent treatment of acupuncture, cupping, and Western medicine as the treatment.99 The forest plot for the acupuncture category contains 6 of the 7 studies; the study of Targino et al101 is not represented because no test statistics or P values were reported for between-group differences. A survey of the plot indicated that most studies showed only a modest treatment effect in favor of acupuncture. A previous meta-analysis of 4

This study provides a systematic review of the literature of RCTs that used a CAM therapy as treatment of pain in adults with FM. Sixty studies were filed under 1 of 11 CAM categories. Using a modified rating system, 63% of the 60 studies were rated as “good” or “moderate.” An examination of overall effect sizes for CAM categories containing more than 5 studies revealed that balneotherapy and mindbody therapies reduced pain in the treatment groups, whereas massage, nutritional supplements, and acupuncture methods were ineffective. The overall effects for manipulative, vibration, magnetic, movement therapies, homeopathic, and energy medicine were not computed because of the limited amount of RCTs in these categories. The number of published RCTs that explore the treatment effect of CAM therapies for FM has grown considerably in the past 5 to 10 years. For perspective, a previous systematic review of the CAM literature for treatment of FM published in 200320 listed only 22 RCTs in their evidence table (articles retrieved through 2002). This is in contrast to the most recent systematic review by Porter et al,25 which provided information on 70 randomized or controlled clinical trials of CAM therapies for adults or children with FM, myalgic encephalomyelitis, or chronic fatigue syndrome. Our updated review differs from the study of Porter et al25 because we retrieved studies published as recently as December 2010, limited our search to RCTs that exclusively recruited patients diagnosed with FM, and used a different rating system. There were some key strengths of our study. First, we have reviewed and summarized a vast amount of literature into evidence tables, which represent the most current systematic review of CAM therapies for FM. Secondly, the forest plots are arranged by CAM category and provide the reader with a visual mechanism by which to compare all of the effect sizes and confidence intervals of the various CAM therapies used to manage FM pain. Lastly, although the forest plots did not provide strong evidence for superior effectiveness of any particular CAM treatment, an overall trend was observed: most trials had effects sizes that favored the experimental groups over the control groups. Most of the studies had wide confidence intervals that crossed the midline, raising uncertainty about the significance of their clinical effectiveness. The balneotherapy and

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mind-body therapies had narrower confidence intervals that did not cross the midline, providing more certainty as to their clinical effectiveness at pain reduction in FM. This result matches with the findings of 2 previous metaanalyses.22,26

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body therapies.” One might argue that the summary effect within these categories is not an accurate reflection of those therapies as a group. However, we did provide a graphic display of each individual trial's effect size and confidence interval on the forest plots, so that the reader could interpret their relative individual importance relative to the group summary effect.

Limitations There are several limitations to our study. The first set of limitations relates the mechanics of our online literature searching. Our search strategy was limited to English language journals; and therefore, we may have missed some high-quality CAM articles that were published in nonEnglish peer-reviewed journals. We used several keywords and terms to search for some specific CAM therapies; however, we could not incorporate terms for every individual therapy used to treat FM pain. There is always the risk for publication bias, in which the more negative trials of CAM therapies were never published in the peerreviewed literature. Another potential limitation involves our pragmatic adaptation of the GRADE rating method33 that did not automatically penalize studies for lack of double blinding or small sample size, which led to 63% of the studies being rated as either “good” or “moderate.” Because our modified rating system was specifically geared to account for limitations frequently encountered in CAM studies, the interpretation of the ratings should be made relative to the context of CAM research only. For instance, if an article is rated as “good” quality, then it has high methodological quality in comparison with other research studies in the CAM field. We are not suggesting that these ratings are generalizable outside of CAM research and recognize that all ratings are inherently subjective. Rather than focusing on these quality ratings, we suggest that the more important finding of our systematic review is the computation of the effect sizes and 95% confidence intervals for all studies within each CAM category. These data are visually displayed in a series of forest plots, 1 for each of the CAM categories. Although we provide summary effects for 5 categories, we felt that there were several drawbacks to synthesizing data within categories. First, there were differences and variations in the treatment methods within each category (eg, mud baths vs Stanger baths or meditation vs hypnotherapy). There were also differences in treatment frequency, duration, and dosage, which varied greatly within each category. Lastly, the pain outcome measures were not all based upon the same selfreport instruments with different primary end points between the trials in each category. In addition to the heterogeneity in treatment frequency, duration, and dosage within each CAM category, we admit that our choice of categories was somewhat arbitrary. There was some heterogeneity to the types of clinical trials within each category. For example, we placed hypnosis, meditation, and biofeedback into the same category labeled “mind-

Suggestions for Future Studies There are several major challenges associated with all FM research that may contribute to a dilution of the observed effect size of many types of treatment. The first challenge is simply trying to make sense of the degree of treatment effectiveness when applied to a condition that has no known etiology or pathogenesis, is long term and recurrent, and is associated with a generally poor prognosis. The second challenge is the vague nature of the FM diagnostic criteria and the accuracy by which a FM diagnosis is made. One study showed a disturbing 64% misdiagnosis rate—mostly observed to be overdiagnosis— in the diagnosis of FM by referring physicians.104 It is plausible that this same inaccuracy rate could be spilling over in the research world, with subjects being included in research trials who do not actually meet the diagnostic criteria for FM. The treatments being compared in these research trials may not be affecting the cause of the symptoms or being applied to the correct type of patients. The greatest challenge to clinical FM research may be the fundamental assumption that patients with FM represent a homogenous group of people having a common underlying pathophysiologic condition. Wolfe and Rasker105 have stated that their research has shown that there is no clinical basis by which FM may be identified as a separate entity. They suggest that the symptom cluster most characteristic of FM—widespread pain and fatigue—exists as a continuous variable across patients with many rheumatic and musculoskeletal disorders and is not specific for FM. If FM is not a distinct clinical entity, then it is likely that any research sample of FM subjects represents a heterogenous group of conditions. The lack of clinical effectiveness with a single therapeutic approach is understandable—and predictable—when one considers this sample heterogeneity. It is quite possible that future research will uncover distinct subsets of patients with FM, each responding to a different treatment approach. This will require modification of the current research designs, which lump all patients into 1 broad category of FM. A treatment-based classification system for management of FM might present a worthy goal for innovative research. This would require subgroup analyses of existing or future trials in which baseline characteristics are found to be predictors of clinical improvement or success with different types of treatment. For example, we may find that certain patients with FM are “yoga and meditation responders,”

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whereas other patients with FM might be “acupuncture responders.” This type of research modification would be suited well to the CAM environment. Lastly, future CAM trials should be designed with larger sample sizes that are adequately powered before definitive estimates of true clinical effectiveness can be made about many commonly used CAM therapies.

CONCLUSION In conclusion, this systematic review provides evidence tables and forest plots that present an overview of the many CAM therapies that are used to treat FM pain. Most of these studies could be classified as preliminary or exploratory pilot studies, have small sample size, and were most likely underpowered. Two CAM categories showed the most promising findings: mind-body therapies and balneotherapy. Most of the other CAM categories showed a trend favoring the treatment group. It appears that several CAM therapies show some preliminary treatment effect for FM pain but larger trials that are more adequately powered are clearly needed.

Practical Applications • This systematic review uncovered 60 RCTs that covered a range of CAM therapies for FM. • Balneotherapy, mind-body, and acupuncture trials showed evidence of effectiveness. • Future CAM trials with larger sample sizes are needed before confirming clinical effectiveness.

ACKNOWLEDGMENT The authors thank Dr Mitchell Haas, DC, MA, for his review of the manuscript and important ideas regarding the unique challenges of synthesizing and summarizing the results of heterogenous CAM therapy trials into evidence tables and forest plots.

FUNDING SOURCES AND POTENTIAL CONFLICTS OF INTEREST No funding sources or conflicts of interest were reported for this study.

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ERRATUM n the article “Predictors for Identifying Patients With Mechanical Neck Pain Who Are Likely to Achieve Short-Term Success With Manipulative Interventions Directed at the Cervical and Thoracic Spine” by Saavedra-

I

Hernández et al in the March/April 2011 issue (2011;34(3): 144-52; doi:10.1016/j.jmpt.2011.02.011), the first author's last name was misspelled. The correct spelling is SaavedraHernández.