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CARE IV Conference Series |
A Christie, PT, MSc, is Research Fellow, National Resource Centre for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vindern, 0319 Oslo, Norway
G Jamtvedt, PT, MPH, is Researcher, Norwegian Knowledge Centre for the Health Services, Oslo, Norway
KT Dahm, PT, MSc, is Research Assistant, Norwegian Knowledge Centre for the Health Services
RH Moe, PT, is Research Fellow, National Resource Centre for Rehabilitation in Rheumatology, Diakonhjemmet Hospital
EA Haavardsholm, MD, is Research Fellow, Department of Rheumatology, Diakonhjemmet Hospital
KB Hagen, PT, PhD, is Researcher, National Resource Centre for Rehabilitation in Rheumatology, Diakonhjemmet Hospital
Address all correspondence to Ms Christie at: anne.christie{at}nrrk.no
Submitted January 31, 2007;
Accepted July 17, 2007
 | Abstract |
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| Introduction |
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 TopAbstract Introduction MethodsResultsDiscussionAppendix 1.Appendix 2.Appendix 3.References |
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The main goals of treatment for RA are to prevent or control joint damage, prevent loss of function, and decease pain.2 Despite substantial progress in the pharmacological and surgical interventions over the last decade, many patients with RA will still experience disability, pain, psychological distress, fatigue, and poor quality of life.3
Besides pharmacological and surgical interventions, conventional therapies such as physical therapy, occupational therapy, and comprehensive rehabilitation and self-management programs are commonly and frequently used interventions. Not surprisingly, given the chronic and persistent nature of the disease, patients with RA tend to be particularly high users of complementary and alternative medicine (CAM) therapies.3 Complementary medicine is used together with conventional medicine, whereas alternative medicine is used in place of conventional medicine. Research indicates that people with RA use a broad range of CAM therapies, such as dietary supplements (herbs and vitamins), movement therapies (yoga and tai chi) and manual therapy, homeopathy, and acupuncture.
Decisions on the provision and reimbursement of health care are increasingly based on the available evidence. Thus, purchasing organizations and policymakers in health care are in need of information on the effectiveness of interventions. Similarly, patients, health care professionals, and researchers are in need of this information to improve self-management strategies, to improve clinical practice, and to set priorities for research, respectively. Conclusions based on a systematic review of randomized controlled trials (RCTs) are considered to provide the highest level of evidence about the effectiveness of an intervention.
While systematic reviews summarize the effectiveness of a specific treatment for a specific condition, an overview of overviews (sometimes called an "umbrella review") typically summarizes the evidence from several systematic reviews on different treatment options for the same condition. Because the number of systematic reviews is rapidly increasing, there might be a need to provide patients and health care providers with synthesized and easily accessible information on different treatment options for a particular condition.
The aim of this overview is to summarize the available evidence from systematic reviews on the effect of nonpharmacological and nonsurgical interventions for patients with RA.
| Methods |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1.Appendix 2.Appendix 3.References |
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Search Strategy
The following databases were searched from January 2000 to January 2007: MEDLINE, CINAHL, AMED, EMBASE, PsycINFO, The Cochrane Library, and PEDro.
The search strategy was formulated in Ovid (MEDLINE, CINAHL, EMBASE, and AMED) in cooperation with a medical librarian to make it applicable to all the databases. A broad computerized search strategy was developed (Appendix 1).
Retrieved hits were assessed by one of the authors (AC), who screened the titles and abstracts to identify relevant studies. If there was doubt about a study's relevance, one of the other authors (KBH) was consulted. Relevant full-text articles were read by 2 authors (AC, KBH).
Assessment of Methodological Quality
The methodological quality of included reviews was independently assessed by 2 reviewers (AC, KBH) using a modified version of a previously validated checklist consisting of 9 criteria7 (Appendix 2). Disagreement was resolved by discussion. Based on a summary of the 9 criteria, an overall scientific quality was applied to each review, as follows: "minor limitations" (at least 7 of the criteria were met), "moderate limitations" (at least 4 of the criteria were met), and "major limitations" (fewer than 4 of the criteria were met). Reviews with major limitations were excluded.
Data Extraction and Synthesis
Data were extracted by one of the authors (AC). If doubt occurred, one of the other authors (KBH) was consulted. The following criteria were applied when data on effects were extracted:
Finally, principles from Grading of Recommendations Assessment, Development, and Evaluation (GRADE) were used to assess an overall quality of evidence for each intervention and outcome.8 The quality of evidence indicates the extent to which a person can be confident that the estimate of effect is correct. Based on judgments considering quality of primary studies, design of primary studies, consistency (similarity of estimates of effect across studies), and directness (the extent to which people, interventions, and outcome measures were similar to those of interest), the evidence for each intervention was classified as "high," "moderate," "low," or "no evidence from systematic reviews." The definitions are listed in Table 1. In the summary of findings (Tab. 2), the following statements were used to indicate direction of effect: improves (function) or reduces (pain) (ie, beneficial effects), no difference, and unclear (inconsistent or unclear evidence of effect).
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| Results |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1.Appendix 2.Appendix 3.References |
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Balneotherapy
Two reviews11,12 included balneotherapy, reporting on interventions as "bathing in water containing minerals (added or natural)"11 or "any type of balneotherapy (mud packs, sulphur baths, Dead Sea baths)."12 Patients were included if they had "clinically confirmed RA"11 or "only RA."12 Again, the methodological quality of the primary studies was low to moderate. One review12 provided quantitative pooling of results (Tab. 3). The pooled results (mudpacks versus control) were based on 2 studies with small sample sizes and showed no statistically significant improvements in pain or patient global assessment. Results from single primary studies showed conflicting evidence related to pain and function (grip strength [force-generating capacity]). Both reviews concluded that firm conclusions on the effectiveness of balneotherapy for people with RA cannot be drawn, mainly because of the heterogeneity of the interventions and the poor methodological quality of the included studies. We conclude, therefore, that the effect of balneotherapy is unclear (Tab. 2). Possible harmful aspects of balneotherapy, such as cardiac problems or risk of bacterial contamination, were not reported in any of the reviews.
Diets
One review13 reported on the effect of fasting followed by a vegetarian diet for at least 3 months (Tab. 4). Patients included were diagnosed with RA. The primary studies were of mixed quality, but the pooling of data from 2 RCTs showed significant improvement in pain. However, based on one review of moderate quality, we conclude that there is low-quality evidence that fasting followed by a vegetarian diet (3 months) reduces pain (Tab. 2). Diets might have a negative effect on nutritional status, but the review did not report on this issue.
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Herbal Therapy
Effect of herbal therapy was reported in 3 reviews16–18 (Tab. 4), defining the interventions as "Ayurvedic medicines as usually complex mixtures of multiple plants administered orally,"8(p705) "any whole plant extract except homeotherapy, aroma therapy or any preparation of synthetic origin or consisting only of plant derivates,"16(p2) or "herbal preparations administered orally or topically for RA."17(p652) Patient populations included were "RA patients"17,18 or "all persons diagnosed with RA."16
All reviews found conflicting evidence for the effect of herbal therapy on pain and function. When reporting on the effect of gamma-linolenic acid (GLA) specifically, 2 reviews16,17 found statistically significant improvement in pain and patient global assessment based on pooled results from 3 RCTs of moderate quality, but they emphasized that further studies are needed to examine the efficacy, safety, and potential drug interactions. We conclude, therefore, that there is moderate-quality evidence that herbal therapy (GLA) reduces pain and improves patient global assessment, while the evidence for other herbals is unclear (Tab. 2). Frequently reported adverse events from ayurvedic medicines included anorexia, nausea, diarrhea, constipation, and abdominal pain, but in general the reviews concluded that the adverse effects reported were few and minor. Thus, the reviews concluded that further research is needed, not only research on the efficacy of herbal interventions but also research on safety and potential drug interactions.
Occupational Therapy Interventions
One review,19 including 38 studies, explored several occupational therapy intervention categories for RA (Tab. 5). Occupational therapy interventions either were classified into 6 specific intervention categories (training of motor function, training of skills, instruction on joint protection and energy conservation, counseling, advice and instruction in the use of assistive devices, or provision of splints and hand orthoses) or were regarded as "comprehensive occupational therapy" (when all 6 interventions were part of the evaluated occupational therapy treatment). The review found no studies concerning the interventions training of skills and counseling. Studies with patients who fulfilled a clinical diagnosis of RA were included. Each intervention category is presented separately below.
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Comprehensive occupational therapy.
Four studies evaluated comprehensive occupational therapy versus no treatment or alternative treatment. Comprehensive occupational therapy was defined as "when all 6 interventions (training of motor function, training of skills, instruction on joint protection and energy conservation, counseling, advice and instruction in the use of assistive devices, and provision of splints and hand orthoses) were part of the evaluated occupational therapy treatment." One RCT of high quality reported a statistically significant positive effect on functional ability, whereas 3 low-quality studies reported no effect. No statistically significant results were found for pain. Based on conflicting results, we conclude that there is low-quality evidence that comprehensive occupational therapy improves function and makes no difference in pain (Tab. 2).
Instruction on joint protection and energy conservation.
Eight studies evaluated instruction in joint protection versus no treatment or alternative treatment. Two RCTs of high quality found statistically significant improvements in functional ability, and the findings were supported by 2 studies of lower quality. Two RCTs of high quality found no statistically significant improvement in pain. There was insufficient information about the results from the low-quality studies. The authors concluded that there is strong evidence that instruction on joint protection leads to an improvement of functional ability. We support this conclusion and conclude that there is high-quality evidence for a positive effect on function, but no difference in pain (Tab. 2). Only one of the included studies reported decreases in grip strength and range of motion (ROM) as possible effects, but the authors questioned whether this was due to improved joint protection behavior or a determinant of increased joint protection behavior.
Provision of splints and hand orthoses.
Sixteen studies related to provision of splints (hand, finger, or wrist) versus other types of splints or no treatment. Three non-RCTs found a statistically significant decrease in pain while participants were wearing working splints, whereas the effects on pain after splinting were conflicting. Only 2 of the studies were RCTs of high quality and reported no difference in pain. Statistically significant improvements in grip strength while wearing a splint were reported (2 non-RCTs), whereas 2 RCTs of high quality reported no statistically significant increase in grip strength after a period of time. The authors concluded that there are indicative findings that splints are effective in reducing pain. Furthermore, they stated that there are indicative findings for a gain in grip strength immediately after provision of the splints.
Egan et al20 included 12 studies assessing the same interventions versus placebo or alternative interventions. Splints and orthoses were defined as "any medical device added to a person's body to support, align, position, immobilize, prevent or correct deformity, assist weak muscles, or improve function." The primary studies were of low to moderate quality. The studies showed conflicting results regarding pain and function, and the authors concluded that there is insufficient evidence to make firm conclusions about the effectiveness of working splints or resting splints on pain and function. Based on the conflicting results in both of the reviews,19,20 we conclude that the effect of splints (hand, finger, or wrist) is unclear (Tab. 2). Twelve of the included studies reported on safety or side effects,19 and both reviews19,20 concluded that there were some indicative findings that splinting has a negative effect on dexterity.
Training of motor function.
Six studies evaluated training of motor function versus no treatment or alternative treatment. One RCT with high methodological quality reported no significant differences between groups on pain and functional ability after training of hand function. The other studies were of low quality, showed conflicting results, and did not report sufficient data to calculate effect sizes. The authors concluded that there is no evidence for the effectiveness of training of motor function on pain or function. Based on the conflicting results, we conclude that there is unclear evidence for the effect of motor function training on pain and function (Tab. 2). One study reported problems with the upper extremity after resistance exercises.
Foot orthoses.
Effects of foot orthoses and special shoes versus placebo, no intervention, or other intervention were reported in 2 reviews,20,21 with 4 and 11 studies included, respectively (Tab. 5). Foot orthoses are prescribed by clinicians as a form of intervention for the symptomatic foot in patients with RA to relieve forefoot, midfoot, and rear-foot pain and to normalize the pain pattern.21 All patients included had a confirmed diagnosis of RA. One review20 reported that 2 low-quality studies found significant improvements in pain, but not in function, and 2 high-quality studies found no significant changes in either pain or function (up to 3 years of orthosis wear). Clark et al21 reported conflicting results on both pain and function, but no exact results were presented. Thus, we conclude, based on the 2 reviews, that the effect of orthosis is unclear (Tab. 2). Safety or side effects were not reported in any of the reviews.
Patient education.
Four reviews3,22–24 reported on the effects of patient education for patients with RA (Tab. 6), describing the interventions as "any set of planned educational activities designed to improve patients health behavior or health status," "a multidisciplinary intervention delivered by a team of health care professionals, providing a systematic approach to care, and including a patient education component," and "psychosocial interventions." Patients included had either "a clinical confirmation of RA" or "adult RA."
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Niedermann et al23 concluded that the results on physical health status are conflicting, and no long-term changes in disability and physical function were found in any study. Badamgarav et al24 reported that pooled effect sizes were small and nonsignificant, but studies with interventions of greater than 5 weeks' duration showed significant differences in functional status. Astin et al3 concluded that there are small, but statistically significant, effect sizes for pain, functional disability, depression, coping, and self-efficacy after treatment.
All included reviews concluded that different types of patient education interventions have small short-term effects on different health outcomes, but there is no evidence for the long-term benefits. Based on the many studies with consistent results, we conclude that there is high-quality evidence that patient education improves function and patient global assessment (Tab. 2).
Physical Therapy Interventions
Exercises.
Five reviews25–29 reported the effects of therapeutic exercises (Tab. 7), including "tai chi instructions," "any form of exercise for the hand," "therapeutic exercises, with an emphasis on the intensity of exercise program," and "aerobic activities." Target populations were ambulatory adults with a diagnosis of RA or clinically confirmed RA. Generally, the methodological quality of the primary studies was low or not reported, and the interventions were heterogeneous. One of the included reviews28 provided quantitative pooling of results based on 2 primary studies of very low quality. Most of the reviews stated that further studies were needed, but the results indicated that exercises may have some beneficial effects on pain and function. One review25 rated the evidence on pain and overall function as "good," but the conclusion is based on studies with conflicting results and no quantitative pooling. Patient global assessment was not statistically significant in the studies that reported this outcome. Based on the conflicting results, we conclude that there is low-quality evidence that exercises reduce pain and improve function and that there is no difference in patient global assessment (Tab. 2).
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Low-level laser therapy (LLLT).
Two reviews were identified,15,30 defining low-level laser therapy as "a light source that generates extremely pure light, of a single wavelength." All patients included had clinically confirmed RA. The methodological quality of the primary studies varied from low to good, and both reviews provided quantitative pooling of results (Tab. 7). Three RCTs of moderate quality showed statistically significant improvements in pain, and 2 RCTs of moderate quality found significant improvements in function (ie, ROM, flexibility). Patient global assessment was not reported. The reviews agreed on the conclusion that LLLT could be considered for relief of pain and rated the evidence to be of "silver" quality30 and "good" quality,15 respectively. We conclude, therefore, that there is moderate-quality evidence that LLLT reduces pain and improves function (Tab. 2). None of the reviews reported on possible side effects and safety.
Therapeutic ultrasound.
Two reviews15,31 reported the effect of therapeutic ultrasound (pulsed or continuous), including 1 and 2 primary studies, respectively (Tab. 7). Patients included had clinically confirmed RA. Results from the 2 primary studies could not be combined in a meta-analysis. One RCT of moderate quality showed statistically significant improvements in pain (tender or painful joints) and function (grip strength, ROM). Patient global assessment was not reported. Based on one primary study of moderate quality, therefore, we conclude that there is low-quality evidence that therapeutic ultrasound reduces pain and improves function (Tab. 2). Neither of the reviews reported side effects.
Thermotherapy.
Three reviews15,32,33 reported the effects of thermotherapy (Tab. 7), including the interventions "melted paraffin wax applications" and "superficial moist heat and cryotherapy." All patients included had clinically confirmed RA. The methodological quality of the primary studies was low, and none of the included reviews provided quantitative pooling of the results. One primary study of low quality reported statistically significant improvements in pain and function (grip strength). The study was included in all 3 reviews, and the results were obtained in the group that received a combination of paraffin wax and exercise therapy. When paraffin wax alone was compared with a control, there were no significant differences in any of the outcomes. All 3 reviews agreed that thermotherapy is more effective as an adjunct therapy than it is alone. Patient global assessment was not reported as an outcome in any of the included studies. On these grounds, we find it reasonable to conclude that the effect of thermotherapy alone is unclear (Tab. 2). No side effects were reported.
Transcutaneous electrical nerve stimulation (TENS).
Two reviews,15,34 including the same primary studies, assessed the outcomes of TENS (low frequency, high frequency) (Tab. 7). All patients included had clinically confirmed RA. Based on a large variation in patients and methodological issues in the included studies, the results were not combined in a meta-analysis. Results regarding pain were conflicting. Two studies, one of low quality and one of moderate quality, found statistically significant improvement in pain (visual analog scale score, joint tenderness), whereas one study of moderate quality found no significant improvement in pain (visual analog scale score). Because of the inconsistent results, we conclude that the effect of TENS is unclear (Tab. 7). No side effects were reported.
| Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1.Appendix 2.Appendix 3.References |
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Although our intention with the present overview was to provide useful information to patients, clinicians, researchers, and policymakers, it surely has several limitations. First, the results from this overview cannot be interpreted as treatment recommendations. Recommendations for practice are normally parts of clinical guidelines, and guideline recommendations should be based on both research evidence and clinical experience. Recommendations should be developed through a process involving both methodologists and clinicians and taking other factors, such as resources and culture, into account. This overview summarizes the empirical evidence, and the bottom line is what is known from systematic reviews. Thus, this overview could be the core element of a clinical guideline, but not a guideline in itself.
Second, based on our results, it is not possible to make conclusions regarding the effects of modalities on patients with various classes of disease because none of the included reviews were distinct on these topics. An overview summarizes results of existing reviews. It does not re-review the literature or add more outcomes or studies. The results of an overview are dependent on the number of high-quality, updated systematic reviews and the quality of the primary studies included. Systematic reviews usually give us the answers in general terms, due to the primary studies' heterogeneity in diagnosis, interventions, and outcomes, and seldom help the clinician who wants to know what type of intervention is most effective in treating a specific patient in a clinical practice. Given these limitations, an overview might be more valuable for policymakers than for clinicians.
Third, possible harmful effects or side effects of the interventions were seldom reported, and no conclusions were drawn in any of the included reviews. This is in accordance with Ethgen et al,35 who found that harm was less often described in reports of nonpharmacological treatment trials than in reports of pharmacological treatment trials. This might partly be explained by a presupposed lower degree of harmful effects; however, most therapy might imply the risk of adverse effects. Unexpected side effects can only be detected if data on all events are systematically collected.
Our overview shows that the evidence for effects of the most common nonpharmacological and nonsurgical interventions for patients with RA is of low quality. Low-quality evidence is not the same as the intervention does not have effect, rather that there is insufficient evidence to draw firm conclusions with regard to the effectiveness of many of the interventions usually offered to patients with RA. The overall methodological quality of the primary studies was frequently relatively weak. However, there are probably better conducted newly published RCTs not captured in the included reviews, which might enhance the quality of evidence for the effects of the interventions. This is possibly the case especially for exercise therapy.
Exercise therapy is considered to be a cornerstone in the treatment of RA in all stages of the disease.36 The American College of Rheumatology2 underscores the necessity of an interdisciplinary approach to the comprehensive management of RA. They recommend patient education, instruction in joint protection, conservation of energy, and a home program of ROM and strengthening exercises as important in achieving the treatment goals. Furthermore, the American College of Rheumatology reports that regular participation in dynamic and aerobic conditioning exercise programs improves joint mobility, muscle strength, aerobic fitness, and function as well as psychological well-being without increasing fatigue or joint symptoms. Apart from the recommendations of patient education and joint protection, their strong recommendations of exercise therapy are not supported by the present overview, which found low-quality evidence for exercise therapy.
Our results are supported by Smidt et al,37 who conducted a best-evidence summary of systematic reviews on the effectiveness of exercise therapy. They concluded that there was insufficient evidence to support or refute the effectiveness of exercise therapy for patients with RA. The Ottawa Panel,25 however, recommend the use of exercise therapy for RA in their guidelines, but they emphasize that their guidelines are limited by generally poorly reported descriptions of therapeutic exercise programs and the outcomes in the included studies.
The latest Cochrane review on exercise therapy for RA38 was conducted in 1998. It concluded that dynamic exercise therapy had positive effects, but that research on long-term effects was needed. Lately, many high-quality studies have been carried out and concluded that exercise is both effective and safe in patients with RA.39–43 Thus, it is likely that an updated, high-quality review on exercise therapy for patients with RA will make it possible to draw firmer conclusions on the effect of exercise therapy for this group of patients.
As pointed out earlier, better conducted primary studies are necessary to draw firm conclusions on the effectiveness of nonpharmacological and nonsurgical interventions for patients with RA. Foley et al44 assessed the quality between pharmacological and nonpharmacological studies. They found that the greatest difference was for subject masking, in which virtually all drug trials succeeded, whereas only a small percentage (35%) of non–drug trials succeeded. It is obvious that masking the patients is difficult in most of the interventions in our study, but masking of the assessors is possible in most cases and should be carried out. Blinding is particularly important when the outcome measures involve patient-reported symptoms such as pain.45 Outcome measures also should be standardized, using valid and reliable tools, and follow-up should be of sufficient length to assess long-term effects.
The summarized evidence may be used by patients, health care practitioners, policymakers, and researchers. The policymakers need research-based evidence to guide their budget decisions on which interventions to reimburse and what kind of research to fund. For the researchers, our overview might identify areas where research is missing and improvements are needed. Clinicians and patients are usually interested in what type of intervention is the most effective in a specific context. An overview of systematic reviews will most often not add new evidence for a single intervention, but rather synthesize available evidence on different interventions for the same condition and thus provide clinicians and patients with an overview of the evidence for the most commonly used interventions. Because the overview gives the answers in general terms, it might be more valuable for policymakers and researchers than for clinicians and patients.
The increasing need for valid, relevant health care information emphasizes the need for rigorous clinical research to guide health care decisions. In the present overview, we found that the quality of evidence for most nonpharmacological and nonsurgical interventions for patients with RA is low. This does not mean that most of the interventions are ineffective, but rather that the quality of research evidence is low. As long as the primary studies have serious limitations, our confidence in the estimate of effect is low. Better conducted primary studies are warranted to provide stakeholders with high-quality information needed in their health care decisions.
| Appendix 1. |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1.Appendix 2.Appendix 3.References |
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| Appendix 2. |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1.Appendix 2.Appendix 3.References |
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| Appendix 3. |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1.Appendix 2.Appendix 3.References |
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| Footnotes |
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This work was inspired by the CARE III and CARE IV International Conferences.
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1.Appendix 2.Appendix 3.References |
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| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
