| Literature DB >> 19881230 |
Hiroharu Kamioka1, Kiichiro Tsutani, Hiroyasu Okuizumi, Yoshiteru Mutoh, Miho Ohta, Shuichi Handa, Shinpei Okada, Jun Kitayuguchi, Masamitsu Kamada, Nobuyoshi Shiozawa, Takuya Honda.
Abstract
BACKGROUND: The objective of this review was to summarize findings on aquatic exercise and balneotherapy and to assess the quality of systematic reviews based on randomized controlled trials.Entities:
Mesh:
Year: 2009 PMID: 19881230 PMCID: PMC3900774 DOI: 10.2188/jea.je20090030
Source DB: PubMed Journal: J Epidemiol ISSN: 0917-5040 Impact factor: 3.211
Figure 1.Flowchart of trial process SR: systematic review. RCT: randomized controlled trial.
Summary of articles based on structured abstracts (aim and methods)
| No. | Author | Journal Year; Vol.; Page. | Title | Aim/Objective | Data source/Search strategy | Selection criteria/period | Data extraction/Data collection and analysis |
| 1 | Bartels EM, et al. | Cochrane Database Syst Rev 2007;4:CD005523. (in English) | Aquatic exercise for the treatment of knee and hip osteoarthritis. | To compare the effectiveness and safety of aquatic exercise interventions in the treatment of knee and hip osteoarthritis. | MEDLINE from 1949, EMBASE from 1980, CENTRAL (Issue 2, 2006), CINAHL from 1982, Web of Science from 1945, all up to May 2006. There was no language restriction. | Randomized controlled trials or quasi-randomized clinical trials. The duration of interventions was from 6 weeks to 12 months. | Two review authors independently selected trials for inclusion, assessed the internal validity of included trials and extracted data. Pooled results were analyzed using standardized mean differences (SMD). |
| 13 | Verhagen AP, et al. | Cochrane Database Syst Rev 2008;3:CD000518. (in English) | Balneotherapy for rheumatoid arthritis. | To assess the effectiveness of balneotherapy for rheumatoid arthritis. | They searched the following databases up to October 2006: CENTRAL (Issue 3, 2006), PubMed, CINAHL, the database from the Cochrane “Rehabilitation and Related Therapies” Field and Pedro, and performed reference checking and personal communications with authors to retrieve eligible studies. | Selection criteria: randomized controlled trials comparing balneotherapy with any other intervention or with no intervention. Included patients were all suffering from definite or classical rheumatoid arthritis as defined by the American Rheumatism Association Criteria or by the criteria of Steinbrocker. At least one of the WHO/ILAR core set of endpoints for RA clinical trials had to be among the main outcome measures. The duration of interventions was from 14 weeks to 6 months and 4 weeks. | Two authors independently assessed quality and extracted data. Disagreements were solved by consensus. |
| 14 | Verhagen AP, et al. | Cochrane Database Syst Rev 2007;4:CD006864. (in English) | Balneotherapy for osteoarthritis. | To assess the effectiveness of balneotherapy for patients with osteoarthritis (OA). | They searched the following databases up to October 2006: EMBASE, PubMed, the Cochrane “Rehabilitation and Related Therapies” Field database, PEDro, CENTRAL (Issue 3, 2006), and performed reference checking and communicated with authors to retrieve eligible studies. | Randomized controlled trials (RCT) comparing balneotherapy with any intervention or no intervention. At least 90% of the patient population had to be diagnosed with osteoarthritis; duration of interventions was from 15 days to 27 weeks. | Two authors independently assessed quality and extracted data. Disagreements were solved by consensus. In the event of clinical heterogeneity or lack of data they refrained from statistical pooling. |
| 15 | Forestier R, et al. | Joint Bone Spine 2008;75:138–148. | Crenobalneotherapy for limb osteoarthritis: Systematic literature review and methodological analysis. | To conduct a systematic literature review on crenobalneotherapy for limb osteoarthritis and to discuss the study methods used to evaluate this treatment modality. | They searched the Medline database. They also reviewed the reference lists of articles retrieved by the Medline search. The studies had to be written in English or French. | Studies that compared crenobalneotherapy to other interventions or to no intervention were considered. Massage (usually an integral part of spa programs) is not specific to spa therapy and therefore was not studied here. Only studies of patients with osteoarthritis of the knee, hip, and/or hands were selected. The duration of interventions was from 16 days to 1 year and 3 months. | They used a checklist specifically designed to evaluate the internal validity of nonpharmacological trials. External validity and the quality of the statistical analysis were also evaluated. |
| 16 | Pittler MH, et al. | Rheumatol 2006;45:880–883. | Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials. | To assess the evidence for or against the effectiveness of spa therapy and balneotherapy for treating low back pain. | Systematic searches were conducted on Medline, Embase, Amed Cochrane Central, the UK National Research Register and ClincalTrials.gov (all until July 2005). | All trials reporting that the sequence of allocation was randomized (RCTs). Testing balneotherapy or spa therapy for treating patients with low back pain were included. Trials reported in duplicate were excluded. The duration of interventions was from 3 weeks to 4 weeks. | Data abstraction was performed systematically and independently according to design, quality, sample size, intervention, water characteristics, results, adverse events and concomitant treatment. |
| 2 | Hall J, et al. | Arch Phys Med Rehabil 2008;89:873–883. | Does aquatic exercise relieve pain in adults with neurologic or musculoskeletal disease? A systematic review and meta-analysis of randomized controlled trials. | To evaluate the literature on the effectiveness of aquatic exercise in relieving pain in adults with neurologic or musculoskeletal disease. | A systematic literature search of 14 databases was examined for research on aquatic exercise over the period from January 1980 to June 2006. | Randomized controlled trials (RCTs) that included adults with neurologic or musculoskeletal disease, pain as an outcome measure, and exercise in water were included. The duration of interventions was from 4 weeks to 12 months. | Information on the participants, interventions, and outcomes was extracted from the included studies. Quality appraisal was assessed using the Scottish Intercollegiate Guidelines Network criteria for RCTs. |
| 17 | Kamioka H, et al. | J Jpn Soc Balneol Climatol Phys Med 2006;69:155–166. (in Japanese with English abstract) | A systematic review of randomized controlled trials on the therapeutic and health-promoting effects of spas. | To review randomized controlled trials of the effects of treatment in spas, thereby clarifying therapeutic effects of these treatments on individual diseases, and its health-promoting effects. | They searched the PubMed database twice: in Sept. 2004 and in April 2005. Articles published after 1990 and written in English were searched. | Key words for study selection were “randomized controlled trial” and “spa” or “balneotherapy”. No criteria were set up concerning the number of subjects, the observation period, or the kind of disease studied. The duration of interventions was from 3 weeks to 12 months. | The quality of individual articles was evaluated on a 13-point modified PEDro scale that was constructed by adding three terms, representing the number of subjects, the observation period, and water characteristics to the 10-point PEDro scale. |
Summary of articles based on structured abstracts (results and conclusion)
| No. | Author | Main results | Conclusion |
| 1 | Bartels EM, et al. | In total, six trials (800 participants) were included. At the end of treatment for combined knee and hip osteoarthritis, there was a small-to-moderate effect on function (SMD 0.26, 95% confidence interval (CI) 0.11 to 0.42) and a small-to-moderate effect on quality of life (SMD 0.32, 95% CI 0.03 to 0.61). A minor effect of a 3% absolute reduction (0.6 fewer points on a 0 to 20 scale) and 6.6% relative reduction from baseline was found for pain. Only two studies reported adverse effects, that is, the interventions did not increase self-reported pain or symptom scores. | Aquatic exercise appears to have some beneficial short-term effects for patients with hip and/or knee OA; no long-term effects were documented. The controlled and randomized studies in this area are still too few to give further recommendations on how to apply the therapy, and studies of clearly defined patient groups with long-term outcomes are needed. |
| 13 | Verhagen AP, et al. | One extra study is included in this update. Now seven trials (412 patients) were included in this review. Most trials reported positive findings on their main outcomes, but were methodologically flawed to some extent. A ‘quality of life’ outcome was reported by two trials. None of the trials performed an intention-to-treat analysis and only two performed a comparison of effects between groups. Pooling of the data was not performed because of heterogeneity of the studies, multiple outcome measurements, and the overall poor data presentation. We found a significant benefit of mineral baths compared to Cyclosporine A at eight weeks on pain in one study (RR = 2.4; 95% CI: 1.4, 3.8). Overall there is insufficient evidence that balneotherapy is more effective than no treatment, that one type of bath is more effective than another, or that one type of bath is more effective than mudpacks, exercise, or relaxation therapy. | Silver level evidence was found for one study in favor of mineral baths compared to drug treatment at eight weeks. Insufficient evidence was found for all other comparisons. However the scientific evidence is insufficient because of poor methodological quality. Therefore, the noted “positive findings” should be viewed with caution. |
| 14 | Verhagen AP, et al. | Seven trials (498 patients) were included in this review. Two studies compared spa treatment with no treatment. One study evaluated baths as an add-on treatment to home exercise and the author compared thermal water from Cserkeszolo with tap water (placebo). Three studies compared sulphur or Dead Sea baths with no treatment or mineral baths with tap water baths or no treatment. Only one of the trials performed an intention-to-treat analysis and two studies provided enough data to perform our own intention-to-treat analysis. A ‘quality of life’ outcome was reported by one trial. | They found silver level evidence concerning the beneficial effects of mineral baths compared to no treatment. Regarding all other balneological treatments, no clear effects were found. However, the scientific evidence is weak because of the poor methodological quality and the absence of adequate statistical analysis and data presentation. The noted “positive findings” should be viewed with caution. |
| 15 | Forestier R, et al. | Crenobalneotherapy was associated with improvements in the evaluation criteria (pain, function, and quality of life) compared to baseline. However, inadequate internal validity precluded the establishment of a causal link between these improvements and crenobalneotherapy. External validity was often poorly defined. Some studies found no significant differences with the control group but failed to include a sample-size calculation, suggesting inadequate statistical power as a possible explanation for the result. In several studies, the use of multiple evaluation criteria and measurements led to a high risk of Type I error. | Although the consistency of the results suggests a therapeutic effect of crenobalneotherapy in limb osteoarthritis, available studies are methodologically inadequate and sample sizes too small to allow definitive conclusions. They suggest a number of solutions to these shortcomings. Carefully designed studies in larger patient populations are needed to determine the role of crenobalneotherapy in knee osteoarthritis. |
| 16 | Pittler MH, et al. | Five randomized clinical trials met all inclusion criteria. Quantitative data synthesis was performed. The data for spa therapy, assessed on a 100-mm visual analogue scale (VAS), suggest significant beneficial effects compared with waiting list control groups (weighted mean difference 26.6 mm, 95% confidence interval 20.4–32.8, | Even though the data are scarce, there is encouraging evidence suggesting that spa therapy and balneotherapy may be effective for treating patients with low back pain. These data are not compelling but warrant rigorous large-scale trials. |
| 2 | Hall J, et al. | Nineteen studies met the inclusion criteria; 8 had a moderate-to-low risk of bias, and 5 of these had data suitable for meta-analyses. This showed that aquatic exercise has a small posttreatment effect in relieving pain compared with no treatment ( | There is sound evidence that there are no differences in pain-relieving effects between aquatic and land exercise. Compared with no treatment, aquatic exercise has a small pain-relieving effect; however, the small number of good-quality studies and inconsistency of results means that insufficient evidence limits firm conclusions. |
| 17 | Kamioka H, et al. | A total of 17 articles were reviewed. Diseases studied in these articles were mostly locomotor disorders, with pain as a main symptom: rheumatism, osteoarthritis, lumbago, Parkinson’s disease, varicosis, psoriasis, and health-promotion. The mean score on the 13-point modified PEDro scale was 7.5 (SD, 2.3), with a minimum score of 2 points and a maximum score of 12 points. In addition to balneotherapy, exercise therapy, mud pack treatment, and douche massage were employed in numerous studies. Improvements in the indicators were always more marked in balneotherapy intervention groups than in control groups, irrespective of the disease studied. | They devised a “3-layer model of evidence to be accumulated in balneotherapy” and concluded that RCT quality, evidence level, and expectation of good results were high for, in descending order, pain-relieving effect, functional recovery and improvement in quality of life, and health-promoting effects. |
Brief summary of 7 systematic reviews
| No. | Author | Year of publication | Intervention type | Meta-analysis | Object disease | Effects noted |
| 1 | Bartels EM, et al. | 2007 | Aquatic exercise | Performed | Hip and knee Osteoarthritis | Short-term effects |
| 13 | Verhagen AP, et al. | 2008 | Balneotherapy | Not performed | Rheumatoid arthritis | Unclear, but effects in some trials |
| 14 | Verhagen AP, et al. | 2007 | Balneotherapy | Not performed | Osteoarthritis | Unclear, but effects in some trials |
| 15 | Forestier R, et al. | 2008 | Balneotherapy | Not performed | Limb osteoarthritis | Unclear, but effects in some trials |
| 16 | Pittler MH, et al. | 2006 | Balneotherapy and aquatic exercise | Performed | Low back pain | Effect for both interventions |
| 2 | Hall J, et al. | 2008 | Aquatic exercise | Performed | Neurologic or musculoskeletal disease | Small effect |
| 17 | Kamioka H, et al. | 2006 | Balneotherapy | Not performed | Locomotor disease and health improvement | Unclear, but effects in some trials |
Description of adverse events and withdrawals in articles
| No. | Author | Title | Withdrawals | Adverse events |
| 1 | Bartels EM, et al. | Aquatic exercise for the treatment of knee and hip osteoarthritis | Yes | Yes |
| 14 | Verhagen AP, et al. | Balneotherapy for rheumatoid arthritis | Yes | Yes |
| 15 | Verhagen AP, et al. | Balneotherapy for osteoarthritis | Yes | Yes |
| 16 | Forestier R, et al. | Crenobalneotherapy for limb osteoarthritis: Systematic literature review and methodological analysis | Yes | No |
| 17 | Pittler MH, et al. | Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials | No | Yes |
| 2 | Hall J, et al. | Does aquatic exercise relieve pain in adults with neurologic or musculoskeletal disease? A systematic review and meta-analysis of randomized controlled trials | Yes | Yes |
| 18 | Kamioka H, et al. | A systematic review of randomized controlled trials on the therapeutic and health-promoting effects of spas | No | No |
Evaluation of the quality of systematic reviews by using the AMSTAR checklist[11]
| No. | Items | Answer | (%) | |
| 1. | Was an ‘a priori’ design provided? | Yes | 7 | (100) |
| No | 0 | (0) | ||
| Can’t answer | 0 | (0) | ||
| Not applicable | 0 | (0) | ||
| 2. | Was there duplicate study selection and data extraction? | Yes | 6 | (86) |
| No | 0 | (0) | ||
| Can’t answer | 1 | (14) | ||
| Not applicable | 0 | (0) | ||
| 3. | Was a comprehensive literature search performed? | Yes | 5 | (71) |
| No | 2 | (29) | ||
| Can’t answer | 0 | (0) | ||
| Not applicable | 0 | (0) | ||
| 4. | Was the status of publication (i.e., grey literature) used as an inclusion criterion? | Yes | 7 | (100) |
| No | 0 | (0) | ||
| Can’t answer | 0 | (0) | ||
| Not applicable | 0 | (0) | ||
| 5. | Was a list of studies (included and excluded) provided? | Yes | 3 | (43) |
| No | 4 | (57) | ||
| Can’t answer | 0 | (0) | ||
| Not applicable | 0 | (0) | ||
| 6. | Were the characteristics of the included studies provided? | Yes | 7 | (100) |
| No | 0 | (0) | ||
| Can’t answer | 0 | (0) | ||
| Not applicable | 0 | (0) | ||
| 7. | Was the scientific quality of the included studies assessed and documented? | Yes | 7 | (100) |
| No | 0 | (0) | ||
| Can’t answer | 0 | (0) | ||
| Not applicable | 0 | (0) | ||
| 8. | Was the scientific quality of the included studies used appropriately in formulating conclusions? | Yes | 7 | (100) |
| No | 0 | (0) | ||
| Can’t answer | 0 | (0) | ||
| Not applicable | 0 | (0) | ||
| 9. | Were the methods used to combine the findings of studies appropriate? | Yes | 5 | (71) |
| No | 1 | (14) | ||
| Can’t answer | 1 | (14) | ||
| Not applicable | 0 | (0) | ||
| 10. | Was the likelihood of publication bias assessed? | Yes | 1 | (14) |
| No | 6 | (86) | ||
| Can’t answer | 0 | (0) | ||
| Not applicable | 0 | (0) | ||
| 11. | Was the conflict of interest stated? | Yes | 5 | (71) |
| No | 2 | (29) | ||
| Can’t answer | 0 | (0) | ||
| Not applicable | 0 | (0) | ||
Overall evidence and future research agenda
| Intervention | Evidence | Specific agenda | Common agenda |
| Aquatic exercise | Small but significant effect | 1. Long-term effect | 1. Randomized controlled trials for various diseases |
| Balneotherapy | Poor/Unclear | Satisfactory methodology | |
Studies excluded in the present review
| No. | Author. Journal (Year) | Title | Reason for exclusion |
| E1 | Cardoso JR, et al. Cochrane Database Systc Rev (2008) | Aquatic therapy exercise for treating rheumatoid arthritis (Protocol) | Not reviewed due to protocol |
| E2 | Beamon S, et al. Cochrane Database Syst Rev (2008) | Hydrotherapy for asthma (Protocol) | Not reviewed due to protocol |
| E3 | Dziedzic K, et al. Best Practice Research Clin Rheumatol (2008) | Land- and water-based exercise therapies for musculoskeletal condition | Not SR |
| E4 | Getz M, et al. Clin Rehabili (2006) | Effects of aquatic interventions in children with neuromotor impairments: a systematic review of the literature | Not SR based on RCTs |
| E5 | Tejirian T, et al. Diseases Colon Rectum (2005) | Sitz bath: where is the evidence? Scientific basis of a common practice | Not SR |
| E6 | Herman PM, et al. BMC Complementary Alternative Med (2005) | Is complementary and alternative medicine (CAM) cost-effective? a systematic review | Not SR based on water |
| E7 | Karagulle MZ, et al. Forsch Komplementarmed Klass Naturheilkd (2004) | Balneotherapy and spa therapy of rheumatic diseases in Turkey: a systematic review (in German) | Not SR based on RCTs |
| E8 | Meremikwu M, et al. Cochrane Database Syst Rev (2008) | Physical methods for treating fever in children | Not SR based on water |
| E9 | Liao WC. Int J Nursing Studies (2002) | Effects of passive body heating on body temperature and sleep regulation in the elderly: a systematic review | Not SR based on RCTs |
| E10 | Pennick VE, et al. Cochrane Database Syst Rev (2007) | Interventions for preventing and treating pelvic and back pain in pregnancy | Not SR based on water |
| E11 | Teschendorf ME, et al. Am J Maternal/Child Nursing (2000) | Hydrotherapy during labor: an example of developing a practice policy | Not SR based on RCTs |
| E12 | Verhagen AP, et al. J Rheumatol (1997) | Taking baths: the efficacy of balneotherapy in patients with arthritis. A systematic review | Not SR based on RCTs |
| E13 | Sim J, et al. Clin J Pain (2002) | Systematic review of randomized controlled trials of nonpharmacological interventions for fibromyalgia | Not SR based on water |
| E14 | Rosimini C, et al. J Am Academy Nurse Practitioners (2003) | Benefits of swim training for children and adolescents with asthma | Not SR based on RCTs |
| E15 | Schiltenwolf M, et al. Schmerz (2008) | Physiotherapy, exercise and strength training and physical therapies in the treatment of fibromyalgia syndrome | Not SR based on RCTs |
| E16 | Toumaire M, et al. e CAM (2007) | Complementary and alternative approaches to pain relief during labor | Not SR |
| E17 | Bouchama A, et al. Critical Care (2007) | Cooling and hemodynamic management in heatstroke: practical recommendations | Not SR based on RCTs |
| E18 | Iarustovskaia OV, et al. Vopr Kurotol Fizioter Lech Fiz Kult (2006) | Thermocontrast hydrotherapy in the treatment of neuroendocrine disorders in females of reproductive age (in Russian) | Not SR based on RCTs |
| E19 | Balint G, et al. Orv Hetil (2006) | Rehabilitation and balneotherapy, wellness 2004 | Not SR based on RCTs |
| E20 | Adilov VB, et al. Vopr Kurotol Fizioter Lech Fiz Kult (2006) | Mineral waters for external (balneological) application. Guide for physicians (in Russian) | Not SR |
| E21 | Markel W. Wien Kiln Wochenschr (2006) | Can the effects of radon therapy be scientifically substantiated? (in Russian) | Not SR |
| E22 | Getenbrunner C. Wien Klin Wochenschr (2006) | Could balneology and medical climatology have more than historic importance in the therapy of chronic diseases? | Not SR |
| E23 | Davydova DB, et al. Vopr Kurotol Fizioter Lech Fiz Kult (2006) | Hydrobalneotherapy of patients with cardiovascular disease. Manual for physicians (in Russian) | Not SR |
| E24 | Hodgson S. Clin Orthopaedics Related Research (2006) | Proximal humerus fracture rehabilitation | Not SR based on RCTs |
| E25 | Liu Y, et al. Current Opinion Rheumatol (2004) | Recent advances in the treatment of the spondyloarthropathies | Not SR based on water |
| E26 | Watts R, et al. Int J Nursing Practice (2003) | Nursing management of fever in children: a systematic review | Not SR based on water |
| E27 | Pengel HM, et al. Clin Rehabili (2002) | Systematic review of conservative interventions for subacute low back pain | Not SR based on water |
| E28 | Constant F, et al. Bull Soc Sci Med Grand Duche Luxemb (1995) | Critical bibliographic analysis of international medical literature in the domain of thermal research | Not SR based on RCTs |