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Langenbeck's Archives of Surgery Jun 2018Surgical strategies for perforated diverticulitis (Hinchey stages III and IV) remain controversial. This systematic review aimed to compare the outcome of primary... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Surgical strategies for perforated diverticulitis (Hinchey stages III and IV) remain controversial. This systematic review aimed to compare the outcome of primary anastomosis, Hartmann procedure and laparoscopic lavage.
METHODS
A systematic literature search was conducted through Medline, Embase, Cochrane Central Register and Health Technology Assessment Database to identify randomized and non-randomized controlled trials involving patients with perforated left-sided colonic diverticulitis comparing different surgical strategies. The methodological quality of the included studies was assessed systematically (Grading of Recommendations, Assessment, Development and Evaluation) and a meta-analysis was performed.
RESULTS
After screening 4090 titles and abstracts published between 1958 and January 2018, 148 were selected for full text assessment. Sixteen trials (7 RCTs, 9 non-RCTs) with 1223 patients were included. Mortality rates were not significantly different between Hartmann procedure and primary anastomosis for Hinchey III and IV, neither in the meta-analysis of three RCTs (RR 2.03 (95% CI 0.79 to 5.25); p = 0.14, moderate quality of evidence) nor in the meta-analysis of six observational studies (RR 1.53 (95% CI 0.89 to 2.65); p = 0.13, very low quality of evidence). However, stoma reversal rates were significantly higher in the primary anastomosis group (RR 0.73 (95% CI 0.58 to 0.98); p = 0.008, moderate quality of evidence). Meta-analysis of four RCTs showed no significant difference between laparoscopic lavage for Hinchey III compared to sigmoid resection neither for mortality (RR 1.07 (95% CI 0.65 to 1.76); p = 0.79, moderate quality of evidence) nor for major complications (RR 0.86 (95% CI 0.69 to 1.08); p = 0.20, moderate quality of evidence).
CONCLUSIONS
This systematic review suggests similar rates of complications but higher rates of colonic restoration after primary anastomosis compared to Hartmann procedure in perforated diverticulitis with generalized peritonitis (Hinchey III and IV). Results in laparoscopic lavage for Hinchey III are not superior to primary resection. However, further studies with a careful interpretation of the meaning of re-interventions are required.
Topics: Anastomosis, Surgical; Diverticulitis, Colonic; Humans; Intestinal Perforation; Laparoscopy; Peritonitis; Therapeutic Irrigation
PubMed: 29931505
DOI: 10.1007/s00423-018-1686-x -
International Journal of Environmental... Apr 2023This systematic review investigated the possible effects of exposing infants to formal activities in aquatic environments. A literature search of eight databases was... (Review)
Review
This systematic review investigated the possible effects of exposing infants to formal activities in aquatic environments. A literature search of eight databases was concluded on 12 December 2022. Studies were eligible if they: (i) focused on 0-36 months of age infants, (ii) addressed the exposure of infants to formal aquatic activities, and (iii) compared the 'same condition of aquatic exposure with the control' or 'before and after exposure'. The PRISMA protocol was used. Articles considered for inclusion ( = 18) were clustered in the health, development, and physiological outcome domains. The results show that research is focused on indoor activities, mainly in baby swimming programs and baby aquatic therapy interventions. Swimming and aquatic therapy practices are generally safe for babies' health, and there are benefits to preterm and newborns exposed to aquatic therapy once the physiological parameters are maintained in normal and safe patterns. A positive effect is also suggested in general gross and fine motor skills, visual motion perception, cognitive flexibility, and response selection accuracy for infants who participated in aquatic programs. Further investigation with high-quality experimental designs is required to establish the effect of exposure of infants to formal aquatic activities (Systematic Review Registration: CRD42021248054).
Topics: Humans; Infant; Infant, Newborn; Aquatic Therapy
PubMed: 37107892
DOI: 10.3390/ijerph20085610 -
Complementary Therapies in Clinical... Aug 2021To systematically evaluate the effectiveness of balneotherapy and/or aquatic exercise on bone metabolism. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To systematically evaluate the effectiveness of balneotherapy and/or aquatic exercise on bone metabolism.
DESIGN
A systematic literature search was conducted from inception to January 4, 2021. Standardized mean differences (SMDs) and 95% confidence intervals (CIs) were calculated using a fixed-effect model according to study heterogeneity.
RESULTS
Seven articles involving 467 participants were selected. Three balneotherapy studies were qualitatively integrated. The results showed that bone resorption slowed down with or without stimulation of bone formation. A pooled meta-analysis of four studies on aquatic exercise showed significant evidence for a reduction in parathyroid hormone (PTH; SMD = -0.71; 95% CI, -1.04 to -0.38; P < 0.001), and a significant increase in osteocalcin (OC; SMD = 0.60; 95% CI, 0.16 to 1.03; P = 0.007) after aquatic exercise.
CONCLUSION
Balneotherapy and aquatic exercise had significant effects on bone metabolism, reducing bone resorption and/or increasing bone formation. This study highlights the importance of balneotherapy and aquatic exercise for bone health.
Topics: Balneology; Exercise; Exercise Therapy; Humans; Hydrotherapy
PubMed: 34167042
DOI: 10.1016/j.ctcp.2021.101429 -
The Cochrane Database of Systematic... Oct 2020Establishing the subgroup analysis of the fallopian tubes (tubes) is a commonly undertaken diagnostic investigation for women with subfertility. This is usually achieved... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Establishing the subgroup analysis of the fallopian tubes (tubes) is a commonly undertaken diagnostic investigation for women with subfertility. This is usually achieved by flushing contrast medium through the tubes and visualising patency on radiographs, ultrasonography or laparoscopy. Many women were noted to conceive in the first three to six months after tubal flushing, raising the possibility that tubal flushing could also be a treatment for infertility. There has been debate about which contrast medium should be used (water-soluble or oil-soluble media) as this may influence pregnancy rates. An important adverse event during tubal flushing is intravasation (backflow of contrast medium into the blood or lymphatic vessels),which could lead to embolism although it is asymptomatic in most cases.
OBJECTIVES
To evaluate the effectiveness and safety of tubal flushing with oil-soluble contrast media (OSCM) and water-soluble contrast media (WSCM) on subsequent fertility outcomes in women with subfertility.
SEARCH METHODS
We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, MEDLINE, Embase, CENTRAL, PsycINFO, reference lists of identified articles and trial registries. The most recent search was conducted in April 2020.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing tubal flushing with OSCM, WSCM with each other or with no treatment, in women with subfertility.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected the trials, assessed risk of bias and extracted data. We contacted study authors for additional information. The overall quality of the evidence was assessed using GRADE methods.
MAIN RESULTS
Fifteen trials involving 3864 women were included in this systematic review. Overall, the quality of evidence varied from very low to moderate: the main limitations were risk of bias, heterogeneity and imprecision. OSCM versus no treatment Four studies (506 women) were included in this comparison. Tubal flushing with OSCM may increase the odds of live birth (odds ratio (OR) 3.27, 95% confidence interval (CI) 1.57 to 6.85, 3 RCTs, 204 women, I = 0, low-quality evidence). This suggests that if the chance of live birth following no treatment is assumed to be 11%, the chance following tubal flushing with OSCM would be between 16% and 46%. Tubal flushing with OSCM may increase in the odds of clinical pregnancy (OR 3.54, 95% CI 2.08 to 6.02, 4 RCTs, 506 women, I = 18%, low-quality evidence). This suggests that if the chance of clinical pregnancy following no treatment is assumed to be 9%, the chance following tubal flushing with OSCM would be between 17% and 37%. No study measured intravasation or other adverse events such as infection, haemorrhage and congenital abnormalities. WSCM versus no treatment Only one study (334 women) was included in this comparison. We are uncertain whether tubal flushing with WSCM increase live birth compared to no treatment (OR 1.13, 95% CI 0.67 to 1.91, 1 RCT, 334 women, low-quality evidence). This suggests that if the chance of live birth following no treatment is assumed to be 21%, the chance following tubal flushing with WSCM would be between 15% and 33%. We are uncertain whether tubal flushing with WSCM increases clinical pregnancy compared to no treatment (OR 1.14, 95% CI 0.71 to 1.84, 1 RCT, 334 women, low-quality evidence). This suggests that if the chance of clinical pregnancy following no treatment is assumed to be 27%, the chance following tubal flushing with WSCM would be between 29% and 40%. One case with pelvic infection was reported in the WSCM group and no case with infection in the no treatment group in a one study (334 women). Meta-analysis was not performed due to the rare events. No study measured intravasation or other adverse events such as infection, haemorrhage and congenital abnormalities. OSCM versus WSCM Six studies (2598 women) were included in this comparison. Three studies reported live birth, including two with higher live birth in the OSCM group (OR 1.64, 95% CI 1.27 to 2.11, 1119 women; OR 3.45, 95% CI 1.97 to 6.03, 398 women); and one with insufficient evidence of a difference between groups (OR 0.92, 95% CI 0.60 to 1.40, 533 women). Given the substantial heterogeneity observed (I = 86%), meta-analysis was not performed. Tubal flushing with OSCM probably increased in the odds of intravasation (asymptomatic) compared to tubal flushing with WSCM (OR 5.00, 95% CI 2.25 to 11.12, 4 RCTs, 1912 women, I = 0, moderate-quality evidence). This suggests that if the chance of intravasation following tubal flushing with WSCM is assumed to be 1%, the chance following tubal flushing with OSCM would be between 2% and 9%. Tubal flushing with OSCM may increase the odds of clinical pregnancy (OR 1.42, 95% CI 1.10 to 1.85, 6 RCTs, 2598 women, I = 41%, low-quality evidence). This suggests that if the chance of clinical pregnancy following tubal flushing with WSCM is assumed to be 26%, the chance following tubal flushing with OSCM would be between 28% and 39%. We are uncertain whether tubal flushing with OSCM decreases the odds of infection (OR 0.22, 95% CI 0.04 to 1.22, 2 RCTs, 662 women, I = 0, very low-quality evidence) or haemorrhage (OR 0.65, 95% CI 0.40 to 1.06, 2 RCTs, 662 women, I = 0, very low-quality evidence). Three neonates with congenital abnormalities were reported in the OSCM group while no congenital abnormality was reported in the WSCM group in one study (1119 women). No meta-analysis was performed due to the rare events.
AUTHORS' CONCLUSIONS
The evidence suggests that compared to no treatment, tubal flushing with OSCM may increase the chance of live birth and clinical pregnancy, while it is uncertain whether tubal flushing with WSCM improves those outcomes. Compared to tubal flushing with WSCM, OSCM may improve clinical pregnancy while meta-analysis was impossible for live birth due to heterogeneity. Evidence also suggests that OSCM is associated with an increased risk of asymptomatic intravasation. Overall, adverse events, especially long-term adverse events, are poorly reported across studies.
Topics: Bias; Contrast Media; Fallopian Tubes; Female; Humans; Infertility, Female; Live Birth; Oils; Pregnancy; Pregnancy Rate; Randomized Controlled Trials as Topic; Solubility; Therapeutic Irrigation; Water
PubMed: 33053612
DOI: 10.1002/14651858.CD003718.pub5 -
The Cochrane Database of Systematic... May 2015Establishing the patency of the fallopian tubes is a commonly undertaken diagnostic investigation for women with subfertility. This is usually achieved by flushing... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Establishing the patency of the fallopian tubes is a commonly undertaken diagnostic investigation for women with subfertility. This is usually achieved by flushing contrast medium through the tubes and taking radiographs. However, it has been noted that many women conceive in the first three to six months after the tubal flushing, which has raised the possibility that tubal flushing could also be a treatment for infertility. There has been debate about which contrast medium should be used (water-soluble or oil-soluble media) as this may influence pregnancy rates.
OBJECTIVES
To evaluate the effect of flushing fallopian tubes with oil- or water-soluble contrast media on live birth and pregnancy rates in women with subfertility.
SEARCH METHODS
We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of trials, MEDLINE, EMBASE, Biological Abstracts, trial registers and reference lists of identified articles. The most recent search was conducted in June 2014.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing tubal flushing with oil-soluble or water-soluble contrast media, or with no treatment, in women with subfertility.
DATA COLLECTION AND ANALYSIS
Two authors independently selected the trials, assessed risk of bias and extracted data. We contacted study authors for additional information. The overall quality of the evidence was assessed using GRADE methods.
MAIN RESULTS
Thirteen trials involving 2914 women were included, of whom 2494 were included in the analysis. Oil-soluble contrast media (OSCM) versus no interventionThe OSCM group had a higher rate of live birth (odds ratio (OR) 3.09, 95% CI 1.39 to 6.91, 1 RCT, 158 women, low quality evidence) and ongoing pregnancy (OR 3.59, 95% CI 2.06 to 6.26, 3 RCTs, 382 women, I(2) = 0%, low quality evidence) than women who had no intervention. Our findings suggest that among subfertile women with a 17% chance of an ongoing pregnancy if they have no intervention, the rate will increase to between 29% and 55% if they have tubal flushing with OSCM. Water-soluble contrast media (WSCM) versus no interventionThere was no evidence of a difference between the groups in rates of live birth (OR 1.13, 95% CI 0.67 to 1.91, 1 RCT, 334 women, very low quality evidence) or ongoing pregnancy (OR 1.14, 95% CI 0.71 to 1.84, 1 RCT, 334 women, very low quality evidence). OSCM versus WSCMTwo RCTs reported live birth: one found a higher live birth rate in the oil-soluble group and the other found no evidence of a difference between the groups. These studies were not pooled due to very high heterogeneity (I(2) = 93%). There was no evidence of a difference between the groups in rates of ongoing pregnancy, however there was high heterogeneity (OR 1.44, 95% CI 0.84 to 2.47, 5 RCTs, 1454 women, I(2) = 76%, random-effects model, very low quality evidence). OSCM plus WSCM versus WSCM aloneThere was no evidence of a difference between the groups in rates of live birth (OR 1.06, 95% CI 0.64 to 1.77, 1 RCT, 393 women, very low quality evidence) or ongoing pregnancy (OR 1.23, 95% CI 0.87 to 1.72, 4 RCTs, 633 women, I(2) = 0%, low quality evidence).There was no evidence of a difference between any of the interventions in rates of adverse events, but such events were poorly reported in most studies.
AUTHORS' CONCLUSIONS
The evidence suggests that tubal flushing with oil-soluble contrast media may increase the chance of pregnancy and live birth compared to no intervention. Findings for other comparisons were inconclusive due to inconsistency and lack of statistical power. There was insufficient evidence on adverse events to reach firm conclusions. Further robust randomised controlled trials are needed.
Topics: Contrast Media; Fallopian Tubes; Female; Humans; Infertility, Female; Live Birth; Oils; Pregnancy; Pregnancy Rate; Randomized Controlled Trials as Topic; Solubility; Therapeutic Irrigation; Water
PubMed: 25929235
DOI: 10.1002/14651858.CD003718.pub4 -
Frontiers in Public Health 2023In the present systematic review and meta-analysis, we aimed to evaluate and update the effects of aquatic exercise on physical fitness and quality of life (QoL) in... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
In the present systematic review and meta-analysis, we aimed to evaluate and update the effects of aquatic exercise on physical fitness and quality of life (QoL) in postmenopausal women.
METHODS
The databases Cochrane Library, PubMed, Web of Science, and MEDLINE were searched for randomized controlled trials (RCTs) on the topic from inception to July 2022. The GetData software was used to extract data from the published images. RevMan5.4 software was used for statistical analysis. Data are expressed as standardized mean difference (SMD) with 95% confidence intervals (CI). I index was employed for heterogeneity. Egger's test was used to assess publication bias. We evaluated the methodological quality of included studies using the Physiotherapy Evidence Database scale.
RESULTS
We included 594 participants in 16 RCTs (19 comparison groups). The results indicated that aquatic exercise can significantly improve lower limb strength (LLS), upper limb strength (ULS), agility, flexibility, and overall QoL. No significant effects were found on aerobic capacity. Subgroup-analysis results indicated that aquatic exercise only significantly improved LLS, ULS, agility, and flexibility in postmenopausal women < 65 years of age. However, aquatic exercise improves the overall QoL both in postmenopausal women < 65 years and ≥ 65 years. Aquatic resistance exercise significantly improves LLS, ULS, agility and flexibility. In addition, aquatic aerobic exercise can effectively increase LLS, and combined aquatic aerobic and resistance exercise can enhance the overall QoL.
CONCLUSIONS
Aquatic exercise can effectively improve physical fitness and overall QoL in postmenopausal women, but has limited effects on aerobic capacity; thus, it is highly recommended in postmenopausal women.
Topics: Female; Humans; Postmenopause; Exercise; Exercise Therapy; Physical Fitness; Quality of Life
PubMed: 37361170
DOI: 10.3389/fpubh.2023.1126126 -
Annals of Physical and Rehabilitation... Jun 2016Osteoarthritis (OA) is a public health problem that will probably increase in the future with the aging of the population. Crenobalneotherapy is commonly used to treat... (Review)
Review
BACKGROUND
Osteoarthritis (OA) is a public health problem that will probably increase in the future with the aging of the population. Crenobalneotherapy is commonly used to treat OA, but evidence from previous reviews was not sufficient. This systematic review aimed to identify the best evidence for the clinical effect of crenobalneotherapy for knee OA.
METHODS
We systematically searched MEDLINE via PubMed, PEDRO and the Cochrane Central Register of Controlled Trials for articles published up to September 2015. Articles were included if trials were comparative, if one or more of the subgroups had knee OA with separate data, and if spa therapy or any hydrotherapy techniques involving mineral water or mineral mud was compared to any other intervention or no treatment. Statistical validity, external validity and quality of side effects assessment were evaluated by personal checklists. Risk of bias was assessed by the CLEAR NTP.
RESULTS
Treatments (hot mineral water baths, mud therapy, hot showers, and sometimes massage and supervised water exercises) delivered in spa centers across Europe and the Middle East seem to improve symptoms in knee OA. They may be effective for pain and function. There are conflicting results about the effect on quality of life and drug consumption.
CONCLUSIONS
Improvements with spa therapy for knee OA appear to be clinically relevant until 3 to 6 months and sometimes 9 months.
Topics: Balneology; Europe; Exercise Therapy; Health Resorts; Humans; Hydrotherapy; Massage; Middle East; Osteoarthritis, Knee; Treatment Outcome
PubMed: 26996955
DOI: 10.1016/j.rehab.2016.01.010 -
BMJ Open Jul 2023Hydrotherapy is a traditional prevention and treatment strategy. This study's aim is to systematically review all available randomised controlled trials (RCTs)...
OBJECTIVE
Hydrotherapy is a traditional prevention and treatment strategy. This study's aim is to systematically review all available randomised controlled trials (RCTs) investigating clinical effects of hydrotherapy according to Kneipp which is characterised by cold water applications.
METHODS
RCTs on disease therapy and prevention with Kneipp hydrotherapy were included. Study participants were patients and healthy volunteers of all age groups. MEDLINE (via PubMed), Scopus, Central, CAMbase, and opengrey.eu were systematically searched through April 2021 without language restrictions and updated by searching PubMed until April 6th 2023. Risk of bias was assessed using the Cochrane tool version 1.ResultsTwenty RCTs (N=4247) were included. Due to high heterogeneity of the RCTs, no meta-analysis was performed. Risk of bias was rated as unclear in most of the domains. Of 132 comparisons, 46 showed significant positive effects in favour of hydrotherapy on chronic venous insufficiency, menopausal symptoms, fever, cognition, emotional function and sickness absenteeism. However, 81 comparisons showed no differences between groups and 5 were in favour of the respective control group. Only half of the studies reported safety issues.
CONCLUSION
Although RCTs on Kneipp hydrotherapy seem to show positive effects in some conditions and outcomes, it remains difficult to ascertain treatment effects due to the high risk of bias and heterogeneity of most of the considered studies. Further high-quality RCTs on Kneipp hydrotherapy are urgently warranted.
PROSPERO REGISTRATION NUMBER
CRD42021237611.
Topics: Humans; Hydrotherapy; Randomized Controlled Trials as Topic
PubMed: 37423627
DOI: 10.1136/bmjopen-2022-070951 -
The Cochrane Database of Systematic... Apr 2016This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Nasal saline irrigation is commonly used to improve patient symptoms.
OBJECTIVES
To evaluate the effects of saline irrigation in patients with chronic rhinosinusitis.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 9); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 30 October 2015.
SELECTION CRITERIA
Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing saline delivered to the nose by any means (douche, irrigation, drops, spray or nebuliser) with (a) placebo, (b) no treatment or (c) other pharmacological interventions.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of local irritation and discomfort. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
MAIN RESULTS
We included two RCTs (116 adult participants). One compared large-volume (150 ml) hypertonic (2%) saline irrigation with usual treatment over a six-month period; the other compared 5 ml nebulised saline twice a day with intranasal corticosteroids, treating participants for three months and evaluating them on completion of treatment and three months later. Large-volume, hypertonic nasal saline versus usual care One trial included 76 adult participants (52 intervention, 24 control) with or without polyps.Disease-specific HRQL was reported using the Rhinosinusitis Disability Index (RSDI; 0 to 100, 100 = best quality of life). At the end of three months of treatment, patients in the saline group were better than those in the placebo group (mean difference (MD) 6.3 points, 95% confidence interval (CI) 0.89 to 11.71) and at six months there was a greater effect (MD 13.5 points, 95% CI 9.63 to 17.37). We assessed the evidence to be of low quality for the three months follow-up and very low quality for the six months follow-up. Patient-reported disease severity was evaluated using a "single-item sinus symptom severity assessment" but the range of scores is not stated, making it impossible for us to determine the meaning of the data presented.No adverse effects data were collected in the control group but 23% of participants in the saline group experienced side effects including epistaxis. General HRQL was measured using SF-12 (0 to 100, 100 = best quality of life). No difference was found after three months of treatment (low quality evidence) but at six months there was a small difference favouring the saline group, which may not be of clinical significance and has high uncertainty (MD 10.5 points, 95% CI 0.66 to 20.34) (very low quality evidence). Low-volume, nebulised saline versus intranasal corticosteroids One trial included 40 adult participants with polyps. Our primary outcome of disease-specific HRQL was not reported. At the end of treatment (three months) the patients who had intranasal corticosteroids had less severe symptoms (MD -13.50, 95% CI -14.44 to -12.56); this corresponds to a large effect size. We assessed the evidence to be of very low quality.
AUTHORS' CONCLUSIONS
The two studies were very different in terms of included populations, interventions and comparisons and so it is therefore difficult to draw conclusions for practice. The evidence suggests that there is no benefit of a low-volume (5 ml) nebulised saline spray over intranasal steroids. There is some benefit of daily, large-volume (150 ml) saline irrigation with a hypertonic solution when compared with placebo, but the quality of the evidence is low for three months and very low for six months of treatment.
Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Chronic Disease; Humans; Hypertonic Solutions; Nasal Polyps; Nasal Sprays; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Sodium Chloride; Therapeutic Irrigation; Time Factors
PubMed: 27115216
DOI: 10.1002/14651858.CD011995.pub2 -
The Cochrane Database of Systematic... Apr 2015No cure for rheumatoid arthritis (RA) is known at present, so treatment often focuses on management of symptoms such as pain, stiffness and mobility. Treatment options... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
No cure for rheumatoid arthritis (RA) is known at present, so treatment often focuses on management of symptoms such as pain, stiffness and mobility. Treatment options include pharmacological interventions, physical therapy treatments and balneotherapy. Balneotherapy is defined as bathing in natural mineral or thermal waters (e.g. mineral baths, sulphur baths, Dead Sea baths), using mudpacks or doing both. Despite its popularity, reported scientific evidence for the effectiveness or efficacy of balneotherapy is sparse. This review, which evaluates the effects of balneotherapy in patients with RA, is an update of a Cochrane review first published in 2003 and updated in 2008.
OBJECTIVES
To perform a systematic review on the benefits and harms of balneotherapy in patients with RA in terms of pain, improvement, disability, tender joints, swollen joints and adverse events.
SEARCH METHODS
We searched the Cochrane 'Rehabilitation and Related Therapies' Field Register (to December 2014), the Cochrane Central Register of Controlled Trials (2014, Issue 1), MEDLIINE (1950 to December 2014), EMBASE (1988 to December 2014), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to December 2014), the Allied and Complementary Medicine Database (AMED) (1985 to December 2014), PsycINFO (1806 to December 2014) and the Physiotherapy Evidence Database (PEDro). We applied no language restrictions; however, studies not reported in English, Dutch, Danish, Swedish, Norwegian, German or French are awaiting assessment. We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing and recently completed trials.
SELECTION CRITERIA
Studies were eligible if they were randomised controlled trials (RCTs) consisting of participants with definitive or classical RA as defined by the American Rheumatism Association (ARA) criteria of 1958, the ARA/American College of Rheumatology (ACR) criteria of 1988 or the ACR/European League Against Rheumatism (EULAR) criteria of 2010, or by studies using the criteria of Steinbrocker.Balneotherapy had to be the intervention under study, and had to be compared with another intervention or with no intervention.The World Health Organization (WHO) and the International League Against Rheumatism (ILAR) determined in 1992 a core set of eight endpoints in clinical trials concerning patients with RA. We considered pain, improvement, disability, tender joints, swollen joints and adverse events among the main outcome measures. We excluded studies when only laboratory variables were reported as outcome measures.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, performed data extraction and assessed risk of bias. We resolved disagreements by consensus and, if necessary, by third party adjudication.
MAIN RESULTS
This review includes two new studies and a total of nine studies involving 579 participants. Unfortunately, most studies showed an unclear risk of bias in most domains. Four out of nine studies did not contribute to the analysis, as they presented no data.One study involving 45 participants with hand RA compared mudpacks versus placebo. We found no statistically significant differences in terms of pain on a 0 to 100-mm visual analogue scale (VAS) (mean difference (MD) 0.50, 95% confidence interval (CI) -0.84 to 1.84), improvement (risk ratio (RR) 0.96, 95% CI 0.54 to 1.70) or number of swollen joints on a scale from 0 to 28 (MD 0.60, 95% CI -0.90 to 2.10) (very low level of evidence). We found a very low level of evidence of reduction in the number of tender joints on a scale from 0 to 28 (MD -4.60, 95% CI -8.72 to -0.48; 16% absolute difference). We reported no physical disability and presented no data on withdrawals due to adverse events or on serious adverse events.Two studies involving 194 participants with RA evaluated the effectiveness of additional radon in carbon dioxide baths. We found no statistically significant differences between groups for all outcomes at three-month follow-up (low to moderate level of evidence). We noted some benefit of additional radon at six months in terms of pain frequency (RR 0.6, 95% CI 0.4 to 0.9; 31% reduction; improvement in one or more points (categories) on a 4-point scale; moderate level of evidence) and 9.6% reduction in pain intensity on a 0 to 100-mm VAS (MD 9.6 mm, 95% CI 1.6 to 17.6; moderate level of evidence). We also observed some benefit in one study including 60 participants in terms of improvement in one or more categories based on a 4-point scale (RR 2.3, 95% CI 1.1 to 4.7; 30% absolute difference; low level of evidence). Study authors did not report physical disability, tender joints, swollen joints, withdrawals due to adverse events or serious adverse events.One study involving 148 participants with RA compared balneotherapy (seated immersion) versus hydrotherapy (exercises in water), land exercises or relaxation therapy. We found no statistically significant differences in pain on the McGill Questionnaire or in physical disability (very low level of evidence) between balneotherapy and the other interventions. No data on improvement, tender joints, swollen joints, withdrawals due to adverse events or serious adverse events were presented.One study involving 57 participants with RA evaluated the effectiveness of mineral baths (balneotherapy) versus Cyclosporin A. We found no statistically significant differences in pain intensity on a 0 to 100-mm VAS (MD 9.64, 95% CI -1.66 to 20.94; low level of evidence) at 8 weeks (absolute difference 10%). We found some benefit of balneotherapy in overall improvement on a 5-point scale at eight weeks of 54% (RR 2.35, 95% CI 1.44 to 3.83). We found no statistically significant differences (low level of evidence) in the number of swollen joints, but some benefit of Cyclosporin A in the number of tender joints (MD 8.9, 95% CI 3.8 to 14; very low level of evidence). Physical disability, withdrawals due to adverse events and serious adverse events were not reported.
AUTHORS' CONCLUSIONS
Overall evidence is insufficient to show 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.
Topics: Antirheumatic Agents; Arthritis, Rheumatoid; Balneology; Cyclosporine; Humans; Hydrotherapy; Mud Therapy; Osteoarthritis; Pain Management; Publication Bias; Radon; Randomized Controlled Trials as Topic
PubMed: 25862243
DOI: 10.1002/14651858.CD000518.pub2