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PubMed2004

Back schools for non-specific low-back pain.

BACKGROUND: Since the introduction of the Swedish back school in 1969, back schools have frequently been used for treating patients with low-back pain (LBP). However, the content of back schools has changed and appears to vary widely today. OBJECTIVES: To assess the effectiveness of back schools for patients with non-specific LBP. SEARCH STRATEGY: We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials to May 2003 for relevant trials reported in English, Dutch, French or German. We also screened references from relevant reviews and included trials. SELECTION CRITERIA: Randomized controlled trials (RCTs) that reported on any type of back school for non-specific LBP were included. DATA COLLECTION AND ANALYSIS: Four reviewers, blinded to authors, institution and journal, independently extracted the data and assessed the quality of the trials. We set the high quality level, a priori, at a trial meeting six or more of 11 internal validity criteria. As data were clinically and statistically too heterogeneous to perform a meta-analysis, we used a qualitative review (best evidence synthesis) to summarize the results. The evidence was classified into four levels (strong, moderate, limited or no evidence), taking into account the methodological quality of the studies. We also evaluated the clinical relevance of the studies. MAIN RESULTS: Nineteen RCTs (3584 patients) were included in this updated review. Overall, the methodological quality was low, with only six trials considered to be high quality. It was not possible to perform relevant subgroup analyses for LBP with radiation versus LBP without radiation. The results indicate that there is moderate evidence suggesting that back schools have better short and intermediate-term effects on pain and functional status than other treatments for patients with recurrent and chronic LBP. There is moderate evidence suggesting that back schools for chronic LBP in an occupational setting, are more effective than other treatments and placebo or waiting list controls on pain, functional status and return to work during short and intermediate-term follow-up. In general, the clinical relevance of the studies was rated as insufficient. REVIEWERS' CONCLUSIONS: There is moderate evidence suggesting that back schools, in an occupational setting, reduce pain, and improve function and return-to-work status, in the short and intermediate-term, compared to exercises, manipulation, myofascial therapy, advice, placebo or waiting list controls, for patients with chronic and recurrent LBP. However, future trials should improve methodological quality and clinical relevance and evaluate the cost-effectiveness of back schools.

Exercise↗

PubMed2002

Multidisciplinary bio-psycho-social rehabilitation for chronic low back pain.

BACKGROUND: Chronic low back pain is, in many countries, the main cause of long term disability in middle age. Patients with chronic low back pain are often referred for multidisciplinary treatment. Previous published systematic reviews on this topic included no randomised controlled trials and pooled together controlled and non-controlled studies. OBJECTIVES: To assess the effect of multidisciplinary bio-psycho-social rehabilitation on pain, function, employment, quality of life and global assessment outcomes in subjects with chronic disabling low back pain. SEARCH STRATEGY: We searched MEDLINE, EMBASE, PsychLIT, CINAHL, Health STAR, and The Cochrane Library from the beginning of the database to June 1998 using the comprehensive search strategy recommended by the Back Review Group of the Cochrane Collaboration. INTERVENTION specific key words for this review were: patient care team, patient care management, multidisciplinary, interdisciplinary, multiprofessional, multimodal, pain clinic and functional restoration. We also reviewed reference lists and consulted the editors of the Back Review Group of the Cochrane Collaboration. SELECTION CRITERIA DESIGN: randomised controlled trials comparing multidisciplinary bio-psycho-social rehabilitation with a non-multidisciplinary control intervention. POPULATION: Adults with disabling low back pain of more than three months in duration. INTERVENTION: Patients had to be assessed and treated by qualified professionals according to a plan that addresses physical and at least one of psychological, or social/occupational dimensions. OUTCOMES: Only trials which reported treatment effect in at least one of pain, function, employment status, quality of life or global improvement. Exclusion: Pure educational interventions (back schools) and pure physical interventions were excluded. DATA COLLECTION AND ANALYSIS: Selection, data extraction and quality grading of studies was done by two independent reviewers using pre-tested data forms. Study quality was assessed according to the scheme recommended by the Back Review Group of the Cochrane Collaboration. Trials with internal validity scores of five or more in a ten point scale were considered high quality. Discrepancies between reviewers were resolved by consensus or by a third reviewer. Given the marked heterogeneity in study settings, interventions and control groups we decided not to pool trial results in a meta-analysis. Instead, we summarized findings by strength of evidence and nature of intervention and control treatments. The evidence was judged to be strong when multiple high quality trials produced generally consistent findings. It was judged to be moderate when multiple low quality or one high quality and one or more low quality trials produced generally consistent findings. Evidence was considered to be limited when only one randomised trial existed or if findings of existing trials were inconsistent. MAIN RESULTS: Ten trials (12 randomised comparisons) were included. They randomised a total of 1964 patients with chronic low back pain. There was strong evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved function when compared with inpatient or outpatient non-multidisciplinary treatments. There was moderate evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary bio-psycho-social intervention. Some trials reported improvements in work readiness, but others showed no significant reduction in sickness leaves. Less intensive outpatient psycho-physical treatments did not improve pain, function or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care. Few trials reported effects on quality of life or global assessments. REVIEWER'S CONCLUSIONS: The reviewed trials provide evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improves pain and function. Less intensive interventions did not show improvements in clinically relevant outcomes.

Back Pain↗

PubMed2004

Bed rest for acute low-back pain and sciatica.

BACKGROUND: Low-back pain (LBP) is a common reason for consulting a general practitioner, and advice on daily activities is an important part of the primary care management of low-back pain. OBJECTIVES: To assess the effects of advice to rest in bed for patients with acute LBP or sciatica. SEARCH STRATEGY: We searched the Cochrane Back Group Specialized Registry, CENTRAL, MEDLINE, EMBASE, Sport, and SCISEARCH to March 2003, reference lists of relevant articles, and contacted authors of relevant articles. SELECTION CRITERIA: Randomised or controlled clinical trials with quasi-randomisation (alternate allocation, case record numbers, dates of birth, etc.), in any language, where the effectiveness of advice to rest in bed was evaluated. The main outcomes of interest were pain, functional status, recovery and return to work. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed the internal validity of included trials and extracted data. Investigators were contacted to obtain missing information. MAIN RESULTS: Eleven trials (1963 patients) were included in this updated version. There is high quality evidence that people with acute LBP who are advised to rest in bed have a little more pain [Standardised Mean Difference (SMD) 0.22 (95% Confidence Interval (CI): 0.02, 0.41)] and a little less functional recovery [SMD 0.29 (95% CI: 0.05, 0.45)] than those advised to stay active. For patients with sciatica, there is moderate quality evidence of little or no difference in pain [SMD -0.03 (95% CI: -0.24, 0.18)] or functional status [SMD 0.19 (95% CI: -0.02, 0.41)] between bed rest and staying active. For patients with acute LBP, there is moderate quality evidence of little or no difference in pain intensity or functional status between bed rest and exercises. For patients with sciatica, there is moderate quality evidence of little or no difference in pain intensity between bed rest and physiotherapy, but small improvements in functional status [Weighted Mean Difference 6.9 (on a 0-100 scale) (95% CI: 1.09, 12.74)] with physiotherapy. There is moderate quality evidence of little or no difference in pain intensity or functional status between two to three days and seven days of bed rest. REVIEWERS' CONCLUSIONS: For people with acute LBP, advice to rest in bed is less effective than advice to stay active. For patients with sciatica, there is little or no difference between advice to rest in bed and advice to stay active. There is little or no difference in the effect of bed rest compared to exercises or physiotherapy, or seven days of bed rest compared with two to three.

Acute Disease↗

PubMed2000

Botulinum toxin type A in the treatment of lower limb spasticity in cerebral palsy.

OBJECTIVES: To determine whether botulinum toxin (BtA) is an effective and safe treatment for lower limb spasticity in children with cerebral palsy. Functional outcomes are of particular interest. SEARCH STRATEGY: Studies for inclusion in the review were identified using the Movement Disorders Review Group trials register, the Cochrane Controlled Trials Register, MEDLINE, pharmaceutical company databases, communication with other researchers in the field and reference lists of papers found using above search strategies. SELECTION CRITERIA: Studies were considered eligible for inclusion in the review if they evaluated the efficacy of BtA for the treatment of leg spasticity in children with cerebral palsy. They must have been randomised and include a concurrent control group receiving another intervention. DATA COLLECTION AND ANALYSIS: A paper pro forma was used to collect data from the included studies using double extraction by two independent reviewers. Each trial was assessed for internal validity by each of the two reviewers. Meta-analysis was not possible because results were presented in an incompatable form. A Peto odds ratio was calculated where this was appropriate, otherwise a descriptive summary of the results of the individual studies was compiled. MAIN RESULTS: Three eligible studies were found each with small numbers of subjects. They were short term, used single injection sessions with follow-up of between 4 and 26 weeks. One study (Koman), of twelve ambulant children, compared BtA with injection of a placebo and found non-significant improvements in gait in the BtA group compared to the placebo group. Two studies (Corry, Flett) compared BtA with the use of casts. Each included 20 ambulant children and found improvements in gait, range of ankle movement and muscle tone in both the BtA and cast groups. However there were no significant differences between the groups in either trial. One of these trials (Flett) also assessed motor function using the gross motor function measure (GMFM) (Russell, 1989) and found significant improvements in each group compared to baseline but no significant differences between the groups. The other trial (Corry) performed 3D gait analysis on those children able to co-operate. Maximal plantar flexion and maximal dorsiflexion during walking were both found to be significantly greater in the BtA group compared to the cast group. In all other dimensions there were no significant differences between the groups. REVIEWER'S CONCLUSIONS: This systematic review has not revealed strong controlled evidence to support or refute the use of BtA for the treatment of leg spasticity in cerebral palsy. Ongoing randomised controlled trials are likely to provide useful data on the short term effects of BtA for leg spasticity. Future research should also assess the longer term use of BtA. Ideally studies should be pragmatic in their approach to dose and distribution of toxin to reflect practise. Outcome measures assessing function and disability would give the most useful information.

Botulinum Toxins, Type A↗

PubMed2001

Patient education for preventing diabetic foot ulceration.

BACKGROUND: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. OBJECTIVES: To assess the effectiveness of patient education on the prevention of foot ulcers in patients with diabetes mellitus. SEARCH STRATEGY: Eligible studies were identified by searching the Wounds Group Specialised Trials Register, which is compiled from regular searches of the major health care databases including MEDLINE, Cinahl and EMBASE, hand searching of wound care journals and relevant conference proceedings. For this review the Register was searched up to March 2001. SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for the prevention of foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality were undertaken by two reviewers independently. MAIN RESULTS: The methodological quality of the 8 included RCTs was poor. The internal validity score (range 0 - 10) of individual RCTs ranged from 2 to 4. Four trials compared the effect of intensive with brief educational interventions; 2 of these reported clinical endpoints. One study involving high-risk patients reported a reduction in ulcer incidence (Peto OR: 0.28 (95% CI 0.13,0.59)) and amputation rate (Peto OR: 0.32 (0.14,0.71)) after 1 year. The other RCT did not find an effect at seven years follow-up. Participants' foot care knowledge significantly improved with education in 2 trials. In one trial, foot care knowledge was significantly worse at 6 months, although foot care behaviour improved significantly. Non-calcaneal callus was significantly reduced by education in one trial. One RCT did not find that patient foot care education, as part of a general diabetes education program reduced foot ulceration compared with usual care. Patient education as part of a complex intervention targeted at both people with diabetes and doctors reduced the number of serious foot lesions at one year, in one RCT (OR: 0.41(0.16-1.00)) and improved foot care behaviour. Evidence from 2 RCTs comparing the effect of patient-tailored education in addition to usual care was conflicting. REVIEWER'S CONCLUSIONS: RCTs evaluating education for people with diabetes, aimed at preventing diabetic foot ulceration, are mostly of poor methodological quality. Existing data suggests that patient education may reduce foot ulceration and amputations, especially in high-risk patients. Foot care knowledge and behaviour of patients seem positively influenced by patient education in the short term. Because of conflicting results and the methodological shortcomings more RCTs are needed.

Diabetic Foot↗

PubMed2005

Patient education for preventing diabetic foot ulceration.

BACKGROUND: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. OBJECTIVES: To assess the effectiveness of patient education on the prevention of foot ulcers in patients with diabetes mellitus. SEARCH STRATEGY: Eligible studies were identified by searching the Cochrane Wounds Group Specialised Register, (September 2004) and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2004). SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for the prevention of foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. DATA COLLECTION AND ANALYSIS: Two reviewers undertook data extraction and assessment of study quality independently. MAIN RESULTS: Nine RCTs were included. Four trials compared the effect of intensive with brief educational interventions; two of these reported clinical endpoints. One study involving high-risk patients reported a reduction in ulcer incidence (Peto OR: 0.28 (95% CI 0.13 - 0.59)) and amputation rate (Peto OR: 0.32 (95% CI 0.14 - 0.71)) after one year. The other RCT did not find an effect at seven years follow-up. Participants' foot care knowledge significantly improved with education in two trials. In one trial foot care knowledge improved significantly in the control group, in contrast to the intervention group. Non-calcaneal callus was significantly reduced by education in one trial. One RCT did not find that patient foot care education, as part of a general diabetes education program, reduced foot ulceration compared with usual care. Patient education as part of a complex intervention, targeted at both people with diabetes and doctors, reduced the number of serious foot lesions at one year in one RCT (OR: 0.41(95% CI 0.16 -1.00)) and improved foot care behaviour. Evidence from three RCTs comparing the effect of patient-tailored education in addition to usual care was conflicting.The methodological quality of the nine included RCTs was poor. The internal validity score (range 0 - 10) of individual RCTs ranged from 2 to 5. AUTHORS' CONCLUSIONS: RCTs evaluating education for people with diabetes, aimed at preventing diabetic foot ulceration, are mostly of poor methodological quality. Weak evidence suggests that patient education may reduce foot ulceration and amputations, especially in high-risk patients. Foot care knowledge and behaviour of patients seem positively influenced by patient education in the short term. Because of conflicting results and the methodological shortcomings more RCTs are needed.

Diabetic Foot↗

PubMed2000

Lumbar supports for prevention and treatment of low back pain.

BACKGROUND: Lumbar supports are used in the treatment of low back pain patients to make the impairment and disability vanish or decrease. Lumbar supports are also used to prevent the onset of low back pain (primary prevention) or to prevent recurrences of a low back pain episode (secondary prevention). OBJECTIVES: The objective of this systematic review was to assess the effects of lumbar supports for prevention and treatment of non-specific low back pain. SEARCH STRATEGY: We searched the Medline, Cinahl and Current Contents databases and the Cochrane Controlled Trials Register up to September 1999, and the Embase database up to September 1998. We also screened references given in relevant reviews and identified controlled trials, and used Science Citation Index to identify additional controlled trials. SELECTION CRITERIA: Controlled clinical trials that reported on any type of lumbar supports as preventive or therapeutic intervention for non-specific low back pain were included. DATA COLLECTION AND ANALYSIS: One reviewer extracted data from the trials considering characteristics of the study population, characteristics of the interventions and the final results for each outcome measure. The reviewer compared these findings to data regarding the same characteristics of the same studies published already in other reviews. The methodological quality was independently assessed by two reviewers. Because it was not possible to perform a quantitative analysis, a qualitative meta-analysis was performed in which the strength of evidence on the effectiveness of lumbar supports was classified as being strong, moderate, limited or conflicting, and no evidence. MAIN RESULTS: Five randomized and two nonrandomized controlled preventive trials and six randomized therapeutic trials were included in our review. Overall the methodological quality of the studies included in our review was rather low. Only four of the thirteen studies scored positive on 50% or more of the the internal validity items. There was moderate evidence that for primary prevention lumbar supports are not more effective than other types of treatment or no intervention. No evidence was found on the effectiveness of lumbar supports for secondary prevention. The systematic review of therapeutic trials showed that there is limited evidence that lumbar supports are more effective than no treatment, while it is still unclear if lumbar supports are more effective than other interventions for treatment of low back pain. REVIEWER'S CONCLUSIONS: There is still a need for high quality randomised trials on the effectiveness of lumbar supports. One of the most essential issues to tackle in these future trials seems to be the realisation of an adequate compliance.

Braces↗

PubMed2006

Biphasic versus triphasic oral contraceptives for contraception.

BACKGROUND: Side effects caused by oral contraceptives discourage compliance with, and continuation of, oral contraceptives. A suggested disadvantage of biphasic compared to triphasic oral contraceptive pills is an increase in breakthrough bleeding. We conducted this systematic review to examine this potential disadvantage. OBJECTIVES: To compare biphasic with triphasic oral contraceptives in terms of efficacy, cycle control, and discontinuation due to side effects. SEARCH STRATEGY: We searched MEDLINE, EMBASE, POPLINE, LILACS and CENTRAL. We searched the reference lists of relevant articles and book chapters. We also contacted the authors of relevant studies and pharmaceutical companies in Europe and the USA. SELECTION CRITERIA: We included randomized controlled trials comparing any biphasic with any triphasic oral contraceptive when used to prevent pregnancy. DATA COLLECTION AND ANALYSIS: We examined the studies found during the searches for possible inclusion and assessed methodological quality using Cochrane guidelines. We contacted the authors of included studies and of possibly randomized studies for supplemental information about the methods and outcomes. We entered the data into RevMan. We calculated Peto odds ratios for incidence of discontinuation due to medical reasons, intermenstrual bleeding, and absence of withdrawal bleeding. MAIN RESULTS: Only two trials of limited quality met our inclusion criteria. Larranaga 1978 compared two biphasic pills and one triphasic pill, each containing levonorgestrel and ethinyl estradiol. No important differences emerged, and the frequency of discontinuation due to medical problems was similar with all three pills. Percival-Smith 1990 compared a biphasic pill containing norethindrone (Ortho 10/11) with a triphasic pill containing levonorgestrel (Triphasil) and with another triphasic containing norethindrone (Ortho 7/7/7). The biphasic pill had inferior cycle control compared with the levonorgestrel triphasic. The odds ratio of cycles with intermenstrual bleeding was 1.7 (95% CI 1.3 to 2.2) for the biphasic compared with the triphasic levonorgestrel pill. The odds ratio of cycles without withdrawal bleeding was 6.5 (95% CI 3.1 to 13). In contrast, cycle control with the biphasic pill was comparable to that of the triphasic containing the same progestin (norethindrone). AUTHORS' CONCLUSIONS: The available evidence is limited and the internal validity of these trials is questionable. Given the high losses to follow up, these reports may even be considered observational. Given that caveat, the biphasic pill containing norethindrone was associated with inferior cycle control compared with the triphasic pill containing levonorgestrel. The choice of progestin may be more important than the phasic regimen in determining bleeding patterns.

Contraception↗

PubMed2001

Conservative treatment for whiplash.

BACKGROUND: Many treatments are available for whiplash-patients, but to date, no evidence exists for their effectiveness. OBJECTIVES: The objective of this systematic review was to assess the efficacy of conservative treatment in patients with whiplash-injuries (rated as Whiplash-Associated Disorders [WAD] I or II). SEARCH STRATEGY: A computerized literature search of Medline, Embase, Cinahl, Psychlit and the Cochrane Controlled Trial Register through June 1998 was carried out. We also screened reference lists of publications of identified randomized trials and relevant systematic reviews. SELECTION CRITERIA: Studies were selected for inclusion if they fit the following criteria: design was a (randomized) clinical trial (RCT); all patients had suffered a whiplash-injury; the type of intervention was a conservative one; pain, global perceived effect, or participation in daily activities was used as one of the outcome measures; and the publication was written in English, French, German or Dutch. DATA COLLECTION AND ANALYSIS: The methodological quality of the studies was independently assessed by two reviewers using the Maastricht-Amsterdam list. Three quality scores were calculated using this criteria list: the Overall methodological Quality Score, the Internal Validity Score and the Delphi Quality Score. The conclusion of the review was based on articles that scored a quality score of at least 50 percent of the maximum available score on two out of three quality scores. MAIN RESULTS: Eleven studies met the inclusion criteria. A broad variety of conservative interventions were evaluated, and only one study was performed in chronic whiplash patients. Only three studies satisfied at least 50 percent on two out of three quality scores indicating poor overall methodological quality. A high rank correlation was observed among the three methods of quality. Because of the heterogeneity of patient selection, interventions and outcome measures, no statistical pooling was performed. This review indicates that active treatments show a beneficial effect on at least one of the primary outcome measures, preferably pain. REVIEWER'S CONCLUSIONS: It appears that "Rest makes rusty." In other words, rest and immobilization using collars are not recommended for the treatment of whiplash, while active interventions, such as advice to 'maintain usual activities' might be effective in whiplash-patients. Nevertheless, caution is needed when attempting to draw conclusions regarding the efficacy of conservative treatments in whiplash-patients, because of the paucity of high-quality studies. No conclusions can be drawn about the most effective therapy for chronic whiplash-patients because only one low quality trial was identified.

Activities of Daily Living↗

PubMed2004

Botulinum toxin A as an adjunct to treatment in the management of the upper limb in children with spastic cerebral palsy.

BACKGROUND: Cerebral palsy (CP) is a central nervous system deficit resulting from a non-progressive lesion in the developing brain. Although the brain lesions are static, the movement disorders that arise are not unchanging and are characterised by atypical muscle tone, posture and movement (Rang 1990). The spastic motor type is the most common form of CP and its conventional therapeutic management may include splinting/casting, passive stretching, facilitation of posture and movement, spasticity-reducing medication and surgery. More recently, health care professionals have begun to use botulinum toxin A (BtA) as an adjunct to interventions in an attempt to reduce muscle tone and spasticity to improve function OBJECTIVES: To assess the effectiveness of intramuscular BtA injections as an adjunct to managing the upper limb in children with spastic CP. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2003), MEDLINE (1966 to March Week 3 2004), EMBASE (1980 to 2003 Week 16) and CINAHL (1982 to Week 3 March 2004). SELECTION CRITERIA: All randomised controlled trials (RCTs) comparing intramuscular BtA injections into any muscle group of the upper limb with placebo, no treatment or other interventions. DATA COLLECTION AND ANALYSIS: Two authors using standardised forms extracted the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data was extracted and entered into RevMan 4.2.3. MAIN RESULTS: Two trials met the inclusion criteria, each having short-term follow up, a small number of subjects and using a single set of injections. The study by Corry 1997 compared BtA with an injection of normal saline and found promising results in elbow extension, elbow and wrist muscle tone. At three months, encouraging results for wrist muscle tone and grasp and release were noted. The trial reported median change, range of changes and the difference in these measures between groups. The study by Fehlings 2000 compared BtA with no intervention. When data were analysed no treatment effect was found for quality of upper limb function, passive range of motion, muscle tone, grip strength or self-care ability. REVIEWERS' CONCLUSIONS: This systematic review has not found sufficient evidence to support or refute the use of intramuscular injections of BtA as an adjunct to managing the upper limb in children with spastic cerebral palsy. Only one of the two identified RCTs reported some promising results in support of reduced muscle tone following BtA injections. Further research incorporating larger sample sizes, rigorous methodology, measurement of upper limb function and functional outcomes is essential.

Botulinum Toxins, Type A↗

PubMed2004

Botulinum toxin A as an adjunct to treatment in the management of the upper limb in children with spastic cerebral palsy.

Adolescent↗

PubMed2006

Marital therapy for depression.

BACKGROUND: Marital therapy for depression has the two-fold aim of modifying negative interaction patterns and increasing mutually supportive aspects of couple relationships, thus changing the interpersonal context linked to depression. OBJECTIVES: 1. To conduct a meta-analysis of all intervention studies comparing marital therapy to other psychosocial and pharmacological treatments, or to non-active treatments. 2. To conduct an assessment of the internal validity and external validity. 3. To assess the overall effectiveness of marital therapy as a treatment for depression. 4. To identify mediating variables through which marital therapy is effective in depression treatment. SEARCH STRATEGY: CCDANCTR-Studies was searched on 5-9-2005, Relevant journals and reference lists were checked. SELECTION CRITERIA: Randomised controlled trials examining the effectiveness of marital therapy versus individual psychotherapy, drug therapy or waiting list/no treatment/minimal treatment for depression were included in the review. Quasi-randomised controlled trials were also included. DATA COLLECTION AND ANALYSIS: Data were extracted using a standardised spreadsheet. Where data were not included in published papers, two attempts were made to obtain the data from the authors. Data were synthesised using Review Manager software. Dichotomous data were pooled using the relative risk (RR), and continuous data were pooled using the standardised mean difference (SMD), and 95% confidence intervals (CIs) were calculated. The random effects model was employed for all comparisons. A formal test for heterogeneity, the natural approximate chi-squared test, was also calculated. MAIN RESULTS: Eight studies were included in the review. No significant difference in effect was found between marital therapy and individual psychotherapy, either for the continuous outcome of depressive symptoms, based on six studies: SMD -0.12 (95% CI -0.56 to 0.32), or the dichotomous outcome of proportion of subjects remaining at caseness level, based on three studies: RR 0.84 (95% CI 0.32 to 2.22). In comparison with drug therapy, a lower drop-out rate was found for marital therapy: RR 0.31 (95% CI 0.15 to 0.61), but this result was greatly influenced by a single study. The comparison with no/minimal treatment, showed a large significant effect in favour of marital therapy for depressive symptoms, based on two studies: SMD -1.28 (95% CI -1.85 to -0.72) and a smaller significant effect for persistence of depression, based on one study only. The findings were weakened by methodological problems affecting most studies, such as the small number of cases available for analysis in almost all comparisons, and the significant heterogeneity among studies. AUTHORS' CONCLUSIONS: There is no evidence to suggest that marital therapy is more or less effective than individual psychotherapy or drug therapy in the treatment of depression. Improvement of relations in distressed couples might be expected from marital therapy. Future trials should test whether marital therapy is superior to other interventions for distressed couples with a depressed partner, especially considering the role of potential effect moderators in the improvement of depression.

Depression↗

PubMed2005

Botulinum toxin type A versus botulinum toxin type B for cervical dystonia.

Botulinum Toxins↗

PubMed2005

Botulinum toxin type B for cervical dystonia.

BACKGROUND: Cervical dystonia is the most common form of focal dystonia. It is characterized by involuntary posturing of the head and frequently is associated with neck pain. Disability and social withdrawal are common. Most cases of cervical dystonia are idiopathic and generally it is a life-long disorder. In recent years, Botulinum toxin type A (BtA) has become the first line therapy. However, some patients become resistant to it. This problem led to the study of another Botulinum toxin (Bt) serotype, Bt type B (BtB) to address the issues of clinical efficacy, effect size, and safety of BtB in the treatment of cervical dystonia. OBJECTIVES: To determine whether botulinum toxin (BtB) is an effective and safe treatment for cervical dystonia. SEARCH STRATEGY: We identified studies for inclusion in the review using the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE; and by handsearching the Movement Disorders Journal and abstracts of international congresses on movement disorders and botulinum toxin, by communication with other researchers in the field, by searching reference lists of papers found using the above search strategies, and by contacting authors and drug manufacturers. SELECTION CRITERIA: We considered studies eligible for inclusion in the review if they evaluated the efficacy of BtB for the treatment of cervical dystonia in randomized, placebo-controlled trials. DATA COLLECTION AND ANALYSIS: We used a paper pro forma to collect data from the included studies with double extraction by two independent reviewers. Both reviewers assessed each trial for internal validity and settled differences by discussion. The outcome measures used included adverse events, improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, changes in pain scores, changes in quality of life assessments. MAIN RESULTS: Studies were short term (16 weeks) employing a single BtB injection session. All were multicentre and conducted in the US. All patients included had previously received BtA. The trials differed with respect to whether or not the patients were still responding to BtA but other entry criteria were similar. All studies used a dose of 10,000 Units of BtB in one group and the technique of administration was the same. Meta-analysis of three trials enrolling 308 participants showed statistically and clinically significant improvements in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score at week four with a Peto odds ratio (OR) for the number of patients who had at least a 20% improvement of 4.69 (95% CI 2.06 to 10.69) and a weighted mean difference of -5.92 (95% CI -9.61 to -2.23). Subjective rating scales (Patient Global Assessment of Change, Investigator Global Assessment of Change, and Patient Analog Pain Assessment) also improved. Adverse events clearly associated with the mechanism of action of BtB included dysphagia and dry mouth and the number of patients with any adverse event were more frequent in BtB treatment groups. Subgroup analyses showed a clear dose-response relationship for subjective and objective benefit, for frequency and severity of adverse events, and a greater benefit for BtA resistant patients than BtA responders in the primary outcome. The duration of effect was about 16 weeks. We found three eligible studies enrolling 308 participants. Studies were short term (16 weeks) employing a single BtB injection session. All were multicentre and conducted in the US. All patients included had previously received BtA. The trials differed with respect to whether or not the patients were still responding to BtA but other entry criteria were similar. Patient groups were appropriately selected and well matched. From the methodological point of view these trials were probably not subjected to important selection, performance or attrition bias and all studies used an intention-to-treat analysis.The dose varied significantly between studies although all used 10,000 Units of BtB in one group and the technique of administration was the same. The primary outcome in all trials was change in TWSTRS total score at week four and other efficacy outcomes were similar between studies. The number of dropouts was small and balanced in all trials. Reasons for withdrawals were given. One randomized double-blind placebo-controlled study was excluded because data couldn't be extracted for the outcomes. Meta-analysis showed statistically and clinically significant improvements with a Peto odds ratio (OR) of 20% in TWSTRS total score at week four (OR 4.69; 95% CI 2.06 to 10.69) and a weighted mean difference of -5.92 (95% CI -9.61 to -2.23). Subjective rating scales (Patient Global Assessment of Change, Investigator Global Assessment of Change, and Patient Analog Pain Assessment) also improved. The weighted mean difference for changes in these subjective scales varied between -13% to -21%. However, for many of the outcomes, we could not combine data from all studies. Only adverse events clearly associated with the mechanism of action of BtB were more frequent in the treatment group. These included dysphagia and dry mouth. The number of patients with any adverse event was more frequent with BtB. Subgroup analyses showed a clear dose-response relationship for subjective and objective benefit and for frequency and severity of adverse events. Subgroup analyses showed a greater benefit for the BtA resistant patients than BtA responders in the primary outcome. The duration of effect was about 16 weeks. These trials did not measure quality of life nor did they establish the long term duration of effect or immunogenicity AUTHORS' CONCLUSIONS: A single injection of BtB was effective and safe for treating cervical dystonia. Long-term uncontrolled studies suggested that further injection cycles continue to work for most patients. Future research should explore technical factors such as the optimum treatment intervals and use of image or electromyographic guidance for administration. Other issues include service delivery, quality of life, long-term efficacy and safety, and the relative indications for BtA, BtB and other treatments such as deep brain stimulation.

Botulinum Toxins↗

PubMed2005

Laxatives for the treatment of hemorrhoids.

BACKGROUND: Symptomatic hemorrhoids are a common medical condition, which increase in prevalence in women during pregnancy and postpartum. Although the evidence appears to be inconclusive, narrative reviews and clinical practice guidelines recommend the use of laxatives (and fiber) for the treatment of hemorrhoids and relief of symptoms. This is due to their safety and low cost. OBJECTIVES: To evaluate the impact of laxatives on a wide range of symptoms in people with symptomatic hemorrhoids. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2005), MEDLINE (1966 to 2005), EMBASE (1980 to 2005), CINAHL (1982 to 2005), BIOSIS, and AMED (Allied and Alternative Medicine Database), for eligible trials (including conference proceedings). We sought missing and additional information from authors, industry, and experts in the field. SELECTION CRITERIA: We selected all published and unpublished randomised controlled trials that compared any type of laxative to placebo or no therapy in any patient population. DATA COLLECTION AND ANALYSIS: Two authors independently screened studies for inclusion and retrieved all potentially relevant studies. Data were extracted from studies that met our selection criteria on study population, intervention used, pre-specified outcomes, and methodology. We extracted methodological information for the assessment of internal validity: existence and method of generation of the randomization schedule, and method of allocation concealment; blinding of caregivers and outcomes assessors; numbers of and reasons for participants lost to follow up; and use of validated outcome measures. MAIN RESULTS: Seven randomised trials enrolling a total of 378 participants to fiber or a non-fiber control were identified. Meta-analyses using random-effects models showed that laxatives in the form of fiber had a beneficial effect in the treatment of symptomatic hemorrhoids. The risk of not improving hemorrhoids and having persisting symptoms decreased by 53% in the fiber group (risk reduction (RR) 0.47, 95% CI 0.32 to 0.68). These results are compatible with large treatment effects regarding prolapse, pain, itching, although the pooled analyses showed a tendency toward no-effect for these parametres. The effect on bleeding showed a significant difference in favour of the fiber (RR 0.50, 95% CI 0.28 to 0.89). Studies including data on multiple follow ups (usually after six weeks and three months) showed consistent results over time. However, we have to stress two possible limitations of this review: the risk of publication bias, and only moderate study quality. AUTHORS' CONCLUSIONS: The use of fiber shows a consistent beneficial effect for relieving overall symptoms and bleeding in the treatment of symptomatic hemorrhoids.

Cathartics↗

PubMed2004

Hyperbaric oxygen therapy for thermal burns.

BACKGROUND: Hyperbaric oxygen therapy (HBOT) consists of intermittently administering 100% oxygen at pressures greater than 1 atmosphere in a pressure vessel. This technology has been used to treat a variety of disease states and has been described as helping patients who have sustained burns. OBJECTIVES: The aim of this review was to assess the evidence for the benefit of hyperbaric oxygen treatment (HBOT) for the treatment of thermal burns. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2002), MEDLINE (Ovid 1966 to November Week 2, 2003), CINAHL (Ovid 1982 to December Week 2 2003), EMBASE (Ovid 1980 to September 2003), DORCTHIM (Database of Randomised Controlled Trials in Hyperbaric Medicine) from inception to 2003, and reference lists of articles. SELECTION CRITERIA: We included all randomised controlled trials that compared the effect of HBOT with no HBOT (no treatment or sham). DATA COLLECTION AND ANALYSIS: Two authors using standardised forms extracted the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data was extracted and entered into RevMan 4.2.3. MAIN RESULTS: Four randomised controlled trials were identified, of which two satisfied the inclusion criteria. The trials were of poor methodological quality. As a result, it was difficult to have confidence in the individual results and it would not have been appropriate to attempt to pool the data. One trial reported no difference in length of stay, mortality, or number of surgeries between the control and HBO-treated groups once these variables were adjusted for the patient's condition. The second trial reported mean healing times that were shorter in patients exposed to HBOT (mean: 19.7 days versus 43.8 days). REVIEWERS' CONCLUSIONS: This systematic review has not found sufficient evidence to support or refute the effectiveness of HBOT for the management of thermal burns. Evidence from the two randomised controlled trials is insufficient to provide clear guidelines for practice. Further research is needed to better define the role of HBOT in the treatment of thermal burns.

Burns↗

PubMed2005

Hyperbaric oxygen therapy for acute ischaemic stroke.

BACKGROUND: Most cases of stroke are caused by impairment of blood flow to the brain (ischaemia) which results in a reduction in oxygen available and subsequent cell death. It has been postulated that hyperbaric oxygen therapy (HBOT) may reduce the volume of brain that will die by greatly increasing the oxygen available, and it may further improve outcome by reducing brain swelling. Some centres are using HBOT routinely to treat stroke. OBJECTIVES: To assess the effectiveness and safety of adjunctive HBOT in the treatment of acute ischaemic stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched 9 January 2004), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 3, 2004), MEDLINE (1966 to July 2004), EMBASE (1980 to July 2004), CINAHL (1982 to July 2004), and DORCTHIM (Database of Randomised Controlled Trials in Hyperbaric Medicine) (from inception to 2004). We handsearched journals and conference proceedings, searched reference lists of articles, and contacted researchers in an effort to identify additional published and unpublished studies. SELECTION CRITERIA: We included all randomised controlled trials that compared the effect of adjunctive HBOT with no HBOT (no treatment or sham). DATA COLLECTION AND ANALYSIS: Two authors used standardised forms to extract the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data were extracted and entered into RevMan 4.2. MAIN RESULTS: Three randomised controlled trials (106 participants) satisfied the inclusion criteria. The methodological quality of the trials varied but was generally high. Data could be pooled for a limited number of clinically important outcomes. There were no significant differences in mortality rate at six months in those receiving HBOT compared to the control group (relative risk 0.61, 95% confidence interval (CI) 0.17 to 2.2, P value 0.45). Two of 15 scale measures of disability and functional indicated an improvement following HBOT, both at one year follow up: the mean Trouillas Disability Scale was lower with HBOT (mean difference (MD) 2.2 points reduction with HBOT, 95% CI 0.15 to 4.3, P value 0.04) and the mean Orgogozo Scale was higher (MD 27.9 points, 95% CI 4.0 to 51.8, P value 0.02). These improvements were not reflected in other trials or functional scales. AUTHORS' CONCLUSIONS: This systematic review has not found evidence to show that HBOT improves clinical outcomes when applied during the acute presentation of ischaemic stroke. While evidence from the three randomised controlled trials is insufficient to provide clear guidelines for practice, clinical benefit does not seem likely. Further research is required to better define the role of HBOT in this condition.

Brain Ischemia↗

PubMed2006

Acupuncture for treatment of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS), a disorder of altered bowel habits associated with abdominal pain or discomfort. The pain, discomfort, and impairment from IBS often lead to healthcare medical consultation (Talley 1997) and workplace absenteeism, and associated economic costs (Leong 2003). A recent randomized controlled trial shows variable results but no clear evidence in support of acupuncture as an effective treatment for IBS (Fireman 2001). OBJECTIVES: The objective of this systematic review is to determine whether acupuncture is more effective than no treatment, more effective than 'sham' (placebo) acupuncture, and as effective as other interventions used to treat irritable bowel syndrome. Adverse events associated with acupuncture were also assessed. SEARCH STRATEGY: The following electronic bibliographic databases were searched irrespective of language, date of publication, and publication status: MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, EMBASE, the Chinese Biomedical Database, the Cumulative Index to Nursing and Allied Health (CINAHL), and the Allied and Complementary Medicine Database (AMED). References in relevant reviews and RCTs were screened by hand. The last date for searching for studies was 7 February 2006. SELECTION CRITERIA: Published reports of randomized controlled trials (RCTs) and quasi-randomised trials of acupuncture therapy for IBS. DATA COLLECTION AND ANALYSIS: All eligible records identified were dually evaluated for eligibility and dually abstracted. Methodological quality was assessed using the Jadad scale and the Linde Internal Validity Scale. Data from individual trials were combined for meta-analysis when the interventions were sufficiently similar. Heterogeneity was assessed using the I squared statistic. MAIN RESULTS: Six trials were included. The proportion of responders, as assessed by either the global symptom score or the patient-determined treatment success rate, did not show a significant difference between the acupuncture and the sham acupuncture group with a pooled relative risk of 1.28 (95% CI 0.83 to 1.98; n=109). Acupuncture treatment was also not significantly more effective than sham acupuncture for overall general well-being, individual symptoms (e.g., abdominal pain, defecation difficulties, diarrhea, and bloating), the number of improved patients assessed by blinded clinician, or the EuroQol score. For two of the studies without a sham control, acupuncture was more effective than control treatment for the improvement of symptoms: acupuncture versus herbal medication with a RR of 1.14(95% CI 1.00 to 1.31; n=132); acupuncture plus psychotherapy versus psychotherapy alone with a RR of 1.20 (95% CI 1.03 to 1.39; n=100). When the effect of ear acupuncture treatment was compared to an unclearly specified combination of one or more of the drugs diazepam, perphenazine or domperidone, the difference was not statistically significant with a RR of 1.49(95% CI 0.94 to 2.34; n=48). AUTHORS' CONCLUSIONS: Most of the trials included in this review were of poor quality and were heterogeneous in terms of interventions, controls, and outcomes measured. With the exception of one outcome in common between two trials, data were not combined. Therefore, it is still inconclusive whether acupuncture is more effective than sham acupuncture or other interventions for treating IBS.

Acupuncture Therapy↗