G. ter Riet

Ultrasound therapy for musculoskeletal disorders : a systematic review

BACKGROUNDnUltrasound therapy is used frequently to reduce pain and related disability, mainly by physiotherapists. The objective of this review was to evaluate the effectiveness of ultrasound therapy in the treatment of musculoskeletal disorders.nnnMETHODSnPublished reports of randomized clinical trials investigating the effects of ultrasound therapy on pain, disability or range of motion were identified by a systematic search of MEDLINE, EMBASE and the Cochrane databases, supplemented with citation tracking. The quality of methods of all selected publications was assessed systematically by two independent and blinded reviewers, using ten validity criteria. Data from the original publications were used to calculate the differences between groups for success rate, pain, disability and range of motion. Statistical pooling was performed if studies were homogeneous with respect to study populations, interventions, outcome measures and timing of follow-up.nnnRESULTSn38 Studies were included in the review, evaluating the effects of ultrasound therapy for lateral epicondylitis (n = 6), shoulder pain (n = 7), degenerative rheumatic disorders (n = 10), ankle distorsions (n = 4), temporomandibular pain or myofacial pain (n = 4) and a variety of other disorders (n = 7). In 11 out of 13 placebo-controlled trials with validity scores of at least five out of ten points, no evidence of clinically important or statistically significant results was found. Statistical pooling was only feasible for placebo-controlled trials on lateral epicondylitis, and produced a pooled estimate for the difference in success rate of 15% (95% confidence interval -8%-38%).nnnCONCLUSIONSnAs yet, there seems to be little evidence to support the use of ultrasound therapy in the treatment of musculoskeletal disorders. The large majority of 13 randomized placebo-controlled trials with adequate methods did not support the existence of clinically important or statistically significant differences in favour of ultrasound therapy. Nevertheless, our findings for lateral epicondylitis may warrant further investigation.

Ultrasound therapy for acute ankle sprains.

BACKGROUNDnUltrasound is used in the treatment of a wide variety of musculoskeletal disorders.nnnOBJECTIVESnTo evaluate the effects of ultrasound therapy in the treatment of acute ankle sprains.nnnSEARCH STRATEGYnMEDLINE and EMBASE up to December 1998 and databases of the Cochrane Rehabilitation and Related Therapies Field and Musculoskeletal Injuries Group were searched. This was supplemented with citation tracking, and contact with colleagues. Date of the most recent search: April 1999.nnnSELECTION CRITERIAnRandomised or pseudo-randomised trials were included in the review if the following conditions were met: at least one study group was treated with active ultrasound; the study included patients with acute lateral ankle sprains; and outcome measures included general improvement, pain, swelling, functional disability, or range of motion. Final selection of papers was conducted by two independent reviewers.nnnDATA COLLECTION AND ANALYSISnTwo reviewers independently assessed trial quality using a standardised checklist, and extracted data. Whenever possible, the results were analysed on an intention-to-treat basis. Fixed odds ratios together with 95% confidence intervals were calculated for dichotomous outcomes, and weighted or, where different scales were used, standardised mean differences together with 95% confidence intervals for continuous outcome measures. Pooling of data was undertaken where there was clinical homogeneity in terms of subjects, treatments, outcomes, and follow-up time points.nnnMAIN RESULTSnThe four included trials, involving 514 patients, were only of modest methodological quality. None of the three placebo-controlled trials (sham ultrasound) could demonstrate statistically significant differences between true and sham ultrasound therapy for any outcome measure at seven days of follow-up. The pooled odds ratio for general improvement was 1.19 (Peto fixed effects model, 95% confidence interval 0.73 to 1.93) for the comparison between ultrasound and sham ultrasound. The differences between intervention groups were generally small, between 0 and 6% for most dichotomous outcomes. However, one trial reported relatively large differences for pain free status (20%) and swelling (25%) in favour of ultrasound treatment.nnnREVIEWERS CONCLUSIONSnThe extent and quality of the available evidence for the effects of ultrasound therapy for acute ankle sprains are limited. The results of three placebo-controlled trials do not support the use of ultrasound in the treatment of ankle sprains. The magnitude of most reported treatment effects appeared to be small, and may be of limited clinical importance. As yet, only few trials are available and no conclusions can be made regarding an optimal and adequate dosage schedule for ultrasound therapy, and whether such a schedule would improve on the reported effectiveness of ultrasound for ankle sprains.

Precision of Dual Energy X-ray Absorptiometry in Determining Periprosthetic Bone Mineral Density of the Hydroxyapatite Coated Hip Prosthesis

The objectives of this study were to demonstrate the potential usefulness of dual-energy X-ray absorptiometry (DEXA) in the assessment of dynamic changes in bone mineral density (BMD) around the femoral stem of non cemented hydroxyapatite-coated hip prostheses and to establish our procedures by determining the variabilities associated with error introduced by the machine, operator, and/or subject. Methods Regional BMD were measured twice by DEXA for 27 patients. All scans were analysed twice by applying large size regions of interest (ROIs), 7 in total, defined by ‘modified’ Gruen zones. The data of 27 patients were analysed for the second time using smaller size ROIs, 14 in total, 7 small ROIs on each of the medial and lateral sides of the prosthesis. Three patients, all of whom exhibited intense ectopic ossification, were scanned twice. The variation associated with rotation of the femur was assessed by scanning six patients first in neutral rotation, thereafter by ± 15° in internal and external rotation position. Results: The overall coefficient of variation (CV) using ‘modified’ Gruen zones was 2.40% and varied according to the zone assessed. When smaller zones were used, the overall CV was 3.42%. The overall CV in the patients with ectopic ossification was 7.56%. When the leg was rotated by ± 15° externally or internally, the overall CV was approximately 10%. Conclusions Patient positioning is probably the most variable condition in the clinical setting. Using large ROIs such as ‘modified’ Gruen zones yields significantly better overall precision than using smaller ROIs. Patients with intense ectopic ossification are not suitable candidates for longitudinal study.

Commentary on rampes et al ‘Does electroacupuncture reduce craving for alcohol? A randomized controlled study’

Dr Rampes and co-workers cite our criteria-based meta-analysis on the effects of (electro)acupuncture that was published 6 years ago. 1 It showed, especially for studies on smoking cessation, that good study design was associated with negative study outcome? In this critical commentary, we show that a negative study outcome (compare groups 1 and 2 in Rampes et als study 1) does not always indicate good study design. Table 1 reproduces the criteria for good methodology that we used in 1990, showing the maximum score and the actual score for the study by Rampes et al? It is clear from the total score (at most 55 out of 100) that there would have been room for improvements. The study illustrates that the designation of study outcomes as positive or negative on the basis of statistical significance (P < cQ can sometimes be arbitrary in more than one way. First, even if we focus only on the outcomes for craving at week 8, the study is negative if we compare groups 1 and 2, but it is positive if we compare group 1 (or 2) with group 3. Second, let us not forget that the (orthodox) choice of an o~-level of 5% is arbitrary. Recently, one of us (AGHK) designed a list of criteria that enables one to judge the usefulness and the quality of clinical trials in a much more consistent way than the one we used in 1990. This list is presented in Table 2, which also illustrates how we (re)assessed the study by Rampes et al. 1 We shall mollify our somewhat reductionist approach by commenting briefly on the rationales behind our judgments. Suppose we are evidence-based practitioners contemplating the use of auricular electroacupuncture (AEA) as an adjunct to conventional treatment for

Do Endorphins Mediate Placebo Analgesia? A Critical Commentary on One of the Seminal Papers

There are only few experimental studies that assess the hypothesis that placebo analgesia is mediated by endogenous opioids. One of these studies [Grevert P, Albert LH, Goldstein A: Partial antagonism of placebo analgesia by naloxone. Pain 1983;16:129–143] had a rather complicated design and data presentation. In this commentary we attempt to clarify the experimental design of that study. Based on a clearer understanding of the study procedures and data analysis we ropose some alternative interpretations of the results.

V. Die Vision einer pragmatischen klinischen Forschung: Methodologie und Studiendesigns / The Vision of Pragmatic Clinical Research: Methodology and Study Designs

Summary The aim of this overview is to discuss the usefulness of two rexad search tools often advocated in complementary medicine: the n = 1 study and case series. These methodologies are defined and their advantages and disadvantages are outlined. It is concluded that both designs have advantages and disadvantages. For testing the efxad ficacy/effectiveness of complementary therapies neither design will lead to conclusive, generalizable results. Yet both methodologies can be valuable adjuncts to other types of investigation.

IV. Die Aufgabe der Medizin und ihre Wissenschaft: Wissenschaftlichkeit als Kompromiss zwischen Wirkungsspezifität und Praxissensitivität / The Mission of Medicine and Its Science: Scientific Soundness Is a Compromise between the Specificity of an Effect and Its Sensitivity to Practice

Objectives: To review the effectiveness of prayer as an additional intervention for those with health problems already receiving standard medical care. Search Strategy: Electronic Searches of Biological Abstracts, CINAHL, The Cochrane Controlled Trials Register, EMBASE, MEDLINE, PsycLIT, and Sociofile were undertaken. All references of articles selected were searched for further relevant trials. Selection Criteria: Randomised and quasi-randomised trials of personal, focused, committed and organised intercessory prayer on behalf of anyone with a health problem were considered. Outcomes such as achievement of desired goals, death, illness, quality of life and well-being for the recipients of prayer, those praying and the caregivers were sought. Data Collection and Analysis: Studies were reliably selected and assessed for methodological quality. Data were extracted by 4 reviewers working independently. Dichotomous data were analysed on an intention-to-treat basis, and continuous data with over 50% completion rate are presented. Main Results: There was no evidence that prayer affected the numbers of people dying from leukaemia or heart disease (OR 0.64, CI 0.32-1.27), or that it decreased coronary care complications (OR 1.05, CI0.49-2.26) or the time participants stayed in hospital. There were significantly fewer intermediate/poor outcomes for those with heart disease in the prayed-for group (OR 0.49, CI0.300.80), and this finding was robust to some changes in definition. Conclusions: This review provides no guidance for those wishing to uphold or refute the effect of intercessory prayer on the outcomes studied in the available trials. Therefore, in the light of the best available data, there are no grounds to change current practices. There are very few completed trials of the value of intercessory prayer. The evidence presented so far is interesting enough to justify further study. If prayer is seen as a human endeavour it mayor may not be beneficial, and further trials could uncover this. It could be the case that any effects are due to elements beyond present scientific understanding that will, in time, be understood. If any benefit derives from Gods response to prayer it may be beyond any such trials to prove or disprove. Schlusselworter Ftirbitte . Systematische Reviews· Randomisierung

III. Empirische Dokumentation von Wirkung und Nutzen in der Hierarchie der Evidenz / Empirical Documentation of Efficacy and Benefit in the Hierarchy of Evidence

Die Medizin als Wissenschaft hat heute die Aufgabe, sich auf eine moÈ glichst intelligente empirische Dokumentation von Therapiewirkung und Therapienutzen zu verstaÈndigen. Fragen der Wirkungsmechanismen bleiben da, aber sie gehen in den Hinterkopf. Der oft noch nicht recht wahrgenommene markante historische Wandel, welcher die neue Schulmedizin der «Evidence-Based Medicine» mit sich bringt, besteht im neuen Evidenz-Begriff. Dieser stellt Wirkungstheorien und das VerstaÈndnis physiologischer Wirkungsmechanismen auf die Stufe blosser Hypothesen und setzt die Ergebnisse kontrollierter, empirischer Studien an die Spitze der Hierarchie der Evidenz. Mit der neuen Grundlagenwissenschaft der klinischen Epidemiologie misst sich die Wissenschaftlichkeit von Medizin heute an der QualitaÈ t der empirischen Wirkungsund Nutzensdokumentation (und nicht mehr an der pathophysiologischen PlausibilitaÈt oder KonformitaÈt einer Wirkungstheorie). FuÈ r die QualitaÈt empirischer Wirkungsund Nutzensdokumentation entscheidend ist die Hierarchie der Evidenz, welche den Studien mit den geringsten FehlermoÈ glichkeiten am meisten Aussagekraft einraÈumt. Wenn zu einer gleichen Frage die Ergebnisse von randomisiert kontrollierten Studien vorhanden sind, dann sind diese Ergebnisse zuverlaÈssiger und damit «wissenschaftlicher» als (moÈ glicherweise widersprechende) Beobachtungen aus Fallstudien oder Kohortenstudien, welche systematischen Fehlern («selection» oder «confounding bias») unterliegen. Dass in der Praxis aufgrund der einseitigen Vorherrschaft pharmakologischer Forschungsfragen nicht bereits die «beste Evidenz» oder die Evidenz aus randomisiert kontrollierten Studien mit der besten Therapie verwechselt werden darf [1], stellt diese Hierarchie der Evidenz nicht im Grundsatz in Frage. DaruÈ ber hinaus bestehen bekannte Beobachtungsfehler (GefaÈ lligkeits-Bias, Beobachter-Voreingenommenheit etc.), welche unabhaÈngig vom Studientyp und seinem Platz in der Hierarchie ebenfalls durch geeignete Massnahmen kontrolliert werden muÈ ssen [2]. Hier spielt etwa das Verblinden der Erfolgsbeurteilung meist eine weit wichtigere Rolle als das Verblinden von Behandler und Patient (in der Doppelblindstudie). «Erfahrung» Editorial Commentary