A study of the effects of acarbose on glucose metabolism in patients predisposed to developing diabetes: the Dutch acarbose intervention study in persons with impaired glucose tolerance (DAISI).

BACKGROUND: We hypothesized that acarbose would delay conversion from impaired glucose tolerance (IGT) to type 2 diabetes by alleviating postprandial hyperglycaemia. Our study's main objective was to investigate the effect of acarbose in IGT-persons on their 2-h plasma glucose level and beta-cell function. SUBJECTS AND METHODS: The study included a random sample of 45-70-year-old residents of Hoorn, Netherlands, with mean fasting plasma glucose < 7.8 mmol/L and mean 2-h plasma glucose of 8.6-11.1 mmol/L (measured by two successive oral glucose tolerance tests). After a qualification period, participants were randomized to acarbose treatment or placebo. Insulin secretion and insulin sensitivity were measured by hyperglycaemic clamp. After a 3-year treatment, analyses were performed of both the intention-to-treat and the per-protocol groups. RESULTS: Of the 12 093 residents who received postal invitations, 118 participants were randomized. The mean difference of the post-load plasma glucose after 3 years, was - 1.16 mmol/L (95% CI: - 2.03; - 0.17). The absolute risk reduction for diabetes was 6% (95% CI: - 9; 21). No effect was seen on insulin secretion and insulin sensitivity. CONCLUSIONS: In patients with IGT, treatment with acarbose was associated with beneficial effects on 2-h plasma glucose levels but not with improvement of beta-cell function.

Dietary polyunsaturated fat intake is associated with low-density lipoprotein size, but not with susceptibility to oxidation in subjects with impaired glucose metabolism and type II diabetes: the Hoorn study.

OBJECTIVE: A high monounsaturated fatty acid (MUFA) and polyunsaturated fatty acid (PUFA) intake is associated with lower plasma low-density lipoprotein (LDL)-cholesterol. However, PUFA may increase the susceptibility of LDL to undergo oxidative modifications. The aim of this study was to analyze the association of habitual dietary fat intake with LDL size and oxidizability. DESIGN: Cross-sectional. SETTING: Cohort study. SUBJECTS: Seven hundred and fifty-eight subjects with normal, impaired glucose metabolism and type II diabetes. INTERVENTIONS: Mean LDL size was measured by high-performance gel-filtration chromatography. In vitro oxidizability of LDL was determined by measuring lag time, reflecting the resistance of LDL to copper-induced oxidation. Information about dietary fat intake was obtained by a validated food frequency questionnaire. RESULTS: PUFA intake (energy percent) was significantly and negatively associated with LDL size in subjects with type II diabetes (standardized beta (95% confidence interval) -0.17 (-0.28;-0.06)) and impaired glucose metabolism - although not statistically significant - (-0.09 (-0.24;0.05)), but not in subjects with normal glucose metabolism (0.01 (-0.10;0.12)) (P-value for interaction=0.02). No significant associations were observed for total, saturated fat and MUFA intake with LDL size. Intake of fat was associated with lag time; however, the small magnitude of the associations suggested that the composition of dietary fat is not a major factor affecting lag time. The same association with lag time was observed in all three glucose metabolism categories. CONCLUSIONS: In individuals with abnormal glucose metabolism, higher PUFA intake is associated with smaller LDL particle size, but does not alter the susceptibility of LDL to in vitro oxidation. SPONSORSHIP: Dutch Diabetes Research Foundation, and the Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO).

Prevalences of hyperhomocysteinemia, unfavorable cholesterol profile and hypertension in European populations.

BACKGROUND: Hyperhomocysteinemia (HHCY) is a risk factor for cardiovascular diseases (CVD). HHCY may interact with hypertension (HTEN) and an unfavorable cholesterol profile (UNFAVCHOL) to alter the risk of CVD. OBJECTIVES: To estimate the prevalences of HHCY (1) isolated and (2) in combination with UNFAVCHOL and/or HTEN in different age categories. To provide information that may improve the screening and treatment of subjects at risk of CVD. DESIGN: Cross-sectional data on 12,541 men and 12,948 women aged 20 + y were used from nine European studies. RESULTS: The prevalence of isolated HHCY was 8.5% in subjects aged 20-40 y, 4.7% in subjects aged 40-60 y and 5.9% in subjects aged over 60 y. When combining all age groups, 5.3% had isolated HHCY and an additional 5.6% had HHCY in combination with HTEN and/or UNFAVCHOL. The combinations of risk factors increased with age and, except for HHCY&UNFAVCHOL, were more prevalent than predicted by chance. Of the young subjects (20-40 y), 24% suffered from one or more of the investigated CVD risk factors. This figure was 75.1% in the old subjects (60+ years). CONCLUSIONS: A substantial number of subjects in selected European populations have HHCY (10.9%). In half of these cases, subjects suffer also from other CVD risk factors like UNFAVCHOL and HTEN. Older people in particular tend to have more than one risk factor. Healthcare professionals should be aware of this when screening and treating older people not only for the conventional CVD risk factors like UNFAVCHOL and HTEN but also HHCY, as this can easily be reduced through increased intake of folic acid via supplement or foods fortified with folic acid.

Non-invasive physical treatments for chronic/recurrent headache.

BACKGROUND: Non-invasive physical treatments are often used to treat common types of chronic/recurrent headache. OBJECTIVES: To quantify and compare the magnitude of short- and long-term effects of non-invasive physical treatments for chronic/recurrent headaches. SEARCH STRATEGY: We searched the following databases from their inception to November 2002: MEDLINE, EMBASE, BIOSIS, CINAHL, Science Citation Index, Dissertation Abstracts, CENTRAL, and the Specialised Register of the Cochrane Pain, Palliative Care and Supportive Care review group. Selected complementary medicine reference systems were searched as well. We also performed citation tracking and hand searching of potentially relevant journals. SELECTION CRITERIA: We included randomized and quasi-randomized controlled trials comparing non-invasive physical treatments for chronic/recurrent headaches to any type of control. DATA COLLECTION AND ANALYSIS: Two independent reviewers abstracted trial information and scored trials for methodological quality. Outcomes data were standardized into percentage point and effect size scores wherever possible. The strength of the evidence of effectiveness was assessed using pre-specified rules. MAIN RESULTS: Twenty-two studies with a total of 2628 patients (age 12 to 78 years) met the inclusion criteria. Five types of headache were studied: migraine, tension-type, cervicogenic, a mix of migraine and tension-type, and post-traumatic headache. Ten studies had methodological quality scores of 50 or more (out of a possible 100 points), but many limitations were identified. We were unable to pool data because of study heterogeneity. For the prophylactic treatment of migraine headache, there is evidence that spinal manipulation may be an effective treatment option with a short-term effect similar to that of a commonly used, effective drug (amitriptyline). Other possible treatment options with weaker evidence of effectiveness are pulsating electromagnetic fields and a combination of transcutaneous electrical nerve stimulation [TENS] and electrical neurotransmitter modulation. For the prophylactic treatment of chronic tension-type headache, amitriptyline is more effective than spinal manipulation during treatment. However, spinal manipulation is superior in the short term after cessation of both treatments. Other possible treatment options with weaker evidence of effectiveness are therapeutic touch; cranial electrotherapy; a combination of TENS and electrical neurotransmitter modulation; and a regimen of auto-massage, TENS, and stretching. For episodic tension-type headache, there is evidence that adding spinal manipulation to massage is not effective. For the prophylactic treatment of cervicogenic headache, there is evidence that both neck exercise (low-intensity endurance training) and spinal manipulation are effective in the short and long term when compared to no treatment. There is also evidence that spinal manipulation is effective in the short term when compared to massage or placebo spinal manipulation, and weaker evidence when compared to spinal mobilization. There is weaker evidence that spinal mobilization is more effective in the short term than cold packs in the treatment of post-traumatic headache. REVIEWERS' CONCLUSIONS: A few non-invasive physical treatments may be effective as prophylactic treatments for chronic/recurrent headaches. Based on trial results, these treatments appear to be associated with little risk of serious adverse effects. The clinical effectiveness and cost-effectiveness of non-invasive physical treatments require further research using scientifically rigorous methods. The heterogeneity of the studies included in this review means that the results of a few additional high-quality trials in the future could easily change the conclusions of our review.

Coffee consumption and incidence of impaired fasting glucose, impaired glucose tolerance, and type 2 diabetes: the Hoorn Study.

AIMS/HYPOTHESIS: Coffee contains several substances that may affect glucose metabolism. The aim of this study was to evaluate the relationship between habitual coffee consumption and the incidence of IFG, IGT and type 2 diabetes. METHODS: We used cross-sectional and prospective data from the population-based Hoorn Study, which included Dutch men and women aged 50-74 years. An OGTT was performed at baseline and after a mean follow-up period of 6.4 years. Associations were adjusted for potential confounders including BMI, cigarette smoking, physical activity, alcohol consumption and dietary factors. RESULTS: At baseline, a 5 cup per day higher coffee consumption was significantly associated with lower fasting insulin concentrations (-5.6%, 95% CI -9.3 to -1.6%) and 2-h glucose concentrations (-8.8%, 95% CI -11.8 to -5.6%), but was not associated with lower fasting glucose concentrations (-0.8%, 95% CI -2.1 to 0.6%). In the prospective analyses, the odds ratio (OR) for IGT was 0.59 (95% CI 0.36-0.97) for 3-4 cups per day, 0.46 (95% CI 0.26-0.81) for 5-6 cups per day, and 0.37 (95% CI 0.16-0.84) for 7 or more cups per day, as compared with the corresponding values for the consumption of 2 or fewer cups of coffee per day (p=0.001 for trend). Higher coffee consumption also tended to be associated with a lower incidence of type 2 diabetes (OR 0.69, CI 0.31-1.51 for >/=7 vs /=7 vs

[Insufficient scientific evidence for efficacy of widely used electrotherapy, laser therapy, and ultrasound treatment in physiotherapy]. / Onvoldoende wetenschappelijk bewijs voor effectiviteit van veelvuldig gebruikte elektrotherapie, lasertherapie en ultrageluidbehandeling in de fysiotherapie.

The Dutch Health Council recently published a report on the efficacy of electrotherapy, laser therapy and ultrasound treatment for musculoskeletal disorders. The assessment was based on three systematic reviews, including 169 randomized clinical trials, and focused on a best-evidence synthesis. Virtually no conclusive clinically relevant effects of the three forms of physical therapy were found. Possible exceptions are electrotherapy for osteoarthrosis of the hip or knee, laser therapy for pain treatment and rheumatoid arthritis, and ultrasound treatment for epicondylitis lateralis. But even for these putative indications, further research is clearly needed before implementation in practice is justifiable. It is strongly recommended that the current widespread use of electrotherapy, laser therapy and ultrasound treatment should be reduced, preferably by self-regulation within the profession itself.

Shoulder disability questionnaire design and responsiveness of a functional status measure.

The Shoulder Disability Questionnaire (SDQ) is a measure covering 16 items designed to evaluate functional status limitation in patients with shoulder disorders. The responsiveness of the SDQ was evaluated for 180 patients with soft tissue shoulder disorders, without underlying systemic disorders. These patients participated in a randomized placebo-controlled trial, in which ultrasound and electrotherapy appeared to be ineffective as adjuvants to standardized exercise therapy. At baseline and at 6-week follow-up, patients completed the SDQ and rated severity of shoulder pain and their chief complaint, while a research physiotherapist rated severity of symptoms and restriction of mobility. At the 6-week follow-up, patients also rated overall change since baseline. According to the calibrated responsiveness ratio (CRR) and the area under the receiver-operator characteristic curve (AUC) the SDQ discriminates accurately between self-rated clinically stable and improved subjects. The presented results suggest that the SDQ is as responsive as the compared outcome measures, and therefore is ready for use in clinical trials.

No effect of bipolar interferential electrotherapy and pulsed ultrasound for soft tissue shoulder disorders: a randomised controlled trial.

OBJECTIVE: To assess the efficacy of bipolar interferential electrotherapy (ET) and pulsed ultrasound (US) as adjuvants to exercise therapy for soft tissue shoulder disorders (SD). METHODS: Randomised placebo controlled trial with a two by two factorial design plus an additional control group in 17 primary care physiotherapy practices in the south of the Netherlands. Patients with shoulder pain and/or restricted shoulder mobility, because of a soft tissue impairment without underlying specific or generalised condition, were enrolled if they had not recovered after six sessions of exercise therapy in two weeks. They were randomised to receive (1) active ET plus active US; (2) active ET plus dummy US; (3) dummy ET plus active US; (4) dummy ET plus dummy US; or (5) no adjuvants. Additionally, they received a maximum of 12 sessions of exercise therapy in six weeks. Measurements at baseline, 6 weeks and 3, 6, 9, and 12 months later were blinded for treatment. OUTCOME MEASURES: recovery, functional status, chief complaint, pain, clinical status, and range of motion. RESULTS: After written informed consent 180 patients were randomised: both the active treatments were given to 73 patients, both the dummy treatments to 72 patients, and 35 patients received no adjuvants. Prognosis of groups appeared similar at baseline. Blinding was successfully maintained. At six weeks seven patients (20%) without adjuvants reported very large improvement (including complete recovery), 17 (23%) and 16 (22%) with active and dummy ET, and 19 (26%) and 14 (19%) with active and dummy US. These proportions increased to about 40% at three months, but remained virtually stable thereafter. Up to 12 months follow up the 95% CI for differences between groups for all outcomes include zero. CONCLUSION: Neither ET nor US prove to be effective as adjuvants to exercise therapy for soft tissue SD.

Reliability of lumbar spine radiograph reading by chiropractors.

STUDY DESIGN: An intraobserver and interobserver study on the reproducibility of data was performed. OBJECTIVES: This study investigates the variability in the interpretation of lumbar spine radiographs by chiropractors working in private practice. SUMMARY OF BACKGROUND DATA: In chiropractic practice radiographs are used often, but this use is currently under debate. Therefore, there is a need for further study of the value of diagnoses made by radiographs by chiropractors. An acceptable intra- and interobserver agreement in radiograph reading is a prerequisite for a useful application of radiographs as a diagnostic tool in daily practice and in research. METHODS: Four chiropractors read 100 blinded sets of standard, erect anteroposterior and lateral lumbar radiographs independently. The same set was read in two separate sessions with a 2-month interval. The first session revealed the interobserver agreement. The comparison of the ratings by the same assessor in the two sessions indicated the intraobserver agreement. The assessors used a specially developed criteria list with emphasis on "nonspecific" radiographic findings. The prevalence of some important categories was increased artificially. Agreement was expressed in percentage agreement and generalized kappa, combining the results of all four assessors. RESULTS: Most kappas ranged from 0.40 to 0.75, representing fair to good agreement. In general, intraobserver agreement was better than interobserver agreement. The low kappas that were found may be explained partially by the high-agreement-low-kappa paradox as a result of a low prevalence. CONCLUSION: The kappas and percentage agreement were acceptable, although not excellent. These results will be beneficial for future research on the value of radiograph diagnosis of nonspecific findings for delivery of safe and effective chiropractic therapy.

Spinal manipulation for low back pain. An updated systematic review of randomized clinical trials.

STUDY DESIGN: Systematic review of randomized clinical trials. OBJECTIVES: To assess the efficacy of spinal manipulation for patients with low back pain. SUMMARY OF BACKGROUND DATA: The management of low back pain remains controversial. Spinal manipulation is a widely used treatment option for low back pain. Recently issued clinical guidelines suggest that spinal manipulation may be effective for patients with acute low back pain. METHODS: A computer-aided search for published papers was conducted, and the methods of the studies identified were assessed. Scores were assigned for quality of methods (based on four main categories: study population, interventions, measurement of effect, and data presentation and analysis), the conclusion of authors regarding spinal manipulation, and the results based on the main outcome measure. RESULTS: Thirty-six randomized clinical trials comparing spinal manipulation with other treatments were identified. The highest score of a trial was 60 points (maximum score was set at 100 points), indicating that most were of poor quality. Nineteen studies (53%) showed favorable results for manipulation. In addition, five studies (14%) reported positive results in one or more subgroups only. Among the five studies with 50-60 points, three were positive, and two were positive only for a subgroup of the study population. Eleven trials compared manipulation with some placebo therapy, with inconsistent results. There appeared to be no clear relation between the methodologic score and the overall outcome of the studies. Twelve trials included patients with acute low back pain only. Of these, five reported positive results, four reported negative results, and three reported positive results in a subgroup of the study population only. There were eight trials comparing manipulation with other conservative treatment modalities, focusing on patients with subacute or chronic low back pain. Of these, five reported positive results, two reported negative results, and in one study no conclusion was presented. There were only 16 studies that included an effect measurement of at least 3 months. In only six of these do the authors report positive effects of manipulation. CONCLUSIONS: The efficacy of spinal manipulation for patients with acute or chronic low back pain has not been demonstrated with sound randomized clinical trials. There certainly are indications that manipulation might be effective in some subgroups of patients with low back pain. These impressions justify additional research efforts on this topic. Methodologic quality remains a critical aspect that should be dealt with in future studies.

The effectiveness of chiropractic for treatment of low back pain: an update and attempt at statistical pooling.

OBJECTIVE: To determine the effectiveness of chiropractic treatment for patients with low back pain by means of a systematic review of the literature. DATA SOURCES: Randomized clinical trials (RCTs) on chiropractic were identified with a Medline and Embase search (1966-1995), by citation tracking, and by hand searching of the relevant chiropractic reference systems (CRAC and Index to Chiropractic Literature). STUDY SELECTION: All RCTs on low back pain that involved chiropractors as therapists. DATA EXTRACTION: Methodological quality was assessed independently by two reviewers on 14 items covering internal validity, informativeness and study size. Data were extracted on: patients (initial referral, duration of complaints, radiation of pain); outcomes (four different types); and timing of follow-up (short-term, intermediate and long-term). Statistical pooling was intended, according to a preset analysis plan, to include subgroup analysis. DATA SYNTHESIS: Eight RCTs were identified. All RCTs had serious flaws in their design, execution and reporting. Because of the great variety of outcome measures and follow-up timing, there was insufficient data to enable statistical pooling of the RCTs. A narrative review, however, did not provide convincing evidence for the effectiveness of chiropractic for acute or chronic low back pain. CONCLUSIONS: There is certainly a need for correctly executed trials. In future research on the effectiveness of chiropractic, guidelines for uniform execution and reporting of RCTs should first be established to enable subsequent statistical pooling in systematic reviews of chiropractic trials.

Vitamin D supplementation and fracture incidence in elderly persons. A randomized, placebo-controlled clinical trial.

OBJECTIVE: To determine whether vitamin D supplementation decreases the incidence of hip fractures and other peripheral bone fractures. DESIGN: Prospective, double-blind trial. SETTING: Community setting (Amsterdam and surrounding area). PATIENTS: 2578 persons (1916 women, 662 men) 70 years of age and older (mean age +/- SD, 80 +/- 6 years) living independently, in apartments for elderly persons, or in homes for elderly persons. INTERVENTION: Participants were randomly assigned to receive either vitamin D3, 400 IU in one tablet daily, or placebo for a maximum of 3.5 years. MEASUREMENTS: Dietary calcium intake and serum 25-hydroxyvitamin D [25(OH)D] were estimated in a subset of participants. During follow-up, attention was concentrated on hip fractures and other peripheral fractures. The maximal follow-up period was 4 years. The results were evaluated by survival analysis. RESULTS: Mean dietary calcium intake from dairy products was 868 mg/d. Mean serum 25(OH)D concentration in the third year of the study was 23 nmol/L in the placebo group and 60 nmol/L in the vitamin D group. Median follow-up was 3.5 years, and total follow-up was 8450 patient-years. During follow-up, 306 persons in the placebo group and 282 persons in the vitamin D group died (P = 0.20). Hip fractures occurred in 48 persons in the placebo group and 58 persons in the vitamin D group (P = 0.39, intention-to-treat analysis). Other peripheral fractures occurred in 74 persons in the placebo group and 77 persons in the vitamin D group (P = 0.86). CONCLUSION: Our results do not show a decrease in the incidence of hip fractures and other peripheral fractures in Dutch elderly persons after vitamin D supplementation.

Prevention of bone loss by vitamin D supplementation in elderly women: a randomized double-blind trial.

The purpose of the study was to determine the effect of vitamin D supplementation on bone turnover and bone loss in elderly women. Three hundred forty-eight women, ages 70 yr and older, were randomized to receive 400 IU vitamin D3 per day (n = 177) or placebo (n = 171), double-blind, for a period of 2 yr. Main outcome measures were bone mineral density of both hips (femoral neck and trochanter) and the distal radius, as well as biochemical markers of bone turnover. The effect of vitamin D supplementation was expressed as the difference in mean (percentage) change between the placebo group and the vitamin D group. The measurements were repeated in 283 women after 1 yr and in 248 women after 2 yr. Vitamin D supplementation significantly increased serum 25-hydroxyvitamin D (250HD) (+35 nmol/L) and 1,25-dehydroxyvitamin D [1,25-(OH)2D] (+7.0 pmol/L) levels and urinary calcium/creatinine ratios (+0.5%) and significantly decreased PTH(1-84) secretion (-0.74 pmol/L) after 1 yr. No effect was found for the parameters of bone turnover. The effect on the bone mineral density of the left femoral neck was +1.8% in the first yr, +0.2% in the second yr, and +1.9% during the whole period (95% confidence interval 0.4, 3.4%). At the right femoral neck the effects were +1.5%, +1.1%, and +2.6% (confidence interval 1.1, 4.0%), respectively. No effect was found at the femoral trochanter and the distal radius. Supplementation with 400 IU vitamin D3 daily in elderly women slightly decreases PTH secretion and increases bone mineral density at the femoral neck.

Chiropractic in The Netherlands: a survey of Dutch chiropractors.

BACKGROUND: In the Netherlands, there is increasing public and political interest in chiropractic treatment. There is, however, very little descriptive information available in the Netherlands on the chiropractic profession. Therefore, a survey was conducted among all Dutch chiropractors. METHODS: A questionnaire was sent to all members of the Netherlands' Chiropractors Association (n = 59). It contained questions on (postgraduate) education, practice management, diagnostics (including radiology use), treatment, interprofessional cooperation and referral. RESULTS: The response was 88%. Chiropractic is growing rapidly: the number of chiropractors has doubled in five years. Chiropractors primarily treat back and neck pain, with an average of 8 treatments. Conventional orthopedic and neurological examination along with motion palpation are the cornerstones of physical examination. The respondents stressed the importance of direct access to radiography and specialized (hospital) diagnostics. Fifty-eight percent of the chiropractors have their own X-ray equipment. The most frequent reason for taking new X-rays was the absence of cooperation with radiology departments. Self-referral is the largest source of patients. The referral rate to other health care professionals is low. CONCLUSIONS: The number of chiropractors is growing rapidly. They have an exceptional position in the Dutch health care system. Access to X-ray and more specialized diagnostics are presently the most important political issues.

A randomized clinical trial of manual therapy and physiotherapy for persistent back and neck complaints: subgroup analysis and relationship between outcome measures.

OBJECTIVE: To study the efficacy of manual therapy and physiotherapy in subgroups of patients with persistent back and neck complaints. The second objective was to determine the correlation between three important outcome measures used in this trial. DESIGN: Randomized clinical trial (subgroup analysis). SETTING: Primary health care in the Netherlands. PATIENTS: Two hundred fifty-six patients with nonspecific back and neck complaints of at least 6 wk duration who had not received physiotherapy or manual therapy in the past 2 yr. INTERVENTIONS: At the discretion of the manual therapists, physiotherapists and general practitioners. Physiotherapy consisted of exercises, massage and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manual therapy consisted of manipulation and mobilization of the spine. Treatment by the general practitioner consisted of drugs (e.g., analgesics), advice about posture, home exercises and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 min) and detuned ultrasound (10 min). MAIN OUTCOME MEASURES: Changes in severity of the main complaint and limitation of physical functioning measured on 10-point scales by a blinded research assistant and global perceived effect measured on a 6-point scale by the patients. RESULTS: Improvement in the main complaint was larger with manual therapy (4.3) than with physiotherapy (2.5) for patients with chronic conditions (duration complaint of 1 yr or longer). Also, improvement in the main complaint was larger with manual therapy (5.5) than with physiotherapy (4.0) for patients younger than 40 yr (both were measured after 12-mo follow-up). Labeling of patients by the treating manual therapists as "suitable" or "not suitable" for treatment with manual therapy did not predict differences in outcomes. Generally, there was a moderate to strong correlation between the three outcome measures, although a considerable number of patients gave a relatively low score for perceived benefit, while the research assistant gave a high improvement score for the main complaint and physical functioning. CONCLUSIONS: The subgroup analysis suggests better results of manual therapy compared to physiotherapy in chronic patients (duration of present complaints of 1 yr or longer) and in patients younger than 40 yr old). Differences for other subgroups were less clear. The explorative findings of these subgroup analyses have to be investigated in future research.

Does the goose really lay golden eggs? A methodological review of Workmen's Compensation studies.

OBJECTIVE: To assess the value of workmen's compensation (WC) studies to determine the effectiveness of chiropractic. Therefore, the results of the available WC studies are summarized and the methodological quality of WC studies is discussed. DATA SOURCES: All studies were eligible without time restriction. Studies were identified by a Medline search from 1966 to 1990 (key words: chiropractic, and manipulation-orthopedic in combination with comparative studies, follow-up studies, evaluation studies) by manual examination of the most important chiropractic reference systems (CRAC and Index to Chiropractic Literature), by tracking the reference lists of identified (reviews of) WC studies and by correspondence with researchers. STUDY SELECTION: Studies were regarded as WC studies if by means of databases of WC boards, a comparison was made between claimants treated by chiropractors and those treated by other health care professionals. At least one of the following outcomes should be reported: compensated days, compensation paid or treatment costs. DATA EXTRACTION: Relevant data (authors, year, state, study population, number of patients, days compensated, compensation paid, number of treatments, consultation costs, additional treatment costs and total cost per case) were extracted by one nonblinded observer. The methodological value was reviewed narratively. DATA SYNTHESIS: The retrospective character of WC studies and the use of large WC databases harbor severe methodological problems like incomparability of study groups, absence of information on prognostic indicators, insufficient outcome measures and missing data. The results of older WC studies (before 1980) and the more recent WC studies, which were of better methodological quality, are presented separately. The older studies are in favor of chiropractic. Two of the six more recent WC studies challenge chiropractic effectiveness. CONCLUSIONS: WC studies in general report positive results for chiropractic. Recent results are more ambiguous. Because of the methodological drawbacks identified, WC studies are insufficient to enable a valid study made of chiropractic effectiveness. Therefore, chiropractic (cost-) effectiveness is not yet convincingly proven. More effort should be directed at establishing randomized clinical trials including the question of (cost-) effectiveness.

The efficacy of chiropractic manipulation for back pain: blinded review of relevant randomized clinical trials.

OBJECTIVE: To assess the efficacy of chiropractic for patients with back pain. DATA SOURCES: Randomized clinical trials (RCTs) on spinal manipulation were identified with a Medline search (1966-1990), by citration tracking, and by manual examination of the relevant chiropractic reference systems [Chiropractic Research Archives Collection and Index to Chiropractic Literature]. [Indexing terms, Medline; backache, musculoskeletal diseases, manipulation, osteopathy or chiropractic in combination with evaluation studies, outcome and process assessment, prospective studies, comparative studies, clinical trials or double blind method. Indexing terms, Chiropractic Research Archives Collection: backache therapy-chiropractic clinical trials, cost benefit analysis, evaluation studies--chiropractic, manipulation--spinal, prospective studies, sciatica-therapy. Indexing terms, Index to Chiropractic Literature, backache therapy, clinical trials, cost benefit analysis, intervertebral disc displacement-therapy.] STUDY SELECTION: All RCTs involving chiropractors as therapists. To find additional evidence from nonchiropractic RCTs, chiropractic standards similar to the type of treatment used in nonchiropractic trials were determined by a panel of blinded chiropractors. DATA EXTRACTION: Review by two blinded reviewers independently, using a list of methodological criteria, each of which was attached to a weight. The maximum was set at 100 points. DATA SYNTHESIS: We identified five chiropractic RCTs. No similarity to chiropractic standards could be detected in any of the nonchiropractic RCTs. No chiropractic RCT had a methodological score of more than 50 points. The authors of four of the trials report favorable results for chiropractic, while one refrains from drawing conclusions. The results of the chiropractic RCTs differed on the timing of maximal effect as well as on the subgroups showing the best treatment results. CONCLUSIONS: Although the small number of chiropractic RCTs and the poor general methodological quality precludes the drawing of strong conclusions, chiropractic seems to be an effective treatment of back pain. However, more studies with a better research methodology are clearly still needed.

Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up.

OBJECTIVE: To compare the effectiveness of manipulative therapy, physiotherapy, treatment by the general practitioner, and placebo therapy in patients with persistent non-specific back and neck complaints. DESIGN: Randomised clinical trial. SETTING: Primary health care in the Netherlands. PATIENTS: 256 patients with non-specific back and neck complaints of at least six weeks' duration who had not received physiotherapy or manipulative therapy in the past two years. INTERVENTIONS: At the discretion of the manipulative therapists, physiotherapists, and general practitioners. Physiotherapy consisted of exercises, massage, and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manipulative therapy consisted of manipulation and mobilisation of the spine. Treatment by general practitioners consisted of drugs (for example, analgesics), advice about posture, home exercises, and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 minutes) and detuned ultrasound (10 minutes). MAIN OUTCOME MEASURES: Changes in severity of the main complaint and limitation of physical functioning measured on 10 point scales by a blinded research assistant and global perceived effect measured on a 6 point scale by the patients. RESULTS: Many patients in the general practitioner and placebo groups received other treatment during follow up. Improvement in the main complaint was larger with manipulative therapy (4.5) than with physiotherapy (3.8) after 12 months' follow up (difference 0.9; 95% confidence interval 0.1 to 1.7). Manipulative therapy also gave larger improvements in physical functioning (difference 0.6; -0.1 to 1.3). The global perceived effect after six and 12 months' follow up was similar for both treatments. CONCLUSIONS: Manipulative therapy and physiotherapy are better than general practitioner and placebo treatment. Furthermore, manipulative therapy is slightly better than physiotherapy after 12 months.

A blinded randomized clinical trial of manual therapy and physiotherapy for chronic back and neck complaints: physical outcome measures.

In a blinded randomized clinical trial, we compared the effectiveness of manual therapy, physiotherapy, (continued) treatment by the general practitioner (GP), and a placebo therapy (detuned ultrasound and detuned short wave diathermy) for patients (n = 256) with chronic nonspecific back and neck complaints. The physical outcome measures (spinal mobility and physical functioning) are presented for 3, 6 and 12 wk follow-up. Manual therapy showed a faster and larger improvement in physical functioning compared to the other three therapies. The changes in spinal mobility among the four study groups appear to be small and show no consistent pattern.