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PubMed2005

Effectiveness of the Coping With Depression (CWD) course for older adults provided by the community-based mental health care system in the Netherlands: a randomized controlled field trial.

BACKGROUND: The Dutch version of the Coping With Depression (CWD) course for older adults has been implemented in the prevention arm of the community-based mental health care system in the Netherlands. The study group included older adults with subclinical depression as well as those with a major depressive disorder; all were enrolled into the course by mental health care professionals. The effectiveness (immediate and long-term) of the course for this heterogeneous population was studied in an effectiveness trial. METHOD: Participants were self-referred, responding to media announcements. A total of 119 participants aged 55-85 years (69% female), with subclinical depression and major depression, were randomized to either the CWD course (N = 61) or the waiting list (N = 58). RESULTS: Nine participants dropped out of the course. According to a diagnostic interview based on the DSM-IV, 39% had a major depressive disorder (MDD), 69% had had a previous MDD, and 45% had an anxiety disorder. Older adults in the intervention group showed a significant decrease in depression symptoms. Gains were maintained over 14 months. In the intervention condition 83% had a pre-treatment score > or = 16 on the Center for Epidemiologic Studies Depression Scale (CES-D); at post-treatment 62% still scored > or = 16. CONCLUSIONS: The course was beneficial for participants with mild or severe depression, and treatment acceptability was high. It should be fitted into a stepped-care protocol that varies intervention intensity according to clinical needs, using the post-treatment level of functioning as an indication for the next step.

Adaptation, Psychological↗

PubMed1995

Do widowers use the health care system differently? Does intervention make a difference?

OBJECTIVE: To describe the health care use patterns of widowers who had participated in a randomized trial of mutual support, and of a matched cohort of married men DESIGN: Retrospective audit of Ministry of Health use data SETTING: The family practice unit in a general teaching hospital. PARTICIPANTS: The 113 new widowers (61 treatment, 52 waiting-list controls) who participated in a randomized trial of mutual support, and 111 married men matched for age INTERVENTIONS: Mutual support program MAIN OUTCOME MEASURES: Monthly rates of visits to family physicians, psychiatrists, and all other specialists for the three cohorts RESULTS: Visit rates to family physicians and specialists (SPs) for the married men were stable for the 20 months of the study; rates for the widowers rose significantly from the time of loss to the end of the intervention (for FPs, f = 13.18, df = 2, P < .01; for SPs, f = 5.34, df = 2, P = .005). Rates for FPs declined after intervention for the treatment group, but kept rising among the controls (f = 4.17, df = 1, P = .044). CONCLUSIONS: The decreased physician visit rate among those taking part in the mutual support program suggests that this program met some of the widowers' social support needs that would otherwise have led to the use of health care resources.

Aged↗

PubMed2003

Intensive group training versus cognitive intervention in sub-acute low back pain: short-term results of a single-blind randomized controlled trial.

OBJECTIVE: To evaluate the short-term effect of physical exercise and a cognitive intervention in low back pain. DESIGN: Randomized controlled trial. SUBJECTS: Ninety-three patients sick-listed for 8-12 weeks for sub-acute low back pain were randomized to an exercise regime (n = 30), a cognitive intervention (n = 34) or a control group (n = 29). METHODS: Primary outcome measures were pain, disability, sick-listing and satisfaction with care. Secondary outcome measures were self-efficacy for pain and for function, fear-avoidance beliefs, emotional distress, generic health status and life satisfaction. RESULTS: Eighteen percent of subjects dropped out. Drop-out was most frequent in the exercise group. At 18 weeks after inclusion fear-avoidance beliefs were reduced in both intervention groups. The cognitive group demonstrated significant improvement in disability, self-efficacy for pain, emotional distress, general health and life satisfaction. Patients in the exercise group were significantly more satisfied with the treatment, and patients following the exercise protocol reduced pain significantly. No effect on sick-listing was seen. CONCLUSION: Cognitive intervention improved disability and may be feasible for most patients sick-listed in the sub-acute phase. Physical exercise reduced patients' symptoms, but requires high motivation by patients. Despite positive effects in intervention groups on variables considered as negative prognostic factors for long-term disability and sickness absence, interventions had no effect on sick-listing.

Adult↗

PubMed2004

Estimating post-traumatic stress disorder in the community: lifetime perspective and the impact of typical traumatic events.

BACKGROUND: Community surveys have assessed post-traumatic stress disorder (PTSD) in relation to traumatic events designated by respondents as the worst they have ever experienced. An assessment of PTSD in relation to all reported traumas would impose too great a burden on respondents, a considerable proportion of whom report multiple traumas. The 'worst event' method is efficient for identifying persons with PTSD, but may overestimate the conditional probability of PTSD associated with the entire range of PTSD-level traumas. In this report, we evaluate this potential bias. METHOD: The Detroit Area Survey of Trauma (n = 2181) estimated the PTSD risk from two samples of traumas: (1) a representative sample of traumas formed by selecting a random trauma from each respondent's list of traumas; and (2) traumas designated by respondents as the worst (the standard method). RESULTS: Both estimation methods converged on key findings, including identifying trauma types with the highest probability of PTSD and sex differences in the risk of PTSD. Compared to the random events, the 'worst event' method yielded a moderately higher conditional probability for PTSD (0.136 v. 0.092). The bias was due almost entirely to the deviation of the distribution of the worst events from expected values, if all event types had equal prior selection probabilities. Direct adjustment, setting the distribution equal to expected values and applying the observed probabilities of PTSD associated with individual event types brought the estimate close to the unbiased estimate, based on the randomly selected traumas. CONCLUSIONS: Only the 'worst event' method can be used as a short-cut to assessing all traumas. The bias in the estimated risk of PTSD is modest and is attenuated by direct adjustment.

Adolescent↗

PubMed2006

Segmental stabilizing exercises and low back pain. What is the evidence? A systematic review of randomized controlled trials.

STUDY DESIGN: A systematic review of randomized controlled trials. OBJECTIVES: To evaluate the effectiveness of segmental stabilizing exercises for acute, subacute and chronic low back pain with regard to pain, recurrence of pain, disability and return to work. METHODS: MEDLINE, EMBASE, CINAHL, Cochrane Controlled Trials Register, PEDro and article reference lists were searched from 1988 onward. Randomized controlled trials with segmental stabilizing exercises for adult low back pain patients were included. Four comparisons were foreseen: (1) effectiveness of segmental stabilizing exercises versus treatment by general practitioner (GP); (2) effectiveness of segmental stabilizing exercises versus other physiotherapy treatment; (3) effectiveness of segmental stabilizing exercises combined with other physiotherapy treatment versus treatment by GP and (4) effectiveness of segmental stabilizing exercises combined with other physiotherapy treatment versus other physiotherapy treatment. RESULTS: Seven trials were included. For acute low back pain, segmental stabilizing exercises are equally effective in reducing short-term disability and pain and more effective in reducing long-term recurrence of low back pain than treatment by GP. For chronic low back pain, segmental stabilizing exercises are, in the short and long-term, more effective than GP treatment and may be as effective as other physiotherapy treatments in reducing disability and pain. There is limited evidence that segmental stabilizing exercises additional to other physiotherapy treatment are equally effective for pain and more effective concerning disability than other physiotherapy treatments alone. There is no evidence concerning subacute low back pain. CONCLUSION: For low back pain, segmental stabilizing exercises are more effective than treatment by GP but they are not more effective than other physiotherapy interventions.

Acute Disease↗

PubMed1997

Task-dependent changes in the shape and thickness of Listing's plane.

We examined the 2D surface formed by 3D eye positions of normal subjects to determine whether the shape and thickness changed in tasks that differed in saccadic directions: random, horizontal, vertical, radial, clockwise and counter-clockwise. Eye positions during the random task did not lie precisely on Listing's plane but on a surface with a small twist. This twist was present before, during, and after saccades. The degree of twist changed with the task; becoming less twisted for horizontal tasks and more twisted in the vertical tasks. The surface thickness changed with the task becoming thicker for multidirectional tasks. This greater thickness may occur because surfaces obtained in multidirectional tasks are the composite of surfaces with slightly different shapes.

Analysis of Variance↗

PubMed2006

Antiarrhythmic drugs for maintaining sinus rhythm after cardioversion of atrial fibrillation: a systematic review of randomized controlled trials.

BACKGROUND: A variety of antiarrhythmic drugs have been used to prevent recurrence of atrial fibrillation after conversion to sinus rhythm. We performed a systematic review to determine the effect of long-term treatment with those drugs on death, embolisms, adverse effects, and atrial fibrillation recurrence. METHODS: We searched MEDLINE, EMBASE, the Cochrane Library (all up to May 2005), and the reference lists of retrieved articles. We included randomized controlled trials that compared any antiarrhythmic against control (placebo or no treatment) or another antiarrhythmic, for more than 6 months. Postoperative atrial fibrillation was excluded. Two evaluators independently reviewed the retrieved studies and extracted all data. Disagreements were resolved by discussion. All results were calculated at 1 year of follow-up. RESULTS: Forty-four trials were included, with a total of 11 322 patients. Several class IA (disopyramide phosphate, quinidine sulfate), class IC (flecainide acetate, propafenone hydrochloride), and class III (amiodarone, dofetilide, sotalol hydrochloride) drugs significantly reduced recurrence of atrial fibrillation (number needed to treat, 2-9), but all increased withdrawals due to adverse effects (number needed to harm [NNH], 9-27) and all but amiodarone and propafenone increased proarrhythmia (NNH, 17-119). Class IA drugs, pooled, were associated with increased mortality compared with controls (Peto odds ratio, 2.39; 95% confidence interval, 1.03-5.59; P = .04; NNH, 109). No other antiarrhythmic showed a significant effect on mortality compared with controls. We could not analyze other outcomes because data were lacking. CONCLUSION: Class IA, IC, and III drugs are effective in maintaining sinus rhythm but increase adverse effects, and class IA drugs may increase mortality.

Anti-Arrhythmia Agents↗

PubMed2003

Cognitive-behavioral therapy for children with anxiety disorders in a clinical setting: no additional effect of a cognitive parent training.

OBJECTIVE: To evaluate a 12-week cognitive-behavioral treatment program for children with anxiety disorders and the additional value of a seven-session cognitive parent training program. METHOD: Seventy-nine children with an anxiety disorder (aged 7-18 years) were randomly assigned to a cognitive behavioral treatment condition or a wait-list control condition. Families in the active treatment condition were randomly assigned to an additional seven-session cognitive parent training program. Semistructured diagnostic interviews were conducted with parents and children separately, before and after treatment and at 3 months follow-up. Questionnaires included child self-reports on anxiety and depression and parent reports on child's anxiety and behavioral problems. RESULTS: Children with anxiety disorders showed more treatment gains from cognitive-behavioral therapy than from a wait-list control condition. These results were substantial and significant in parent measures and with regard to diagnostic status, but not in child self-reports. In the active treatment condition, children improved on self-reported anxiety and depression, as well as on parent reports on their child's anxiety problems. These results were equal for clinically referred and recruited children. Child self-reports decreased to the normal mean, whereas parents reported scores that were lower than before treatment but were still elevated from the normal means. No significant outcome differences were found between families with or without additional parent training. CONCLUSIONS: Children with anxiety disorders profited from cognitive-behavioral therapy. Children improved equally whether or not additional parent training was offered.

Adolescent↗

PubMed2005

Intrinsic joint kinematic planning. I: reassessing the Listing's law constraint in the control of three-dimensional arm movements.

This study tested the validity of the assumption that intrinsic kinematic constraints, such as Listing's law, can account for the geometric features of three-dimensional arm movements. In principle, if the arm joints follow a Listing's constraint, the hand paths may be predicted. Four individuals performed 'extended arm', 'radial', 'frontal plane', and 'random mixed' movements to visual targets to test Listing's law assumption. Three-dimensional rotation vectors of the upper arm and forearm were calculated from three-dimensional marker data. Data fitting techniques were used to test Donders' and Listing's laws. The coefficient values obtained from fitting rotation vectors to the surfaces described by a second-order equation were analyzed. The results showed that the coefficients that represent curvature and twist of the surfaces were often not significantly different from zero, particularly not during randomly mixed and extended arm movements. These coefficients for forearm rotations were larger compared to those for the upper arm segment rotations. The mean thickness of the rotation surfaces ranged between approximately 1.7 degrees and 4.7 degrees for the rotation vectors of the upper arm segment and approximately 2.6 degrees and 7.5 degrees for those of the forearm. During frontal plane movements, forearm rotations showed large twist scores while upper arm segment rotations showed large curvatures, although the thickness of the surfaces remained low. The curvatures, but not the thicknesses of the surfaces, were larger for large versus small amplitude radial movements. In conclusion, when examining the surfaces obtained for the different movement types, the rotation vectors may lie within manifolds that are anywhere between curved or twisted manifolds. However, a two-dimensional thick surface may roughly represent a global arm constraint. Our findings suggest that Listing's law is implemented for some types of arm movement, such as pointing to targets with the extended arm and during radial reaching movements.

Adolescent↗

PubMed2002

Delisting of infants and children from the heart transplantation waiting list after carvedilol treatment.

OBJECTIVES: We performed a prospective, randomized, double-blind, placebo-controlled study of carvedilol effects in children with severe, chronic heart failure (HF), despite the use of conventional therapy. BACKGROUND: Little is known about the effects of carvedilol in youngsters with chronic HF and severe left ventricular (LV) dysfunction. METHODS: We conducted a double-blind, placebo-controlled study of 22 consecutive children with severe LV dysfunction. The children had chronic HF and left ventricular ejection fraction (LVEF) <30%. Patients were randomly assigned to receive either placebo (8 patients) or the beta-blocker carvedilol (14 patients) at 0.01 mg/kg/day titrated up to 0.2 mg/kg/day, followed-up for six months. RESULTS: During the follow-up and the up-titration period in the carvedilol group, four patients died and one underwent heart transplantation. In patients receiving carvedilol evaluated after six months, a significant increase occurred in LVEF, from 17.8% (95% confidence interval [CI], 14.1 to 21.4%) to 34.6% (95% CI, 25.2 to 44.0%); p = 0.001. Modified New York Heart Association (NYHA) functional class improved in nine patients taken off the transplant waiting list. All nine patients were alive at follow-up. In the placebo group, during the six-month follow-up, two patients died, and two underwent heart transplantation. Four patients persisted with HF symptoms (NYHA functional class IV). No significant change occurred in LVEF or fractional shortening. CONCLUSIONS: Carvedilol added to standard therapy may reduce HF progression and improve cardiac function, allowing some youngsters to be removed from the heart transplantation waiting list.

Adrenergic beta-Antagonists↗

PubMed1986

Random assignment of treatments in a 96-well (8 X 12) microtiter plate. A practical method.

A computer program, written in BASIC, has been developed to assign treatments strictly at random to the wells of a microtiter plate. A hard copy is printed of the treatment numbers with their assigned wells, followed by an 8 X 12 matrix of the treatment numbers. When a microtiter plate is placed over the matrix these numbers may be viewed directly through the wells. A program listing is reproduced. The effects of randomization on within-plate variation have been investigated and compared with two systematic methods of assignment.

Analysis of Variance↗

PubMed2001

Strengthening clinical effectiveness trials: equipoise-stratified randomization.

As psychiatric practice patterns evolve to take advantage of the growing list of treatments with proven efficacy, research studies with broader aims will become increasingly important. Randomized trials may need to accommodate multiple treatment options. In completely randomized designs, patients are assigned at random to one of the options, requiring that patients and clinicians find each of the options acceptable. In "clinician's choice" designs, patients are randomized to a small number of broad strategies and the choice of specific option within the broad strategy is left up to the clinician. The clinician's choice design permits some scope to patient and clinician preferences, but sacrifices the ability to make randomization-based comparisons of specific options. We describe a new approach, which we call the "equipoise stratified" design, that merges the advantages and avoids the disadvantages of the other two designs for clinical trials. The three designs are contrasted, using the National Institute of Mental Health Sequenced Treatment Alternatives to Relieve Depression trial as an example.

Antidepressive Agents↗

PubMed2003

Interventions for angle-closure glaucoma: an evidence-based update.

PURPOSE: To assess the interventions to treat acute angle closure (AAC) and primary angle closure (PAC) with or without glaucomatous optic neuropathy. CLINICAL RELEVANCE: Primary angle closure is one of the leading causes of blindness in East Asia. At present, there are few clinical guidelines on the optimal treatment of AAC or PAC in the affected or contralateral eye. METHODS: All randomized clinical trials, prospective controlled clinical trials, nonprospective controlled clinical trials, and retrospective case series with >50 cases that evaluated treatments for AAC or PAC were included. Studies published in the English language were identified from MEDLINE, PubMed, EMBASE, and the Cochrane Collaborations, as well as by a hand search of the reference lists of important articles. RESULTS: Nine randomized clinical trials and 24 nonrandomized clinical trials and large case series were evaluated. Laser peripheral iridotomy (LPI) has been found to be as effective as surgical peripheral iridectomy in randomized clinical trials of the affected and contralateral eyes of AAC or PAC patients with or without evidence of glaucoma. In another randomized clinical trial, latanoprost was found to decrease intraocular pressure (IOP) more than timolol for PAC in patients for whom LPI alone failed. CONCLUSIONS: This review suggests that LPI should be recommended for the treatment of affected and contralateral eyes of AAC patients. In patients with PAC and insufficient treatment with LPI, latanoprost eye drops may decrease IOP more than timolol. There is still insufficient evidence about other interventions for the treatment of AAC and PAC.

Acute Disease↗

PubMed2005

Prophylactic Oral Amiodarone for the Prevention of Arrhythmias that Begin Early After Revascularization, Valve Replacement, or Repair: PAPABEAR: a randomized controlled trial.

CONTEXT: Atrial tachyarrhythmias after cardiac surgery are associated with adverse outcomes and increased costs. Previous trials of amiodarone prophylaxis, while promising, were relatively small and yielded conflicting results. OBJECTIVE: To determine whether a brief perioperative course of oral amiodarone is an effective and safe prophylaxis for atrial tachyarrhythmias after cardiac surgery overall and in important subgroups. DESIGN, SETTING, AND PATIENTS: Double-blind randomized controlled trial of 601 patients listed for nonemergent coronary artery bypass graft (CABG) surgery and/or valve replacement/repair surgery between February 1, 1999, and September 26, 2003, at a tertiary care hospital. The patients were followed up for 1 year. INTERVENTION: Oral amiodarone (10 mg/kg daily) or placebo administered 6 days prior to surgery through 6 days after surgery (13 days). Randomization was stratified for subgroups defined by age, type of surgery, and use of preoperative beta-blockers. MAIN OUTCOME MEASURE: Incidence of atrial tachyarrhythmias lasting 5 minutes or longer that prompted therapy by the sixth postoperative day. RESULTS: Atrial tachyarrhythmias occurred in fewer amiodarone patients (48/299; 16.1%) than in placebo patients (89/302; 29.5%) overall (hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.34-0.69; P<.001); in patients younger than 65 years (19 [11.2%] vs 36 [21.1%]; HR, 0.51 [95% CI, 0.28-0.94]; P = .02); in patients aged 65 years or older (28 [21.7%] vs 54 [41.2%]; HR, 0.45 [95% CI, 0.27-0.75]; P<.001); in patients who had CABG surgery only (22 [11.3%] vs 46 [23.6%]; HR, 0.45 [95% CI, 0.26-0.79]; P = .002); in patients who had valve replacement/repair surgery with or without CABG surgery (25 [23.8%] vs 44 [44.1%]; HR, 0.51 [95% CI, 0.31-0.84; P = .008); in patients who received preoperative beta-blocker therapy (27 [15.3%] vs 42 [25.0%]; HR, 0.58 [95% CI, 0.34-0.99]; P = .03); and in patients who did not receive preoperative beta-blocker therapy (20 [16.3%] vs 48 [35.8%]; HR, 0.40 [95% CI, 0.22-0.71]; P<.001), respectively. Postoperative sustained ventricular tachyarrhythmias occurred less frequently in amiodarone patients (1/299; 0.3%) than in placebo patients (8/302; 2.6%) (P = .04). Dosage reductions of blinded therapy were more common in amiodarone patients (34/299; 11.4%) than in placebo patients (16/302; 5.3%) (P = .008). There were no differences in serious postoperative complications, in-hospital mortality, or readmission to the hospital within 6 months of discharge or in 1-year mortality. CONCLUSION: Oral amiodarone prophylaxis of atrial tachyarrhythmias after cardiac surgery is effective and may be safe overall and in important patient subgroups. Clinical Trials Registration ClinicalTrials.gov Identifier: NCT00251706.

Administration, Oral↗

PubMed2005

Recruiting seniors with chronic low back pain for a randomized controlled trial of a self-management program.

OBJECTIVE: To identify recruitment challenges and elucidate specific strategies that enabled recruitment of seniors for a randomized trial on low back pain comparing the Chronic Disease Self-management Program of the Stanford University to a 6-month wait-list control group. DESIGN: Recruitment for a randomized controlled trial. SETTING: Community-based program offered at 12 locations. PARTICIPANTS: Community-dwelling seniors 60 years and older with chronic low back pain of mechanical origin. METHODS: Passive recruitment strategies included advertisement in local and senior newspapers, in senior e-mail newsletters and listservs, in local community centers and businesses. Active strategies included meeting seniors at health fairs, lectures to the public and organizational meetings, and the help of trusted professionals in the community. RESULTS: A total of 100 white and 20 African American seniors were recruited. The program seemed to have the most appeal to white, middle-class older adults, educated through high school level. Advertisement failed to attract any participants to the program. Successful strategies included interaction with seniors at health fairs and lectures on health care, especially when the program was endorsed by a trusted community professional. CONCLUSION: Generating interest in the self-management program required keen communication skills because the idea of "self-management" was met with a myriad of responses, ranging from disinterest to disbelief. Generating interest also required active participation within the communities. Initial contacts had to be established with trusted professionals, whose endorsement enabled the project managers to present the concept of self-management to the seniors. More complex recruitment strategies were required for this study involving the self-management approach to back pain than for studies involving treatment.

Aged↗

PubMed2006

Remote treatment of panic disorder: a randomized trial of internet-based cognitive behavior therapy supplemented with telephone calls.

OBJECTIVE: This study evaluated a 10-week Internet-based bibliotherapy self-help program with short weekly telephone calls for people suffering from panic disorder with or without agoraphobia. METHOD: After the authors confirmed the diagnosis by administering the Structured Clinical Interview for DSM-IV by telephone, 60 participants were randomly assigned to either a wait-listed control group or a multimodal treatment package based on cognitive behavior therapy plus minimal therapist contact via e-mail. A 10-minute telephone call was made each week to support each participant. Total mean time spent on each participant during the 10 weeks was 3.9 hours. The participants were required to send in homework assignments before receiving the next treatment module. RESULTS: Analyses were conducted on an intention-to-treat basis, which included all randomly assigned participants. From pretreatment to posttreatment, all treated participants improved significantly on all measured dimensions (bodily interpretations, maladaptive cognitions, avoidance, general anxiety and depression levels, and quality of life). Treatment gains on self-report measures were maintained at the 9-month follow-up. A blind telephone interview after the end of treatment revealed that 77% of the treated patients no longer fulfilled the criteria for panic disorder, whereas all of the wait-listed subjects still suffered from it. CONCLUSIONS: This study provides evidence to support the use of treatment distributed via the Internet with the addition of short weekly telephone calls to treat panic disorder. Replication should be made to compare self-help and telephone treatment based on cognitive behavior methods with nonspecific interventions.

Adult↗

PubMed1999

Reviewer bias against the unconventional? A randomized double-blind study of peer review.

OBJECTIVE: To test the hypothesis that there is a reviewer bias against publication of a test of an unconventional drug. DESIGN: Randomized, controlled, double-blind study of peer review. PARTICIPANTS: Convenience sample of 291 medical doctors from a wide variety of specialties drawn from a list of conference participants. METHODS: Reviewers were randomly assigned to receive one of two versions of a manuscript. Version M related to an in-vitro experiment on a mainstream drug (Metoprolol). The otherwise identical version V used a highly unconventional drug (beef spleen cell extract) for the same experiment. Reviewers were asked to complete a standardised evaluation sheet including visual analogue scales (VASs) on a set of predefined quality criteria. All participants were debriefed after completion of the study. RESULTS: The response rate was 61%. There were no significant differences in VAS ratings between the two versions of the manuscript. Ratings covered the entire range of the VASs. CONCLUSION: In the present setting, there was no evidence for a reviewer-bias against testing an unconventional drug. The low inter-rater reliability, however, suggested inadequate validity of peer review.

Animals↗

PubMed2000

How to evaluate the effectiveness of complementary therapies.

The most important question about any treatment is whether it is effective. This article summarizes basic theoretic and practical aspects that are relevant to the evaluation of the effectiveness of a treatment. The factors that can explain why patients improve over time and the ways to separate these factors are outlined. It is explained why, theoretically, randomized clinical trials are the best method to answer questions about effectiveness. Reasons that such trials sometimes fail in practice to provide valid answers are listed. It is argued why evidence from randomized trials must be "complemented" by a variety of different research methods and quality assurance projects.

Complementary Therapies↗