How the psychosocial context of clinical trials differs from usual care: A qualitative study of acupuncture patients

Background

Qualitative studies of participants' experiences in randomised clinical trials (RCTs) suggest that the psychosocial context of treatment in RCTs may be quite different to the psychosocial context of treatment in usual practice. This is important, as the psychosocial context of treatment is known to influence patient outcomes in chronic illness. Few studies have directly compared the psychosocial context of treatment across RCTs and usual practice. In this study, we explored differences in psychosocial context between RCT and usual practice settings, using acupuncture as our model.

Methods

We undertook a secondary analysis of existing qualitative interviews with 54 patients. 27 were drawn from a study of western and traditional acupuncture in usual practice (for a range of painful conditions). 27 were drawn from a qualitative study nested in an RCT of western acupuncture for osteoarthritis of the hip or knee. We used qualitative analysis software to facilitate an inductive thematic analysis in which we identified three main themes.

Results

In usual practice, starting acupuncture was more likely to be embedded in an active and ongoing search for pain relief, whereas in the RCT starting acupuncture was opportunistic. Usual practice patients reported few uncertainties and these had minimal consequences for them. In the RCT, patients experienced considerable uncertainties about their treatment and its effectiveness, and were particularly concerned about whether they were receiving real (or fake) acupuncture. Patients stopped acupuncture only at the end of the fixed course of treatment in the RCT, which was similar to those receiving acupuncture in the public sector National Health Service (NHS). In comparison, private sector patients re-evaluated and re-negotiated treatments particularly when starting to use acupuncture.

Conclusions

Differences in psychosocial context between RCTs and usual practice could reduce the impact of acupuncture in RCT settings and/or lead to under-reporting of benefit by patients in trials. New trial designs that ensure participants' experiences are similar to usual practice should minimise differences in psychosocial context and help attenuate these potentially confounding effects.

     

A systematic review of vanadium oral supplements for glycaemic control in type 2 diabetes mellitus

Objective: To assess the effectiveness of oral vanadium supplementationfor glycaemic control in type 2 diabetes by conducting a systematicreview of the literature. Design and Methods: Eligible studies were identified by searching14 databases using standardized terms. Experts, study authorsand manufacturers were also contacted. Hand-searching was notundertaken. Selection criteria for inclusion in the review werecontrolled human trials of vanadium vs. placebo in adults withtype 2 diabetes of minimum 2 months duration, and a minimumof 10 subjects per arm. Data extraction, assessment of studyquality and outcome analysis were undertaken by two independentreviewers. Results: One hundred and fifty one studies were found but nonemet the inclusion criteria. We proceeded to summarize the stateof existing evidence and plan for a future clinical trial byapplying revised, less restrictive criteria to our search, forclinical trials of 30–150 mg daily oral vanadium supplementationin diabetic humans. Only five were identified. These demonstratedsignificant treatment-effects, but due to poor study quality,must be interpreted with caution. Treatment with vanadium oftenresults in gastrointestinal side-effects. Conclusion: There is no rigorous evidence that oral vanadiumsupplementation improves glycaemic control in type 2 diabetes.The routine use of vanadium for this purpose cannot be recommended.A large-scale randomized controlled trial is needed to addressthis clinical question.     

Devil's Claw (Harpagophytum procumbens) as a treatment for osteoarthritis: a review of efficacy and safety

BACKGROUND: Osteoarthritis (OA) is a highly prevalent musculoskeletal disorder. Conventional treatment (i.e., the use of nonsteroidal anti-inflammatory drugs-NSAIDs) is associated with well-documented adverse effects. Devil's Claw (Harpagophytum procumbens) a traditional South African herbal remedy used for rheumatic conditions, may be a safer treatment option. To date, 14 clinical trials have assessed its efficacy/ effectiveness in OA. AIM: To address the two main questions of importance to clinicians: (1) Does Devil's Claw work for the treatment of OA, and (2) Is it safe? METHODS: A review of the literature on Devil's Claw and OA from 1966 to 2006 was performed using multiple search databases, monographs, and citation tracking. Relevant trials in all languages were identified and included. Both internal validity (i.e., adequacy of the dosage and period of treatment for this condition, reporting of randomization, rates of dropout, blinding, and statistical analysis) and external validity (i.e., inclusion/ exclusion criteria, baseline characteristics of the study populations, trial setting, and the appropriateness of the outcome measures of the trials) were assessed. RESULTS: Fourteen studies were identified: eight observational studies; 2 comparator trials (1 open, the other randomized to assess clinical effectiveness); and 4 double-blinded, placebo-controlled, randomized controlled trials to assess efficacy. Many of the published trials lacked certain important methodological quality criteria. However, the data from the higher quality studies suggest that Devil's Claw appeared effective in the reduction of the main clinical symptom of pain. The assessment of safety is limited by the small populations generally evaluated in the clinical studies. From the current data, Devil's Claw appears to be associated with minor risk (relative to NSAIDs), but further long-term assessment is required. CONCLUSIONS: The methodological quality of the existing clinical trials is generally poor, and although they provide some support, there are a considerable number of methodologic caveats that make further clinical investigations warranted. The clinical evidence to date cannot provide a definitive answer to the two questions posed: (1) Does it work? And (2) is it safe? A definitive high-quality trial that addresses the necessary methodologic improvements noted is needed to answer these important clinical questions.