Do standards for the design and reporting of nonpharmacological trials facilitate hypnotherapy studies?

The design and quality of 30 recent hypnotherapy trials (years 2000-2008) were assessed using the checklist for evaluating a report of nonpharmacological treatment (CLEAR NPT). Randomization was adequately reported in 53% of studies. The masking of participants and care providers is not feasible in hypnotherapy studies. Assessor masking is rarely introduced in randomized, controlled trials (27%). Reporting and quality of published hypnotherapy trials need to be improved. Investigators may consider using CLEAR NPT to evaluate study quality but attention should be paid to document intervention adherence, standardization of cointerventions, participant and care-provider expectations and beliefs, and, finally, hypnotizability.     

Has CONSORT improved the reporting of randomized controlled trials in the palliative care literature? A systematic review

BACKGROUND: In 1996, the CONSORT (CONsolidated Standards Of Reporting Trials) statement for the reporting of clinical trials was produced, based on empirical evidence regarding bias. AIMS: This study assessed the quality of reporting of randomized controlled trials (RCTs) in the palliative care literature. METHODS: Three specialist journals were hand searched for RCTs. A checklist was devised based on CONSORT recommendations. Two investigators independently assessed all the trials against this checklist. The trials were grouped into time cohorts of five years and quality comparisons made. Trials looking at pain were compared with those trials looking at other aspects of palliative care. RESULTS: Ninety-three RCTs were identified. The number of trials has increased over time: nine in the first cohort, 37 in the second and 47 in the last cohort. The number of patients in the individual trials has also increased over time. Generally, the reporting quality was poor, particularly the areas of allocation concealment, randomization technique and intention to treat analysis, where there is empirical evidence, that it leads to trial bias. Although there were more pain papers than non-pain papers, the quality of reporting was only better for blinding and intention to treat analysis. CONCLUSION: The quality of reporting of RCTs in the palliative care literature is generally poor. However, there has been an increase in the number and the size of RCTs being carried out. This shows recognition of the importance of an evidence base in palliative care. However, in order to guide clinical decision making, future trials need to improve the quality of their reporting by adhering to the CONSORT statement.     

Adverse effects of homeopathy,what do we know? A systematic review and meta-analysis of randomized controlled trials

ObjectivesHomeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients’ symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed.Design and settingSixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis.ResultsA total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86–1.14, I² = 54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high.ConclusionAdverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine.     

Outcomes in acute pain trials: systematic review of what was reported?

Single-dose clinical trial methods for evaluating analgesics have been used successfully for over 50 years. The aims of this review were to examine which pain measurement scales have been used in high quality acute pain trials, to investigate other common measurements or characteristics, to confirm that different scales used by standard methods give the same estimate of analgesic effect, to investigate remedication methodologies and the potential of 'time to remedication' as a standard outcome. Published reports of randomised, double blind, placebo-controlled trials, investigating at least 20 adult patients (10 patients per treatment arm) experiencing moderate or severe pain using at least one standard pain intensity or pain relief scale were sought. Key design features, outputs and outcomes were catalogued for each report. The main outcomes reported were misleading, detailing only the mean values of data with a demonstrably skewed distribution. After 50 years, the reporting of results from acute pain trials warrants a fresh look. Possible improvements include reporting the number of patients with certain levels of pain relief, or the actual number (percentage) of patients with a certain level of pain relief at a certain time, or more useful information on remedication from trials of at least 12 h duration. Most useful would be all three. Further exploration would only be possible from analysis at the individual patient level.     

A review of the relationship between depression and diabetes in adults: is there a link?

OBJECTIVE: To review the support for two hypotheses concerning the interrelationship between depression and diabetes and to identify areas in which more research is needed. RESEARCH DESIGN AND METHODS: A review was conducted using primarily electronic databases. Articles relating to diabetes and depressive symptomatology, depressive disorder, and dysthymic disorder were selected. The study focuses mainly on adults with diabetes. RESULTS: The initial onset of major depressive disorder (MDD) seems to be independent of the onset of type 2 diabetes, but results remain equivocal for type 1 diabetes. However, in both type 1 and type 2 diabetes, diabetes-related psychological and physiological processes may be involved in the higher recurrence and longer duration of MDD and depressive symptomatology CONCLUSIONS: The hypotheses that the initial occurrence of clinically significant depression, MDD, results from either biochemical changes directly due to type 2 diabetes or its treatment or from the psychosocial demands imposed by the illness or its treatment do not seem to be supported. MDD in diabetic individuals represents a multidetermined phenomenon resulting from interactions between biologic and psychosocial factors. This interaction may increase the probability of developing type 2 diabetes in otherwise healthy individuals.     

Lessons from the infuse trials: do we need a classification of bias in scientific publications and editorials?

The original 13 Food and Drug Administration industry-sponsored recombinant human bone morphogenetic protein-2 (rhBMP-2) trials investigating its use in spinal fusion all reported no associated adverse events. However, subsequent series of studies began reporting complication rates that were much higher than those that were initially published. Critical analysis of the original rhBMP-2 industry-associated data found systematic alignment favoring positive outcomes with no proven clinical advantage over bone graft. The sources of potential bias leading to inaccurate reporting of original rhBMP-2 efficacy and safety profile include flawed study design, methodological technique, data reporting and analysis, and significant financial conflict of interest. As such, to ensure the integrity of the scientific literature, further measures should be taken by researchers, surgeons, authors, journal editors and reviewers to assess for potential sources of bias.     

Effectiveness and safety of acupuncture in the treatment of Parkinson’s disease: A systematic review and meta-analysis of randomized controlled trials

ObjectiveThis study aimed to examine the effectiveness and safety of acupuncture in the treatment of Parkinson’s disease (PD).MethodsEnglish, Chinese, and Korean electronic databases were searched up to June 2016. Randomized controlled trials (RCTs) were eligible. The methodological quality was assessed using Cochrane’s risk of bias tool. Meta-analysis was performed using RevMan 5.3.ResultsIn total, 42 studies involving 2625 participants were systematically reviewed. Participants treated using combined acupuncture and conventional medication (CM) showed significant improvements in total Unified PD Rating Scale (UPDRS), UPDRS I, UPDRS II, UPDRS III, and the Webster scale compared to those treated using CM alone. The combination of electroacupuncture and CM was significantly superior to CM alone in total UPDRS, UPDRS I, UPDRS II, and UPDRS IV. Similarly, the combination of scalp electroacupuncture, acupuncture, and CM was significantly more effective than CM alone in total UPDRS. However, our meta-analysis showed that the combination of electroacupuncture and CM was not significantly more effective than CM alone in UPDRS III, the Webster, and the Tension Assessment Scale. The results also failed to show that acupuncture was significantly more effective than placebo acupuncture in total UPDRS. Overall, the methodological quality of the RCTs was low. No serious adverse events were reported.ConclusionsWe found that acupuncture might be a safe and useful adjunctive treatment for patients with PD. However, because of methodological flaws in the included studies, conclusive evidence is still lacking. More rigorous and well-designed placebo-controlled trials should be conducted.     

Standards for reporting interventions in controlled trials of acupuncture:The STRICTA Recommendations

Summary: Acupuncture treatment and control group interventions in parallel-group randomised trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them.STRICTA: Standards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journal editors are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations.The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, ther     

What is the place of thrombolysis in acute stroke? A review of the literature and a current perspective

The global burden of stroke, the undisputed success of intravenous thrombolysis in the management of myocardial infarction and subsequent evidence from animal models of cerebral infarction have all fuelled intense interest in the potential role for thrombolytic agents in the acute management of stroke in clinical practice. Before any clinical treatment is introduced universally its safety and efficacy must be demonstrated in the routine clinical environment and not just within the ideal conditions of controlled clinical trials. Similarly, the cost effectiveness of a new treatment modality is an essential consideration before its use is promulgated. This paper reviews the current scientific evidence for thrombolysis in stroke with reference to issues of safety, efficacy and cost effectiveness.     

Do botulinum toxins have a role in the management of neuropathic pain?: a focused review

ABSTRACT: Botulinum neurotoxin (BoNT) is usually used in physiatric practice in the treatment of spasticity and dystonia. Research involving both animal and human subjects has emerged suggesting potential benefits in painful neuropathic conditions. The animal data strongly support the use of BoNT in the treatment of sensitized pain states. BoNT is probably effective at treating postherpetic neuralgia, probably or possibly effective at treating postoperative/posttraumatic neuropathic pain, and probably effective at treating painful diabetic neuropathy. BoNT's proposed mechanism of action is described as decreasing sensitized nociception in four ways by (1) inhibiting glutamate release in peripheral tissues, (2) decreasing calcitonin gene-related peptide release in peripheral tissue, (3) decreasing transient receptor potential cation channel subfamily V member 1 trafficking to peripheral neuron cell membrane, and (4) decreasing substance P release in peripheral tissue. This review discusses pertinent cellular/animal basic science research in conjunction with clinical research with regard to the role of BoNT in treating neuropathic pain.