1,721,056 research outputs found
Developing a research strategy for acupuncture
No full textThis strategic overview revisits some of the basic assumptions that relate to the clinical evaluation of acupuncture. We look at the evidence available to estimate both the specific and nonspecific effect size of acupuncture (efficacy and effectiveness) and consider the placebo within acupuncture trials, as well as the value of both placebo controlled trials and pragmatic acupuncture studies. We argue for an augmented, mixed methodology that integrates basic mechanism studies, including modern imaging techniques such as functional magnetic resonance, quantitative and qualitative research, as well as safety and health economic data to obtain a more rigorous understanding of acupuncture. We hope that by taking a broad, patient-centered, and rigorous approach we may arrive at a realistic and thoughtful evaluation of its relative value in comparison to placebo treatment, conventional medicine, and its potential for integration into conventional clinical care
Scientific tools, fake treatments, or triggers for psychological healing: How clinical trial participants conceptualise placebos.
No full textPlacebos are an essential tool in randomised clinical trials, where they are used to control for bias and contextual healing effects. Placebos and their effects are also studied from multiple diverse perspectives, but the perspectives of placebo recipients are seldom considered. Research shows that people form cognitive and affective representations of active treatments such as medicines, and that they use these representations to guide their behaviour; it seems reasonable to suggest that people might also think about and develop representations of placebos. We adopted a qualitative approach to examine in detail how participants in one RCT, conducted in the USA, conceptualised placebos. 12 people were interviewed 3 times each, at the start, middle, and end of a trial of placebo effects and acupuncture for Irritable Bowel Syndrome (IBS). The interview data were analysed inductively and we identified four ways in which the participants conceptualised placebos: placebos are necessary for research; placebo effects are fake; placebo acupuncture is not real acupuncture; placebos have real effects mediated by psychological mechanisms. Participants' conceptualisations of placebos were dynamic and situated in a broader psychological and socio-cultural context. Seeing placebo effects as legitimate seemed to be facilitated by having more holistic models of healing, viewing IBS as psychological, and seeing treatment as multifactorial. However, some participants maintained a negative view of placebo effects (e.g. as illusions) that was apparently inconsistent with their other beliefs (e.g. in mind-body healing mechanisms). This may indicate a dominance of negative discourses around placebos at a socio-cultural level. Negative views of placebos are inconsistent with evidence that placebo treatments can have positive effects on symptoms. RCT participants should be informed about potential benefits of placebo treatments to avoid misunderstandings and unease. Future work should improve methods of providing participants with full accurate information about placebos and their effects
Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos
Full text linkBackgroundPlacebo groups are used in randomised clinical trials (RCTs) to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.Methods and FindingsWe conducted a content analysis of 45 Participant Information Leaflets (PILs) using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database). Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%), but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001) and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001) or adverse effects (4 vs. 39, p<001). 8 PILs (18%) explicitly stated that the placebo treatment was either undesirable or ineffective.ConclusionsPILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled trials
Southampton needle sensation questionnaire: development and validation of a measure to gauge acupuncture needle sensation
No full textObjective: the specific sensations (deqi) generated during acupuncture are thought to be important for a positive clinical outcome, particularly when treating pain. It is important to be able to measure these sensations and discriminate between deqi and pain. A greater understanding of this will greatly aid researchers who wish to conduct mechanistic studies of acupuncture. Previous questionnaire designs failed to consider patient experience and, hence, may have been flawed. The aim of this study was to generate and validate a new sensation questionnaire, that was able to discriminate between pain and deqi, taking into account patient experience and expert opinions.Design: the questionnaire was designed following qualitative interviews with patients, literature review, and consultation with experts. The questionnaire was piloted and then validated. It was successfully completed by 227 patients and analyzed using factor analysis and partial correlation.Setting: patients were recruited via the physical therapy department at Southampton General Hospital and from private practice clinics in and around the Southampton area.Subjects: the subjects were patients receiving acupuncture for any condition.Results: two (2) factors were clearly demonstrated: “Aching deqi” (7 items) which suggested deqi with pain and “Tingling deqi” (7 items) suggesting deqi only. One (1) item related solely to pain and 2 further items did not load into any factor.Conclusions: the final questionnaire is presented containing 17 items and is shown to be a valid, rigorous, soundly grounded, and patient-centered measure, capable of accurately recording deqi. We suggest that analysis should include a partial correlation of certain sensations against a pain visual analogue scale to ascertain how painful each sensation was, particularly if the questionnaire is to be used in a context in which pain and deqi need to be separated or their relationship clarified
Neural activities in human somatosensory cortical areas evoked by acupuncture stimulation
No full textObjectives: To investigate neural representation evoked by acupuncture from human somatosensory cortices, especially from primary (SI) and secondary (SII) somatosensory areas. Design and setting: Neuroimaging study - Blood-oxygenation-level-dependent (BOLD) functional MRI was performed during acupuncture on LI4 (n = 12 healthy participants). Sham acupuncture and innocuous tactile stimulation were also applied on the same acupuncture site as control comparisons. Outcome measures: Responsive neural substrates were visualized and identified based on both individual and group-level surface activation maps. Results: Discrete regions within the precentral gyrus (area 4) and the fundus of the central sulcus (area 3a) were selectively activated during the real acupuncture stimulation. In SII, the activation was extended in a postero-inferior direction to the fundus of the lateral sulcus. Conclusion: This specific pattern of acupuncture-related activation indicates that deep tissue stimulation (as seen in area 3a activation) and concurrent processing of sensory stimulation (as seen in activation in SII) may mediate neural responses to manual acupuncture. (C) 2007 Elsevier Ltd. All rights reserved.Grants from Korean Ministry of Commerce, Industry, and Energy(to S.S. Yoo and H.Park; 2004-02012)as well as by funds from the Osher Institute, Division for Research
and Education on Complementary and Integrative Medical Therapies, Harvard Nedical School
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Topical Clonazepam and Placebo Effect in Burning Mouth Syndrome
No full textBurning mouth syndrome (BMS) is a chronic pain condition reported to affect up to 7.9% of the general population, with associated detrimental impact on patients’ quality of life. Currently employed treatment regimens follow therapy for other neuropathic pain conditions. Very few placebo-controlled randomized trials (RCTs) have been conducted to evaluate the efficacy of these regimens, with a wide range of placebo responses documented. Low-dose clonazepam is considered first-line therapy for BMS, either in a topical or systemic mode of administration. An innovative formulation of topical clonazepam in the form of a compounded oral solution has been used at the Division of Oral Medicine and Dentistry at Brigham and Women’s Hospital (DOM-BWH) since 2008 for the management of BMS and other oral dysesthesias. An initial concentration of 0.5 mg/mL was used until 2012, when this was changed to a 0.1 mg/mL solution.
The objectives of this project were to 1) quantify the magnitude of placebo response in BMS, 2) evaluate the tolerability, safety, and efficacy of the two concentrations of topical clonazepam solution for the management of BMS, and 3) compare their effectiveness in improving burning symptoms.
We first conducted a systematic review of published randomized, blinded, placebo-controlled trials of therapies for BMS and evaluated the magnitude of the placebo response compared with the response to the treatment. Twelve RCTs were included. Ten studies (83%) reported at least some improvement in the symptomatology of patients receiving active treatment compared with baseline. In six of these studies (60%), there was also a positive response to placebo. On average, treatment with placebos produced a response that was 72% as large as the response to active drugs.
Next, we conducted a retrospective chart review of all patients with oral dysesthesia, including BMS, managed with topical clonazepam solution (0.1 mg/mL or 0.5 mg/mL) in DOM-BWH from 2008 to 2015. The relative safety of the two concentrations of the solution was evaluated in terms of occurrence of adverse drug reactions (ADRs) and occurrence of change to treatment plan secondary to ADRs. A total of 541 charts were reviewed. 162 subjects met the inclusion criteria, 84 patients in the 0.1 mg/mL cohort and 78 in the 0.5 mg/mL cohort, evaluated at a median follow-up of 6 weeks. Thirty-eight (23%) patients developed ADRs. The most frequently reported ADR was sedation (62% of ADRs), followed by altered mental status and dizziness (7% each). In total, dose adjustments were required in nine patients (6%), and treatment was discontinued in 13 patients (8%). ADRs were more frequently reported in the 0.5 mg/mL cohort, but no significant difference was found between the two concentrations, either in terms of occurrence of ADRs or change to treatment secondary to ADRs, or in terms of types of ADRs (p>0.05).
Finally, we conducted a retrospective chart review of all patients diagnosed specifically with BMS and managed with topical clonazepam solution (0.1 mg/mL or 0.5 mg/mL) from 2008 to 2015. The efficacy of the two concentrations in improving burning symptoms was compared using patient-reported outcome measures, including the percentage improvement in burning symptoms as reported at first follow-up, and the change from baseline to first follow-up in the worst burning severity over the week prior to evaluation, ranked on an 11-point numeric rating scale (NRS). The study included 57 subjects, with 32 patients in the 0.1 mg/mL cohort and 25 patients in the 0.5 mg/mL cohort, who were evaluated at a median follow-up of 7 weeks. The median overall percentage improvement associated with the 0.1 mg/mL solution was 32.5% (range 0-100%), not significantly higher than the commonly used 30% cut-off. Treatment with the 0.5 mg/mL solution was associated with median overall percentage improvement of 75% (range 0-100%), significantly higher than the more conservative 50% cut-off (p<0.01). The median reduction in NRS score was 6 points in the 0.5 mg/mL concentration, and 0.5 points in the 0.1 mg/mL concentration. Using either outcome measure, response to treatment with the 0.5 mg/mL solution was superior to that associated with the 0.1 mg/mL solution (p<0.01).
This thesis is the first to suggest a potentially considerable role for placebo effect in treatments for BMS. Our results suggest that treatment with topical clonazepam solution is generally safe and well-tolerated, with a similar safety profile for both concentrations. A 0.5 mg/mL concentration is highly effective in the management of burning dysesthesia in patients with BMS, significantly more than a 0.1 mg/mL concentration.BMS, oral dysesthesia, placebo analgesia, clonazepa
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