Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components. We conducted a systematic review of clinical trials in which patients were randomly assigned to either placebo or no treatment. A placebo could be pharmacologic. A placebo is a medical treatment or procedure designed to deceive the participant of a clinical experiment. It does not contain any active ingredients but. CASH OUT BETTING COMPANIES IN UGANDA

Second, induced skin redness under the electrode, which is not uncommon in the active condition, makes double-blinding more challenging. Finally, although the currents are ramped down after a short time, cortical effects may still be induced. With Actisham, the same electrode montages are used across conditions to ensure double blinding, and only the individual currents at each electrode are changed.

In the active sham condition, currents are configured to produce similar itching to the active condition, but very low cortical electric fields. Physically this is possible by maximizing current shunt through the scalp. This is achieved by the use of the optimization algorithm Stimweaver , which has now the objective of a null electric field on the cortical target, with the additional constraint that some electrodes deliver sizable currents e.

This method ensures double blinding and delivers similar PNS stimulation across conditions, so putative PNS effects will be present in both active and sham stimulation. The Actisham method has been already been used successfully in previous work Dagan et al, , i. When comparing the different types of stimulation conditions, no significant difference was found in the number of subjects who reported real or sham.

The confidence levels were also similar after real and sham responses. Figure 1: Physics of shunting. E-field magnitude and direction in the tissues beneath the electrodes in the two optimized montages used in this study: active 4-channel montage left and ACTISHAM 6-channel montage right.

Actisham takes advantage of current shunting through the scalp to place the electrodes and decrease the E-field in the target M1 area. Anodes are shown in red, cathodes in blue and inactive electrodes in white. The electric field in the cortex during transcranial current stimulation.

Blinding the patients and the evaluator is an alternative. In this process, a researcher may evaluate the blinding effect, not just report that the patients were blinded Researchers have implied that, unlike inexperienced subjects or subjects with limited acupuncture experience, experienced subjects may be able to distinguish the different appearance or sensation between real and sham acupuncture For instance, a number of patients knew the exact sensation associated with acupuncture.

Thus, subjects with different background knowledge and previous experience of acupuncture may induce a different result in the blinding procedure. Other factors 24 , 25 also influence the blinding procedure, including the needle point a needle in an insensitive point may have a better blinding effect , the visual impact of needling if the subject observed the manipulation of the acupuncturist, the effect of the blinding procedure may be influenced , and the therapists the needling differences between acupuncture therapists should be minimized.

Control groups in acupuncture trials The use of an appropriate control group was found to improve the reliability of acupuncture studies However, selecting an ideal control group for acupuncture research is a challenging methodological issue Questions about acupuncture cannot be answered by a single control group, since acupuncture is a complex intervention. Therefore, an appropriate control group should be selected according to the specific questions being asked in the study The common categories of control groups in acupuncture studies are: Waiting-list control no-treatment control group ; standard care such as medications ; and sham interventions, which attempt to manage placebo and other nonspecific effects.

The placebo effect cannot be managed in the waiting-list control and standard care groups and thus attention has been focussed on the control groups of sham interventions. Sham intervention is a complicated control which has been often applied as a control for nonspecific or placebo effects, in order to investigate whether verum acupuncture is more effective than sham intervention The benefit of this control is that the blinding procedure may be more effective compared with other methods, and the disadvantages are the potential nonspecific needling effects Therefore, partly because of the non-specific needling effects, the differences in clinical effects between the real and sham acupuncture groups are unclear.

Selecting an appropriate sham intervention If a sham intervention was an absolutely inert procedure and its appearance was difficult to distinguish from the real acupuncture group, it could be regarded as the optimum condition in acupuncture RCTs for determining the effects of acupuncture interventions Several sham interventions, including superficial needling, needling in irrelevant true points, needling in non-points, non-penetrating sham needles, non-needling sham interventions and minimal acupuncture, were often used in acupuncture RCTs Each type of sham intervention has certain advantages and disadvantages.

All the aforementioned methods of sham intervention cannot be regarded as absolutely inert interventions, as they may induce certain therapeutic effects 33 — In addition, the various manipulations and insert directions were not allowed by the device 37 in a non-penetrating sham needle. This sham intervention-induced effect may result in the difference between verum and sham group not being significant In addition, these controls were often investigated in inexperienced subjects 29 , 39 , so the blinding of this method should be considered when the subjects have had extensive experience in acupuncture.

Designing an appropriate control requires understanding the traditional acupuncture theory and the modern mechanism of acupuncture, and should match the specific objective of the study. To date, no sham intervention can be regarded as an ideal control and this question should be further investigated by methodologists.

A powerful placebo effect may result in a potential bias Placebo effect Positive results were often produced from studies that applied a non-acupuncture control group, and the results were usually negative in studies that used sham acupuncture or mock transcutaneous electrical nerve stimulation Vickers et al 41 found that potent placebo effects were contributing to the total effects of acupuncture.

Generally, placebo implied an inert substance or procedure and a placebo effect was an essential component of all therapeutic interventions Intervention should be divided into specific and placebo non-specific aspects in order to design a placebo-controlled procedure Specific elements was considered to be responsible for the specific therapeutic actions, and other aspects that influenced the effects were placebo elements, such as the patient expectations and the communication between therapists and subjects A previous study considered that the placebo effect was derived from factors included in a social, cultural and clinical context, rather than from the sham interventions per se Other studies 42 , 45 , 46 demonstrated that a placebo effect was a complexity resulting from psychological, social and cultural background factors, as well as real physiological responses.

The psychological mechanisms 42 of the placebo effect include many aspects associated with the procedure of acupuncture, including expectations, memory, motivation, cognitive and conditioning mechanisms. Minimizing the placebo effect If the major mechanisms of placebo responsiveness could be identified, strategies aimed at minimizing placebo effects could be developed, so that the true effect of an intervention can be revealed in trials Systematic research was conducted to explore how to minimize the placebo effect.

Researchers successfully reduced the placebo effect by decreasing the interaction between therapists and participants Other studies demonstrated that strong placebo effects could significantly influence the outcome of subjective symptoms and this significant influence may be confined to subjective outcomes Therefore, in future experiments, multiple outcome measurements should be selected, including subjective and objective outcomes.

Although the placebo effect is complex, research demonstrated that the placebo effect from sham acupuncture was stronger compared with the effect from a placebo pill These results may be due to more complex medical interventions having a higher placebo effect than medication Given the potential physiological effects of sham interventions and the powerful placebo effects, the results of acupuncture RCTs may be undervalued in numerous studies Insufficient acupuncture administration Acupuncture administration One of the least investigated areas of acupuncture research may be acupuncture administration.

Researchers have to increase the effectiveness of drugs to prove that their effect is greater than placebo control; however, this has not been the case in acupuncture trials. An insufficient acupuncture treatment group may also provide potential bias regarding study outcomes. The results of acupuncture efficacy based on insufficient acupuncture treatment groups can be compared with formulating conclusions on the pharmaceutical efficacy of a drug with an inadequate dose It is important to emphasize that acupuncture is not a straightforward needling intervention.

The evaluation is therefore far more challenging than that of a pharmacological agent. When the results of two studies about acupuncture on hypertension are compared 10 , 55 , the data may demonstrate that the effects of active or verum acupuncture groups are different. Macklin et al 10 revealed that active acupuncture groups provided no greater benefit than sham acupuncture, while Flachskampf et al 55 reported a clear-cut effect on blood pressure in the active treatment group.

The setting of acupuncture administration was different in the two trials. Each session lasted 30 min after the needle was inserted into the points. The needling points were selected according to the Chinese type of hypertension in Traditional Chinese Medicine theory, and the acupuncture details, including angle, depth and type of manipulation of needling, were consistent with typical prescriptions.

By contrast, in the trial that obtained a negative result 10 , the principles of diagnoses and treatment were consistent with the description of Cheng Therefore, it can be concluded that the difference in the acupuncture administration setting may induce certain potential bias. Principal features of acupuncture intervention efficacy Although there were a variety of factors that may account for the improvement in the acupuncture group, two principal features should be emphasized: Acupoint specificity and manipulation of acupuncture.

Acupoint specificity Acupoint specificity is often considered as the foundation of the theory and treatment of acupuncture Evidence derived from brain imaging and biological studies demonstrated that the point specificity does exist 58 — Clinical research identified that acupuncture stimulation of different points on similar body regions in patients with migraine reduced pain and induced different levels of cerebral glucose metabolism in pain-related brain regions We strongly suggest that the international classification of acupoints by the World Health Organization should be used and referenced in clinical trials.

The optimal selection of acupoints requires expert knowledge and standard textbooks and the accurate location of acupoints should be strictly conducted. Acupuncture manipulation Apart from acupoint localization, acupuncture manipulation was also considered to be a pivotal potential modifier of acupuncture effects.

Normally, needling manipulation refers to various manipulations of acupuncture to induce a needling sensation once a needle is inserted The fundamental manipulation techniques can be divided into various aspects, and these techniques may be used alone or in combination, according to the clinical condition of the patient.

Manipulation methods may differ in the depth of needling, the form of needle stimulation e. Mastering the manipulations of acupuncture may improve its therapeutic effects in clinical practice, according to the theory of TCM. Over the past several years, numerous studies have been published to investigate the effect of acupuncture manipulation. Previous studies 64 , 65 have demonstrated that different acupuncture manipulations a different effect on pain, as demonstrated by cellular responses in mouse subcutaneous connective tissue.

In addition, Han et al 66 revealed that different frequencies of electrical stimulation affected the release of different neuropeptides. Changes in functional magnetic resonance imaging also found that various durations of acupuncture intervention would influence the effect in the brain Furthermore, Langevin et al 65 demonstrated that subtle differences in needle-manipulation techniques induced different cellular responses in mouse subcutaneous connective tissue and the maximal cellular responses were produced by specific combinations of cycle amplitude and cycle number.

Therefore, different acupuncture manipulations may play a role in the clinical outcomes and inappropriate acupuncture techniques may induce a potential bias in acupuncture studies.

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The power of the placebo effect - Emma Bryce

CQ's web blog on the issues in biostatistics and clinical trials.

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Bettys place boston ymca	And by placebos had lost much of their previous popularity as therapy. Personality, after all, has little effect on subconscious conditioning. This is not a placebo effect, but simply reflects normal fluctuations in pain. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances: — Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or — Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm. Notably, there has been much debate of whether to use a placebo pill or conduct a sham procedure as a control.
Meaning of the word ethereum	Even simple lactose pills are active for diabetics or people with lactose intolerance. In one study, cellulose acetate phthalate typically used to coat pills was reported to have activity against several sexually transmitted diseases, including herpes, in mice [ 14 ]. Biochemical Mediators The evidence is compelling that the placebo effect is due to biochemical effects, and is not a purely psychological phenomenon. This is an open access article distributed under the terms of the Creative Commons Attribution Licensewhich permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Flintp. Optimisation of the checklist S2 Text has full details of the optimisation process.
Naming ethers practice	In the study of orthopaedic surgery for the treatment of acute and chronic pain conditions, there have only been 7 sham controlled trials. The placebo effect is enhanced by cholecystokinin antagonists. And yet the other patients in the hospital who had received Krebiozen showed no improvement. This demonstrates that it is possible to undertake such studies and that the findings are important. Recent research [35] strongly indicates that a "placebo response" is a complex psychobiological phenomenon, contingent upon the psychosocial context of the subject, that may be due to a wide range of neurobiological mechanisms with the specific response mechanism differing from circumstance to circumstance.
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