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Designing and Delivering a DTx Clinical Research Program: No Need to Re-invent the Wheel
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Colin A. Espie, Alasdair L. Henry
Building on this, a common and straightforward control often implemented in early-stage clinical testing is a “waitlist control.” This is where participants randomized to the control do not receive any intervention at all; however, they are told they will receive the intervention once the trial is completed. Effects can, however, be exaggerated (Mohr et al., 2009; Cunningham et al., 2013; Cuijpers et al., 2016, 2019) with a waitlist control as participants may be less likely to access other treatments or seek help from healthcare professionals knowing they will eventually receive the intervention and as they have been asked to wait to receive an intervention (Furukawa et al., 2014). This, too, raises ethical considerations arising from the fact that an effective intervention may be withheld. Furthermore, and although contested, some have also raised concerns about potential “nocebo” effects resulting from waitlist controls due to more significant improvements being observed in no-treatment controls relative to waitlist participants (Furukawa et al., 2014). A nocebo effect is considered the opposite of a placebo effect, whereby an inactive intervention has harmful effects (Colloca and Miller, 2011). Due to the reasons mentioned above, it is suggested that waitlist controls should not be routinely used to examine the effectiveness of psychotherapy. Therefore, they may be best suited to earlier stage testing (Cristea, 2019).
Introduction
Published in Rubin Battino, Using Guided Imagery and Hypnosis in Brief Therapy and Palliative Care, 2020
The essence of how the placebo effect works is via the expectation of the listener or receiver that whatever is being said or being done will be effective. In fact, the history of healing and curing (distinctions made later) is the history of the placebo effect. In prehistoric times (and continuing to the present in various cultures) mental or physical illness was believed to be caused by the mind or the body being “possessed” by evil spirits. Thus, you can find skulls with holes drilled in them from prehistoric times. The belief then was that by drilling a hole in the skull (trephining) that the evil spirit would be let out. For physical ailments, the causing agent (or spirit) would be removed from the body by: bloodletting, purgatives, sudorifics (cause or increase sweating), emetics and enemas, or cupping (attaching heated glass cups to the back—these cups can still be purchased online!). In the recent movie Victoria and Abdul Queen Victoria’s physician frequently asks for stool samples so he can study them. Not too long ago there were advocates of “colonic cleansing” to cure cancers. On the other hand, the modern medical practice of doing urine and blood analyses and tests of fecal samples are backed up with scientific studies that show that these tests can and do provide useful medical information. There are many cultures and religions who practiced various versions of exorcism for both mental and physical ailments. All of these methods depend on the belief and expectation of both the practitioners and the patients that these “cleansings” are effective.
A critical look at orthodox medical approaches
Published in Geraldine Lee-Treweek, Tom Heller, Hilary MacQueen, Julie Stone, Sue Spurr, Complementary and Alternative Medicine: Structures and Safeguards, 2020
Tom Heller, Dick Heller, Gavin Yamey
The second theory could be called the process of treatment theory. This theory argues that what matters in the placebo effect is the way in which the health professional shows care and attention to the person who comes for help (Kaptchuk, 2002). This process triggers physical changes in the person that lead to healing. So, it is not the placebo pill itself but the act of a professional giving the pill that matters.
Clinical hypnosis as a nondeceptive placebo: empirically derived techniques
Published in American Journal of Clinical Hypnosis, 2023
Medical research has established that placebos produce effects that depend on subjects’ beliefs about the drug being administered, beliefs that are shaped by such factors as the information that is provided and by the appearance and mode of administration of the placebo vehicle (Kirsch, 1985, 1990). For these reasons, the effects of placebos are assumed to be due to a particular psychological variable-expectancy. More specifically, placebo effects are related to response expectancies, that is, to expectancies about responses that are experienced as occurring automatically or nonvolitionally (Kirsch, 1985, 1990). Placebo effects reveal a basic principle of human experience and behavior: When people expect changes in their own responses and reactions, their expectations can produce those changes.
Placebo and hypnosis in the clinical setting: Contextual factors in hypnotic analgesia
Published in American Journal of Clinical Hypnosis, 2022
Shapiro (1960) defined the placebo effect as: “any therapeutic procedure (or that component of any therapeutic procedure) which is given deliberately to have an effect, or unknowingly, and has an effect on a symptom, syndrome, disease, or patient but which is objectively without specific activity for the condition being treated. The placebo effect is defined by the changes produced by placebos.” Recent research has emphasized the role of the placebo in medicine, which is well documented in Parkinson’s disease, irritable bowel syndrome, depression, and other conditions, including chronic pain (Ashar, Chang, & Wager, 2017). Placebo effects contribute to the effectiveness of all types of drugs, and the power of analgesic drugs is reduced if subjects are unaware that they are taking an analgesic (Benedetti et al., 2003a). Conditioning and contextual factors contribute to placebo effects (Benedetti et al., 2014; Colloca, 2019), but medical and psychotherapeutic practice have consistently underestimated their role, as underlined by Shapiro as far back as 1970.
Effectiveness and tolerability of the thyme/ivy herbal fluid extract BNO 1200 for the treatment of acute cough: an observational pharmacy-based study
Published in Current Medical Research and Opinion, 2021
Peter Kardos, Claudia B. Bittner, Jan Seibel, Dimitri Abramov-Sommariva, Surinder S. Birring
The study presented here has some limitations that are directly related to its nature of a pharmacy-based, non-controlled, observational questionnaire study: First of all is the lack of a placebo control. In the self-limiting condition of acute cough a large placebo effect has been described23. It is possible that a placebo effect of similar magnitude as observed in previous trials may have occurred in the current study. However, the purpose of the current study was not an RCT, it was a real-world observational study. Notwithstanding, as a similar thyme/ivy combination had shown efficacy over placebo in a placebo-controlled clinical trial with similar effect magnitudes as observed in this study4, it can be concluded that the observed effect reflects not only a mere placebo effect.