Active placebo versus standard placebo control interventions in pharmacological randomised trials

Laursen, David Ruben Teindl; Hansen, Camilla Dalby; Paludan-Müller, Asger Sand; Hróbjartsson, Asbjørn

doi:10.1002/14651858.mr000055

Cited by 10 publications

(7 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Notably, two previous studies failed to find any effect of psychoeducation on preventing PTSD (Rose, Brewin, Andrews, & Kirk, 1999 ; Wong E, Marshall G, & Miles J, 2013 ). Hence, psychoeducation can be considered an active placebo, similar to the reduced drug dose placebo used in some pharmacological trials (Laursen, Hansen, Paludan-Müller, & Hróbjartsson, 2020 ).…”

Section: Methodsmentioning

confidence: 99%

The ABCDE psychological first aid intervention decreases early PTSD symptoms but does not prevent it: results of a randomized-controlled trial

Figueroa

Cortés

Marín

et al. 2022

European Journal of Psychotraumatology

View full text Add to dashboard Cite

Background Early Psychological First Aid (PFA) has been widely recommended for preventing posttraumatic stress disorder (PTSD). However, its lack of empirical evidence of safety and effectiveness has been criticized. Objectives To assess the effectiveness of PFA-ABCDE, an original PFA protocol, for preventing PTSD one month after the intervention and decreasing PTSD symptoms at one and six months of follow up. Methods We assessed the eligibility of 1,140 adult survivors of recent trauma (≤ 72 hours) consulting five emergency departments in Chile. Two hundred twenty-one were randomized to receive either PFA-ABCDE (active listening, breathing retraining, categorization of needs, referral to ancillary services, and psychoeducation) or only psychoeducation. We used the Composite International Diagnostic Interview (CIDI) to assess PTSD diagnosis. The Posttraumatic Checklist (PCL), the Beck Depression Inventory-II (BDI-II), and a 0–10 points analogue visual scale were used to assess PTSD symptoms, depressive symptoms, and immediate distress relief after the intervention. Results We found no difference between the experimental and control groups in the frequency of PTSD one month after the intervention (PFA-ABCDE = 23/76 [30.3%], psychoeducation = 18/75 [24.0%], adjusted odds ratio = 1.39, 95% confidence interval = 0.63–3.07, p = .408). Immediately after the intervention, participants who received PFA-ABCDE reported greater distress relief (PFA-ABCDE mean = 9.06, psychoeducation mean = 8.55, Cohen’s d = 0.30, p = .038). Fewer PTSD symptoms were reported by those who received PFA-ABCDE one month after the intervention (PFA-ABCDE mean = 36.26, psychoeducation mean = 43.62, Cohen’s d = 0.42, p = .033). We found no difference in depressive symptoms at one-month follow up ( p = .713) nor in PTSD symptoms six months after the intervention ( p = .986). Conclusions PFA-ABCDE does not prevent PTSD diagnosis, but it provides immediate distress relief and decreases PTSD symptoms in the short term.

show abstract

Section: Methodsmentioning

confidence: 99%

The ABCDE psychological first aid intervention decreases early PTSD symptoms but does not prevent it: results of a randomized-controlled trial

Figueroa

Cortés

Marín

et al. 2022

European Journal of Psychotraumatology

View full text Add to dashboard Cite

show abstract

“… Note : Active placebo is designed to imitate some of the physiological effects of the experimental treatment under investigation but without being therapeutically active (Laursen et al, 2020). …”

Section: Resultsmentioning

confidence: 99%

“…Moreover, patient expectation and knowledge of the effects of the psychedelics could also bias the effect of the drug itself (Mertens & Preller, 2021). To overcome this limitation, some trials used the psychedelic drug at very low doses as an active placebo (Laursen et al, 2020).…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

The changing outlook of psychedelic drugs: The importance of risk assessment and occupational exposure limits

Videira,

Nair,

Paquet

et al. 2023

J of Applied Toxicology

View full text Add to dashboard Cite

Serotonergic psychedelics, such as lysergic acid diethylamide (LSD), psilocybin, dimethyltryptamine (DMT), and 5‐methoxy‐N,N‐dimethyltryptamine (5‐MeO‐DMT), are currently being investigated for the treatment of psychiatric disorders such as depression and anxiety. Clinical trials with psilocybin and LSD have shown improvement in emotional and psychological scores. Although these drugs are reported to be safe in a controlled environment (such as clinical trials), exposure to low doses of these drugs can result in psychedelic effects, and therefore, occupational safety is an important consideration to prevent adverse effects in the workplace from low daily exposure. This article will discuss the factors involved in the derivation of occupational exposure limits (OELs) and risk assessment of these psychedelic drugs. To support the OEL derivations of psychedelic drugs, information regarding their mechanism of action, adverse effect profiles, pharmacokinetics, clinical effects, and nonclinical toxicity were considered. Additionally, psilocybin and LSD, which are the most extensively researched psychedelic substances, are employed as illustrative examples in case studies. The OELs derived for psilocybin and for LSD are 0.05 and 0.002 μg/m3, respectively, which indicates that these are highly hazardous compounds, and it is important to take into account suitable safety measures and risk‐management strategies in order to minimize workplace exposure.

show abstract

“…We designed this RCT as a double-blinded, placebo-controlled trial to evaluate the efficacy of CHM as a bath therapy. A placebo should be designed to be indistinguishable from all sensory specification compared with the trial medication without pharmaceutical activity [ 69 ]. Chinese herbal medicine preparations carry special macroscopic, sensory characteristics including appearance, color, smell and taste [ 70 , 71 ].…”

Section: Discussionmentioning

confidence: 99%

Add-on effects of Chinese herbal medicine external application (FZHFZY) to topical urea for mild-to-moderate psoriasis vulgaris: Protocol for a double-blinded randomized controlled pilot trial embedded with a qualitative study

Wang,

Zhang,

Zhang

et al. 2024

PLoS ONE

View full text Add to dashboard Cite

Psoriasis vulgaris is a chronic dermatological disease with a high global prevalence. It significantly reduces patients’ quality of life and is associated with a substantial economic burden. Conventional therapies for mild-to-moderate psoriasis are often associated with insufficient long-term symptomatic relief and side effects. Chinese herbal medicine (CHM) is commonly used for psoriasis management. A CHM formula, namely Fu zheng he fu zhi yang (FZHFZY), has shown promising treatment effects in clinical practice when used as a bath therapy. However, its efficacy and safety has not been evaluated by a rigorous randomized controlled trial (RCT). Therefore, we designed a double-blinded pilot RCT embedded with a qualitative study on CHM formula FZHFZY plus topical urea for mild-to-moderate psoriasis vulgaris to advance the evidence development and practice of CHM external application for psoriasis. This will be a mixed-method design consisting of a pilot RCT and a qualitative study. The pilot RCT is a two-arm, parallel, placebo-controlled, double-blinded trial. Sixty eligible participants will be randomized at a 1:1 ratio to receive eight weeks’ treatment of either FZHFZY plus 10% urea cream, or placebo plus 10% urea cream, with 12-week follow-up visits after the treatment phase. The CHM or placebo will be administered externally as a bath therapy. Outcome measures include trial feasibility, efficacy and safety. The primary efficacy outcome will be Psoriasis Area Severity Index (PASI). Secondary efficacy outcomes include Physician Global Assessment, PASI-75, PASI-50, Body Surface Area, Dermatology Life Quality Index, Skindex-16, itch visual analogue scale and relapse. The qualitative study will be conducted to collect participants’ feedback on CHM external application and their experience with the pilot RCT. This study will advance the evidence-based clinical practice of using CHM for psoriasis vulgaris and then to support translation of findings into clinical practice in the future. Trial registration number: ChiCTR2200064092.

show abstract

Active placebo versus standard placebo control interventions in pharmacological randomised trials

Cited by 10 publications

References 30 publications

The ABCDE psychological first aid intervention decreases early PTSD symptoms but does not prevent it: results of a randomized-controlled trial

The ABCDE psychological first aid intervention decreases early PTSD symptoms but does not prevent it: results of a randomized-controlled trial

The changing outlook of psychedelic drugs: The importance of risk assessment and occupational exposure limits

Add-on effects of Chinese herbal medicine external application (FZHFZY) to topical urea for mild-to-moderate psoriasis vulgaris: Protocol for a double-blinded randomized controlled pilot trial embedded with a qualitative study

Contact Info

Product

Resources

About