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Fulltext Placebo effects in randomized trials of pharmacological and neurostimulation interventions for mental disorders: An umbrella review

Huneke NTM, Amin J, Baldwin DS, Bellato A, Brandt V, Chamberlain SR, et al.

Mol Psychiatry, 2024 Dec;29(12):3915-3925.
PMID: 38914807 DOI: 10.1038/s41380-024-02638-x

There is a growing literature exploring the placebo response within specific mental disorders, but no overarching quantitative synthesis of this research has analyzed evidence across mental disorders. We carried out an umbrella review of meta-analyses of randomized controlled trials (RCTs) of biological treatments (pharmacotherapy or neurostimulation) for mental disorders. We explored whether placebo effect size differs across distinct disorders, and the correlates of increased placebo effects. Based on a pre-registered protocol, we searched Medline, PsycInfo, EMBASE, and Web of Knowledge up to 23.10.2022 for systematic reviews and/or meta-analyses reporting placebo effect sizes in psychopharmacological or neurostimulation RCTs. Twenty meta-analyses, summarising 1,691 RCTs involving 261,730 patients, were included. Placebo effect size varied, and was large in alcohol use disorder (g = 0.90, 95% CI [0.70, 1.09]), depression (g = 1.10, 95% CI [1.06, 1.15]), restless legs syndrome (g = 1.41, 95% CI [1.25, 1.56]), and generalized anxiety disorder (d = 1.85, 95% CI [1.61, 2.09]). Placebo effect size was small-to-medium in obsessive-compulsive disorder (d = 0.32, 95% CI [0.22, 0.41]), primary insomnia (g = 0.35, 95% CI [0.28, 0.42]), and schizophrenia spectrum disorders (standardized mean change = 0.33, 95% CI [0.22, 0.44]). Correlates of larger placebo response in multiple mental disorders included later publication year (opposite finding for ADHD), younger age, more trial sites, larger sample size, increased baseline severity, and larger active treatment effect size. Most (18 of 20) meta-analyses were judged 'low' quality as per AMSTAR-2. Placebo effect sizes varied substantially across mental disorders. Future research should explore the sources of this variation. We identified important gaps in the literature, with no eligible systematic reviews/meta-analyses of placebo response in stress-related disorders, eating disorders, behavioural addictions, or bipolar mania.

Matched MeSH terms: Placebo Effect*
Randomized comparison of W.A.R.A. (Wiring Affect with ReAttach) versus distraction: A pilot study assessing the efficacy of an ultrafast transdiagnostic intervention

Weerkamp-Bartholomeus P, Marazziti D, Chan E, Srivastava A, van Amelsvoort T

Heliyon, 2020 Aug;6(8):e04660.
PMID: 32802985 DOI: 10.1016/j.heliyon.2020.e04660

Background: Generally, neuropsychiatric patients share different symptoms across nosological categories, such as, amongst other, psychological distress, mood alterations, anxiety, and self-regulation disturbances.ReAttach is a novel psychological intervention with its key elements being external affect and arousal regulation, stimulation of multiple sensory processing, conceptualization, affective mentalization, and associative memory processing. ReAttach has been hypothesized to be effective in reducing symptom severity in different psychiatric conditions. Given the limited information currently available, the present study aimed to investigate the effect of main ReAttach elements called "Wiring Affect with ReAttach" (W.A.R.A.) on negative affect (N.A.), and to compare it with "Distraction," another well-established affect-regulating strategy.
Methods: We used a single-blind, randomized controlled crossover equivalence design to compare the efficacy on N.A. regulation of W.A.R.A. versus Distraction in 101 patients with different neuropsychiatric disorders.
Results: The results showed a significant difference (p < 0.001) in response to W.A.R.A. vs. Distraction, with W.A.R.A. being significantly more effective in regulating N.A., with a large effect size (dRMpooled = 2.38) and a high probability (95%) of success.
Limitations: The heterogeneity of the study population makes generalization and clear recommendations for specific patient groups difficult. The Numeric Rating Scale might have prevented detection of increased N.A. when the baseline scores were high. More in-depth research is needed to explore the W.A.R.A. technique and the extent of confounding variables such as the placebo effect.
Conclusions: The findings suggest that W.A.R.A. may be an effective, accessible, and brief intervention reducing negative affect. Although premature, these first results are encouraging.

Matched MeSH terms: Placebo Effect
Fulltext Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis

Fu Y, Persson MS, Bhattacharya A, Goh SL, Stocks J, van Middelkoop M, et al.

Syst Rev, 2016 10 28;5(1):183.
PMID: 27793184

BACKGROUND: The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA.

METHODS: This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses.

DISCUSSION: This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016033212.

Matched MeSH terms: Placebo Effect*
Fulltext Effects of self-prepared hypertonic nasal saline irrigation in allergic rhinitis: A randomized controlled trial

Sansila K, Eiamprapai P, Sawangjit R

Asian Pac J Allergy Immunol, 2020 Sep;38(3):200-207.
PMID: 30525740 DOI: 10.12932/AP-090618-0331

BACKGROUND: Nasal saline irrigation has been reported to be effective as an adjunctive therapy for allergic rhinitis (AR), but concerns about adverse events, supply problems, and high costs have limited its widespread clinical use. Aqueous 1.8% sodium chloride solution prepared by patients using drinking water (1.8% self-prepared hypertonic nasal saline irrigation; 1.8% SPHNSI) could solve some of these problems, but its clinical efficacy and safety need to be determined.
OBJECTIVE: We aimed to compare the efficacy and safety of 1.8% SPHNSI and 0.9% commercial isotonic nasal saline irrigation (0.9% CINSI) in patients with AR.
METHODS: A randomised, single-blinded, placebo-controlled trial was performed as a pilot study. Seventy-eight patients with AR were included. Each patient was randomised to nasal irrigation with 80 mL of either 1.8% SPHNSI or 0.9% CINSI twice-daily for 4 weeks. Randomised codes were generated using a computer and a block of 4 procedure. The primary outcome was improvement of quality of life scores in Thai patients with allergic rhinoconjunctivitis (Rcq-36). Secondary outcomes were clinical symptoms using total nasal symptom scores (TNSS) and adverse events. All outcomes were assessed by blinded assessors at baseline, week 2, and week 4.
RESULTS: At week 4, nasal irrigation with 1.8% SPHNSI had significantly improved the Rcq-36 score (54% versus 50%; p < 0.032) and congestion symptom score (96% versus 84%; p < 0.018) compared to nasal irrigation with 0.9% CINSI. Adverse events were comparable for both groups at week 4.
CONCLUSIONS: This pilot study indicates that regular use of 1.8% SPHNSI in AR patients for 4 weeks is safe and has superior efficacy to 0.9% CINSI for alleviating congestion and improving quality of life scores.

Matched MeSH terms: Placebo Effect
Fulltext The efficacy and safety of Ginkgo biloba extract as an adjuvant in type 2 diabetes mellitus patients ineffectively managed with metformin: a double-blind, randomized, placebo-controlled trial

Aziz TA, Hussain SA, Mahwi TO, Ahmed ZA, Rahman HS, Rasedee A

Drug Des Devel Ther, 2018;12:735-742.
PMID: 29670330 DOI: 10.2147/DDDT.S157113

Background and aim: Type 2 diabetes mellitus (T2DM) is one of the major diseases confronting the health care systems. In diabetes mellitus (DM), combined use of oral hypoglycemic medications has been shown to be more effective than metformin (Met) alone in glycemic control. This study determined the effects of Ginkgo biloba (GKB) extract as an adjuvant to Met in patients with uncontrolled T2DM.
Subjects and methods: Sixty T2DM patients were recruited in a randomized, placebo-controlled, double-blinded, and multicenter trial. The patients, currently using Met, were randomly grouped into those treated with either GKB extract (120 mg/day) or placebo (starch, 120 mg/day) for 90 days. Blood glycated hemoglobin (HbA1c), fasting serum glucose, serum insulin, body mass index (BMI), waist circumference (WC), insulin resistance, and visceral adiposity index (VAI) were determined before (baseline) and after 90 days of GKB extract treatment.
Results: GKB extract significantly decreased blood HbA1c (7.7%±1.2% vs baseline 8.6%±1.6%, P<0.001), fasting serum glucose (154.7±36.1 mg/dL vs baseline 194.4±66.1 mg/dL, P<0.001) and insulin (13.4±7.8 μU/mL vs baseline 18.5±8.9 μU/mL, P=0.006) levels, BMI (31.6±5.1 kg/m2 vs baseline 34.0±6.0 kg/m2, P<0.001), waist WC (102.6±10.5 cm vs baseline 106.0±10.9 cm, P<0.001), and VAI (158.9±67.2 vs baseline 192.0±86.2, P=0.007). GKB extract did not negatively impact the liver, kidney, or hematopoietic functions.
Conclusion: GKB extract as an adjuvant was effective in improving Met treatment outcomes in T2DM patients. Thus, it is suggested that GKB extract is an effective dietary supplement for the control of DM in humans.

Matched MeSH terms: Placebo Effect