The Social Epistemology of Clinical Placebos.

Many extant theories of placebo focus on their causal structure wherein placebo effects are those that originate from select features of the therapy (e.g., client expectations or "incidental" features like size and shape). Although such accounts can distinguish placebos from standard medical treatments, they cannot distinguish placebos from everyday occurrences, for example, when positive feedback improves our performance on a task. Providing a social-epistemological account of a treatment context can rule out such occurrences, and furthermore reveal a new way to distinguish clinical placebos from standard medical treatments.

Would You Take an Open-Label Placebo Pill or Give One to Your Child? Findings from a Cross-Sectional Survey.

Background: Open-label placebos (OLPs), honestly prescribed regarding their inert nature, have been associated with positive health-related effects in both children and adults. However, OLPs are not always perceived by laypeople as a viable treatment option. Methods: A brief online survey with 806 adult participants (age range: 18-75 years; 29% parents) was conducted to identify predictor variables that are associated with the willingness to take an OLP pill (criterion 1) or to give an OLP to one's child (criterion 2). The survey covered aspects including the perceived plausibility of the treatment concept for both OLPs and deceptive placebos (DPs), self-reported knowledge about placebos, the expected effectiveness of OLPs in treating emotional/ somatic problems, and attitudes concerning taking pills in general. Multiple hierarchical regressions were carried out. Results: The expected effectiveness of OLPs in alleviating both emotional and physical ailments and the plausibility of the treatment concepts for both OLPs and DPs significantly predicted the willingness to use OLPs (R2 = 0.485). A similar finding was observed when predicting the willingness to administer an OLP to one's child (R2 = 0.443). Conclusion: Favorable expectations regarding the reduction of emotional and somatic symptoms with OLPs, along with a strong belief in the credibility of placebo mechanisms, play a vital role in influencing the willingness to accept this kind of treatment. These factors can be incorporated into psychoeducational programs.

Evidencing general acceptability of open-label placebo use for tackling overtreatment in primary care: a mixed methods study.

BACKGROUND: Overtreatment poses a challenge to healthcare systems due to harmful consequences of avoidable side-effects and costs. This study presents the first account for examining the feasibility of placebo use for reducing overtreatment in primary care, including whether public attitudes support the use of different placebo types in place of inappropriate prescriptions of antibiotics, antidepressants, or analgesics. METHODS: We used a multi-study, mixed-methods design, including patient and public (PPI) consultations, focus groups (Study 1) and two pre-registered online experiments (Studies 2 and 3). RESULTS: Study 1 (N = 16) explored everyday conceptions and practicalities of potential placebo use in the context of respiratory infections. Findings highlighted the importance of trusting doctor-patient relationships and safety-netting. Study 2 employed a randomised experiment with a representative UK sample (N = 980), investigating attitudes towards 5 different treatment options for respiratory infections: (1) blinded + pure placebo, (2) open-label + pure placebo, (3) open-label + impure placebo, (4) antibiotic treatment, and (5) no treatment. Study 2 also examined how attitudes varied based on wording and individual differences. Findings indicated general support (ηp2 = .149, large effect size) for replacing inappropriate antibiotics with open-label + impure placebos, although personal placebo acceptability was lower. Also, older people, individuals suffering from chronic illness or those showing higher levels of health anxiety appeared less amenable to placebo use. Study 3 (N = 1177) compared attitudes towards treatment options across three clinical scenarios: respiratory infection, depression and pain. Findings suggested significant differences in the acceptability of placebo options based on the clinical context. In the infection scenario, options for open-label + pure placebos, open-label + impure placebos and no treatment were rated significantly more acceptable (ηp2 = .116, medium effect size) compared to the depression and pain scenarios. Again, general support for placebos was higher than placebo acceptability for personal use. CONCLUSIONS: Findings from PPI and three studies indicate general support for combatting overprescribing in primary care through clinical placebo use. This is an indicator for wider UK public support for a novel, behavioural strategy to target a long-standing healthcare challenge. General acceptability appears to be highest for the use of open-label + impure placebos in the context of antibiotic overprescribing.

Efficacy of intraosseous saline injection for pain management during surgical removal of impacted mandibular third molars: a randomized double-blinded clinical trial.

Background: Surgical extraction of impacted mandibular third molars is the most common procedure performed by oral surgeons. The procedure cannot be performed effectively without achieving profound anesthesia. During this procedure, patients may feel pain during surgical bone removal (at the cancellous level) or during splitting and luxation of the tooth, despite administration of routine nerve blocks. Administration of intraosseous (IO) lignocaine injections during third molar surgeries to provide effective anesthesia for pain alleviation has been documented. However, whether the anesthetic effect of lignocaine is the only reason for pain alleviation when administered intraosseously remains unclear. This conundrum motivated us to assess the efficacy of IO normal saline versus lignocaine injections during surgical removal of impacted mandibular third molars. The aim of this study was to assess the efficacy of IO normal saline as a viable alternative or adjunct to lignocaine for alleviation of intraoperative pain during surgical removal of impacted mandibular third molars. Methods: This randomized, double-blind, interventional study included 160 patients who underwent surgical extraction of impacted mandibular third molars and experienced pain during surgical removal of the buccal bone or sectioning and luxation of the tooth. The participants were divided into two groups: the study group, which included patients who would receive IO saline injections, and the control group, which included patients who would receive IO lignocaine injections. Patients were asked to complete a visual analog pain scale (VAPS) at baseline and after receiving the IO injections. Results: Of the 160 patients included in this study, 80 received IO lignocaine (control group), whereas 80 received IO saline (study group) following randomization. The baseline VAPS score of the patients and controls was 5.71 ± 1.33 and 5.68 ± 1.21, respectively. The difference between the baseline VAPS scores of the two groups was not statistically significant (P > 0.05). The difference between the numbers of patients who experienced pain relief following administration of IO lignocaine (n=74) versus saline (n=69) was not statistically significant (P > 0.05). The difference between VAPS scores measured after IO injection in both groups was not statistically significant (P >0.05) (1.05 ± 1.20 for the control group vs. 1.72 ± 1.56 for the study group). Conclusion: The study demonstrates that IO injection of normal saline is as effective as lignocaine in alleviating pain during surgical removal of impacted mandibular third molars and can be used as an effective adjunct to conventional lignocaine injection.

Delivery of acupuncture in clinical trials: Research acupuncturists' perspectives.

Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine (TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM- and Western-trained practitioners, that would help to standardize the research acupuncturist's role and help to strengthen the design and execution of acupuncture studies. Please cite this article as: Anastasi JK, Capili B, Neumaier J, Hackett L. Delivery of acupuncture in clinical trials: Research acupuncturists' perspectives. J Integr Med. 2023; 21(4):315-319.

Taking Placebos as Needed to Reduce Appetite: A Randomized Controlled Trial with Ecological Momentary Assessment.

Placebos can reduce appetite. However, when placebos are prescribed over a longer period of time, compliance and response rates are not always satisfactory. A new administration approach 'as needed' was tested to improve adherence to placebo treatment and its effectiveness. Participants could decide on the time of placebo intake (when their appetite had increased substantially). A randomized controlled trial was conducted over seven days. The participants were allocated to one of two groups: a placebo group (PG; n = 41) or a control group with no placebo treatment (CG; n = 34). During the intervention, participants used a mobile phone application to rate their daily appetite, mood, and the occurrence of binge-eating episodes in their normal environment. The placebo effect was short-lived; the placebo reduced self-reported appetite only on days 1 and 2 of the trial. The placebo neither influenced mood nor binge-eating frequency. This study found an app-assisted approach with continuous monitoring to be helpful for identifying the temporal course of the placebo response. Future placebo trials should implement this method.

The alliance in mental health care: conceptualization, evidence and clinical applications.

The concept of alliance reflects the collaborative relationship between a clinician and a patient, defined as consisting of three elements: a) the agreement on the goals of treatment; b) the agreement on a task or series of tasks; c) the development of a bond. Although much of the theory and research on the alliance comes from the domain of psychotherapy, the concept is applicable to any practice involving a person seeking help and a socially sanctioned healer. An extensive research evidence suggests that the alliance (typically measured at the third or fourth session) is a robust predictor of the outcomes of various forms of psychotherapy, even when prior symptom improvement and other factors are considered. Both the clinician and the patient bring to the therapy situation different capacities to form an alliance. Factors concerning the patient include, among others, the diagnosis, attachment history and style, motivation, and needs for affiliation. However, the benefits of the alliance have been found to be mostly due to the therapist's contribution, in particular his/her facilitative interpersonal skills, including verbal fluency, communication of hope and positive expectations, persuasiveness, emotional expression; warmth, acceptance and understanding; empathy, and alliance rupture-repair responsiveness. Placebo studies have allowed to experimentally manipulate aspects of the relationship between a therapist and a patient in non-psychotherapy contexts. In these settings, two components of the relationship have emerged: an emotional one (involving being cared for and understood by the clinician) and a cognitive one (including the belief in the competence of the therapist to select and administer an effective treatment). Here we propose a model that describes three pathways through which the alliance creates benefits, named CARE (caring, attentive, real and empathic), EXPECTANCY, and SPECIFIC. Although research and clinical attention have mostly focused on the alliance between a clinician and a patient in face-to-face interactions, there is preliminary evidence concerning the alliance between patients and other clinic staff, systems of care, or the program in Internet-mediated services. These new research areas clearly require further development.

Irving Kirsch opens a window on antidepressant medications.

When it comes to antidepressant medications - popular, backbone drugs of modern psychiatry - even learned scholars and savvy clinicians find it difficult to separate honest, rigorous research from that which thrives on hidden agendas and ulterior motives. Fortunately, a mounting corpus of data-based studies, mostly meta-analyses, casts new and critical light on the clinical efficacy, side effects, and therapeutic outcomes of antidepressants. Spearheading these efforts over the past few decades, Irving Kirsch and colleagues have challenged the hegemonic view of antidepressants as an effective therapeutic intervention. Notably, Kirsch illuminates the small difference between antidepressants and placebos in mitigating depression-a difference that may be statistically significant yet fails to reach clinical significance. This piece sketches the important contributions Kirsch has made to the scientific understanding of antidepressant medications.

Proportion attributable to contextual effects in general medicine: a meta-epidemiological study based on Cochrane reviews.

OBJECTIVES: Our objectives were to examine the magnitude of the proportion attributable to contextual effects (PCE), which shows what proportion of the treatment arm response can be achieved by the placebo arm across various interventions, and to examine PCE variability by outcome type and condition. DESIGN: We conducted a meta-epidemiological study. SETTING: We searched the Cochrane Database of Systematic Reviews with the keyword 'placebo' in titles, abstracts and keywords on 1 January 2020. PARTICIPANTS: We included reviews that showed statistically significant beneficial effects of the intervention over placebo for the first primary outcome. MAIN OUTCOME MEASURES: We performed a random-effects meta-analysis to calculate PCEs based on the pooled result of each included review, grouped by outcome type and condition. The PCE quantifies how much of the observed treatment response can be achieved by the contextual effects. PUBLIC AND PATIENT INVOLVEMENT STATEMENT: No patient or member of the public was involved in conducting this research. RESULTS: We included 328 out of 3175 Cochrane systematic reviews. The results of meta-analyses showed that PCEs varied greatly depending on outcome type (I2=98%) or condition (I2=98%), but mostly lie between 0.40 and 0.95. Overall, the PCEs were 0.65 (95% CI 0.59 to 0.72) on average. Subjective outcomes were 0.50 (95% CI 0.41 to 0.59), which was significantly smaller than those of semiobjective (PCE 0.78; 95% CI 0.72 to 0.85) or objective outcomes (PCE 0.94; 95% CI 0.91 to 0.97). CONCLUSIONS: The results suggest that much of the observed benefit is not just due to the specific effect of the interventions. The specific effects of interventions may be larger for subjective outcomes than for objective or semiobjective outcomes. However, PCEs were exceptionally variable. When we evaluate the magnitude of PCEs, we should consider each PCE individually, for each condition, intervention and outcome in its context, to assess the importance of an intervention for each specific clinical setting.

Delivery of acupuncture in clinical trials: Research acupuncturists' perspectives / 中西医结合学报

Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine (TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM- and Western-trained practitioners, that would help to standardize the research acupuncturist's role and help to strengthen the design and execution of acupuncture studies. Please cite this article as: Anastasi JK, Capili B, Neumaier J, Hackett L. Delivery of acupuncture in clinical trials: Research acupuncturists' perspectives. J Integr Med. 2023; 21(4):315-319.

Ethical considerations on placebo-controlled vaccine trials in pregnant women / Consideraciones éticas sobre los ensayos de vacunas controlados con placebo en mujeres embarazadas / Considerações éticas sobre estudos de vacina controlada com placebo em gestantes

Abstract Placebo use in clinical trials, whenever a proven effective treatment exists, is one of the most debated topics in contemporary research ethics. This article addresses the ethical framework for placebo use in clinical trials assessing vaccine efficacy in pregnant women. Vaccine trial participants are healthy at the outset and some must be infected during the study to demonstrate the product's efficacy, meaning that placebo-treated participants are under risk of serious and irreversible harm. If effective vaccines exist, such risk precludes placebo use. This interdiction should be extended to any clinical trial of vaccine efficacy in pregnant women, because a demonstration of clinical efficacy in nonpregnant individuals and comparable immunogenic responses in pregnant women are predictors of efficacy in pregnancy as well. Moreover, product effectiveness in real-world use scenarios can be ascertained by observational studies conducted after its inclusion in vaccination campaigns.

Resumen El uso de placebo en ensayos clínicos es uno de los principales temas debatidos sobre la ética en investigación contemporánea cuando existe un tratamiento eficaz probado. Este artículo aborda la ética en el uso de placebo en ensayos clínicos sobre la eficacia de vacuna en mujeres embarazadas. Las participantes en los ensayos de vacunas estaban sanas al inicio del estudio, y algunas fueron vacunadas durante el estudio para demostrar la eficacia del producto. Las participantes tratadas con placebo corren el riesgo de sufrir daños graves e irreversibles. Si existen vacunas efectivas, este riesgo impide el uso de placebo. Este impedimento debe extenderse a cualquier ensayo clínico de eficacia de vacuna en embarazadas, pues la eficacia clínica demostrada en mujeres no embarazadas y las respuestas inmunogénicas comparables con las embarazadas son predictores de eficacia en el embarazo. Además, la efectividad del producto se constata en estudios observacionales realizados tras las campañas de vacunación.

Resumo O uso de placebo em ensaios clínicos, quando um tratamento comprovadamente eficaz existe, é um dos principais tópicos debatidos na ética em pesquisa contemporânea. Este artigo aborda o quadro ético para o uso de placebo em ensaios clínicos que avaliam a eficácia de vacina em gestantes. Participantes em ensaios de vacina são saudáveis no início e alguns devem ser inoculados durante o estudo para demonstrar a eficácia do produto. Ou seja, participantes tratados com placebo estão sob risco de danos graves e irreversíveis. Se existirem vacinas eficazes, esse risco impede o uso de placebo. Essa interdição deve ser estendida a qualquer ensaio clínico de eficácia de vacina em gestantes, pois a demonstração de eficácia clínica em não gestantes e as respostas imunogênicas comparáveis em gestantes também são preditoras de eficácia na gravidez. Ademais, a eficácia do produto em cenários reais de uso pode ser verificada por estudos observacionais realizados após sua inclusão em campanhas de vacinação.

Complexity theory in the management of patients with musculoskeletal pain / Teoría de la complejidad en la atención del paciente con dolor musculoesquelético

Nonlinear systems are not susceptible to research with a reductionist approach. In this sense, the complexity theory provides an alternative approach to quantify the importance of contextual factors in patients with musculoskeletal pain. The use of positive (placebo) or negative (nocebo) contextual factors in the therapeutic setting could largely account for the non-specific component of treatment efficacy, directly affecting the quality of patients' health-related outcomes (e.g., pain, disability, or satisfaction). In recent years, there has been a better understanding of the effects of contextual factors. However, the knowledge and awareness of them is limited and heterogeneous among physical therapists, reducing their translational value in the field of physiotherapy. The purpose of this essay is to describe the management of patients with musculoskeletal pain from the complexity theory perspective.

Los sistemas no lineales no son susceptibles de ser investigados con métodos reduccionistas. En este sentido, la teoría de la complejidad ofrece un enfoque alternativo para cuantificar la importancia de los factores contextuales en el paciente con dolor musculoesquelético. El resultado del uso positivo (placebo) o negativo (nocebo) de factores contextuales en el entorno terapéutico, podría ser responsable de gran parte de un componente inespecífico en la eficacia del tratamiento, afectando directamente la calidad de los resultados relacionados con la salud del paciente (por ejemplo, dolor, funcionalidad o satisfacción). En los últimos años, se ha incrementado la comprensión del valor de estos efectos. A pesar del creciente interés, el conocimiento y el reconocimiento de los efectos terapéuticos, continúan siendo limitados y heterogéneos entre los fisioterapeutas, lo cual reduce su valor traslacional en el campo de la fisioterapia. El propósito de este estudio es presentar el abordaje el paciente con dolor  musculoesquelético desde la perspectiva la teoría de la complejidad.

Teoría de la complejidad en la atención del paciente con dolor musculoesquelético / Complexity theory in the management of patients with musculoskeletal pain

Los sistemas no lineales no son susceptibles de ser investigados con métodos reduccionistas. En este sentido, la teoría de la complejidad ofrece un enfoque alternativo para cuantificar la importancia de los factores contextuales en el paciente con dolor musculoesquelético. El resultado del uso positivo (placebo) o negativo (nocebo) de factores contextuales en el entorno terapéutico, podría ser responsable de gran parte de un componente inespecífico en la eficacia del tratamiento, afectando directamente la calidad de los resultados relacionados con la salud del paciente (por ejemplo, dolor, funcionalidad o satisfacción). En los últimos años, se ha incrementado la comprensión del valor de estos efectos. A pesar del creciente interés, el conocimiento y el reconocimiento de los efectos terapéuticos, continúan siendo limitados y heterogéneos entre los fisioterapeutas, lo cual reduce su valor traslacional en el campo de la fisioterapia. El propósito de este estudio es presentar el abordaje el paciente con dolor musculoesquelético desde la perspectiva la teoría de la complejidad.

Nonlinear systems are not susceptible to research with a reductionist approach. In this sense, the complexity theory provides an alternative approach to quantify the importance of contextual factors in patients with musculoskeletal pain. The use of positive (placebo) or negative (nocebo) contextual factors in the therapeutic setting could largely account for the non-specific component of treatment efficacy, directly affecting the quality of patients' health-related outcomes (e.g., pain, disability, or satisfaction). In recent years, there has been a better understanding of the effects of contextual factors. However, the knowledge and awareness of them is limited and heterogeneous among physical therapists, reducing their translational value in the field of physiotherapy. The purpose of this essay is to describe the management of patients with musculoskeletal pain from the complexity theory perspective.

Patients' acceptance of placebo antibiotics in Japan: a prescription for antimicrobial resistance.

BACKGROUND: The generalized use of antibiotics has led to the emergence of bacteria which are resistant to antimicrobial agents. This stems in part from the patient's tendencies to seek antibiotics for diseases when not necessary. Hence, this article investigated patient acceptance of prescribing placebos as a substitute for unnecessary antibiotics in Japan, where physicians are under severe time constraints and are unable to offer explanations and persuade patients who demand unnecessary antibiotics prescription. METHODS: A web-based questionnaire was administered to assess patients' acceptance of the placebo treatment under informed consent. One thousand participants representing all genders and age-class were randomly selected from the online panel of a web-survey company. RESULTS: The results showed that 67.9% of the participants were "satisfied" to receive such treatments, whereas 20.6% indicated acceptance of the prescription but without satisfaction. In total, 88.5% of the participants accepted the prescription of placebo, a result consistent with that of a preceding study on placebo treatments conducted in the United States. In the survey, tone of persuasion did not affect the patients' attitudes; however, patients who were loyal to their physicians exhibited lower refusal rates. CONCLUSION: The survey results showed that the prescription of "ethical placebos" could be an acceptable option for the patients in Japan. For ethical concerns, an additional literature survey was conducted and the result suggested that such a radical treatment option could be justified, provided that the prescription benefits patients and informed consent is properly obtained. Albeit it is impractical to use, because of ethical and operational concerns, it would be worth further investigation to ensure diversity in the countermeasures for antimicrobial resistance, a major public health threat nowadays.

The ethical case for placebo control in HIV-cure-related studies with ART interruption.

Many studies that seek to cure HIV must ask participants to interrupt their antiretroviral treatment. In such circumstances, is it permissible to include a placebo group in the study? We explain why doing so is a scientific and an ethical necessity, and more benign than imagined.

Feasibility of Using Detuned Laser as a Placebo In Manual Therapy Research: An Analysis of Participant Perceptions.

OBJECTIVE: The purpose of this study was to determine the feasibility of using detuned laser as a placebo intervention in manual therapy research. METHODS: We performed a secondary data analysis of a randomized controlled trial. In our analysis, 30 participants with chronic ankle instability (manual therapy group: n = 13, age = 33.1 ± 8.1 years, female participants = 50%; detuned laser group: n = 17, age = 31.9 ± 11.8 years, female participants = 72%) were asked to indicate which intervention (manual therapy [active] or detuned laser [placebo]), they thought they had received and to give a confidence rating on their response regarding the received intervention at the conclusion of the course of intervention. Independent t tests were used to compare the groups. Participants in both groups were asked the following open-ended question: "What did you think of the intervention?". RESULTS: There were 52.9% participants in the detuned laser group and 53.8% participants in the manual therapy group who perceived that they had received the active intervention. The confidence ratings about their perceptions (6.7 ± 2.0, detuned laser group; 6.3 ± 2.4, manual therapy group) (P = .66) and the self-reported recovery ratings (1.9 ± 1.5 and 1.8 ± 1.2, respectively) (P = .77) were similar. CONCLUSIONS: Participants in this study confidently perceived that detuned laser was an active intervention. They positively rated their recovery following the course of the placebo intervention and perceived that detuned laser was effective in treating their condition. Therefore, it is feasible for detuned laser to be used as a placebo for manual therapy trials.

Benefits and Harms of Interventions With Surgery Compared to Interventions Without Surgery for Musculoskeletal Conditions: A Systematic Review With Meta-analysis.

OBJECTIVE: To estimate the benefits and harms of interventions with and without surgery for musculoskeletal (MSK) conditions. DESIGN: Intervention systematic review with meta-analysis of randomized controlled trials (RCTs). LITERATURE SEARCH: MEDLINE, EMBASE, CINAHL, Web of Science, and CENTRAL, all up to January 7, 2021. STUDY SELECTION CRITERIA: RCTs (English, German, Danish, Swedish, and Norwegian) of interventions with and without surgery conducted in any setting for any non-fracture MSK condition in adults (mean age: 18+ years) evaluating the outcomes on a continuous (benefits) or count (harms) scale. Outcomes were pain, self-reported physical function, quality of life, serious adverse events (SAEs), and death at 1 year. DATA SYNTHESIS: Random-effects metaanalyses for MSK conditions where there were data from at least 2 trials. RESULTS: One hundred RCTs (n = 12 645 patients) across 28 different conditions at 9 body sites were included. For 9 out of 13 conditions with data on pain (exceptions include some spine conditions), 11 out of 11 for function, and 9 out of 9 for quality of life, there were no clinically relevant differences (standardized mean difference of 0.50 or above) between interventions with and without surgery. For 13 out of 16 conditions with data on SAEs and 16 out of 16 for death, there were no differences in harms. Only 6 trials were at low risk of bias. CONCLUSION: The low certainty of evidence does not support recommending surgery over nonsurgical alternatives for most MSK conditions with available RCTs. Further high-quality RCTs may change this conclusion. J Orthop Sports Phys Ther 2022;52(6):312-344. doi:10.2519/jospt.2022.11075.

Reporting quality of sham needles used as controls in acupuncture trials: a methodological evaluation.

OBJECTIVE: The description of controls is important in acupuncture clinical trials to interpret its effectiveness without fallacy. This paper aims to evaluate the reporting quality of acupuncture studies on the characteristics of sham needles. STUDY DESIGN AND SETTING: Using a checklist developed from previously published reporting guidelines, the distribution of reported items and changes of reporting rates over time were investigated. Two-way ANOVA and linear regression were conducted. RESULTS: Original articles of RCTs of any design involving sham needles as controls were eligible for assessment. 117 trials from three 2-year time periods between 2009 and 2018 were included. Seven items out of 25 were reported in more than 50% of the studies. While significant differences of reporting scores among categories were observed, there were no significant differences among time periods; no significant improvement was observed over time. CONCLUSIONS: Low reporting qualities of sham needles used in acupuncture studies may influence how researchers understand the effectiveness of acupuncture. This study evaluated previous publications from 2009 to 2018 and found that reporting qualities on sham needles did not improve over time. Further studies are required to validate the items used in this study to endorse better reporting of controls in acupuncture trials.