In recent years, some large rigorous acupuncture randomized controlled trials (RCTs) frequently draw the conclusion that the therapeutic effects of acupuncture is equivalent to placebo effect, which has aroused wide attention and controversy. Thus, some studies attempted to assess the adequacy of acupuncture regimen in clinical trials. In this study, the concept of acupuncture regimen adequacy in clinical trials is clarified and the research status and limitations are summarized. Moreover, the suggestions in the future researches are proposed in association with clinical practice characteristics of acupuncture, i.e. classifying assessment according to different types of acupuncture; conducting the assessment according to the treatment characteristics of different types of acupuncture; assessing the maturity of acupuncture regimens; evaluating the rationality of the control group according to the purpose of the study; and focusing on domains evaluation.
Acupuncture Therapy ; Clinical Trials as Topic ; Placebo Effect

The silver nanocrystalline is widely used for biological field because of its biocompatibility and anti-microbial effect. The objective of this study was to evaluate the therapeutic efficacy of the silver nanocrystalline ointment on the temporomandibular joint (TMJ) capsulitis. Total 39 patients were included in this study and all patients were received single topical application of the silver nanocrystalline ointment (group A, n=30) or placebo ointment (group B, n=19). Measured variables were maximum mouth opening (MMO), visual analog scale (VAS) for pain, and VAS for function. In results, we could not assess any therapeutic efficacy of single application in the chronic TMJ capsulitis (p>0.05). However, the single application of silver nanocrystalline ointment showed significant improvement in MMO and VAS for pain compared to placebo effect in the acute TMJ capsulitis (p<0.05). We could not find any complications related to ointment application in both groups. In conclusion, the single application of silver nanocrystalline ointment was effective in improving patient's symptom in acute TMJ capsulitis without any noticing complications.
Humans ; Mouth ; Placebo Effect ; Silver* ; Temporomandibular Joint* ; Visual Analog Scale

The correspondence of modern western medicine efficacy research basis and traditional Chinese medicine are discussed through analysis of differences in treatment pattern that modern western medicine and traditional Chinese medicine are based on. At the same time, the true meaning of "placebo" concept is re-analyzed and the latent contradiction of this concept when applied to traditional Chinese medicine studies is given in-depth reflection. It turns out that conflicts exist in treatment pattern between the two medicine theories and efficacy research basis of the two medicine theories lack correspondence. The "placebo" and "placebo effect" concepts have a different meaning when applied to traditional Chinese medicine. The "placebo" concept is applicable to just a small field of modern western medicine experimental studies. The research results and conclusions drawn from traditional Chinese medicine studies based on this concept should be given the necessary discretion and criticism.
Humans ; Medicine, Chinese Traditional ; Placebo Effect ; Research Design ; Treatment Outcome

As the placebo effect is inevitable in almost all types of treatment implemented in the context of the doctor-patient relationship, it would be a wise strategy to try to enhance the treatment effect by understanding its mechanism and applying it clinically. However, for various reasons there is resistance to therapeutical application of placebos. The main reason for this resistance comes from the confusion about the concept of the placebo, and it is necessary to differentiate the placebo response and the placebo effect and understand them clearly. Meta-analytical reviews of clinical studies showed that the placebo effect accounts for part of clinical effect of drugs. Authors reviewed meta-analytic studies dealing with the placebo effect on depression, sleep disorders, dementia, anxiety and addiction. In addition, we discussed the current state of placebo use and also the way to promote the placebo effect.
Antidepressive Agents ; Anxiety ; Dementia ; Depression ; Effect Modifier, Epidemiologic ; Placebo Effect ; Placebos* ; Sleep Wake Disorders

OBJECTIVE: This study is to evaluate the efficacy of terazosin in the treatment of overactive bladder (OAB) symptoms and sexual dysfunction in patients with symptomatic benign prostatic hyperplasia (BPH) and OAB. METHODS: Of 200 men aged 50-80 years with symptomatic BPH, an International Prostatic Symptom Score (IPSS) > or =8 accompanied by OAB symptoms, 185 patients completed treatment with terazosin 2-5 mg once daily for 8 weeks. Patients were asked to complete a voiding diary, the International Index of Erectile Function (IIEF) questionnaire, and the IPSS at baseline, 4 and 8 weeks. RESULTS: 8-week terazosin treatment improved OAB symptoms as well as reducing IPSS (19.8 to 12.7) and IIEF (34.4 to 37.4) scores. OAB symptoms improved significantly, irrespective of symptom severity by the IPSS, but the IIEF score only increased in patients with severe symptoms. CONCLUSIONS: Additional studies are needed to further evaluate the placebo effect. However, terazosin monotherapy is effective in patients with symptomatic BPH and OAB, and may increase sexual function in patients with severely symptomatic BPH.
Adrenergic alpha-Antagonists ; Humans ; Male ; Placebo Effect ; Prospective Studies* ; Prostatic Hyperplasia* ; Surveys and Questionnaires ; Urinary Bladder, Overactive*

Biofeedback therapy has emerged as a useful adjunct for patients with functional evacuation disorders over the past decade. The goals of biofeedback retraining may vary and could depend on the underlying dysfunction. In patients with obstructive defecation, the goals are to relax the anal sphincter, improve rectoanal coordination, and improve sensory perception. Methods of biofeedback therapy varied widely between centers. However, no difference was described when EMG-based biofeedback was compared to manometry-based biofeedback, or when visual or auditory feedback was given. In regards to biofeedback adjuncts, including sensory retraining with either an intrarectal balloon, a portable home-training unit or both can be practicable. There are inconsistencies in the literature regarding the patient selection criteria for biofeedback treatment. The patient group is not homogeneous. Different case selection, different regimens and different methods of biofeedback may explain the variability in success rate. Quality research that would assist in predicting outcome is still lacking. Although no specific denominator could possibly be assigned to correctly predict the overall outcome of therapy, biofeedback is not successful in all patients with outlet obstructed constipation. Results with success rates is ranging from 8.3 percent to 100 percent. The treatment of constipation by biofeedback has been viewed with some skepticism as the low success rate may simply be a placebo effect. The majority of scepticism to therapeutic outcome are derived from entry criteria for treatment. Lower success rates have been described when entry criteria were broadened. Prebiofeedback clinical findings which are presupposed to prognostic relevance are age, gender, duration of symptoms and presence of rectal pain, lower motor neuron disease, and psychiatric problems. I feel strongly that informations about the predictive factors are vital to all physicians either performing or recommending biofeedback to their patients. If biofeedback could be undertaken according to specific criteria, we, colorectal surgeon will save a fruitless endeavour, one would expect more improvements in more patients. Additional well-designed controlled trials are needed to establish the clinical and physiologic factors.
Anal Canal ; Biofeedback, Psychology* ; Constipation ; Defecation ; Humans ; Motor Neuron Disease ; Patient Selection ; Placebo Effect

BACKGROUND: Topical calcineurin inhibitors (TCIs) have been successfully used to treat seborrheic dermatitis (SD) patients. Meanwhile, treatment of atopic dermatitis (AD) with low-dose, intermittent TCI has been proved to reduce disease flare-ups. This regimen is known as a maintenance treatment. OBJECTIVE: The aim of this trial was to investigate the efficacy and tolerability of a maintenance treatment with tacrolimus ointment in patients with facial SD. METHODS: During the initial stabilization period, patients with facial SD or AD applied 0.1% tacrolimus ointment twice daily for up to 4 weeks. Clinical measurements were evaluated on either in the whole face or on separate facial regions. When an investigator global assessment score 1 was achieved, the patient applied tacrolimus twice weekly for 20 weeks. We also compared our results with recent published data of placebo controlled study to allow an estimation of the placebo effect. RESULTS: The time to the first relapse during phase II was similar in both groups otherwise significantly longer than the placebo group. The recurrence-free curves of two groups were not significantly different from each other; otherwise the curve of the placebo group was significantly different. There were no significant differences between the 2 groups in the number of DEs, and treatment days for disease exacerbations (DEs). The adverse event profile was also similar between the 2 groups. During the 20 weeks of treatment, the study population tolerated tacrolimus ointment well. CONCLUSION: The results of this study suggest that maintenance treatment with tacrolimus may be effective in preventing the occurrence of facial SD exacerbations.
Calcineurin ; Dermatitis, Atopic ; Dermatitis, Seborrheic* ; Humans ; Placebo Effect ; Recurrence ; Research Personnel ; Tacrolimus*

BACKGROUND: Topical calcineurin inhibitors (TCIs) have been successfully used to treat seborrheic dermatitis (SD) patients. Meanwhile, treatment of atopic dermatitis (AD) with low-dose, intermittent TCI has been proved to reduce disease flare-ups. This regimen is known as a maintenance treatment. OBJECTIVE: The aim of this trial was to investigate the efficacy and tolerability of a maintenance treatment with tacrolimus ointment in patients with facial SD. METHODS: During the initial stabilization period, patients with facial SD or AD applied 0.1% tacrolimus ointment twice daily for up to 4 weeks. Clinical measurements were evaluated on either in the whole face or on separate facial regions. When an investigator global assessment score 1 was achieved, the patient applied tacrolimus twice weekly for 20 weeks. We also compared our results with recent published data of placebo controlled study to allow an estimation of the placebo effect. RESULTS: The time to the first relapse during phase II was similar in both groups otherwise significantly longer than the placebo group. The recurrence-free curves of two groups were not significantly different from each other; otherwise the curve of the placebo group was significantly different. There were no significant differences between the 2 groups in the number of DEs, and treatment days for disease exacerbations (DEs). The adverse event profile was also similar between the 2 groups. During the 20 weeks of treatment, the study population tolerated tacrolimus ointment well. CONCLUSION: The results of this study suggest that maintenance treatment with tacrolimus may be effective in preventing the occurrence of facial SD exacerbations.
Calcineurin ; Dermatitis, Atopic ; Dermatitis, Seborrheic* ; Humans ; Placebo Effect ; Recurrence ; Research Personnel ; Tacrolimus*

BACKGROUND: Menopausal symptoms have remarkable negative effects on women's quality of life, justifying the need to assess various therapeutic options. This research aimed to determine the effectiveness of Vitex agnus-castus extracts in alleviating menopausal symptoms in comparison with that of placebo. METHODS: This study was a randomized controlled double-blind clinical trial with a study group of 52 women referred to a clinic in Kermanshah in 2017. The participants were randomly divided into two groups: Vitex group (26 subjects) and placebo group (26 subjects). Menopausal symptoms were assessed using the Greene Scale before and 8 weeks after the intervention. RESULTS: After the intervention, the mean scores for total menopausal disorder, anxiety, and vasomotor dysfunction were significantly lower in the Vitex group than in the placebo group (P<0.05). The mean scores of the variables of somatic complications, depression, and sexual dysfunction did not show significant differences between the Vitex and placebo groups (P>0.05). CONCLUSION: Administration of Vitex agnus-castus extracts as a phytoestrogenic medicine can alleviate menopausal symptoms in women.
Anxiety Disorders ; Depression ; Double-Blind Method ; Female ; Humans ; Menopause ; Phytoestrogens ; Placebo Effect ; Quality of Life ; Vitex

The placebo effect, a response observed during the placebo arm of a clinical trial, is produced by the psychobiological action of the placebo as well as by other potential contributors to symptom amelioration such as spontaneous improvement, regression to the mean, biases, concurrent treatments, and study design. From a psychological viewpoint, there are many mechanisms that contribute to placebo effects, including expectations, conditioning, learning, and anxiety reduction. Placebo responses are also mediated by opioid and non-opioid mechanisms including dopamine, serotonin, cholecystokinin, and immune mediators. During recent years, a trend towards increased placebo effects in clinical trials of neuropsychiatric drugs has been noted. Indeed, the placebo effects observed in clinical trials constitute an increasing problem and interfere with signal-detection analyses of potential treatments. Several potential factors including protocol/study design and conduct related factors may account for the placebo effect observed in clinical trials. This paper reviews key issues related to this problem and aims to identify potential solutions.
Antipsychotic Agents ; Anxiety ; Arm ; Bias (Epidemiology) ; Cholecystokinin ; Dopamine ; Learning ; Placebo Effect ; Serotonin