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BACKGROUND:Hydrogen,as an antioxidant,can reduce oxidative stress induced by strenuous exercise and achieve the effect of improving fatigue.Several studies have been reported on the potential effects of hydrogen-rich water or hydrogen-rich gas on improving exercise fatigue and athletic performance. OBJECTIVE:To investigate the effects of hydrogen-rich gas inhalation prior to high-intensity exercise on proprioception and muscular endurance performance after exercise fatigue. METHODS:Through a randomized,double-blind,crossover,and repeated measurement experimental design,24 healthy men were randomly divided into group A and group B,with 12 in each group.In the first phase of the crossover experiment,group A inhaled hydrogen-rich gas(hydrogen group)for 20 minutes and group B inhaled placebo gas(air;placebo group)for 20 minutes.Then,cycle ergometers were used to establish the fatigue model.Visual analog fatigue scale,heart rate variability,knee joint proprioception(passive position perception,joint motion perception,and muscle force perception)and isometric knee extension muscle endurance were tested before and after intervention.After a 7-day washout period,two groups exchanged intervention methods and the above tests were performed again in the second phase of the experiment.Differences between the results of groups A and B in the two phases were compared,and finally the results of the two phases were integrated to compare the overall differences between hydrogen intervention and placebo intervention. RESULTS AND CONCLUSION:In the first phase of the crossover experiment,the visual analog fatigue scale score of the hydrogen group after intervention was significantly lower than that of the placebo group(P<0.01).The root mean square of the difference between the adjacent R-R,mean low-frequency output power,mean high-frequency output power,and isometric muscle endurance after intervention in the hydrogen group were significantly higher than those in the placebo group(P<0.05).Passive position perception and joint motion perception after intervention in the hydrogen group were significantly better than those in the placebo group(P<0.05).There was no significant difference in muscle force perception between the two groups(P>0.05),but muscle force perception in the placebo group after intervention was significantly worse than that before intervention(P<0.01).The difference trend of all test results after intervention in the two groups in the first phase of the experiment showed the same results in the second phase of the experiment.The integrated results also showed that the hydrogen group had better test values for the above indicators than the placebo group(P<0.05).Linear regression analysis showed a positive correlation between post-intervention visual analog fatigue scale scores and passive position perception results(r=0.327,P=0.023),i.e.,the higher subjective fatigue level after high-intensity exercise indicated the worse passive position perception results.To conclude,inhaling hydrogen-rich gas before high-intensity exercise can reduce the degree of fatigue after exercise,thereby improving proprioception and muscle endurance performance,which may be a new strategy to reduce the occurrence of injury.And its effectiveness can be achieved repeatedly.
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Clinical research is usually aimed at and guided by therapeutic efficacy. Clarifying the placebo effect and the nocebo effect from treatment outcomes is an important issue in clinical research. This paper reviews the meaning of the placebo effect, suggesting that factors that may produce the placebo effect in clinical practice include past experience associations, patient expectations, suggestion, and doctor-patient relationships. It also summarizes the characteristics of the nocebo effect, its influencing factors, and its impact on clinical prognosis. Combining the characteristics of traditional Chinese medicine, this paper explores the design of acupuncture clinical trials that can reflect the measurement of the placebo effect, attempting to provide a clearer interpretation of the placebo effect in the evaluation of acupuncture efficacy in traditional Chinese medicine. Taking primary insomnia as an example, a prospective randomized placebo-controlled trial is designed to observe and evaluate the relationship between the treatment effects of acupuncture and the placebo effect in different patients under the treatment of the same doctor. Group comparisons will help better distinguish clinical effects in different situations. The authors also attempt to explore the responsive population to the placebo effect and the effects of placebos in different populations.
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ObjectiveTo analyse the current implementation status of Chinese herbal medicine (CHM) placebo and systematically evaluate the placebo effect in randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for the treatment of functional dyspepsia (FD). MethodsA combination of medical subject terms and free words was used to search six databases, including PubMed, EMBASE, Cochrane Library, Web of Science, China National Knowledge Infrastructure, and Wanfang, for RCTs with CHM placebo group for FD published from January 31st, 1994 to September 30th, 2023. The dosage forms, composition, and methodological quality were collected and evaluated. The quality of the included articles was evaluated by Cochrane risk of bias assessment tool, and meta-analysis was performed on the CHM placebo response rate of patients with FD, and subgroup analysis and meta-regression was performed according to diagnostic criteria, efficacy criteria, duration of treatment, type of placebo, whether it contained active ingredient, and whether it evaluated placebo effects. ResultsA total of 34 publications were included involving 5046 participants, of which 2221 FD patients received CHM placebo treatment. Granules were the predominant placebo preparation, accounting for 71% (24/34); 32.35% (11/34) of the studies added real CHM to the placebo, and only 12 (35%) of the studies described appearance, odour, and taste. The placebo response rate in FD patients in the placebo group was 41% (95% CI: 0.35 to 0.47; P<0.01, I2 = 87%); there was significant difference between groups with different diagnostic criteria and different treatment durations (P<0.05 or P<0.01), but there was no significant difference between the different efficacy evaluation criteria, the different placebo preparation, the presence of a low-dose active ingredient, and the presence or absence of placebo assessment (P>0.05). ConclusionThere was a significant CHM placebo effect in patients with FD, with granules as the main preparation of placebop. Different diagnostic criteria and different treatment times may affect the response rate of patients, and the addition of low-dose real medicine to the CHM placebos has not been seen to have an effect on the response rate. Clinical investigators have not paid enough attention to placebos, and there is a lack of uniform standards and norms for the preparation and evaluation of CHM placebos.
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Clinical trials aim to invent new, better, safer, more effective ways to prevent, detect, or treat health conditions and to compare them to existing standards of care as applicable. This scientific inquiry prompts researchers to design and develop proposed clinical trial protocols to evaluate preliminary information about the product and develop research questions and objectives. The average budget for new product development is enormous, and this eventuality is because almost 90 percent of a trial drugs never get approved. Hence, having an appropriate clinical trial design is crucial for successful product development. A trial's ability to deliver the proposed indication relies on its suitable design, background information, the trial justification to sample size, interim monitoring rules, and ways to review and analyze study data. In this article, we presented an overview of clinical trial designs emphasizing adaptive designs in a simplified way for field-based clinical research professionals.
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Background: Considerable placebo response rate is commonly observed in placebo-controlled trials involving analgesics. However, there is paucity of evidence with regard to comparison of effect of open-label placebo versus double-blind placebo on pain perception. Methods: In this study, cold water maintained at 4±1°C was used to induce experimental pain. Enrolled subjects were randomized to receive either 2% lignocaine gel as active drug or K-Y jelly as placebo as per the groups in open-label (two groups) and double-blind (two groups) study. Pain perception was evaluated using pain threshold time and pain tolerance time after immersion of subject’s hand in the cold water. Pain intensity was assessed using visual analogue scale (VAS). Results: Sixty-nine subjects were randomized into 4 study groups namely open-label lignocaine (OLL; N=17), open-label placebo (OLP; N=18), double-blind lignocaine (DBL; N=17) and double-blind placebo (DBP; N=17). OLP application increased pain intensity on VAS from 67 (47, 84) to 72 (39, 88) mm (p=0.018). OLL application reduced pain perception pain threshold time from 20.4 (4.0, 45.1) to 24.1 (6.3, 124.2) seconds (p=0.049) and pain tolerance time from 32.7 (6.8, 110.2) to 40.0 (7.7, 156.7) seconds (p=0.019). The change in pain parameters (before and after application of study intervention) was comparable without any significant difference among the four study groups (p=0.257 for pain threshold time, p=0.165 for pain tolerance time and p=0.563 for pain intensity score). Conclusions: Lignocaine and placebo gel application showed comparable change in pain perception irrespective of blinding.
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Evaluar la eficacia y seguridad del estrógeno potenciado en comparación con el placebo en el tratamiento homeopático del dolor pélvico asociado a endometriosis (EAPP, por sus siglas en inglés). Diseño del estudio: El presente fue un estudio clínico aleatorizado, doble ciego, controlado con placebo, de 24 semanas, el cual incluyó a 50 mujeres de entre 18 y 45 años de edad con diagnóstico de endometriosis infiltrante profunda con base en ultrasonido transvaginal o imágenes de resonancia magnética después de preparación intestinal, así como puntaje ≥ 5 en una escala visual analógica (VAS: rango de 0 a 10 puntos) para el dolor pélvico asociado con la endometriosis. Se administró estrógeno potenciado (12cH, 18cH y 24cH) o placebo dos veces al día por vía oral. La medida principal de resultado fue el cambio en la severidad de los puntajes parcial y global de EAPP (VAS) de la línea basal a la semana 24, determinada como la diferencia en el puntaje medio de cinco modalidades de dolor pélvico crónico (dismenorrea, dispareunia profunda, dolor pélvico no cíclico, dolor intestinal cíclico y/o dolor urinario cíclico). Las medidas secundarias de resultado fueron la diferencia media de puntaje para la calidad de vida evaluada con el Cuestionario de Salud SF-36, los síntomas de depresión en el Inventario de la Depresión de Beck (BDI) y los síntomas de ansiedad en el Inventario de Ansiedad de Beck (BAI). Resultados: El puntaje global de EAPP (VAS: rango de 0 a 50 puntos) se redujo en 12.82 (p < 0.001) en el grupo tratado con estrógeno potenciado de la línea basal a la semana 24. El grupo que utilizó estrógeno potenciado también presentó una reducción en el puntaje parcial (VAS: rango de 0 a 10 puntos) en tres modalidades de EAPP: dismenorrea (3.28; p < 0.001), dolor pélvico no cíclico (2.71; p = 0.009) y dolor intestinal cíclico (3.40; p < 0.001). El grupo de placebo no mostró cambio significativo alguno en los puntajes global o parcial de EAPP. Además, el grupo de estrógeno potenciado mostró un mejoramiento significativo en tres de ocho ámbitos de SF-36 (dolor de cuerpo, vitalidad y salud mental) y síntomas de depresión (BDI). El grupo de placebo no mostró un mejoramiento significativo a este respecto. Estos resultados demuestran la superioridad del estrógeno potenciado sobre el placebo. Se asociaron pocos eventos adversos con el estrógeno potenciado. Conclusiones: El estrógeno potenciado (12cH, 18cH y 24cH) en dosis de 3 gotas dos veces al día durante 24 semanas fue significativamente más efectivo que el placebo para reducir el dolor pélvico asociado con la endometriosis. Registro del estudio clínico: ClinicalTrials.gov Identificador: https://clinicaltrials.gov/show/NCT02427386.
To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, doubleblind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p < 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p < 0.001), non-cyclic pelvic pain (2.71; p = 0.009), and cyclic bowel pain (3.40; p < 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.
Subject(s)
Humans , Female , Adolescent , Adult , Middle Aged , Homeopathic Therapeutics , Pelvic Pain/therapy , Endometriosis/complications , Estrogens/therapeutic use , Placebos , Double-Blind MethodABSTRACT
Objective: The placebo effect can enhance the response to treatment, even in the absence of pharmacological ingredients. One possible factor explaining the likelihood of the placebo effect in individuals is genetic polymorphisms in neurotransmitters. This study focused on gene polymorphisms in the catechol-O-methyltransferase (COMT) as an interindividual variable of the placebo effect.Design・Methods: All 120 participants were explained the effects of caffeine, including its ability to ameliorate drowsiness and increase concentration, and then given a placebo (lactose). The onset of the placebo effect was measured in terms of the degree of caffeine-reduced sleepiness using subjective indices of the Stanford Sleepiness Scale (SSS) and a feeling of drowsiness-Visual Analogue Scale (VAS). The mechanism of the placebo effect was objectively examined in terms of changes in cerebral blood flow in the prefrontal cortex of the brain. In addition, we investigated participants’ susceptibility to the placebo effect by examining genetic polymorphisms in COMT.Results: After taking the drug, sleepiness on the SSS and VAS was significantly improved (p<0.001), although there was no change in prefrontal cortex activity. Among the 120 participants, 63 had a Val/Val-type polymorphism in COMT (52.5%), 45 had a Val/Met-type (37.5%), and 12 had a Met/Met-type (10.0%). There were no significant differences among COMT gene polymorphisms in the subjective measures of SSS and VAS. However, there was a tendency for the cerebral blood flow changes to be larger in the left hemisphere of the brain in individuals with the Met/Met type.Conclusion: There seems to be a relationship between prefrontal cortex activity and genetic polymorphisms. In particular, there may be a correlation between the expression of a placebo effect and COMT gene polymorphisms.
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OBJECTIVE@#To observe the effect of standardized Jin's three-needle therapy on limb motor function and nerve function defect in stroke patients, and to evaluate the placebo control method.@*METHODS@#A total of 66 patients with stroke were randomly divided into a Jin's three-needle group (33 cases, 3 cases dropped off) and a placebo needle group (33 cases, 4 cases dropped off). All the patients were treated with conventional medication and rehabilitation treatment. In addition, the patients in the Jin's three-needle group were treated with standardized Jin's three-needle therapy at temporal three points, spirit four points, hand three points, foot three points, upper extremity spasm three points, lower extremity spasm three points, etc.; while the patients in the placebo needle group were treated with placebo needling at identical points. All the treatments were given once a day, 5 days a week, and 3-week treatment was given with an interval of 2 days between weeks. The scores of Fugl-Meyer assessment scale (FMA) and National Institutes of Health stroke scale (NIHSS) were observed before treatment, 10 d and 21 d into treatment, and the blind evaluation was conducted after treatment.@*RESULTS@#On the 10 d and 21 d into treatment, the FMA scores in both groups were higher than those before treatment (P<0.01), and the NIHSS scores were lower than those before treatment (P<0.01). On the 10 d and 21 d into treatment, the FMA scores in the Jin's three-needle group were higher than those in the placebo needle group (P<0.05); on the 10 d into treatment, the NIHSS score in the Jin's three-needle group was were lower than that in the placebo needle group (P<0.05). There was no significant difference between the two groups on judging the type of treatment (P>0.05), and the consistency with the real situation was poor (Cohen's kappa coefficient<0.20).@*CONCLUSION@#The standardized Jin's three-needle therapy could effectively improve the limb motor function and nerve function defect in stroke patients. The placebo control method used in this study shows good clinical operability and masking effect.
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Humans , Acupuncture Therapy/methods , Acupuncture Points , Stroke/therapy , Lower Extremity , Needles , Treatment Outcome , Stroke RehabilitationABSTRACT
OBJECTIVE@#To compare the therapeutic efficacy of governor vessel moxibustion combined with fluoxetine hydrochloride capsule, simple fluoxetine hydrochloride capsule and placebo moxibustion combined with fluoxetine hydrochloride capsule for mild to moderate depression with kidney-yang deficiency.@*METHODS@#A total of 126 patients with mild to moderate depression with kidney-yang deficiency were randomized into a governor vessel moxibustion group (42 cases, 2 cases dropped off), a western medication group (42 cases, 1 case dropped off) and a placebo moxibustion group (42 cases, 1 case dropped off). The western medication group was given fluoxetine hydrochloride capsule orally, 20 mg a time, once a day. On the basis of the treatment in the western medication group, governor vessel moxibustion was applied from Dazhui (GV 14) to Yaoshu (GV 2) in the governor vessel moxibustion group, once a week; placebo moxibustion was applied in the placebo moxibustion group, once a week. Treatment of 8 weeks was required in the 3 groups. Before and after treatment, the scores of Hamilton depression scale-17 (HAMD-17), Asberg's rating scale for side effects (SERS) and TCM clinical symptom were compared, and the clinical efficacy was evaluated.@*RESULTS@#After treatment, the scores of HAMD-17, SERS and TCM clinical symptom were decreased compared before treatment in the 3 groups (P<0.05), the decrease ranges of above scores in the governor vessel moxibustion group were larger than those in the western medication group and the placebo moxibustion group (P<0.05). The total effective rate was 92.5% (37/40) in the governor vessel moxibustion group, which was higher than 75.6% (31/41) in the western medication group and 80.5% (33/41) in the placebo moxibustion group (P<0.05).@*CONCLUSION@#Governor vessel moxibustion combined with fluoxetine hydrochloride capsule can improve the degree of depression and relieve the clinical symptoms in mild to moderate depression patients with kidney-yang deficiency, the efficacy is superior to simple fluoxetine hydrochloride capsule, and can reduce the fluoxetine hydrochloride capsule-induced adverse effect to a certain extent.
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Humans , Moxibustion , Yang Deficiency/drug therapy , Depression/etiology , Fluoxetine , Acupuncture Points , KidneyABSTRACT
The commonly used terms "sham acupuncture" and "placebo acupuncture" in clinical acupuncture research is compared and analyzed in this article. In terms of their respective characteristics, sham acupuncture has a wider scope, including various types of acupoints, needle insertion at non-acupoint or non-insertion at acupoints, while placebo acupuncture mainly focuses on non-insertion at acupoints. Sham acupuncture mainly emphasizes the appearance similarity to real acupuncture, while placebo acupuncture emphasizes both similarity in appearance and the absence of therapeutic effects. Properly distinguishing and applying sham acupuncture and placebo acupuncture can help standardize their usage in terminology. Considering the difficulty in setting up qualified placebo acupuncture, it is suggested that researchers use the term "sham acupuncture" to describe the acupuncture control methods used in clinical research.
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Humans , Acupuncture Therapy , Needles , Research Personnel , Clinical Trials as TopicABSTRACT
OBJECTIVE@#To assess the efficacy of a curcumin supplementation on cognitive abilities in women suffering from premenstrual syndrome (PMS) and dysmenorrhea.@*METHODS@#A randomized, triple-blind, placebo-controlled trial was conducted from December 2019 to March 2020. A total of 124 women who had both PMS and dysmenorrhea were enrolled, and were equally and randomly assigned to the curcumin group or placebo group, 62 cases in each. Each subject received either a capsule containing 500 mg of curcuminoid, or a placebo daily, for 10 days (7 days before and until 3 days after the onset of menstrual bleeding) over 3 menstrual cycles. The cognitive abilities questionnaire was used to measures cognitive functions in 7 specific areas. Adverse reactions were monitored during and after the trial in both groups.@*RESULTS@#Administration of curcumin was associated with a significant increase in memory score (P=0.002), inhibitory control and selective attention (P=0.020), and total cognitive ability task (P=0.024). In addition, significant increments were found in scores of memory (3.5±3.1 vs. 0.4±3.8 in the curcumin and placebo groups, respectively; P=0.035), inhibitory control and selective attention (3.0±3.7 vs. 0.4±3.7; P=0.027) and total cognitive abilities (8.3±12.3 vs. 2.2±12.4; P=0.025) in the curcumin group versus placebo groups. Curcumin was safe and well-tolerable in current clinical trial.@*CONCLUSION@#Curcumin has a beneficial efficacy on cognitive function scores in women with PMS and dysmenorrhea, with improvements in memory, inhibitory control and selective attention. (Registration No. IRCT20191112045424N1, available at: https://www.irct.ir ).
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Humans , Female , Curcumin/therapeutic use , Dysmenorrhea/drug therapy , Premenstrual Syndrome/psychology , Cognition , Double-Blind MethodABSTRACT
ObjectiveTo confirm the clinical efficacy and safety of Yishen Yangxin Anshen tablets in the treatment of insomnia (heart-blood deficiency and kidney-essence insufficiency syndrome). MethodA randomized block, double-blind, placebo-controlled, multi-center clinical trial design method was adopted, and a total of 480 patients with insomnia due to deficiency of heart blood and insufficiency of kidney essence (treatment group-control group 3∶1) from seven hospitals (Guang'anmen Hospital, China Academy of Chinese Medical Sciences, The First Clinical Hospital, Jilin Province Academy of Traditional Chinese Medicine(TCM), The Second Affiliated Hospital of Liaoning University of TCM, The First Affiliated Hospital of Henan University of Chinese Medicine, Henan Province Hospital of TCM, Hebei General Hospital, The First Hospital of Hunan University of Chinese Medicine) were enrolled. The treatment group was given Yishen Yangxin Anshen tablets and the control group received placebo tablets (4 tablets/time, 3 times/day, 4 weeks of administration, 4 weeks of follow-up after drug withdrawal). The sleep dysfunction rating scale (SDRS) score, pittsburgh sleep quality index (PSQI) score, TCM, polysomnography (PSG) indicators from four hospital (Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Henan Province Hospital of TCM, Hebei General Hospital, The First Hospital of Hunan University of Chinese Medicine), and other efficacy indicators were compared between the two groups before and after treatment. Through general physical examination, laboratory examination, and observation of adverse events, the safety of the drugs was evaluated. ResultThe baseline indexes of the two groups showed no significant difference and thus the two groups were comparable. After treatment, the total score of SDRS in the treatment group was lower than that in the control group (P<0.01). After drug withdrawal for 4 weeks, the total score of SDRS demonstrated no significant change in the treatment group as compared with that at the end of treatment, indicating that the rebound change of curative effect was not obvious. After treatment, the total score of PSQI in the treatment group decreased as compared with that in the control group (P<0.01), and the change of total score of PSQI in the treatment group was statistically significant (P<0.05) after drug withdrawal for 4 weeks but small, indicating that the rebound change of curative effect was not obvious. After treatment, the total effective rate about the TCM symptoms in the treatment group was higher than that in the control group (χ2=137.521,P<0.01). After treatment, the disappearance rates of single indexes in the treatment group, such as difficulty in falling asleep, easily waking up after sleeping, early awakening, short sleep time, dreamfulness, palpitation, forgetfulness, dizziness, mental fatigue, and weakness of waist and knee, increased compared with those in the control group (P<0.01). After treatment, the treatment group demonstrated fewer awaking times (AT), longer total sleep time (TST), lower ATA/TST ratio, and higher sleep efficiency (%) than the control group (P<0.05). No abnormal value or aggravation related to drugs was observed in either group. The incidence of adverse events in the treatment group and the control group was 5.57% and 8.40% respectively. No serious adverse events or adverse events leading to withdrawal happened in either group. ConclusionYishen Yangxin Anshen tablets is effective and safe for patients with insomnia of deficiency of heart-blood and insufficiency of kidney-essence.
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OBJECTIVES@#To observe the clinical efficacy of moxibustion combined with western medication on ureteral stent-related symptoms after ureteroscopic lithotripsy (URL).@*METHODS@#One hundred and fifty patients with upper urinary tract calculus implanted with ureteral stents after URL were randomly divided into a moxibustion group (50 cases, 1 case dropped out), a placebo moxibustion group (50 cases, 3 cases dropped out) and a blank control group (50 cases). No intervention was performed in the blank control group. On the basis of oral administration with tamsulosin hydrochloride sustained release capsule (starting from the first day after surgery, once a day, 0.2 mg each time, continuously for 4 weeks), in the moxibustion group, moxibustion was operated at Guanyuan (CV 4) and bilateral Shenshu (BL 23); the sham-moxibustion was delivered at the same acupoints in the placebo moxibustion group, once daily, 6 times a week, for 15 min in each treatment. The duration of treatment was 4 weeks. Before treatment, and after 1, 2 and 4 weeks of treatment, the scores of lower urinary tract symptoms, body pain, general health, work performance and satisfaction of sexual matters were compared among the 3 groups. The tract calculus clearance rate, urinary infection and the oral administration of painkillers were compared after 4 weeks of treatment in the 3 groups.@*RESULTS@#The scores of lower urinary tract symptoms, body pain and general health after 1 week of treatment, and the scores of lower urinary tract symptoms, body pain, general health and work performance after 2 and 4 weeks of treatment were lower than those before treatment in the 3 groups (P<0.01). The scores of lower urinary tract symptoms and body pain in the moxibustion group after 1, 2 and 4 weeks of treatment were lower than those in the blank control group and the placebo moxibustion group (P<0.01, P<0.05) respectively. The score of general health in the moxibustion group was lower than that in the blank control group after 1 week of treatment (P<0.01), and lower than those of the blank control group and the placebo moxibustion group after 2 and 4 weeks of treatment (P<0.01, P<0.05). Regarding the score of work performance, it was lower in the moxibustion group after 1 and 2 weeks of treatment compared with those in the blank control group (P<0.05, P<0.01), and lower than those of the blank control group and the placebo moxibustion group after 4 weeks of treatment (P<0.01, P<0.05). The tract calculus clearance rate in the moxibustion group was 95.9% (47/49), higher than that in the blank control group (80.0%, 40/50, P<0.05). The proportion of oral administration of painkillers in the moxibustion group (28.6%, 14/49) and the placebo moxibustion group (40.4%, 19/47) was lower than that in the blank control group (76.0%, 38/50, P<0.01) respectively.@*CONCLUSIONS@#Moxibustion combined with western medication relieves lower urinary tract symptoms and body pain, and accelerate the recovery of general health and work performance in the patients after URL.
Subject(s)
Humans , Ureteroscopy/adverse effects , Moxibustion , Lithotripsy/adverse effects , Pain , Lower Urinary Tract Symptoms , Calculi , Stents/adverse effects , Acupuncture PointsABSTRACT
BACKGROUND@#Low back pain (LBP) is a prevalent and debilitating condition that poses a significant burden on healthcare systems. Acupuncture has been proposed as a promising intervention for LBP, but the evidence supporting its specific effect is insufficient, and the use of sham acupuncture as a control in clinical trials presents challenges due to variations in sham acupuncture techniques and the magnitude of the placebo effect.@*OBJECTIVE@#To investigate the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and to assess whether different types of sham acupuncture are associated with different responses.@*METHODS@#Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges'g) were applied to estimate the effect size.@*RESULTS@#A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD -1.43, 95% confidence interval (CI) -1.95 to -0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD -0.49, 95% CI -0.70 to -0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI -0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.@*CONCLUSIONS@#Sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study. (PROSPERO registration No. CRD42022304416).
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Objective:To evaluate the simulation effect of the placebo in a clinical trial of whole nutrition formula, and to inform the preparation of placebo in the clinical trial of foods for special medical purposes.Methods:Evaluators assessed the appearance, color, smell, and taste, and made the distinction between the placebo and the experimental product independently. The similarity and consistency between the placebo and experimental product were also assessed using a manual scoring method.Results:In the group assessing experimental product, 40% evaluators made the correct judgment while 50% did not. In the group assessing placebo, 10% evaluators made the correct judgment while 70% did not. Compared with the reference product, the experimental product and placebo were scored 9.75±0.79 vs. 6.63±3.73 for appearance, 9.75±0.79 vs. 7.25±3.99 for color, 8.75±3.17 vs. 8.50±3.16 for smell, and 9.00±1.29 vs. 7.75±2.99 for taste. The intra-evaluator consistency rate for the appearance, color, smell and taste of different products was 80%, 80%, 90%, and 90%, respectively. Conclusions:The blinding effect of placebo was relatively satisfactory in the trial we assessed. The placebo was comparable with the experimental product in terms of color, smell, and taste, but not appearance. The approaches for preparing and evaluating placebo in this clinical trial could give some clues for similar trials involving foods for special medical purposes.
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In clinical trials and animal models, indolent substances have been observed to induce pain relief (placebo analgesia) or increased pain (nocebo hyperalgesia). In recent years, advances in neurobiology field are not only about simple superposition of psychological mechanisms, but also about complex changes in neural networks. This article summarizes the neurophysiological changes and activated characteristics of brain regions in placebo analgesia and nocebo hyperalgesia, and expounds the underlying mechanisms involved in placebo analgesia and nocebo hyperalgesia in these brain regions, and how different brain regions interact with each other.
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BACKGROUND@#The placebo response of sham acupuncture in patients with primary dysmenorrhea is a substantial factor associated with analgesia. However, the magnitude of the placebo response is unclear.@*OBJECTIVE@#This meta-analysis assessed the effects of sham acupuncture in patients with primary dysmenorrhea and the factors contributing to these effects.@*SEARCH STRATEGY@#PubMed, Embase, Web of Science, and Cochrane CENTRAL databases were searched from inception up to August 20, 2022.@*INCLUSION CRITERIA@#Randomized controlled trials (RCTs) using sham acupuncture as a control for female patients of reproductive age with primary dysmenorrhea were included.@*DATA EXTRACTION AND ANALYSIS@#Pain intensity, retrospective symptom scale, and health-related quality of life were outcome measures used in these trials. Placebo response was defined as the change in the outcome of interest from baseline to endpoint. We used standardized mean difference (SMD) to estimate the effect size of the placebo response.@*RESULTS@#Thirteen RCTs were included. The pooled placebo response size for pain intensity was the largest (SMD = -0.99; 95% confidence interval [CI], -1.31 to -0.68), followed by the retrospective symptom scale (Total frequency rating score: SMD = -0.20; 95% CI, -0.80 to -0.39. Average severity score: SMD = -0.35; 95% CI, -0.90 to -0.20) and physical component of SF-36 (SMD = 0.27; 95% CI, -0.17 to 0.72). Studies using blunt-tip needles, single-center trials, studies with a low risk of bias, studies in which patients had a longer disease course, studies in which clinicians had < 5 years of experience, and trials conducted outside Asia were more likely to have a lower placebo response.@*CONCLUSION@#Strong placebo response and some relative factors were found in patients with primary dysmenorrhea. PROSPERO registration number: CRD42022304215. Please cite this article as: Sun CY, Xiong ZY, Sun CY, Ma PH, Liu XY, Sun CY, Xin ZY, Liu BY, Liu CZ, Yan SY. Placebo response of sham acupuncture in patients with primary dysmenorrhea: A meta-analysis. J Integr Med. 2023; 21(5): 455-463.
Subject(s)
Female , Humans , Dysmenorrhea/therapy , Acupuncture Therapy , Pain Management , Needles , Placebo EffectABSTRACT
Resumo O efeito placebo é um ponto de passagem obrigatório para a compreensão da racionalidade envolvida nos ensaios clínicos randomizados. A partir da antropologia da ciência e da tecnologia, este artigo analisa como a noção de efeito placebo tem sido utilizada pela ciência na produção de fronteiras biossociais. Assim, enfoca fenômenos que inicialmente eram atribuídos à imaginação e analisa as consequências de novas metodologias científicas que têm reconhecido outras potencialidades desse efeito, mas tendem a privilegiar marcadores biológicos. O argumento central é que a disputa epistemológica oculta a existência múltipla do efeito placebo que pode ser reconhecida em função das diferentes práticas às quais ele confere racionalidade.
Abstract The placebo effect is an obligatory passage point to understand rationality in randomized clinical trials. From the perspective of science and technology studies, this paper analyzes how the notion of the placebo effect has been used by science in the production of biosocial borders. Thus, it will pay attention to the phenomena considered caused by imagination, and we will analyze the consequences of new methodologies that have recognized other potentialities of this effect but tend to favor biological markers. The central argument is that the epistemological dispute hides the multiple existences of the placebo effect to be recognized due to the different scientific practices to which it confers rationality.
Subject(s)
Biomarkers , Placebo Effect , Randomized Controlled Trials as Topic , Neuroimaging , Imagination , Medicine , Science , Technology , AnthropologyABSTRACT
Resumo Espiritualidade é a força que une os diferentes aspectos componentes do ser e, quando trabalhada, proporciona uma vivência harmônica e promove equilíbrio entre bem-estar físico, social e mental. Nesse sentido, objetivou-se abordar, secularmente, como a espiritualidade é vista na medicina, sua influência na saúde e a percepção de profissionais e pacientes acerca desse assunto. Para tanto, realizou-se revisão narrativa que priorizou buscas na plataforma PubMed por meio dos seguintes descritores: "medicine and spirituality and secularismo" e "placebo effect and spirituality and medicine". Em seguida foram analisadas fontes referenciadas pela leitura dos artigos primordiais. Percebeu-se que há confusão quanto ao uso do termo espiritualidade e que a capacidade e efetividade do cuidado espiritual prestado por profissionais da saúde são débeis, contrastando com inúmeros benefícios oferecidos por essa atenção, que é uma ferramenta para um trabalho mais ético e humano.
Abstract Spirituality is a uniting force between different constituents of the human being and, when exercised, provides a harmonious experience and promotes balance between physical, social, and mental well-being. As such, this narrative review proposes a secular approach to how spirituality is understood by medicine, its influence on health, and how it is perceived by professionals and patients. Bibliographic search was conducted on the PubMed database, using the following descriptors: "medicine and spirituality and secularism" and "placebo effect and spirituality and medicine." After reading the primary articles, the referenced sources were analyzed. Results show a confusion on how the term spirituality is used and a weak capacity and effectiveness with respect to the spiritual care provided by health personnel, thus ignoring the several benefits offered by such care, which is a tool for a more ethical and humane work.
Resumen La espiritualidad es la fuerza que une los diferentes componentes del ser y al estimularse proporciona una experiencia armoniosa, además de promover el equilibrio de bienestar físico, social y mental. Ante lo anterior, este texto tuvo por objetivo abordar cómo se ve secularmente la espiritualidad en la medicina, su influencia en la salud y la percepción de profesionales y pacientes sobre este tema. Para ello, se realizó una revisión narrativa en la base de datos PubMed utilizando los siguientes descriptores: "medicine and spirituality and secularismo" y "placebo effect and spirituality and medicine". Después, se analizaron las fuentes mediante la lectura de los artículos principales. Se encontró una confusión con relación al uso del término espiritualidad, y es deficiente la habilidad y eficacia del cuidado espiritual que brindan los profesionales de la salud, contrastando con los numerosos beneficios de este cuidado, una herramienta para un trabajo más ético y humanizado.
Subject(s)
Societies , Placebo Effect , Spirituality , MedicineABSTRACT
Study Objective:Preoperative anemia results in two? to sixfold increased incidence of perioperative blood transfusion requirements and reduced postoperative hemoglobin (Hb) level. This prospective study was designed to investigate the effect of preoperative intravenous infusion of iron on Hb levels, blood transfusion requirements, and incidence of postoperative adverse events in patients undergoing coronary artery bypass grafting. Design: Prospective randomized trial. Setting: Academic university hospital. Patients: Eighty patients (52–67 years old) underwent coronary artery bypass grafting and received either iron therapy or saline infusion preoperatively. Interventions: Patients were randomly allocated to iron or placebo groups. In the iron group, patients received a single intravenous dose of ferric carboxymaltose (1000 mg in 100 mL saline) infused slowly over 15 min 7 days before surgery. In placebo group, patients received a single intravenous dose of saline (100 mL saline) infused slowly over 15 min 7 days before surgery. Measurements: Patients were followed up with regards to incidence of anemia, Hb level on admission, preoperatively, postoperatively, 1 week and 4 weeks after discharge, aortic cross?clamp time, the number of packed red blood cells (pRBCs) units, the percentage of reticulocytes pre–postoperatively and 1 week later, hospital stay and intensive care unit (ICU) stay length, and the incidence of postoperative complications. Main Results: Iron therapy was associated with lower incidence of anemia 4 weeks after discharge (P < 0.001). Hb level was significantly higher in the iron group compared to the placebo group preoperatively and postoperatively, and 4 weeks after discharge (P < 0.001). Iron therapy resulted in shorter hospital and ICU stay (P < 0.001) and shorter aortic cross?clamp time, reduced pRBCs requirements postoperatively. Percentage of reticulocytes was significantly higher in placebo group than in iron group postoperatively and 1 week after discharge and the incidence of postoperative complications was similar to the placebo group. Conclusions: Preoperative IV iron infusion is a safe and feasible way to manage preoperative anemia. Preoperative administration of IV iron is associated with a higher postoperative Hb level, shorter hospital and ICU stay, and reduced perioperative red blood cell transfusion requirements with insignificant difference in incidence of postoperative complications.