The Methodology of Controlled Trials of Acupuncture

1989 ◽  
Vol 6 (1) ◽  
pp. 9-13 ◽  
Author(s):  
C A Vincent
Keyword(s):  
Controlled Trial ◽  
Specific Effect ◽  
Control Group ◽  
Placebo Control ◽  
Controlled Trials ◽  
Control Procedure ◽  
Therapeutic Effects ◽  
Trial Methodology ◽  
Double Blind ◽  
Single Blind

The double-blind controlled trial methodology cannot be straightforwardly applied to trials of acupuncture. The double-blind condition, where the clinician is ignorant of the treatment allocation, cannot be sensibly maintained in trials of acupuncture or other physical treatments. The definition of an appropriate control group is also a difficult matter. The great majority of controlled trials of acupuncture so far conducted are seriously flawed by the use of a placebo control that itself has therapeutic effects. Recently more appropriate control groups have been developed, notably mock TENS, which is inert, and minimal acupuncture, which has only a very slight specific effect. As trials can only be single blind, if is especially important to monitor the adequacy of the control procedure, to ensure that it is perceived as being as effective as the true treatment. It is suggested that this can be achieved by assessing the: credibility of the two treatment procedures. Controlled trials of acupuncture should therefore be single blind, and employ a control condition that has no more than minimal specific effects, but is nevertheless seen as a credible, bona fide treatment by patients.

scholarly journals Randomized controlled trials in schizophrenia: opportunities, limitations, and trial design alternatives

2011 ◽  
Vol 13 (2) ◽  
pp. 155-172 ◽  
Keyword(s):  
Randomized Controlled Trials ◽  
Trial Design ◽  
Controlled Trial ◽  
Mood Stabilizers ◽  
Controlled Trials ◽  
Trial Methodology ◽  
Double Blind ◽  
Randomized Controlled ◽  
Design Alternatives ◽  
Novel Design

State-of-the art clinical trial design and methodology are enormously important for the advancement of the field. In contrast, the critical relevance of trial conduct and implementation have only more recently been the focus of discussion and research. Although randomized controlled trials are generally considered the gold standard for the assessment of pharmacologic and nonpharmacologic interventions in medicine, trials are vulnerable to complications and influences that can seriously compromise their success. Like interventions, trial design and conduct are also contextual. They need to be individualized and adapted to a number of relevant variables, such as setting, population, illness phase, interventions, patient and rater expectations and biases, and the overall aims of the investigation. While this means that there is no unified approach possible, certain general principles and guidelines require careful consideration. Knowledge of basic solutions and alternatives, and the recognition of the complex challenges that need to be addressed proactively can help to minimize unwanted outcomes, including trial failure and uninformative or falsely negative outcomes. Moreover, novel design alternatives need to be explored that target sample enrichment according to the study question and enhancement of precision in the measurement of relevant outcomes. We propose two novel design strategies that take advantage of the recently validated early antipsychotic response paradigm (that has also been observed with antidepressants and mood stabilizers). In the "early responder randomized discontinuation design" all patients are assigned to the active drug, and only those who had at least a minimal response at 2 weeks are enrolled in a double-blind, placebo-controlled discontinuation trial, enriching the placebo controlled trial portion with true drug responders. In the mirror image "early nonresponder randomized dose increase or augmentation design," early nonresponders at 2 weeks are assigned to staying on the medication or going either to a higher dose or an augmentation agent. It is hoped that through increased attention to the issues raised in this article and further refinement of trial methodology and conduct, the field will make much needed additional progress in the prevention and treatment of schizophrenia.

Randomized double-blind placebo-controlled trial of primary maintenance vigil immunotherapy (VITAL study) in stage III/IV ovarian cancer: Efficacy assessment in BRCA1/2-wt patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6017-6017 ◽  
Author(s):  
Rodney Paul Rocconi ◽  
Elizabeth A. Grosen ◽  
Sharad A. Ghamande ◽  
John K. Chan ◽  
Minal A. Barve ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Controlled Trial ◽  
Stage Iii ◽  
Cell Vaccine ◽  
Control Group ◽  
Placebo Control ◽  
Molecular Testing ◽  
Autologous Tumor ◽  
Double Blind ◽  
Double Blind Placebo

6017 Background: Vigil is an autologous tumor cell vaccine constructed from autologous harvested tumor tissue transfected with a DNA plasmid encoding GMCSF and bi-shRNA-furin thereby creating TGFβ expression control. Methods: A randomized double-blind placebo-controlled trial of Vigil vs. placebo was performed in advanced stage frontline OC patients. Relapse-free survival (RFS) and safety were endpoints. Patients who achieved complete clinical response were randomized [1:1 to placebo (control group, CG) or Vigil (Vigil group, VG)] after completion of frontline surgery and chemotherapy. All patients received 1 x 10e7 cells/ml of Vigil or placebo intradermally once a month for up to 12 doses. Results: Ninety-two patients were randomized with 91 patients in the per-protocol population (PP), (VG n=46; CG n=45). 62 patients were tested for BRCA1/2 status. VG showed no added overall toxicity compared to CG and no grade 4/5 toxicities were observed. Grade 2/3 toxic events were observed in 18% of CG patients (most common bone pain, fatigue) compared to 8% of VG patients (most common nausea, musculoskeletal pain). From time of randomization median RFS for all 91 patients was favorable in the VG (HR 0.69, one-sided p 0.088).Stratified by BRCA status, an advantage in RFS was seen in the BRCA1/2-wt patients in VG (19.4 mo) compared to CG (8 mo) (HR 0.51, 90% CI 0.26 – 1.01, one-sided p 0.050) from time of randomization and HR of 0.49 (90% CI 0.25 – 0.97, one-sided p 0.038) from time of surgery. Median time from surgery to randomization was 208.5 days (6.9 mo) in VG vs. 200 days (6.6 mo) in CG. 37.5% BRCA1/2-wt Vigil treated patients relapsed compared to 71% of placebo at time of data snap for analysis (HR 0.51, one-sided p 0.05), (median follow-up of 34.3 mo for all n=91 subjects). Germline and somatic BRCA1/2 molecular testing via central third party is underway on all 91 patients under continued blinded conditions to validate activity in BRCA1/2-wt. Conclusions: Vigil immunotherapy as frontline maintenance in Stage III/IV ovarian cancer is well tolerated and showed RFS clinical benefit, particularly in BRCA1/2-wt disease. Clinical trial information: NCT02346747. [Table: see text]

scholarly journals The Efficacy of Lactobacillus plantarum as Adjunctive Therapy of Bacterial Vaginosis: A Double-blind, Randomized, Placebo-controlled Trial

2020 ◽  
Vol 32 (3) ◽  
pp. 214
Author(s):  
Ridha Ramadina Widiatma ◽  
Muhammad Yulianto Listiawan ◽  
Dwi Murtiastutik ◽  
Cita Rosita Sigit Prakoeswa ◽  
Sawitri Sawitri ◽  
...  
Keyword(s):  
Placebo Group ◽  
Bacterial Vaginosis ◽  
Lactobacillus Plantarum ◽  
Adjunctive Therapy ◽  
Controlled Trial ◽  
Vaginal Flora ◽  
Control Group ◽  
Therapeutic Effects ◽  
Cure Rate ◽  
Double Blind

Background: Bacterial vaginosis (BV) is a clinical syndrome caused by the changing of Lactobacillus spp., a producer of hydrogen peroxide, in the normal vagina with a high concentration of anaerobic bacteria, Gardnerella vaginalis and Mycoplasma hominis. This study reports a resistance of BV therapy regimens, high recurrence rates, and side effects of an antibiotic. Therefore, adjunctive therapy for BV management is needed. Research has reported the therapeutic effects of probiotic in BV; however, the results are inconsistent. Purpose: To evaluate the efficacy of standard therapy using metronidazole and Lactobacillus plantarum for BV measured by the cure rate and vaginal flora balance. Methods: A randomized, double-blind, placebo-controlled trial, 30 subjects were randomized to take metronidazole 500 mg twice a day for seven days with weekly evaluation. The Lactobacillus plantarum or placebo group was evaluated every 4 weeks. The cure rate and vaginal flora balance were evaluated using the Amsel criteria and Nugent score before and after the intervention. Result: A total of 30 subjects returned for 28-day follow-up, of which 60% subjects of the antibiotic/probiotic group were cured compared to 40% in the antibiotic/placebo group (p>0.05). Conclusion: There was no difference in the increase of cure rate and vaginal flora balance between the treatment group and significant control group.

scholarly journals Comparison of lidocaine, huffing maneuver and combination of both in prevention fentanyl induced cough before induction of anesthesia: a double-blind, prospective, randomized placebo-controlled study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Laleh Dehghanpisheh ◽  
Mohammadhossein Eghbal ◽  
Fatemeh Bagheri Baravati ◽  
Pooya Vatankhah
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Placebo Control ◽  
Anesthesia Induction ◽  
Double Blind ◽  
Lidocaine Group ◽  
Cough Reflex ◽  
Significant Difference

Abstract Background Intravenous bolus injection of fentanyl has been frequently reported to be associated with cough reflex during patient anesthesia. However, the search for the most effective protocol continues. This study aimed to compare the effect of reducing cough reflex after injection of fentanyl in a fusion protocol by combining the injections of lidocaine and Huffing maneuver and comparing with a placebo control group, before anesthesia induction. Methods This prospective randomized controlled trial study was performed on 400 patients who were divided into four groups of combined protocol (group 1), lidocaine group (group 2), Huffing maneuver group (group 3), and the control receiving normal saline (group 4). Then patients were injected with 2. 5 μg /kg fentanyl and monitored for 2 min regarding their cough reflex, as well as the severity. Results In group one, 9 patients (9%), in group two, 45 patients (45%), 22 patients (22%) in group three, and in group four, 75 patients (75%), developed cough reflex following fentanyl injection. Also, 13 patients (13%) developed moderate and 4 (4%) developed severe coughs in the control group reported, while no reports of severe or moderate cough were among the intervention groups. There was a significant difference between the intervention group and the control group both in terms of the rate and severity of the fentanyl-induced cough. Conclusion By using a combination of lidocaine injection along and Huffing maneuver, better results can be obtained in reducing the frequency, and also the severity of cough followed by fentanyl injection. Trial registration The trial was registered with IRCT.IR (09/03/2018-No. IRCT20141009019470N74).

scholarly journals Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽  
2021 ◽  
Vol 41 (3) ◽  
pp. 294-304 ◽  
Author(s):  
Messoud Ashina ◽  
Uwe Reuter ◽  
Timothy Smith ◽  
Judith Krikke-Workel ◽  
Suzanne R Klise ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Statistical Testing ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Primary Endpoints ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

scholarly journals Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1280
Author(s):  
Jan Mieszkowski ◽  
Andżelika Borkowska ◽  
Błażej Stankiewicz ◽  
Andrzej Kochanowicz ◽  
Bartłomiej Niespodziński ◽  
...  
Keyword(s):  
Vitamin D ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Oncostatin M ◽  
Control Group ◽  
High Dose ◽  
Double Blind ◽  
Single High Dose ◽  
High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

scholarly journals Consumption of a Double-Fortified Salt Affects Perceptual, Attentional, and Mnemonic Functioning in Women in a Randomized Controlled Trial in India

2017 ◽  
Vol 147 (12) ◽  
pp. 2297-2308 ◽  
Author(s):  
Michael J Wenger ◽  
Laura E Murray-Kolb ◽  
Julie EH Nevins ◽  
Sudha Venkatramanan ◽  
Gregory A Reinhart ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Status ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Deficiency Anemia ◽  
Control Group ◽  
Attention And Memory ◽  
Double Blind ◽  
Iron Deficient ◽  
Mnemonic Function

Abstract Background: Iron deficiency and iron deficiency anemia have been shown to have negative effects on aspects of perception, attention, and memory. Objective: The purpose of this investigation was to assess the extent to which increases in dietary iron consumption are related to improvements in behavioral measures of perceptual, attentional, and mnemonic function. Methods: Women were selected from a randomized, double-blind, controlled food-fortification trial involving ad libitum consumption of either a double-fortified salt (DFS) containing 47 mg potassium iodate/kg and 3.3 mg microencapsulated ferrous fumarate/g (1.1 mg elemental Fe/g) or a control iodized salt. Participants' blood iron status (primary outcomes) and cognitive functioning (secondary outcomes) were assessed at baseline and after 10 mo at endline. The study was performed on a tea plantation in the Darjeeling district of India. Participants (n = 126; 66% iron deficient and 49% anemic at baseline) were otherwise healthy women of reproductive age, 18–55 y. Results: Significant improvements were documented for iron status and for perceptual, attentional, and mnemonic function in the DFS group (percentage of variance accounted for: 16.5%) compared with the control group. In addition, the amount of change in perceptual and cognitive performance was significantly (P < 0.05) related to the amount of change in blood iron markers (mean percentage of variance accounted for: 16.0%) and baseline concentrations of blood iron markers (mean percentage of variance accounted for: 25.0%). Overall, there was evidence that the strongest effects of change in iron status were obtained for perceptual and low-level attentional function. Conclusion: DFS produced measurable and significant improvements in the perceptual, attentional, and mnemonic performance of Indian female tea pickers of reproductive age. This trial was registered at clinicaltrials.gov as NCT01032005.

Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

1992 ◽  
Vol 17 (1) ◽  
pp. 69-70 ◽  
Author(s):  
M. A. LAMBERT ◽  
R. J. MORTON ◽  
J. P. SLOAN
Keyword(s):  
Local Anaesthetic ◽  
Steroid Injection ◽  
Controlled Trial ◽  
Trigger Finger ◽  
Controlled Study ◽  
Control Group ◽  
Methylprednisolone Acetate ◽  
Double Blind ◽  
Local Steroid Injection ◽  
Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

scholarly journals Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037842
Author(s):  
Wei Chen ◽  
Naya Huang ◽  
Haiping Mao ◽  
Xiao Yang ◽  
Qian Zhou ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Cardiovascular Outcomes ◽  
Control Group ◽  
Type I ◽  
Dialysis Patients ◽  
Double Blind ◽  
Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

Placebo-Controlled Trial of Lithium Augmentation of Fluoxetine and Lofepramine

1995 ◽  
Vol 166 (1) ◽  
pp. 80-86 ◽  
Author(s):  
Cornelius L. E. Katona ◽  
Mohammed T. Abou-Saleh ◽  
Deborah A. Harrison ◽  
Bertrand A. Nairac ◽  
Denzil R. L. Edwards ◽  
...  
Keyword(s):  
Rating Scale ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Depressive Illness ◽  
Controlled Trials ◽  
Major Depressive ◽  
Double Blind ◽  
Primary Care Settings ◽  
Resistant Depression ◽  
Lithium Augmentation

BackgroundThis study was designed to establish whether (as suggested in a number of open and relatively small controlled trials) lithium augmentation is more effective than continued antidepressant alone, where response to a standard course of antidepressant treatment has been absent or partial.MethodLithium or placebo was added on a double-blind basis for six weeks to the drug regime of 62 patients with major depressive illness (in both hospital and primary care settings) who had failed to respond to a controlled trial of fluoxetine or lofepramine. Response was defined as a final Hamilton Depression Rating Scale (HDRS) score of < 10.ResultsResponse was seen more frequently in patients taking lithium (15/29) than in those remaining on antidepressant alone (8/32; P < 0.05). Rapid response to lithium augmentation (LA) was not consistently observed in this cohort. Mean HDRS scores after six weeks were significantly lower (P < 0.01) in the lithium group after excluding those who had not achieved significant exposure to lithium (arbitrarily defined as two or more lithium levels ≥ 0.4 mmol/1). No differences in the efficacy of LA were apparent between fluoxetine and lofepramine.ConclusionsOur results confirm that LA is a useful strategy in the treatment of antidepressant-resistant depression. Partial response was, however, frequently observed with continued antidepressant treatment alone, and the superiority of LA appears to depend on achieving adequate serum lithium levels.

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