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Curative Properties of Chamomile in Gastrointestinal Disorders
Published in Megh R. Goyal, Preeti Birwal, Durgesh Nandini Chauhan, Herbs, Spices, and Medicinal Plants for Human Gastrointestinal Disorders, 2023
Mouth ulcers are associated with a number of etiologies.20 Stomatitis is the main dose-limiting toxicity for chemotherapy regimens dependent on 5-fluorouracil (5-FU) bolus. There was a double-blind, placebo-controlled clinical trial with 164 volunteers. At the time of their first 5-FU-based chemotherapy phase, patients were admitted into the study and randomized for 14 days of accepted chamomile liquid formulation three times in a day.18 In case of stomatitis, no significant difference was observed among the clinical trial volunteers. No toxicity was reported. The same outcome was acquired in this condition by other chamomile trials. The pre-study theory was not assisted by evidence of clinical studies that chamomile could decrease stomatitis induced by 5-FU. Whether chamomile is beneficial in this case, the findings remain unclear.
Topical Pain Medications and Their Role in Pain Management
Published in Sahar Swidan, Matthew Bennett, Advanced Therapeutics in Pain Medicine, 2020
A study was performed by Ala et al.15 that investigated the effects of topical 5% baclofen in patients after a hemorrhoidectomy. They conducted a randomized, double-blind, placebo-controlled clinical trial with 60 participants. Participants received either baclofen (5%) cream or placebo immediately after surgery and then every 12 hours for 14 days. Pain was assessed using the VAS, and analgesic requirement was measured by analgesic consumption. Pain ratings did not differ significantly between the baclofen and placebo groups at both 24 and 48 hours after the surgical procedure. The baclofen group showed a significantly lower pain score on weeks 1 and 2 post-surgery compared to the placebo group. The baclofen group also reported less concomitant use of oral systemic analgesics compared to placebo on week 1 and 2. There were reports of slight itching and bleeding from both groups, but there was no discontinuation of treatment due to adverse effects.
Historical Review
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
Donald D. Vogt, Michael Montagne
The objective of a clinical trial is to ensure a high probability that the better treatment is identified. Integral to this approach is the use of controls—a collection of patients who provide responses with which the effects of a specific therapy can be compared. The term "control" does not necessarily involve randomization, and a controlled clinical trial is not necessarily a randomized clinical trial. Controls may consist of patients receiving no treatment, different treatment, or the same treatment with a different dose or administered according to a different dosing schedule. When a control group is chosen by a method other than randomization, the researcher must assume that either the control and treatment groups are identical with respect to all important variables except the treatment under study or that all relevant differences can be corrected. The randomized trial is most useful and appropriate when the value of a new therapy is uncertain [14].
Effect of patient-reported outcomes as a dialogue-based tool in cancer consultations on patient self-management and health-related quality of life: a clinical, controlled trial
Published in Acta Oncologica, 2021
Pernille Christiansen Skovlund, Henriette Vind Thaysen, Henrik Schmidt, Jan Alsner, Niels Henrik Hjollund, Kirsten Lomborg, Berit Kjærside Nielsen
In this prospective non-randomized controlled, clinical trial, patients were assigned to either the intervention (systematic feedback of completed PRO-measures to physicians during each consultation) or the control group (treatment as usual without any use of PRO-measures in the consultation). No extra time was allocated for consultations in any of the two groups. The intervention took place at the Department of Oncology, Aarhus University Hospital, Denmark. Patients in the control group were recruited from two other departments in Denmark treating patients with metastatic melanoma (Odense University Hospital and Herlev Hospital). All patients were recruited from June 2017 to July 2019. Outcomes were measured at baseline, and after 3, 6, and 12 months using the following questionnaires: Patient Activation Measure (PAM), Functional Assessment of Cancer Therapy – Melanoma (FACT-M), Cancer Behavior Inventory – Brief Version (CBI-B), Perceived Efficacy in Patient–Physician Interaction (PEPPI).
Blinding and expectancy confounds in psychedelic randomized controlled trials
Published in Expert Review of Clinical Pharmacology, 2021
Suresh D. Muthukumaraswamy, Anna Forsyth, Thomas Lumley
At their heart, clinical trials consist of experimental units of observation (participants), treatments and the evaluation of outcomes (see [5,6] for comprehensive descriptions). The aim of the randomized controlled clinical trial is to establish the existence of a causal relationship between treatments and outcomes. In this regard it is worth considering the logic behind making causal inferences from clinical trials within the formalism of Rubin’s causal model [7,8]. Let U be a population of units with u denoting an individual unit and Y be a response variable we will seek to explain, with Y(u) being the response of an individual unit. Take a simple case in which there are two binary treatment options (t for treatment and c for control) and let S be a variable that indicates to which treatment a unit is exposed, hence S(u) = t ∨ S(u) = c. Notably, Y is an attribute of U, whereas S indicates exposure to a cause and hence Y(u) must be measured at some time after exposure of u to S(u). Prior to exposure there are two potential states Y could have been in the future, that is Yt or Yc. Any unit could then take values Yt(u) and Yc(u). The causal effect of t on u is called the individual treatment effect (ITE) and can be defined by:
Monopolar dielectric diathermy by emission of radiofrequency in Patellofemoral pain. A single-blind-randomized clinical trial
Published in Electromagnetic Biology and Medicine, 2020
M Albornoz-Cabello, AJ Ibáñez-Vera, ME Aguilar-Ferrándiz, L Espejo-Antúnez
A single-blind randomized-controlled clinical trial was conducted (the researcher in charge of collecting data from patients remained blind as to the treatment applied to each participant for the duration of the study). The investigation protocol was designed following the Helsinki Declaration and good clinical practice rules according to CONSORT Standards and considering all the clinical regulations for research in humans. The study was approved by the Virgen del Rocio University Hospital Ethics Investigation Committee (Seville, Spain; project approval code CEI 1696-N-17, dated 01/29/2018) and prospectively registered at the Australian and New Zealand Clinical Trials Registry with trial number ACTRN12618001259235. All participants were appropriately informed about the study and their rights, and signed an informed consent form accepting to participate.