Gyejigachulbutang (Gui‐Zhi‐Jia‐Shu‐Fu‐Tang, Keishikajutsubuto, TJ‐18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo‐Controlled Double‐Blind Clinical Trial

Kim, Myung Kwan; Leem, Jungtae; Kim, Young Il; Kim, Eun-Seok; Park, Yang-Chun; Sul, Jae-Uk; Jo, Hee-Geun; Yoon, Sang-Hoon; Kim, Jeeyong; Jeon, Ju Hyun; Jung, In Chul

doi:10.1155/2020/2376581

Cited by 3 publications

(1 citation statement)

References 38 publications

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“…Increasing evidence has demonstrated that complementary and alternative medicine is important and effective in the management of different chronic diseases, including urinary retention [ 3 ], degenerative knee osteoarthritis [ 4 ], gastroesophageal reflux disease [ 5 ], chronic idiopathic urticaria [ 6 ], and shigellosis [ 7 ].…”

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confidence: 99%

Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial

Zhang

Guan

Wang

et al. 2021

Evidence-Based Complementary and Alternative Medicine

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Objectives. To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods. This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial. Results. After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group ( P < 0.05 ). In addition, the clinical efficacy rate of the NMT group was significantly higher than that of the LVX group (55% vs. 8.33%, P < 0.0001 ), indicating that NMT has a rapid effect on chronic epididymitis. After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens ( P > 0.05 ); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group ( P < 0.0001 ). Moreover, after 4 weeks of treatment, the patients in the LVX + NMT group, which had a clinical efficacy rate of 97.22%, had lower CESI scores (both P < 0.01 ) and a smaller epididymal nodule diameter (vs. LVX, P < 0.0001 ; vs. NMT, P < 0.05 ) than those in the other two groups. No adverse events or abnormal hepatorenal function were found during the study. Conclusion. NMT significantly improved CESI scores and epididymal nodule diameter in patients with chronic epididymitis. The combination of NMT and LVX provides a much better effect than monotherapy, and this treatment regimen was well tolerated.

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Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial

Zhang

Guan

Wang

et al. 2021

Evidence-Based Complementary and Alternative Medicine

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Analgesic effect of Keishinieppiittokajutsubu on low barometric pressure-induced pain response in arthritic model rats

Kurauchi,

Inoue,

Kawakami

et al. 2024

Journal of Pharmacological Sciences

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Randomized Controlled Trials Studying Nonoperative Treatments of Osteoarthritis Often Use Misleading and Uninformative Control Groups: A Systematic Review

Adu,

Ring,

Teunis

2024

Clin Orthop Relat Res

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Background Because there are no known treatments that alter the natural course of the pathophysiology of osteoarthritis, nonoperative treatment needs to be compared with known effective treatments that seek to mitigate symptoms or with similarly invasive inert (placebo) treatments to determine effectiveness. Comparing a treatment to an uninformative control group may inappropriately legitimize and support the use of potentially ineffective treatments. We therefore investigated the prevalence of inappropriate control groups in musculoskeletal research and asked whether these are associated with reporting a positive treatment effect. Questions/purposes We systematically reviewed randomized trials of nonoperative treatments of osteoarthritis and asked: (1) What proportion of randomized trials use uninformative control groups (defined as a treatment less invasive than the tested treatment, or a treatment that might possibly not outperform placebo but is not acknowledged as such)? (2) Is the use of uninformative control groups independently associated with reporting a positive treatment effect (defined as p < 0.05 in favor of the intervention, or as making a recommendation favoring the intervention over the control treatment)? Methods In a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched PubMed, Cochrane, and Embase up to September 2023 for randomized controlled trials published between 2020 to 2022 that compared one or more nonoperative treatments for the symptoms of osteoarthritis. We excluded studies that contained a surgical treatment group. We identified 103 trials that met eligibility criteria, with a total of 15,491 patients. The risk of bias was high in 60% (n = 62) of trials using the Cochrane Risk of Bias Tool, version 2. Although the high risk of bias in the included studies is concerning, it does not invalidate our design; instead, it highlights that some studies may use flawed methods to recommend treatments with unproven effectiveness beyond nonspecific effects because the kinds of bias observed would tend to increase the apparent benefit of the treatment(s) being evaluated. We used logistic regression to test the association of uninformative control groups with a positive treatment effect, accounting for potential confounders such as conflict of interest and study bias using the Cochrane Risk of Bias score. Results The use of uninformative control groups (treatments less invasive than the tested treatment, or treatments that might not outperform placebo but are not acknowledged as such) was found in 46% (47 of 103) of included studies. After accounting for potential confounding, there was no association between reporting positive treatment effects and the use of an uninformative control group. Studies with a low risk of bias had a lower likelihood of reporting a positive treatment effect (OR 0.2 [95% confidence interval 0.05 to 0.9]; p = 0.04, model pseudo R2 = 0.21). Conclusion The finding that recent studies that mimic high-level evidence often use uninformative control groups that do not adequately account for nonspecific effects (perceived treatment benefits unrelated to a treatment’s direct physiological effects) points to a high risk of legitimizing ineffective treatments. This raises the ethical imperative for patients, clinicians, journal peer reviewers, and journal editors to hold researchers to the standard of an adequate, informative control group. Awareness and risk of bias checklists might help patients and clinicians forgo new treatments based on seemingly high-level evidence that may carry only iatrogenic, financial, and psychological harm (false hope, in particular). Level of Evidence Level I, therapeutic study.

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Gyejigachulbutang (Gui‐Zhi‐Jia‐Shu‐Fu‐Tang, Keishikajutsubuto, TJ‐18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo‐Controlled Double‐Blind Clinical Trial

Cited by 3 publications

References 38 publications

Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial

Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial

Analgesic effect of Keishinieppiittokajutsubu on low barometric pressure-induced pain response in arthritic model rats

Randomized Controlled Trials Studying Nonoperative Treatments of Osteoarthritis Often Use Misleading and Uninformative Control Groups: A Systematic Review

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