Efficacy and Safety of Tongning Gel for Knee Osteoarthritis: A Multicentre, Randomized, Double‐Blinded, Parallel, Placebo‐Controlled, Clinical Trial
Notice bibliographique
Résumé
Objective . To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo‐controlled (PC) for knee osteoarthritis (KOA). Methods . A multicentre, randomized, double‐blinded, parallel, placebo‐controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276 ). Results . Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups ( P < 0.05), and the decreased value of WOMAC pain score in the TNG group were better than those in the PC group ( P < 0.05). Secondary efficiency outcome: the WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes of the two groups of patients after treatment were statistically significant ( P < 0.05), and the improvement of the above indexes in the TNG group was better than that of the PC group ( P < 0.05). Safety Evaluation . A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group. And 8 adverse reactions were reported by 6 patients including 2 adverse reactions by 2 patients (0.46%) in the experimental group and 6 adverse reactions by 4 patients (2.78%) in the control group. Two cases of significant adverse events occurred in the experimental group. Both groups had one serious adverse event, respectively, which were not relevant to the intervention. Conclusion . These results of the trial demonstrate that TNG is superior to placebo in the treatment of patients with KOA, and TNG can improve other symptoms of KOA, such as stiffness and physical function. TNG is safe for the treatment of knee osteoarthritis as a whole.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».