Diclofenac Sodium Sustained Release Tablets Research Articles

Efficacy of Qingpeng ointment (a Tibetan medicine) for acute gouty arthritis: a multi-center, randomized, double-blind, placebo-controlled trial

BackgroundThis study aims to assess the efficacy and safety of Qingpeng ointment (QPO), a Tibetan medicine for alleviating symptoms in individuals with acute gouty arthritis (AGA).MethodsThis study was a randomized, double-blind, placebo-controlled trial that involved individuals with AGA whose joint pain, as measured on a visual analog scale (VAS) from 0 to 10, was equal to or greater than 3. The participants were randomly assigned to either the QPO or the placebo group and received their respective treatments twice daily for seven consecutive days. In case of intolerable pain, the participants were allowed to use diclofenac sodium sustained-release tablets as a rescue medicine. The primary outcomes measured were joint pain and swelling, while the secondary outcomes included joint mobility, redness, serum uric acid levels, C-reactive protein levels, and the amount of remaining rescue medicine. Any adverse events that occurred during the trial were also recorded.ResultsA total of 203 cases were divided into two groups, with balanced baselines: 102 in the QPO group and 101 in the placebo group. For joint pain, differences between the groups were notable in the VAS scores [1.75 (0, 3.00) versus 2.00 (1.00, 3.50); P = 0.038], changes in VAS [5.00 (3.00, 6.00) versus 4.00 (2.00, 6.00); P = 0.036], and disappearance rate [26.47% compared to 15.84%; P = 0.046] after treatment. Concerning joint swelling, significant between-group differences were observed in the VAS scores [1.00 (0, 2.30) versus 2.00 (0.70, 3.00); P = 0.032] and disappearance rate [33.33% compared to 21.78%; P = 0.046] at treatment completion. The QPO group exhibited a statistically significant mobility improvement compared to the placebo group (P = 0.004). No significant differences were found in other secondary outcomes. Five patients, four from the QPO group and one from the other, encountered mild adverse events, primarily skin irritation. All of these cases were resolved after dosage reduction or discontinuation of the medication.ConclusionsCompared to the placebo, QPO exhibits positive effects on AGA by alleviating pain, reducing swelling, and enhancing joint mobility, without causing significant adverse effects.Trial RegistrationISRCTN34355813. Registered on 25/01/2021.

Efficacy and Safety of Qinpi Tongfeng Formula in the Treatment of Acute Gouty Arthritis: A Double-Blind, Double-Dummy, Multicenter, Randomized Controlled Trial.

Objective Traditional Chinese medicine (TCM) has certain curative effect against acute gouty arthritis (AGA), but it lacks high-quality evidence-based studies. In this randomized controlled trial, we try to evaluate the clinical efficacy and safety of Qinpi Tongfeng Formula (QPTFF) in the treatment of AGA. Methods One hundred and fourteen patients with AGA (damp heat accumulation syndrome) who met the inclusion and exclusion criteria were randomly divided into treatment group and control group in a ratio of 1 : 1. Patients in the treatment group were treated with QPTFF, and patients in the control group were treated with diclofenac sodium sustained-release tablets for 7 days. The primary outcome measure was the change in visual analog scale (VAS) score for pain from the baseline to day 8. The secondary outcome measures were joint symptom score, TCM syndrome score, total effective rate, pain cure rate, complete pain relief time, patient satisfaction score, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and serum uric acid level. The safety outcome measures were routine blood test, urinalysis, liver function including alanine aminotransferase and aspartate aminotransferase, renal function including blood urea nitrogen and serum creatinine, and the rate of treatment-related adverse events (TRAEs). Results 105 patients with 53 in the treatment group and 52 in the control group completed the 7-day treatment. There was no significant difference between two groups in demographic characteristics, VAS score for pain, joint symptom score, TCM syndrome score, ESR, CRP, and serum uric acid level before enrollment at baseline (based on both the full analysis set (FAS) and per protocol set (PPS), P > 0.05). The 95% confidence interval of the difference between the eighth and first VAS score for pain of the two groups was (−0.57, 0.42) in FAS and (−0.48, 0.47) in PPS. The lower bound of both FAS and PPS is greater than the bound value of −0.7. On day 8, there was no significant difference between the two groups in joint symptom score, TCM syndrome score, total effective rate, pain cure rate, complete pain relief time, patient satisfaction score, ESR, and CRP (FAS and PPS, P > 0.05). The serum uric acid level and TRAEs in the treatment group were significantly lower than those in the control group (FAS and PPS, P < 0.05). Conclusions QPTFF could alleviate the symptoms of patients with AGA, which is not inferior to diclofenac sodium sustained-release tablets in analgesic. Moreover, QPTFF overmatches diclofenac sodium sustained-release tablets in decreasing serum uric acid level and TRAEs. Therefore, the results provide reliable foundation for QPTTF in the treatment of AGA. Trial Registration. This study protocol was registered in Chinese Clinical Trial Registry (registration number: ChiCTR2100050638).

Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial

BackgroundAcute gouty arthritis (AGA) is an inflammatory arthritis clinically characterized by severe pain, swelling, and restricted movement of joints, which may cause physical disability and decrease quality of life. The use of recommended first-line treatment agents for AGA may be limited by adverse events. There has been a traditional use of alternative therapies for AGA. Tibetan medicine Qingpeng ointment is one of the on-market herbal products used for symptom relief of AGA. Previous clinical studies indicated that Qingpeng ointment can relieve pain, swelling, redness, and dysfunction of joints in patients with AGA. However, there is no rigorous randomized trial to demonstrate its benefit for AGA. In order to evaluate the efficacy and safety of Qingpeng ointment for AGA, we designed a randomized controlled trial.MethodsThis study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Two hundred and six adults with acute flare of gout, and visual analogue scale (VAS) score of joint pain ≥ 3 points will be recruited. Participants will be randomly assigned to herbal treatment or placebo group at a ratio of 1:1. Qingpeng ointment, or equal placebo ointment, will be applied topically at involved joints twice a day for consecutive 7 days. Patients in both groups would be allowed giving diclofenac sodium sustained-release tablets as rescue therapy when VAS score of joint pain ≥ 7 points during the treatment. The primary outcomes will be joint pain measured by VAS score, and joint swelling measured using width and thickness of affected joints and VAS score. Other outcome measures will be joint mobility, joint redness, C-reactive protein, serum uric acid, and the use of rescue medicine as well as adverse effect.DiscussionTo the best of our knowledge, this study is the first multi-center, randomized, double-blind, and placebo-controlled clinical trial to assess the efficacy of Tibetan medicine Qingpeng ointment for AGA. The findings of this study would provide evidence for its use to relieve symptoms of AGA.Trial registrationISRCTN ISRCTN34355813. Registered on 25 January 2021

Comparison of oral diclofenac transdermal patch versus oral diclofenac sustained release tablet as a post-operative analgesia following orthodontic extractions of premolar teeth

Aim: This study was performed to compare the degree of post operative analgesia, patient compliance, and frequency of adverse events with the use of oral diclofenac tablets and transdermal diclofenac patch following multiple premolar extractions in patients undergoing orthodontic treatment. Materials and Methods: Thirty young pre-orthodontic patients requiring bilateral maxillary and mandibular first premolar extractions were selected for the study. The right maxillary and mandibular first premolars were extracted first and 100mg oral diclofenac sodium sustained release tablets were prescribed to be taken thrice a day for three days. In the next appointment, the contralateral first premolars were extracted and a 100 mg transdermal diclofenac patch was applied once a day for three days. Pain relief and pain intensity with both the diclofenac formulations was recorded for each of using5-point Verbal Pain Intensity and Pain Relief Score Charts.Results and Conclusions: Statistical analyses revealed that there was a gradual increase in pain relief scores and a gradual decrease in pain intensity scores with the use of oral diclofenac tablets as well as with the transdermal patch.

Herbal cake separated moxibustion combined with umbrella shaped acupuncture with round sharp needle for chronic scapulohumeral periarthritis of cold-damp stagnation

To explore the effective therapy for treating chronic scapulohumeral periarthritis of cold-damp stagnation. A total of 90 cases of patients with chronic scapulohumeral periarthritis of cold-damp stagnation were randomly divided into an acupuncture and moxibustion group, a herbal cake separated moxibustion group and a routine rehabilitation group, 30 cases in each group. The routine rehabilitation group was treated with diclofenac sodium sustained-release tablets (0.1 g each time, taken after breakfast) and rehabilitation exercise, once a day. On the basis of the treatment in the routine rehabilitation group, the herbal cake separated moxibustion group was treated with herbal cake separated moxibustion at the affected side of Jianyu (LI 15), Jianliao (TE 14) and Jianzhen (SI 9), once a day. On the basis of the treatment in the herbal cake separated moxibustion group, the acupuncture and moxibustion group was additionally given umbrella shaped acupuncture with round sharp needle at the affected side of Jianyu (LI 15), Jianliao (TE 14), Jianzhen (SI 9), Naohui (TE 13), Jianqian (Extra), Jugu (LI 16), etc. once every other day. Each group was treated for 10 d. Before and after treatment the pain visual analogue scale (VAS) score and activities of daily living (ADL) score, and degree of changes in shoulder joint activity were compared in each group, and the clinical effect was evaluated. After treatment, the pain VAS scores of three groups were decreased (P<0.05), and the ADL scores were increased (P<0.05); the pain VAS score in the acupuncture and moxibustion group was lower than the herbal cake separated moxibustion group and the routine rehabilitation group after treatment (P<0.05), and the herbal cake separated moxibustion group was lower than the routine rehabilitation group (P<0.05); the ADL score in the acupuncture and moxibustion group after treatment was higher than the herbal cake separated moxibustion group and the routine rehabilitation group (P<0.05), and the herbal cake separated moxibustion group was higher than the routine rehabilitation group (P<0.05). The degree of changes in shoulder joint activity in the acupuncture and moxibustion group was larger than the herbal cake separated moxibustion group and the routine rehabilitation group, and the herbal cake separated moxibustion group was larger than the routine rehabilitation group (P<0.05). The total effective rate of the acupuncture and moxibustion group was 93.3% (28/30), which was higher than 83.3% (25/30) of the herbal cake separated moxibustion group and 73.3% (22/30) of the routine rehabilitation group (P<0.05). On the basis of routine rehabilitation training, herbal cake separated moxibustion combined with umbrella shaped acupuncture with round sharp needle treating chronic scapulohumeral periarthritis of cold-damp stagnation can significantly reduce shoulder joint pain and improve shoulder joint function.

Therapeutic effect observation on thumb-tack needling for knee osteoarthritis in elderly patients: A radom control trial 揿针治疗老年膝关节骨性关节炎疗效观察： 随机对照试验

ObjectiveTo observe the effects of the thumb-tack needling therapy on knee joint pain and joint function in the elderly patients with knee osteoarthritis (KOA) and compared with medication. MethodsA total of 60 patients were randomized into a thumb-tack needling group and a medication group, 30 cases in each one. In the thumb-tack needling group, the therapy with the thumb-tack needle retaining and waiting for qi was adopted. The acupoints were Hèdĭng (EX-LE2鹤顶), Nèixīyăn (内膝眼EX-LE4), Dúbí (犊鼻ST35), Xuèhăi (血海SP10), Liángqiū (梁丘ST34) and Ashi points on the affected side. The needles were retained for 24 h. This therapy was given once every two days, 3 times a week. The treatment for 2 weeks was as one course and consecutive 2 courses of treatment were required. In the medication group, diclofenac sodium sustained release tablets were taken orally, 75 mg each time, once daily, consecutively for 4 weeks. Successively, the score of visual analogue scale (VAS) at the affected knee before treatment, after treatment and 3 months after treatment as well as Lequesne indicator before and after treatment were evaluated. The clinical therapeutic effect was observed in the patients of the two groups after treatment. Results(1) After treatment, VAS scores were reduced as compared with those before treatment in the patients of the two groups (both P < 0.05). After treatment, VAS score in the thumb-tack needling group was lower than that in the medication group (P < 0.05). (2) After treatment, the scores of all the items of Lequesne indices reduced as compared with those before treatment in the patients of the both groups, indicating significance differences (all P < 0.05). After treatment, compared with the medication group, the score of pain, morning stiffness and walking ability as well as the total score were all lower in the thumb-tack needling group, indicating significant differences (all P < 0.05). (3) The curative and remarkably effective rate and the total effective rate were 66.7% and 93.3% in the thumb-tack needling group, higher than 56.7% and 86.7% in the medication group respectively (both P < 0.05). ConclusionThe thumb-tack needling therapy effectively relieves knee joint pain and improves joint function in the patients and the therapeutic effect is better than medication group. Hence, this therapy deserves to be promoted in clinical practice.

Rheumatoid arthritis treated with the triple strong-stimulation technique of acupuncture and moxibustion at specific acupoints: A randomized controlled trial

ObjectiveTo explore the clinical therapeutic effects and the mechanism on rheumatic arthritis (RA) treated with the combination of the instruments and techniques of acupuncture and moxibusiton. MethodsA total of 60 RA patients were randomized into an observation group and a control group, 30 cases in each one. In the control group, diclofenac sodium sustained release tablets were prescribed for oral administration, 0.3 g each time, twice a day, methotrexate tablets (MTX) for oral administration, 10 mg each time, once a week and folic acid tablets for oral administration, 5 mg each time, once a week. In the observation group, besides the treatment with western medicines, simultaneously, the specific acupoints were selected and stimulated with the triple strong-stimulation therapy, in which, the strong bloodletting technique, the strong cupping technique and the strong moxibustion technique were combined together, with different instruments of acupuncture and moxibustion adopted. The treatment was given once every 3 days, consecutively for 10 times. In 30 days of treatment, the therapeutic effects were observed in the two groups. Separately, before and after treatment, the rheumatoid factors (RF), hypersensitive-C reactive protein (hs-CRP) and erythrocyte sedimentation rate (ESR), the scores of joint symptoms and physical signs as well as the disease activity score (DAS-28) were observed in the two groups. ResultsRegarding RF, there were statistical significant differences before and after treatment in the observation group and the control group (the observation group 248.01 ± 79.81 vs 31.17 ± 29.01, the control group 254.11 ± 72.16 vs 66.42 ± 37.07, both P < 0.05). The result in the observation group was lower significantly than the control group after treatment (P < 0.05). Regarding hs-CRP, there were statistical significant differences before and after treatment in the observation group and the control group (the observation group 26.12 ± 9.22 vs 8.98 ± 7.66, the control group 23.18 ± 7.18 vs 16.01 ± 5.02, both P < 0.05). The result in the observation group was lower significantly than the control group after treatment (P < 0.05). Regarding ESR, there were statistical significant differences before and after treatment in the observation group and the control group (the observation group 30.56 ± 11.38 vs 12.58 ± 5.91, the control group 35.52 ± 9.67 vs 21.47 ± 6.91, both P < 0.05). The result in the observation group was lower significantly than the control group after treatment (P < 0.05). Regarding DAS-28, there were statistical significant differences before and after treatment in the observation group and the control group (the observation group 8.89 ± 2.01 vs 3.01 ± 0.74, the control group 8.14 ± 1.38 vs 4.12 ± 0.96, both P < 0.05). The result in the observation group was lower significantly than the control group after treatment (P < 0.05). Regarding the quantitative grading score of symptom, there were statistical significant differences before and after treatment in the observation group and the control group (the observation group 7.87 ± 1.69 vs 3.82 ± 1.96, the control group 7.77 ± 1.68 vs 5.01 ± 11.23, both P < 0.05). The result in the observation group was lower significantly than the control group after treatment (P < 0.05). The total effective rate was 96.67% (29/30) in the observation group and was 80.0% (24/30) in the control group, indicating the statistical significant difference between the two groups (P < 0.01). ConclusionBased on western medications, the triple strong-stimulation therapy of acupuncture and moxibustion at specific acupoints significantly relieves the joint symptoms, reduces the inflammatory reaction indicators and improves the clinical therapeutic effects on RA in the patients.

Observation on therapeutic effect of electroacupuncture plus acupoint-injection for nerve root sciatica

To observe the clinical effects of electroacupuncture (EA) plus acuoint-injection for nerve root sciatica. A total of 114 cases were randomly divided into an observation group and a control group, 57 cases in each group. The observation group was given EA plus acupoint-injection therapy with Cobamamide. The control group was given oral administration of Diclofenac Sodium Sustained-release Tablets plus muscular injection of Cobamamide. After one-course treatment, the clinical effects were compared between the two groups. The total effective rate was 96.5% in the observation group and 91.2% in the control group, without a statistical significance in the difference between the two groups (P>0.05). The curative rate was 57.9% in the observation group and 21.1% in the control group, with a statistical significance in the difference between the two groups (P<0.05). In the follow-up on the fourth day after the treatment, the recurrence rate was 23.1% in the observation group and 47.9% in the control group, with statistical difference between the two groups (P<0.05). EA plus acupoint-injection therapy for sciatica of nerve roots is remarkable in the clinical effect and needs promotion in clinic.

Clinical observation of Chinese herbal fumigation plus mulberry stick beating for heel pain

To observe the clinical efficacy of Chinese herbal fumigation plus beating with mulberry stick in treating heel pain. Sixty patients with heel pain were randomized into a treatment group and a control group, 30 in each group. The treatment group was intervened by Chinese herbal fumigation plus beating with mulberry stick, and the control group was by orally taking Diclofenac Sodium Sustained Release Tablets plus external use of She Xiang Zhen Tong Gao (Moschus Analgesic Plaster). After one treatment course, the visual analogue scale (VAS) was used to observe the change of pain, and the clinical efficacies were also evaluated. After intervention, the improvement of VAS score in the treatment group was more significant than that in the control group (P<0.01). The total effective rate of the treatment group was significantly higher than that of the control group (P<0.01). Chinese herbal fumigation plus beating with mulberry stick can produce a higher clinical efficacy than orally taking Diclofenac Sodium Sustained Release Tablets in treating heel pain.

Low prevalence of hypersensitivity to nonsteroidal anti-inflammatory drugs in Chinese patients with chronic rhinosinusitis

The exact prevalence of hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) remains unclear in patients with chronic rhinosinusitis (CRS) because many of these patients routinely avoid the use of NSAIDs. Since the diagnosis of aspirin hypersensitivity is based mainly on history, the aspirin challenge protocol is seldom used clinically in China. The objective of this study is to investigate the prevalence of NSAID hypersensitivity in Chinese patients diagnosed with CRS. In a unique cohort study, consecutive CRS patients received intramuscular diclofenac sodium injection or diclofenac sodium sustained-release tablets to relieve intraoperative and postoperative pain following nasal surgery. In addition, data on NSAID hypersensitivity in large-sample series of CRS patients were collected by searching relevant literature published in Chinese to determine the prevalence of NSAID hypersensitivity in Chinese patients with CRS. A total of 244 consecutive CRS patients were included in this study. Three (1.34%) patients experienced a severe asthmatic attack after intramuscular diclofenac sodium injection and were diagnosed with NSAID hypersensitivity. Despite the use of different methods to diagnose NSAID hypersensitivity, the prevalence of NSAID hypersensitivity in Chinese CRS patients was between 0.28 and 1.46%. The prevalence of NSAID hypersensitivity in Chinese patients with CRS is low, which is a distinct clinical characteristic of Chinese CRS patients. Despite the apparently low prevalence of the condition in this population, a large number of patients in China are affected by this disorder, which should not be overlooked or regarded with an indifferent attitude in medical research and clinical practices.

STUDIES ON THE EFFECT OF pH OVER DISSOLUTION PROFILE OF DICLOFENAC SODIUM SUSTAINED RELEASE TABLETS

The present study was performed to illustrate the effect of pH on dissolution profile of diclofenac sodium sustained release tablets. Diclofenac sodium has analgesic, antipyretic and anti- inflammatory activities. It is a potent relatively non-selective cyclooxygenase inhibitor. It is absorbed rapidly and completely after oral administration; peak Concentrations in plasma reached within 2-3 hours. The drug extensively binds to plasma proteins (99%) and its half- life in plasma is 1-2 hours. Diclofenac sodium extended release tablets are prescribed for long-term symptomatic treatment of Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Dissolution studies in different pH mediums were performed to mimic the in-vivo condition by doing in-vitro tests. The pH/buffer selection bases on the exposure of drug from stomach to intestine/colon and ensures the impact of pH changes on dissolution and release of drug substance for absorption. The study ensures the impact of pH changes on dissolution and release of drug substance for absorption.

Determination of Interchangeability of Different Brands of Diclofenac Sodium Sustained Release Tablets in Healthy Subjects Using Pharmacokinetic End Points

This was an open label, balanced, randomized, three-treatment, three-sequence, three period, single-dose, crossover bioavailability study in which healthy adults (age18-45 years) were randomized to receive sustained release tablets of Voveran SR (Product R), Nac SR (Product A) and Reactin SR (Product B) each containing diclofenac sodium 100 mg with at least 3 days wash out between treatments. Eighteen healthy, adult, male, human subjects who met the inclusion and exclusion criteria as described in the protocol were enrolled in the study. Pharmacokinetic parameters like Tmax, Cmax, AUC 0-t, AUC 0-∞, AUC0-t/ AUC 0-∞, Kel, T1/2 & MRT were calculated for the Products A, B and R. Product A fared better than product B in some bioequivalence parameters. However, both the test products (Nac SR and Reactin SR) were not bioequivalent to product R (Voveran SR). Keywords: Diclofenac Sodium, Sustained Release, Cmax, Tmax, AUC0-t, AUC0-inf, Bioequivalence

Clinical Observation on the Treatment of Rheumatoid Arthritisin Early Stage with TongLuoShu Liquid

Objective To investigate the clinical efficacy of TongluoShu Liquid in treating rheumatoid arthritis at early stage. Methods 100 cases were randomly recruited into a control group and a treatment group with 50 cases in each group. The treatment group was given TongluoShu liquid, 150ml / time, twice a day; and the control group was given Diclofenac Sodium Sustained Release Tablets (Deegan), one granule for each time, twice a day, and Methotrexate 7.5mg / time, once per week. Results In the treatment group, symptoms, signs and biochemical indicators were significantly improved, and the swelling of the soft tissue around the joints in stage Ⅰ and Ⅱ were also reduced. Besides, osteoporosis was controlled and the progress of destruction to the cartilage of stage Ⅲ was detained, though there was no statistical difference between the two groups after the treatment. Conclusion ShuTongluo liquid is a safe and effective medicine with less adverse reactions in treating rheumatoid arthritis. Key words: Tongluoshu Liquid; Rheumatoid arthritis; Accumulation of toxic evil