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Effects of Goshajinkigan (TJ-107) for oxaliplatin-induced peripheral neurotoxicity using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire in a Phase II, multicenter, randomized, double-blind, placebo-controlled trial.
Aoyama, T, Morita, S, Kono, T, Hata, T, Mishima, H, Sakamoto, J
Journal of cancer research and therapeutics. 2021;(6):1473-1478
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Abstract
BACKGROUND The aim of the present study was to evaluate the efficacy of TJ-107 for oxaliplatin-induced peripheral neurotoxicity in prospective, multi-institutional, randomized, double-blind, placebo-controlled Phase II trials using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire (FACT-GOG-NTX-12). PATIENTS AND METHODS The patients who were registered to the Goshajinkigan oxaliplatin neurotoxicity evaluation study (UMIN000002211) were analyzed. A NTX-12 from the validated FACT/GOG-NTX-12 was assessed before treatment and at the end of every 2 cycles. RESULTS The comparisons of the median scores for TJ-107 and the placebo at 8 and 26 weeks were as follows: numbness or tingling in the hands (P = 0.5820), numbness or tingling in the feet (P = 0.3236), feeling of discomfort in the hands (P = 0.8219), feeling of discomfort in the feet (P = 0.5361), joint pain or muscle cramps (P = 0.1974), feeling weak all over (P = 0.2771), trouble hearing (P = 0.2832), ringing or buzzing in ears (P = 0.1031), trouble buttoning buttons (P = 0.1653), trouble feeling the shape of small objects when held in hand (P = 0.2919), trouble walking (P = 0.5406), and pain in the hands or feet when exposed to cold temperatures (P = 0.1872). CONCLUSION There might be no clinically significant difference between the use of TJ-107 and the severity and quality of life for patients treated with oxaliplatin.
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Therapeutic effect of Chinese prescription Kangen-karyu in patients with diabetic nephropathy.
Park, CH, Hiratani, K, Natazuka, T, Yokozawa, T
Drug discoveries & therapeutics. 2020;(2):84-88
Abstract
Diabetic nephropathy is the kidney disease that occurs as a result of diabetes. A number of new therapies have been developed based on the pathogenic factors of diabetic nephropathy such as intensive glycemic control, precise hypertension control, lifestyle modifications including exercise and an energy-restricted diet, and numerous novel agents. The utilization of traditional Chinese medicine for patients with diabetic nephropathy has also received increasing attention due to its wide availability, weak side-effects, and proven therapeutic mechanisms and benefits. In this paper, we report the case of patients with diabetic nephropathy, stage 2 or 3. Kangen-karyu extract (7.5 g/day) was administered three times per day for 6 months. The estimated glomerular filtration rate was increased at the 6-month follow-up. The serum creatinine level decreased following administration. At that time, somatic and subjective symptoms had partially disappeared. Here, we present evidence that Kangen-karyu exerts a renoprotective effect against the development of diabetic nephropathy.
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Topical Delivery of Modified Da-Cheng-Qi Decoction () Using Low-Frequency Ultrasound Sonophoresis for Refractory Metastatic Malignant Bowel Obstruction: An Open-Label Single-Arm Clinical Trial.
Tian, AP, Yin, YK, Yu, L, Yang, BY, Li, N, Li, JY, Bian, ZM, Hu, SY, Weng, CX, Feng, L
Chinese journal of integrative medicine. 2020;(5):382-387
Abstract
OBJECTIVE To evaluate the efficacy and safety of topical delivery of modified Da-Cheng- Qi Decoction (, MDCQD) by low-frequency ultrasound sonophoresis (LFUS) in patients with refractory metastatic malignant bowel obstruction (MBO) using an objective performance criteria (OPC) design. METHODS Fifty patients with refractory metastatic MBO were enrolled in this open-label single-arm clinical trial. Alongside fasting, gastrointestinal decompression, glycerol enema, intravenous nutrition and antisecretory therapy, a 50 g dose of MDCQD (prepared as a hydrogel) was applied through topical delivery at the site of abodminal pain or Tianshu (S 25) using LFUS for 30 min, twice daily for 5 consecutive days. The overall outcome was the remission of intestinal obstruction, and improvement on abdominal pain, abdominal distention, nausea and vomiting scores. Indicators of safety evaluation included liver and renal function as well as blood coagulation indicators. RESULTS Among 50 patients, 5 patients (10%) showed complete remission of intestinal obstruction and 21 patients (42%) showed improvement of intestinal obstruction. The overall remission rate of bowel obstruction was 52%. The results of the symptom score, based on the severity and frequency of the episode, are as follows: 26 patients (52%) showed improvment on symptom scores, 20 patients (40%) did not respond to treatment, and 4 patients (8%) discontinued treatment due to intolerance. No serious adverse effects or abnormal changes on liver and renal function or blood coagulation were observed. CONCLUSION Topical delivery of MDCQD at 100 g/day using LFUS can improve the treatment response in patients with refractory metastatic MBO.
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Patient characteristics associated with treatment response in patients receiving salvianolate injection for stable angina.
Qi, Y, Yu, C, Tang, L, Li, S, Sun, X
Journal of evidence-based medicine. 2018;(2):83-88
Abstract
OBJECTIVE To explore patient characteristics associated with treatment response in patients receiving salvianolate injection for stable angina. METHODS An analysis was conducted of data from a multicenter, phase IV clinical trial undertaken in China that enrolled 2150 patients hospitalized for stable angina from 50 hospitals. The treatment outcomes were changes of angina severity and nitroglycerin use between baseline and the last day of treatment. We used logistic regression models to explore patient characteristics associated with the treatment response. RESULTS Patients who were overweight or obese (ORa 1.20, 95% CI 1.01 to 1.44), present with hypertension (ORa 1.23, 95% CI 1.01 to 1.49), experienced with 3 or more episodes of angina per week (ORa 1.77, 95% CI 1.44 to 2.17), or concomitantly using antiplatelet agents (ORa 1.44, 95% CI 1.17 to 1.78) were associated with better treatment response defined with the change of angina severity. Those of overweight or obesity (ORa 1.57, 95% CI 1.17 to 2.12) or concomitantly using calcium antagonists (ORa 2.38, 95% CI 1.39 to 4.08) fared better treatment response according to discontinuation or reduction of nitroglycerin use. CONCLUSIONS Patients diagnosed with stable angina and receiving salvianolate injection might fare better treatment response if they were overweight or obese, experienced with hypertension, three or more episodes of angina per week, or concomitantly using antiplatelet agents and calcium antagonists.
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Effect of Xianling Gubao capsules on bone mineral density in osteoporosis patients.
Wu, ZH, Zhu, X, Xu, CK, Chen, YJ, Zhang, L, Zhang, CL
Journal of biological regulators and homeostatic agents. 2017;(2):359-363
Abstract
This paper aimed to analyze the clinical effects of Xianling Gubao capsules on the bone mineral density (BMD) of 94 patients with osteoporosis. After reviewing and analyzing the clinical information in our hospital from January 2015 to January 2016, the patients were divided into a control group and a treatment group with 47 cases in each group. Patients in the control group were treated with routine Western medicine, while the treatment group received Xianling Gubao capsules. Both groups were treated continuously for 3 courses (30 days each course) and had their BMD analyzed and compared. The effective rates of the treatment group and control group were 91.48% and 70.21%, respectively, with statistical significance (P less than 0.05). Compared with the same group before the treatment, the bone metabolic indexes (blood calcium, phosphorus, and alkaline phosphate) and the BMD of the femoral neck and lumbar vertebrae (L1-2, L3-4, L2-4) of both groups were all improved with statistical significance (P less than 0.05) after the treatment. The above indexes of the treatment group were all significantly higher than those of the control group, with statistical significance (P less than 0.05). Compared with the same group before treatment (P less than 0.05), the osteocalcin (OC) levels of both groups were increased, and the Cross-linked N-telopeptide of type 1 collagen (CTX-1) levels were decreased after the treatment. The OC level in the treatment group was higher when compared with the control group, while the CTX-1 level was lower compared to the control group (P less than 0.05). Moreover, no significant side-effects or adverse events were observed during the treatment and observation period. The Xianling Gubao Capsule possesses a therapeutic effect for BMD in osteoporosis patients, which can effectively increase their BMD, improve their bone metabolism, and control the loss of bone mass, therefore, can be used in clinical promotion and application.
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Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis.
Ha, CW, Park, YB, Min, BW, Han, SB, Lee, JH, Won, YY, Park, YS
Journal of ethnopharmacology. 2016;:1-7
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE This prospective, randomized, double-blinded, double-dummy, multicenter study compared the efficacy and safety of PG201 (Layla®), a new product from extracts of 12 plant sources and SKI306X (Joins®) which have been well investigated and in relatively wide usage among herbal medicine, for the treatment of patients with knee osteoarthritis. AIM OF THE STUDY To compare the efficacy and safety of PG201 and SKI306X in patients with knee osteoarthritis. MATERIALS AND METHODS A prospective, double-blinded multicenter study was conducted in 124 patients with Kellgren and Lawrence grade 2-3 knee osteoarthritis. Patients were randomly assigned to receive 600mg of PG201 (300mg, twice daily) and 600mg of SKI306X placebo (200mg, thrice daily) or 600mg of SKI306X (200mg, thrice daily) and PG201 placebo (300mg, twice daily) for 12 weeks. The primary outcome was the improvement of pain by week 8 as assessed by the 100-mm pain visual analog scale (VAS). Secondary outcomes included pain VAS improvement level at week 12, pain VAS improvement rate at weeks 8 and 12, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) improvement level at weeks 8 and 12, the improvement of the quality of life (EQ-5D), overall symptom self-assessment score, and rescue medication consumption. RESULTS The pain VAS improvement at 8 weeks was 14.2±16.2 in the experimental group and 11.9±13.1 in control group (p=0.557), confirming that the experimental group was not inferior to the control group as lower limit (-8.38) of 95% CI of the difference of VAS improvement between two groups was well above the allowed limit (-10 mm). There was no significant difference in all secondary outcomes including pain VAS, WOMAC, EQ-5D, overall symptom self-assessment score, and rescue medication consumption. Adverse events were low and similar between the two groups. CONCLUSIONS The results of this study showed that PG201 significantly reduced knee pain and improved knee function and were comparable to SKI306X. PG201 can be suggested as an effective treatment of knee osteoarthritis. Trial registration ClinicalTrials.gov:NCT01768468.
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Evaluating the effect of Matricaria recutita and Mentha piperita herbal mouthwash on management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: A randomized, double blind, placebo controlled clinical trial.
Tavakoli Ardakani, M, Ghassemi, S, Mehdizadeh, M, Mojab, F, Salamzadeh, J, Ghassemi, S, Hajifathali, A
Complementary therapies in medicine. 2016;:29-34
Abstract
OBJECTIVES To investigate the effects of Matricaria recutita and Mentha piperita on oral mucositis (OM) in patients undergoing hematopoietic stem cell transplantation (HSCT). DESIGN Randomized double blind placebo controlled clinical trial. SETTING Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, and Bone Marrow Transplantation Center at Taleghani Teaching Hospital, Tehran, Iran. PARTICIPANTS Sixty patients undergoing HSCT were randomly assigned to two groups: placebo (n=33), and herbal mouthwash group (n=27). INTERVENTIONS All patients received the mouthwash one week before HSCT and were instructed to use it three times daily for at least 30s. MAIN OUTCOME MEASURES OM was graded using National Cancer Institute Common Toxicity Criteria (NCI-CTC) scale (grade 0-5). The Numerical Rating Scale (NRS: 0-10 scale) measured the severity of OM symptoms. RESULTS The duration, maximum and average daily grade of OM were significantly reduced in the treatment group (P<0.05). The use of herbal mouthwash led to significant improvements in pain intensity (P=0.009), dryness (P=0.04) and dysphagia (P=0.009). Other significant results included: reduced need for complementary medications (P=0.03), narcotic analgesics (P=0.047), total parenteral nutrition (TPN) (P=0.02) and the duration of TPN (P=0.03). CONCLUSION This study shows that patients receiving the herbal mouthwash experienced less complications and symptoms associated with OM. In summary, it seems that the use of our prepared herbal mouthwash is beneficial for patients undergoing HSCT.
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A Selective Estrogen Receptor Beta Agonist for the Treatment of Hot Flushes: Phase 2 Clinical Trial.
Tagliaferri, MA, Tagliaferri, MC, Creasman, JM, Koltun, WD
Journal of alternative and complementary medicine (New York, N.Y.). 2016;(9):722-8
Abstract
OBJECTIVE The aim of this study was to evaluate the safety, tolerability, and efficacy of a selective estrogen receptor beta (ERβ) agonist, Dr. Tagliaferri's Menopause Formula (MF102), to treat the symptoms of menopause. METHODS An open-label trial of MF102 taken for 12 weeks by 30 postmenopausal women aged 40-65 years, who experienced a minimum of five moderate to severe hot flushes per day. The primary efficacy outcome was a change in the frequency of moderate to severe hot flushes from baseline to week 12. A change in the frequency of hot flushes that woke participants from their sleep from baseline to 12 weeks was a secondary endpoint. Lipid profile and endometrial thickness were also evaluated. RESULTS Thirty postmenopausal women with an average of nine moderate to severe hot flushes per day were treated with MF102 4 g/day; 27 participants completed the study. The median percent reduction in moderate to severe hot flushes was 71% (p < 0.001). The median percent reduction in hot flushes that woke participants from their sleep was 54% (p < 0.001). Low-density lipoprotein (LDL-C) and total cholesterol both declined significantly from baseline. There were no serious adverse events, reports of abnormal uterine bleeding, or significant changes in double-wall endometrial thickness. CONCLUSIONS Treatment with MF102 resulted in a marked decrease in the frequency of moderate to severe hot flushes, was well-tolerated, and demonstrated no safety concerns.
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Efficacy of Shenzhuo formula on diabetic kidney disease: a retrospective study.
Tian, J, Zhao, L, Zhou, Q, Liu, W, Chen, X, Lian, F, Tong, X
Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan. 2015;(5):528-36
Abstract
OBJECTIVE To observe the efficacy of a traditional Chinese medicine, Shenzhuo formula, on patients with diabetic kidney disease (DKD). METHODS Eighty-eight outpatients with DKD were enrolled. Changes in estimated glomerular filtration rate (eGFR), creatinine clearance, serum creatinine, blood-urea-nitrogen, albuminuria, glycosylated hemoglobin (HbA1C), blood pressure, and lipid profile were measured and analyzed before and after intervention with Shenzhuo formula for 1, 3, 6, 9, 12, and 18 months. RESULTS Compared with the baseline amounts, serum creatinine decreased, and eGFR and creatinine clearance increased, significantly after intervention for 1, 3, 6, 9, 12, and 18 months (all P < 0.05). Mean eGFR increased by 2.11 mL/min per 1.73 m²/y after 18-month treatment. Urinary protein at 24 h decreased significantly after 1, 3, 9, and 12 months (P < 0.05). HbA1C decreased significantly (P < 0.05) after 3, 6, 9, 12, and 18 months, and systolic blood pressure decreased significantly (P < 0.05) after 1, 3, and 6 months. Total cholesterol decreased significantly (P < 0.05) after 1, 3, 6, and 18 months. Triglyceride and low-density lipoprotein-cholesterol decreased significantly (P < 0.05) after 1 and 3 months. CONCLUSION Shenzhuo formula can improve eGFR and possibly slow DKD progression. Shenzhuo formula can also lower HbA1C, lipid levels and blood pressure.
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[Treating irritable bowel syndrome by wuling capsule combined pinaverium bromide: a clinical research].
Wu, XW, Hou, Y, Ji, HZ, Liang, MM, Xu, LE, Wang, FY
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2015;(4):415-8
Abstract
OBJECTIVE To evaluate the efficacy and safety of wuling Capsule combined with Pinaverium Bromide in treatment of irritable bowel syndrome (IBS). METHODS Sixty-four IBS patients were randomized into two groups, the treatment group and the control group, 32 in each group. Patients in the treatment group took wuling Capsule (0. 33 g/capsule, 3 times per day) and Pinaverium Bromide (50 mg/tablet, one tablet each time, 3 times per day) , while those in the control group only took Pinaverium Bromide (50 mg/tablet, one tablet each time, 3 times per day). The therapeutic course for all was 6 weeks. IBS symptom score questionnaire, IBS-Quality of Life (IBS-QOL) , Self-Rating Depression Scale (SDS) , and Self-Rating Anxiety Scale (SAS) were assessed before and after treatment. Adverse reactions were also observed. RESULTS The improvement of abdominal pain, stool frequency, and stool properties, as well as changing rates of integrals were significantly higher in the treatment group than in the control group (P <0. 05). The improvement of dysphoria, body image, concerns for health, and dietary restriction of IBS-QOL, as well as changing rates of integrals were significantly higher in the treatment group than in the control group (P <0. 05). The improvement of SDS and SAS, as well as changing rates of integrals were significantly higher in the treatment group than in the control group (P <0. 05). No severe adverse reaction occurred in either group. CONCLUSION Combination therapy of wuling Capsule and Pinaverium Bromide could improve abdominal pain and defecation, attenuate depression and anxiety of IBS patients with higher safety.