Yan Yang1, Yao Lu2, Deping Zhou3, Fenglan Pei4, Qin Li5, Shuqiong Chen6, Qiufeng Wang7, Yanting Wang8, Zhe Jin1, Yanxia Liu1. 1. Department of Gynecology, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100078, China. 2. Department of Clinical Pharmacological Base, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100078, China. 3. Department of Emergency Gynecology, Chongqing health center for women and children, Chongqing 401147, China. 4. Department of Obstetrics and Gynecology, Chinese medicine hospital of Handan, Hebei 056000, China. 5. Department of Gynecology and Reproductive Medicine, The secondary hospital affiliated to Shanxi university of Chinese Medicine, Shanxi 712000, China. 6. Department of Gynecology, Hunan Health Center for Women and Children, Changsha 410008, China. 7. Department of Obstetrics and Gynecology, Chinese medicine hospital of Luohe, Luohe 462000, China. 8. Department of Obstetrics, People's Hospital of Xinzhou, Xinzhou 034000, China.
Abstract
OBJECTIVE: To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease (PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine (TCM). METHODS: We conducted a double-blinded, multicenter, randomized, placebo-controlled clinical trial which included 155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation. They were randomly divided into experimental group (n = 78) and control group (n = 77) according to a random number table. The treatment lasted for a period of 28 d. The experimental group was given Jinying capsules and oral levofloxacin plus oral metronidazole for first 7 d. They continued with Jinying capsules and levofloxacin placebo and metronidazole placebo for another 7 d. For the remaining 14 d, they continued with Jinying capsules only. Whereas, the control group was treated with oral levofloxacin and metronidazole and Jinying capsule placebo for the first 14 d in the same way as the experimental group and then continued with Jinying capsule placebo only for the remaining 14 d. The clinical efficacy was assessed using McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge, and pelvic ultrasound. RESULTS: Comparing McCormack scale between both groups after treatment, the difference in curative effect between both groups was significant (P = 0.0269). The cure rate of the experimental group and control group is 76.32% and 59.46% respectively at week 4. Comparing TCM symptom pattern scores between both groups before and after treatment, the differences in total effective rate were both significant (P < 0.05). The curative effect rate of experimental group is 2.63% and 13.70% of the control group at week 1 (P = 0.0131), and 73.33% of the experimental group and 56.94% of the control group at week 4 (P = 0.0369). No significant differences were found between the two groups on the Physicochemical indexes (all P > 0.05). No adverse events or reactions occurred in the experimental groups. CONCLUSION:Jinying capsule can reduce the dosage of antibiotics needed for PID treatment, and improve the symptoms in PID patients.
RCT Entities:
OBJECTIVE: To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease (PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine (TCM). METHODS: We conducted a double-blinded, multicenter, randomized, placebo-controlled clinical trial which included 155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation. They were randomly divided into experimental group (n = 78) and control group (n = 77) according to a random number table. The treatment lasted for a period of 28 d. The experimental group was given Jinying capsules and oral levofloxacin plus oral metronidazole for first 7 d. They continued with Jinying capsules and levofloxacin placebo and metronidazole placebo for another 7 d. For the remaining 14 d, they continued with Jinying capsules only. Whereas, the control group was treated with oral levofloxacin and metronidazole and Jinying capsule placebo for the first 14 d in the same way as the experimental group and then continued with Jinying capsule placebo only for the remaining 14 d. The clinical efficacy was assessed using McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge, and pelvic ultrasound. RESULTS: Comparing McCormack scale between both groups after treatment, the difference in curative effect between both groups was significant (P = 0.0269). The cure rate of the experimental group and control group is 76.32% and 59.46% respectively at week 4. Comparing TCM symptom pattern scores between both groups before and after treatment, the differences in total effective rate were both significant (P < 0.05). The curative effect rate of experimental group is 2.63% and 13.70% of the control group at week 1 (P = 0.0131), and 73.33% of the experimental group and 56.94% of the control group at week 4 (P = 0.0369). No significant differences were found between the two groups on the Physicochemical indexes (all P > 0.05). No adverse events or reactions occurred in the experimental groups. CONCLUSION: Jinying capsule can reduce the dosage of antibiotics needed for PID treatment, and improve the symptoms in PID patients.
Authors: Mi Li; Lijuan Zhao; Li Ma; Wen Zhang; Hua Huang; Jun Wei; Jun Sun; Fenying Lu; Lijiang Ji Journal: Evid Based Complement Alternat Med Date: 2021-11-25 Impact factor: 2.629