The Role of Traditional Chinese Formula Ding-Kun Pill (DKP) in Expected Poor Ovarian Response Women (POSEIDON Group 4) Undergoing In Vitro Fertilization-Embryo Transfer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Objective: The primary objective of the study was to assess traditional Chinese formula DKP supplementation in terms of efficacy and safety on reproductive outcomes of expected poor ovarian responder (POR, POSEIDON Group 4) undergoing in vitro fertilization-embryo transfer (IVF-ET). Design Setting and Participants: Women eligible for IVF-ET were invited to participate in this randomized, double-blind, placebo-controlled, superiority trial at academic fertility centers of ten public hospitals in Chinese Mainland. A total of 462 patients (35-44 years) equally divided between DKP and placebo groups with antral follicle count (AFC) <5 or anti-müllerian hormone (AMH) <1.2 ng/ml were randomized. Interventions: All participants were given DKP or 7 g placebo twice daily on the previous menstrual cycle day 5 until oocyte retrieval, which took approximately 5 to 6 weeks. Main Outcome Measure: The primary outcome was the ongoing pregnancy defined as more than 20 gestational weeks of an intrauterine living fetus confirmed by pelvic ultrasonography. Results: Demographic characteristics were equally distributed between the study populations. Intention-to-treat (ITT) analysis revealed that ongoing pregnancy rate (OPR) was not significantly different between DKP and placebo groups [26.4% (61/231) versus 24.2% (56/231); relative risk (RR) 1.09, 95% confidence interval (CI) 0.80 to 1.49, P = 0.593]. No significant differences between groups were observed for the secondary outcomes. The additional per protocol (PP) analysis was in line with ITT results: OPR in DKP group was 27.2% (61/224) versus 24.1% (55/228) in placebo group [RR 1.13, 95%CI (0.82 to 1.55), P = 0.449]. After subgroup analysis the findings concluded that POR population of 35-37 years had a significantly higher OPR after 5-6 weeks of oral DKP (41.8%, 33/79) versus placebo (25.4%, 18/71) [RR 1.65, 95% CI (1.02 to 2.65), P = 0.034, P for interaction = 0.028]. Conclusion: This well-designed randomized controlled trial (RCT) offers new high-quality evidence to supplement existing retrospective literature concerning DKP performance in expected PORs. DKP could be recommended as a safe and natural remedy for expected PORs (aged 35-37 years) who fulfill the POSEIDON group 4 criteria. However, additional interventional clinical studies are undoubtedly required to be conducted in the future to validate this hypothesis. Clinical Trial Registration: www.chictr.org.cn, identifier ChiCTR1900026614.

[Impacts on repeated common cold for the adults with different constitutions treated by acupoint application in the dog days and the three nine-day periods after the winter solstice].

OBJECTIVE: To observe the impacts on repeated common cold for the adults with different constitutions treated by acupoint application in the dog days (the three periods of the hottest days) and the three nine-day periods after the winter solstice (the three periods of the coldest days). METHODS: One hundred and fifty-two cases of repeated common cold were divided into four zones according to the body constitution. Each zone was sub-divided into a group of the dog days + the three nine-day periods of the coldest days (group A), and a simple group of the dog periods (group B). In both groups, Dazhui (GV 14), Feishu (BL 13), Tiantu (CV 22), Danzhong (CV 17), Zhongfu (LU 1) and Shenshu (BL 23) were selected. In group A, the acupoint application was given on the 1st or 2nd day of the first, second and third periods of the hottest days in 2010, as well as the 1st or 2nd day of the first, second and third periods of the coldest days in 2010 separately. In group B, the acupoint application was only given on the 1st or 2nd day of the first, second and third periods of the hottest days in 2010. The follow-up visit was conducted before the acupoint application in the three periods of the coldest days in 2010 and before the acupoint application in the three periods of the hottest days in 2011. Additionally, the frequency of disease attack and the symptom score in sickness were taken as the observation indices for the efficacy assessment in both groups. RESULTS: (1) In both groups, the attack frequency was reduced obviously in half a year after the three periods of the hottest days for the patients of qi deficiency constitution, yang deficiency constitution and qi stagnation constitution and the clinical symptom score were reduced apparently (all P<0.01), which were superior to those for the patients of phlegm damp constitution (P<0.01, P<0.05). For the patients of phlegm damp constitution, only the clinical symptom score was reduced (P<0.01). (2) In group A, the improvements were received in the attack frequency and the clinical symptom score in half a year after the three periods of the coldest days for the patients of those four constitutions as compared with those before treatment (all P<0.01). In group B, the attack frequency and the clinical symptom score were all back to the level as those before treatment. (3) In group A, in half a year after the three periods of the coldest days, the efficacy for reducing the attack frequency and the improvements in the clinical symptoms were better than those in group B (all P<0.01). CONCLUSION: The acupoint application in the dog days and the three nine-day periods after the winter solstice reduces the attack frequency and relieves the clinical symptoms of common cold for the adults of individual constitutions to different extents. The efficacy can be further improved in the treatment with the acupoint application in the three nine-day periods after the winter solstice half a year after the acupoint application in the dog days.

[Observation of the therapeutic effect on COPD of cold phlegm blocking the lung type at stable stage treated with acupoint sticking therapy in different season].

OBJECTIVE: To systematically observe the clinical effect on chronic obstructive pulmonary disease (COPD) at the stable stage, differentiated as cold phlegm blocking the lung type, treated with acupoint sticking therapy during the dog days and the three nine-day periods after the winter solstice so as to propose the latest clinical idea and theoretic evidence for the treatment of COPD. METHODS: One hundred and fifty cases of COPD at stable stage, which were in accordance with the inclusive standard were randomly divided into three groups, named group A (treatment in dog days and the three nine-day periods after the winter solstice), group B (treatment in dog days) and group C (treatment in the three nine-day periods after the winter solstice), 50 cases in each group. The ingredients (Semen Brassicae, Euphoribia Kansui, Asarum, Rhizome Corydalis, Cinnamon, ginger juice) and doses of herbal medicine plaster were same in each group. The herbal plaster was applied to Feishu (BL 13), Shenshu (BL 23), Dazhui (GV 14), Tiantu (CV 22), Danzhong (CV 17) and Zhongfu (LU 1). In group B, the treatment was given once on the 1st day of each dog-day period, totally 3 treatments were included. In group C, the treatment was given once on the 1st day of each nine-day periods after the winter solstice, totally, 3 treatments were involved. In group A, the treatment was given once on the 1st day of each dog-day period and each nine-day periods after the winter solstice separately, totally 6 treatments were required. The therapeutic effect was evaluated in 4 aspects, named comprehensive clinical efficacy, survival quality (the scores for symptoms, activity limitation and influence on daily life), the attach frequency and pulmonary function. RESULTS: The total effective rate was 88.0% (46/50) in group A, which was superior to 76.0% (38/50) in group B and 70.0% (35/50) in group C separately (P < 0.01, P < 0.001). The results of the attack frequency, clinical symptom score and pulmonary function indices after treatment were all improved apparently as compared with those before treatment in each group (all P < 0.01). All the above indices in group A were improved much apparently as compared with the other two groups (P < 0.01, P < 0.001). Except for the level of forced vital capacity (FVC), the results of clinical symptom score and the other pulmonary function indices in group B were all improved significantly as compared with group C (P < 0.05, P < 0.001). CONCLUSION: Acupoint sticking therapy during different season of the year achieves a superior clinical efficacy for the patients with COPD at stable stage. This therapy can reduce the attack frequency and improve the survival quality and pulmonary function for the patients. It is concluded that the efficacy of the treatment in dog days and the three nine-day periods after the winter solstice is superior to simple dog-day treatment and the treatment in the three nine-day periods after the winter solstice, and the efficacy of dog days treatment is better than that in the three nine-day periods after the winter solstice.