Effectiveness of Zhenqi Buxue Oral Liquid Combined with Progesterone for Treatment of Oligomenorrhea and Hypomenorrhea with Qi-Blood and Kidney (Shen) Essence Deficiency: A Randomized Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the effectiveness and safety of Zhenqi Buxue Oral Liquid (ZQ), progesterone capsules, and their combination in treating oligomenorrhea and hypomenorrhea with qi-blood and Kidney (Shen) essence deficiency.@*METHODS@#This was a prospective, randomized, multi-center controlled trial between June 2022 to December 2022. Ninety-six oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency were randomly assigned to receive ZQ (ZQ group, 29 cases), progesterone capsules (PG group, 32 cases), or the combined Chinese and Western medicine (COM group, 31 cases) at a ratio of 1:1:1. Patients in the ZQ or PG group took daily 10 mL twice a day of ZQ or 200 mg once a day of progesterone capsules for 10 consecutive days on day 15 of the menstrual cycle respectively, and patients in the COM group received the same ZQ combined with progesterone capsules. The treatment course lasted for 3 months and follow-up was performed at 1 and 3 months after the end of treatment. Primary endpoint was the menstrual Traditional Chinese Medicine Syndrome Scale (TCMSS) scores. Secondary endpoints included pictorial blood loss assessment chart (PBAC) scores, clinical efficacy rate, 36-item Short Form Health Survey (SF-36) scores, sex hormones and thickness of endometrium. Adverse events (AEs) were recorded.@*RESULTS@#TCMSS scores after 1- and 3-month treatment in all groups were significantly lower than those at baseline (P<0.05). Only TCMSS scores after 3-month treatment in the ZQ and COM groups continuously decreased compared with those after 1-month treatment in the same group (P<0.01). TCMSS scores after 3-month treatment in the ZQ and COM groups were significantly lower than those in the PG group (P<0.05, P<0.01). Compared with baseline, PBAC scores in the ZQ and COM groups after 3 months of treatment were also significantly higher (both P<0.01). The total effective rates of TCM syndrome of 3-month treatment were significantly improved in all groups compared with that after 1 month of treatment (P<0.05). The total effective rate of the COM group was the highest in the 3rd month of treatment and significantly higher than that of PG group alone (P<0.05). Compared with baseline, only the SF-36 scores of COM group were significantly improved after 3 months of treatment (P<0.05). No serious adverse reactions were observed after treatment.@*CONCLUSIONS@#The combination of ZQ and PG, or ZQ only had better effects on reducing TCMSS scores compared with PG, and COM showed the higher total effective rate compared with monotherapy. Besides, COM could effectively improve menstrual blood loss and quality of life. ZQ combined with PG may be an effective and safe option for oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency.

Treatment outcome of hyperprolactinaemic infertility with carbegoline in sub saharan Africa

Hyperprolactinaemia is a known cause of infertility. We explored the efficacy of carbegoline, the long acting dopamine agonist that was recently introduced into our medical practice. Seventy six patients with infertility secondary to hyperprolactinaemia were studied over a period of 20 weeks each. All the patients had carbegoline twice weekly for eight weeks. Two dosage regimen were used based on the pretreatment prolactin level; less than 50ng/ml had 0.25mg twice weekly [n=58] and 50ng/ml and above 0.5mg twice weekly [n=18]. Normalization of prolactin level was achieved in 75 [98.7%] patients. At the end of the study period, there was resumption of menstrual flow in 10 [76.9%] of the 13 patients that were amenorrhoiec and all the 39 [100%] patients that were oligomenorrhoeic had their normal menstrual cycle restored. Resumption of ovulatory cycles occurred in 87.7% of those with anovulatory cycles. Of the 76 patients, 69 [90.8%] got pregnant during the 20 weeks study. However, out of the 69 that got pregnant, 13 [18.8%] got pregnant while on carbegoline therapy. There was no case of carbegoline resistance or discontinuation recorded in this study. Carbegoline is a cost effective first line therapy in the management of infertile women with hyperprolactinaemia