Objective:

2

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:

2

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:

2

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:

2

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.