Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy : A Randomized, Controlled, 2 × 2 Factorial Trial.

BACKGROUND: An effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking. OBJECTIVE: To assess the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in women with moderate to severe NVP. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. (ClinicalTrials.gov: NCT04401384). SETTING: 13 tertiary hospitals in mainland China from 21 June 2020 to 2 February 2022. PARTICIPANTS: 352 women in early pregnancy with moderate to severe NVP. INTERVENTION: Participants received daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days. MEASUREMENTS: The primary outcome was the reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at the end of the intervention at day 15 relative to baseline. Secondary outcomes included quality of life, adverse events, and maternal and perinatal complications. RESULTS: No significant interaction was detected between the interventions (P = 0.69). Participants receiving acupuncture (mean difference [MD], -0.7 [95% CI, -1.3 to -0.1]), doxylamine-pyridoxine (MD, -1.0 [CI, -1.6 to -0.4]), and the combination of both (MD, -1.6 [CI, -2.2 to -0.9]) had a larger reduction in PUQE score over the treatment course than their respective control groups (sham acupuncture, placebo, and sham acupuncture plus placebo). Compared with placebo, a higher risk for births with children who were small for gestational age was observed with doxylamine-pyridoxine (odds ratio, 3.8 [CI, 1.0 to 14.1]). LIMITATION: The placebo effects of the interventions and natural regression of the disease were not evaluated. CONCLUSION: Both acupuncture and doxylamine-pyridoxine alone are efficacious for moderate and severe NVP. However, the clinical importance of this effect is uncertain because of its modest magnitude. The combination of acupuncture and doxylamine-pyridoxine may yield a potentially larger benefit than each treatment alone. PRIMARY FUNDING SOURCE: The National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team.

[A preliminary study of serum free testosterone and testosterone secreting index in men with erectile dysfunction].

OBJECTIVE: To observe the changes of serum free testosterone (FT) and testosterone secreting index (TSI) in ED patients, and to assess the contribution of these two indexes to the diagnosis of ED caused by endocrine factors. METHODS: We studied 120 ED patients and 30 healthy men undergoing pre-marital medical check-up in Jiangsu Province Hospital of TCM by analyzing the scores on erectile function and desire domain in IIEF, testing the serum total testosterone, luteinizing hormone by chemiluminescent enzyme immunoassay (CLIA), measuring free testosterone by radioimmunoassay( RIA), and calculating TSI. RESULTS: Of the 120 ED patients, 5% and 1538% were below the reference norm of TT and FT values respectively. TT, FT and TSI decreased with age, with statistical with FT and TSI, but not with TT. FT and TSI statistically declined with lower IIEF score on ED domain, but this was not the case with TT. There were no significant differences in TI, FT and TSI among different sexual desire groups the ED patients. CONCLUSION: FT is much more valuable than TF in the diagnosis of ED with hypogonadism. Both FT and TSI are important parameters in assessing the severity of ED.