Efficacy and safety of mirogabalin treatment in patients with diabetic peripheral neuropathic pain: A systematic review and meta-analysis of randomised controlled trials.

AIM: We aimed to perform a systematic review and meta-analysis to examine the efficacy and safety of mirogabalin in patients with diabetic peripheral neuropathic pain (DPNP). METHODS: We searched four databases from inception to 1st July 2020. We included all randomised controlled trials (RCTs) which assessed the effectiveness and safety of mirogabalin in patients with DPNP. We evaluated the quality of the included RCTs using the Cochrane risk of bias assessment tool. We pooled dichotomous outcomes as risk ratios and continuous outcomes as mean differences with 95% confidence intervals, both under the random- or fixed-effects model. RESULTS: Three RCTs matched our inclusion criteria with a total of 1732 patients with DPNP: 1057, 534 and 141 patients received mirogabalin, placebo and pregabalin, respectively. The quality of included RCTs was marked as moderate-to-high. Mirogabalin treatment was significantly associated with a significant reduction in the average daily pain score (ADPS) compared with placebo over 7 weeks. Compared with pregabalin, mirogabalin was significantly associated with more decrease in ADPS only after 3, 4 and 5 weeks. The proportion of patients with ≥30% and ≥50% reduction in the ADPS was significantly higher in the mirogabalin vs placebo and pregabalin groups. Compared with placebo, mirogabalin was significantly associated with more adverse events of dizziness, increased weight, peripheral oedema and somnolence. The safety profile was comparable between mirogabalin and pregabalin. CONCLUSIONS: Our systematic review and meta-analysis revealed that in patients with DPNP, mirogabalin treatment was superior to placebo and pregabalin in decreasing the ADPS over time. Besides, mirogabalin was largely safe and associated with some adverse events that could be managed conservatively.

Prevalence of subclinical hypothyroidism in pregnancy in Saudi Arabia.

OBJECTIVES: To estimate the prevalence of subclinical hypothyroidism (SCH) in Saudi Arabia and assess the need for an SCH screening program. Methods: This cross-sectional study was conducted at King Abdulaziz Medical City and the Khashmulaan Clinic at the National Guard Health Affairs, Riyadh, Saudi Arabia in August 2016. All women attending the antenatal clinics were  invited to participate in the study. In addition, data were retrieved from the files of pregnant women who had been screened for hypothyroidism from January 2016 to August 2016. A total of 384 pregnant women were included in the study. Results: The prevalence of SCH in pregnant women in this study was 50/384 (13%) with 95% confidence intervals (CIs): 9.82%-16.80%. Pregnant women who were randomly screened using a survey (n=127) were 3 times more likely (OR: 3.1; 95% CI:  1.182 to 8.704, p=0.022) to have SCH compared to pregnant women who were screened based on their physician's judgement (n=257). Results showed older age (≥40 years) was associated with an insignificant decrease in the risk of SCH. Conclusion: Random screening for SCH in pregnant women showed a higher prevalence in comparison to women who were screened as a result of physician referrals. The results highlight the urgent need for larger studies to investigate the prevalence of SCH as well as the need for an SCH screening program.