Vitamin D analogs combined with different types of phototherapy in the treatment of vitiligo: A systematic review of randomized trials and within-patient studies.

OBJECTIVES: This systematic review was to assess the effects of phototherapies (psoralen plus ultraviolet A [PUVA], narrowband ultraviolet B [NBUVB], or 308 nm excimer laser [EL]) in combination with vitamin D analogs compared with phototherapy alone on vitiligo. METHODS: Four databases were searched up to 18 October 2021 for relevant studies. The primary outcome was the proportion of response to treatment (≥50% repigmentation) after treatment. Secondary outcomes included excellent response, treatment failure, and safety. The risk ratio (RR) was used as the estimate measure in meta-analyses. RESULTS: Fourteen studies (n = 642) were included. The meta-analyses showed that the combination of either calcipotriol or tacalcitol and NBUVB was superior to NBUVB monotherapy for vitiligo in the proportion of response to treatment (RR 1.67, 95% CI 1.21-2.31), treatment failure (RR 0.43, 95% CI 0.22-0.85), and excellent response (RR 7.48, 95% CI 1.09-51.13). The tacalcitol was more effective than calcipotriol in increasing the rate of response to treatment when combined with NBUVB (RR 2.25 versus 1.24, interaction p = 0.002). The results did not support better efficacy with the combination of PUVA or EL with vitamin D analogs over phototherapy alone in all outcomes. Adverse events were minor and transient. CONCLUSIONS: The current evidence suggests that the additional use of topical calcipotriol or tacalcitol to NB-UVB may increase the treatment effect of vitiligo, and the effect of tacalcitol is greater than that of calcipotriol. None of the vitamin D analogs were found to enhance the efficacy of PUVA or EL for vitiligo.

Community-based heat-sensitive moxibustion for primary hypertension: study protocol for a randomized controlled trial with patient-preference arms.

BACKGROUND: Low- and middle-income countries have a high prevalence of primary hypertension, but its treatment and control are often low. Heat-sensitive moxibustion (HSM), an innovative acupoint stimulation technique, may be effective for treating hypertension and thus used appropriately in primary healthcare. The objective of this study is to investigate whether HSM is effective and safe for the treatment of primary hypertension in the community. METHODS: This study is a multicenter, pragmatic, randomized controlled trial (RCT) with patient-preference arms. Four hundred patients with primary hypertension from seven communities will be enrolled. Initially, the communities will be randomly assigned into two study clusters, one using compulsory randomization and the other allowing treatment selection by patient preferences. Then, patients in the compulsory randomization cluster will be randomized to receive HSM plus their original antihypertensive regimen (HSM group) or only their original antihypertensive regimen (control group) for 6 months. Patients in the patient preference cluster may choose to receive HSM or control if they have a preference; otherwise, patients will be randomly assigned. The primary outcome is the change in systolic blood pressure from baseline; secondary outcomes include change in diastolic blood pressure, dosage of antihypertensive drugs, quality of life (QoL), severity of hypertensive symptoms, and incidence of cardiovascular events. Patient compliance with the HSM regimen, the cost-effectiveness ratio, and safety outcomes will also be evaluated. Outcome data will be collected at 6 monthly visits. DISCUSSION: This trial will provide important evidence regarding HSM as a technique for primary hypertension in primary healthcare settings. Given the randomization with patient preferences considered, the trial will also allow analyzing patient-preference effects and the comparison of randomized and nonrandomized samples, to improve the robustness and extrapolation of study conclusions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04788563 . Registered on March 9, 2021.