Therapeutic Effect of Jinzhen Oral Liquid for Hand Foot and Mouth Disease: A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial

Abstract

BackgroundNo specific antiviral agent against hand foot and mouth disease (HFMD) is available for clinical practice today.ObjectiveTo evaluate the efficacy and safety of Jinzhen oral solution in treating uncomplicated HFMD.MethodsIn this randomized, double-blind, placebo-controlled trial, 399 children aged 1 to 7 years with laboratory confirmed HFMD were randomized to receive Jinzhen oral liquid or placebo 3 times daily for 7 days with a 3-day follow-up. The primary outcomes were time to the first disappearance of oral ulcers and vesicles on hand or foot and time to the first normalization of temperature (fever clearance).ResultsThere were 199 children enrolling into the Jinzhen group including 79 with fever and 200 into the placebo group including 93 with fever. Jinzhen reduced the time to the first disappearance of oral ulcers and vesicles on hand or foot to 4.9 days (95% CI, 4.6 to 5.2 days), compared with 5.7 days (95% CI, 5.4 to 6.0 days) in the placebo group (P = 0.0036). The median time of fever clearance was shorter in the 79 children who received Jinzhen (43.41 hrs, 95% CI, 37.05 to 49.76) than that in the 93 children who received placebo (54.92 hrs, 95% CI, 48.16 to 61.68) (P = 0.0161). Moreover, Jinzhen reduced the risk of symptoms by 28.5% compared with placebo (HR, 0.7150, 95% CI, 0.5719 to 0.8940, P = 0.0032). More importantly, treatment failure rate was significantly lower in the Jinzhen group (8.04%) compared with that in the placebo group (15.00%) (P = 0.0434). The incidence of serious adverse events did not differ significantly between the two groups (9 in Jinzhen group vs. 18 in placebo, P = 0.075).ConclusionsChildren with HFMD may benefit from Jinzhen oral liquid treatment as compared with placebo.Trial RegistrationChinese Clinical Trial Registry (http://www.chictr.org/en/) ChiCTR-TRC-10000937

Hand-foot-mouth disease and use of steroids, intravenous immunoglobulin, and traditional Chinese herbs in a tertiary hospital in Shantou, China

“…In fact, Lan-Qin significantly shortened the recovery rate of the mild HFMD cases when given alone or in combination with steroid although it showed no significant effect on severe cases. The efficacies of other TCHs for HFMD have been validated in both basic science and clinical studies [ 19 – 22 ]. Two commonly used herbs— Houttuynia cordata Thunb and Mentha haplocalyx Briq—recommended for HFMD by the China national guidelines have been shown to have significant anti-viral and anti-inflammatory activities: Houttuynia cordata Thunb inhibited EV-71 replication and Mentha haplocalyx Briq suppressed CA16 infection [ 21 ].…”

“…One double-blind comparative study showed that, in combination with the conventional therapy, TCH Jinlianqingre (tablet) shortened the time of both fever clearance and healing in the mild HFMD cases [ 19 ]. Another RCT study showed that TCH Jinzhen (oral liquid) significantly reduced the time of rash disappearance and fever clearance [ 22 ]. However, as described previously [ 20 ], the untoward effects of TCHs, especially when used in combination with other drugs in HFMD management—the information not available from retrospective medical record review—should be investigated prospectively in future research.…”

Efficacy of Scutellaria baicalensis for the Treatment of Hand, Foot, and Mouth Disease Associated with Encephalitis in Patients Infected with EV71: A Multicenter, Retrospective Analysis

“…Some traditional Chinese medications have been reported to exert antiviral effects, including Gan-Lu-Siao-Du-yin [11] and Jinzhen oral liquid [12], which have been assessed for their ability to treat HFMD. However, all of the traditional Chinese medications are oral preparations, and the biological mechanisms underlying their effects on the clinical course of HFMD are unknown.…”

Developing Placebos for Clinical Research in Traditional Chinese Medicine: Assessing Organoleptic Properties of Three Dosage Forms (Oral Liquid, Capsule and Granule)

“…For objective evaluation, some researchers have begun to use intelligent sensory analysis to evaluate placebo quality, including visual sensors, electronic tongue sensors, and other technologies. These are used to assess placebo consistency with the investigational drug in organoleptic properties, and they can transform subjective evaluation reports into objective data to standardize evaluations (Luo, 2012;Jin et al, 2014b;Liu et al, 2014;Fan, 2018).…”