Efficacy and Safety of Makabuhay (Tinospora rumphii) 25% Cream Versus Hydrocortisone 1% Cream in the Management of Mosquito Bite Reactions: Randomized Double-Blind Controlled Trial

Abstract

Background: Most insect bite reactions resolve spontaneously, but the inflammation and pruritus induced have been shown to decrease the quality of life. Previous studies have shown the potential anti-inflammatory properties of Tinospora rumphii.

Objective: The aim of the study is to assess the efficacy and safety of T rumphii 25% cream versus hydrocortisone 1% cream in the management of local cutaneous reactions caused by mosquito bites.

Methods: This study was a parallel-group, double-blind, randomized, placebo-controlled trial with a 1-week duration in a span of 3 months (June 2019 to August 2019). Participants were exposed to sterile noninfectious mosquitoes (Aedes aegypti) for 5-10 minutes to elicit cutaneous lesions. Tinospora 25% cream or hydrocortisone 1% cream was applied twice daily throughout the 7-day study period. Of the 70 participants screened for this study, which was approved by an institutional review board (IRB 2019-07) at the Dermatology Outpatient Department of the Research Institute for Tropical Medicine, Alabang, Muntinlupa, Philippines, 58 participants in total met the inclusion criteria and were randomized to treatment (Tinospora: n=29) and active control (hydrocortisone: n=29) groups.

Results: In total, 58 participants were randomized to receive Tinospora cream (n=29) or hydrocortisone cream (n=29). All participants completed the follow-up. There was a significant decrease in lesion size in both groups from the first 15 minutes to day 7 (P<.001). Comparing the lesion size in both groups, there was a statistically significant decrease in lesion size in the first hour (P=.003) and after 24 hours (P=.03). On day 1, 10% (n=29) of participants in the hydrocortisone group and 7% (n=29) in the Tinospora group experienced complete resolution. On day 3, all participants experienced complete resolution. No adverse effects were documented.

Conclusions: Tinospora 25% cream is safe, effective, and comparable to hydrocortisone 1% cream as an anti-inflammatory agent for mosquito bite reactions based on the decrease in lesion size, the proportion of participants with complete resolution of wheals, and improvement in pruritus intensity score using a visual analog scale. Long-term safety studies are recommended.

Trial registration: Philippine Health Research Registry PHRR230716-005932; https://www.herdin.ph/index.php/registry?view=research&layout=details&cid=5932.

Keywords: hydrocortisone; mosquito bite reaction; randomized controlled trial; tinospora.

Figure 1

Cage containing female laboratory-reared Aedes aegypti mosquitoes.

Figure 2

Rubber gloves with an 8 × 3.5 cm opening on the volar aspect.

Figure 3

Mosquitoes feeding on the exposed volar aspect of the arm of participants.

Figure 4

Jars containing either (1) hydrocortisone 1% cream and (2) Tinospora 25% cream.

Figure 5

A 10 mm visual analog scale.

Figure 6

CONSORT 2010 flow diagram. Flow of participants through each stage of the trial (adapted from Schultz et al [26], with permission from Kenneth Schultz). CONSORT: Consolidated Standards of Reporting Trials.

Figure 7

Representative photos showing the effect on lesion sizes treated with Tinospora 25% cream.

Figure 8

Representative photos showing the effect on lesion sizes treated hydrocortisone 1% cream.

Figure 9

Graph showing the comparison of change in the median of all lesion size in mosquito bites treated with hydrocortisone 1% cream and Tinospora 25% cream during the 7-day study period.

Figure 10

Comparison of changes in the median visual analog scores in mosquito bites treated with hydrocortisone 1% cream and Tinospora 25% cream during the 7-day study period.