To demonstrate the efficacy of the Therapik device for its intended use, clinical evaluations were conducted in Venezuela, France, Italy and Reunion (Mascarene Islands).

Therapik Clinical Experience in Venezuela (1988-1989)

Patient Population:
In Venezuela, a total of 35 individuals were treated (self-administered therapy) with the Therapik over a 4 month period in 1988-89. Employees of a forest clearing company were invited to carry the Therapik device, and to use it in accordance with the product instructions if stung by a bee, wasp or other insect. This user population was selected for the study because of the relatively high frequency of bee and wasp stings during forest clearing operations. The individual users in this study included both male and female subjects ranging in age from 18 months to 53 years of age. This group included two of the employee’s children (ages 18 months and 6 years) who were treated with the Therapik device.  

Type of Injury Treated:
Thirty-two of the 35 users had received hymenopterous insect stings (thermolabile venom) and the remaining 3 users applied the device to treat mosquito and flea bites (non-thermolabile venom). It was reported that several varieties of insects within the generic categories of “bees” and “wasps” were included, but the users were unable to identify the actual species.  

Number of Stings per Device Use:
Most commonly, the Therapik was used to treat a single sting. In some cases, however, multiple stings were treated including one 30 year old male who incurred a total of 30 wasp stings. Here, the Therapik was used to provide palliative pain relief during transportation to the hospital for further medical treatment. This patient was successfully treated at the hospital with antihistamine injections.  

Elapsed Time Between Sting and Therapik Treatment:
Each study participant was provided with their own device; therefore, the elapsed time between the sting and the treatment was usually quite short (from a “few seconds” to 1 minute). In the one instance in which the device was not applied until 15 minutes after the wasp sting was received, however, the user still rated the device effectiveness as “very good.”  

Duration of Heat Application:
In all cases, the average duration of heat application from the Therapik device ranged from 8 – 18 seconds. The participants in this study counted the duration of heat application from the moment that the actual sensation of heat was initially felt.  

Data Collection Procedure:
Users were asked to record the number and type of stings or bites, the time elapsed between the sting and the Therapik treatment, and the duration of heat application. Users were also asked to rate the efficacy of the device on a scale from 1 (very good) to 4 (no effect), and to detail any side effects.

Summary of Specific Injuries Treated:

The specific breakdown of the injuries treated in the Venezuelan study was as follows:

Bee stings: 6 subjects/12 stings
Mosquito bites: 2 subjects/20 – 25 bites
Wasp stings: 25 subjects/63 stings
Ant stings: 1 subject/2 stings
Flea bites: 1 subject/10 bites

Device Efficacy:
In 33 of 35 cases, the efficacy of the Therapik was rated as “very good.” The remaining ratings consisted of one “good” rating for a total of 10 mosquito bites, and one “moderate” for the individual with 30 wasp stings. With the exception of the man with 30 wasp stings and one 30 year old male with an allergic reaction to a bee sting, no side effects were reported. A detailed summary of the data from this study is presented in Table 1.

Side Effects:
Two users reported side effects in the Venezuelan study.  Patient #3, who had received 30 bee stings, required hospital-administered antihistamine injections to relieve the pain and inflammation resulting from this large number of stings. This patient also reported that he had previously experienced a strong localized reaction to a single bee sting. The patient’s wife applied the Therapik to each sting site while he was being transported to the hospital, and reported that her husband’s pain and “haziness” was improved following the Therapik treatment. Patient #24 also reported that he was an “allergic patient” with respect to bee stings, but did not provide any additional details. Despite his allergic status, this patient rated the device’s effectiveness as “very good.” No users reported pain or burns resulting from the action of the device itself.

Therapik Clinical Experience in France, Italy and Reunion (1988)

Patient Population:
In 1988, a similar 4-month clinical study was conducted at various locations in France, Italy, and in Africa on the Mascarene Island of Reunion. A total of 34 subjects of both sexes ranging in age from 1 to 78 years were included in the study.

Type of Injury Treated:
In addition to insect stings and bites, this study also included stings from various sea animals (weaver fish, jellyfish, and scorpion fish) as well as two incidents involving stinging nettles.  

Number of Stings per Device Use:
In the cases involving insect stings, the Therapik was most commonly used to treat a single sting. Both encounters with stinging nettles resulted in multiple injuries (8 and 10). Both jellyfish encounters resulted in multiple stings; because of the configuration of the animal’s tentacles, it was difficult to accurately determine the number of actual stings. Both users reported the number of jellyfish stings as a range (10 – 15, and 7 – 10). In the case of multiple injuries, all users were instructed to apply the device to the site of each sting.  

Elapsed Time Between Sting and Therapik Treatment:
In this study, the time elapsed between the sting and the initial application of heat from the Therapik device ranged from as little as 10 seconds for a wasp sting to 12 hours for a tick bite. The vast majority of the most painful injuries such as bee or wasp stings and jellyfish stings were treated within a few minutes; the two cases with a prolonged time lapse between injury and treatment were insect bites which may be characterized as more irritating than painful (tick and mosquito bites).

Duration of Heat Application:
In this study, the duration of heat application ranged from 20 seconds to one minute or more. In most cases, the bee and wasp stings were treated with heat application for 60 seconds or less. The sea creature stings required slightly longer heat applications (60 seconds to 2 minutes).  

There was a slight difference in the data recording between the two studies in that the Venezuelans recorded the duration of application as the time for which a sensation of heat was actually felt, while the subjects at all other sites counted the application period as the time during which the power button was actually depressed. The data may be compared by adding approximately 10 seconds to the Venezuelan data.  

Data Collection Procedure:
As in the Venezuelan study, the users were asked to record the number and type of stings or bites, the time elapsed between the sting and the Therapik treatment, and the duration of heat application. Users were also asked to rate the efficacy of the device on a scale from 1 (very good) to 4 (no effect), and to detail any side effects.

Summary of Specific Injuries Treated:  

The specific breakdown of the injuries treated in the France/Italy/Reunion study was as follows:  

Bee stings: 13 subjects/13 stings
Mosquito bites: 3 subjects/11 bites
Wasp stings: 4 subjects/4 stings
Spider bites: 1 subject/1 bite
Hornet stings: 2 subjects/2 stings
Nettle stings: 2 subjects/18 stings
Ant stings: 2 subject/7 stings Tick bites: 1 subject/1 bite

Sea Creatures
Weaver fish stings: 3 subjects/3 stings
Jellyfish stings: 2 subjects w/17 – 25 stings
Scorpion fish stings: 1 subject/1 sting  

Device Efficacy:
In 28 of 34 cases in this study, the efficacy of the Therapik was rated as “very good.” Five users rated the efficacy of the device as “good;” these subjects had received stings from a hornet, a scorpion fish, a weaver fish, a jellyfish and a spider. One subject rated the efficacy as “moderate” for a single bee sting. Two users reported itching following the Therapik treatment, and the spider bite victim reported the presence of a vesicle at the site of the injury. A detailed summary of the data from this study is presented in Table 2.

Side Effects:
In this study, three users reported side effects, all of which were attributed to the injury rather than the use of the device. One user who had been stung by a bee (#28) and one user who had received 10 – 15 jellyfish stings (# 29) reported post-treatment itching. One user who had been bitten by a spider reported the development of a vesicle at the site of the bite. Side effect results were not provided by one user (#3). As in the Venezuelan study, no burns or injuries were reported to have been caused by the Therapik device itself.