To demonstrate the effectiveness of Therapik® for its intended use, clinical evaluations were conducted in Venezuela, France, Italy and Reunion (Mascarene Islands). In Venezuela, a total of thirty-five individuals were treated over a four month period in 1988-89. Thirty-two of the thirty-five users has received hymenopterous insect stings and the remaining three users were using the device to treat mosquito and flea bites. Most commonly, Therapik® was used to treat a single sting. In some cases, however, multiple stings were treated including a thirty year old male who incurred a total of thirty wasp stings. Here, the Therapik® was used to provide palliative pain relief during transportation to the hospital for further medical treatment. The specific breakdown of the injuries treated in the Venezuelan study is as follows:

Hymenopterous Insects

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

The individual users in this study included both male and female subjects ranging in age from eighteen months to fifty-three years. 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.

In thirty-three of the thirty-five cases, the effectiveness of Therapik® was rated as “very good”. The remaining ratings consisted of a “good” rating for a total of ten mosquito bites, and a “moderate” rating for the individual with thirty wasp stings. With the exception of the man with thirty wasp stings and one thirty year old male with an allergic reaction to a bee sting, no side effects were reported. A detailed summary of this study is presented in a table included with this document.

In 1988, a similar four month clinical study was conducted at various locations in France, Italy and in Africa on the Mascarene Island of Reunion. In addition to insect stings and bites, this study also included stings from various sea animals. A total of thirty-four subjects of both sexes ranging in age from one year to seventy-eight years of age were included in the study. The specific treatment breakdown is as follows:

Hymenopterous Insects

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 bites: 2 subjects/18 stings
Ant stings: 2 subjects/7 stings Tick bites: 1 subject/1 bite

Sea Creatures

Weaver fish stings: 3 subjects/3 stings
Jellyfish stings: 2 subjects/17 – 25 stings
Scorpion fish stings: 1 subject/1 sting
As in 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.

In twenty-eight of the thirty-four cases in this study, the efficacy of 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 this study is presented in a table included with this document.

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 adjusted by adding approximately ten seconds to the Venezuelan data.

We wish to stress that none of the users reported a burn or other skin injury resulting from the use of Therapik®. In fact, no device-related side effects at all were noted. It is believed that the data collected during these clinical trials effectively documents the device’s utility and efficacy for the treatment of pain and discomfort resulting from a variety of insect and sea animal stings. In addition, the device appears to provide relief from the itching and discomfort of other non-venomous insect bites.