An Evaluation of Proglucamune in the Treatment of Protective Qi Insufficiency
Condition: Protective Qi Insufficiency
Study type: Interventional

Summary: 
      According to Traditional Chinese Medicine (TCM) principle, Protective Qi (PQi) is a one
      specific concept of Qi that provides the vital energy of the body. It works primarily on the
      body surface as a defensive barrier. In this context, PQi is analogous to anatomical barriers
      of the innate immune system located for example, at the skin surface and the mucosal surfaces
      of the respiratory and digestive tract. Individuals with PQi Insufficiency are predisposed to
      frequent cold and other symptoms caused by invasion of external pathogens ("Wai Xie" or
      "external evil" in TCM).

      ß-glucan is a polysaccharide that activates macrophage (Dectin-1) and neutrophil (CR3)
      receptors, and therefore enhances immune defense at digestive and respiratory mucosa.
      Clinical trials have shown its immune activity such as preventing upper respiratory tract
      infection (URTI) and Traveler's diarrhea. Notably, ß-glucan is a component of Ganoderma
      Luciderm (or Reishi / Lingzhi), one TCM ingredient well-known for improving Qi. Based on this
      connection, investigators hypothesized that ß-glucan is the active ingredient in Reishi that
      at least partially accounts for Reishi's activity on Qi.

      To test our hypothesis, investigators have conducted an uncontrolled pilot trial that
      investigated the effect of a commercially available, high ß-glucan containing product,
      Proglucamune®, on PQi status. Proglucamune contains ß-glucan from three different natural
      sources: Reishi mushroom, Shiitaki mushroom, and Bakers' yeast, each providing ß-glucan that
      differs slightly in their molecular structure. Through this pilot investigators sought to
      obtain an estimate of the effect size of Proglucamune on PQi that would allow us, via
      statistical methods, to estimate the necessary sample size for more definitive future trials.
    

Detailed description: 
      Unlike mainstream Western medicine (WM), alternative medicines (AM) such as Traditional
      Chinese Medicine (TCM), emphasizes individually-differentiated therapies. As such, AM
      therapies are normally not tested in clinical studies that statistically demonstrate the
      efficacy at the populational level for applicable patients, and this makes it difficult to
      objectively evaluate and compare different therapies. The lack of clinical studies stands as
      a barrier for the advance of AMs as well as their engagement with WM. In fact, most
      researchers view AMs primarily as untapped sources of "active ingredients/compounds" for drug
      development, but disregard the rationales under which the therapies were developed. A
      "One-Way-Traffic" research paradigm is thus created wherein AM therapies are investigated for
      their efficacy by WM standards, whereas the vast potential of employing WM therapies for AM
      therapeutics is ignored. In light of this, investigators set up a novel strategy that bridges
      TCM and WM, i.e., testing a WM-based therapy by TCM standards through clinical
      trial/statistics- based method.

      Qi is a central concept of traditional Chinese medicine (TCM) and was first documented in the
      oldest TCM writings more than 2000 years ago. Generally speaking, Qi refers to the vital
      energy of the body and is derived from two primary sources: 1) inborn Qi (that may be
      construed as genetics), and 2) pectoral Qi (can be construed as metabolism). Moreover, Qi
      manifests itself in two forms: Nutritive Qi and Protective Qi, which can be understood to
      reflect an individual's nutritional state and immune health, respectively. Regarding the
      latter, protective Qi functions to defend the body from the invasion of external pathogens.
      TCM also emphasizes that Protective Qi works primarily on the body surface as a defensive
      barrier. In this context, Protective Qi is analogous to anatomical barriers of the innate
      immune system located for example, at the skin surface and the mucosal surfaces of the
      respiratory and digestive tract.

      TCM has developed a number of methods to strengthen the Qi. Prominent among these is the use
      of Reishi, either alone or in combination with other TCM remedies. The use of Reishi was
      described in detail in the first TCM pharmacopeia "Compendium of Materia Medica" published in
      year 1,600. Nonetheless, although Protective Qi is part of the general Qi, the specific
      effect of Reishi on Protective Qi is less documented. Anecdotal reports are available that
      claim significant improvement of Protective Qi with Reishi or Reishi-containing formulas
      within days. Notably, Western medicine has identified immune-boosting properties of Reishi,
      which may explain the Qi enhancing effects of this plant. Specifically, beta-glucan - a
      component of Reishi - has been shown to activate macrophage (large white blood cells in the
      immune system that destroy bacteria and other harmful substances), neutrophil (type of white
      blood cells that are important for protection against infections), and other immunocytes (a
      type of cells capable of producing an immune response), and may exhibit particular benefits
      among macrophage-rich organs such as the lung, liver and spleen. In fact, ß-glucans from
      sources other than Reishi, such as baker's yeast, are able to initiate the same immune
      response and clinical benefits.

      The overlap of TCM and western medicine concerning the beneficial effects of Reishi for its
      Qi enhancing and immune-modulating effects, respectively, has prompted us to investigate
      whether or not Reishi, in conjunction with other natural products used in TCM, can enhance an
      individual's Protective Qi. More specifically, the objective of the current protocol is to
      determine if a commercially available dietary supplement (Proglucamune®, USANA Health
      Sciences) containing powdered Reishi and Shitake mushrooms as well as baker's yeast extract,
      and which is comprised of 11% ß-glucans by weight, will improve Protective Qi in subjects
      diagnosed by practitioners of TCM as having low or insufficient Protective Qi. Specifically,
      in this a pilot study, investigators sought to obtain an estimate of the effect size of
      Proglucamune on PQi that would allow us, via statistical methods, to estimate the necessary
      sample size for more definitive future trials. The trial also aimed to provide information on
      individuals who are responsive to Proglucamune treatment (responder), and subsequently
      recruit targeted individuals for the follow-up trials.
    

Intervention name(s): Proglucamune
Intervention type(s): Dietary Supplement
Intervention description(s): Following screening and enrollment, participants were treated with 2 tablets of Proglucamune per day for a total duration of 8 weeks. Each Proglucamune tablet contained ~100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes).
Intervention model: Single Group Assignment
Intervention model description: Subjects with Protective Qi Insufficiency
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Protective Qi; Immunity