A Follow-up Trial of Proglucamune® in the Treatment of Protective Qi Deficiency, a TCM Condition
Condition: Protective Qi Insufficiency (a Condition Term From TCM)
MeSH terms: Disease
Study type: Interventional

Summary: 
      This is a follow-up Phase II study of a previously complete pilot trial (Protocol ID: 201875)
      with the same goal: evaluating the activity of Proglucamune on Protective Qi (PQi)
      Insufficiency.

      According to Traditional Chinese Medicine (TCM) principle, Protective Qi 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, 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. 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
      Lucidum (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. The data obtained demonstrated a statistically
      significant effect of Proglucamune on improving PQi in individuals with PQi Insufficiency.
      The current study is aimed to further determine this effect in a more stringent
      (placebo-controlled, randomized, and triple-blinded) way.
    

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 in 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 (PQi), 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 pharmacopedia "Compendium of Materia Medica" published
      in year 1,600. Nonetheless, although PQi 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, WM 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 (a type of white blood cells that are
      important for protection against infections), and other immunocytes (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. A previous Pilot trial has been conducted that aimed 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, would improve Protective Qi in subjects diagnosed by
      practitioners of TCM as having low or insufficient Protective Qi. The data obtained
      demonstrated a statistically significant effect of Proglucamune on improving PQi. Based on
      the effect size and variability, investigators have arrived, via statistical methods, at the
      necessary sample size for a more definitive (placebo-controlled, randomized, and
      triple-blinded) trial.
    

Intervention name(s): beta glucan
Intervention type(s): Dietary Supplement
Intervention description(s): Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Individuals with Protective Qi Insufficiency
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Protective Qi; Immunity