NICEVIVA
MONOGRAPH SPEC LATEST 2023

Damiana

BOTANICALS · Evidence Monograph

Damiana is an evidence-graded botanicals monograph evaluated across 10 peer-reviewed PubMed studies (1 meta-analyses, 1 systematic reviews, and 1 randomized controlled trials, encompassing n = 377 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 10 Studies
Meta-Analyses · Reviews 1 Meta · 1 Systematic Reviews
Randomized Trials (RCT) 1 RCTs (5 Double-Blind)
Cumulative Participants n = 377
Reported Trial Dosages 400 µg · 5g · 59.5g
Trial Duration Range 4 weeks · 10 days · 45 days
Reading Time ~5 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 10 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (400 µg · 5g · 59.5g) over a structured 4 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (10 PubMed studies)
Quantitative biomarker & outcome analysis (5 studies with effect-size/sample data)
Randomized controlled trial verification (1 RCTs · 5 double-blind)
Systematic review & meta-analysis synthesis (1 meta-analyses · 1 reviews)
01

What Is Damiana & Why Does Form Matter?

Damiana is classified under BOTANICALS and has been investigated across 10 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (400 µg, 5g, 59.5g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Damiana frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (1 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Damiana acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Damiana an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 10 PubMed studies: 1 meta-analyses, 1 systematic reviews, and 1 randomized controlled trials (5 double-blind, n = 377 total participants).

Representative peer-reviewed findings include: • PMID:16159994 (2005) — "Evaluation of herbal dietary supplements marketed on the internet for recreational use." (CONCLUSIONS: This study demonstrates that herbal DS are being marketed for use as legal alternatives to illicit drugs of abuse.) • PMID:37833756 (2023) — "Effect of genotype on individual response to the pharmacological treatment of glaucoma: a systematic review and meta-analysis." (Since one of the main risk factors for the development of POAG is the increase of intraocular pressure (IOP) causing retinal ganglion cells death, the medical treatment of POAG consists in the use of drugs endowed with neuroprotective effect and able to reduce IOP.) • PMID:27832646 (2017) — "The Impact of a Standardized Oral Multinutrient Supplementation on Embryo Quality in in vitro Fertilization/Intracytoplasmic Sperm Injection: A Prospective Randomized Trial." (In conclusion, a multinutrient supplementation that includes folic acid, selenium, vitamin E, catechins, glycyrrhizin, diosgenin, damiana and omega-3-fatty acids seems beneficial in terms of embryo quality.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 400 µg · 5g · 59.5g · 31.9g over 4 weeks · 10 days · 45 days · 12 months. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Damiana, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (400 µg · 5g · 59.5g) and re-evaluate efficacy after 4 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (10 Studies) · 5 Quantitative Analyses

01
CLINICAL STUDY The Annals of pharmacotherapy (2005) PMID: 16159994 ↗
Evaluation of herbal dietary supplements marketed on the internet for recreational use.
Clinical Trial Synthesis 2005 Clinical Study published in The Annals of pharmacotherapy. Key conclusion: CONCLUSIONS: This study demonstrates that herbal DS are being marketed for use as legal alternatives to illicit drugs of abuse.
View Original PubMed Abstract ↓

BACKGROUND: The Internet is a popular tool for marketing and purchasing herbal dietary supplements (DS). Various Web sites sell these products purely for recreational use. OBJECTIVE: To describe the content of Web sites that advertise and market herbal DS for recreational use (ie, for the purpose of altering mood/behavior/or perception, "getting high," or as a substitute for a drug of abuse). METHODS: Four major search engines and the search terms "buy herbal high" and "buy legal high" were used to identify Web sites selling herbal DS for recreational use. Web sites were evaluated for their country of origin and for compliance with the Dietary Supplement Health and Education Act (DSHEA). Products were evaluated for their ingredient lists, effect claims, comparisons with illicit drugs, adverse effects, drug interactions, and contraindications. RESULTS: Twenty-eight unique Web sites with 119 products were evaluated. Most sites were in the US (54%) and were in compliance with DSHEA. Forty-seven percent of the products were likened to illicit drugs, typically marijuana (48%) or 3-,4-methylene dioxyamphetamine (Ecstasy; 23%). The most common product ingredients were ephedra alkaloids (27%), Salvia divinorum (17%), kava (10%), guarana (10%), Acorus calamus (10%), and damiana (10%). Effect claims frequently involved the products' use as a hallucinogen (51%) or stimulant (39%). Sixty-four percent of the sites mentioned adverse effects, and 54% mentioned drug interactions. CONCLUSIONS: This study demonstrates that herbal DS are being marketed for use as legal alternatives to illicit drugs of abuse. Healthcare professionals need to be aware of this trend and the products that are involved.

02
META-ANALYSIS Biology direct (2023) PMID: 37833756 ↗
Effect of genotype on individual response to the pharmacological treatment of glaucoma: a systematic review and meta-analysis.
Clinical Trial Synthesis 2023 Meta-Analysis published in Biology direct. Key conclusion: Since one of the main risk factors for the development of POAG is the increase of intraocular pressure (IOP) causing retinal ganglion cells death, the medical treatment of POAG consists in the use of drugs endowed with neuroprotective effect and able to reduce IOP.
View Original PubMed Abstract ↓

The social impact of glaucoma is worth of note: primary open-angle glaucoma (POAG) is one of the leading causes of irreversible blindness worldwide, affecting some 68.56 million people with overall prevalence of 2.4%. Since one of the main risk factors for the development of POAG is the increase of intraocular pressure (IOP) causing retinal ganglion cells death, the medical treatment of POAG consists in the use of drugs endowed with neuroprotective effect and able to reduce IOP. These drugs include beta-blockers, prostaglandin analogues, carbonic anhydrase inhibitors, alpha or cholinergic agonists and rho kinase inhibitors. However, not all the patients respond to the same extent to the therapy in terms of efficacy and safety. Genetics and genome wide association studies have highlighted the occurrence of mutations and polymorphisms influencing the predisposition to develop POAG and its phenotype, as well as affecting the response to pharmacological treatment. The present systematic review and meta-analysis aims at identifying genetic variants and at verifying whether these can influence the responsiveness of patients to therapy for efficacy and safety. It follows the most updated Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020 recommendations. The literature search was conducted consulting the most relevant scientific databases, i.e. PubMed/MEDLINE, Scopus, Web of Science and Public Health Genomics and Precision Health Knowledge Base up to June 14th, 2023. The search retrieved 1026 total records, among which eight met the eligibility criteria for inclusion in the analysis. The results demonstrated that the most investigated pharmacogenetic associations concern latanoprost and timolol, and that efficacy was studied more in depth than safety. Moreover, the heterogeneity of design and paucity of studies prompt further investigation in randomized clinical trials. In fact, adequately powered and designed pharmacogenetic association studies are needed to provide body of evidence with good certainty for a more appropriate use of medical therapy in POAG.PROSPERO registration: CRD42023434867. © 2023. BioMed Central Ltd., part of Springer Nature.

03
RANDOMIZED TRIAL (RCT) Gynecologic and obstetric investigation (2017) PMID: 27832646 ↗
The Impact of a Standardized Oral Multinutrient Supplementation on Embryo Quality in in vitro Fertilization/Intracytoplasmic Sperm Injection: A Prospective Randomized Trial.
Clinical Trial Synthesis 2017 Randomized Controlled Trial (RCT) published in Gynecologic and obstetric investigation involving n = 50 participants; statistical significance reported at p = 0.045 (RR 1.611). Key conclusion: In conclusion, a multinutrient supplementation that includes folic acid, selenium, vitamin E, catechins, glycyrrhizin, diosgenin, damiana and omega-3-fatty acids seems beneficial in terms of embryo quality.
View Original PubMed Abstract ↓

The role of micronutrients in fertility has recently gained increased attention. We aimed to test the impact of a standardized, multinutrient supplementation on outcomes after in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) in a pilot study. One hundred women undergoing IVF/ICSI were prospectively included and randomized to receive either a multinutrient supplementation named PROfertil® female that included folic acid, selenium, vitamin E, catechins, glycyrrhizin, diosgenin, damiana and omega-3-fatty acids (study group; n = 50), or 400 µg folic acid (control group; n = 50). Outcome parameters were embryo quality on day 3 after oocyte retrieval (good quality vs. poor quality) and the clinical pregnancy rate. In an intention-to-treat analyses, a higher rate of women with at least one good quality embryo (with at least 6 cells and a fragmentation rate <20%) were found for the study (29/50, 58.0%) compared to the control group (18/50, 36.0%; p = 0.045 in chi-square test; relative risk 1.611, 95% CI 1.009-2.597). In conclusion, a multinutrient supplementation that includes folic acid, selenium, vitamin E, catechins, glycyrrhizin, diosgenin, damiana and omega-3-fatty acids seems beneficial in terms of embryo quality. © 2016 S. Karger AG, Basel.

04
CLINICAL STUDY Journal of sex & marital therapy (2006) PMID: 16959660 ↗
The enhancement of female sexual function with ArginMax, a nutritional supplement, among women differing in menopausal status.
Clinical Trial Synthesis 2006 Randomized Controlled Trial (RCT) published in Journal of sex & marital therapy involving n = 108 participants; statistical significance reported at p = 0.03. Key conclusion: Level of desire was shown to increase significantly in POST women.
View Original PubMed Abstract ↓

We conducted a double-blind, placebo-controlled study to determine the role of dietary supplementation on sexual function in women of differing menopausal status. One hundred eight (108) women, age 22-73 years, who reported a lack of sexual desire, enrolled as participants. Of these, 55 received ArginMax for women and 53 received placebo. ArginMax for women contains L-arginine, ginseng, ginkgo, damiana, multivitamins, and minerals. The 108 women, given definitions, self-reported as 59 premenopausal (PRE); 20 perimenopausal (PERI), and 29 postmenopausal (POST). After 4 weeks, PRE women on ArginMax primarily reported significant improvement in level of sexual desire (72%; p = 0.03) and satisfaction with overall sex life (68%; p = 0.007), compared with placebo group, according to the Female Sexual Function Index (FSFI; Kaplan et al., 1999) scales. Frequency of sexual desire (60%; p = 0.05) and frequency of intercourse (56% p = 0.01) also increased among the PRE women. In contrast, among PERI women, primary improvements were reported for frequency of intercourse (86%; p = 0.002), satisfaction with sexual relationship (79%; p = 0.03), and vaginal dryness (64%; p = 0.03) compared with placebo group. POST women primarily showed an increased in level of sexual desire, with 51% showing improvement, compared with only 8% in the placebo group (p = 0.008). Nutritional intervention plays an important role in women's sexual health, but issues and areas of greatest improvement differ among women of different menopausal states. The largest number of attribute improvements were seen in PRE and PERI women, although attribute types vary among these groups. Level of desire was shown to increase significantly in POST women. Since ArginMax for women has been shown to exhibit no estrogen activity, it may be desirable alternative to hormone therapy for sexual concerns.

05
CLINICAL STUDY Journal of sex & marital therapy (2001) PMID: 11554217 ↗
A double-blind placebo-controlled study of ArginMax, a nutritional supplement for enhancement of female sexual function.
Clinical Trial Synthesis 2001 Randomized Controlled Trial (RCT) published in Journal of sex & marital therapy involving n = 77 participants; statistical significance reported at p = 0.01. Key conclusion: No significant side effects were noted.
View Original PubMed Abstract ↓

This study was open to women over the age of 21 years with an interest in improving their sexual function. Of the 77 participants, 34 received ArginMax and 43 received a placebo. ArginMax for Women is a proprietary nutritional supplement consisting of extracts of ginseng, ginkgo, and damiana, L-arginine, multivitamins, and minerals. After 4 weeks, 73.5% of the ArginMax group improved in satisfaction with their overall sex life, compared with 37.2% of the placebo group (p < 0.01). Notable improvements were also observed in sexual desire, reduction of vaginal dryness, frequency of sexual intercourse and orgasm, and clitoral sensation. No significant side effects were noted.

06
SYSTEMATIC REVIEW Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie (2022) PMID: 34891121 ↗
Is there a rational basis for cannabinoids research and development in ocular pain therapy? A systematic review of preclinical evidence.
Clinical Trial Synthesis 2022 Meta-Analysis published in Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. Key conclusion: CONCLUSIONS: The role of the endocannabinoid system in ocular pain is underinvestigated, since only two studies assessing the effects of cannabinoid receptors modulators on pain behavior and other two on pain-related inflammatory processes are found.
View Original PubMed Abstract ↓

BACKGROUND: Purpose of the present systematic review is to investigate preclinical evidence in favor of the working hypothesis of efficacy of cannabinoids in ocular pain treatment. METHODS: Literature search includes the most relevant repositories for medical scientific literature from inception until November, 24 2021. Data collection and selection of retrieved records adhere to PRISMA criteria. RESULTS: In agreement with a priori established protocol the search retrieved 2471 records leaving 479 results after duplicates removal. Eleven records result from title and abstract screening to meet the inclusion criteria; only 4 results are eligible for inclusion in the qualitative synthesis impeding meta-analysis. The qualitative analysis highlights the antinociceptive and anti-inflammatory efficacy of Δ8-tetrahydrocannabinol, cannabidiol and its derivative HU-308 and of new racemic CB1 allosteric ligand GAT211 and its enantiomers GAT228 and GAT229. Moreover, CB2R agonists RO6871304 and RO6871085 and CB2R ligand HU910 provide evidence of anti-inflammatory efficacy. CB2 agonist HU308 reduces of 241% uveitis-induced leukocyte adhesion and changes lipidome profile. Methodological and design issues raise concern of risk of bias and the amount of studies is too small for generalization. Furthermore, the ocular pain model used can resemble only inflammatory but not neuropathic pain. CONCLUSIONS: The role of the endocannabinoid system in ocular pain is underinvestigated, since only two studies assessing the effects of cannabinoid receptors modulators on pain behavior and other two on pain-related inflammatory processes are found. Preclinical studies investigating the efficacy of cannabinoids in ocular inflammatory and neuropathic pain models are needed to pave the way for clinical translation.

07
CLINICAL STUDY Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie (2022) PMID: 36076584 ↗
NAbiximols Clinical Translation To the treatment of Pain and Agitation In Severe Dementia (NACTOPAISD): Clinical trial protocol.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. Key conclusion: It is approved by Calabria Region Ethics Committee and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and the Consolidated Standards of Reporting Trials (CONSORT) statements.
View Original PubMed Abstract ↓

Up to 80 % nursing home residents with dementia experiences chronic pain. Contextually, 97 % presents fluctuant neuropsychiatric symptoms (NPS). Among the most challenging is agitation, connected with undertreated pain and managed through neuroleptics doubling death risk. Evidence is accumulating in favor of the involvement of the endocannabinoid system in nociception and NPS. This double-blind, placebo-controlled, randomized trial (NAbiximols Clinical Translation To the treatment of Pain and Agitation In Severe Dementia [NACTOPAISD]) aims at investigating efficacy and safety of oral spray nabiximols, containing Δ9-tetrahydrocannabinol and cannabidiol (Sativex®), for pain and agitation treatment in severe dementia patients (Mini-Mental State Examination ≤ 12) over 65. The coprimary endpoints are efficacy on pain and agitation, assessed through the recently validated Italian Mobilization-Observation-Behavior-Intensity-Dementia and the Cohen-Mansfield Agitation Inventory. The secondary endpoint is the evaluation of efficacy duration after wash-out and the assessment of quality of life through the DEMQOL. Any adverse events will be reported. The results undergo statistical analysis plan. NACTOPAISD might provide rationale for a translational safer pain and agitation treatment in severe dementia. It is approved by Calabria Region Ethics Committee and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and the Consolidated Standards of Reporting Trials (CONSORT) statements.

08
CLINICAL STUDY Appetite (2013) PMID: 23207186 ↗
Acute effects of a herb extract formulation and inulin fibre on appetite, energy intake and food choice.
Clinical Trial Synthesis 2013 Clinical Study published in Appetite. Key conclusion: Significant reductions in AUC hunger and AUC desire to eat were also observed after YGD+SFF combination.
View Original PubMed Abstract ↓

The impact of two commercially available products, a patented herb extract Yerbe Maté, Guarana and Damiana (YGD) formulation and an inulin-based soluble fermentable fibre (SFF), alone or in combination, on appetite and food intake were studied for the first time in a double blind, placebo-controlled, cross-over design. 58 normal to slightly overweight women consumed a fixed-load breakfast followed 4h later by an ad libitum lunch. They were administered YGD (3 tablets) and SFF (5g in 100ml water), YGD and water (100ml), SFF and placebo (3 tablets) or water and placebo 15min before meals. Appetite was assessed using visual analogue scales, and energy intake was measured at lunch. Significant reductions in food intake and energy intake were observed when YGD was present (59.5g, 16.3%; 112.4kcal, 17.3%) and when SFF was present (31.9g, 9.1%; 80kcal, 11.7%) compared with conditions were products were absent. The lowest intake (gram and kcal) was in the YGD+SFF condition. Significant reductions in AUC hunger and AUC desire to eat were also observed after YGD+SFF combination. The data demonstrate that YGD produces a robust short-term effect on caloric intake, an effect augmented by SFF. Caloric compensation for SFF indicates independent effects on appetite regulation.

09
CLINICAL STUDY Forschende Komplementarmedizin (2006) (2011) PMID: 22105039 ↗
Effectiveness of a herbal formula in women with menopausal syndrome.
Clinical Trial Synthesis 2011 Randomized Controlled Trial (RCT) published in Forschende Komplementarmedizin (2006) involving n = 120 participants; statistical significance reported at p = 0.001. Key conclusion: CONCLUSION: Lady 4 may be beneficial in the treatment of menopausal syndrome and can be used as a safe natural promoter of health and well-being in women during the menopausal transition.
View Original PubMed Abstract ↓

BACKGROUND: Lady 4 is a combination of 4 natural components (evening primrose oil, damiana, ginseng, royal jelly) with a known history of traditional use for menopausal symptoms. OBJECTIVE: To study efficacy and safety of Lady 4 in women suffering from menopausal syndrome. METHODS: 120 women with menopausal symptoms were randomised into an experimental group treated with 2 capsules of Lady 4 daily and a control group treated with placebo. The outcome was measured by the Menopause Rating Scale II (MRS-II). RESULTS: There was a statistically significant improvement in the MRS-II score in both groups after 2 and 4 weeks of treatment, but the improvement was significantly better in the Lady 4 group (p < 0.001). 86.7% in the Lady 4 group and 56.7% in the placebo group rated the therapy success as 'much improved' or 'very much improved'. CONCLUSION: Lady 4 may be beneficial in the treatment of menopausal syndrome and can be used as a safe natural promoter of health and well-being in women during the menopausal transition.

10
CLINICAL STUDY Journal of human nutrition and dietetics (2001) PMID: 11424516 ↗
Weight loss and delayed gastric emptying following a South American herbal preparation in overweight patients.
Clinical Trial Synthesis 2001 Randomized Controlled Trial (RCT) published in Journal of human nutrition and dietetics involving n = 22 participants; statistical significance reported at p = 0.025. Key conclusion: Body weight reductions were 0.8 +/- 0.05 kg after YGD capsules compared to 0.3 +/- 0.03 kg after placebo capsules over 10 days, and 5.1 +/- 0.5 kg after PGD capsules compared to 0.3 +/- 0.08 kg after placebo over 45 days.
View Original PubMed Abstract ↓

BACKGROUND: Obesity and overweight may soon affect more than half of the population in some regions of the world and are associated with diabetes, hypertension and other diseases that cause morbidity, mortality and high health-care expenditure. No one approach, whether dietetic management, medication, or commercial weight loss programme, can alone solve the problem--all potential treatments need to be investigated and exploited. Among the herbal preparations known to non-western cultures are materials which may have applications in modulating physiological processes which influence gut motility, food intake and energy balance. One such mixed herbal preparation is 'YGD' containing Yerbe Maté (leaves of Ilex paraguayenis), Guarana (seeds of Paullinia cupana) and Damiana (leaves of Turnera diffusa var. aphrodisiaca). AIMS: This study had two distinct aims: to determine the effect of a herbal preparation 'YGD' containing Yerbe Maté, Guarana and Damiana on gastric emptying; to determine the effect of the same preparation on weight loss over 10 days and 45 days and weight maintenance over 12 months. METHODS: Gastric emptying was observed using ultrasound scanning in seven healthy volunteers following YGD and placebo capsules taken with 420 mL apple juice. Body weight was observed before and after 10 days of treatment with three YGD capsules or three placebo capsules before each meal for 10 days in 44 healthy overweight patients attending a primary health care centre. Forty-seven healthy overweight patients entered a double-blind placebo-controlled parallel trial of three capsules of YGD capsules before each main meal for 45 days compared with three placebo capsules on body weight. Body weight was monitored in 22 patients who continued active (YGD capsules) treatment for 12 months. RESULTS: The herb preparation YGD was followed by a prolonged gastric emptying time of 58 +/- 15 min compared to 38 +/- 7.6 min after placebo (P = 0.025). Body weight reductions were 0.8 +/- 0.05 kg after YGD capsules compared to 0.3 +/- 0.03 kg after placebo capsules over 10 days, and 5.1 +/- 0.5 kg after PGD capsules compared to 0.3 +/- 0.08 kg after placebo over 45 days. Active treatment

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