Clinical Studies: Botanical Combination Therapy
Certain botanicals used in combination have proven to be effective in treating dysglycemia. In this trial, jambul, nopal, globe artichoke, milk thistle, and devil’s club were combined.
Methods: Starting in September 1998, we tested a herbal formula on 20 patients suffering from dysglycemia. The encapsulated formula contained the herbs jambul, devil’s club, milk thistle, nopal, and globe artichoke, which was referred to as the Jambul combo. Ten patients with NIDDM were given the formula for a 3-month period. One patient with Type I/II was given the herbs for 3 months. One patient with Type I was given the formula for a 3-month period. One patient with hyperinsulinemia was given the herbs for 3 months, and seven patients with sub-clinical hypoglycemia were given the formula for 6 weeks.
Most participants in the study were also taking pharmacological agents. One NIDDM patient and the hypoglycemia patients were not on any pharmaceutical treatments during the study period.
Criteria: Five people were disqualified after the study for not matching the above criteria. Patients who had a weight change of more than 5 pounds within the 3 months were not included in the final data. Patients who had made dietary, lifestyle, and/or prescription drug changes were also disregarded. Patients who had not taken prescribed herbal dosages were disqualified at the end of the study.
Setting: Five outpatient clinics in Canada, the United States, and India, supervised by medical doctors and licensed naturopathic physicians.
Results:
Patient #1
Condition: Diabetes Type II
Onset of Diabetes: 6 years
Pharmacological Treatment: Metformin 500 mg b.i.d. and Diamicron 160 mg b.i.d. The patient had poor blood sugar control with the medicine before the study. She had taken chromium with little result.
Natural Medicine: Jambul combo three pills t.i.d.
Fasting Blood Sugar and Other Indications:
Average for the week of May 23, 1999 was about 16 mmol/L (288 mg/dL).
Average on June 1st was 15.9 mmol/L (286 mg/dL).
Average on June 7th was 13.6 mmol/L (245 mg/dL).
Average on June 14th was 12.2 mmol/L (220 mg/dL).
Average on June 21 was 12.3 mmol/L (221 mg/dL).
Average on June 27 was 9.5 mmol/L (171 mg/dL)
After 3 months, the patient averaged about 11.2mmol/L (201.6mg/dL). She had noticed effects of the treatment within two weeks. Her glycosylated hemoglobin HbA1c value was 10.2%, and after 3 months of treatment was 9.8%. She maintained her pharmacological treatment during the study.
Patient #2
Condition: Diabetes Type II
Onset of Diabetes: 10 years
Pharmacological Treatment: For NIDDM, Humulin 44 AM and PM, Toronto AM, and six units of insulin PM. History of diabetic treatment before the study was 9 years of oral hypoglycemics and 1 year of insulin. During this time the patient developed hypertension, angina, chronic renal failure (60% failure in both kidneys).
Natural Medicine: Jambul combo one pill t.i.d., and 600 mcg of chromium. A goldenrod tincture was prescribed for kidney support.
Fasting Blood Sugar and Other Indications: Fasting blood sugar level before the study was 2.2 mmol/L (220mg/dL). After 3 months, levels dropped to 8.8 mmol/L (158 mg/dL). Glycosylated hemoglobin was 7.9% before the study and after 3 months was 7.8%. Blood sugar levels were reduced while she decreased the dosage of her pharmaceutical drugs. Patient’s insulin levels lowered to 42 Humulin and 4 Toronto. After the study, the patient needed three injections daily, instead of the five, as needed previously. The patient also experienced less back pain, which allowed her to start walking again, something she was unable to do before due to the severity of pain caused by her kidney damage. Her creatinine level decreased from 138 to115 mmol/L.
Patient #3
Condition: Diabetes Type II
Onset of Diabetes: 25 years
Pharmacological Treatment: For NIDDM, Metformin 500 mg, 2 pills b.i.d., Glyburide 5 mg, b.i.d. These pharmaceutical drugs were discontinued upon starting the study. This patient was able to achieve normal blood sugar levels while on the drugs. However, due to the severe side effects of the pharmaceutical agents, specifically leg edema and flu like symptoms, she had discontinued the drugs.
Natural Medicine: Jambul combo three pills t.i.d.
Fasting Blood Sugar/Other indications: Fasting blood sugar on waking averaged around 15 mmol/L (270 mg/dL). She maintained this level for several weeks without the use of any treatment. Within several days of taking the herbs, her fasting blood sugar level went down to 9 mmol/L (162mg/dL). She had no leg edema or flu-like symptoms. Glycosylated hemoglobin was normal before the study, and after, it was 7.0%. The patient was near the American Diabetic Association recommendation target range of glycosylated hemoglobin without using the pharmacological agents sulfonylurea and biguanide due to her use of Jambul combo. The patient had no kidney pain at the end of the study.
Patient #4
Condition: Diabetes Type II
Onset of Diabetes: 25 years
Pharmacological Treatment: For NIDDM, insulin for the past 25 years.
Natural Medicine: Jambul Combo, two pills b.i.d., and 400 mg of lipoic acid and golden rod tincture for kidney support. (Note at this dose, lipoic acid has no effect on fasting blood sugar levels.)
Fasting Blood Sugar/Other Indications: Fasting blood sugar levels averaged around 158 mg/dL (8.8 mmol/L). After 3 months, levels averaged around 100 mg/dL (5.56 mmol/L), which is a completely normal blood sugar level. Her diabetic nephropathy had decreased and the edema and blood streaks in her legs were gone at the end of this study. Exogenous insulin requirements decreased by half.
Patient #5
Condition: Diabetes Type II
Onset of Diabetes: 2 years
Pharmacological Treatment: For NIDDM, Glyburide 5 mg b.i.d..
Natural Medicine: Jambul combo 3 pills t.i.d.
Fasting blood sugar/Other indications: Before the study fasting blood sugar levels were around 12 mmol/L (216 mg/dL) and after the study were 10 to 12 mmol/L (180-216 mg/dL). The patient also had an increase in Glyburide from two pills two times per day to two pills three times a day, again with no effect. The patient did not respond to natural therapeutics or pharmacological agents. It is interesting to note that this patient’s was thin, while all the other patients in this study were obese.
Patient #6
Condition: Hyperinsulinemia
Onset of Hyperinsulinemia: 2 years
Pharmacological Treatment: Metformin 2 pills b.i.d.
Natural Medicine: Jambul combo 3 pills t.i.d.
Fasting Insulin Levels/Other Indications: Before the study, the patient’s fasting insulin level was 36.8u/ ml. After 3 months of taking the herbal formula, her levels dropped to 28.7 u/ml. Within 2 weeks, she had noticed symptomatic relief. A rash that she attributed to the hyperinsulinemia had subsided. She stated that she felt better within a few weeks of taking the herbal formula.
Patient #7
Condition: Diabetes Type I
Onset of Diabetes: 2 years
Pharmacological Treatment: Insulin.
Natural Medicine: Jambul combo 3 pills t.i.d.
Fasting Blood Sugar/Other Indications: Fasting blood sugar levels were completely normal before the study. After the study, no decrease of daily exogenous insulin requirements were noticed. Before the study, the patient required higher insulin doses after rigorous exercise. Afterwards, an increase in insulin injections was not needed after rigorous exercises.
Patient #8
Condition: Sub-clinical Hypoglycemia
Onset of Sub-clinical Hypoglycemia: 15 to 20 years
Pharmacological Treatment: None.
Natural Medicine: Jambul combo three pills t.i.d.
Fasting Blood Sugar/Other Indications: Before the study, fasting blood sugar levels averaged 2.2 mmol/l (40 mg/dl). After the study, fasting blood sugar levels rose to 4.4 mmol/l (80 mg/dl). There was a significant decrease in hypoglycemic hunger and the patient’s frequent need to eat. The patient also noted a significant decrease in sugar cravings. The patient had taken 500 mcg of chromium daily for the previous 6 months. She had not noticed any significant changes with the past use of chromium.
Patient #9
Condition: Diabetes Type II
Onset of Diabetes: 15 to 20 years
Pharmacological Treatment: Insulin
Natural Medicine: Jambul combo one pill t.i.d. During the last week of the study, the dosage was increased to two pills t.i.d.
Fasting Blood Sugar and Other Indications: Before insulin therapy the patient’s fasting blood sugar level was 200 to 240 mg/dL (11.1-13.3 mmol/L). Fasting glucose level on insulin therapy was between 150 and 160 mg/dL (8.3 -8.8 mmol/L). Fasting glucose after three months on the herbal formula was (7.4 mmol/L) 133 mg/dL.
Patient #10
Condition: Subclinical Hypoglycemia
Onset of Subclinical Hypoglycemia: 10 years
Pharmacological Agents: None
Natural Medicine: Jambul combo 3 pills t.i.d.
Fasting Blood Sugar and Other Indications: After 3 weeks of taking Jambul Combo, the patient did not need to eat as often, did not feel jittery when missing a meal, and noticed an overall improvement in how she felt. She had taken chromium before but never noticed any significant changes. The patient lost 2 pounds a week while taking the herbal formula.
Patient #11
Condition: Reactive Hypoglycemia
Onset of Reactive Hypoglycemia: 8 years
Pharmacological Treatment: None
Natural Medicine: Jambul Combo three pills t.i.d., 500 mg of vitamin C daily, and vitamin B12 injections monthly.
Fasting Blood Sugar and Other Indications: Before the study, the patient had to eat 6 meals a day to avoid hypoglycemic symptoms. Hypoglycemic index before study was 26; after the study, it was 8. The patient reported significant improvements over the course of the study in feelings of shakiness, irritability upon missing meals, heart palpitations after eating sweets, dependence on coffee in the mornings, mood disturbances, fatigue after eating, general feelings of faintness, poor concentration, and forgetfulness. The only symptom that did not improve was food cravings. Before the study period, patient noticed waking headaches relieved by food. After the study, she experiences only two waking headaches per week.
Patient #12
Condition: Diabetes Type I/II
Onset of Diabetes: 4 years
Pharmacological Treatment: GE NPH insulin 20 units at bedtime, fast-acting Humalog insulin at breakfast, 15 units lunch, 15 units supper. Progression of diabetes before study: started with hypoglycemics (sulfonylurea) for 1 year then switched to insulin.
Natural Medicine: Jambul combo three pills t.i.d.
Fasting Blood Sugar and Other Indications: Patient’s blood sugars before the study ranged from 4-15. After the study, they were stabilized at a range from 4-10. Before the study, the patient’s high reading would last for a day or more; after the study, he would only get one high reading in a day. He also experiences less tiredness since taking Jambul. His insulin levels have decreased 5 units each at noon and bedtime. Before taking Jambul, the patient’s insulin levels were increasing with time.
Patient # 13
Condition: Subclinical Hypoglycemia
Onset of Subclinical Hypoglycemia: 6 years
Pharmacological treatment: None
Natural medicine: Jambul combo three pills t.i.d.
Fasting Blood Sugar and Other Indications: Initially, the patient reported increased hunger, which disturbed her as she was trying to lose weight. She was instructed to reduce the dose to two pills, three times a day. Following this, she found a marked improvement in her energy levels, so much so that she quit smoking during the study period. Initially, her hypoglycemic score was 28; after the study, it was 13. She experienced significant decreases in irritability, headaches, and shaky feelings. The only symptoms not improved were related to memory, concentration, forgetfulness, and sugar cravings. No other side effects were reported.
Patient #14
Condition: Subclinical Hypoglycemia
Onset of Subclinical Hypoglycemia: 10 years
Pharmacological Treatment: None
Natural Medicine: Jambul combo three pills t.i.d. She also took a multi B-vitamin, magnesium, vitamin E, and deglycyrrhizinated licorice to treat her other conditions.
Fasting Blood Sugar and Other Indications: Patient’s hypoglycemic score before the study was 28; after 6 weeks, it dropped to 13. She noted a decrease in dizziness, impaired vision when standing, sugar cravings, palpitations, and tiredness after eating. Her concentration problems were not affected by the treatment. She reported improvement in fibromyalgia pain, but this may be due to other factors. No side effects reported.
Conclusion
The Jambul combo was an effective treatment in 5 out of 6 patients with NIDDM after 3 months. Most NIDDM patients noticed effects within 2 months. The treatment was effective in all 5 obese NIDDM patients. The only NIDDM patient who did not respond to natural therapeutics was thin. He also did not respond to pharmacological treatments. One patient with hyperinsulinemia noticed a significant decrease in fasting insulin after 3 months of taking the herbal formula.
One patient with Type I/II noticed a decrease in fasting blood sugar levels after 2 months of taking the herbal treatment. One patient with Type I noticed no decrease in fasting blood sugar after taking Jambul combo for 3 months.
Six patients with hypoglycemia noticed a decrease in hypoglycemic score within 6 weeks. The Jambul combo was an effective treatment in 13 patients out of 15. It was not effective in one NIDDM and one Type I patient. Most patients reported decrease in diabetic complications and the progression of the illness itself.
Side Effects
One patient noticed an initial increase in hunger after taking Jambul, but it went away after a week upon lowering the dosage to two pills, three times a day. Lowering of dosage may be coincidental or not. One patient noticed gastric acidity upon taking the herbal formula more than 15 minutes apart from a meal.
Notes of Reference to Pharmacological Drugs
Oral hypoglycemic drugs, such as sulfonylureas, have no long-term effect in blood sugar control for about 20% to 30% of NIDDM patients. In a study of Glucophage treatment of 228 patients, glycosylated hemoglobin levels of patients started at 9.43, after 6 months went down to 8.30, and after 9 months went up to 8.72.
