12/03/2015

1. 1. Hintonia concentrate: for the dietary treatment of increased blood sugar values: results of a multicentric, prospective, non-interventional study with a defined dry concentrate of hintonia latiflora.
      [Translated from German] Preparations from the bark of hintonia latiflora are used to regulate the blood sugar levels. The objective of this study was to prove the nutritional benefit within the framework of a dietary treatment of increased blood sugar values with pre-diabetes and slight diabetes type 2 as well as the assessment of the tolerance and application safety. In an open, prospective, multicentric and non-interventional application study, the effects of a dry concentrate from the bark of hintonia latiflora in the form of capsules were examined for the laboratory parameters of the blood sugar levels (HbA1c, fasting and postprandial glucose) as well as for the development of diabetic accompanying symptoms (sweating, gastrointestinal symptoms, paraesthesiae, itching and neuropathies). Particular attention was also given to the tolerance and (if available) further clinical (laboratory) parameters (blood pressure, liver values and blood lipids). An eight-month treatment was documented in 178 test persons with type 2 diabetes/pre-diabetes, who were treated with oral antidiabetics and/or insulin or only with a diet. At the end of the study, 177 data records were available. The HbA_1c values improved over the course of the study with a high level of clinical relevance and significance from 7.2 ± 0.4% to 6.4 ± 0.5%, in accordance with a relative improvement by 10.4% (p < 0.0001). In parallel, the values of fasting and postprandial glucose also improved by an average of 23.3 ± 12.5% (from 152.1 ± 27.4 mmol/l to 114.4 ± 18.2 mmol/l) and 24.9 ± 11.4% (from 189.5 ± 34.1 mmol/l to 140.1 ± 22.3 mmol/l). The sum score of the diabetic accompanying symptoms improved from initially 4.8 points to 1.3 points at the end of the study. Improvements were also determined in blood pressure, blood fats and liver values. The tolerance was excellent, no unwanted effects occurred, in particular no hypoglycaemic episodes. In 55 of 114 patients with antidiabetic medication (39.5%), the substance could be reduced (n = 45) or stopped entirely (n = 10). The study confirms the positive effects of the dry concentrate from the bark of hintonia latiflora on the main parameters of the blood sugar levels and the diabetic accompanying symptoms. In the event of pre-diabetes or minor cases of type 2 diabetes mellitus, this can contribute towards stabilizing the blood sugar homeostasis in particular, achieving a lower load from accompanying medication and deferring the necessity of using oral antidiabetic drugs and / or insulin. [Schmidt M, Hladikova M. Hintonia concentrate—for the dietary treatment of increased blood sugar values: Results of a multicentric, prospective, non-interventional study with a defined dry concentrate of hintonia latifloa. Naturheilpraxis mit Naturmedizin. February 2014.]
   2. Treatment of mild and moderate type-2 diabetes: open prospective trial with Hintonia latiflora extract. Background: Extracts from the bark of Hintonia latiflora are used as di tetic measures to support the regulation of glucose metabolism and the stabilization of blood glucose values. Methods: A dry concentrated extract from the bark of Hintonia latiflora in capsule form was tested in an open, prospective clinical study in 41 dietetically stabilized subjects with type 2 diabetes. The effects on parameters of blood glucose control were documented over a period of six months. Results: Fasting and postprandial glucose and the HbA1c value declined significantly. In the case of HbA1c, this meant a reduction of the absolute value from 7.49 ± 0.72% to 6.82 ± 0.67% (from 58.4 to 51.0 mmol/mol Hb; intention to treat (ITT) population). Furthermore, cholesterol and triglycerides were slightly reduced and no negative effect on other laboratory parameters and no change of the liver values were observed. Tolerance was very good. In particular, no side effects and no hypoglycemic episodes or worsening of diabetic symptoms occurred. Conclusions: The study confirms the positive effect of extracts from the bark of Hintonia latiflora on blood glucose values suggesting a potential benefit in the management of glucose metabolism in cases of type 2 diabetes.[Korecova M, Hladikova M. Treatment of mild and moderate type-2 diabetes: open prospective trial with Hintonia latiflora extract. European Journal of Medical Research. 2014;19(1):16.]
   3. Hintonia latiflora in patients with type 2 diabetes: A long-term study. [Hintonia latiflora bei Typ-2-Diabetes.] The antidiabetic efficacy and safety of an extract from Hintonia latiflora (drug-extract ratio 1:4.5, extraction solvent 32% ethanol) was tested in a monocenter open, uncontrolled study on 30 patients with type 2 diabetes. Patients were adjusted to a stable diet at least two months prior to therapy and during the entire duration of the study in order to rule out a dietary impact on the study outcome. After 12 months of treatment, fasting blood glucose was reduced by 20.6%, postprandial glucose by 19% and the mean HbA1c by 10.3% (p < 0.001). In the patients remaining in the study, these parameters were stable thereafter (up to 33 months of treatment). There were no hypoglycemic episodes or adverse events throughout the entire treatment period. [Korecova M, Hladicova M, Korec R. Hintonia latiflora bei Typ-2-Diabetes. Zeitschrift für Phytotherapie. 2006;27:272-278.]
   4. Natural treatment of Type II diabetes utilizing an herbal antidiabetic product. Case Report. [Naturheilkundliche Therapie des Typ-II-Diabetes mit Hilfe des Phyto-Antidiabetikums.] One female patient with diabetes mellitus received an 8-week course with 5×50 Hintonia drops daily. Fasting glucose decreased in a female patient after a three-week treatment with Hintonia after a prior exacerbation of glycaemic control, despite the use of metformin as an oral antidiabetic. She was initially considered for insulin treatment. During her 8-week course with 5×50 Hintonia drops daily, the fasting glucose level was reduced from 191 mg to 176 mg. No adverse reactions were observed. [Ploss O. Naturheilkundliche Therapie des Typ-II-Diabetes mit Hilfe des Phyto-Antidiabetikums. HP Naturheilkunde. 2002;25(1/2):40-44.
   5. Therapeutic trial with Copalchi [Hintonia latiflora] bark in patients with impaired glucose tolerance. [Therapieversuch mit Copalchi-Rinde bei pathologischer Glucosetoleranz.] The effect of 2 – 3×30 Hintonia drops on glucose tolerance was examined on a group of fourteen subjects with impaired glucose tolerance not treated with oral antidiabetics or insulin. Although an effect of an 8-week onwards intake of the investigational medicinal product exhibited no immediate effect on the glucose tolerance test, positive long-term effects were seen in at least 7 patients (treated for several years) because none of these cases developed full diabetes. Diabetes is a progressive disease and the necessity for the adjustment to antidiabetic drugs is merely a matter of time. The delaying of the time point of an antidiabetic therapy may be considered to be an important prophylactic factor. No adverse reactions were recorded and reported [Machens R. Therapieversuch mit Copalchi-Rinde bei pathologischer Glucosetoleranz. Erfahrungsheilkunde. 1996;45(9):605-608.]
   6. A long-term test with Copalchi fluid extract, a herbal anti-diabetic drug. [Eim Langzeitversuch mit Copalchi-Fluidextrakt, einem pflanzlichen Antidiabetikum.] Open long-term study. Fourteen patients with type 2 diabetes received approximately 10 drops of a copalchi (Hintonia latiflora) extract twice daily for a duration of 10 months. The patients were stabilized to glibenclamide and diet prior to the administration of copalchi drops. In 9 patients “good” to “very good” improvement of their HbA1c –values was found and in 4 of these patients glibenclamide could be discontinued within 10 months. With regard to safety, no pathologic changes in liver parameters during long-term application of copalchi drops in 16 subjects with diabetes mellitus were detected. [Machens R. Eim Langzeitversuch mit Copal chi-Fluidextrakt, einem pflanzlichen Antidiabetikum. Erfahrungsheilkunde. 1992;6:416-420.]
   7. Two cases of spontaneous regression of diabetes mellitus Type 2 after treatment with a phytotherapeutic natural medicine. [Zwei Fälle spontaner Regression des Diabetes mellitus Type 2 nach Behandlung mit einem Phytotherapeutikum.] The effects of copalchi drops (Hintonia latiflora) were assessed in eight patients with diabetes mellitus. An initial increase of HbA1c values on short-term intake of 20 drops 3 times daily for 4 weeks was found. A substantial decrease in the fasting glucose level was observed in 4 of the 8 cases, whereas HbA1c -values were unaltered or increased in 7/8 patients. With regard to the relatively long half-life of HbA1c it was concluded that a measurement after only 4 weeks of copalchi intake is not likely a meaningful result. No adverse reactions were observed. [Machens R. Zwei Fälle spontaner Regression des Diabetes mellitus Type 2 nach Behandlung mit einem Phytotherapeutikum. Erfahrungsheilkunde. 1991;6:433-436.]
   8. Oral diabetes therapy with a copalchi extract. [Orale Diabetestherapie mit einem Eupharbiazeenextrakt.] In order to determine the effects of a liquid copalchi (Hintonia latiflora) extract, a dose of 50 drops three times daily was evaluated in healthy volunteers and diabetic patients. The investigation was performed by the use of a cross-over design on three consecutive days. Baseline glucose levels were measured in 10 healthy volunteers, in 15 patients with mild forms of diabetes mellitus, especially in those suffering type 2 diabetes, in cases of moderately severe diabetes mellitus (as judged by a daily insulin requirement of 30-40 IU), and in severe and insulin-resistant cases of diabetes type 2 and in diabetes type 1 (n=6). Results: In the ten healthy volunteers the administration of insulin (5 IU) distinctly lowered blood glucose levels, whereas the application of the copalchi extract (50 drops) did not produce hypoglycaemia. In the fifteen patients with mild forms of diabetes mellitus (especially in type 2 diabetes) the effects were expressed in a reduced requirement of auxiliary insulin from 15-25 IU to 5-10 IU. Insulin was discontinued in cases where the administered dose was in the range of 10-15 IU. Two reports were presented in which up to 25 IU of insulin were replaced by copalchi 50 drops/ 3 times daily with even better effects on glucose control. In cases with moderately severe diabetes mellitus (as judged by a daily insulin requirement of 30-40 IU) the insulin sparing effect was less, reaching only 5 IU insulin reduction at its maximum. A reduction in renal urine excretion was also detected. The observed effects were dose-dependent: two patients who accidentally reduced the ingested dose to 20 drops t.i.d. experienced a reoccurrence of diabetic symptoms such as thirst, diuresis and an increase of blood glucose within 1-2 days. In both cases the resetting of the dose to the initially recommended quantity of 50 drops t.i.d completely restored these effects. In severe and insulin-resistant cases of diabetes type 2 and in diabetes type 1 (n=6) the blood glucose-lowering effect was far less pronounced or missing, as demonstrated in two case reports. Co-symptoms of diabetes such as pruritus or thirst were effectively counteracted by the intake of the investigational extract. Adverse reactions were not recorded in any of the 31 cases. [Kuhr R. Orale diabetestherapie mit einem Eupharbiazeenextrakt. Landarzt. 1953;29(23):542-549.]
   9. Clinical validation for an herbal Hintonia product. [Klinisches Gutachten über das Hintonia latifloria Produkt.] The study was undertaken to compare the influence of Hintonia drops on blood glucose level, urinary glucose and acidosis, in mild to moderate cases of diabetes, especially in patients suffering type 2 diabetes. The dosages applied to patients with mild to moderate diabetes, (especially patients suffering type 2 diabetes) ranged between 3 x 30-50 drops/day. In order to avoid an influence of the diet, only patients were tested who were compliantly adjusted to a standard diet for a minimum of 4-5 days. In five of eight cases a distinct improvement in symptoms was observed. No adverse reactions were observed in any of the described cases. [Pellegrini A. Klinisches Gutachten über das Hintonia latiflora Produkt. Sonderdruck Fa. Sippel, Konstanz. 1951:1-7.]
   10. Clinical case reports: the effectiveness of the oral antidiabetic Hintonia latiflora. [Bericht über die Behandlung mit dem peroralen Antidiabetikum Hintonia latiflora.] Severe cases did not satisfactorily respond to this treatment, whereas in mild to moderate cases a significant reduction of diabetic symptoms was achieved, as expressed in a distinct reduction of urinary glucose and of blood glucose. Co-morbidity caused by the diabetes, such as pruritus, nightly sweating, furunculosis and thirst resolved quickly. Even in cases of severe diabetes (in whom no noticeable reductions of blood glucose values were observed), complaints – related to early stages of acidosis such as headache, tiredness or dizziness – were reduced. No adverse effects were observed. The author concluded that especially mild and moderate cases or diabetes and type-2 diabetes can successfully be treated with Hintonia drops. In severe cases of juvenile diabetes the treatment can at least positively influence the general health condition of the patient, even though no amelioration of blood sugar values would be expected. [Schmid P. Bericht über die Behandlung mit dem peroralen Antidiabetikum Hintonia latiflora. Sonderdruck Fa. Sippel, Konstanz. 1951: 1-4.
   11. Review of the oral antidiabetic, Hintonia latiflora. [Erfahrungsbericht mit dem peroralen Antidiabetikum Hintonia latiflora.] Following a run-in period of at least 6 days with a standardized diet, a 6-day treatment phase with Hintonia, 30-50 drops 3-times daily was started. Thereafter, the drops were discontinued and during this post-treatment observation period insulin was replaced as needed. “Severe” cases of DM were defined as states with an acidosis and a regular excretion of >50 g of glucose with the urine. “Moderately severe” cases were defined as having no acidosis and 20-50 g of glucose in the urine, whereas “mild” cases exhibited a daily urinary excretion below 20 g glucose. None of the patients with severe diabetes responded to the treatment with Hintonia drops. In contrast, a reduction of blood sugar and glucose excretion into the urine was achieved in 9/14 patients with moderate diabetes. The effect could be maintained over the whole treatment period and lasted up to 2-3 days after discontinuation. With the exception of diarrhea in one case during the treatment period (6 days), no adverse reactions were observed. [Vida F. Erfahrungsbericht mit dem peroralen Antidiabetikum Hintonia latiflora. Med Welt. 1951;20:1623-1624.]
   12. Contribution to diabetes treatment. [Beitrag zur Diabetes-Behandlung.] Diabetic patients were treated with Hintonia drops (average dose: 3×30 drops/day) within a period of 4 months. The author reported that mild to moderate cases responded best to the treatment. In patients previously (and unsuccessfully) treated with diet only diabetic symptoms reverted to normal within only 14 days of treatment with Hintonia drops. Glycaemia, glucosuria and the amount of urine within 24 hours were distinctly reduced. Accompanying diabetic-related diseases and damages such as furunculosis or pruritus were completely resolved, whereas the late occurring diabetic damages such as polyneuritis or retinopathy were not influenced. The author also noted that patients immediately felt a subjective amelioration of symptoms, as expressed in an amelioration of weakness, tiredness or nervous restlessness. No adverse effects were observed. [Ritzmann H. Beitrag zur Diabetes-Behandlung. Hippokrates. 1950;21(6):161-168.]
   13. Experimental Animal Studies on the Hypoglycemic Effects of a Copalchi Extract. [Tierexperimentelle Untersuchungen zur hypoglykamischen Wirksamkeit eines Copalchi-Extraktes.] The hypoglycemic effects of a Copalchi extract was tested in 60 adults – male and female – Wistar rats in the presenta randomized, placebo-controlled, parallel-comparative animal study. A control group receiving only an Altromin standard chow was compared to treatment groups which received an Altromin chow enriched with Copalchi dry substance at 0.028% m/m or at 0.28% m/m. The study period was 30 days. The distinctly significant blood glucose lowering effect of the Copalchi extract could be demonstrated in both treatment groups. No significant difference in the antidiabetic effect was seen between the two concentrations. The onset of action of the Copalchi extract was observed between treatment days 1 and 3. A 20-25% decrease in the blood glucose concentration was achieved between the 7th and 15th day of treatment and remained at this level thereafter. This plateau was reached in the female rats already between treatment day 3 and 5. The parallel observed increase in the mean body weight was not striking and generally was the same between the test animals and the control animals. [Pinto A, Capasso A, Sorrentino L. Tierexperimentelle Untersuchungen zur hypoglykamischen Wirksamkeit eines Copalchi-Extraktes. Antidiabetika. 1997;47(7):829-833.]