A prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy.

OBJECTIVES: To evaluate homeopathic treatment in the management of diabetic distal symmetric polyneuropathy. METHODS: A prospective multi-centric clinical observational study was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) (India) at its five institutes/units. Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the diabetic distal symmetric polyneuropathy symptom score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months. RESULTS: Out of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analyzed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only. CONCLUSION: This study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the quality of life (QOL) assessment.

Efficacy of homoeopathic treatment for diabetic distal symmetric polyneuropathy: A multicentric randomised double-blind placebo-controlled clinical trial.

BACKGROUND: In course of diabetes, some 20-90% of individuals eventually develop diabetic neuropathy. Looking at the disease burden research studies in Homoeopathy were conducted and have shown positive results. These studies were not robust enough to prove the efficacy of individualized homoeopathy. OBJECTIVE: To assess efficacy of individualized homoeopathic medicines in management of DDSP. METHODS: A multi-centric double-blind, placebo controlled, randomised clinical trial was conducted by the Central Council for Research in Homoeopathy at six centres with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homoeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention. Primary outcome measure was change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score at 12 months. RESULTS: Data of 68 enrolled cases was considered for data analysis. Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group. Positive trend was noted for Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homoeopathic medicines 11 medicines were prescribed in potencies in ascending order from 6C to 1M. CONCLUSION: Further studies must be taken up with larger sample size and defined parameters for NCS to assess the effectiveness of homoeopathy.

The effect of Neuragen PN on neuropathic pain: A randomized, double blind, placebo controlled clinical trial.

BACKGROUND: A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN" for the treatment of neuropathic pain. METHODS: Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. RESULTS: There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. CONCLUSIONS: This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. TRIAL REGISTRATION: ISRCTN registered: ISRCTN13226601.

[Clinical report of 60 cases of diabetic cardio-vascular autonomous neuropathy by stasis removing treatment of combined traditional and Western medicine].

OBJECTIVE: To study the treatment of diabetic cardio-vascular autonomous neuropathy (DCVAN) by TCM-WM following the principle of promoting blood circulation to remove blood stasis. METHODS: Sixty patients with DCVAN were randomly divided into two groups, the treatment group (30 patients) were treated with combined TCM-WM therapy. Based on the control of blood sugar by WM effectively, then use TCM-Tangxinshen ([symbol: see text], TXS) with the function of supplementing the Qi and nourishing Yin, promoting blood circulation to remove blood stasis. Thirty cases of the control group were treated with WM alone. The course of treatment was three months. RESULTS: The total effective rate of the treatment group and the control group was 77.3% and 33.4% respectively, which were significantly different statistically (P < 0.005). CONCLUSION: The therapeutic effect of TCM-WM was better than that of WM.