Oral Methylcobalamin Research Articles

Clinical Efficacy of Ultrasonic Medicinal Penetration in the Removal of Blood Stasis and Alleviation of Zhuyu Juanbi Formula in the Treatment of Peripheral Neuropathy Induced by Paclitaxel

Objective: To observe the clinical efficacy and differences of the Zhuyu Juanbi formula delivered through ultrasound at Zusanli on patients with chemotherapy-induced peripheral neuropathy (CIPN) due to paclitaxel injection. Methods: A total of 72 breast cancer patients with CIPN were randomly divided into two groups. The treatment group (36 cases) was treated with oral methylcobalamin plus ultrasonic medicine permeating Zhuyu Juanbi formulae, while the control group (36 cases) was treated with oral methylcobalamin alone. Following two 2 cycles of continuous treatment, the efficacy of peripheral neurotoxicity, TCM syndrome score, FACT/GOG-Ntx score, total neuropathy score, and safety indicators of gynecological cancer patients were observed in the two groups. Result: In the treatment of CIPN, the addition of ultrasonic medicine permeating Zhuyu Juanbi formulae was more effective than oral methylcobalamin alone in reducing peripheral neurotoxicity and improving the quality of life of patients. The difference between the two groups was statistically significant (P < 0.05), and ultrasound drug penetration Zhuyu Juanbi formulae significantly reduced the FACT/GOG-Ntx score and TNS score in the treatment group. In terms of drug safety, it rarely caused adverse reactions such as grade 3 and 4 leukopenia, and the safety profile was therefore good. Conclusion: The combination of ultrasonic medicine permeating Zhuyu Juanbi formulae and methylcobalamin has been demonstrated to be an effective treatment for peripheral neurotoxicity in patients with PIPN. It has been shown to significantly improve the clinical symptoms of PIPN patients, improve the quality of life of patients, and have a good safety profile.

Comparison of oral versus intranasal methylcobalamin in patients of tinnitus

Background: Tinnitus is perception of sound in the absence of an external auditory stimulus. It is an experience that originates from a cause or trigger in the cochlea, brainstem or at higher centres. Methods: A randomized, double-blinded pilot study was conducted, wherein a total of 64 patients were enrolled. Of which 32 were considered as Group A (oral methylcobalamin was administered) and 32 in Group B (intranasal methylcobalamin was administered). Group A patients enrolled randomly received oral methylcobalamin therapy (tablet methylcobalamin 500 mcg tablet once a day for a period of 6 weeks). Group B patients enrolled randomly received intranasal methylcobalamin treatment (nasal spray 500 mcg per day) for a period of 6 weeks. Results: A sum of 19 patients of the total patients included in the study were found to be Vitamin B12 deficient that is 42.1% were considered to be Vitamin B12 deficient when the normal levels were considered to be 250 pg/ml, which could be considered to be a significantly high prevalence. Patients having Vitamin B12 deficiency showed improvement in visual analogue scale score after vitamin B12 therapy. Conclusions: Supplementation of Vitamin B12 in vitamin B12 deficient patients having tinnitus has shown symptomatic improvement. However, no significant improvement in visual analogue scale scores in patients without B12 deficiency was observed. There was improvement in VAS in cobalamin-deficient patients receiving Vitamin B12 weekly for 6 weeks.

Comparison of the Efficacy of Oral Methylcobalamin Tablets vs. Nasal Spray (NASO B12) in Diabetic Patients on Metformin Therapy

Context: Metformin is known to increase in the risk of developing vitamin B12 deficiency. This study aimed to compare the effectiveness of nasal spray of methylcobalamin (NASO B12) and methylcobalamin tablets for treating vitamin B12 deficiency in diabetic patients receiving metformin. Materials and Methods: In this parallel-group, comparative, open-label clinical study, patients (n = 100) were assigned to two groups: nasal spray of methylcobalamin (NASO B12) (methylcobalamin 250 µg/spray), sprayed in each nostril every alternate day for a total of seven doses (Group 1: a total of 3500 µg methylcobalamin per patient) and oral methylcobalamin tablets, a single daily dose of 1500 µg for a total of seven doses (Group 2: a total of 10,500 µg methylcobalamin per patient). The assessment of efficacy was carried out by measuring serum vitamin B12 levels at baseline, day 7, and day 14. Statistical Analysis Used: The analysis used is Student’s unpaired t-test. Results: NASO B12 treatment resulted in vitamin B12 levels of ≥400 pg/mL (recently updated normal levels as per American Academy of Family Physicians) in 86% and 92% of patients, on day 7 and day 14, respectively, whereas no patient attained ≥400 pg/mL with oral therapy. NASO B12 therapy resulted in higher mean vitamin B12 levels of 485.88 and 570.16 pg/mL when compared with 172.26 and 185.44 pg/mL with oral tablets on day 7 and day 14, respectively. Conclusion: NASO B12 provided much superior absorption of vitamin B12 when compared with oral vitamin B12 tablets and can be used as an effective alternative.

Scraping needling technique combined with western medication for neurogenic tinnitus of kidney essence deficiency：a randomized controlled trial

To compare the clinical efficacy of scraping needling technique combined with western medication and simple western medication for neurogenic tinnitus of kidney essence deficiency. A total of 68 patients with neurogenic tinnitus of kidney essence deficiency were randomly divided into an observation group and a control group, 34 cases in each group. In the control group, oral methylcobalamin tablets were given, 0.5 mg each time, 3 times a day; oral flunarizine hydrochloride capsules were given before bed, 5 mg each time, once a day, 4 weeks in total. On the basis of the treatment as the control group, scraping needling technique was applied at Tinghui (GB 2), Yifeng (TE 17), Yangchi (TE 4) on the affected side and Shenshu (BL 23), Lieque (LU 7), 5 min each acupoint, once a day, 5 times a week for 4 weeks. Before treatment, 2, 4 weeks into treatment and 4 weeks after treatment (follow-up), the tinnitus severity score, tinnitus visual analogue scale (VAS) score and pure tone average (PTA) were observed, and the clinical efficacy was evaluated in the two groups. The tinnitus severity scores, VAS scores and PTA of each time point after treatment in the two groups were lower than those before treatment (P<0.05), and those in the observation group were lower than the control group (P<0.05). The total effective rates of each time point after treatment in the observation group were 50.0% (17/34), 79.4% (27/34), 79.4% (27/34), which were higher than 26.5% (9/34), 64.7% (22/34), 61.8% (21/34) in the control group (P<0.05). Scraping needling technique combined with western medication could improve tinnitus severity, tinnitus volume and hearing in patients with neurogenic tinnitus of kidney essence deficiency, and its curative effect is better than simple western medication.

Are herbal medicines alone or in combination for diabetic peripheral neuropathy more effective than methylcobalamin alone? A systematic review and meta-analysis

Background and purposeIn Asian countries, herbal medicines have been used to treat diabetic peripheral neuropathy (DPN) as an adjunctive therapy. This review aims to assess the effectiveness and safety of herbal medicines for the treatment of DPN. MethodsA literature search was conducted on PubMed, Embase, CENTRAL, Scopus, CINAHL, CNKI, DBPIA, and OASIS for randomized controlled trials that evaluated the effects of herbal medicines on DPN. The oral methylcobalamin administered group was selected as the control. The primary outcome measure was nerve conduction velocity (NCV), and the secondary outcome measure was the total efficacy rate (TER). The methodological quality of the included studies was assessed using the Cochrane risk of bias tool. A meta-analysis was conducted using Review Manager 5.4.1 software. ResultsSeventy-two RCTs with a total of 6260 patients were included. The meta-analysis showed that herbal medicine and co-administration of herbal medicine and methylcobalamin (CHM) treatment for DPN significantly increased the sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (MNCV) of the median and common peroneal nerves than methylcobalamin treatment alone. Herbal medicine and CHM treatment for DPN also significantly improved the TER compared to the control group. Herbal medicine and CHM treatment was found to be relatively safe. ConclusionOur study suggests that herbal medicine and CHM might be more effective than methylcobalamin alone in the management of DPN. Further rigorous studies should be conducted to make more definite conclusions.

Vitamin B12 Supplementation in Diabetic Neuropathy: A 1-Year, Randomized, Double-Blind, Placebo-Controlled Trial.

Aim: To investigate the effect of normalizing vitamin B12 (B12) levels with oral B12 (methylcobalamin) 1000 μg/day for one year in patients with diabetic neuropathy (DN). Patients and methods: In this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin for at least four years and both peripheral and autonomic DN were randomized to an active treatment group (n = 44) receiving B12 and a control group (n = 46) receiving a placebo. All patients had B12 levels less than 400 pmol/L. Subjects underwent measurements of sural nerve conduction velocity (SNCV), sural nerve action potential (amplitude) (SNAP), and vibration perception threshold (VPT), and they performed cardiovascular autonomic reflex tests (CARTs: mean circular resultant (MCR), Valsalva test, postural index, and orthostatic hypotension). Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF, respectively). We also used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE, respectively) and questionnaires to evaluate quality of life (QoL) and level of pain (pain score). Results: B12 levels increased from 232.0 ± 71.8 at baseline to 776.7 ± 242.3 pmol/L at follow-up, p < 0.0001, in the active group but not in the control group. VPT, MNSIQ, QoL, pain score, SNCV, SNAP, and ESCF significantly improved in the active group (p < 0.001, p = 0.002, p < 0.0001, p < 0.000, p < 0.0001, p < 0.0001, and p = 0.014, respectively), whereas CARTS and MNSIE improved but not significantly. MCR, MNSIQ, SNCV, SNAP, and pain score significantly deteriorated in the control group (p = 0.025, p = 0.017, p = 0.045, p < 0.0001, and p < 0.0001, respectively). Conclusions: The treatment of patients with DN with 1 mg of oral methylcobalamin for twelve months increased plasma B12 levels and improved all neurophysiological parameters, sudomotor function, pain score, and QoL, but it did not improve CARTS and MNSIE.

Oral Methylcobalamin Treatment Effectiveness of Newborn with Vitamin B12 Deficiency

Introduction: Vitamin B12 (Vit-B12) levels between the mothers and their infants in a neonatology unit were investigated and the effectiveness of oral methylcobalamin treatment in neonatal Vit-B12 deficiency was evaluated. Materials and Methods: Eighty patients born between July 2018 and April 2020 at 34–42 weeks of gestation and who were found to have Vit-B12 deficiency were included in this cross-sectional study. Oral methylcobalamin was given to 40 patients, and 40 patients were followed up. Vit-B12 level and blood gas were measured in the umbilical cord blood of the infants, and a complete blood count was performed on the first day. Vit-B12 levels of the mothers were assessed. Complete blood count and Vit-B12 level were measured on the postnatal 30th day in patients who were followed up without treatment and 5 days after treatment in patients who received oral methylcobalamin treatment for 1 month. Results: In the treatment group, the mean umbilical cord Vit-B12 level was 155.5 (±29.1) pg/ml, and the mean Vit-B12 level of the mothers was 158.8 (±57.6) pg/ml. The mean follow-up Vit-B12 level was 801.8 (±394.7) pg/ml. In the untreated group, the mean umbilical cord Vit-B12 level was 159.3 (±34.1) pg/ml, and the mean Vit-B12 level in mothers was 146.2 (±49.7) pg/ml. The mean follow-up Vit-B12 level was 189.2 (±57.6) pg/ml. Conclusion: There was a positive correlation between umbilical cord Vit-B12 and mothers' Vit-B12 levels. Oral methylcobalamin treatment was found to be effective and safe in Vit-B12 deficiency.

Effects of silkworm excrement ironing on peripheral neuropathy of type 2 diabetes mellitus with cold coagulation and blood stasis

Objective To investigate the effects of silkworm excrement ironing on blood levels of glucose, lipids and Hcy in diabetic peripheral neuropathy patients with cold coagulation and blood stasis. Methods A total of 260 diabetic peripheral neuropathy patients with cold coagulation and blood stasis were randomly divided into the control group(n=130)and the observation group(n=130). Both groups were treated with oral methylcobalamin(500 μg, tid), and in addition, the observation group was given silkworm excrement ironing on areas of the limb with numbness and pain.Patients underwent one single course of treatment lasting 4 weeks.Blood levels of glucose, lipids and Hcy pre- and post-treatment were analyzed. Results Blood lipid profiles and hemorheology improved in both groups after treatment, compared with pre-treatment data, and greater improvement was seen in the observation group than in the control group(all P<0.05). Plasma Hcy levels decreased in both groups after treatment, compared with pre-treatment levels, and deeper decline was seen in the observation group than in the control group after treatment(all P<0.05). Conclusions Silkworm excrement ironing can effectively improve the blood glucose profile and lipid metabolism, reduce plasma Hcy levels and may exert beneficial preventive and therapeutic effects on diabetic peripheral neuropathy. Key words: Diabetic neuropathies; Blood stasis

Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial

After Roux-en-Y gastric bypass (RYGB), patients often develop a vitamin B-12 deficiency. Our objective was to investigate whether oral supplementation increases and normalizes low vitamin B-12 concentrations (vitamin B-12>200 pmol/L) in RYGB patients as compared to intramuscular injections. A randomized controlled trial in RYGB patients with subnormal serum B-12 concentrations was performed. One group (IM B-12) received bimonthly intramuscular hydroxocobalamin injections (2000 µg as loading dose and 1000 µg at follow-up) for 6 mo. The second group (oral B-12) received daily doses of oral methylcobalamin (1000 µg). Serum vitamin B-12 was determined at baseline (T0) and at 2 (T1), 4 (T2), and 6 mo (T3) after start of treatment. Concentrations of the secondary markers methylmalonic acid (MMA) and homocysteine (Hcy) were measured at T0 and T3. Fifty patients were included and randomized, 27 in IM B-12 and 23 in oral B-12. The median vitamin B-12 concentration at T0 was 175 pmol/L (range: 114-196 pmol/L) for IM B-12 and 167 pmol/L (range: 129-199 pmol/L) for oral B-12. Vitamin B-12 normalized in all individuals, and there was no significant difference in vitamin B-12 between the two groups. MMA and Hcy concentrations decreased significantly after 6 mo within each group (P<0.001 and P<0.001 for MMA and P=0.03 and P=0.045 for Hcy, respectively). There was no significant difference between the groups at 6 mo for both MMA and Hcy (P=0.53 and P=0.79). The efficacy of oral vitamin B-12 supplementation was similar to that of hydroxocobalamin injections in the present study. Oral supplementation can be used as an alternative to hydroxocobalamin injections to treat RYGB patients with low values of serum vitamin B-12. This trial was registered at clinicaltrials.gov as NCT02270749.

Efficacy of oral methylcobalamin in treatment of vitamin B12 deficiency anemia in children.

To demonstrate the efficacy of oral methylcobalamin in treating vitamin B12 (vitB12) deficiency anemia, our prospective observational study enrolled 28 children with both macrocytic anemia and low holotranscobalamin (HoloTC) levels. Their hematological and biochemical parameters pre- and posttreatment at 1 month were compared. Hemoglobin showed mean increase of 2.89g/dl (P<0.001), rising above 10g/dl in 24 patients (85.7%). Reticulocytes peaked at 1 week. Mean fall in mean corpuscular volume of 24.83 fl (P<0.001) and mean improvement in platelets of 122,100/μl (P=0.001) were noted, and mean rise in HoloTC and vitB12 were 111.36pmol/l (P<0.001) and 918.34pg/ml (P<0.001), respectively. Thus, initial responses to oral methylcobalamin in children with vitB12 deficiency anemia were adequate.

Acupuncture combined with methylcobalamin for the treatment of chemotherapy-induced peripheral neuropathy in patients with multiple myeloma

BackgroundChemotherapy-induced peripheral neuropathy (CIPN) seriously affects the quality of life of patients with multiple myeloma (MM) as well as the response rate to chemotherapy. Acupuncture has a potential role in the treatment of CIPN, but at present there have been no randomized clinical research studies to analyze the effectiveness of acupuncture for the treatment of CIPN, particularly in MM patients.MethodsThe MM patients (104 individuals) who met the inclusion criteria were randomly assigned into a solely methylcobalamin therapy group (500 μg intramuscular methylcobalamin injections every other day for 20 days; ten injections) followed by 2 months of 500 μg oral methylcobalamin administration, three times per day) and an acupuncture combined with methylcobalamin (Met + Acu) group (methylcobalamin used the same way as above accompanied by three cycles of acupuncture). Of the patients, 98 out of 104 completed the treatment and follow-ups. There were 49 patients in each group. The evaluating parameters included the visual analogue scale (VAS) pain score, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire scores, and electromyographic (EMG) nerve conduction velocity (NCV) determinations. We evaluated the changes of the parameters in each group before and after the therapies and made a comparison between the two groups.ResultsAfter 84 days (three cycles) of therapy, the pain was significantly alleviated in both groups, with a significantly higher decrease in the acupuncture treated group (P < 0.01). The patients’ daily activity evaluated by Fact/GOG-Ntx questionnaires significantly improved in the Met + Acu group (P < 0.001). The NCV in the Met + Acu group improved significantly while amelioration in the control group was not observed.ConclusionsThe present study suggests that acupuncture combined with methylcobalamin in the treatment of CIPN showed a better outcome than methylcobalamin administration alone.Trial registrationChina Clinical Trials Register (registration no. ChiCTR-INR-16009079, registration date August 24, 2016).

Efficacy of Methylcobalamin to Normalise Elevated Homocysteine of Vitamin B12 Deficient Vegetarians: A Double Blind Placebo Control Study

Vegetarians are known to be deficient in vitamin B12, due to a lack of dietary animal products, which can elevate plasma total homocysteine (tHcy). Elevated total tHcy can render vegetarians susceptible to cardiovascular disease (CVD). There are a limited number of published studies in relation to the efficacy of methylcobalamin to normalise plasma tHcy of vitamin B12 deficient vegetarians. The primary objective of the present study was to explore the relationship between supplementary oral methylcobalamin and levels of tHcy of vitamin B12 deficient vegetarians; to reduce the risk of developing primary CVD. A randomised double blind placebo controlled pilot study was conducted to monitor and analyse baseline and post treatment levels of plasma tHcy, 49 volunteer vegetarians were recruited to participate in this study. Statistical analysis employing SPSS software indicated that methylcobalamin reduced mean baseline plasma tHcy of 15.5 µmolL-1 (n=39) to a mean plasma tHcy level of 8.4 µmolL-1 (P &lt; 0.001). In a second group that contained details of ten withdrawn participants, which was conducted on an ‘Intention to Treat’ (ITT) basis, indicated that methylcobalamin was shown to be reduced from a mean baseline plasma tHcy of 14.7 µmolL-1(n=49) to a mean plasma tHcy level of 9.1 µmolL-1 (P &lt; 0.001). The findings of the study have the potential to alert vegetarians of the possible risk of becoming vitamin B12 deficient, and to help avoid the risk of developing homocysteine related CVD. The quality data obtained in the study will allow an accurate sample size to be calculated for a future definite clinical study.

Oral α-lipoic acid combined with methylcobalamin in treatment of diabetic peripheral neuropathy

Objective To observe the clinical efficacy and safety of oral α-lipoic acid combined with methylcobalamin in treatment of diabetic peripheral neuropathy(DPN).MethodsSixty-four DPN patients were selected and randomly divided into experimental group(n=32) and control group(n=32).All the patients were given diet control,insulin or oral hypoglycaemic agent and the blood glucose was satisfactorily controlled;the original antihypertensive and antilipemic therapies were maintained.Meanwhile,patients in the control group were also given oral methylcobalamin(three times per day and each for 0.5 mg),and those in the experimental group were given oral α-lipoic acid(once a day and each for 600 mg) and oral methylcobalamin(three times per day and each for 0.5 mg).The total symptom scores(TSS) and the nerve conduction velocity(NCV) were evaluated in the two groups before and 12 weeks after treatment;and the adverse drug reactions were also observed.ResultsThe TSS and NCV were significantly improved in both groups after treatment compared with before treatment(P0.05). After treatment,TSS was significantly lower in the experimental group than in the control group(P0.05),and there were significant differences in the transmission velocities of the median motor nerve,nervus peroneus communis motor nerve and its sensory nerve between two groups(P0.05). No serious side effects were found in the two groups during the treatment.ConclusionOral α-lipoic acid combined with methylcobalamin on DPN is superior to methylcobalamin used alone for treatment of DPN,and the combined treatment is simple and has better patient compliance,making it worth popularizing.

A Single-Center Randomized Controlled Trial of Local Methylcobalamin Injection for Subacute Herpetic Neuralgia

This study explored the efficacy of local methylcobalamin injection in relieving pain and improving the quality of life among subjects with subacute herpetic neuralgia. A single-center, randomized controlled trial of local methylcobalamin injection was performed. Ninety-eight subjects (age, ≥ 50 years) with unilateral, dermatomal pain ≥ 4 related to herpes zoster on the torso lasting for 30 days after onset of rash were enrolled. Subjects were randomized to receive local methylcobalamin injection (N = 33), oral methylcobalamin (N = 33), or subcutaneous 1.0% lidocaine injection (N = 32) for 4 weeks. Worst pain severity, global impression of change, continuous spontaneous pain, paroxysmal pain, allodynia, paresthesia, interference with activities of daily living, and quality of life were assessed after 28-day treatment period. Time per group interaction and group difference on overall pain at each follow-up point were statistically significant (P < 0.001) among groups. In the injected methylcobalamin group, the overall pain (P < 0.001), continuous spontaneous pain (P < 0.05), paroxysmal pain (P < 0.05), and allodynia (P < 0.05) revealed a significant effect at each follow-up point as compared with the other groups. Twenty subjects achieved pain reduction ≥ 50%, 24 perceived worst pain ≤ 3, 24 stopped using analgesics at end point; activities of daily living and quality of life improved significantly as compared with the other groups (P < 0.001). Although both of the other groups showed a significant response after the 14-day treatment (P < 0.001) compared with the baseline, oral methylcobalamin did not provide any significantly pain relief (P > 0.05). Local methylcobalamin injection was not only efficacious in relieving pain, but also appears to be tolerable and a potential choice of treatment for subacute herpetic neuralgia.

A prospective, open label, 24-week trial of methylcobalamin in the treatment of diabetic polyneuropathy

Introduction: Vitamin B complex has been used for peripheral neuropathy for a long time and continues to be part of current practice despite lack of strong evidence for its use and its non-inclusion in treatment guidelines. Objective: To determine the clinical and neurophysiological effects of 1500 μgm/day of oral methylcobalamin among subjects with diabetic polyneuropathy. Methodology: We conducted a prospective, open-label study on adult diabetic subjects with polyneuropathy who were given 1500 μgm/day of oral methylcobalamin over 24-weeks. The primary outcome measure was the Toronto Clinical Scoring System (CSS) and secondary measures were Subjective Impression of Change, Clinicians Impression of Change and neurophysiological parameters. Results: Out of forty eight subjects, thirty seven completed treatment and twenty one agreed to have repeat neurophysiologic study post-treatment. At the end of treatment, there was a significant decline in the Toronto CSS score (p < 0.0001) indicating improvement. This was observed across all stages of severity and in any duration of diabetes whether more or less than 10 years. The symptoms that improved compared to baseline and that did not emerge over the course of 24 weeks were tingling (p < 0.03), upper limb symptoms (p < 0.003), ataxia (p < 0.004), and signs of impaired position (P < 0.009) sense, vibration sense (p < 0.0001), pinprick sensation (p < 0.004) and knee reflex (p < 0.004). No significant improvement was seen in the secondary outcomes (both p=0.06) except for ulnar nerve amplitude and distal latency. Conclusion: This 24-week open label study demonstrated that symptoms of diabetic polyneuropathy significantly improved among subjects given methylcobalamin 1500 μgm/day and new symptoms did not emerge over the 24 week observation period. Larger controlled trials are needed to corroborate these findings.