Randomized, double-blind, placebo-controlled study of the safety and efficacy of vitamin B complex in the treatment of nocturnal leg cramps in elderly patients with hypertension.

Abstract

Nocturnal leg cramps is a common and troublesome problem in elderly individuals, and their etiology is unknown. Treatment with quinine is a common practice, but the effectiveness of the drug is doubtful and adverse drug effects are common. This randomized, double-blind, placebo-controlled study was conducted to evaluate the safety and efficacy of vitamin B complex capsules (fursulthiamine 50 mg, hydroxocobalamin 250 micrograms, pyridoxal phosphate 30 mg, and riboflavin 5 mg) in 28 elderly patients with hypertension who had severe nocturnal leg cramps that disturbed their sleep. Self-reported ratings of leg cramp frequency, duration, and intensity were used to evaluate severity of nocturnal leg cramps. Both the patients taking vitamin B capsules (n = 14) and those taking placebo (n = 14) received medications three times daily, and were examined regularly at 2-week intervals for 3 months. After 3 months, 86% of the patients taking vitamin B had prominent remission of leg cramps, whereas those taking placebo had no significant difference from baseline. Treatment with vitamin B complex significantly reduced the frequency, intensity, and duration of nocturnal leg cramps. Because quinine is not without potential for side effects, and vitamin B complex is a relatively safe and effective alternative, clinicians should reconsider the treatment of choice for nocturnal leg cramps.

• Authors: P Chan, T Y Huang, Y J Chen, W P Huang, Y C Liu
• Journal: Journal of clinical pharmacology (J Clin Pharmacol) Vol. 38 Issue 12 Pg. 1151-4 (Dec 1998) ISSN: 0091-2700 [Print] England
• PMID: 11301568 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Vitamin B Complex
• Quinine

Topics

• Aged
• Double-Blind Method
• Female
• Humans
• Hypertension (drug therapy)
• Male
• Quinine (therapeutic use)
• Sleep-Wake Transition Disorders (drug therapy)
• Vitamin B Complex (adverse effects, therapeutic use)