Clinical effects of Garcinia kola in knee osteoarthritis.

Clinical effects of Garcinia kola in knee osteoarthritis.
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DOI:
10.1186/1749-799x-3-34
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发表时间:
2008-07-30
影响因子:
2.6
通讯作者:
Iwalewa, Ezekiel O
Iwalewa, Ezekiel O
中科院分区:
医学3区
文献类型:
--
作者:
Adegbehingbe, Olayinka O;Adesanya, Saburi A;Iwalewa, Ezekiel O

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目的:近年来,越来越多的膝骨性关节炎(KOA)患者不愿接受长期的非类固醇抗炎药(NSAID)治疗,而希望使用中草药抗风湿药物。方法和方法:采用前瞻性随机、安慰剂对照、双盲、机构医学伦理审查委员会批准的临床试验,并获得每个患者的书面知情同意。所有出现在Obafemi Awolowo大学教学医院综合体的膝关节骨性关节炎患者都被招募到研究中。患者被分成4组(A=安慰剂,B=萘普生,C=藤黄,D=塞来布司)。这些药物和安慰剂每天服用两次,每次口服。每个剂量包括200毫克的葛根素、500毫克的萘普生、200毫克的塞来布雷克斯和100毫克的抗坏血酸。在六周的研究期间,主要的结果测量是平均WOMAC疼痛视觉模拟评分(VAS)的变化。次要观察指标包括关节僵硬和身体功能(活动/行走)的平均变化。结果:143名患者中84名(58.7%,男性24名,女性60名)符合选择标准并完成了研究。在受试者中,膝关节骨关节炎的双侧性对他们的预后没有显著影响(p>0.05)。与安慰剂相比,服用G.kola六周后平均WOMAC疼痛VAS的变化显著减少(p<0.001)。多重比较葛根素组的平均VAS疼痛变化与萘普生组和塞来布雷克组比较,差异无统计学意义(p>0.05)。柯拉症状性疼痛缓解的起效时间比安慰剂更快(p<0.001)。然而,它比主动比较器慢(p>0.05)。藤黄的疗效持续时间长于安慰剂(p>0.001)。葛根素的起效时间短于萘普生和塞来昔布(p<0.001)。六周后,G.Kola受试者的平均变化活动度/步行能力改善优于对照组(p<0.001)。与活跃的对照组相比,G-kola组的平均活动度变化并不明显(p<0.05)。与安慰剂相比,服用可口可乐的患者膝关节僵硬的平均变化(p<0.001)和WOMAC评分的平均变化(p<0.001)均有所改善。11名卡氏藤黄受试者在停止使用后的中期结果显示,平均疼痛缓解期为17.27±5.15天(范围:9-26天)。结论:藤黄对膝骨性关节炎患者有明显的镇痛抗炎作用。藤黄是一种潜在的骨关节炎疾病活性修饰物,具有良好的中期疗效。需要进一步的研究来标准化剂量并确定长期效果。
OBJECTIVES: Over the past years, there has been a growing number of knee osteoarthritis (KOA) patients who are not willing to comply with long-term non-steroidal anti-inflammatory drugs (NSAID) treatment and wish to use herbal anti- rheumatic medicine. This study assessed the clinical effects of Garcinia kola (GK) in KOA patients.PATIENTS AND METHODS: Prospective randomized, placebo controlled, double blind, clinical trial approved by the institutional medical ethics review board and written informed consent obtained from each patient. All KOA patients presenting at the Obafemi Awolowo University Teaching Hospital complex were recruited into the study. The patients were grouped into four (A = Placebo, B = Naproxen, C = Garcinia kola, D = Celebrex). The drugs and placebo were given twice a day per oral route. Each dose consisted of 200 mg of G. kola, Naproxen (500 mg), Celebrex (200 mg) and Ascorbic acid (100 mg). The primary outcome measure over six weeks study period was the change in mean WOMAC pain visual analogue scales (VAS). Secondary outcome measures included the mean change in joint stiffness and physical function (mobility/walking).RESULTS: 143 patients were recruited, 84 (58.7%, males--24, females--60) satisfied the selection criteria and completed the study. The effect of knee osteoarthritis bilateralism among the subjects was not significant on their outcome (p > 0.05). The change in the mean WOMAC pain VAS after six weeks of G. kola was significantly reduced compared to the placebo (p < 0.001). Multiple comparisons of the mean VAS pain change of G. kola group was not lowered significantly against the naproxen and celebrex groups (p > 0.05). The onset of G. kola symptomatic pain relief was faster than the placebo (p < 0.001). However, it was slower than the active comparators (p > 0.05). The duration of therapeutic effect of Garcinia kola was longer than the placebo (p > 0.001). G. kola period of effect was less than naproxen and celebrex (p < 0.001). G. kola subjects had improved mean change mobility/walking after six weeks better than the control group(p < 0.001). The mean change in mobility of the G. kola group when compared to the active comparators was not significantly better (p < 0.05). The mean change of knee joint stiffness (p < 0.001) and the change of mean WOMAC score (p < 0.001) were improved on Garcinia kola as compared to the placebo. The mid term outcome of eleven Garcinia kola subjects after cessation of use had a mean pain relief period of 17.27 +/- 5.15 days (range: 9-26 days). There was no significant cardiovascular, renal or drug induced adverse reaction to Garcinia kola.CONCLUSION: Garcinia kola appeared to have clinically significant analgesic/anti-inflammatory effects in knee osteoarthritis patients. Garcinia kola is a potential osteoarthritis disease activity modifier with good mid term outcome. Further studies are required for standardization of dosages and to determine long-term effects.