来自日本旭川医科大学泌尿外科的Seiji Matsumotoa等关于氢气水治疗膀胱炎的研究在线发表在Urology上，这是目前关于氢水临床研究第8种疾病的报道。去年我曾经对这一研究的临床注册信息介绍过。虽然本次研究的结果并没有显示氢气水对这一疾病具有治疗作用，但是结果显示出非常明显的对抗疼痛的效果(安慰剂对照组也出现疼痛的缓解作用,效果不如氢气水,但两组差别11%不具有统计学差异)。

 

 

实验设计

Effect of Supplementation With Hydrogen-rich Water in Patients With Interstitial.pdf

 

过去日本学者曾经报道过氢气在糖尿病、代谢综合征、类风湿关节炎、脑干缺血、皮肤红斑、肝癌放射治疗生活质量、血液透析不良作用等的临床研究。关于氢气相关的临床研究目前大部分都支持氢气具有一定治疗效果，但是这些临床研究的病例数量都比较少（没有超过100例的报道），而且有些缺乏非常严格的对照，不足以获得非常明确的有效性证据。因此，关于氢气的临床研究仍需要大规模多中心的双盲对照研究。至少从文字描述上分析，这一研究可能是目前设计上最具有可信度的研究。不过本次研究只有患者30名，其中治疗组20名，安慰剂组10名，而且有2名患者中途退出实验。因此观察的数量比较少，结论尚无法最终确认。

疼痛效应结果

间质性膀胱炎（IC Interstitial cystitis）一种慢性盆腔疼痛综合症，是一种导致膀胱和盆腔周围不适或疼痛的疾病，女性患者要多于男性，在美国估计有超过70万患者，90%为女性。正在研究的一种理论认为IC是继发于膀胱感染后的自身免疫反应。另一种理论认为细菌存在膀胱细胞内，但常规尿液检查不能发现。间质性膀胱炎患者的个体症状差异较大，即使在同一患者，也可出现不同的症状。患者可以有膀胱和盆腔周围的轻度不适、压迫感、压痛，或剧烈疼痛。症状可能包括急迫排尿（尿急），频繁排尿（尿频），或者这些同时存在。在膀胱充满尿液时这些症状会加重，也可能在空虚时加重。

目前还没有一种可治愈该疾病的方法，因此也不能预测谁将对那种治疗反应最好。没有扩张、或碰巧饮食改变、或经过治疗，症状都可能消失。尽管症状消失，但经过几天、几周、几年，症状也许又出现。因此这一疾病在研究上也非常困难，患者数量太少很难判断治疗效果。

许多人担心如果出现阴性结果，似乎难以发表论文，其实象这一明显“阴性”的研究仍可以在比较好的杂志上发表，而且对人们正确认识疾病规律，认识客观现象有很正面的帮助。相信这一研究仍会受到氢气分子医学研究的关注，建议发现阴性结果的研究仍进行大胆报道，特别是具有新意的重要资料和证据。

Effect of Supplementation With Hydrogen-rich Water in Patients With Interstitial Cystitis/Painful Bladder Syndrome

 

 Seiji Matsumotoa, , , Tomohiro Uedab, Hidehiro Kakizakia

a Department of Renal and Urologic Surgery, Asahikawa Medical University, Hokkaido, Japan

b Department of Urology, Kyoto City Hospital, Kyoto, Japan

Reprint requests: Seiji Matsumoto, M.D., Ph.D., Department of Renal and Urologic Surgery, Asahikawa Medical University, 2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido 078-8510 Japan.

Received 24 August 2012Accepted 15 October 2012Available online 30 January 2013

http://dx.doi.org/10.1016/j.urology.2012.10.026, How to Cite or Link Using DOIPermissions & Reprints

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Objective

To investigate the efficacy of hydrogen-rich water for the treatment of patients with interstitial cystitis/painful bladder syndrome (IC/PBS).

 

Methods

We conducted a prospective, randomized, double-blind, placebo-controlled clinical trial of hydrogen-rich water in patients with IC/PBS. Inclusion criteria were stable symptoms of IC/PBS for ≥12 weeks after bladder hydrodistension, Interstitial Cystitis Symptom Index score of ≥7 and bladder pain (question 4 on Interstitial Cystitis Symptom Index) of ≥4. They were randomized by a 2:1 ratio to receive hydrogen-rich water or placebo water for 8 weeks. The symptoms were assessed using the Interstitial Cystitis Symptom Index, Interstitial Cystitis Problem Index, Parsons’ Pelvic Pain and Urgency/Frequency Patient Symptom Scale, visual analog scale bladder pain scores, and a standard 3-day voiding diary. The primary outcome was improvement of patient-reported symptoms evaluated after treatment.

 

Results

A total of 30 participants (29 women and 1 man, age 64.0 ± 14.8 years) were enrolled in the present study, and 2 patients (both women) were withdrawn from the study. The score of bladder pain was significantly reduced in both groups. However, the effect of hydrogen-rich water on symptoms was not significantly different from that of placebo, although supplementation with hydrogen-rich water was extremely effective in improving the bladder pain score in 11% of the patients.

 

Conclusion

The results of the present study do not support the use of supplementation with hydrogen-rich water for treating patients with IC/PBS.

 

Patients with interstitial cystitis/painful bladder syndrome (IC/PBS) present with a constellation of symptoms, including bladder pain, frequency, and urgency. The proposed etiology for the symptoms of IC/PBS includes bladder ischemia and reperfusion injury. Previous reports showed pathologic findings of IC/PBS focusing on ischemia and a reduction in bladder capacity owing to fibrosis of the bladder wall.1, 2 and 3 Hyperbaric oxygen therapy has been reported to be effective in patients with IC/PBS resistant to conventional treatment.4 and 5 Oxidative stress due to free radicals, which are formed by reperfusion after bladder ischemia, can cause bladder damage. Reperfusion injury is more harmful than the damage caused by ischemia alone.6 Previous studies using an experimental cystitis animal model revealed that free radical-mediated tissue damage is also involved in the pathogenesis.7 and 8

 

Recently, several investigators have shown that hydrogen has potential as an antioxidant in preventive and therapeutic applications. Ohsawa et al9 reported that hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. These findings led us to consider the possibility that hydrogen-rich water might be useful as a therapeutic supplement for IC/PBS. We hypothesized that oxidative stress could be one of the causes of IC/PBS, because the disturbance of bladder blood flow has been suggested in IC/PBS. However, to our knowledge, no clinical data are available to prove the efficacy of hydrogen in patients with IC/PBS. In the present study, we assessed whether supplementation with hydrogen-rich water had beneficial effects on the symptoms in patients with IC/PBS.

Table 1. Summary of measured variables at baseline and after 8 weeks of hydrogen-rich water or placebo

	Hydrogen-rich Water			Placebo Water
Variable	Before	After	P Value	Before	After	P Value
Subjects randomized	18			10
Sex
Male	0			1
Female	18			9
Age (y)	65.2 ± 7.9			64.5 ± 4.5
VAS (0-10)	6.0 (1.9)	4.9 (2.8)	.186	6.3 (1.5)	5.1 (2.4)	.182
24-h Voiding frequency	13.0 (3.9)	14.3 (5.4)	.402	13.1 (3.6)	12.5 (4.2)	.736
Voiding volume	124.0 (36.4)	138.7 (54.0)	.346	142.3 (27.3)	160.6 (48.7)	.313
ICSI (0-20)	13.2 (3.3)	11.4 (5.0)	.217	13.3 (2.0)	11.2 (3.8)	.141
Pain score (Q4; ICSI, 0-5)	4.3 (0.5)	3.1 (1.3)	.001∗	4.4 (0.5)	3.2 (1.3)	.047∗
ICPI (0-12)	10.1 (3.3)	9.4 (3.4)	.448	10.3 (2.6)	9.6 (3.2)	.595
PUF total score (0-33)	18.4 (4.1)	16.7 (5.8)	.298	19.4 (5.2)	15.9 (5.7)	.168
PUF symptom score (0-21)	12.4 (2.5)	11.6 (3.9)	.480	12.1 (2.8)	10.2 (3.2)	.177
PUF problem score (0-12)	6.1 (1.9)	5.0 (2.3)	.163	7.3 (2.6)	5.7 (2.8)	.203
Urgency score: Q8a in PUF (0-3)	1.7 (0.7)	1.7 (0.7)	.986	1.9 (0.7)	1.6 (1.0)	.493

ICPI, Interstitial Cystitis Problem Index; ICSI, Interstitial Cystitis Symptom Index; PUF, Pelvic Pain and Urgency/Frequency; VAS, visual analog scale.

∗P <.05. Full-size table

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