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Topical glyceryl trinitrate for rotator cuff disease

  • Review
  • Intervention

Authors

  • Miranda Cumpston,

    1. Monash University, Monash Institute of Health Services Research, Clayton, Victoria, Australia
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  • Renea V Johnston,

    1. Department of Epidemiology and Preventive Medicine, Monash University, Monash Department of Clinical Epidemiology at Cabrini Hospital, Malvern, Victoria, Australia
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  • Lainie Wengier,

    1. Department of Epidemiology and Preventive Medicine, Monash University, Monash Department of Clinical Epidemiology at Cabrini Hospital, Malvern, Victoria, Australia
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  • Rachelle Buchbinder

    Corresponding author
    1. Department of Epidemiology and Preventive Medicine, Monash University, Monash Department of Clinical Epidemiology at Cabrini Hospital, Malvern, Victoria, Australia
    • Rachelle Buchbinder, Monash Department of Clinical Epidemiology at Cabrini Hospital, Department of Epidemiology and Preventive Medicine, Monash University, Suite 41, Cabrini Medical Centre, 183 Wattletree Road, Malvern, Victoria, 3144, Australia. rachelle.buchbinder@med.monash.edu.au.

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Abstract

Background

Rotator cuff disease is a common cause of shoulder pain. Topical glyceryl trinitrate is a possible new treatment.

Objectives

To determine the effectiveness and safety of topical glyceryl trinitrate for rotator cuff disease.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, SPORTDiscus, PEDro, the Australian Clinical Trials Registry, Current Controlled Trials (to October 2007) and the references and citations of included studies.

Selection criteria

We included randomised controlled trials and controlled clinical trials of people with rotator cuff disease who received topical glyceryl trinitrate, alone or in combination, compared to placebo or active therapy.

Data collection and analysis

Two authors independently assessed risk of bias and extracted data.

Main results

Three small studies, one at moderate risk of bias and two at high risk of bias, were included. Meta-analysis was precluded due to different interventions and outcome measures. Study participants also had differing durations of symptoms and data for pain and function could only be extracted from one study. One placebo-controlled trial (20 participants) tested 5 mg glyceryl trinitrate patches, used daily for three days, among participants with 'acute supraspinatus tendinitis' of less than seven days duration. Treatment resulted in reduced pain intensity (adjusted MD -3.50, 95% CI -3.96 to -3.04). Function was not measured. One trial (53 participants) compared one quarter of a 5 mg glyceryl trinitrate patch used daily for up to 24 weeks combined with rehabilitation to placebo patches and rehabilitation among participants with 'supraspinatus tendinopathy' for longer than six months. A third trial (48 participants) tested 5 mg glyceryl trinitrate patches, used daily for three days, compared to corticosteroid injection among participants with 'rotator cuff tendinitis' of less than six-weeks duration. Fifteen out of 24 participants in the glyceryl trinitrate treatment reported headache (RR 0.11, 95% CI 0.01 to 1.96).

Authors' conclusions

There is some evidence from one study at high risk of bias that topical glyceryl trinitrate is more effective than placebo for rotator cuff disease among patients with acute symptoms (< seven-days duration), but there is insufficient evidence to be certain about their longer-term effects. Headache was a common side effect in one trial and any benefits of treatment need to be balanced against the risk of headache. Further high quality research is needed to determine the effectiveness and safety of this new therapy.

摘要

背景

局部三硝酸甘油治療旋轉肌疾病之效果

旋轉肌疾病是肩部疼痛原因之一,用局部三硝酸甘油治療是新可能治療法之一。

目標

旋轉肌疾病是肩部疼痛原因之一,此研究是探討用局部三硝酸甘油治療旋轉肌疼痛之效果及安全性。

搜尋策略

搜尋包括Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, SPORTDiscus, PEDro, the Australian Clinical Trials Registry, Current Controlled Trials (to October 2007)。同時手動搜尋所選文章之參考文獻。

選擇標準

選入三硝酸甘油比上安慰劑或其它處置,治療旋轉肌疾病之隨機對照試驗或對照控制試驗研究。

資料收集與分析

兩位作者獨立進行資料摘錄,並評估偏差風險。

主要結論

3個研究,包括1篇中度偏差風險及2篇高度偏差風險研究包含分析中。因不同處置及結果,參加者症狀長短不一,且疼痛及功能僅有1篇可摘錄,而無法作統合分析。1篇對照控制試驗(20位急性上旋轉肌肌腱炎小於7天患者),每日使用5 mg三硝酸甘油貼布共3天,結果減少疼痛強度 (調整之平均差異 −3.50, 95% CI −3.96 to −3.04),未測功能。1篇試驗(53位旋轉肌肌腱炎大於6個月患者),每日使用四分之一片5 mg三硝酸甘油貼布合併復健共24週。第三篇研究(48位旋轉肌肌腱炎小於6週患者)每日使用5 mg三硝酸甘油貼布共3天,比上類固醇注射效果。24位使用5 mg硝酸甘油中15位有頭痛現象 (RR 0.11, 95% CI 0.01 to 1.96)。

作者結論

1篇高度偏差風險研究顯示,急性旋轉肌肌腱炎小於7天患者,每日使用5 mg三硝酸甘油貼布比安慰劑有效,但長期效果未知。頭痛為常見副作用,需列入風險考量。此外需高品質研究決定其療效。

翻譯人

本摘要由林口長庚醫院余光輝翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

此Cochrane review摘要了我們所知道有關硝酸甘油貼片治療旋轉肌疾病之效果。疼痛,三硝酸甘油貼片(5毫克/天)可輕微改善疼痛。硝酸甘油片(1.25毫克/天)合併復健指導(例如運動)和三硝酸甘油貼片(5毫克/日)相比於注射皮質類固醇和止痛藥,在被納入本回顧的試驗中,對於疼痛的效果是未經報告的。旋轉肌疾病症狀由於非常低品質的證據,目前尚不能確定是否三硝酸甘油片(5毫克/天)可消除RCD症狀。相比於單用復健,三硝酸甘油(1.25毫克/天)合併復健指導(例如運動)可能沒有更多的可能用以消除症狀。相比於注射皮質類固醇和止痛藥,三硝酸甘油片(5毫克/日)的效果無法在這次回顧中確定。身體功能在被納入本回顧的試驗中,病患的身體功能的改善都沒有被測量。副作用─因為是非常低品質的證據,不確定是否外用三硝酸甘油(5毫克/天)會有副作用,如頭痛。相比於單用復健,三硝酸甘油(1.25毫克/天)合併復健指導(例如運動)可能沒有更容易引起頭痛或皮疹。什麼是旋轉肌疾病和三硝酸甘油是什麼?旋轉肌是一組環繞肩關節的肌腱。在一些人移動他們肩膀時,肌肉和肌腱會一遍又一遍的夾住肩膀。這樣的夾住可能導致旋轉肌膨脹,破裂,它可能會導致遠離骨的旋轉肌撕裂這被稱為旋轉肌疾病或肌腱炎。在很多人,這是一種正常老化的一部分,他們可能沒有症狀。但是,許多人的旋轉肌疾病會使肩膀疼痛,可能在一段時間內不會消失。外用硝酸甘油(又稱nitroglycerin 或nitroglycerine)已被用於治療胸痛多年,並已提出有希望用來治療肌肉和肌腱損傷。用在治療軟組織情況,硝酸甘油會被調成局部使用,通過皮膚,使用藥布方式。

Plain language summary

Glyceryl trinitrate patches for rotator cuff disease

This summary of a Cochrane review presents what we know from research about the effect of glyceryl trinitrate patches on rotator cuff disease (RCD).

Pain

- glyceryl trinitrate patches (5 mg/day) may improve pain slightly.
- the effects of glyceryl trinitrate patches (1.25 mg/day) along with rehabilitation instruction (such as exercise) and glyceryl trinitrate patches (5 mg/day) compared to injection with corticosteroid and painkillers on pain were not reported by the studies included in the review.

Symptoms of RCD

- it is uncertain whether glyceryl trinitrate patches (5 mg/day) eliminate symptoms of RCD because of the very low quality of the evidence.
- glyceryl trinitrate (1.25 mg/day) along with rehabilitation instruction (such as exercise) may be no more likely to eliminate symptoms than rehabilitation instruction alone.
- the effect of glyceryl trinitrate patches (5 mg/day) compared to injection with corticosteroid and painkillers could not be determined in this review.

Physical Function
- improvement in peoples’ physical function was not measured by any of the studies included in the review.

Side Effects

- it is uncertain whether topical glyceryl trinitrate (5 mg/day) has side effects such as headache because of the very low quality of the evidence.
- glyceryl trinitrate (1.25 mg/day) along with rehabilitation instruction (such as exercise) may be no more likely to cause headache or rash than rehabilitation instruction alone.

What is rotator cuff disease and what is glyceryl trinitrate?

The rotator cuff is a group of tendons that surrounds the shoulder joint. In some people, the muscles and tendons pinch when they move their shoulder over and over again. The pinching can cause the rotator cuff to swell, break down and it may tear away from the bone - this is called rotator cuff disease or tendonitis. In a lot of people, it is a normal part of ageing and they may not have symptoms. But many people with rotator cuff disease do have pain in their shoulder at some time that may not go away on its own.

Topical glyceryl trinitrate (also called nitroglycerin or nitroglycerine) has been used to treat chest pain for many years, and has been proposed as a promising treatment for muscle and tendon injuries. For treatment of soft tissue conditions glyceryl trinitrate is delivered topically, through the skin, using medicated patches.