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Effectiveness of low-dose doxycycline (LDD) on clinical symptoms of Sjögren's syndrome: a randomized, double-blind, placebo controlled cross-over study.

Seitsalo H, Niemelä RK, Marinescu-Gava M, Vuotila T, Tjäderhane L, Salo T - J Negat Results Biomed (2007)

Bottom Line: The effect was evaluated for each medication and washout period separately.The differences may, however, reflect normal fluctuation of symptoms in SS patients.LDD may not be useful in reducing the primary SS symptoms.

View Article: PubMed Central - HTML - PubMed

Affiliation: Institute of Dentistry, University of Helsinki, and Department of Oral and Maxillofacial Diseases, Helsinki University Central Hospital (HUCH), PO BOX 14, 00014 University of Helsinki, Finland. hseitsalo@medone.fi

ABSTRACT

Background: Matrix metalloproteinases (MMPs) are proteolytic enzymes that may contribute to tissue destruction in Sjögren's syndrome (SS). Low-dose doxycycline (LDD) inhibits MMPs. We evaluated the efficacy of LDD for the subjective symptoms in primary SS patients. This was a randomized, double blind, placebo controlled cross-over study. 22 patients were randomly assigned to receive either 20 mg LDD or matching placebo twice a day for 10 weeks. The first medication period was followed by 10-week washout period, after which the patient received either LDD or placebo, depending on the first drug received, followed by the second washout period. Stimulated saliva flow rates and pH were measured before and after one and ten weeks of each medication and after washout periods. VAS scale was used to assess the effect of LDD and placebo on following six subjective symptoms: xerostomia; xerophtalmia; difficulty of swallowing; myalgia; arthralgia; and fatigue. The effect was evaluated for each medication and washout period separately.

Results: Overall, the effects of medications on subjective symptoms were minor. Wilcoxon test demonstrated increased fatigue with LDD during medication (p < 0.05). The differences may, however, reflect normal fluctuation of symptoms in SS patients.

Conclusion: LDD may not be useful in reducing the primary SS symptoms.

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Related in: MedlinePlus

The outline of the study protocol and time-table. After each medication period or washout period the VAS score sheets were collected and new sheets for the subsequent period were provided for the patient. Post-experimental interview was performed to evaluate whether the patients had felt overall subjective alleviation of symptoms during the medication.
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Figure 4: The outline of the study protocol and time-table. After each medication period or washout period the VAS score sheets were collected and new sheets for the subsequent period were provided for the patient. Post-experimental interview was performed to evaluate whether the patients had felt overall subjective alleviation of symptoms during the medication.

Mentions: At the onset of the study, the patients underwent a thorough oral and dental examination as a part of normal dental treatment. One of the patients had gingivitis. Some patients had a few secondary caries lesions or primary cervical caries lesions. The normal dental treatment was provided at the onset of the study according to the need. The patients were randomly assigned to receive either low-dose doxycycline (20 mg doxycycline; Periostat®; further referred as LDD) or matching placebo (both from CollaGenex Pharmaceuticals, Inc. Newtown, PA, USA) twice a day for a period of 10 weeks (Medication 1; see Figure 4). The first medication period was followed by 10-week washout period (Washout 1; Figure 4), after which the patient received either LDD or placebo, depending on the first drug received (Medication 2; Figure 4), followed by the second washout period. Stimulated and unstimulated saliva was collected, and flow rate and pH were measured at the onset and after one and 10 weeks of each medication period, as well as after 10-week washout periods.


Effectiveness of low-dose doxycycline (LDD) on clinical symptoms of Sjögren's syndrome: a randomized, double-blind, placebo controlled cross-over study.

Seitsalo H, Niemelä RK, Marinescu-Gava M, Vuotila T, Tjäderhane L, Salo T - J Negat Results Biomed (2007)

The outline of the study protocol and time-table. After each medication period or washout period the VAS score sheets were collected and new sheets for the subsequent period were provided for the patient. Post-experimental interview was performed to evaluate whether the patients had felt overall subjective alleviation of symptoms during the medication.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2235889&req=5

Figure 4: The outline of the study protocol and time-table. After each medication period or washout period the VAS score sheets were collected and new sheets for the subsequent period were provided for the patient. Post-experimental interview was performed to evaluate whether the patients had felt overall subjective alleviation of symptoms during the medication.
Mentions: At the onset of the study, the patients underwent a thorough oral and dental examination as a part of normal dental treatment. One of the patients had gingivitis. Some patients had a few secondary caries lesions or primary cervical caries lesions. The normal dental treatment was provided at the onset of the study according to the need. The patients were randomly assigned to receive either low-dose doxycycline (20 mg doxycycline; Periostat®; further referred as LDD) or matching placebo (both from CollaGenex Pharmaceuticals, Inc. Newtown, PA, USA) twice a day for a period of 10 weeks (Medication 1; see Figure 4). The first medication period was followed by 10-week washout period (Washout 1; Figure 4), after which the patient received either LDD or placebo, depending on the first drug received (Medication 2; Figure 4), followed by the second washout period. Stimulated and unstimulated saliva was collected, and flow rate and pH were measured at the onset and after one and 10 weeks of each medication period, as well as after 10-week washout periods.

Bottom Line: The effect was evaluated for each medication and washout period separately.The differences may, however, reflect normal fluctuation of symptoms in SS patients.LDD may not be useful in reducing the primary SS symptoms.

View Article: PubMed Central - HTML - PubMed

Affiliation: Institute of Dentistry, University of Helsinki, and Department of Oral and Maxillofacial Diseases, Helsinki University Central Hospital (HUCH), PO BOX 14, 00014 University of Helsinki, Finland. hseitsalo@medone.fi

ABSTRACT

Background: Matrix metalloproteinases (MMPs) are proteolytic enzymes that may contribute to tissue destruction in Sjögren's syndrome (SS). Low-dose doxycycline (LDD) inhibits MMPs. We evaluated the efficacy of LDD for the subjective symptoms in primary SS patients. This was a randomized, double blind, placebo controlled cross-over study. 22 patients were randomly assigned to receive either 20 mg LDD or matching placebo twice a day for 10 weeks. The first medication period was followed by 10-week washout period, after which the patient received either LDD or placebo, depending on the first drug received, followed by the second washout period. Stimulated saliva flow rates and pH were measured before and after one and ten weeks of each medication and after washout periods. VAS scale was used to assess the effect of LDD and placebo on following six subjective symptoms: xerostomia; xerophtalmia; difficulty of swallowing; myalgia; arthralgia; and fatigue. The effect was evaluated for each medication and washout period separately.

Results: Overall, the effects of medications on subjective symptoms were minor. Wilcoxon test demonstrated increased fatigue with LDD during medication (p < 0.05). The differences may, however, reflect normal fluctuation of symptoms in SS patients.

Conclusion: LDD may not be useful in reducing the primary SS symptoms.

Show MeSH
Related in: MedlinePlus